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OBJECTIVE The objective of this paper is to review the available literature regarding the use of cannabis and cannabinoids in adult oncologic pain management . DESIGN AND DATA SOURCES A integrative review was conducted on March 1 , 2018 using PubMed , MEDLINE , CINAHL , Embase , and Scopus . A snowball method was used to extract studies included in systematic review s that were not included in the primary literature search . REVIEW METHOD Articles review ed address the use of cannabinoids or cannabis for pain management in oncology patients , either as st and - alone or adjuvant therapy . RESULTS The final number of articles included is nine articles . Of the nine studies review ed , eight review ed the effect of the cannabinoid THC on cancer pain , and one study review ed the use of medicinally available whole plant cannabis . The following study types were included : multiple multi-center , r and omized , placebo- controlled trials and two prospect i ve observational survey studies . RESULTS AND CONCLUSIONS Of the eight studies that review ed the effect of the cannabinoid THC , five found THC to be more effective than placebo , one found THC to be more effective than placebo in American patients but ineffective in patients from other countries , and two found THC to be no more effective than placebo . The study that review ed the effect of the whole plant cannabis found that there was a significant decrease in pain among those patients smoking cannabis . NURSING PRACTICE IMPLICATION S The lack of evidence in this field of research suggests a need to change policy surrounding cannabis research
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"A preliminary trial of oral delta-9-tetrahydrocannabinol ( THC ) demonstrated an analgesic effect of the drug in patients experiencing cancer pain . Placebo and 5 , 10 , 15 , and 20 mg THC were administered double blind to ten patients . Pain relief significantly superior to placebo was demonstrated at high dose levels ( 15 and 20 mg ) . At these levels , substantial sedation and mental clouding were reported",
"The administration of single oral doses of delta‐9‐tetrahydrocannabinol ( THC ) to patients with cancer pain demonstrated a mild analgesic effect . At a dose of 20 mg , however , THC induced side effects that would prohibit its therapeutic use including somnolence , dizziness , ataxia , and blurred vision . Alarming adverse reactions were also observed at this dose . THC , 10 mg , was well tolerated and , despite its sedative effect , may have analgesic potential",
"OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences",
"UNLABELLED Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge . Nabiximols ( Nabiximols is the U.S. Adopted Name [ USAN ] for Sativex [ GW Pharma Ltd , Wiltshire , U.K. ] , which does not yet have an INN ) , a novel cannabinoid formulation , is undergoing investigation as add-on therapy for this population . In a r and omized , double-blind , placebo-controlled , grade d-dose study , patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose ( 1 - 4 sprays/day ) , medium dose ( 6 - 10 sprays/day ) , or high dose ( 11 - 16 sprays/day ) . Average pain , worst pain and sleep disruption were measured daily during 5 weeks of treatment ; other question naires measured quality of life and mood . A total of 360 patients were r and omized ; 263 completed . There were no baseline differences across groups . The 30 % responder rate primary analysis was not significant for nabiximols versus placebo ( overall P = .59 ) . A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall ( P = .035 ) , and specifically in the low-dose ( P = .008 ) and medium-dose ( P = .039 ) groups . In the low-dose group , results were similar for mean average pain ( P = .006 ) , mean worst pain ( P = .011 ) , and mean sleep disruption ( P = .003 ) . Other question naires showed no significant group differences . Adverse events were dose-related and only the high-dose group compared unfavorably with placebo . This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials . PERSPECTIVE Nabiximols , a novel cannabinoid formulation , may be a useful add-on analgesic for patients with opioid-refractory cancer pain . A r and omized , double-blind , placebo-controlled , grade d-dose study demonstrated efficacy and safety at low and medium doses",
"Two consecutive , r and omized , double‐blind trials were performed to test the analgesic properties of a synthetic nitrogen analog of tetrahydrocannabinol ( NIB ) . In the first trial , the test preparation was superior to placebo and approximately equivalent to 50 mg of codeine phosphate . In the second study , the tetrahydrocannabinol analog was superior to placebo and to 50 mg secobarbital . NIB is not useful clinical ly because of the frequency of side effects",
"CONTEXT Chronic pain in patients with advanced cancer poses a serious clinical challenge . The Δ9-tetrahydrocannabinol (THC)/cannabidiol ( CBD ) oromucosal spray ( U.S. Adopted Name , nabiximols ; Sativex ( ® ) ) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group . OBJECTIVES This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer . METHODS In total , 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing , who had participated in a previous three-arm ( THC/CBD spray , THC spray , or placebo ) , two-week parent r and omized controlled trial , entered this open-label , multicenter , follow-up study . Patients self-titrated THC/CBD spray ( n=39 ) or THC spray ( n=4 ) to symptom relief or maximum dose and were regularly review ed for safety , tolerability , and evidence of clinical benefit . RESULTS The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for \" pain severity \" and \" worst pain \" domains showed a decrease ( i.e. , improvement ) at each visit in the THC/CBD spray patients . Similarly , the European Organization for Research and Treatment of Cancer Quality of Life Question naire-C30 scores showed a decrease ( i.e. , improvement ) from baseline in the domains of insomnia , pain , and fatigue . No new safety concerns associated with the extended use of THC/CBD spray arose from this study . CONCLUSION This study showed that the long-term use of THC/CBD spray was generally well tolerated , with no evidence of a loss of effect for the relief of cancer-related pain with long-term use . Furthermore , patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time , suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit",
"CONTEXT Neuropathic pain caused by chemotherapy limits dosing and duration of potentially life-saving anti-cancer treatment and impairs quality of life . Chemotherapeutic neuropathy responds poorly to conventional treatments , and there is an urgent medical need for new treatments . Recent pre clinical studies demonstrate that cannabinoid agonists suppress established chemotherapy-evoked neuropathy . OBJECTIVES This was a pilot trial to begin to investigate a currently available cannabinoid agent , nabiximols ( oral mucosal spray containing cannabinoids ) , in the treatment of chemotherapy-induced neuropathic pain . METHODS A r and omized , placebo-controlled crossover pilot study was done in 16 patients with established chemotherapy-induced neuropathic pain . A 0 - 10 point numeric rating scale for pain intensity ( NRS-PI ) was used as the primary outcome measure . RESULTS When examining the whole group , there was no statistically significant difference between the treatment and the placebo groups on the NRS-PI . A responder analysis demonstrated that there were five participants who reported a two-point or greater reduction in pain that trended toward statistical significance and the number needed to treat was five . CONCLUSION Chemotherapy-induced neuropathic pain is particularly resistant to currently available treatments . This pilot trial found a number needed to treat of five and an average decrease of 2.6 on an 11-point NRS-PI in five \" responders \" ( as compared with a decrease of 0.6 with placebo ) and supports that it is worthwhile to study nabiximols in a full r and omized , placebo-controlled trial of chemotherapy-induced neuropathic pain",
"Background : Opioids are critical for managing cancer pain , but may provide inadequate relief and /or unacceptable side effects in some cases . Objective : To assess the analgesic efficacy of adjunctive Sativex ( Δ9-tetrahydrocannabinol ( 27 mg/mL ) : cannabidiol ( 25 mg/mL ) ) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy . Methods : This report describes two phase 3 , double-blind , r and omized , placebo-controlled trials . Eligible patients had advanced cancer and average pain numerical rating scale ( NRS ) scores ≥4 and ≤8 at baseline , despite optimized opioid therapy . In Study -1 , patients were r and omized to Sativex or placebo , and then self-titrated study medications over a 2-week period per effect and tolerability , followed by a 3-week treatment period . In Study -2 , all patients self-titrated Sativex over a 2-week period . Patients with a ≥15 % improvement from baseline in pain score were then r and omized 1:1 to Sativex or placebo , followed by 5-week treatment period ( r and omized withdrawal design ) . Results : The primary efficacy endpoint ( percent improvement ( Study -1 ) and mean change ( Study -2 ) in average daily pain NRS scores ) was not met in either study . Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients ( median treatment difference : 8.8 ; 95 % confidence interval ( CI ) : 0.00–17.95 ; p = 0.040 ) that was not observed in patients ( median treatment difference : 0.2 ; 95 % CI : −5.00 to 7.74 ; p = 0.794 ) . Treatment effect in favour of Sativex was observed on quality -of-life question naires , despite the fact that similar effects were not observed on NRS score . The safety profile of Sativex was consistent with earlier studies , and no evidence of abuse or misuse was identified . Conclusions : Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy , although further exploration of differences between United States and patients from the rest of the world is warranted"
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4116402a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Although the link between cannabis use and development of psychosis is well established , less is known about the effect of continued versus discontinued cannabis use after the onset of psychosis . We aim ed to summarise available evidence focusing on the relationship between continued and discontinued cannabis use after onset of psychosis and its relapse . METHODS In this systematic review and meta- analysis , we search ed MEDLINE for articles published in any language from the data base inception date up until April 21 , 2015 that included a sample of patients with a pre-existing psychotic disorder with a follow-up duration of at least 6 months . We used a combination of search terms for describing cannabis , the outcome of interest ( relapse of psychosis ) , and the study population . We excluded studies if continued cannabis use or discontinued cannabis use could not be established . We compared relapse outcomes between those who continued ( CC ) or discontinued ( DC ) cannabis use or were non-users ( NC ) . We used summary data ( individual patient data were not sought out ) to estimate Cohen 's d , which was entered into r and om effects models ( REM ) to compare CC with NC , CC with DC , and DC with NC . Meta-regression and sensitivity analyses were used to address the issue of heterogeneity . FINDINGS Of 1903 citations identified , 24 studies ( 16 565 participants ) met the inclusion criteria . Independent of the stage of illness , continued cannabis users had a greater increase in relapse of psychosis than did both non-users ( dCC-NC=0·36 , 95 % CI 0·22 - 0·50 , p well as longer hospital admissions than non-users ( dCC-NC=0·36 , 0·13 to 0·58 , p=0·02 ) . By contrast , cannabis discontinuation was not associated with relapse ( dDC-NC=0·02 , -0·12 to 0·15 ; p=0·82 ) . Meta-regression suggested greater effects of continued cannabis use than discontinued use on relapse ( dCC-NC=0·36 vs dDC-NC=0·02 , p=0·04 ) , positive symptoms ( dCC-NC=0·15 vs dDC-NC=-0·30 , p=0·05 ) and level of functioning ( dCC-NC=0·04 vs dDC-NC=-0·49 , p=0·008 ) but not on negative symptoms ( dCC-NC=-0·09 vs dDC-NC=-0·31 , p=0·41 ) . INTERPRETATION Continued cannabis use after onset of psychosis predicts adverse outcome , including higher relapse rates , longer hospital admissions , and more severe positive symptoms than for individuals who discontinue cannabis use and those who are non-users . These findings point to reductions in cannabis use as a crucial interventional target to improve outcome in patients with psychosis . FUNDING UK National Institute of Health Research
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"OBJECTIVE We sought to examine the relation between cannabis abuse and the symptomatic course of recent-onset schizophrenia and related disorders . DESIGN A prospect i ve cohort study over a year using monthly Brief Psychiatric Rating Scale assessment s. PARTICIPANTS Cannabis-abusing patients ( n = 24 ) were compared with nonabusers ( n = 69 ) . Eleven patients were mild and 13 were heavy cannabis-abusing patients . RESULTS Significantly more and earlier psychotic relapses occurred in the cannabis-abusing group ( P = .03 ) . This association became stronger when mild and heavy cannabis abuse were distinguished ( P = .002 ) . No confounding effect of other variables , eg , other street drugs , was found . In all but one patient , cannabis abuse preceded the onset of the first psychotic symptoms for at least 1 year . CONCLUSIONS Cannabis abuse and particularly heavy abuse can be considered a stressor eliciting relapse in patients with schizophrenia and related disorders and possibly a premorbid precipitant",
"BACKGROUND Cannabis use is a major problem in inner cities and has been causally implicated in psychosis . Very few of the available hospital-based studies of the implication s of cannabis usage have involved psychiatric intensive care units ( PICU ) ; but PICU receive many of the most challenging and re source -hungry- and incompletely understood- patients in the mental health system . AIMS To study the clinical impact of cannabis abuse in a PICU , and to compare the use of atypical and typical antipsychotics in this setting . METHOD 115 patients admitted to a PICU consented to take part in an open label naturalistic study . BPRS , TCI-240 , weight , length of admission and routine bloods were evaluated in all participants . RESULTS There was a high rate of cannabis abuse ( 71.3 % ) in the PICU population . Patients who abused cannabis spent longer in PICU because their psychoses were more severe . They were younger at first hospital admission . Cannabis also had metabolic implication s , with higher blood glucose levels at admission and greater weight increase . Atypical antipsychotics were effective in treating psychosis in patients positive to cannabis at admission . CONCLUSION Our findings suggest that cannabis abusers had a more severe psychotic illness , especially in schizophrenia . There are additional complications in terms of weight gain for cannabis users",
"OBJECTIVE Relapse is a frequently used outcome measure in schizophrenia research . However , difficulties in reliably measuring relapse diminish its usefulness . Hospitalization is a potential alternative , but its relationship to relapse has not been assessed . METHODS This study used data from a two-year , prospect i ve study to examine associations between relapse and hospitalization in a cohort of 200 Canadian patients with first-episode psychosis . First , the relationship between relapse and hospitalization was assessed by cross-tabulating relapse and hospitalization . Next , survival curves of time to first relapse or hospitalization were compared . Finally , to examine the convergent validity of relapse and hospitalization , the predictive capacity of three predictors were examined : a substance use disorder diagnosis , prior hospitalization , and medication adherence . RESULTS Rates of both relapse and hospitalization were similar . During the two-year follow-up , 37 % of the patients experienced a relapse , and 26 % were hospitalized . As an indicator of relapse , hospitalization had a low sensitivity ( 47 % ) and high specificity ( 87 % ) . A higher risk of hospitalization and relapse was associated with prior hospitalization , a substance use disorder diagnosis , and medication nonadherence . CONCLUSIONS Results indicated that relapse and hospitalization are separate but related outcome measures . They had similar frequencies and were found to have similar relationships with some predictors . Relapse is a more useful outcome measure in smaller clinical studies in which routine st and ardized clinical measures can be used . Hospitalization is more relevant in larger studies or as a quality indicator for studies using administrative data bases , and it serves as a good measure for quality management in health systems",
"Objective To determine whether use of cannabis in adolescence increases the risk for psychotic outcomes by affecting the incidence and persistence of sub clinical expression of psychosis in the general population ( that is , expression of psychosis below the level required for a clinical diagnosis ) . Design Analysis of data from a prospect i ve population based cohort study in Germany ( early developmental stages of psychopathology study ) . Setting Population based cohort study in Germany . Participants 1923 individuals from the general population , aged 14 - 24 at baseline . Main outcome measure Incidence and persistence of subthreshold psychotic symptoms after use of cannabis in adolescence . Cannabis use and psychotic symptoms were assessed at three time points ( baseline , T2 ( 3.5 years ) , T3 ( 8.4 years ) ) over a 10 year follow-up period with the Munich version of the composite international diagnostic interview ( M-CIDI ) . Results In individuals who had no reported lifetime psychotic symptoms and no reported lifetime cannabis use at baseline , incident cannabis use over the period from baseline to T2 increased the risk of later incident psychotic symptoms over the period from T2 to T3 ( adjusted odds ratio 1.9 , 95 % confidence interval 1.1 to 3.1 ; P=0.021 ) . Furthermore , continued use of cannabis increased the risk of persistent psychotic symptoms over the period from T2 to T3 ( 2.2 , 1.2 to 4.2 ; P=0.016 ) . The incidence rate of psychotic symptoms over the period from baseline to T2 was 31 % ( 152 ) in exposed individuals versus 20 % ( 284 ) in non-exposed individuals ; over the period from T2 to T3 these rates were 14 % ( 108 ) and 8 % ( 49 ) , respectively . Conclusion Cannabis use is a risk factor for the development of incident psychotic symptoms . Continued cannabis use might increase the risk for psychotic disorder by impacting on the persistence of symptoms",
"BACKGROUND Cannabis use has been identified as a potent predictor of the earlier onset of psychosis , but meta- analysis has not indicated that it has a clear effect in established psychosis . AIM To assess the association between cannabis and outcomes , including whether change in cannabis use affects symptoms and functioning , in a large sample of people with established nonaffective psychosis and comorbid substance misuse . METHODS One hundred and sixty participants whose substance use included cannabis were compared with other substance users ( n = 167 ) on baseline demographic , clinical , and substance use variables . The cannabis using subgroup was examined prospect ively with repeated measures of substance use and psychopathology at baseline , 12 months , and 24 months . We used generalized estimating equation models to estimate the effects of cannabis dose on subsequent clinical outcomes and whether change in cannabis use was associated with change in outcomes . RESULTS Cannabis users showed cross-sectional differences from other substances users but not in terms of positive symptoms . Second , cannabis dose was not associated with subsequent severity of positive symptoms and change in cannabis dose did not predict change in positive symptom severity , even when patients became abstinent . However , greater cannabis exposure was associated with worse functioning , albeit with a small effect size . CONCLUSIONS We did not find evidence of an association between cannabis dose and psychotic symptoms , although greater cannabis dose was associated with worse psychosocial functioning , albeit with small effect size . It would seem that within this population , not everyone will demonstrate durable symptomatic improvements from reducing cannabis",
" All 533 patients in the acute and subacute psychiatric wards of a VA psychiatric facility were evaluated by nursing staff for substance abuse history and for illicit drug use . Eighteen percent had a history of either drug or combined drug and alcohol problems , 40 % had a history of alcohol abuse , and only 42 % had no substance abuse problems . Fifty-six of the patients with a history of drug problems ( 58 % ) were illicitly using drugs in the hospital . They were compared with a group of 64 r and omly chosen patients with no substance abuse history . Drug users were much younger and tended to be black ; they had more re-admissions , even though their original hospital admission was much more recent . Eighty-three percent of both groups had a primary diagnosis of schizophrenia , but drug users were more likely to be diagnosed paranoid schizophrenic . The groups did not differ significantly in treatment status and progress , except that drug users were more likely to exhibit marked mood changes . Half of the drug users were taking drugs three or more times weekly . Marijuana use was by far the most common substance observed . Ten consequences of drug use occurred in at least one-third of the users on a regular basis , the most common effects being negative attitudes toward treatment , cliquishness , secretiveness , and a need for greater supervision . The treatment problems and effects of drug use were much more serious for about half of the drug users than for the others",
"CONTEXT Cannabis sativa use can impair verbal learning , provoke acute psychosis , and increase the risk of schizophrenia . It is unclear where C. sativa acts in the human brain to modulate verbal learning and to induce psychotic symptoms . OBJECTIVES To investigate the effects of 2 main psychoactive constituents of C. sativa , Delta9-tetrahydrocannabinol ( Delta9-THC ) and cannabidiol , on regional brain function during verbal paired associate learning . DESIGN Subjects were studied on 3 separate occasions using a block design functional magnetic resonance imaging paradigm while performing a verbal paired associate learning task . Each imaging session was preceded by the ingestion of Delta9-THC ( 10 mg ) , cannabidiol ( 600 mg ) , or placebo in a double-blind , r and omized , placebo-controlled , repeated- measures , within-subject design . SETTING University research center . PARTICIPANTS Fifteen healthy , native English-speaking , right-h and ed men of white race/ethnicity who had used C. sativa 15 times or less and had minimal exposure to other illicit drugs in their lifetime . MAIN OUTCOME MEASURES Regional brain activation ( blood oxygen level-dependent response ) , performance in a verbal learning task , and objective and subjective ratings of psychotic symptoms , anxiety , intoxication , and sedation . RESULTS Delta9-Tetrahydrocannabinol increased psychotic symptoms and levels of anxiety , intoxication , and sedation , whereas no significant effect was noted on these parameters following administration of cannabidiol . Performance in the verbal learning task was not significantly modulated by either drug . Administration of Delta9-THC augmented activation in the parahippocampal gyrus during blocks 2 and 3 such that the normal linear decrement in activation across repeated encoding blocks was no longer evident . Delta9-Tetrahydrocannabinol also attenuated the normal time-dependent change in ventrostriatal activation during retrieval of word pairs , which was directly correlated with concurrently induced psychotic symptoms . In contrast , administration of cannabidiol had no such effect . CONCLUSION The modulation of mediotemporal and ventrostriatal function by Delta9-THC may underlie the effects of C. sativa on verbal learning and psychotic symptoms , respectively",
"BACKGROUND There are inconsistencies in findings as to whether cannabis use has a negative impact on clinical outcomes for people with established psychosis . Effects may be more evident on patients with recent onset psychosis . AIM To investigate the relationship between cannabis use and clinical outcome , including whether change in cannabis use affects psychotic symptoms , affective symptoms , functioning and psychotic relapse in a sample of people in early psychosis with comorbid cannabis abuse or dependence . METHODS One hundred and ten participants were examined prospect ively with repeated measures of substance use antecedent to psychopathology at baseline , 4.5 , 9 , and 18 months . We used r and om intercept models to estimate the effects of cannabis dose on subsequent clinical outcomes and whether change in cannabis use was associated with change in outcomes . RESULTS There was no evidence of a specific association between cannabis use and positive symptoms , or negative symptoms , relapse or hospital admissions . However , a greater dose of cannabis was associated with subsequent higher depression and anxiety . Change in the amount of cannabis used was associated with statistically significant corresponding change in anxiety scores , but not depression . Additionally , reductions in cannabis exposure were related to improved patient functioning . CONCLUSIONS Reducing cannabis may be directly associated with improvements in anxiety and functioning , but not other specific symptoms",
"It has long been known that acute marijuana administration impairs working memory ( e.g. , the discrimination of stimuli separated by a delay ) . The determination of which of the individual components of memory are altered by marijuana is an unresolved problem . Previous human studies did not use test protocol s that allowed for the determination of delay-independent ( initial discrimination ) from delay-dependent ( forgetting or retrieval ) components of memory . Using methods developed in the experimental analysis of behavior and signal detection theory , we tested the acute effects of smoked marijuana on forgetting functions in 5 humans . Immediately after smoking placebo , a low dose , or a high dose of marijuana ( varying in delta9-THC content ) , subjects completed delayed match-to- sample testing that included a range of retention intervals within each test session ( 0.5 , 4 , 12 , and 24 s ) . Performances ( discriminability ) at each dose were plotted as forgetting functions , as described and developed by White and colleagues ( White , 1985 ; White & Ruske , 2002 ) . For all 5 subjects , both delta9-THC doses impaired delay-dependent discrimination but not delay-independent discrimination . The outcome is consistent with current nonhuman studies examining the role of the cannabinoid system on delayed matching procedures , and the data help illuminate one behavioral mechanism through which marijuana alters memory performance",
"BACKGROUND Well- design ed prospect i ve studies of substance misuse in first-episode psychosis can improve our underst and ing of the risks associated with comorbid substance misuse and psychosis . AIMS To examine the potential effects of substance misuse on in-patient admission and remission and relapse of positive symptoms in first-episode psychosis . METHOD The study was a prospect i ve 15-month follow-up investigation of 103 patients with first-episode psychosis recruited from three mental health services . RESULTS Substance misuse was independently associated with increased risk of in-patient admission , relapse of positive symptoms and shorter time to relapse of positive symptoms after controlling for potential confounding factors . Substance misuse was not associated with remission or time to remission of positive symptoms . Heavy substance misuse was associated with increased risk of in-patient admission , relapse and shorter time to relapse . CONCLUSIONS Substance misuse is an independent risk factor for a problematic recovery from first-episode psychosis",
"BACKGROUND The aim was to examine the temporal relationships over 10 months between cannabis use and symptoms of psychosis and depression in people with schizophrenia and related disorders . The design was a prospect i ve study of 101 patients with schizophrenia and related disorders who were assessed monthly over 10 months on medication compliance , cannabis and other drug use , symptoms of depression and symptoms of psychosis . METHOD Linear regression methods to assess relationships between cannabis use and symptoms of psychosis and depression while adjusting for serial dependence , medication compliance and other demographic and clinical variables . RESULTS Cannabis use predicted a small but statistically significant increase in symptoms of psychosis , but not depression , after controlling for other differences between cannabis users and non-users . Symptoms of depression and psychosis did not predict cannabis use . CONCLUSION Continued cannabis use by persons with schizophrenia predicts a small increase in psychotic symptom severity but not vice versa",
"Cognitive impairment and cannabis use are common among patients with schizophrenia . However , the moderating role of cannabis on cognition remains unclear . We sought to examine cognitive performance as a function of cannabis use patterns in schizophrenia . A secondary aim was to determine the effects of cumulative cannabis exposure on cognition . Cognition was assessed in male out patients with current cannabis dependence ( n=18 ) and no current cannabis use disorders ( n=29 ) . We then parsed non-current users into patients with lifetime cannabis dependence ( n=21 ) and no lifetime cannabis dependence ( n=8 ) . Finally , as an exploratory analysis , we examined relationships between cumulative cannabis exposure and cognition in lifetime dependent patients . Cross-sectional comparisons suggest that lifetime cannabis users demonstrate better processing speed than patients with no lifetime dependence . Exploratory analyses indicated that patients with current dependence exhibited robust negative relationships between cumulative cannabis exposure and cognition ; these associations were absent in former users . Cannabis status has minimal effects on cognition in males with schizophrenia . However , cumulative cannabis exposure significantly impairs cognition in current , but not former users , suggesting that the state dependent negative effects of cannabis may be reversed with sustained abstinence . Prospect i ve studies are needed to confirm these findings",
"OBJECTIVE Cannabis use has been found to increase the risk of psychosis . It is unclear whether , after a first psychotic episode has occurred , continued cannabis use is associated with poor functional outcome of psychosis . METHOD As part of a r and omized , open-label , controlled trial , the association of cannabis use and measures for psychopathology and social role functioning after 2 years of follow-up and for the recently proposed outcome measures of symptomatic remission , functional remission , and clinical recovery was explored in a group of 124 patients suffering from nonaffective first-episode psychosis ( diagnosed according to DSM-IV and included from a catchment area in the Netherl and s of 3.1 million inhabitants from October 2001 through December 2002 ) . Other patient characteristics that were expected to be independently associated with outcome , among them alcohol and other drug use , were assessed at baseline . RESULTS Continued cannabis use was not associated with symptomatic or functional remission or clinical recovery . After 2 years , cannabis use was related to certain aspects of social role functioning ( economic and social activities ; explained variance 5.6 % and 8.4 % , respectively ) but not to psychopathology ( Positive and Negative Syndrome Scale Positive , Negative , or General symptoms ) . CONCLUSIONS Our findings support the notion that continued cannabis use after the onset of a first-episode psychosis is correlated with worse social outcome and should be discouraged whenever possible , but its role in outcome is modest in comparison to other factors . TRIAL REGISTRATION Nederl and s Trial Register : http://www.trialregister.nl ( ID : NTR 374 )",
"BACKGROUND Prospect i ve studies on the relationship between course of cannabis use and clinical outcome in patients with non-affective psychotic disorders are inconclusive . The current study examined whether ( 1 ) persistent , recently started , discontinued and non-cannabis-using patients with a psychotic disorder differed with regard to illness outcome at 3-year follow-up , and ( 2 ) whether timing of cannabis discontinuation was associated with course of clinical outcome . METHOD This 3-year follow-up study was part of a multi-center study in the Netherl and s and Belgium ( Genetic Risk and Outcome of Psychosis ; GROUP ) . We used mixed-model analyses to investigate the association between pattern of cannabis use and symptoms , global functioning and psychotic relapse . RESULTS In our sample of 678 patients , we found persistent users to have more positive and general symptoms , worse global functioning and more psychotic relapses compared with non-users and discontinued users [ Positive and Negative Syndrome Scale ( PANSS ) positive , p PANSS general , p Global Assessment of Functioning ( GAF ) symptoms , p = 0.017 ; GAF disability , p relapses , p = 0.038 ] . Patients who started using cannabis after study onset were characterized by worse functioning at baseline and showed an increase in general symptoms ( including depression and anxiety ) at the 3-year follow-up ( p = 0.005 ) . Timing of cannabis discontinuation was not associated with clinical outcome . CONCLUSIONS These findings suggest that cannabis use in patients with a psychotic disorder has a long-lasting negative effect on illness outcome , particularly when persistent . Treatment should focus on discouraging cannabis use",
"BACKGROUND Findings on the impact of cannabis use on the course of schizophrenia are inconsistent and not conclusive . AIMS To study the effect of cannabis use on the course of schizophrenia taking into account the effects of the quantity of cannabis use and important confounders . METHODS Prospect i ve cohort study with assessment s of symptoms , confounders and hospitalizations at baseline , 6 month and 12 month follow up . RESULTS In a representative cohort of 145 male patients with schizophrenia , 68 ( 46.9 % ) used cannabis . Mean age at onset of schizophrenia in cannabis using patients was significantly lower than in non-cannabis using patients . No other cross-sectional demographic or clinical differences were observed between users and non-users . In a series of longitudinal analyses , cannabis use was not associated with differences in psychopathology , but relapse in terms of the number of hospitalizations was significantly higher in cannabis using patients compared to non-cannabis using patients . CONCLUSIONS Patients with schizophrenia using cannabis are more frequently hospitalized than non-cannabis using patients but do not differ with respect to psychopathology . Possible explanations for these findings are discussed",
"BACKGROUND Recent advances in the neurobiology of cannabinoids have renewed interest in the association between cannabis and psychotic disorders . METHODS In a 3-day , double-blind , r and omized , placebo-controlled study , the behavioral , cognitive , motor , and endocrine effects of 0 mg , 2.5 mg , and 5 mg intravenous Delta-9-tetrahydrocannabinol ( Delta-9-THC ) were characterized in 13 stable , antipsychotic-treated schizophrenia patients . These data were compared with effects in healthy subjects reported elsewhere . RESULTS Delta-9-tetrahydrocannabinol transiently increased 1 ) learning and recall deficits ; 2 ) positive , negative , and general schizophrenia symptoms ; 3 ) perceptual alterations ; 4 ) akathisia , rigidity , and dyskinesia ; 5 ) deficits in vigilance ; and 6 ) plasma prolactin and cortisol . Schizophrenia patients were more vulnerable to Delta-9-THC effects on recall relative to control subjects . There were no serious short- or long-term adverse events associated with study participation . CONCLUSIONS Delta-9-tetrahydrocannabinol is associated with transient exacerbation in core psychotic and cognitive deficits in schizophrenia . These data do not provide a reason to explain why schizophrenia patients use or misuse cannabis . Furthermore , Delta-9-THC might differentially affect schizophrenia patients relative to control subjects . Finally , the enhanced sensitivity to the cognitive effects of Delta-9-THC warrants further study into whether brain cannabinoid receptor dysfunction contributes to the pathophysiology of the cognitive deficits associated with schizophrenia"
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41164066-06ff-11f0-808a-c43d1ab1c353
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Upper extremity motor performance declines with increasing age . However , older adults need to maintain , learn new and relearn known motor tasks . Research with young adults indicated that regular and acute physical activity might facilitate motor performance and motor learning processes . Therefore , this review aim ed to examine the association between chronic physical activity and acute bouts of exercise on motor performance and motor learning in upper extremity motor tasks in older adults . Literature was search ed via Cochrane library , PubMED , PsycINFO and Scopus and 27 studies met all inclusion criteria . All studies dealt with the influence of chronic physical activity on motor performance or motor learning , no appropriate study examining the influence of an acute bout of exercise in older adults was found . Results concerning the association of chronic physical activity and motor performance are mixed and seem to be influenced by the study design , kind of exercise , motor task , and exercise intensity . Regarding motor learning , a high physical activity or cardiovascular fitness level seems to boost the initial phase of motor learning ; results differ with respect to motor retention . Overall , ( motor-coordinative ) intervention studies seem to be more promising than cross-sectional studies
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"The current study examined how a r and omized one-year aerobic exercise program for healthy older adults would affect serum levels of brain-derived neurotrophic factor ( BDNF ) , insulin-like growth factor type 1 ( IGF-1 ) , and vascular endothelial growth factor ( VEGF ) - putative markers of exercise-induced benefits on brain function . The study also examined whether ( a ) change in the concentration of these growth factors was associated with alterations in functional connectivity following exercise , and ( b ) the extent to which pre-intervention growth factor levels were associated with training-related changes in functional connectivity . In 65 participants ( mean age=66.4 ) , we found that although there were no group-level changes in growth factors as a function of the intervention , increased temporal lobe connectivity between the bilateral parahippocampus and the bilateral middle temporal gyrus was associated with increased BDNF , IGF-1 , and VEGF for an aerobic walking group but not for a non-aerobic control group , and greater pre-intervention VEGF was associated with greater training-related increases in this functional connection . Results are consistent with animal models of exercise and the brain , but are the first to show in humans that exercise-induced increases in temporal lobe functional connectivity are associated with changes in growth factors and may be augmented by greater baseline VEGF",
"Past studies have shown that electroencephalographic alpha activity increases as people learn to perform a novel motor task . Additionally , it has been suggested that motor performance and learning decline as people age beyond 60 years , and it has been hypothesized that physical fitness may attenuate this decline through its impact on the cerebral environment . This study was design ed to replicate past research by assessing changes in alpha activity as a function of learning and to extend past research by examining differences in motor performance , motor learning , and alpha activity as a function of age and fitness . VO2max was assessed in 41 older ( ages 60 - 80 years ) and 42 younger ( ages 20 - 30 years ) participants . Participants were r and omly assigned to experimental or control conditions , which differed in the amount of practice received . Participants performed trials on the mirror star trace on both an acquisition and a retention day . Results indicated that younger participants performed better and had greater learning than older participants . Fitness was not found to impact either performance or learning . Participants in the experimental group improved more than those in the control group and maintained this difference at retention , which suggests that learning occurred . Associated with these improvements in performance capabilities was an increase in alpha power",
"Implicit motor sequence learning refers to an important human ability to acquire new motor skills through the repeated performance of a motor sequence . This learning process is characterized by slow , incremental gains of motor performance . The present fMRI study was developed to better delineate the areas supporting these temporal dynamics of learning . By using the serial color matching paradigm , our study focused on the motor level of sequence learning and tracked the time course of learning-related neural changes . Imaging results showed a significant contribution of the left anterior hippocampus in an early sequence acquisition stage ( first scanning session ) as well as during a later stage with stabilized learning effects ( second scanning session ) . Hippocampal activation significantly correlated with the behavioral learning process and was affected by a change of the motor sequence . These results suggest a strong involvement of the hippocampus in implicit motor sequence learning . On the other h and , a very extensive and bilateral neural network of parietal , temporal and frontal cortical areas ( including SMA , pre-SMA ) together with parts of the cerebellum and striatum were found to play a role during r and om visuo-motor task performance",
"The Lifestyle Interventions and Independence for Elders ( LIFE ) Study is a Phase III r and omized controlled clinical trial ( Clinical trials.gov identifier : NCT01072500 ) that will provide definitive evidence regarding the effect of physical activity ( PA ) on major mobility disability in older adults ( 70–89 years old ) who have compromised physical function . This paper describes the methods employed in the delivery of the LIFE Study PA intervention , providing insight into how we promoted adherence and monitored the fidelity of treatment . Data are presented on participants ’ motives and self-perceptions at the onset of the trial along with accelerometry data on patterns of PA during exercise training . Prior to the onset of training , 31.4 % of participants noted slight conflict with being able to meet the dem and s of the program and 6.4 % indicated that the degree of conflict would be moderate . Accelerometry data collected during PA training revealed that the average intensity – 1,555 counts/minute for men and 1,237 counts/minute for women – was well below the cutoff point used to classify exercise as being of moderate intensity or higher for adults . Also , a sizable subgroup required one or more rest stops . These data illustrate that it is not feasible to have a single exercise prescription for older adults with compromised function . Moreover , the concept of what constitutes “ moderate ” exercise or an appropriate volume of work is dictated by the physical capacities of each individual and the level of comfort/stability in actually executing a specific prescription",
"Background : Falls in the elderly are a major health problem . Although exercise programs have been shown to reduce the risk of falls , the optimal exercise components , as well as the working mechanisms that underlie the effectiveness of these programs , have not yet been established . Objective : To test whether the Nijmegen Falls Prevention Program was effective in reducing falls and improving st and ing balance , balance confidence , and obstacle avoidance performance in community-dwelling elderly people . Methods : A total of 113 elderly with a history of falls participated in this study ( exercise group , n = 79 ; control group , n = 28 ; dropouts before r and omization , n = 6 ) . Exercise sessions were held twice weekly for 5 weeks . Pre- and post-intervention fall monitoring and quantitative motor control assessment s were performed . The outcome measures were the number of falls , st and ing balance and obstacle avoidance performance , and balance confidence scores . Results : The number of falls in the exercise group decreased by 46 % ( incidence rate ratio ( IRR ) 0.54 , 95 % confidence interval ( CI ) 0.36–0.79 ) compared to the number of falls during the baseline period and by 46 % ( IRR 0.54 , 95 % CI 0.34–0.86 ) compared to the control group . Obstacle avoidance success rates improved significantly more in the exercise group ( on average 12 % ) compared to the control group ( on average 6 % ) . Quiet stance and weight-shifting measures did not show significant effects of exercise . The exercise group also had a 6 % increase of balance confidence scores . Conclusion : The Nijmegen Falls Prevention Program was effective in reducing the incidence of falls in otherwise healthy elderly . There was no evidence of improved control of posture as a mechanism underlying this result . In contrast , an obstacle avoidance task indicated that subjects improved their performance . Laboratory obstacle avoidance tests may therefore be better instruments to evaluate future fall prevention studies than posturographic balance assessment",
"We have recently shown that a single bout of acute cardiovascular exercise improves motor skill learning through an optimization of long-term motor memory . Here we exp and this previous finding , to explore potential exercise-related biomarkers and their association with measures of motor memory and skill acquisition . Thirty-two healthy young male subjects were r and omly allocated into either an exercise or control group . Following either an intense bout of cycling or rest subjects practice d a visuomotor tracking task . Motor skill acquisition was assessed during practice and retention 1 h , 24 h and 7 days after practice . Plasma levels of brain-derived neurotrophic factor ( BDNF ) , vascular endothelial growth factor ( VEGF ) , insulin-like growth factor ( IGF-1 ) , epinephrine , norepinephrine , dopamine and lactate were analyzed at baseline , immediately after exercise or rest and during motor practice . The exercise group showed significantly better skill retention 24h and 7 days after acquisition . The concentration of all blood compounds increased significantly immediately after exercise and remained significantly elevated for 15 min following exercise except for BDNF and VEGF . Higher concentrations of norepinephrine and lactate immediately after exercise were associated with better acquisition . Higher concentrations of BDNF correlated with better retention 1 h and 7 days after practice . Similarly , higher concentrations of norepinephrine were associated with better retention 7 days after practice whereas lactate correlated with better retention 1h as well as 24 h and 7 days after practice . Thus , improvements in motor skill acquisition and retention induced by acute cardiovascular exercise are associated with increased concentrations of biomarkers involved in memory and learning processes . More mechanistic studies are required to eluci date the specific role of each biomarker in the formation of motor memory",
"Regular physical activity has a positive impact on cognition and brain function . Here we investigated if a single bout of exercise can improve motor memory and motor skill learning . We also explored if the timing of the exercise bout in relation to the timing of practice has any impact on the acquisition and retention of a motor skill . Forty-eight young subjects were r and omly allocated into three groups , which practice d a visuomotor accuracy-tracking task either before or after a bout of intense cycling or after rest . Motor skill acquisition was assessed during practice and retention was measured 1 hour , 24 hours and 7 days after practice . Differences among groups in the rate of motor skill acquisition were not significant . In contrast , both exercise groups showed a significantly better retention of the motor skill 24 hours and 7 days after practice . Furthermore , compared to the subjects that exercised before practice , the subjects that exercised after practice showed a better retention of the motor skill 7 days after practice . These findings indicate that one bout of intense exercise performed immediately before or after practicing a motor task is sufficient to improve the long-term retention of a motor skill . The positive effects of acute exercise on motor memory are maximized when exercise is performed immediately after practice , during the early stages of memory consolidation . Thus , the timing of exercise in relation to practice is possibly an important factor regulating the effects of acute exercise on long-term motor memory",
"BACKGROUND The Short Physical Performance Battery ( SPPB ) , which includes walking , balance , and chair st and s tests , independently predicts mobility disability and activities of daily living disability . To date , however , there is no definitive evidence from r and omized controlled trials that SPPB scores can be improved . Our objective was to assess the effect of a comprehensive physical activity ( PA ) intervention on the SPPB and other physical performance measures . METHODS A total of 424 sedentary persons at risk for disability ( ages 70 - 89 years ) were r and omized to a moderate-intensity PA intervention or a successful aging ( SA ) health education intervention and were followed for an average of 1.2 years . RESULTS The mean baseline SPPB score on a scale of 0 - 12 , with 12 corresponding to highest performance , was 7.5 . At 6 and 12 months , the PA versus SA group adjusted SPPB ( + /- st and ard error ) scores were 8.7 + /- 0.1 versus 8.0 + /- 0.1 , and 8.5 + /- 0.1 versus 7.9 + /- 0.2 , respectively ( p 400-meter walking speed was also significantly improved in the PA group . The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk ( hazard ratio = 0.71 , 95 % confidence interval = 0.44 - 1.20 ) . CONCLUSIONS A structured PA intervention improved the SPPB score and other measures of physical performance . An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes , such as mobility disability",
"From animal research , it is known that combining physical activity with sensory enrichment has stronger and longer-lasting effects on the brain than either treatment alone . For humans dancing has been suggested to be analogous to such combined training . Here we assessed whether a newly design ed dance training program that stresses the constant learning of new movement patterns is superior in terms of neuroplasticity to conventional fitness activities with repetitive exercises and whether extending the training duration has additional benefits . Twenty-two healthy seniors ( 63–80 years ) who had been r and omly assigned to either a dance or a sport group completed the entire 18-month study . MRI , BDNF and neuropsychological tests were performed at baseline and after 6 and 18 months of intervention . After 6 months , we found a significant increase in gray matter volume in the left pre central gyrus in the dancers compared to controls . This neuroplasticity effect may have been mediated by the increased BDNF plasma levels observed in the dancers . Regarding cognitive measures , both groups showed significant improvements in attention after 6 months and in verbal memory after 18 months . In addition , volume increases in the parahippocampal region were observed in the dancers after 18 months . The results of our study suggest that participating in a long-term dance program that requires constant cognitive and motor learning is superior to engaging in repetitive physical exercises in inducing neuroplasticity in the brains of seniors . Therefore , dance is highly promising in its potential to counteract age-related gray matter decline ",
"OBJECTIVES To examine whether 12 months of aerobic training ( AT ) moderated the relationship between change in mobility and change in basal ganglia volume than balance and toning ( BAT ) exercises in older adults . DESIGN Secondary analysis of a r and omized controlled trial . SETTING Champaign-Urbana , Illinois . PARTICIPANTS Community-dwelling older adults ( N=101 ; mean age 66.4 ) . INTERVENTION Twelve-month exercise trial with two groups : AT and BAT . MEASUREMENTS Mobility was assessed using the Timed Up and Go test . Basal ganglia ( putamen , cau date nucleus , pallidum ) was segmented from T1-weighted magnetic resonance images using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain Software Library Integrated Registration and Segmentation Tool . Measurements were obtained at baseline and trial completion . Hierarchical multiple regression was conducted to examine whether exercise mode moderates the relationship between change in mobility and change in basal ganglia volume over 12 months . Age , sex , and education were included as covariates . RESULTS Exercise significantly moderated the relationship between change in mobility and change in left putamen volume . Specifically , for the AT group , volume of the left putamen did not change , regardless of change in mobility . Similarly , in the BAT group , those who improved their mobility most over 12 months had no change in left putamen volume , although left putamen volume of those who declined in mobility levels decreased significantly . CONCLUSION The primary finding that older adults who engaged in 12 months of BAT training and improved mobility exhibited maintenance of brain volume in an important region responsible for motor control provides compelling evidence that such exercises can contribute to the promotion of functional independence and healthy aging",
"Cardiovascular activity has been shown to be positively associated with gray and white matter volume of , amongst others , frontal and temporal brain regions in older adults . This is particularly true for the hippocampus , a brain structure that plays an important role in learning and memory , and whose decline has been related to the development of Alzheimer ’s disease . In the current study , we were interested in whether not only cardiovascular activity but also other types of physical activity , i.e. , coordination training , were also positively associated with the volume of the hippocampus in older adults . For this purpose we first collected cross-sectional data on “ metabolic fitness ” ( cardiovascular fitness and muscular strength ) and “ motor fitness ” ( e.g. , balance , movement speed , fine coordination ) . Second , we performed a 12-month r and omized controlled trial . Results revealed that motor fitness but not metabolic fitness was associated with hippocampal volume . After the 12-month intervention period , both , cardiovascular and coordination training led to increases in hippocampal volume . Our findings suggest that a high motor fitness level as well as different types of physical activity were beneficial to diminish age-related hippocampal volume shrinkage or even increase hippocampal volume",
"BACKGROUND AND PURPOSE Although much is known about the benefits of aerobic exercise on cardiovascular health , little research has been done on the effect of aerobic exercise on motor performance . This study examined whether aerobic exercise has an effect on visuospatial information processing during finger-movement tracking in elderly subjects . SUBJECTS Fifteen elderly subjects ( mean age=83.2 years , SD=5.7 , range=72 - 91 ) from a senior housing complex were r and omly assigned to a control group or an experimental ( exercise ) group . Twelve subjects completed the study , and data obtained for 10 subjects were used for data analysis ( 2 control subjects were eliminated to allow for matched-pairs analysis between the experimental and control groups ) . The control group ( n=5 ) had a mean age of 80.2 years ( SD=7.8 ) . Subjects in the experimental group ( n=5 ) had a mean age of 84.8 years ( SD=2.5 ) . METHODS The intervention consisted of group exercise 3 times a week for 8 consecutive weeks , and included calisthenics ( eg , marching in place , side stepping , mock boxing ) , stationary bicycling , and walking . A finger-movement tracking test and submaximal grade d exercise tolerance step tests were performed before and after training to determine changes in finger-movement tracking and any aerobic training effects . RESULTS Matched-pairs t tests showed a difference in tracking from pretest to posttest in the experimental group compared with the control group . Step test performance did not differ between the 2 groups . DISCUSSION AND CONCLUSION The results of this small-scale study with a limited number of subjects indicate that , for elderly people , finger-movement tracking performance can improve with aerobic exercise , despite the absence of an aerobic training effect . Possible mechanisms for the treatment effect on information processing are discussed",
"The aim of this study was to assess the changes in the postural control ( PC ) during quiet stance among elderly men with fatigue induced by moderate exercise , and to assess the relationships between changes in PC and somatic indices ( body mass index ( BMI ) , waist to hip ratio ( WHR ) ) , load during exercise , and post-exercise blood lactate ( BL ) concentration . The study involved 17 elderly men ( 68.4±2.9 years of age , ranging between 65 and 74 years ) . Mean velocity of the center of pressure ( COP ) displacements was measured using a force plate both before and after fatigue induced by a cycle ergometer exercise . Following physical exercise , the mean velocity of the COP and its components , both in the sagittal and frontal plane , increased significantly . It was found that increasing BMI was associated with increasing exercise-induced changes in the mean velocity of the frontal plane . Additionally , BL level was positively correlated with changes in the mean velocity of the sagittal plane . Higher post-exercise values of the mean velocity of the COP may suggest a temporary increase in the risk of falls . Therefore , it seems advisable to caution the elderly men in regards to the increased risk of falling following exercise . Analysis showed that the changes in the PC as indicated by the increase in the COP displacements velocity may be related to the level of fatigue ( as indicated by BL ) . Moreover , elderly men possessing a higher BMI may exhibit a tendency toward the greater increase in the postural sway after exercise-induced fatigue",
"The effects of a physical activity intervention on strength , balance , motor coordination , and mobility were tested in a quasi-experiment at rural congregate nutrition sites . Twice-weekly sessions of low intensity movements were conducted for one year . Logistic regression results showed significant differences between intervention ( n = 61 ) and comparison ( n = 49 ) groups on several performance-based measures . Intervention subjects perceived significantly greater improvements in physical functioning over the previous year than did comparison subjects . A qualitative evaluation revealed perceived program benefits of pain reduction , increased flexibility , muscle strengthening , increased walking speed , and improved mental outlook",
"Kalapotharakos VI , Michalopoulos M , Strimpakos N , Diamantopoulos K , Tokmakidis SP : Functional and neuromotor performance in older adults : Effect of 12 wks of aerobic exercise . Am J Phys Med Rehabil 2006;85:61–67 . Objective : There is little information regarding the effect of aerobic exercise on physical and neuromotor performance in older adults . The aim of this r and omized , controlled trial was to determine the effects of a 12-wk aerobic exercise program on functional and neuromotor performance in inactive healthy older adults . Design : A total of 22 inactive healthy older adults , aged 60–75 yrs , voluntarily participated in the study and were r and omly assigned to a progressively increased high-intensity aerobic exercise group ( n = 12 ) or to a control group ( n = 10 ) . The aerobic exercise group exercised three times per week for 12 wks on nonconsecutive days . Both groups were evaluated before and after the exercise period in the one-repetition maximum of knee extensors and flexors , 6-min walk distance , chair-rising time , and whole-body reaction time . Results : Multivariate analysis of variance repeated measures ( 2 × 2 ) revealed significant ( P interaction for one-repetition maximum knee extension and flexion strength , 6-min walk distance , chair-rising time , and whole-body reaction time . For the aerobic exercise group , the following variables improved significantly ( P : the one-repetition maximum knee extensors ( 12 % ) and flexors ( 19 % ) muscle strength , 6-min walk distance ( 17 % ) , chair-rising time ( 8 % ) , and whole-body reaction time ( 20 % ) . No significant differences were observed in the control group . Conclusions : The results of the present study show that short-term progressively increased high-intensity aerobic exercise improved the physical and neuromotor performance in inactive healthy older adults . These findings suggest that the participation in a progressively increased high-intensity aerobic exercise program may improve mobility and ability to carry out activities of daily living in older adults",
"BACKGROUND AND PURPOSE Exercise programs targeting muscle strength and balance can reduce falls . The study aim ed to compare the Otago Exercise Program ( OEP ) , originally design ed as supervised home training ( HT ) , with the same programme performed as GT , on functional balance and muscle strength , mobility , fall efficacy and self-reported health . METHODS A single-blind r and omized controlled trial with assessment s at baseline ( T1 ) , following the 12-week intervention ( T2 ) , and 3 months following intervention ( T3 ) , was performed . 125 people , mean age 82.5 ( SD = 5.7 ) years , 73 % women , referred to a Falls Outpatient Clinic , participated . 74 % had fallen , and 37 % had a fall-related hospital stay during the previous year . OEP supervised by physiotherapists was performed as GT twice weekly or as HT three times a week , for 12 weeks . Total exercise time was comparable between groups . The primary outcome was the Berg Balance Scale assessed at T2 . RESULTS From T1-T2 , Berg Balance Scale improved significantly more in the GT group than in the HT group ( mean group difference in change of 3.2 points , 95%CI = 0.7 - 5.8 , p = 0.014 ) . Of the secondary outcomes , the 30-second sit-to-st and test ( p = 0.004 ) , and physical health measured by the Short Form-36 ( p = 0.004 ) , improved significantly more for the GT group . Change in mobility measured by the Timed Up and Go test , mental health by the Short Form-36 , and fall efficacy by the Fall Efficacy Scale International did not differ between groups . The 30-second sit-to-st and test and the Timed Up and Go , but not the Berg Balance Scale , was still better in the GT group at T3 . DISCUSSION In fall-prone home-dwelling older people , the OEP performed as GT is more effective for improving functional balance , muscle strength and physical health , but not fall efficacy and mental health than when performed as HT . The OEP provided as GT should be considered in this population",
"Dancing is a complex sensorimotor activity involving physical and mental elements which have positive effects on cognitive functions and motor control . The present r and omized controlled trial aims to analyze the effects of a dancing program on the performance on a motor-cognitive dual task . Data of 35 older adults , who were assigned to a dancing group or a health-related exercise group , are presented in the study . In pretest and posttest , we assessed cognitive performance and variability of minimum foot clearance , stride time , and stride length while walking . Regarding the cognitive performance and the stride-to-stride variability of minimum foot clearance , interaction effects have been found , indicating that dancing lowers gait variability to a higher extent than conventional health-related exercise . The data show that dancing improves minimum foot clearance variability and cognitive performance in a dual-task situation . Multi-task exercises ( like dancing ) might be a powerful tool to improve motor-cognitive dual-task performance",
"Background . Cognitive deficits impede stroke recovery . Aerobic exercise ( AEX ) improves cognitive executive function ( EF ) processes in healthy individuals , although the learning benefits after stroke are unknown . Objective . To underst and AEX-induced improvements in EF , motor learning , and mobility poststroke . Methods . Following cardiorespiratory testing , 38 chronic stroke survivors were r and omized to 2 different groups that exercised 3 times a week ( 45-minute sessions ) for 8 weeks . The AEX group ( n = 19 ; 9 women ; 10 men ; 64.10 ± 12.30 years ) performed progressive resistive stationary bicycle training at 70 % maximal heart rate , whereas the Stretching Exercise ( SE ) group ( n = 19 ; 12 women ; 7 men ; 58.96 ± 14.68 years ) performed stretches at home . Between-group comparisons were performed on the change in performance at “ Post ” and “ Retention ” ( 8 weeks later ) for neuropsychological and motor function measures . Results . VO2max significantly improved at Post with AEX ( P = .04 ) . AEX also improved motor learning in the less-affected h and , with large effect sizes ( Cohen ’s d calculation ) . Specifically , AEX significantly improved information processing speed on the serial reaction time task ( SRTT ; ie , “ procedural motor learning ” ) compared with the SE group at Post ( P = .024 ) , but not at Retention . Also , at Post ( P = .038 ) , AEX significantly improved predictive force accuracy for a precision grip task requiring attention and conditional motor learning of visual cues . Ambulation and sit-to-st and transfers were significantly faster in the AEX group at Post ( P = .038 ) , with balance control significantly improved at Retention ( P = .041 ) . EF measurements were not significantly different for the AEX group . Conclusion . AEX improved mobility and selected cognitive domains related to motor learning , which enhances sensorimotor control after stroke",
"Regular physical exercise improves cognitive functions and lowers the risk for age-related cognitive decline . Since little is known about the nature and the timing of the underlying mechanisms , we probed whether exercise also has immediate beneficial effects on cognition . Learning performance was assessed directly after high impact anaerobic sprints , low impact aerobic running , or a period of rest in 27 healthy subjects in a r and omized cross-over design . Dependent variables comprised learning speed as well as immediate ( 1 week ) and long-term ( > 8 months ) overall success in acquiring a novel vocabulary . Peripheral levels of brain-derived neurotrophic factor ( BDNF ) and catecholamines ( dopamine , epinephrine , norepinephrine ) were assessed prior to and after the interventions as well as after learning . We found that vocabulary learning was 20 percent faster after intense physical exercise as compared to the other two conditions . This condition also elicited the strongest increases in BDNF and catecholamine levels . More sustained BDNF levels during learning after intense exercise were related to better short-term learning success , whereas absolute dopamine and epinephrine levels were related to better intermediate ( dopamine ) and long-term ( epinephrine ) retentions of the novel vocabulary . Thus , BDNF and two of the catecholamines seem to be mediators by which physical exercise improves learning"
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411640a2-06ff-11f0-808a-c43d1ab1c353
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Presently , hydrolyzed formulas ( HF ) are used primarily in infants that can not be exclusively breastfed , those with cow 's milk allergy and for primary prevention of allergic disease , but HFs are increasingly being used worldwide , begging the question if they may be recommended as the optimal choice for all st and ard-risk , full-term , non-exclusively breastfed infants . Data regarding the nutritional adequacy of modern-day HFs are scarce and lack long-term data suggesting that growth in infants fed HF versus an intact protein formula ( IPF ) is different . While human breast milk is the optimal source of nutrition for multiple reasons , a 2006 systematic review determined there were no comparable long-term studies regarding prolonged use of HFs versus breastfeeding . Meta-analyses of formula consumption and risk of atopic dermatitis ( AD ) have found that infants fed partially HF compared to IPF had a lower risk of AD , but there are significant limitations to these studies , making conclusions about the general use of HFs problematic . Costs should be considered in decision-making regarding the choice of the formula , but global comparison of this is difficult given large cost differences in different countries . Despite the issues raised here , the desire to provide concrete recommendations of widespread HF use needs to be balanced carefully in order not to overstate cl aims of benefit . Long-term studies are needed to investigate the feasibility of HF as a routine feeding option for healthy , st and ard-risk infants . Because of the paucity of data , routine use of HF as an equivalent option to breastfeeding or IPF can not be supported at present based on available scientific evidence
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"BACKGROUND It has been suggested that a protein hydrolysate , as opposed to its intact protein , is more easily digested and absorbed from the gut , which results in greater plasma amino acid availability and a greater muscle protein synthetic response . OBJECTIVE We aim ed to compare dietary protein digestion and absorption kinetics and the subsequent muscle protein synthetic response to the ingestion of a single bolus of protein hydrolysate compared with its intact protein in vivo in humans . DESIGN Ten elderly men ( mean + /- SEM age : 64 + /- 1 y ) were r and omly assigned to a crossover experiment that involved 2 treatments in which the subjects consumed a 35-g bolus of specifically produced L-[1-(13)C]phenylalanine-labeled intact casein ( CAS ) or hydrolyzed casein ( CASH ) . Blood and muscle-tissue sample s were collected to assess the appearance rate of dietary protein-derived phenylalanine in the circulation and subsequent muscle protein fractional synthetic rate over a 6-h postpr and ial period . RESULTS The mean ( + /-SEM ) exogenous phenylalanine appearance rate was 27 + /- 6 % higher after ingestion of CASH than after ingestion of CAS ( P Splanchnic extraction was significantly lower in CASH compared with CAS treatment ( P Plasma amino acid concentrations increased to a greater extent ( 25 - 50 % ) after the ingestion of CASH than after the ingestion of CAS ( P Muscle protein synthesis rates averaged 0.054 + /- 0.004 % and 0.068 + /- 0.006%/h in the CAS and CASH treatments , respectively ( P = 0.10 ) . CONCLUSIONS Ingestion of a protein hydrolysate , as opposed to its intact protein , accelerates protein digestion and absorption from the gut , augments postpr and ial amino acid availability , and tends to increase the incorporation rate of dietary amino acids into skeletal muscle protein",
"Background Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional . Up to one-half of formula-fed infants experience a formula change during the first six months of life . Methods The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy , term infants . Infants ( 335 ) were r and omized to receive either a st and ard intact cow milk protein formula ( INTACT ) or a partially hydrolyzed cow milk protein formula ( PH ) in a 60 day non-inferiority trial . Discontinuance due to study physician-assessed formula intolerance was the primary outcome . Secondary outcomes included number of infants who discontinued for any reason , including parent-assessed . Results Formula intolerance between groups ( INTACT , 12.3 % vs. PH , 13.7 % ) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance . Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants ( 14.4 vs.11.1 % ) was significantly different ( P = 0.001 ) . Conclusion This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy , term infants over a 60-day feeding trial , suggesting nonst and ard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants . Parents frequently perceived infant behavior as formula intolerance , paralleling previous reports of unnecessary formula changes . Trial Registration clinical trials.gov :",
"BACKGROUND Recommendations for primary prevention of allergic diseases in high-risk children include feeding with hydrolyzed formulas if breast-feeding is insufficient . OBJECTIVE The primary objective of the German Infant Nutritional Intervention study was to investigate the allergy preventive effect of 3 hydrolyzed formulas compared with cow 's milk formula in the first 3 years of life in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were allocated to a group receiving cow 's milk formula , partially or extensively hydrolyzed whey formula , or extensively hydrolyzed casein formula as a milk substitute for the first 4 months if breast-feeding was insufficient . Main outcome parameters were allergic manifestations , atopic dermatitis ( AD ) , and asthma . RESULTS After 3 years , 396 of 2252 children ( 17.6 % ) had dropped out . Breast-fed infants without formula feeding during the intervention ( n = 889 ) were considered separately . A significant reduction of the incidence of AD was achieved with the extensively hydrolyzed casein formula in the intention-to-treat ( ITT ; n = 1363 ) and per protocol ( PP ; n = 904 ) analyses ( ITT : population odds ratio [ 95 % CI ] , 0.67 [ 0.45 - 0.99 ] ; PP : adjusted odds ratio [ OR(adj ) ] , 0.53 [ 0.32 - 0.88 ] ) , and with the partially hydrolyzed whey formula in the PP analysis ( ITT : population odds ratio , 0.76 [ 0.52 - 1.11 ] ; PP : OR(adj ) , 0.60 [ 0.37 - 0.97 ] ) . None of the formulas reduced the incidence of asthma . CONCLUSION The risk for AD , but not for asthma , can be reduced with certain cow 's milk hydrolyzates in high-risk infants when breast-feeding is insufficient . CLINICAL IMPLICATION S Early nutritional intervention in high-risk children has significant influence on the incidence of AD , but not of asthma",
"Background and Aim : Many mothers consult physicians because of frequent infant regurgitation . Guidelines recommend reassurance and dietary treatment as first approaches . The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae ( ARF ) . Methods : A prospect i ve , double-blind , r and omized cross-over trial was performed for a 1-month period in 115 formula-fed infants ( ages 2 weeks–5 months ) comparing 2 ARF ( ARF-1 : nonhydrolyzed protein , locust bean gum ; ARF-2 : specific whey hydrolysate , locust bean gum , specially treated starch ) . The primary endpoint was the incidence of regurgitation . Results : At inclusion , mean age was 9.1 weeks ; anthropometric parameters did not differ between the groups . According to the intention-to-treat analysis , the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 ( statistically significant difference between both ARF , P = 0.0091 ) . The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 ( P = 0.0265 ) . There was no significant difference in stool frequency and consistency between both groups . Conclusions : The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations . ARF-2 was statistically more effective than ARF-1 . Comparative trials enable the selection of the best therapeutic option",
"The allergy preventive effect of extensively ( N ) and partially ( PH ) hydrolysed cows ’ milk formulas compared with a regular formula ( RM ) was assessed in 155 infants with a family history of allergy . No cows ’ milk was given during the first nine months of life and no egg and fish up to 12 months of age . Breast feeding mothers avoided the same foods . At weaning the infants were r and omised to one of the formula groups . The cumulative incidence of atopic symptoms at 18 months was 51 , 64 , and 84 % in the N , PH , and RM groups , respectively . From 6 to 18 months there were significantly less cumulative atopic symptoms in the N group compared with the RM group , and significantly less than the PH group up to 6 ( N = 25 % ; PH = 46 % ) and 9 months ( N = 34 % , PH = 58 % ) . At 9 months significantly fewer infants in the N group ( 10 % ) than in the PH group ( 33 % ) had a positive skin prick test to eggs . The findings support an allergy preventive effect of an extensively hydrolysed formula , but not of a partially hydrolysed formula , during the first 18 months of life of high risk infants",
"Summary Background and Aims To test the hypothesis that a peptide-based enteral product was equivalent to a low-fat , free amino acid-based formula in the nutritional and functional recovery of the starved rat . Methods Sixteen male Wistar rats were starved for 3 days . Then , rats were r and omised to a whey protein hydrolysate-based diet or a free amino acid-based diet and refed for 3 days . The experiment was design ed to provide the same energy intake in both groups . The parameters studied included body weight gain , nitrogen retention , plasma free amino acid concentrations , muscle glutamine concentrations and glutathione levels in gut mucosa and liver . Results Weight gain was statistically higher on the peptide-based diet than on the elemental diet after rhe refeeding period . This difference in weight gain was associated with a statistically higher nitrogen retention . Plasma and muscle free glutamine concentrations were higher in rats fed the whey protein hydrolysate-based diet than those in rat refed the free amino acid-based diet , even though the glutamine intake was higher in the latter group . Glutathione concentrations in liver and gut mucosa were similar in the groups . Conclusion We conclude that enteral diets containing peptides were more effective than a diet containing free amino acids in the nutritional recovery of the starved rat",
"A masked , r and omized , parallel growth study was conducted in infants fed an amino acid – based formula ( AF ) or an extensively hydrolyzed casein-based formula ( HF ) . Infants were enrolled between 0 and 9 days and studied to 112 days of age . Growth , formula intake , stool patterns , and serum albumin concentrations were assessed . There were no significant differences between groups in weight , length , or head circumference , gains in weight or length , or study formula intake . The number of stools parents rated as being formed , and the mean daily number of stools were greater in the HF than in the AF group at 14 and 28 days of age . Mean serum albumin concentrations were not significantly different between groups and were within the normal range . This study demonstrates that AF supports normal growth of infants comparable to that of infants fed HF during the critical first 4 months of life",
"BACKGROUND The long-term effect of nutritional intervention with hydrolyzed infant formulas on allergy development has not been sufficiently evaluated . OBJECTIVE We performed a follow-up of the German Infant Nutritional Intervention study until 6 years of life to investigate the long-term allergy-preventive effect of 3 hydrolyzed infant formulas compared with cow 's milk formula ( CMF ) in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were r and omly assigned at birth to receive one of 4 blinded formulas : partially or extensively hydrolyzed whey formula , extensively hydrolyzed casein formula , or CMF as milk substitute for the first 4 months when breast-feeding was insufficient . The cohort was followed from birth until 6 years of age with yearly question naires . Outcomes were physician-diagnosed allergic diseases ( atopic dermatitis , food allergy , allergic urticaria , asthma , and hay fever/allergic rhinitis ) . Log-binomial regression modeled with generalized estimation equations was used for the statistical analysis . RESULTS In the intent-to-treat analysis the relative risk of a physician 's diagnosis of allergic manifestation ( AM ) compared with CMF was 0.82 ( 95 % CI , 0.70 - 0.96 ) for partially hydrolyzed whey formula , 0.90 ( 95 % CI , 0.78 - 1.04 ) for extensively hydrolyzed whey formula , and 0.80 ( 95 % CI , 0.69 - 0.93 ) for extensively hydrolyzed casein formula . The corresponding figures for atopic eczema were 0.79 ( 95 % CI , 0.64 - 0.97 ) , 0.92 ( 95 % CI , 0.76 - 1.11 ) , and 0.71 ( 95 % CI , 0.58 - 0.88 ) , respectively . In the per- protocol analysis all effects were stronger and significant . No significant effect on other AMs was found . CONCLUSION The data confirm a long-term allergy-preventive effect of hydrolyzed infant formulas on AM and atopic eczema until 6 years of age",
"BACKGROUND The diversity in the perceived prevalence , recovery , and risk factors for cow 's milk allergy ( CMA ) necessitated a large-scale , population -based prospect i ve study . OBJECTIVE We sought to determine the prevalence , cross-reactivity with soy allergy , and risk factors for the development of CMA . METHODS In a prospect i ve study the feeding history of 13,019 infants was obtained by means of telephone interview ( 95.8 % ) or question naire ( 4.2 % ) . Infants with probable adverse reactions to milk were examined , skin prick tested , and challenged orally . RESULTS Ninety-eight percent of the cohort participated in the study . The cumulative incidence for IgE-mediated CMA was 0.5 % ( 66/13,019 patients ) . The mean age of cow 's milk protein ( CMP ) introduction was significantly different ( P days ) and those with IgE-mediated CMA ( 116.1 + /- 64.9 days ) . Only 0.05 % of the infants who were started on regular CMP formula within the first 14 days versus 1.75 % who were started on formula between the ages of 105 and 194 days had IgE-mediated CMA ( P IgE-mediated CMA among infants with exposure to CMP at the age of 15 days or more ( P Sixty-four patients with IgE-mediated CMA tolerated soy , and none had a proved allergy to soy . CONCLUSIONS IgE-mediated CMA is much less common than generally reported . Early exposure to CMP as a supplement to breast-feeding might promote tolerance . Finally , soy is a reasonable feeding alternative in patients with IgE-mediated CMA",
"Aim : Protein hydrolysates have been introduced in preterm formulae , but it is not clear whether they are needed for the feeding of preterm infants . We design ed a r and omized , controlled trial to test the effects of a preterm formula with hydrolysed cow 's milk proteins on short‐term growth and urinary and plasma amino acids levels . Methods : Infants with a birthweight 1750 g and gestational age 34 wk fed a conventional preterm infant formula ( formula B ) or a hydrolysed formula ( formula A ) . Weight was measured daily ; length , head circumference , mid‐arm circumference and total skinfold thickness were measured weekly . Blood and urine were analysed for amino acid concentrations at start , 14 and 28 d. Results : Twenty‐one infants met the criteria for r and omization . The daily feeding volumes were : formula A 172.8±5.6 vs formula B 170.1±2.8 ml/kg/d . Infants fed with formula A showed slower weight gain ( 17.4±3.4 vs 20.5±3.3 g/kg/d ; p=0.045 ) and lower mean change in Z‐scores for weight ( −0.18±0.16 vs 0.00±0.09 ; p=0.009 ) and for head circumference ( −0.06±0.13 vs 0.06±0.13 ; p=0.049 ) . After 14 d , infants receiving formula A had statistically significant higher urinary levels of essential amino acids compared to infants receiving formula",
"BACKGROUND The potential of extensively or partially hydrolyzed formulas to reduce the risks for allergies is controversial . OBJECTIVE We sought to assess the preventive effect of differently hydrolyzed formulas compared with cow 's milk formula ( CMF ) in high-risk infants . METHODS Between 1995 and 1998 , 2252 infants with a hereditary risk for atopy were enrolled in the German Infant Nutritional Intervention Study and r and omly assigned at birth to one of 4 blinded formulas : CMF , partially hydrolyzed whey formula , extensively hydrolyzed whey formula , and extensively hydrolyzed casein formula ( eHF-C ) . The primary end point at 1 year of age was the presence of allergic manifestation , which was defined as atopic dermatitis ( AD ) , gastrointestinal manifestation of food allergy , allergic urticaria , or a combination of these factors . RESULTS At 12 months per protocol , analysis was performed on 945 infants exposed to study formula : 304 ( 13.5 % ) infants had left the study , 138 ( 6.1 % ) infants were excluded because of noncompliance , and 865 infants were exclusively breast-fed the first 4 months of life . The incidence of allergic manifestation was significantly reduced by using eHF-C compared with CMF ( 9 % vs 16 % ; adjusted OR , 0.51 ; 95 % CI , 0.28 - 0.92 ) , and the incidence of AD was significantly reduced by using eHF-C ( OR , 0.42 ; 95 % CI , 0.22 - 0.79 ) and partially hydrolyzed whey formula ( OR , 0.56 ; 95 % CI , 0.32 - 0.99 ) . Family history of AD was a significant risk factor and modified the preventive effect of the hydrolysates . CONCLUSIONS Prevention of allergic diseases in the first year of life is feasible by means of dietary intervention but influenced by family history of AD . The preventive effect of each hydrolyzed formula needs to be clinical ly evaluated",
"BACKGROUND Children with cow 's milk allergy ( CMA ) are at risk for inadequate nutritional intake and growth . Dietary management of CMA , therefore , requires diets that are not only hypoallergenic but also support adequate growth in this population . This study assessed growth of CMA infants when using a new amino acid-based formula ( AAF ) with prebiotics and probiotics ( synbiotics ) and evaluated its safety in the intended population . METHODS In a prospect i ve , r and omized , double-blind controlled study , full-term infants with diagnosed CMA received either an AAF ( control ; n = 56 ) or AAF with synbiotics ( oligofructose , long-chain inulin , acidic oligosaccharides , Bifidobacterium breve M-16V ) ( test ; n = 54 ) for 16 wk . Primary outcome was growth , measured as weight , length and head circumference . Secondary outcomes included allergic symptoms and stool characteristics . RESULTS Average age ( ±SD ) of infants at inclusion was 4.5 ± 2.4 months . Both formulas equally supported growth according to WHO 2006 growth charts and result ed in similar increases of weight , length and head circumference . At week 16 , differences ( 90 % CI ) in Z-scores ( test-control ) were as follows : weight 0.147 ( -0.10 ; 0.39 , p = 0.32 ) , length -0.299 ( -0.69 ; 0.09 , p = 0.21 ) and head circumference 0.152 ( -0.15 ; 0.45 , p = 0.40 ) . Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups . Both formulas were well tolerated and reduced allergic symptoms ; the number of adverse events was not different between the groups . CONCLUSIONS This is the first study that shows that an AAF with a specific synbiotic blend , suitable for CMA infants , supports normal growth and growth similar to the AAF without synbiotics . This clinical trial is registered as NCT00664768",
"BACKGROUND The long-term effect of nutritional intervention with hydrolysate infant formulas on allergic manifestations in high-risk children is uncertain . OBJECTIVE We sought to investigate the effect of hydrolysate infant formulas on allergic phenotypes in children with family history of allergies at school age . METHODS We analyzed data from participants of the prospect i ve German Infant Nutritional Intervention study after 10 years of follow-up . At birth , children were r and omly assigned to receive , for the first 4 months , one of 4 blinded formulas as breast milk substitute , if necessary : partially hydrolyzed whey formula ( pHF-W ) , extensively hydrolyzed whey formula ( eHF-W ) , extensively hydrolyzed casein formula ( eHF-C ) , or st and ard cow 's milk formula . Outcomes were parent-reported , physician-diagnosed allergic diseases . Log-binomial regression models were used for statistical analysis . RESULTS The relative risk for the cumulative incidence of any allergic disease in the intention-to-treat analysis ( n = 2252 ) was 0.87 ( 95 % CI , 0.77 - 0.99 ) for pHF-W , 0.94 ( 95 % CI , 0.83 - 1.07 ) for eHF-W , and 0.83 ( 95 % CI , 0.72 - 0.95 ) for eHF-C compared with st and ard cow 's milk formula . The corresponding figures for atopic eczema/dermatits ( AD ) were 0.82 ( 95 % CI , 0.68 - 1.00 ) , 0.91 ( 95 % CI , 0.76 - 1.10 ) , and 0.72 ( 95 % CI , 0.58 - 0.88 ) , respectively . In the per- protocol analysis ( n = 988 ) effects were stronger . The period prevalence of AD at 7 to 10 years was significantly reduced with eHF-C in this analysis , but there was no preventive effect on asthma or allergic rhinitis . CONCLUSION The significant preventive effect on the cumulative incidence of allergic diseases , particularly AD , with pHF-W and eHF-C persisted until 10 years without rebound , whereas eHF-W showed no significant risk reduction . There is insufficient evidence of ongoing preventive activity at 7 to 10 years of age"
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411640e8-06ff-11f0-808a-c43d1ab1c353
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Background Moxibustion is a traditional Chinese method that uses the heat generated by burning herbal preparations containing Artemisia vulgaris to stimulate acupuncture points . Considering moxibustion is closely related to acupuncture , it seems pertinent to evaluate the effectiveness of moxibustion as a treatment of symptoms of cancer . The objective of this review was to systematic ally assess the effectiveness of moxibustion for supportive cancer care . Methods We search ed the literature using 11 data bases from their inceptions to February 2010 , without language restrictions . We included r and omised clinical trials ( RCTs ) in which moxibustion was employed as an adjuvant treatment for conventional medicine in patients with any type of cancer . The selection of studies , data extraction , and validations were performed independently by two review ers . Results Five RCTs compared the effects of moxibustion with conventional therapy . Four RCTs failed to show favourable effects of moxibustion for response rate compared with chemotherapy ( n = 229 , RR , 1.04 , 95 % CI 0.94 to 1.15 , P = 0.43 ) . Two RCTs assessed the occurrence of side effects of chemotherapy and showed favourable effects of moxibustion . A meta- analysis showed significant less frequency of nausea and vomiting from chemotherapy for moxibustion group ( n = 80 , RR , 0.38 , 95 % CIs 0.22 to 0.65 , P = 0.0005 , heterogeneity : χ2 = 0.18 , P = 0.67 , I2 = 0 % ) . Conclusion The evidence is limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting . However , all studies have a high risk of bias so effectively there is not enough evidence to draw any conclusion . Further research is required to investigate whether there are specific benefits of moxibustion for supportive cancer care
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[
"Clinical and experimental data indicate that most acupuncture clinical results are mediated by the central nervous system , but the specific effects of acupuncture on the human brain remain unclear . Even less is known about its effects on the cerebellum . This fMRI study demonstrated that manual acupuncture at ST 36 ( Stomach 36 , Zusanli ) , a main acupoint on the leg , modulated neural activity at multiple levels of the cerebro-cerebellar and limbic systems . The pattern of hemodynamic response depended on the psychophysical response to needle manipulation . Acupuncture stimulation typically elicited a composite of sensations termed deqi that is related to clinical efficacy according to traditional Chinese medicine . The limbic and paralimbic structures of cortical and subcortical regions in the telencephalon , diencephalon , brainstem and cerebellum demonstrated a concerted attenuation of signal intensity when the subjects experienced deqi . When deqi was mixed with sharp pain , the hemodynamic response was mixed , showing a predominance of signal increases instead . Tactile stimulation as control also elicited a predominance of signal increase in a subset of these regions . The study provides preliminary evidence for an integrated response of the human cerebro-cerebellar and limbic systems to acupuncture stimulation at ST 36 that correlates with the psychophysical response",
"Moxibustion has been used to treat various types of disease . However , there is still insufficient evidence regarding its effectiveness . This study was performed to summarize and evaluate the effectiveness of moxibustion . A search was performed for all r and omized controlled trials in PubMed between January 1998 and July 2008 with no language restriction . The results yielded 47 trials in which six moxibustion types were applied to 36 diseases ranging from breech presentation to digestive disorders . Moxibustion was compared to three types of control group : general care , Oriental medical therapies or waiting list . Moxibustion was superior to the control in 14 out of 54 control groups in 46 studies . There were no significant differences among groups in 7 studies , and the outcome direction was not determined in 33 studies . Seven studies were included in a meta- analysis . Moxibustion was more effective than medication in two ulcerative colitis studies ( relative risk ( 95 % CI ) , 2.20 ( 1.37 , 3.52 ) , P = .001 , I 2 = 0 % ) . Overall , our results did not support the effectiveness of moxibustion in specific diseases due to the limited number and low quality of the studies and inadequate use of controls . In order to provide appropriate evidence regarding the effectiveness of moxibustion , more rigorous clinical trials using appropriate controls are warranted",
"OBJECTIVES Moxibustion , a Traditional Chinese Medicine technique related to acupuncture , was proposed to facilitate cephalic version of breech presentation . Several trials were conducted to evaluate the efficacy , but there are few reports on the safety of moxibustion . Our objective was to assess the side-effects and acceptability of this intervention . DESIGN We are conducting a r and omized controlled trial to evaluate the efficacy of moxibustion for breech version . The first 12 participants r and omized in the moxibustion group had additional fetal surveillance by electronic monitoring . SUBJECTS Pregnant women with a fetus in breech presentation are included in the trial between 34 and 36 weeks of gestation . INTERVENTIONS We performed a cardiotocogram during 10 minutes before , 20 minutes during , and 10 minutes after each session . A maximum of 9 sessions were scheduled every other day , and stopped when cephalic version was diagnosed . The recordings were assessed by 3 independent readers using the Fischer scoring system . OUTCOME MEASURES Fetal well-being was evaluated by the cardiotocogram ; effect on the mother was evaluated by blood pressure recorded before and after each session ; maternal views , contractions , and perceived changes in fetal movements were assessed using a question naire . RESULTS A total of 65 cardiotocograms were analyzed . All scores were considered as normal , being at 8 or more on a 0 - 10 scale . Acceptability for the women and compliance to the intervention were good . No significant maternal or fetal side-effect was observed . CONCLUSIONS We have not detected alterations of fetal and maternal well-being or other side-effects associated with moxibustion applied to the BL 67 for cephalic version of breech presentations . Moxibustion appears to be safe for both the mother and the fetus",
"OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries",
"OBJECTIVE To evaluate the effect of supplementary moxibustion in treating III , IV a stage nasopharyngeal carcinoma ( NPC ) with radio- and chemotherapy . METHODS Fifty-six cases of NPC were r and omly divided into two groups , 28 in each group . They were treated with radiotherapy in routine or chemotherapy adopting AD protocol . Salt-separated moxibustion on Shenque ( Ren 8) point was given to the treated group from beginning of radio- and chemotherapy for 30 times as one therapeutic course . RESULTS The remission rate in the two groups after radio- and chemotherapy was not different significantly . The toxic and side-effect occurrence was less in the treated group than that in the control group ( P 5-year local control rates of NPC and cervical lymphnode were 85.7 % and 85.0 % in the treated group , which were higher than those in the control group ( 78.6 % and 78.9 % ) . The 5-year survival rate in the two groups were 50.0 % and 35.7 % respectively . After radio- and chemotherapy , the blood content of malonyldialdehyde ( MDA ) , middle molecular substance and sulfhydryl reduced the SOD activity ascended in the treated group , the difference was significant as compared with those in the control group ( P supplementary moxibustion on Shenque point could obviously reduce the toxic side-effect of advanced NPC patients treated with radio- and chemotherapy",
"OBJECTIVE To observe the complementary function of moxibustion and Guben Yiliu III ( GBYL ) , a Chinese herbal composite preparation , in combination with chemotherapy . METHODS Eighty-one patients of middle-late stage malignant tumor were r and omly divided into three groups , 16 in the control group treated with chemotherapy alone , 35 in the TCM group treated with chemotherapy combined GBYL and 30 in the TCM combined moxibustion group . The therapeutic effect of treatment was evaluated according to the immediate effect , living quality scoring , etc . RESULTS The comprehensive living quality score and Karnofsky score dropped significantly in the control group after treatment with significant increase of pain score and decrease of tongue figure score ( P TCM combined moxibustion group , all the four criteria were improved better than those in the control group ( P GBYL combined or not combined with moxibustion could improve the living quality of patients received chemotherapy",
"AIM To observe the effects of pre-moxibustion on apoptosis and proliferation of gastric mucosal cell in rats with stress-induced ulcer , and to analyze the relationship between those effects and the expression of heat-shock protein 70 ( HSP70 ) . METHODS Sixty healthy Sprague Dawley rats were r and omly assigned into four groups , namely group A , B , C and D. The animal model of stress ulcer was established by water immersion and restraint stress . The rats in group A , B , and D served as the restraint , model , and non-acupoint controls , respectively , while those in group C received moxibustion at Zusanli and Liangmen points . Immunohistochemical methodology was used to detect the expression of HSP70 , apoptosis index ( AI , multiply 10(-6)/microm(2 ) ) and proliferation index ( PCNA-LI , multiply 10(-6)/microm(2 ) ) . The mucosal expression of transforming growth factor alpha(TGF-alpha ) was detected by radioimmunoassay . RESULTS Moxibustion at Zusanli and Liangmen points significantly decreased the gastric injury and the apoptosis of gastric mucosal cells , while markedly increased the mucosal expression of TGF-alpha and HSP70 as well as the proliferation of gastric mucosal cells . Compared with group A , ulcer index ( UI ) ( 26.8 + /- 9.8 vs 12.0 + /- 5.9 , P expression of HSP70 ( 9.6 + /- 4.2 vs 4.4 + /- 2.6 , P content of TGF-alpha ( 104.7 + /- 51.2 pg/mL vs 254.0 + /- 86.9 pg/mL , P ulcer index values ( UI ) and AI were obviously lower in group C compared to groups B and D ( 14.1 + /- 5.4 vs 26.8 + /- 9.8 and 26.2 + /- 7.7 , P TGF-alpha ( 237.0 + /- 72.6 pg/mL vs 104.7 + /- 51.2 pg/mL and 154.1 + /- 61.3 pg/mL , P expression of HSP70 ( 0.13 + /- 0.03 vs 0.08 + /- 0.06 and 0.06 + /- 0.04 , P PCNA-LI was significantly higher in group C than in group B ( 21.6 + /- 4.1 vs 6.9 + /- 4.7 , P Moxibustion at Zusanli and Liangmen points has a protective effect on rats gastric mucosa in stress-induced gastric ulcer , which is closely related to its actions in promoting synthesis of TGF-alpha and proliferation of gastric mucosal cells , suppressing gastric mucosal cell apoptosis , and up-regulating HSP70 expression"
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41164124-06ff-11f0-808a-c43d1ab1c353
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Abstract Hypertension is the most important risk factor for stroke and stroke recurrence . However , the preferred blood pressure (BP)-lowering drug class for patients who have suffered from a stroke has yet to be determined . To investigate the relative effects of BP-lowering therapies [ angiotensin-converting enzyme inhibitor ( ACEI ) , angiotensin receptor blockers ( ARB ) , & bgr ; blockers , calcium channel blockers ( CCBs ) , diuretics , and combinations of these drugs ] in patients with a prior stroke history , we performed a systematic review and meta- analysis using both traditional frequentist and Bayesian r and om-effects models and meta-regression of r and omized controlled trials ( RCTs ) on the outcomes of recurrent stroke , coronary heart disease ( CHD ) , and any major adverse cardiac and cerebrovascular events ( MACCE ) . Trials were identified from search es of published hypertension guidelines , electronic data bases , and previous systematic review s . Fifteen RCTs composed of 39,329 participants with previous stroke were identified . Compared with the placebo , only ACEI along with diuretics significantly reduced recurrent stroke events [ odds ratio ( OR ) = 0.54 , 95 % credibility interval ( 95 % CI ) 0.33–0.90 ] . On the basis of the distribution of posterior probabilities , the treatment ranking consistently identified ACEI along with diuretics as the preferred BP-lowering strategy for the reduction of recurrent stroke and CHD ( 31 % and 35 % , respectively ) . For preventing MACCE , diuretics appeared to be the preferred agent for stroke survivors ( 34 % ) . Moreover , the meta-regression analysis failed to demonstrate a statistical significance between BP reduction and all outcomes ( P = 0.1618 for total stroke , 0.4933 for CHD , and 0.2411 for MACCE ) . Evidence from RCTs supports the use of diuretics-based treatment , especially when combined with ACEI , for the secondary prevention of recurrent stroke and any vascular events in patients who have suffered from stroke
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"Although the benefits of antihypertensive treatment in \" young \" elderly ( under 70 years ) hypertensive patients are well established , the value of treatment in older patients ( 70 - 84 years ) is less clear . The Swedish Trial in Old Patients with Hypertension ( STOP-Hypertension ) was a prospect i ve , r and omised , double-blind , intervention study set up to compare the effects of active antihypertensive therapy ( three beta-blockers and one diuretic ) and placebo on the frequency of fatal and non-fatal stroke and myocardial infa rct ion and other cardiovascular death in hypertensive Swedish men and women aged 70 - 84 years . We recruited 1627 patients at 116 health centres throughout Sweden , who were willing to participate , and who met the entry criteria of three separate recordings during a 1-month placebo run-in period of systolic blood pressure between 180 and 230 mm Hg with a diastolic pressure of at least 90 mm Hg , or a diastolic pressure between 105 and 120 mm Hg irrespective of the systolic pressure . The total duration of the study was 65 months and the average time in the study was 25 months . 812 patients were r and omly allocated active treatment and 815 placebo . The mean difference in supine blood pressure between the active treatment and placebo groups at the last follow-up before an endpoint , death , or study termination was 19.5/8.1 mm Hg . Compared with placebo , active treatment significantly reduced the number of primary endpoints ( 94 vs 58 ; p = 0.0031 ) and stroke morbidity and mortality ( 53 vs 29 ; p = 0.0081 ) . Although we did not set out to study an effect on total mortality , we also noted a significantly reduced number of deaths in the active treatment group ( 63 vs 36 ; p = 0.0079 ) . The benefits of treatment were discernible up to age 84 years . We conclude that antihypertensive treatment in hypertensive men and women aged 70 - 84 confers highly significant and clinical ly relevant reductions in cardiovascular morbidity and mortality as well as in total mortality",
"Background and Purpose — In hypertensive stroke patients , for the same level of blood pressure control , eprosartan will be more effective than nitrendipine in reducing cerebrovascular and cardiovascular morbidity and mortality . Methods — A total of 1405 well-defined , high-risk hypertensives with cerebral event during the last 24 months ( proven by cerebral computed tomography scan or nuclear magnetic resonance ) were r and omized to eprosartan or nitrendipine ( mean follow-up 2.5 years ) . Primary end point was the composite of total mortality and all cardiovascular and cerebrovascular events , including all recurrent events . Results — R and omization was successful without significant differences in the baseline characteristics . Blood pressure was reduced to a comparable extent without any significant differences between the 2 groups during the whole study period ( 150.7/84 mm Hg and 152.0/87.2 mm Hg with eprosartan and nitrendipine therapy to 137.5/80.8 mm Hg and 136.0/80.2 mm Hg , respectively , confirmed by ambulatory blood pressure monitoring ) . Moreover , already after 3 months , normotensive mean values were achieved , and 75.5 % reached values eprosartan regimen and 77.7 % with the nitrendipine regimen . During follow-up , in total , 461 primary events occurred : 206 eprosartan and 255 nitrendipine ( incidence density ratio [ IDR ] , 0.79 ; 95 % CI , 0.66 to 0.96 ; P=0.014 ) . Cardiovascular events were : 77 eprosartan and 101 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.55 to 1.02 ; P=0.06 ) ; cerebrovascular events : 102 eprosartan and 134 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.58 to 0.97 ; P=0.03 ) . Conclusions — The Morbidity and Mortality After Stroke , Eprosartan Compared With Nitrendipine for Secondary Prevention ( MOSES ) study was the first to compare an angiotensin II type 1 receptor antagonist with a calcium antagonist in secondary stroke prevention . In these high-risk hypertensive stroke patients , an early normotensive and comparable blood pressure was achieved . The combined primary end point was significantly lower in the eprosartan group",
"It has been almost 5 years since the publication of the 2010 hypertension guidelines of the Taiwan Society of Cardiology ( TSOC ) . There is new evidence regarding the management of hypertension , including r and omized controlled trials , non-r and omized trials , post-hoc analyses , subgroup analyses , retrospective studies , cohort studies , and registries . More recently , the European Society of Hypertension ( ESH ) and the European Society of Cardiology ( ESC ) published joint hypertension guidelines in 2013 . The panel members who were appointed to the Eighth Joint National Committee ( JNC ) also published the 2014 JNC report . Blood pressure ( BP ) targets have been changed ; in particular , such targets have been loosened in high risk patients . The Executive Board members of TSOC and the Taiwan Hypertension Society ( THS ) aim ed to review up date d information about the management of hypertension to publish an up date d hypertension guideline in Taiwan . We recognized that hypertension is the most important risk factor for global disease burden . Management of hypertension is especially important in Asia where the prevalence rate grows faster than other parts of the world . In most countries in East Asia , stroke surpassed coronary heart disease ( CHD ) in causing premature death . A diagnostic algorithm was proposed , emphasizing the importance of home BP monitoring and ambulatory BP monitoring for better detection of night time hypertension , early morning hypertension , white-coat hypertension , and masked hypertension . We disagreed with the ESH/ESH joint hypertension guidelines suggestion to loosen BP targets to BP target to patients between 60 - 80 years of age . For patients with diabetes , CHD , chronic kidney disease who have proteinuria , and those who are receiving antithrombotic therapy for stroke prevention , we propose BP targets of BP targets are patients ≥80 years of age in whom a BP target of hypertension , we proposed a treatment algorithm , starting with life style modification ( LSM ) including S-ABCDE ( Sodium restriction , Alcohol limitation , Body weight reduction , Cigarette smoke cessation , Diet adaptation , and Exercise adoption ) . We emphasized a low-salt strategy instead of a no-salt strategy , and that excessively aggressive sodium restriction to lowering BP , we proposed the \" Rule of 10 \" and \" Rule of 5 \" . With a st and ard dose of any one of the 5 major classes of anti-hypertensive agents , one can anticipate approximately a 10-mmHg decrease in systolic BP ( SBP ) ( Rule of 10 ) and a 5-mmHg decrease in diastolic BP ( DBP ) ( Rule of 5 ) . When doses of the same drug are doubled , there is only a 2-mmHg incremental decrease in SBP and a 1-mmHg incremental decrease in DBP . Preferably , when 2 drugs with different mechanisms are to be taken together , the decrease in BP is the sum of the decrease of the individual agents ( approximately 20 mmHg in SBP and 10 mmHg in DBP ) . Early combination therapy , especially single-pill combination ( SPC ) , is recommended . When patient 's initial treatment can not get BP to targeted goals , we have proposed an adjustment algorithm , \" AT GOALs \" ( Adherence , Timing of administration , Greater doses , Other classes of drugs , Alternative combination or SPC , and LSM + Laboratory tests ) . Treatment of hypertension in special conditions , including treatment of resistant hypertension , hypertension in women , and perioperative management of hypertension , were also mentioned . The TSOC/THS hypertension guidelines provide the most up date d information available in the management of hypertension . The guidelines are not m and atory , and members of the task force fully realize that treatment of hypertension should be individualized to address each patient 's circumstances . Ultimately , the decision of the physician decision remains of the utmost importance in hypertension management",
"AIM To determine the effects of a perindopril-based blood pressure lowering regimen on major cardiac events among hypertensive and non-hypertensive patients with a history of cerebrovascular disease . METHODS AND RESULTS A total of 6105 individuals with a history of stroke or transient ischaemic attack were r and omly assigned active treatment ( n=3051 ) or placebo ( n=3054 ) . Active treatment comprised the angiotensin-converting-enzyme inhibitor perindopril ( 4 mg daily ) , with the addition of the diuretic indapamide at the discretion of treating physicians . Over a mean of 3.9 years of follow-up , active treatment reduced blood pressure by 9/4 mm Hg compared with placebo and reduced the primary outcome , stroke , by 28 % . Major coronary events occurred in 269 participants ( active 3.8 % , placebo 5.0 % ) and heart failure was diagnosed in 264 participants ( active 3.7 % , placebo 4.9 % ) . Active treatment reduced the risk of major coronary events by 26 % ( 95 % CI : 6 - 42 % ; p=0.02 ) and the risk of congestive heart failure by 26 % ( 5 - 42 % ; p=0.02 ) . For each of these outcomes , there was no clear evidence of differences between the treatment effects in participants classified as hypertensive or non-hypertensive , and those with or without a history of coronary heart disease . CONCLUSIONS Among individuals with cerebrovascular disease , blood pressure lowering with a regimen involving perindopril and indapamide not only reduced the risk of stroke , but also substantially reduced the risks of cardiac outcomes",
"Vascular dementia is a major cause of mental and physical disability in Western countries . Treatment of vascular dementia is currently based on the recognition and control of vascular risk factors , while specific drugs have not been approved yet . The aim of the present multinational , double-blind , placebo-controlled study was to evaluate the safety and efficacy of nimodipine administered for as long as 26 weeks in improving cognition or slowing cognitive deterioration in patients defined as having multi-infa rct dementia ( DSM-III-R criteria ) . Two hundred and fifty-nine patients were included ( 128 nimodipine , 131 placebo ) , and 251 were available for the intention-to-treat analysis . No significant difference between drug-treated and placebo patients was noted on the Gottfries-Brâne-Steen scale score ( primary efficacy criterion ) , the remaining neuropsychological tests ( Zahlen-Verbindungs-Test , Fuld-Object-Memory Evaluation , Word Fluency Test , Digit Span , Mini-Mental State Examination ) , and the functional scales ( index of Activity of Daily Living , Instrumental Activity of Daily Living , Rapid Disability Scale , Clinical Dementia Rating ) , although the majority of changes were in favor of the active drug group . A lower incidence of cerebrovascular and cardiac events was observed in the nimodipine-treated patients in comparison with the placebo group . This study failed to show a significant effect of nimodipine on cognitive , social or global assessment s in patients defined as affected by multi-infa rct dementia according to the DSM-III-R criteria . A post-hoc analysis ( presented in an accompanying paper ) suggests that nimodipine may have a favorable effect in the subgroup of patients defined as affected by subcortical ( small vessel ) vascular dementia",
"BACKGROUND Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke . In addition , inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events , including stroke . However , the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established . We evaluated the effects of therapy with an angiotensin-receptor blocker , telmisartan , initiated early after a stroke . METHODS In a multicenter trial involving 20,332 patients who recently had an ischemic stroke , we r and omly assigned 10,146 to receive telmisartan ( 80 mg daily ) and 10,186 to receive placebo . The primary outcome was recurrent stroke . Secondary outcomes were major cardiovascular events ( death from cardiovascular causes , recurrent stroke , myocardial infa rct ion , or new or worsening heart failure ) and new-onset diabetes . RESULTS The median interval from stroke to r and omization was 15 days . During a mean follow-up of 2.5 years , the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group . A total of 880 patients ( 8.7 % ) in the telmisartan group and 934 patients ( 9.2 % ) in the placebo group had a subsequent stroke ( hazard ratio in the telmisartan group , 0.95 ; 95 % confidence interval [ CI ] , 0.86 to 1.04 ; P=0.23 ) . Major cardiovascular events occurred in 1367 patients ( 13.5 % ) in the telmisartan group and 1463 patients ( 14.4 % ) in the placebo group ( hazard ratio , 0.94 ; 95 % CI , 0.87 to 1.01 ; P=0.11 ) . New-onset diabetes occurred in 1.7 % of the telmisartan group and 2.1 % of the placebo group ( hazard ratio , 0.82 ; 95 % CI , 0.65 to 1.04 ; P=0.10 ) . CONCLUSIONS Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke , major cardiovascular events , or diabetes . ( Clinical Trials.gov number , NCT00153062 .",
"OBJECTIVE To assess the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal ( total ) stroke in isolated systolic hypertension . DESIGN Multicenter , r and omized , double-blind , placebo-controlled . SETTING Community-based ambulatory population in tertiary care centers . PARTICIPANTS 4736 persons ( 1.06 % ) from 447,921 screenees aged 60 years and above were r and omized ( 2365 to active treatment , 2371 to placebo ) . Systolic blood pressure ranged from 160 to 219 mm Hg and diastolic blood pressure was less than 90 mm Hg . Of the participants , 3161 were not receiving antihypertensive medication at initial contact , and 1575 were . The average systolic blood pressure was 170 mm Hg ; average diastolic blood pressure , 77 mm Hg . The mean age was 72 years , 57 % were women , and 14 % were black . INTERVENTIONS -- Participants were stratified by clinical center and by antihypertensive medication status at initial contact . For step 1 of the trial , dose 1 was chlorthalidone , 12.5 mg/d , or matching placebo ; dose 2 was 25 mg/d . For step 2 , dose 1 was atenolol , 25 mg/d , or matching placebo ; dose 2 was 50 mg/d . MAIN OUTCOME MEASURES Primary . Nonfatal and fatal ( total ) stroke . Secondary . Cardiovascular and coronary morbidity and mortality , all-cause mortality , and quality of life measures . RESULTS Average follow-up was 4.5 years . The 5-year average systolic blood pressure was 155 mm Hg for the placebo group and 143 mm Hg for the active treatment group , and the 5-year average diastolic blood pressure was 72 and 68 mm Hg , respectively . The 5-year incidence of total stroke was 5.2 per 100 participants for active treatment and 8.2 per 100 for placebo . The relative risk by proportional hazards regression analysis was 0.64 ( P = .0003 ) . For the secondary end point of clinical nonfatal myocardial infa rct ion plus coronary death , the relative risk was 0.73 . Major cardiovascular events were reduced ( relative risk , 0.68 ) . For deaths from all causes , the relative risk was 0.87 . CONCLUSION In persons aged 60 years and over with isolated systolic hypertension , antihypertensive stepped-care drug treatment with low-dose chlorthalidone as step 1 medication reduced the incidence of total stroke by 36 % , with 5-year absolute benefit of 30 events per 1000 participants . Major cardiovascular events were reduced , with 5-year absolute benefit of 55 events per 1000",
"Post-stroke Antihypertensive Treatment Study ( PATS ) was a r and omized , double-blind and placebo-controlled trial , which aim ed at determining whether antihypertensive treatment could reduce the risk of fatal and nonfatal stroke incidence in patients with a history of stroke or transient ischemic attack ( TIA ) . 5,665 patients were r and omized by a sealed envelope system . Systolic blood pressure ( SBP ) ranged from 80 to 280 mm Hg and diastolic ( DBP ) from 50 to 150 mmHg . The average SBP was 154 mmHg and average DBP 93 mmHg . The mean age was 60 years . Among the patients , women accounted for 28 % . In 71 % the latest stroke was ischemic . Average follow-up approximated to 2 years . The three-year average SBP was 149 mmHg for the placebo group and 144 mmHg for the indapamide treatment group , and the three-year DBP was 89 mmHg and 87 mmHg respectively . The three-year first incidence of fatal and nonfatal stroke was 12.3 per 100 patients placebo treatment and 9.4 per 100 with indapamide . The relative risk by proportional hazards regression analysis was 0.71 ( P = 0.0009 ) . For deaths from all causes , the relative risk was 0.91 . ( P > 0.05 ) . The findings of this trial indicate that in patients with a history of stroke or TIA , blood pressure reduction of 5/2 mmHg with 2.5 mg indapamide reduced the first incidence of fatal and nonfatal stroke by 29 % , with three-year absolute benefit of 29 events per 1000 participants",
"BACKGROUND The apparent shortfall in prevention of coronary heart disease ( CHD ) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used . For a given reduction in blood pressure , some suggested that newer agents would confer advantages over diuretics and beta blockers . Our aim , therefore , was to compare the effect on non-fatal myocardial infa rct ion and fatal CHD of combinations of atenolol with a thiazide versus amlodipine with perindopril . METHODS We did a multicentre , prospect i ve , r and omised controlled trial in 19 257 patients with hypertension who were aged 40 - 79 years and had at least three other cardiovascular risk factors . Patients were assigned either amlodipine 5 - 10 mg adding perindopril 4 - 8 mg as required ( amlodipine-based regimen ; n=9639 ) or atenolol 50 - 100 mg adding bendroflumethiazide 1.25 - 2.5 mg and potassium as required ( atenolol-based regimen ; n=9618 ) . Our primary endpoint was non-fatal myocardial infa rct ion ( including silent myocardial infa rct ion ) and fatal CHD . Analysis was by intention to treat . FINDINGS The study was stopped prematurely after 5.5 years ' median follow-up and accumulated in total 106 153 patient-years of observation . Though not significant , compared with the atenolol-based regimen , fewer individuals on the amlodipine-based regimen had a primary endpoint ( 429 vs 474 ; unadjusted HR 0.90 , 95 % CI 0.79 - 1.02 , p=0.1052 ) , fatal and non-fatal stroke ( 327 vs 422 ; 0.77 , 0.66 - 0.89 , p=0.0003 ) , total cardiovascular events and procedures ( 1362 vs 1602 ; 0.84 , 0.78 - 0.90 , p all-cause mortality ( 738 vs 820 ; 0.89 , 0.81 - 0.99 , p=0.025 ) . The incidence of developing diabetes was less on the amlodipine-based regimen ( 567 vs 799 ; 0.70 , 0.63 - 0.78 , p amlodipine-based regimen prevented more major cardiovascular events and induced less diabetes than the atenolol-based regimen . On the basis of previous trial evidence , these effects might not be entirely explained by better control of blood pressure , and this issue is addressed in the accompanying article . Nevertheless , the results have implication s with respect to optimum combinations of antihypertensive agents ",
"A r and omised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years . The principal antihypertensive agents were atenolol and bendrofluazide . There was a reduction in the rate of fatal stroke in the treatment group to 30 % of that in the control group ( 95 % confidence interval 11 - 84 % , p less than 0.025 ) . The rate of all strokes ( fatal and non-fatal ) in the treatment group was 58 % of that in the control group ( 95 % confidence interval 35 - 96 % , p less than 0.03 ) . The incidence of myocardial infa rct ion and total mortality was unaffected by treatment . Question naires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment",
"BACKGROUND The optimal combination drug therapy for hypertension is not established , although current U.S. guidelines recommend inclusion of a diuretic . We hypothesized that treatment with the combination of an angiotensin-converting-enzyme ( ACE ) inhibitor and a dihydropyridine calcium-channel blocker would be more effective in reducing the rate of cardiovascular events than treatment with an ACE inhibitor plus a thiazide diuretic . METHODS In a r and omized , double-blind trial , we assigned 11,506 patients with hypertension who were at high risk for cardiovascular events to receive treatment with either benazepril plus amlodipine or benazepril plus hydrochlorothiazide . The primary end point was the composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for angina , resuscitation after sudden cardiac arrest , and coronary revascularization . RESULTS The baseline characteristics of the two groups were similar . The trial was terminated early after a mean follow-up of 36 months , when the boundary of the prespecified stopping rule was exceeded . Mean blood pressures after dose adjustment were 131.6/73.3 mm Hg in the benazepril-amlodipine group and 132.5/74.4 mm Hg in the benazepril-hydrochlorothiazide group . There were 552 primary - outcome events in the benazepril-amlodipine group ( 9.6 % ) and 679 in the benazepril-hydrochlorothiazide group ( 11.8 % ) , representing an absolute risk reduction with benazepril-amlodipine therapy of 2.2 % and a relative risk reduction of 19.6 % ( hazard ratio , 0.80 , 95 % confidence interval [ CI ] , 0.72 to 0.90 ; P death from cardiovascular causes , nonfatal myocardial infa rct ion , and nonfatal stroke , the hazard ratio was 0.79 ( 95 % CI , 0.67 to 0.92 ; P=0.002 ) . Rates of adverse events were consistent with those observed from clinical experience with the study drugs . CONCLUSIONS The benazepril-amlodipine combination was superior to the benazepril-hydrochlorothiazide combination in reducing cardiovascular events in patients with hypertension who were at high risk for such events . ( Clinical Trials.gov number , NCT00170950 .",
"Background and Purpose : & bgr;‐Blockers prevent vascular events in patients after myocardial infa rct ion and lower blood pressure , the main risk factor for stroke . Hence , we assessed the effects of atenolol on the occurrence of death from vascular causes , stroke , or myocardial infa rct ion and on blood pressure in patients after a transient ischemic attack or nondisabling ischemic stroke . Methods : In a double‐blind , placebo‐controlled r and omized clinical trial we studied the occurrence of the outcome event death from vascular causes , nonfatal stroke , or nonfatal myocardial infa rct ion and the outcome event fatal or nonfatal stroke as well as blood pressure on follow‐up . A total of 1,473 aspirin‐treated patients with transient ischemic attack or nondisabling ischemic stroke were r and omized to 50 mg atenolol daily or placebo . The mean follow‐up was 2.6 years . Results : Patients on atenolol had a risk of 97/732 ( 13.3 % ) for the combined outcome event versus a risk of 95/741 ( 12.8 % ) for those on placebo ( adjusted hazard ratio , 1.00 ; 95 % confidence interval , 0.76‐1.33 ) . The adjusted hazard ratio for fatal or nonfatal stroke was 0.82 ( 95 % confidence interval , 0.57‐1.19 ) . More patients on & bgr;‐blocker ( 153 ) reported adverse effects than on placebo ( 103 ) . At the first follow‐up visit after r and omization ( median at 4 months ) systolic blood pressure in the atenolol group had dropped by 8.0 mm Hg compared with 2.2 mm Hg in the placebo group ( difference , 5.8 mm Hg ; 95 % confidence interval , 2.9‐8.6 mm Hg ) . For diastolic blood pressure this difference was 2.9 mm Hg ( 95 % confidence interval , 1.5‐4.4 mm Hg ) . Conclusions : Our data neither confirm nor rule out that atenolol prevents important vascular events in patients after transient ischemic attack or nondisabling ischemic stroke , given the modest effect on blood pressure , the restrictions in patient selection , and the limited number of patient‐years . ( Stroke 1993;24:543‐548",
"The Study on COgnition and Prognosis in the Elderly ( SCOPE ) assessed the effect of c and esartan on cardiovascular outcomes in elderly patients with mild to moderate hypertension . Patients were r and omized to c and esartan 8–16 mg daily ( n = 2477 ) or placebo ( n = 2460 ) . Due to extensive add‐on therapy , blood pressure reduction was only about 3/2 mmHg greater in the c and esartan group than in the control group . Nevertheless , non‐fatal stroke was reduced by 28 % ( p = 0.04 ) in the c and esartan group compared to the control group , and there was a non‐significant 11 % reduction in major cardiovascular events ( p = 0.19 ) . This report provides results in pre‐specified subgroups of patients ( age , gender , diabetes , history of stroke , smoking and cardiovascular risk at r and omization ) . Reductions in major cardiovascular events and stroke with c and esartan‐based therapy were indicated in all subgroups . A significant interaction between treatment and subgroups was found for one pair of subgroups only ; the reduction in major cardiovascular events with c and esartan was greater in patients with a previous stroke ( 64 % reduction , p = 0.004 ) than in those without ( 5 % reduction , p>0.20 ) . In conclusion , this analysis indicates consistent favourable effects of c and esartan‐based therapy on major cardiovascular events and stroke across the different subgroups of patients . However , the benefit was particularly pronounced in patients who entered the study with a previous stroke",
"Summary The latter was due to a reduction in cardiac mortality ( −38 % , p=0.036 ) and a nonsignificant decrease in cerebrovascular mortality ( −32 % , p=0.16 ) . In the double-blind part of the trial , the total mortality rate was not significantly reduced ( −26 % , p=0.077 ) . However , cardiovascular mortality was reduced in the actively treated group ( −38 % , p=0.023 ) , owing to a reduction in cardiac deaths ( −47 % , p=0.048 ) and a non-significant decrease in cerebrovascular mortality ( −43 % , p=0.15 ) . Deaths from myocardial infa rct ion were reduced ( −60 % , p=0.043 ) , and study -terminating morbid cardiovascular events were significantly reduced by active treatment ( −60 % , p=0.0064 ) . Non-terminating cerebrovascular events were reduced ( −52 % , p=0.026 ) , but the non-terminating cardiac events were not ( + 3 % , p=0.98 ) . In the patients r and omised to active treatment there were 29 fewer cardiovascular events and 14 fewer cardiovascular deaths per 1000 patient years during the double-blind part of the trial . A double-blind r and omised placebo-controlled trial of antihypertensive treatment was conducted in patients over the age of 60 . Entry criteria included both a sitting diastolic blood pressure on placebo treatment in the range 90 to 119 mm Hg and a systolic pressure in the range 160 to 239 mm Eg . 840 patients were r and omised either to active treatment ( hydrochlorothiazide and triamterene ) or to matching placebo . If the blood pressure remained raised , methyldopa was added to the active regimen and matching placebo in the placebo group . An overall intention-to-treat analysis , combining the double-blind part of the trial and all subsequent follow-up , revealed a non-significant change in total mortality rate ( −9 % , p=0.41 ) but a significant reduction in cardiovascular mortality rate ( −27 % , p=0.037 )",
"Hypertension is the most common condition seen in primary care and leads to myocardial infa rct ion , stroke , renal failure , and death if not detected early and treated appropriately . Patients want to be assured that blood pressure ( BP ) treatment will reduce their disease burden , while clinicians want guidance on hypertension management using the best scientific evidence . This report takes a rigorous , evidence -based approach to recommend treatment thresholds , goals , and medications in the management of hypertension in adults . Evidence was drawn from r and omized controlled trials , which represent the gold st and ard for determining efficacy and effectiveness . Evidence quality and recommendations were grade d based on their effect on important outcomes . There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg ; however , there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal , or in those younger than 30 years for a diastolic goal , so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion . The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease ( CKD ) as for the general hypertensive population younger than 60 years . There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor , angiotensin receptor blocker , calcium channel blocker , or thiazide-type diuretic in the nonblack hypertensive population , including those with diabetes . In the black hypertensive population , including those with diabetes , a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy . There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes . Although this guideline provides evidence -based recommendations for the management of high BP and should meet the clinical needs of most patients , these recommendations are not a substitute for clinical judgment , and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient"
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Background : Respiratory tract infections ( RTIs ) represent one of the main health problems in children . Probiotics are viable bacteria that colonize the intestine and affect the host intestinal microbial balance . Accumulating evidence suggests that probiotic consumption may decrease the incidence of or modify RTIs . The authors systematic ally review ed data from r and omized controlled trials ( RCTs ) to investigate the effect of probiotic consumption on RTIs in children . Methods : MEDLINE / PubMed , Embase , Cochrane Library , and Web of Science were systematic ally search ed for RCTs regarding the effect of probiotics on RTIs in children . The outcomes included number of children experienced with at least 1 RTI episode , duration of illness episodes , days of illness per subject , and school/day care absenteeism due to infection . A r and om-effects model was used to calculate pooled relative risks , or mean difference ( MD ) with the corresponding 95 % confidence interval ( CI ) . Results : A total of 23 trials involving 6269 children were eligible for inclusion in the systematic review . None of the trials showed a high risk of bias . The quality of the evidence of outcomes was moderate . The age range of subjects was from newborn to 18 years . The results of meta- analysis showed that probiotic consumption significantly decreased the number of subjects having at least 1 RTI episode ( 17 RCTs , 4513 children , relative risk 0.89 , 95 % CI 0.82–0.96 , P = 0.004 ) . Children supplemented with probiotics had fewer numbers of days of RTIs per person compared with children who had taken a placebo ( 6 RCTs , 2067 children , MD −0.16 , 95 % CI −0.29 to 0.02 , P = 0.03 ) , and had fewer numbers of days absent from day care/school ( 8 RCTs , 1499 children , MD −0.94 , 95 % CI −1.72 to −0.15 , P = 0.02 ) . However , there was no statistically significant difference of illness episode duration between probiotic intervention group and placebo group ( 9 RCTs , 2817 children , MD −0.60 , 95 % CI −1.49 to 0.30 , P = 0.19 ) . Conclusion : Based on the available data and taking into account the safety profile of RCTs , probiotic consumption appears to be a feasible way to decrease the incidence of RTIs in children
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"Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters ",
"Background : To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases ( CIDs ) and the change of behavior because of illness in children . Subjects/ Methods : We conducted a double-blinded , r and omized , placebo-controlled allocation concealment clinical trial in the Washington , DC metropolitan area . Participants were 638 children 3–6 years old in daycare/schools . The intervention was a fermented dairy drink containing a specific probiotic strain or matching placebo with no live cultures for 90 consecutive days . Two primary outcomes were assessed : incidence of CIDs and change of behavior because of illness ( both assessed by parental report ) . Results : The rate of change of behavior because of illness was similar among active and control groups . However , the incidence rate for CIDs in the active group ( 0.0782 ) is 19 % lower than that of the control group ( 0.0986 ) ( incidence rate ratio=0.81 , 95 % CI : 0.65 , 099 ) P=0.046 . Conclusions : Daily intake of a fermented dairy drink containing the probiotic strain L. casei DN-114 001 showed some promise in reducing overall incidence of illness , but was primarily driven by gastrointestinal infections and there were no differences in change of behavior",
"Background : Viral respiratory infections are common in infants and can be severe . The new p and emic influenza virus H1N1v2009 was feared to cause particularly severe outcomes . Objective : This study aim ed at evaluating the impact of H1N1v2009 on the viral epidemiology , the clinical presentation and the severity of respiratory infections in infants . Patients and Methods : This prospect i ve epidemiologic study included all infants A nasal swab was taken for viral detection and analyzed by immunofluorescence and , if negative , polymerase chain reaction . Severe respiratory infection was defined by a score of respiratory severity . Results : One thous and twenty-one infectious episodes with a respiratory sample met inclusion criteria . Eight hundred thirty-four sample s ( 81.7 % ) were positive . The viruses with the highest incidence were the respiratory syncytial virus ( 34.2 % ) , the rhinoviruses ( 23.9 % ) , the coronaviruses ( 9.3 % ) and H1N1v2009 ( 7.7 % ) . Of all infections , 28.6 % were severe and more frequent in infants with risk factors . H1N1v2009 infections had a low risk of severe respiratory disease ( odds ratios = 0.15 ) and hospitalization ( odds ratios = 0.40 ) compared with the other viruses . Respiratory syncytial virus infections had a high risk of respiratory severity ( odds ratios = 7.85 ) and were responsible for 71.4 % of admissions to the intensive care unit . Conclusion : Despite the modest impact of H1N1v2009 observed in this study , further surveillance is needed to detect virological factors that may increase its severity",
"Background and aims : The purpose of this study was to investigate the efficacy of a synbiotic supplementation in reducing common winter diseases in children . Methods : A r and omized , double-blind , placebo-controlled , multicentre study was conducted in young school-age children ( 3—7 years old ) during a winter period . Participants were otherwise healthy children who suffered from at least three episodes of ear , nose and throat ( ENT ) , respiratory tract or gastrointestinal illness during the previous winter . They were supplemented daily with either a synbiotic preparation ( Lactobacillus helveticus R0052 , Bifidobacterium infantis R0033 , Bifidobacterium bifidum R0071 , and fructooligosaccharide ) or a matched placebo for 3 months . Over this period , all emergent health episodes of any type were recorded by parents in a diary . They were checked by investigators at regular monthly visits . The main study outcome was the percentage of children free of any episode during the study course . Results : We r and omized 135 children ( mean age : 4.1±1.0 years ) to the synbiotic group ( n = 62 ) or placebo ( n = 73 ) group . At least one illness episode was reported in 32 children in the synbiotic group and 50 in the placebo group ( 51.6 % versus 68.5 % ) . This corresponded to a significant 25 % relative risk reduction ( 95 % CI 0.6—44.3 % ; p = 0.045 ) . This difference was due to a decrease in the number of children who suffered from at least one ENT , respiratory tract or gastrointestinal disorder ( 50.0 % with synbiotic versus 67.1 % with placebo ; p = 0.044 ) . At least one sickness school day loss was noted in 25.8 % of children with the synbiotic as compared with 42.5 % with placebo ( p = 0.043 ) . No treatment related side effects were detected in either group . Conclusions : This study suggests that a 3-month supplementation with this synbiotic preparation can decrease the risk of occurrence of common infectious diseases in children and limits the risk of school day loss ",
"BACKGROUND & AIMS The aim of our study was to investigate the role of Bifidobacterium animalis subsp . lactis ( BB-12 ( ® ) ) in the prevention of common ( gastrointestinal and respiratory ) infections in healthy children who attend day care centers . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in 210 children who attend day care centers . They were r and omly allocated to receive placebo ( Placebo group , n = 106 ) or BB-12 ( ® ) at a dose of 10(9 ) colony-forming units ( CFU ) ( Intervention group , n = 104 ) during the 3-month intervention period . RESULTS Intention to treat analysis was used . There were overall 99 infections in Placebo group and 97 in Intervention group ( incidence rate ratio = 1.0014 , p = 0.992 , Poisson regression model ) . Overall 65 children ( 61.3 % ) in Placebo group and 67 ( 64.4 % ) in Intervention group had common infections ( p = 0.642 ) . Mean number of infections per child was 0.93 ( range 0 - 3 ) in Placebo group and 0.93 ( range 0 - 3 ) in Intervention group ( p = 0.898 ) . There was no difference in secondary ( duration of symptoms , number of children with gastrointestinal and respiratory tract infections , absence from day care center due to infections , use of antibiotics ) and exploratory ( type of gastrointestinal and respiratory tract infection ) endpoints between groups . CONCLUSION Results of performed study show that BB-12 ( ® ) has no effect on the prevention of gastrointestinal and respiratory tract infections in healthy children who attend day care centers",
"Background : Specific probiotic bacteria have proven to be effective in the prevention and treatment of infectious diseases in early life in at-risk population s. The impact of administration of Bifidobacterium animalis subsp . lactis BB-12 ( BB-12 ) on the risk of acute infectious diseases was studied in healthy children . Methods : In this double-blind , placebo-controlled study , 109 1-mo-old infants were assigned r and omly to a probiotic group receiving a BB-12–containing tablet ( n = 55 ) or a placebo ( n = 54 ) . Test tablets were administered to the infants twice a day ( daily dose of BB-12 10 billion colony-forming units ) until the age of 2 y with a novel slow-release pacifier or a spoon . Breastfeeding habits , pacifier use , dietary habits , medications , and all signs and symptoms of acute infections were registered in diaries by parents and in question naires by trained professionals . Results : The infants receiving BB-12 were reported to have experienced fewer respiratory tract infections ( RTIs ; 87 vs. 100 % ; risk ratio : 0.87 ; 95 % confidence interval : 0.76 , 1.00 ; P = 0.033 ) than the controls . No significant differences between the groups were observed in reported gastrointestinal symptoms , otitis media , or fever . The baseline characteristics of the two groups were similar , as was the duration of breastfeeding . Conclusion : Administration of BB-12 in early childhood may reduce RTIs",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Abstract Objective : To examine whether long term consumption of a probiotic milk could reduce gastrointestinal and respiratory infections in children in day care centres . Design : R and omised , double blind , placebo controlled study over seven months . Setting : 18 day care centres in Helsinki , Finl and . Participants : 571 healthy children aged 1 - 6 years : 282 ( mean ( SD ) age 4.6 ( 1.5 ) years ) in the intervention group and 289 ( mean ( SD ) age 4.4 ( 1.5 ) years ) in the control group . Intervention : Milk with or without Lactobacillus GG . Average daily consumption of milk in both groups was 260 ml . Main outcome measures : Number of days with respiratory and gastrointestinal symptoms , absences from day care because of illness , respiratory tract infections diagnosed by a doctor , and course of antibiotics . Results : Children in the Lactobacillus group had fewer days of absence from day care because of illness ( 4.9 ( 95 % confidence interval 4.4 to 5.5 ) v 5.8 ( 5.3 to 6.4 ) days , 16 % difference , P=0.03 ; age adjusted 5.1 ( 4.6 to 5.6 ) v 5.7 ( 5.2 to 6.3 ) days , 11 % difference , P=0.09 ) . There was also a relative reduction of 17 % in the number of children suffering from respiratory infections with complications and lower respiratory tract infections ( unadjusted absolute % reduction −8.6 ( −17.2 to −0.1 ) , P=0.05 ; age adjusted odds ratio 0.75 ( 0.52 to 1.09 ) , P=0.13 ) and a 19 % relative reduction in antibiotic treatments for respiratory infection ( unadjusted absolute % reduction −9.6 ( −18.2 to −1.0 ) , P=0.03 ; adjusted odds ratio 0.72 ( 0.50 to 1.03 ) , P=0.08 ) in the Lactobacillus group . Conclusions : Lactobacillus GG may reduce respiratory infections and their severity among children in day care . The effects of the probiotic Lactobacillus GG were modest but consistently in the same direction . What is already known on this topic Children attending day care centres are at high risk of respiratory and gastrointestinal infection The successful prevention of respiratory infections could be extremely useful for families and for society in general Short term use of probiotic bacteria has been shown to reduce the severity of rotavirus diarrhoea and the incidence of diarrhoea associated with the use of antibiotics What this study adds In a double blind , r and omised , long term study milk containing Lactobacillus GG slightly reduced the incidence of respiratory infections and antibiotic treatment in",
"Background / Objectives : Evidence suggests that the long-term consumption of probiotics may help in reducing the incidence of or modifying acute respiratory infection ( ARI ) . We assessed the role of the short-term use of probiotics in ARI in children . Subjects/ Methods : This was a r and omized , double-blind , controlled study that enrolled 315 children with 90 dropouts . On the first day of appearance of a sick household member , otherwise healthy children of both sexes aged 3–12 years were allocated to receive Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABLA-12 ( Up4-Junior ) in a dose of 5 billion colony-forming units daily with 50 mg of fructooligosaccharide ( the probiotic group ) or rice maltodexrin ( the control group ) . Test supplementation and follow-up lasted for 2 weeks or until the end of the secondary ARI in a child . The primary outcome measure was the incidence of ARI . Time to resolution and the severity of ARI served the secondary outcome measures . Results : In all , 64 of 113 children in the probiotic group ( 57 % ) and 73 of 112 children in the control group ( 65 % ) developed ARI ( P=0.261 ) . Time to resolution of the secondary ARI was shorter in the probiotic group ( 5.0 ( interquartile range ( IQR ) : 4.0–6.0 ) vs 7.0 ( IQR : 6.0–8.0 ) days , P The median severity of ARI was 240 ( IQR : 163–350 ) score-days in the probiotic vs 525 ( IQR : 364–736 ) score-days in the control group ( P<0.001 ) . Conclusions : The short-term use of probiotics does not reduce the incidence , but shortens ARI in preschool and elementary school children",
"Background Psychological models can be used to underst and and predict behaviour in a wide range of setting s. However , they have not been consistently applied to health professional behaviours , and the contribution of differing theories is not clear . The aim of this study was to explore the usefulness of a range of psychological theories to predict health professional behaviour relating to management of upper respiratory tract infections ( URTIs ) without antibiotics . Methods Psychological measures were collected by postal question naire survey from a r and om sample of general practitioners ( GPs ) in Scotl and . The outcome measures were clinical behaviour ( using antibiotic prescription rates as a proxy indicator ) , behavioural simulation ( scenario-based decisions to managing URTI with or without antibiotics ) and behavioural intention ( general intention to managing URTI without antibiotics ) . Explanatory variables were the constructs within the following theories : Theory of Planned Behaviour ( TPB ) , Social Cognitive Theory ( SCT ) , Common Sense Self-Regulation Model ( CS-SRM ) , Operant Learning Theory ( OLT ) , Implementation Intention ( II ) , Stage Model ( SM ) , and knowledge ( a non-theoretical construct ) . For each outcome measure , multiple regression analysis was used to examine the predictive value of each theoretical model individually . Following this ' theory level ' analysis , a ' cross theory ' analysis was conducted to investigate the combined predictive value of all significant individual constructs across theories . Results All theories were tested , but only significant results are presented . When predicting behaviour , at the theory level , OLT explained 6 % of the variance and , in a cross theory analysis , OLT ' evidence of habitual behaviour ' also explained 6 % . When predicting behavioural simulation , at the theory level , the proportion of variance explained was : TPB , 31 % ; SCT , 26 % ; II , 6 % ; OLT , 24 % . GPs who reported having already decided to change their management to try to avoid the use of antibiotics made significantly fewer scenario-based decisions to prescribe . In the cross theory analysis , perceived behavioural control ( TPB ) , evidence of habitual behaviour ( OLT ) , CS-SRM cause ( chance/bad luck ) , and intention entered the equation , together explaining 36 % of the variance . When predicting intention , at the theory level , the proportion of variance explained was : TPB , 30 % ; SCT , 29 % ; CS-SRM 27 % ; OLT , 43 % . GPs who reported that they had already decided to change their management to try to avoid the use of antibiotics had a significantly higher intention to manage URTIs without prescribing antibiotics . In the cross theory analysis , OLT evidence of habitual behaviour , TPB attitudes , risk perception , CS-SRM control by doctor , TPB perceived behavioural control and CS-SRM control by treatment entered the equation , together explaining 49 % of the variance in intention . Conclusion The study provides evidence that psychological models can be useful in underst and ing and predicting clinical behaviour . Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour . However , a number of conceptual and method ological challenges remain",
"A r and omised , double-blind , placebo-controlled study was conducted to determine whether probiotics might be effective in reducing the risk of infections in infancy . Infants requiring formula before the age of 2 months were recruited from community well-baby clinics . Infant formula supplemented with the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 or placebo was administered daily until the age of 12 months . Incidence of early infections ( before the age of 7 months ) and incidence of recurrent ( three or more ) infections during the first year of life were recorded as the main outcome measures of the study . During the first 7 months of life , seven out of thirty-two ( 22 % ) infants receiving probiotics and twenty out of forty ( 50 % ) infants receiving placebo experienced acute otitis media ( risk ratio ( RR ) 0.44 ( 95 % CI 0.21 , 0.90 ) ; P = 0.014 ) and antibiotics were prescribed for ten out of thirty-two ( 31 % ) infants receiving probiotics and twenty-four out of forty ( 60 % ) infants receiving placebo ( RR 0.52 ( 95 % CI 0.29 , 0.92 ) ; P = 0.015 ) . During the first year of life , nine out of thirty-two ( 28 % ) infants receiving probiotics and twenty-two out of forty ( 55 % ) infants receiving placebo encountered recurrent respiratory infections ( RR 0.51 ( 95 % CI 0.27 , 0.95 ) ; P = 0.022 ) . These data suggest that probiotics may offer a safe means of reducing the risk of early acute otitis media and antibiotic use and the risk of recurrent respiratory infections during the first year of life . Further clinical trials are warranted",
"OBJECTIVE : The incidence of nosocomial infections , predominantly gastrointestinal and respiratory , in children in developed countries is high , ranging from 5 % to 44 % . There is no effective strategy for preventing these infections . The objective of our study was to investigate the role of Lactobacillus GG ( LGG ) in preventing nosocomial gastrointestinal and respiratory tract infections at a pediatric hospital . METHODS : We conducted a r and omized , double-blind , placebo-controlled trial of 742 hospitalized children . They were r and omly allocated to receive for their hospitalization LGG at a dose of 109 colony-forming units in 100 mL of a fermented milk product ( LGG group , n = 376 ) or placebo that was the same postpasteurized fermented milk product without LGG ( placebo group , n = 366 ) . RESULTS : In the LGG group , compared with the placebo group , we found a significantly reduced risk for gastrointestinal infections ( relative risk [ RR ] : 0.40 [ 95 % confidence interval ( CI ) : 0.25–0.70 ] ; number needed to treat : 15 [ 95 % CI : 9–34 ) ] , respiratory tract infections ( RR : 0.38 [ 95 % CI : 0.18–0.85 ] ; number needed to treat : 30 [ 95 % CI : 16–159 ] ) , vomiting episodes ( RR : 0.5 [ 95 % CI : 0.3–0.9 ] ) , diarrheal episodes ( RR : 0.24 [ 95 % CI : 0.10–0.50 ] ) , episodes of gastrointestinal infections that lasted > 2 days ( RR : 0.40 [ 95 % CI : 0.25–0.70 ] ) , and episodes of respiratory tract infections that lasted > 3 days ( RR : 0.4 [ 95 % CI : 0.2–0.9 ] ) . Groups did not differ in hospitalization duration ( P = .1 ) . CONCLUSIONS : LGG administration can be recommended as a valid measure for decreasing the risk for nosocomial gastrointestinal and respiratory tract infections in pediatric facilities",
"OBJECTIVE : Probiotic consumption effects on cold and influenza-like symptom incidence and duration were evaluated in healthy children during the winter season . METHODS : In this double-blind , placebo-controlled study , 326 eligible children ( 3–5 years of age ) were assigned r and omly to receive placebo ( N = 104 ) , Lactobacillus acidophilus NCFM ( N = 110 ) , or L acidophilus NCFM in combination with Bifidobacterium animalis subsp lactis Bi-07 ( N = 112 ) . Children were treated twice daily for 6 months . RESULTS : Relative to the placebo group , single and combination probiotics reduced fever incidence by 53.0 % ( P = .0085 ) and 72.7 % ( P = .0009 ) , coughing incidence by 41.4 % ( P = .027 ) and 62.1 % ( P = .005 ) , and rhinorrhea incidence by 28.2 % ( P = .68 ) and 58.8 % ( P = .03 ) , respectively . Fever , coughing , and rhinorrhea duration was decreased significantly , relative to placebo , by 32 % ( single strain ; P = .0023 ) and 48 % ( strain combination ; P Antibiotic use incidence was reduced , relative to placebo , by 68.4 % ( single strain ; P = .0002 ) and 84.2 % ( strain combination ; P reductions in days absent from group child care , by 31.8 % ( single strain ; P = .002 ) and 27.7 % ( strain combination ; P dietary probiotic supplementation for 6 months was a safe effective way to reduce fever , rhinorrhea , and cough incidence and duration and antibiotic prescription incidence , as well as the number of missed school days attributable to illness , for children 3 to 5 years of age",
"Objective : The risk of infection may be increased in people under stress such as shift workers . This study examined the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 ( verum ) on the incidence of respiratory and gastrointestinal common infectious diseases ( CIDs ) and on immune functions in healthy shift workers . Methods : The study was single-center , r and omized , double-blind , and controlled . Volunteers received 200 g/day of verum ( n = 500 ) or control product ( n = 500 ) for 3 months ; 1-month follow-up was carried out . Results : The cumulated number of CIDs ( primary outcome ) was not significantly different between groups . Because the Poisson distribution of the primary parameter did not fully fit the observed data , a post hoc categorical analysis was applied and showed a significantly lower cumulated number of CIDs in the verum group during the product consumption phase ( odds ratio [ OR ] = 0.75 , 95 % confidence interval [ CI ] 0.59–0.95 , p = 0.017 ) . Verum also reduced the proportion of volunteers experiencing at least 1 CID ( 43 % vs. 51 % , p = 0.005 ) , increased the time to the first occurrence of CID ( p = 0.017 ) in the whole population , and reduced the cumulated number of CIDs in the subgroup of smokers ( p = 0.033 ) . In the course of CID , cumulated duration of fever was lower in the verum group ( in the whole study phase ) ( p = 0.022 ) , and an increase in leukocyte , neutrophil , and natural killer ( NK ) cell counts and activity ( p = 0.047 to p safe and well tolerated . Conclusion : The results indicate that daily consumption of a fermented dairy product containing Lactobacillus casei DN-114 001 could reduce the risk of common infections in stressed individuals such as shift workers",
"Abstract Objective : To study the effect of recolonisation with α streptococci with the ability to inhibit the growth of otopathogens ( “ interfering ” activity ) on the recurrence of acute otitis media in susceptible children and the effect on the frequency of secretory otitis media . Design : Double blind , r and omised , placebo controlled study . Setting : Ear , nose , and throat clinic with three doctors . Participants : 130 children prone to otitis media aged between 6 months and 6 years , 108 of whom were eligible and followed for 3 months . Main outcome measures : Recurrence of otitis media during follow up and a normal tympanic membrane at the last valid visit . Interventions : Children with no recurrences during the last month received phenoxymethylpenicillin ( n=22 ) , and those with a recurrence within 1 month received amoxicillin clavulanic acid ( n=86 ) , both twice daily for 10 days . These were followed by a streptococcal or placebo solution sprayed into the nose for a further 10 days . At day 60 the same spray was started for another 10 days . Results : At 3 months 22 children ( 42 % ) given the streptococcal spray were healthy and had a normal tympanic membrane compared with 12 ( 22 % ) of those given placebo . This difference was shown separately for recurrences of both acute otitis media and secretory otitis media . Conclusions : Selected bacteria with the ability to inhibit the growth of common otopathogens can be used to protect against recurrent acute otitis media and secretory otitis media in children",
"Background / Objectives : To determine whether long-term daily consumption of milk containing probiotic Lactobacillus rhamnosus GG ( GG ) decreases respiratory illness in children . Subjects/ Methods : A r and omized , double-blind , placebo-controlled trial was conducted with 523 children aged 2–6 years attending day care centers in Finl and . Subjects received either normal milk or the same milk with GG on three daily meals for 28 weeks . Daily recording of childrens ’ symptoms was done by parents . Primary outcome data from 501 subjects were available for analysis , and data from 128 subjects were analyzed as completed cases in terms of recovery of GG in fecal sample s. Results : Number of days with at least one respiratory symptom in all subjects was 5.03/month ( 95 % confidence interval ( CI ) : 4.92–5.15 ) in the GG group and 5.17/month ( 95 % CI : 5.05–5.29 ) in the placebo group incidence rate ratio ( IRR ) 0.97 ; 95 % CI : 0.94–1.00 ; P=0.098 ) . In the completed cases , the figures were 4.71 days/month ( 95 % CI : 4.52–4.90 ) in the GG group and 5.67 days/month ( 95 % CI : 5.40–5.94 ) in the placebo group ( IRR 0.83 ; 95 % CI : 0.78–0.88 ; P<0.001 ) . Conclusions : Consumption of GG reduced the occurence of respiratory illness in children attending day care centers in the completed cases subgroup , but not in the total population . Thus , future clinical trials are warranted to clarify the association between fecal recovery of a probiotic and the symptom prevalence",
"BACKGROUND The common cold is responsible for the largest proportion of school and work absenteeism and causes a huge economic burden . None of the current interventions is greatly effective for prevention . Our aim was to assess the efficacy of a two-strain combination probiotic for prevention of common cold symptoms in healthy schoolchildren . METHODS A double-blind r and omized controlled trial was performed during the winter season in a public school of central Thail and . Children , aged 8 - 13 years , were r and omized to receive either a two-strain combination probiotic ( Lactobacillus acidophilus and Bifidobacterium bifidum ) or placebo given twice a day for 3 months . The primary outcome was any symptom of cold during the 3-month study period while vomiting , diarrhea , use of antibiotics , school absence due to any cause , school absence due to cold and duration of all symptoms were secondary outcomes . RESULTS Of the 40 children in each group , 31 ( 77 % ) in the probiotic group , compared to 38 ( 95 % ) in the placebo group ( P= 0.048 ) , developed at least one symptom of cold . Children in the probiotics group had significantly lower risk of fever , cough , rhinorrhea , school absence and school absence related to common cold compared to children in the placebo group . There was no impact on diarrhea and vomiting . CONCLUSION A two-strain probiotic combination given twice a day for 3 months was able to reduce the symptoms of the common cold and school absenteeism in schoolchildren",
"Background : Several studies have suggested that probiotics ( proB ) and /or prebiotics ( preB ) could reduce the burden of infection in infants and toddlers . We aim ed to determine whether follow-up formula supplemented with proB and preB could reduce the risk of acute otitis media ( AOM ) . Methods : In this double-blind , placebo-controlled trial from November 2007 to April 2009 , 37 pediatricians in France enrolled children 7 to 13 months of age with high risk of AOM who were r and omly assigned to receive follow-up formula supplemented with proB ( Streptococcus thermophilus NCC 2496 , Streptococcus salivarius DSM 13084 , Lactobacillus rhamnosus LPR CGMCC 1.3724 ) and preB ( Raftilose/Raftiline ) or follow-up formula alone ( placebo ) . During 12 months , the 2 groups were compared for number of AOM episodes diagnosed ( primary outcome ) and secondary outcomes by the Poisson model ( incidence rate ratio [ IRR ] ) or logistic regression ( odds ratio ; and 95 % confidence interval [ 95 % CI ] ) after adjustment on covariates of interest . Results : We enrolled 224 children ( 112 in each group ) . All children were vaccinated ( 4 doses ) with the 7-valent pneumococcal conjugate vaccine ; demographic characteristics were similar in the 2 groups . In total , 486 AOM episodes were reported , 249 and 237 in the treatment and control groups , respectively . The treatment and control groups did not differ in incidence of AOM ( IRR 1.0 , 95 % CI : 0.8–1.2 ) , lower respiratory tract infections ( IRR 0.9 , 0.7–1.2 ) or number of antibiotic treatment courses ( IRR = 1.0 , 95 % CI : 0.8–1.2 ) . Treatment was not associated with recurrent AOM ( odds ratio 1.0 , 95 % CI : 0.5–1.7 ) . With regard to gastrointestinal disorders , both formulas were well tolerated . Conclusion : The proB and preB included in follow-up formula given to children at 7 to 13 months of age did not reduce the risk of AOM , recurrent AOM , antibiotic use or lower respiratory tract infections at 1 year",
"BACKGROUND The incidence of nosocomial infections in children in developed countries is still high , ranging from 8 % to 30 % , and st and ard preventive measures , such as increased hygiene , are not sufficiently efficacious . One of the potential strategies for their prevention is the use of probiotics . OBJECTIVE The aim of the study was to investigate the role of Bifidobacterium animalis subsp . lactis in preventing nosocomial infections in the acute hospital setting . DESIGN We conducted a r and omized , double-blind , placebo-controlled trial in 727 hospitalized children ( aged 1 - 18 y ) . The children were r and omly allocated to receive placebo ( placebo group , n = 365 ) or B. animalis subsp . lactis at a dose of 10(9 ) colony-forming units/d ( intervention group , n = 362 ) once daily for the entire duration of the hospital stay . Nosocomial infections were defined as infections that occurred > 48 h after hospital admission and that were not present or incubating at the time of admission . RESULTS Analysis was performed on an intention-to-treat basis . There was no difference in the study primary outcome or incidence of common nosocomial gastrointestinal and respiratory tract infections between groups ( 22 vs. 29 infections , respectively ; incidence rate ratio = 0.76 ; 95 % CI : 0.41 , 1.36 ; P = 0.32 ) . No difference was found for the duration of common nosocomial infections [ mean ( range ) : 3.58 ( 1 - 7 ) vs. 3.79 ( 1 - 8 ) d , in placebo vs. intervention group ; P = 0.74 ] . There was also no difference between the intervention and placebo groups for any of the other secondary outcomes ( incidence of gastrointestinal and respiratory tract infections separately , duration of gastrointestinal and respiratory infections , and duration of hospitalization ) and exploratory outcomes ( gastrointestinal and respiratory symptoms , severity of gastrointestinal and respiratory tract infections , and the use of antibiotics ) . CONCLUSIONS The results of this study show that the use of B. animalis subsp . lactis failed to prevent nosocomial infections in an acute- setting pediatric hospital in children who were > 1 y of age . However , it should be taken into account that the overall incidence of nosocomial infections was lower than expected . This trial was registered at clinical trials.gov as NCT01702766",
"Objectives : The aim of the study was to examine the effects of a follow-on formula containing Lactobacillus fermentum CECT5716 ( L fermentum ) on the incidence of infections in infants between the ages of 6 and 12 months . Patients and Methods : A r and omized double-blinded controlled study including infants at the age of 6 months was conducted . Infants were assigned r and omly to either follow-on formula supplemented with L fermentum plus galactooligosaccharide ( experimental group , EG ) , or the same formula supplemented with only galactooligosaccharide ( control group , CG ) . The main outcome was the incidence of infections for the 6-month duration of the study . Results : The EG showed a significant 46 % reduction in the incidence rate ( IR ) of gastrointestinal infections ( EG : 0.196 ± 0.51 , CG : 0.363 ± 0.53 , IR ratio 0.54 , 95 % confidence interval [ CI ] 0.307–0.950 , P = 0.032 ) , 27 % reduction in the incidence of upper respiratory tract infections ( EG : 0.969 ± 0.96 , CG : 1.330 ± 1.23 , IR ratio 0.729 , 95 % CI 0.46–1.38 , P = 0.026 ) , and 30 % reduction in the total number of infections ( EG : 1.464 ± 1.15 , CG : 2.077 ± 1.59 , IR ratio 0.70 , 95 % CI 0.46–1.38 , P = 0.003 ) , at the end of the study period compared with CG . Conclusions : Administration of a follow-on formula with L fermentum CECT5716 may be useful for the prevention of community-acquired gastrointestinal and upper respiratory infections ",
"OBJECTIVE Two r and omized controlled clinical trials have shown that Lactobacillus ( L ) reuteri DSM 17938 reduces the duration of diarrhea in children hospitalized due to acute infectious diarrhea . This was the first trial evaluating the efficacy of L. reuteri DSM 17938 in outpatient children with acute infectious diarrhea . METHODS This was a multicenter , r and omized , single-blinded , case control clinical trial in children with acute watery diarrhea . A total of 64 children who presented at outpatient clinics were enrolled . The probiotic group received 1 × 10(8)CFU L. reuteri DSM 17938 for five days in addition to oral rehydration solution ( ORS ) and the second group was treated with ORS only . The primary endpoint was the duration of diarrhea ( in hours ) . The secondary endpoint was the number of children with diarrhea at each day of the five days of intervention . Adverse events were also recorded . RESULTS The mean duration of diarrhea was significantly reduced in the L. reuteri group compared to the control group ( approximately 15h , 60.4±24.5h [ 95 % CI : 51.0 - 69.7h ] vs. 74.3±15.3h [ 95 % CI : 68.7 - 79.9h ] , p ) . The percentage of children with diarrhea was lower in the L. reuteri group ( 13/29 ; 44.8 % ) after 48h than the control group ( 27/31 ; 87 % ; RR : 0.51 ; 95 % CI : 0.34 - 0.79 , p the percentage of children with diarrhea . No adverse effects related to L. reuteri were noted . CONCLUSION L. reuteri DSM 17938 is effective , safe , and well-tolerated in outpatient children with acute infectious diarrhea",
"The impact of controlled administration of Bifidobacterium animalis subsp . lactis BB-12 ( BB-12 ) on the risk of acute infectious diseases was studied in healthy newborn infants . In this double-blind , placebo-controlled study , 109 newborn 1-month-old infants were assigned r and omly to a probiotic group receiving a BB-12-containing tablet ( n 55 ) or to a control group receiving a control tablet ( n 54 ) . Test tablets were administered to the infants twice a day ( daily dose of BB-12 10 billion colony-forming units ) from the age of 1 - 2 months to 8 months with a novel slow-release pacifier or a spoon . Breastfeeding habits , pacifier use , dietary habits , medications and all signs and symptoms of acute infections were registered . At the age of 8 months , faecal sample s were collected for BB-12 determination ( quantitative PCR method ) . The baseline characteristics of the two groups were similar , as was the duration of exclusive breastfeeding . BB-12 was recovered ( detection limit log 5 ) in the faeces of 62 % of the infants receiving the BB-12 tablet . The daily duration of pacifier sucking was not associated with the occurrence of acute otitis media . No significant differences between the groups were observed in reported gastrointestinal symptoms , otitis media or use of antibiotics . However , the infants receiving BB-12 were reported to have experienced fewer respiratory infections ( 65 v. 94 % ; risk ratio 0·69 ; 95 % CI 0·53 , 0·89 ; P = 0·014 ) than the control infants . Controlled administration of BB-12 in early childhood may reduce respiratory infections",
"BACKGROUND We aim ed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces cerevisiae in a r and omized double-blind placebo-controlled clinical trial . METHODS Overall , 179 adults with irritable bowel syndrome ( Rome III criteria ) were r and omized to receive once daily 500 mg of Saccharomyces cerevisiae , delivered by one capsule ( n = 86 , F : 84 % , age : 42.5 ± 12.5 ) , or placebo ( n = 93 , F : 88 % , age : 45.4 ± 14 ) for 8 weeks followed by a 3-week washout period . After a 2-week run-in period , cardinal symptoms ( abdominal pain/discomfort , bloating/distension , bowel movement difficulty ) and changes in stool frequency and consistency were recorded daily and assessed each week . A safety assessment was carried out throughout the study . RESULTS The proportion of responders , defined by an improvement of abdominal pain/discomfort , was significantly higher ( p = 0.04 ) in the treated group than the placebo group ( 63 % vs 47 % , OR = 1.88 , 95 % , CI : 0.99 - 3.57 ) in the last 4 weeks of treatment . A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms . Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency . CONCLUSION Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores without stool modification . Thus , Saccharomyces cerevisiae may be a new promising c and i date for improving abdominal pain in subjects with irritable bowel syndrome",
"Objective : Secretory otitis media ( SOM ) is characterised by persistent fluid in the middle ear cavity , but the cause is unknown . We investigated the clinical , bacteriological and immunological effects of treatment with probiotic bacteria on SOM . Design : In this double-blind pilot/preliminary study , 60 children with long-st and ing SOM ( median 6 months ) who were scheduled for insertion of tympanostomy tubes were r and omised to nasal spray treatment with Streptococcus sanguinis , Lactobacillus rhamnosus or placebo for 10 days before surgery . Clinical evaluation was carried out after 10 days of treatment . Middle ear fluid ( MEF ) was collected during surgery for quantification of cytokines and detection of bacteria by culture and polymerase chain reaction ( PCR ) . Nasopharyngeal swabs were obtained before treatment and at surgery . Results : Complete or significant clinical recovery occurred in 7/19 patients treated with S sanguinis compared to 1/17 patients in the placebo group ( p rhamnosus treatment group , 3/18 patients were cured or much better ( p = 0.60 compared with placebo ) . Spray treatment did not alter the composition of the nasopharyngeal flora or the cytokine pattern observed in the nasopharynx or MEF , except for a higher level of IL-8 found in the nasopharynx of L rhamnosus treated children . Conclusions : This study shows that spray treatment with S sanguinis may be effective against SOM . The mechanism for the effect remains to be investigated",
"Data on the economic burden of lower respiratory tract infections ( LRTI ) in young children are lacking in Germany . The objective of the cost-of-illness study was to estimate the economic impact of community-acquired LRTI and nosocomial LRTI as well as of infections due to respiratory syncytial virus ( RSV ) , parainfluenza viruses ( PIV ) and influenza viruses ( IV ) . The economic analysis is part of the PRI.DE study , a prospect i ve , multi-centre , population -based epidemiological study on the impact of LRTI in children aged 0 to 36 months in Germany . The analysis includes children with community-acquired infections ( 1329 cases treated as out patients , 2039 cases treated as in patients ) and nosocomial infections ( 90 cases ) . Medical services consumed were generated by chart abstract ion and parental expenses data by telephone interviews within four weeks after physician visit or hospitalisation . Costs were evaluated from following perspectives : third party payer , parent and society . Total costs for outpatient treatment are € 123 per LRTI case . Stratified by virus type , total costs per case are € 163 ( RSV ) , € 100 ( PIV ) and € 223 ( IV ) . Total costs per hospitalised LRTI case amount to € 2579 . Stratified by virus type , total costs per case are € 2772 ( RSV ) , € 2374 ( PIV ) and € 2597 ( IV ) . Total costs per nosocomial case are € 2814 . Economic burden due to LRTI is € 213 million annually . It is concluded that treatment of LRTI in children up to age three causes a considerable economic burden in Germany . Presented results are the first data describing the economic burden of LRTI in young children assessed by means of the incidence data for Germany . This cost-of-illness study provides basic data for further decision-making , focusing on the economic assessment of preventive strategies for RSV , PIV and IV infections",
"BACKGROUND : Constipation is a frustrating symptom affecting 3 % of children worldwide . A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women . Our aim was to assess the effects of this product in constipated children . METHODS : In this prospect i ve r and omized , double-blind , controlled trial , 159 constipated children ( defecation frequency were r and omly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 ( n = 79 ) or a control product ( n = 80 ) twice a day for 3 weeks . The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption . Analyses were by intention to treat . RESULTS : Eleven children did not return to any follow-up visit ( 5 in the probiotic group , 6 in the control group ) and were therefore excluded from the final analysis . Thus , 74 children in each group were analyzed . The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups , but the difference was not statistically significant ( 2.9 ± 3.2 in probiotic group versus 2.6 ± 2.6 in control group , P = .35 ) . There were no serious adverse events . CONCLUSIONS : In constipated children , the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency , but this increase was comparable in the control group . There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients . Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation",
"ABSTRACT The probiotic potential of 47 selected strains ofLactobacillus spp . was investigated . The strains were examined for resistance to pH 2.5 and 0.3 % oxgall , adhesion to Caco-2 cells , and antimicrobial activities against enteric pathogenic bacteria in model systems . From the results obtained in vitro , five strains , Lactobacillus rhamnosus 19070 - 2 , L. reuteri DSM 12246 , L. rhamnosus LGG , L. delbrueckii subsp.lactis CHCC 2329 , and L. casei subsp.alactus CHCC 3137 , were selected for in vivo studies . The daily consumption by 12 healthy volunteers of two doses of 1010 freeze-dried bacteria of the selected strains for 18 days was followed by a washout period of 17 days . Fecal sample s were taken at days 0 and 18 and during the washout period at days 5 and 11.Lactobacillus isolates were initially identified by API 50CHL and internal transcribed spacer PCR , and their identities were confirmed by restriction enzyme analysis in combination with pulsed-field gel electrophoresis . Among the tested strains , L. rhamnosus 19070 - 2 , L. reuteri DSM 12246 , and L. rhamnosus LGG were identified most frequently in fecal sample s ; they were found in 10 , 8 , and 7 of the 12 sample s tested during the intervention period , respectively , whereas reisolations were less frequent in the washout period . The bacteria were reisolated in concentrations from 105 to 108 cells/g of feces . Survival and reisolation of the bacteria in vivo appeared to be linked to pH tolerance , adhesion , and antimicrobial properties in vitro",
"BACKGROUND & AIMS The aim of our study was to investigate the role of Lactobacillus GG ( LGG ) in the prevention of gastrointestinal and respiratory tract infections in children who attend day care centers . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in 281 children who attend day care centers . They were r and omly allocated to receive LGG at a dose of 10(9 ) colony-forming units in 100ml of a fermented milk product ( LGG group , n=139 ) or placebo that was the same post-pasteurized fermented milk product without LGG ( placebo group , n=142 ) during the 3-month intervention period . RESULTS Compared to the placebo group , children in the LGG group had a significantly reduced risk of upper respiratory tract infections ( RR 0.66 , 95 % CI 0.52 to 0.82 , NNT 5 , 95 % CI 4 to 10 ) , a reduced risk of respiratory tract infections lasting longer than 3 days ( RR 0.57 , 95 % CI 0.41 to 0.78 , NNT 5 , 95 % CI 4 to 11 ) , and a significantly lower number of days with respiratory symptoms ( p no risk reduction in regard to lower respiratory tract infections ( RR 0.82 , 95 % CI 0.24 to 2.76 ) . Compared with the placebo group , children in the LGG group had no significant reduction in the risk of gastrointestinal infections ( RR 0.63 , 95 % CI 0.38 to 1.06 ) , vomiting episodes ( RR 0.60 , 95 % CI 0.29 to 1.24 ) , and diarrheal episodes ( RR 0.63 , 95 % CI 0.35 to 1.11 ) as well as no reduction in the number of days with gastrointestinal symptoms ( p=0.063 ) . CONCLUSION LGG administration can be recommended as a valid measure for decreasing the risk of upper respiratory tract infections in children attending day care centers",
"OBJECTIVE : To test the efficacy of Lactobacillus reuteri on infantile colic and to evaluate its relationship to the gut microbiota . STUDY DESIGN : Fifty exclusively breastfed colicky infants , diagnosed according to modified Wessel 's criteria , were r and omly assigned to receive either L reuteri DSM 17 938 ( 108 colony-forming units ) or placebo daily for 21 days . Parental question naires monitored daily crying time and adverse effects . Stool sample s were collected for microbiologic analysis . RESULTS : Forty-six infants ( L reuteri group : 25 ; placebo group : 21 ) completed the trial . Daily crying times in minutes/day ( median [ interquartile range ] ) were 370 ( 120 ) vs 300 ( 150 ) ( P = .127 ) on day 0 and 35.0 ( 85 ) vs 90.0 ( 148 ) ( P = .022 ) on day 21 , in the L reuteri and placebo groups , respectively . Responders ( 50 % reduction in crying time from baseline ) were significantly higher in the L reuteri group versus placebo group on days 7 ( 20 vs 8 ; P = .006 ) , 14 ( 24 vs 13 ; P = .007 ) , and 21 ( 24 vs 15 ; P = .036 ) . During the study , there was a significant increase in fecal lactobacilli ( P = .002 ) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only ( P = .001 ) . There were no differences in weight gain , stooling frequency , or incidence of constipation or regurgitation between groups , and no adverse events related to the supplementation were observed . CONCLUSION : L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of infantile colic and was well tolerated and safe . Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement"
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Background Improving physical functioning may be a future intervention to keep older adults driving safely longer as it can help maintain both physical and cognitive health longer . This systematic review assesses the evidence on the association between three physical functioning measures : the Short Physical Performance Battery , the Timed Up- and -Go test , and the Rapid Pace Walk with driving outcomes in older adults . Methods Older adult studies published between 1994 and 2015 that included the Short Physical Performance Battery , the Timed Up- and -Go test , or the Rapid Pace Walk as a measure of physical functioning and included a driving-related outcome were identified through a comprehensive search and review ed following Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines . Results Thirteen studies involving 5,313 older adults met the inclusion criteria . Lower Short Physical Performance Battery scores were associated with reduced driving exposure and increased cessation in all three Short Physical Performance Battery studies . The Timed Up- and -Go test was not associated with the driving outcomes ( cessation , ability , crashes , and citations ) in either of the two Timed Up- and -Go studies . Poorer Rapid Pace Walk scores were associated with decreased driving ability in two studies and with reduced driving exposure in one study , but not associated with driving ability , crashes , citations , or cessation in the remaining five Rapid Pace Walk studies . Conclusions The Timed Up- and -Go test measure appears not to be a useful measure of physical functioning for the driving outcomes included here . The Rapid Pace Walk may be useful in studies of driving ability and exposure . More driving studies should consider using the Short Physical Performance Battery to determine if it may be useful as a risk factor assessment for identifying individuals at risk of certain driving outcomes
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"We examined the physical , visual , health , and cognitive abilities of 1,656 older adults as prospect i ve predictors of self-reported driving cessation over a 5-year period . We examined the time to driving cessation across 5 years after we controlled for days driven per week at baseline and any cognitive intervention participation . Older age , congestive heart failure , and poorer physical performance ( according to the Turn 360 Test ) were statistically significant risk factors for driving cessation . Slower speed of processing ( according to the Digit Symbol Substitution and Useful Field of View tests ) was a significant risk factor even after we took baseline driving , age , health , vision , and physical performance into consideration . Implication s are that assessment s of cognitive speed of processing can provide valuable information about the subsequent risk of driving cessation",
"A summary performance measure comprised of a hierarchical balance task , a 4-meter walk , and five repetitive chair st and s is increasingly being used as a predictor of independent living for older persons . The reliability and sensitivity to change of this summary performance measure have not been investigated , however . Because a measure can be reliable while being unresponsive to change , this study presents information on both the reliability and sensitivity to change for the summary performance measure . This is a 3-year prospect i ve cohort study of 1,002 moderately to severely disabled older women . Short- and long-term reliability was assessed by intraclass correlation coefficients ( ICC ) . Sensitivity to change was assessed by slope differences for three age categories ( 65 - 74 , 75 - 84 , and > or=85 ) over six 6-month follow-up periods . Sensitivity to change was also assessed by summary performance change scores for those who did and did not suffer from one of four medical events [ myocardial infa rct ion ( MI ) , stroke , hip fracture , or congestive heart failure ( CHF ) ] at follow-up . The summary performance measure showed excellent reliability . Intraclass correlation coefficients ranged from 0.88 to 0.92 for measures made 1 week apart . The 6-month average intraclass correlation coefficient was 0.77 ( range 0.72 - 0.79 ) . The summary performance measure was also highly responsive to change . Subjects who suffered an incident MI , stroke , hip fracture , or CHF at follow-up were significantly more likely to have poorer summary performance change scores ( -2.25 ) compared with those who did not have one of these medical events ( -0.24 ) . Additionally , subjects who suffered one of these events improved their summary performance scores in the following assessment period by 0.72 . With increasing utilization of the summary performance measure by research ers and clinicians it is important that the measurement properties of this instrument are known . Our results show that the summary performance measure has excellent reliability and is highly sensitive to change",
"BACKGROUND Hospitalization represents a stressful and potentially hazardous event for older persons . We evaluated the value of the Short Physical Performance Battery ( SPPB ) in predicting rates of functional decline , rehospitalization , and death in older acutely ill patients in the year after discharge from the hospital . METHODS Prospect i ve cohort study of 87 patients aged 65 years and older who were able to walk and with a Mini-Mental State Examination score ≥ 18 and admitted to the hospital with a clinical diagnosis of congestive heart failure , pneumonia , chronic obstructive pulmonary disease , or minor stroke . Patients were evaluated with the SPPB at hospital admission , were reevaluated the day of hospital discharge , and 1 month later . Subsequently , they were followed every 3 months by telephone interviews to ascertain functional decline , new hospitalizations , and vital status . RESULTS After adjustment for potential confounders , including self-report activity of daily living and comorbidity , the SPPB score at discharge was inversely correlated with the rate of decline in activity of daily living performance over the follow-up ( p poor SPPB scores at hospital discharge ( 0 - 4 ) had a greater risk of rehospitalization or death ( odds ratio : 5.38 , 95 % confidence interval : 1.82 - 15.9 ) compared with those with better SPPB scores ( 8 - 12 ) . Patients with early decline in SPPB score after discharge also had steeper increase in activity of daily living difficulty and higher risk of rehospitalization or death over the next year . CONCLUSIONS In older acutely ill patients who have been hospitalized , the SPPB provides important prognostic information . Lower extremity performance-based functional assessment might identify older patients at high risk of poor outcomes after hospital discharge",
"PURPOSE Recent prospect i ve studies have found that cognition is a more salient predictor of driving cessation than physical performance or demographic factors among community-dwelling older adults . However , these studies have been limited to 5 years of follow-up . The current study used data from the Maryl and Older Drivers Project to examine predictors of driving cessation in older adults over a 10-year period . DESIGN AND METHODS Participants ( N = 1,248 ) completed baseline and 5-year assessment s of physical and cognitive abilities . Driving status was ascertained at baseline and annually thereafter . RESULTS Cox proportional hazard models were used to examine the risk of driving cessation as a function of demographic , physical , and cognitive predictors . The final model indicated three significant predictors of driving cessation , older age at baseline ( hazard ratio [ HR ] = 1.12 , p days driven per week ( HR = 0.83 , p = .05 ) , and slower speed of processing as measured by the Useful Field of View Test ( HR = 1.76 , p cognitive speed of processing to the maintenance of driving . Brief cognitive assessment can be conducted in the field to potentially identify older adults at increased risk for driving cessation . Further research is needed to determine the costs and potential benefits of such screening",
"PROBLEM To develop appropriate assessment criteria to measure the performance of older drivers using an interactive PC-based driving simulator , and to determine which measures were associated with the occurrence of motor-vehicle crash . METHOD One hundred and twenty-nine older drivers residing in a metropolitan city volunteered to participate in this retrospective cohort study . Using the driving simulator , appropriate driving tasks were devised to test the older drivers , whose performances were assessed by 10 reliable assessment criteria . Logistic regression analysis was then undertaken to determine those criteria that influence the self-reported crash outcome . RESULTS As expected , driving skill of older drivers was found to decline with age . Over 60 % of the sample participants reported having at least one motor-vehicle crash during the past year . Adjusting for age in a logistic regression analysis , the cognitive abilities associated with the crash occurrence were working memory , decision making under pressure of time , and confidence in driving at high speed . SUMMARY The findings of this retrospective study indicated those individuals at inflated risk of vehicle crashes could be identified using the PC-based interactive driving simulator . Prospect i ve studies need to be undertaken to determine whether the driving simulator can predict future crash events . IMPACT ON INDUSTRY This study demonstrated an economical driving simulator approach to screen out problematic or unsafe older drivers before a more detailed but expensive road test is considered",
"OBJECTIVES To determine the prevalence of driving in older adults with mild to moderate physical frailty and to compare characteristics of current frail older adult drivers with those of former drivers in the sample . DESIGN Retrospective study of frail older adults enrolled in r and omized trials of exercise and hormone replacement therapy . SETTING Urban , academic medical center . PARTICIPANTS One hundred eighty-three sedentary community-dwelling men and women aged 75 and older with mild to moderate physical frailty , as defined by two of the following three criteria : modified Physical Performance Test ( PPT ) score between 18 and 32 , peak oxygen uptake ( VO2 ) between 10 and 18 mL/kg per minute , and self-report of difficulty or assistance with one activity of daily living ( ADL ) or two instrumental ADLs . Participants were classified as current or former drivers . MEASUREMENTS Demographic characteristics , medical diagnoses , medication use , modified PPT score , and psychometric tests . RESULTS The majority ( 85 % ) of the participants were drivers . Former drivers were more likely to be older , be female , reside in congregate independent living for the elderly , have a higher incidence of arthritis and congestive heart failure , take sedating medications , have lower total ADL scores , have lower VO2 peak scores , and have more impairment on tests of cognition and physical strength , although only age , type of residence , and grip strength were independent predictors of driving cessation in the regression analysis . CONCLUSION Despite the presence of physical frailty , many older adults choose to continue to drive . Further studies are needed to better underst and the driving behaviors of frail older adults and explore opportunities for optimizing driving abilities",
"Objective Performance measures provide important information , but the meaning of change in these measures is not well known . The purpose of this research is to 1 ) examine the effect of treatment assignment on the relationship between self-report and performance ; 2 ) to estimate the magnitude of meaningful change in 400- meter walk time ( 400MWT ) , 4-meter gait speed ( 4MGS ) , and Short Physical Performance Battery ( SPPB ) and 3 ) to evaluate the effect of direction of change on estimates of magnitude . Design This is a secondary analysis of data from the LIFE-P study , a single blinded r and omized clinical trial . Using change over one year , we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT , 4MGS and SPPB . Setting Four university-based clinical research sites . Participants Sedentary adults aged 70–89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline ( n=424 ) . Interventions A structured exercise program versus health education . Measurements 400MWT , 4MGS , SPPB . Results Relationships between self-report and performance measures were consistent between treatment arms . Minimally significant change estimates were 400MWT : 20–30 seconds , 4MGS : 0.03–0.05 m/s and SPPB : 0.3–0.8 points . Substantial changes were 400MWT : 50–60 seconds , 4MGS : 0.08 m/s , SPPB : 0.4–1.5 points . Magnitudes of change for improvement and decline were not significantly different . Conclusions The magnitude of clinical ly important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise . Due to limited power , the effect of direction of change on estimates of magnitude remains uncertain",
"BACKGROUND The present study examined whether aerobic fitness training of older humans can increase brain volume in regions associated with age-related decline in both brain structure and cognition . METHODS Fifty-nine healthy but sedentary community-dwelling volunteers , aged 60 - 79 years , participated in the 6-month r and omized clinical trial . Half of the older adults served in the aerobic training group , the other half of the older adults participated in the toning and stretching control group . Twenty young adults served as controls for the magnetic resonance imaging ( MRI ) , and did not participate in the exercise intervention . High spatial resolution estimates of gray and white matter volume , derived from 3D spoiled gradient recalled acquisition MRI images , were collected before and after the 6-month fitness intervention . Estimates of maximal oxygen uptake ( VO2 ) were also obtained . RESULTS Significant increases in brain volume , in both gray and white matter regions , were found as a function of fitness training for the older adults who participated in the aerobic fitness training but not for the older adults who participated in the stretching and toning ( nonaerobic ) control group . As predicted , no significant changes in either gray or white matter volume were detected for our younger participants . CONCLUSIONS These results suggest that cardiovascular fitness is associated with the sparing of brain tissue in aging humans . Furthermore , these results suggest a strong biological basis for the role of aerobic fitness in maintaining and enhancing central nervous system health and cognitive functioning in older adults",
"PURPOSE The purpose of this article was to investigate the role of control beliefs in mediating the relationship between driving cessation and change in depressive symptoms in a population -based sample of older adults . DESIGN AND METHODS We report results from a prospect i ve , community-based cohort study that included two waves of data collected in 1992 and 1994 . Participants consisted of 700 men and women aged 70 and older , including 647 drivers and 53 participants who ceased driving between baseline ( 1992 ) and follow-up ( 1994 ) . Participants took part in interviews that included assessment s of driving status , sociodemographic characteristics , self-rated health , sensory function , depressive symptoms ( through the Center for Epidemiologic Studies -Depression scale ) , and expectancy of control . Using multilevel general linear models , we examined the extent to which driving status , expectancy of control , and relevant covariates explained change in depressive-symptom scores between baseline and follow-up . RESULTS Driving cessation was associated with an increase in depressive symptoms from baseline to follow-up . The higher depressive-symptom scores of ceased drivers relative to those of individuals who remained drivers at both waves was partly explained by a corresponding decrease in the sense of control among ceased drivers , and increased control beliefs among drivers . IMPLICATION S Interventions aim ed at promoting the maintenance of personal agency and associated control beliefs could be protective against the negative psychological concomitants of driving cessation",
"OBJECTIVES To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness . DESIGN Secondary data analyses using distribution- and anchor-based methods to determine meaningful change . SETTING Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors . PARTICIPANTS Older adults with mobility disabilities in a strength training trial ( n=100 ) , subacute stroke survivors in an intervention trial ( n=100 ) , and a prospect i ve cohort of community-dwelling older people ( n=492 ) . MEASUREMENTS Gait speed , Short Physical Performance Battery ( SPPB ) , 6-minute-walk distance ( 6MWD ) , and self-reported mobility . RESULTS Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed , 0.27 to 0.55 points for SPPB , and 19 to 22 m for 6MWD . Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed , 0.99 to 1.34 points for SPPB , and 47 to 49 m for 6MWD . Based on responsiveness indices , per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change . CONCLUSION Best initial estimates of small meaningful change are near 0.05 m/s for gait speed , 0.5 points for SPPB , and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed , 1.0 point for SPPB , and 50 m for 6MWD . For clinical use , substantial change in these measures and small change in gait speed and 6MWD , but not SPPB , are detectable . For research use , these measures yield feasible sample sizes for detecting meaningful change",
"PURPOSE The purpose of this study was to prospect ively examine the role of cognitive and instrumental functional performance in driving cessation while simultaneously accounting for any contributions of demographics , vision , physical performance , and health among a sample of older adults without dementia . DESIGN AND METHODS Included in the analyses were 1,838 participants from the Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) study who were drivers at baseline and completed the third-year assessment . Participants completed baseline assessment s of sociodemographic characteristics , health , sensory function , physical function , cognitive abilities , instrumental functional performance , and depressive symptoms . Driving status was again ascertained 3 years later . RESULTS We used Cox proportional hazard analyses to examine prospect i ve predictors of driving cessation over a 3-year period . The final model indicated four significant risk factors for driving cessation : older age ( hazard ratio [ HR ] = 1.06 , p = .009 ) , poorer balance as measured by the Turn 360 degrees test ( HR = 1.17 , p = .002 ) , slower cognitive speed of processing as measured by the Useful Field of View test ( HR = 1.37 , p = .004 ) , and poorer instrumental functional performance as assessed by the Everyday Problems Test ( HR = 1.59 , p cognitive speed of processing and instrumental functional performance may be better indicators of subsequent likelihood of driving cessation across 3 years among older adults . Poor health and vision may only impact driving cessation to the extent that cognitive speed of processing and instrumental functioning are affected",
"Older adults represent the fastest-growing population of drivers with a valid driver 's licence . Also common in this age group are multiple chronic medical conditions that may have an effect on physical function and driving ability . Determining the reliability of physical measures used to assess older drivers ' functional ability is important to identifying those who are safe to continue driving . Most previous reliability studies of clinical physical measures of health used test-retest intervals shorter than those between patient visits with a clinician . In the present study we examined a more clinical ly representative interval of 1 year to determine the stability of commonly used physical measures collected during the C and rive II prospect i ve cohort study of older drivers . Reliability statistics indicate that the sequential finger-thumb opposition , rapid pace walk and the Pelli-Robson contrast sensitivity tests have adequate stability over 1 year . Poor stability was observed for the one-legged stance and Snellen visual acuity test . Several assessment s with nominal data ( Marottoli method [ functional neck range of motion ] , whispered voice test , range of motion and strength testing ) lacked sufficient variability to conduct reliability analyses ; however , a lack of variability between test days suggests consistency over a 1-year time frame . Our results provide evidence that specific physical measures are stable in monitoring functional ability over the course of a year",
"OBJECTIVES To examine psychological , medical , and sensorimotor risk factors that predict driving cessation in older adults . DESIGN Prospect i ve cohort study including five waves of data collected in 1992 , 1993 , 1994 , 1995 , and 1997 . SETTING The Australian Longitudinal Study of Aging . PARTICIPANTS One thous and four hundred sixty-six men and women aged 70 and older drawn from the electoral roll and including 753 drivers at baseline . MEASUREMENTS Interviews , including assessment s of self-rated health ( indicating general well-being ) ; medical conditions ; driving status ; and clinical assessment s of vision , hearing , cognitive function , and grip strength , were conducted in 1992 ( baseline ) and 1994 . Information on current driving status was obtained at baseline and four subsequent waves ( 1993 , 1994 , 1995 , and 1997 ) . Drivers and nondrivers were compared at baseline . Risk factors for driving cessation were identified using logistic regression . RESULTS Drivers were younger and more likely to be male and had better self-rated health , vision , hearing , and cognitive performance than nondrivers at baseline . Seventeen percent of drivers in the study had vision of 6/18 or worse , and 7.3 % were classified as possibly cognitively impaired . In those identified as drivers at baseline , subsequent cessation was associated with increasing age , low grip strength , poorer cognitive performance , and poorer self-rated health . CONCLUSION Self-rated health and cognitive function were more important than medical conditions or sensory function for predicting driving cessation",
"The main aim of this research was to study the effects of a specific exercise program on the speed of behavior of older adults during on-the-road driving . Twenty-six drivers ( 55 - 78 yr old ) were r and omly assigned to either an exercise group or a control group . The exercise program ( 3 sessions of 60 min/wk for 8 wk ) incorporated tasks that induced the participants to respond quickly to challenging situations . On-the-road driving tasks ( under single- and dual-task conditions ) included measures of simple and choice reaction time , movement time , and response time . Significant positive effects were found at follow-up result ing from participation in the exercise program : Improvements were found for several measures in all driving tasks , and a composite score reflected a better general drivers ' speed of behavior . These results show that exercise can enhance speed of behavior in older drivers and should therefore be promoted",
"Background As the number of older drivers increases , concern has been raised about the potential safety implication s. Flexibility , coordination , and speed of movement have been associated with older drivers ’ on road performance . Objective To determine whether a multicomponent physical conditioning program targeted to axial and extremity flexibility , coordination , and speed of movement could improve driving performance among older drivers . Design R and omized controlled trial with blinded assignment and end point assessment . Participants r and omized to intervention underwent graduated exercises ; controls received home , environment safety modules . Participants Drivers , 178 , age ≥ 70 years with physical , but without substantial visual ( acuity 20/40 or better ) or cognitive ( Mini Mental State Examination score ≥24 ) impairments were recruited from clinics and community sources . Measurements On-road driving performance assessed by experienced evaluators in dual-brake equipped vehicle in urban , residential , and highway traffic . Performance rated three ways : ( 1 ) 36-item scale evaluating driving maneuvers and traffic situations ; ( 2 ) evaluator ’s overall rating ; and ( 3 ) critical errors committed . Driving performance reassessed at 3 months by evaluator blinded to treatment group . Results Least squares mean change in road test scores at 3 months compared to baseline was 2.43 points higher in intervention than control participants ( P = .03 ) . Intervention drivers committed 37 % fewer critical errors ( P = .08 ) ; there were no significant differences in evaluator ’s overall ratings ( P = .29 ) . No injuries were reported , and complaints of pain were rare . Conclusions This safe , well-tolerated intervention maintained driving performance , while controls declined during the study period . Having interventions that can maintain or enhance driving performance may allow clinician – patient discussion s about driving to adopt a more positive tone , rather than focusing on driving limitation or cessation",
"OBJECTIVES Increasing age , socioeconomic factors , and declining function and health have been linked to driving cessation , but little is known about the consequences of stopping driving . This study was design ed to test the hypothesis that driving cessation leads to a decline in out-of-home activity levels . METHODS In 1989 a survey of driving practice s was administered to surviving noninstitutionalized members of the New Haven Established Population s for Epidemiologic Studies of the Elderly ( EPESE ) cohort . Of 1,316 respondents , 502 were active drivers as of 1988 , 92 had stopped driving between 1982 and 1987 , and 722 never drove or stopped before 1982 . Information on sociodemographic and health-related variables came from in-home EPESE interviews in 1982 , 1985 , and 1988 , and from yearly phone interviews . Activity was measured at all three in-home interviews , and an activity measure was created based on self-reported participation in nine out-of-home activities . A repeated measures r and om-effects model was used to test the effect of driving cessation on activity while controlling for potential confounders . RESULTS Driving cessation was strongly associated with decreased out-of-home activity levels ( coefficient-1.081 , st and ard error 0.264 , p older drivers and developing alternative transportation strategies to help maintain their mobility",
"OBJECTIVE To determine how multiple risk factors for osteoporotic fractures could be modified by high-intensity strength training exercises in postmenopausal women . DESIGN R and omized controlled trial of 1-year duration . SETTING Exercise laboratory at Tufts University , Boston , Mass. POPULATION Forty postmenopausal white women , 50 to 70 years of age , participated in the study ; 39 women completed the study . The subjects were sedentary and estrogen-deplete . INTERVENTIONS High-intensity strength training exercises 2 days per week using five different exercises ( n = 20 ) vs untreated controls ( n = 19 ) . MAIN OUTCOME MEASURES Dual energy x-ray absorptiometry for bone status , one repetition maximum for muscle strength , 24-hour urinary creatinine for muscle mass , and backward t and em walk for dynamic balance . RESULTS Femoral neck bone mineral density and lumbar spine bone mineral density increased by 0.005 + /- 0.039 g/cm2 ( 0.9 % + /- 4.5 % ) ( mean + /- SD ) and 0.009 + /- 0.033 g/cm2 ( 1.0 % + /- 3.6 % ) , respectively , in the strength-trained women and decreased by -0.022 + /- 0.035 g/cm2 ( -2.5 % + /- 3.8 % ) and -0.019 + /- 0.035 g/cm2 ( -1.8 % + /- 3.5 % ) , respectively , in the controls ( P = .02 and .04 ) . Total body bone mineral content was preserved in the strength-trained women ( + 2.0 + /- 68 g ; 0.0 % + /- 3.0 % ) and tended to decrease in the controls ( -33 + 77 g ; -1.2 % + /- 3.4 % , P = .12 ) . Muscle mass , muscle strength , and dynamic balance increased in the strength-trained women and decreased in the controls ( P = .03 to High-intensity strength training exercises are an effective and feasible means to preserve bone density while improving muscle mass , strength , and balance in postmenopausal women",
"The purpose of this study was to investigate the effects of participation in an exercise program on several abilities associated with driving performance in older adults . Thirty-two subjects were r and omly assigned to either an exercise group ( 60 - 81 years , n=16 ) or a control group ( 60 - 82 years , n=16 ) . The exercise program was planned to stress perceptive , cognitive , and physical abilities . It lasted 12 weeks with a periodicity of three sessions of 60 min per week . Assessment s were conducted before and after the intervention on behavioral speed ( in single- and dual-task conditions ) , visual attention , psychomotor performance , speed perception ( time-to-contact ) , and executive functioning . Significant positive effects were found at 12-week follow-up result ing from participation in the exercise program . Behavioral speed improvements were found in reaction time , movement time , and response time ( both in single- and dual-task conditions ) ; visual attention improvements took place in speed processing and divided attention ; psychomotor performance improvements occurred in lower limb mobility . These results showed that exercise is capable of enhancing several abilities relevant for driving performance and safety in older adults and , therefore , should be promoted",
"BACKGROUND Chronic health conditions associated with ageing can lead to changes in driving ability . The Canadian Driving Research Initiative for Vehicular Safety in the Elderly ( C and rive II ) is a 5-year prospect i ve study funded by the Canadian Institutes of Health Research aim ing to develop an in-office screening tool that will help clinicians identify potentially at-risk older drivers . Currently , no tools exist to directly predict the risk of motor vehicle collision ( MVC ) in this population . The American Medical Association ( AMA ) , in collaboration with the National Highway Traffic Safety Association , has design ed an opinion-based guide for assessing medical fitness to drive in older adults and recommends that physicians use the Assessment of Driving Related Skills ( ADReS ) as a test battery to measure vision , cognition and motor/somatosensory functions related to driving . The ADReS consists of the Snellen visual acuity test , visual fields by confrontation test , Trail Making Test part B , clock drawing test , Rapid Pace Walk , and manual tests of range of motion and motor strength . We used baseline data from the C and rive/Ozc and rive common cohort of older drivers to evaluate the validity of the ADReS subtests . We hypothesized that participants who crashed in the 2 years before the baseline assessment would have poorer scores on the ADReS subtests than participants who had not crashed . METHODS In the C and rive/Ozc and rive study , 1230 participants aged 70 years or older were recruited from 7 Canadian cities , 1 Australian city and 1 New Zeal and city , all of whom completed a comprehensive clinical assessment at study entry . The assessment included all tests selected as part of the ADReS. For this historical cohort study , data on all crashes ( at-fault and non-at-fault ) that occurred within 2 years preceding the baseline assessment were obtained from the respective licensing jurisdictions . Those who crashed were compared to those who had not crashed on their ADReS subtest scores using Pearson 's chi-squared test and Student 's t-test . RESULTS Sixty-three of the 1230 participants ( 5.1 % ) were involved in an MVC within the 2 years preceding the baseline assessment . Contrary to our hypothesis , there were no statistically significant associations between abnormal performance on the tests constituting the ADReS and history of crash in the previous 2 years ( p>0.01 ) . DISCUSSION We found that a history of crash in the previous 2 years was not associated with abnormalities on the subtests comprising the ADReS. This suggests the need for prospect i ve analyses of risk factors over time to establish sensitive , valid predictors of crash that can be incorporated in clinical practice guidelines",
"OBJECTIVES To assess the ability of gait speed alone and a three-item lower extremity performance battery to predict 12-month rates of hospitalization , decline in health , and decline in function in primary care setting s serving older adults . DESIGN Prospect i ve cohort study . SETTING Primary care programs of a Medicare health maintenance organization ( HMO ) and Veterans Affairs ( VA ) system . PARTICIPANTS Four hundred eighty-seven persons aged 65 and older . MEASUREMENTS Lower extremity performance Established Population for Epidemiologic Studies of the Elderly ( EPESE ) battery including gait speed , chair st and s , and t and em balance tests ; demographics ; health care use ; health status ; functional status ; probability of repeated admission scale ( Pra ) ; and primary physician 's hospitalization risk estimate . RESULTS Veterans had poorer health and higher use than HMO members . Gait speed alone and the EPESE battery predicted hospitalization ; 41 % ( 21/51 ) of slow walkers ( gait speed hospitalized at least once , compared with 26 % ( 70/266 ) of intermediate walkers ( 0.6 - 1.0 m/s ) and 11 % ( 15/136 ) of fast walkers ( > 1.0 m/s ) ( P decline in function and health status in both health systems . Performance measures , alone or in combination with self-report measures , were more able to predict outcomes than self-report alone . CONCLUSION Gait speed and a physical performance battery are brief , quantitative estimates of future risk for hospitalization and decline in health and function in clinical population s of older adults . Physical performance measures might serve as easily accessible \" vital signs \" to screen older adults in clinical setting ",
"BACKGROUND This study examines , in initially nondisabled older persons , the impact of reduced lower extremity performance on subsequent hospitalizations . METHODS A 4-year prospect i ve cohort study was conducted among 3381 persons , aged 71 years and older , who initially reported no disability . At baseline , lower extremity performance was measured by an assessment of st and ing balance , a timed 2.4-m walk , and a timed test of rising from a chair five times . Data on subsequent hospital admissions and discharge diagnoses over 4 years were obtained from the Medicare data base . RESULTS During the follow-up period , nondisabled persons with poor lower extremity performance spent significantly more days in the hospital ( 17.7 days ) than those with intermediate and high performance ( 11.6 and 9.7 days , respectively ) . Poor lower extremity performance in nondisabled persons significantly predicted subsequent hospitalization over 4 years ( relative risk for hospitalization in those with poor vs high performance : 1.78 ; 95 % confidence interval , 1.45 - 2.17 ) . This increased hospitalization risk could not be explained by several indicators of baseline health status . Increased hospitalization risks were especially found for geriatric conditions , such as dementia , decubitus ulcer , hip fractures , other fractures , pneumonia , dehydration , and acute infections . CONCLUSIONS Even in persons who are currently nondisabled , a simple measure of lower extremity performance is predictive of subsequent hospitalization , especially for geriatric conditions",
"This prospect i ve cohort study evaluate the predictive value of physical performance measures for mortality in older French women , in particular those with a high health status . The subjects were 7,250 community-dwelling non-disabled French women aged 75 years or older , enrolled in the Epidémiologie de l’ostéoporose ( EPIDOS ) study . The short physical performance battery ( SPPB ) , including walking speed , repeated chair st and s , and balance tests , was administered and h and grip strength was measured . Anthropometric measurements , physical function , cognitive performance , sensory status , smoking , medical history , medication use , subjective self- assessment of health status , and physical activity level were assessed at the baseline visit . During a mean follow-up of 3.8 years , 754 ( 10.4 % ) participants died . Complementary analysis was performed on the 2,157 non-disabled healthiest participants ( no disease at baseline ) . The SPPB and h and grip strength distinguished a gradient of risk for mortality from a low to high functional spectrum . Risk of death was 2.04-fold higher in poor ( SPPB 0–6 ) than in good ( SPPB 10–12 ) performers and 1.56-fold higher in participants with lower tertile grip strength . Walking speed alone also distinguished a gradient of mortality risk . After adjustment for confounders , low SPPB , grip strength score and slow walking speed remained significantly associated with death . In the non-disabled healthiest women , no physical performance measure predicted death . In community-dwelling elderly French women , physical performance measures significantly and independently predicted mortality . Increased risk of death was partly explained by baseline health status and was absent in the healthiest elderly",
"OBJECTIVES To develop a cognitive and functional screening battery for the on-road performance of older drivers with dementia . DESIGN Prospect i ve observational study . SETTING On-road driving evaluation clinic at an academic rehabilitation center . PARTICIPANTS Ninety-nine older people with dementia ( 63 % male , mean age 74.2 ± 9 ) , referred by community physicians to an occupational therapy driving clinic . MEASUREMENTS The outcome variable was pass or fail on the modified Washington University Road Test . Predictor measures were tests of visual , motor , and cognitive functioning , selected for their empirical or conceptual relationship to the complex task of driving safely . RESULTS Sixty-five ( 65 % ) participants failed the on-road driving test . The best predictive model , with an overall accuracy of up to 85 % when participants were blinded , included the Eight-item Informant Interview to Differentiate Aging and Dementia , Clock Drawing Test score , and time to complete the Snellgrove Maze Test or Trail Making Test Part A. Visual and motor functioning were not associated with road test failure . CONCLUSION A screening battery that could be performed in less than 10 minutes predicted with good accuracy failure rate for the on-road driving test in this sample of older drivers with dementia . A probability of failure calculator is provided from a logistic regression model that may be useful for clinicians in their decision to refer impaired older adults for further testing . More studies are needed in larger community-based sample s , along with discussion s with patients , families , and clinicians , with regard to acceptable levels of test uncertainty",
"BACKGROUND Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people , the efficacy of interventions targeted specifically at these deficits has not been carefully studied . METHODS We conducted a r and omized , placebo-controlled trial comparing progressive resistance exercise training , multinutrient supplementation , both interventions , and neither in 100 frail nursing home residents over a 10-week period . RESULTS The mean ( + /- SE ) age of the 63 women and 37 men enrolled in the study was 87.1 + /- 0.6 years ( range , 72 to 98 ) ; 94 percent of the subjects completed the study . Muscle strength increased by 113 + /- 8 percent in the subjects who underwent exercise training , as compared with 3 + /- 9 percent in the nonexercising subjects ( P Gait velocity increased by 11.8 + /- 3.8 percent in the exercisers but declined by 1.0 + /- 3.8 percent in the nonexercisers ( P = 0.02 ) . Stair-climbing power also improved in the exercisers as compared with the nonexercisers ( by 28.4 + /- 6.6 percent vs. 3.6 + /- 6.7 percent , P = 0.01 ) , as did the level of spontaneous physical activity . Cross-sectional thigh-muscle area increased by 2.7 + /- 1.8 percent in the exercisers but declined by 1.8 + /- 2.0 percent in the nonexercisers ( P = 0.11 ) . The nutritional supplement had no effect on any primary outcome measure . Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation . CONCLUSIONS High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people . In contrast , multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty",
"OBJECTIVES To evaluate the relationship between performance-based risk factors and subsequent at-fault motor vehicle collision ( MVC ) involvement in a cohort of older drivers . DESIGN Prospect i ve cohort study . SETTING Motor Vehicle Administration ( MVA ) field sites in Maryl and . PARTICIPANTS Of the 4,173 older drivers invited to participate in the study , 2,114 individuals aged 55 to 96 agreed to do so . These analyses focus on 1,910 individuals recruited through MVA field sites . MEASUREMENTS Gross Impairment Screening Battery , which included Rapid Pace Walk , Head/Neck Rotation , Foot Tap , Arm Reach , Cued Recall , Symbol Scan , Visual Closure subtest of the Motor Free Visual Perception Test ( MVPT ) , Delayed Recall , and Trail Making Test with an Abbreviated Part A and st and ard Part B ; Useful Field of View ( UFOV ) subtest 2 ; a Mobility Question naire ; and MVC occurrence . RESULTS In drivers aged 55 and older with intact vision ( 20/70 far visual acuity and 140 degrees visual field ) , age , sex , history of falls , and poorer cognitive performance , as measured using Trails B , MVPT , and UFOV subtest 2 , were predictive of future at-fault MVC involvement . After adjusting for annual mileage , participants aged 78 and older were 2.11 as more likely to be involved in an at-fault MVC , those who made four or more errors on the MVPT were 2.10 times as likely to crash , those who took 147 seconds or longer to complete Trails B were 2.01 times as likely to crash , and those who took 353 ms or longer on subtest 2 of the UFOV were 2.02 times as likely to incur an at-fault MVC . Older adults , men , and individuals with a history of falls were more likely to be involved in subsequent at-fault MVCs . CONCLUSION Performance-based cognitive measures are predictive of future at-fault MVCs in older adults . Cognitive performance , in particular , is a salient predictor of subsequent crash involvement in older adults . High-risk older drivers can be identified through brief , performance-based measures administered in a MVA setting",
"IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity , hospitalization , disability , and mortality . Limited evidence suggests that physical activity may help prevent mobility disability ; however , there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability . OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program ( also referred to as a successful aging program ) in reducing the risk of major mobility disability . DESIGN , SETTING , AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders ( LIFE ) study was a multicenter , r and omized trial that enrolled participants between February 2010 and December 2011 , who participated for an average of 2.6 years . Follow-up ended in December 2013 . Outcome assessors were blinded to the intervention assignment . Participants were recruited from urban , suburban , and rural communities at 8 centers throughout the United States . We r and omized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations , defined as a score on the Short Physical Performance Battery of 9 or below , but were able to walk 400 m. INTERVENTIONS Participants were r and omized to a structured , moderate-intensity physical activity program ( n = 818 ) conducted in a center ( twice/wk ) and at home ( 3 - 4 times/wk ) that included aerobic , resistance , and flexibility training activities or to a health education program ( n = 817 ) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises . MAIN OUTCOMES AND MEASURES The primary outcome was major mobility disability objective ly defined by loss of ability to walk 400 m. RESULTS Incident major mobility disability occurred in 30.1 % ( 246 participants ) of the physical activity group and 35.5 % ( 290 participants ) of the health education group ( hazard ratio [ HR ] , 0.82 [ 95 % CI , 0.69 - 0.98 ] , P = .03).Persistent mobility disability was experienced by 120 participants ( 14.7 % ) in the physical activity group and 162 participants ( 19.8 % ) in the health education group ( HR , 0.72 [ 95 % CI , 0.57 - 0.91 ] ; P = .006 ) . Serious adverse events were reported by 404 participants ( 49.4 % ) in the physical activity group and 373 participants ( 45.7 % ) in the health education group ( risk ratio , 1.08 [ 95 % CI , 0.98 - 1.20 ] ) . CONCLUSIONS AND RELEVANCE A structured , moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability . These findings suggest mobility benefit from such a program in vulnerable older adults . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01072500",
"IMPORTANCE Epidemiological evidence suggests that physical activity benefits cognition , but results from r and omized trials are limited and mixed . OBJECTIVE To determine whether a 24-month physical activity program results in better cognitive function , lower risk of mild cognitive impairment ( MCI ) or dementia , or both , compared with a health education program . DESIGN , SETTING , AND PARTICIPANTS A r and omized clinical trial , the Lifestyle Interventions and Independence for Elders ( LIFE ) study , enrolled 1635 community-living participants at 8 US centers from February 2010 until December 2011 . Participants were sedentary adults aged 70 to 89 years who were at risk for mobility disability but able to walk 400 m. INTERVENTIONS A structured , moderate-intensity physical activity program ( n = 818 ) that included walking , resistance training , and flexibility exercises or a health education program ( n = 817 ) of educational workshops and upper-extremity stretching . MAIN OUTCOMES AND MEASURES Prespecified secondary outcomes of the LIFE study included cognitive function measured by the Digit Symbol Coding ( DSC ) task subtest of the Wechsler Adult Intelligence Scale ( score range : 0 - 133 ; higher scores indicate better function ) and the revised Hopkins Verbal Learning Test ( HVLT-R ; 12-item word list recall task ) assessed in 1476 participants ( 90.3 % ) . Tertiary outcomes included global and executive cognitive function and incident MCI or dementia at 24 months . RESULTS At 24 months , DSC task and HVLT-R scores ( adjusted for clinic site , sex , and baseline values ) were not different between groups . The mean DSC task scores were 46.26 points for the physical activity group vs 46.28 for the health education group ( mean difference , -0.01 points [ 95 % CI , -0.80 to 0.77 points ] , P = .97 ) . The mean HVLT-R delayed recall scores were 7.22 for the physical activity group vs 7.25 for the health education group ( mean difference , -0.03 words [ 95 % CI , -0.29 to 0.24 words ] , P = .84 ) . No differences for any other cognitive or composite measures were observed . Participants in the physical activity group who were 80 years or older ( n = 307 ) and those with poorer baseline physical performance ( n = 328 ) had better changes in executive function composite scores compared with the health education group ( P = .01 for interaction for both comparisons ) . Incident MCI or dementia occurred in 98 participants ( 13.2 % ) in the physical activity group and 91 participants ( 12.1 % ) in the health education group ( odds ratio , 1.08 [ 95 % CI , 0.80 to 1.46 ] ) . CONCLUSIONS AND RELEVANCE Among sedentary older adults , a 24-month moderate-intensity physical activity program compared with a health education program did not result in improvements in global or domain-specific cognitive function . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01072500",
"BACKGROUND Relatively little is known about why older persons develop long-term disability in community mobility . OBJECTIVE To identify the risk factors and precipitants for long-term disability in walking a quarter mile and driving a car . DESIGN Prospect i ve cohort study from March 1998 to December 2009 . SETTING Greater New Haven , Connecticut . PARTICIPANTS 641 persons , aged 70 years or older , who were active drivers or nondisabled in walking a quarter mile . Persons who were physically frail were over sample d. MEASUREMENTS C and i date risk factors were assessed every 18 months . Disability in community mobility and exposure to potential precipitants , including illnesses or injuries leading to hospitalization or restricted activity , were assessed every month . Disability that lasted 6 or more consecutive months was considered long-term . RESULTS 318 ( 56.0 % ) and 269 ( 53.1 % ) participants developed long-term disability in walking and driving , respectively . Seven risk factors were independently associated with walking disability and 8 were associated with driving disability ; the strongest associations for each outcome were found for older age and lower score on the Short Physical Performance Battery . The precipitants had a large effect on long-term disability , with multivariate hazard ratios for each outcome greater than 6.2 for hospitalization and greater than 2.4 for restricted activity . The largest differences in absolute risk were generally observed in participants with a specific risk factor who were subsequently hospitalized . LIMITATIONS The observed associations may not be causal . The severity of precipitants was not assessed . The effect of the precipitants may have been underestimated because their exposure after the initial onset of disability was not evaluated . CONCLUSION Long-term disability in community mobility is common among older persons . Multiple risk factors , together with subsequent precipitants , greatly increase the likelihood of long-term mobility disability . PRIMARY FUNDING SOURCE National Institute on Aging , National Institutes of Health"
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41164246-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To review the evidence concerning the effects of postoperative exercise interventions on exercise capacity and health-related quality of life following resection for non-small cell lung cancer , and to review whether different initiation times of exercise produce different effects on exercise capacity . DATA SOURCES Comprehensive literature search of MEDLINE , Embase , CENTRAL , CINAHL and PEDro . STUDY SELECTION R and omized controlled trials examining the effects of exercise interventions were eligible for inclusion . DATA EXTRACTION Postoperative outcome measurements were extracted and the quality of evidence was grade d using Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) Working Group . DATA SYNTHESIS Four r and omized controlled trials were identified involving 262 participants . Short-term follow-up ( 12 - 20 weeks ) showed significantly higher exercise capacity and physical component of health-related quality of life in the intervention group ( st and ardized mean difference ( SMD ) 0.48 ; 95 % confidence interval ( CI ) 0.04 - 0.93 ) compared with the control group ( SMD 0.50 ; 95 % CI 0.19 - 0.82 ) . There was no difference between the effect of late- and early-initiated exercise intervention . CONCLUSION Exercise has a small-to-moderate effect at short-term follow-up on exercise capacity and the physical component of health-related quality of life in patients operated for lung cancer . The long-term effects of exercise capacity are unknown . Early-initiated exercise programmes ( 2 weeks post-operation ) did not show an effect on exercise capacity . These findings should be interpreted with caution
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"QUESTION Does a postoperative physiotherapy exercise program incorporating shoulder exercises improve shoulder function , pain , range of motion , muscle strength , and health-related quality of life in patients undergoing elective pulmonary resection via open thoracotomy ? DESIGN R and omised trial with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS 76 patients who underwent pulmonary resection via open thoracotomy . INTERVENTION All participants received st and ard medical and nursing care involving a clinical pathway . The experimental group also received physiotherapy interventions that included daily supervised , progressive exercises until discharge and a postoperative exercise booklet on discharge . OUTCOME MEASURES Preoperatively and up to 3 months postoperatively pain was measured with a numerical rating scale , shoulder function with the Shoulder Pain and Disability Index , and quality of life with the Short Form-36 . Shoulder range of motion and muscle strength were measured in a subgroup . RESULTS The experimental group had 1.3 units ( 95 % CI 0.3 to 2.2 ) less shoulder pain ( scored /10 ) and 2.2 units ( 95 % CI 0.2 to 4.3 ) less total pain ( scored /30 ) at discharge , and 7.6 % ( 95 % CI 1.7 to 13.6 ) better function at 3 months . The Short Form-36 physical component score was 4.8 points ( 95 % CI -0.3 to 10.0 ) better for the experimental group than the control group at 3 months . Differences between groups in all range of motion and strength measures were small and statistically non-significant . CONCLUSION A physiotherapist-directed postoperative exercise program result ed in significant benefits in pain and shoulder function over usual care for patients following open thoracotomy . TRIAL REGISTRATION ANZCTRN 12605000201673",
"Abstract Background . Patients with lung cancer are often burdened by dyspnoea , fatigue , decreased physical ability and loss of weight . Earlier studies of physical exercise of patients with COPD have shown promising results . The aim of this study was to investigate , if a well-documented COPD rehabilitation protocol can improve physical fitness and quality of life ( QoL ) in patients with lung cancer . Material and methods . Forty-five patients , with a minimum walking distance of 50 meters , absence of cognitive deficits or severe heart disease and motivated for physical training were invited to an exercise intervention . The intervention consisted of seven weeks of twice weekly training , focusing on walking training , circuit training , h and ling of dyspnoea and instructions in daily diary-based training at home . Prior to , and after the intervention , Incremental- and Endurance Shuttle Walk Test ( ISWT and ESWT ) were performed , and pulmonary function as well as self-reported QoL ( EORTC-QLQ-C30 and LC13 ) were measured . Results . Fourteen subjects dropped out before commencement of the intervention . Seven were excluded after physiotherapeutic evaluation . Of the remaining 24 , three were excluded because of insufficient attendance ( thus 21 patients completed the intervention . For 17 patients with complete pre- and post intervention data , ISWT increased 9 % ( −77 to 39 % ) ( median and range ) ( p = 0.021 ) , while ESWT increased 109 % ( −70 to 432 % ) ( p = 0.002 ) . Twelve of 17 improved in ISWT , while 15 improved in ESWT . No changes in pulmonary function and improvements in QoL were observed . Conclusion . Patients with pulmonary cancer can achieve significant improvements in physical fitness measured with ISWT and ESWT after completion of the intervention program . No changes in pulmonary function and QoL were observed . In addition , we found that a large number of patients dropped out before intervention and that the patients , who succeeded , often discontinued training at home",
"Background Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis . In patients with non-small cell lung cancer ( NSCLC ) , fibrinogen levels correlate with neoplasia . Here we compared the effects of pulmonary rehabilitation ( PR ) with chest physical therapy ( CPT ) on fibrinogen and albumin levels in patients with LC and previous inflammatory lung disease awaiting lung resection . Methods We conducted a r and omized clinical trial with 24 patients who were r and omly assigned to Pulmonary Rehabilitation ( PR ) and Chest Physical Therapy ( CPT ) groups . Each group underwent training 5 days weekly for 4 weeks . All patients were assessed before and after four weeks of training through clinical assessment , measurement of fibrinogen and albumin levels , spirometry , 6-minute Walk Test ( 6MWT ) , quality of life survey , and anxiety and depression scale . PR involved strength and endurance training , and CPT involved lung expansion techniques . Both groups attended educational classes . Results A mixed between-within subjects analysis of variance ( ANOVA ) revealed a significant interaction between time ( before and after intervention ) and group ( PR vs. CPT ) on fibrinogen levels ( F(1 , 22 ) = 0.57 , p effect of time ( F(1 , 22 ) = 0.68 , p = 0.004 ) . Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F(1 , 22 ) = 0.96 , p = 0.37 ) nor the main effects of time ( F(1 , 22 ) = 1.00 , p = 1.00 ) and group ( F(1 , 22 ) = 0.59 , p = 0.45 ) . A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F(1 , 22 ) = 0.77 , p = 0.02 ) , endurance time ( F(1 , 22 ) = 0.60 , p = 0.001 ) , levels of anxiety ( F(1 , 22 ) = 0.60 , p = 0.002 ) and depression ( F(1 , 22 ) = 0.74 , p = 0.02 ) , and the SF-36 physical component summary ( F(1 , 22 ) = 0.83 , p = 0.07 ) . Conclusion PR reduced serum fibrinogen levels , improved functional parameters , and quality of life of patients with LC and inflammatory lung disease awaiting lung resection . Trial registration Current Controlled Trials RBR-3nm5bv",
"INTRODUCTION Post-operative pulmonary rehabilitation in patients who have undergone surgery for lung cancer is a subject of open debate . Clinical practice in this setting is based on the results of observational trials , such as the one described here . Prospect i ve r and omized controlled trials have been registered and recruitment is ongoing . METHODS From 2005 to 2008 , 110 patients with surgical non-small cell lung cancer were entered into a post-operative inpatient pulmonary rehabilitation programme for 3 weeks . All patients were evaluated for pulmonary function after surgery ( time 0 ; T0 ) and at the end of pulmonary rehabilitation programme ( time 1 ; T1 ) . Statistical analysis focused on improvement in pulmonary function parameters and physical performance in the 6-min walking test ( 6MWT ) . Mixed models multiple linear regression was used to identify parameters related to the primary end-points of this research . RESULTS Patients ' mean age was 70.1 years ( st and ard deviation ( SD ) 8.5 years ) ; male/female ratio 73/37 . A total of 94 patients underwent lobectomy , 8 underwent pneumonectomy , and the remaining 8 underwent bilobectomy . Among the analysed parameters a significant improvement could be detected only with regards to the 6MWT ( 257.4 ( SD 112.2 ) at T0 and 382.8 ( SD 11.09 ) at T1 ) . CONCLUSION Post-operative pulmonary rehabilitation in patients with surgical non-small cell lung cancer is effective in terms of exercise tolerance",
"PURPOSE The purpose of this study was to identify the effects of a Progressive Walking program ( PW ) on physical activity , exercise tolerance , recovery , and post-operative complications for patients with a lung resection . METHODS A nonequivalent control group non-synchronized design was utilized and 37 participants with a lung resection ( 22 for control group , 15 for experimental group ) were recruited at A university hospital from December 2012 to August 2013 . The PW consisted of preoperative education , goal setting , and feedback , provided to the experimental group , and usual care to the control group . Data were analyzed using the SPSS WIN 18.0 . RESULTS A higher proportion of patients in the experimental group showed adequate levels of physical activity ( p=.001 ) , shorter period of chest tube retention ( ≤ 7 days ; p=.011 ) , and shorter stay in the hospital ( ≤ 10 days ; p=.036 ) than patients in the control group . Patients in the experimental group reported longer 6-minute walking distance ( p=.032 ) and lower levels of dyspnea ( p=.049 ) than patients in the control group . The PW did not influence the occurrence of pulmonary complications . CONCLUSION The findings of this study suggest that the PW could be a useful strategy for improving patients ' post-operative health and reducing cost after lung resection",
"Objectives Breathlessness in patients with lung cancer is a common and distressing symptom affecting 50–70 % of patients , rising to some 90 % for those with advanced lung cancer . The aim of the current study was to assess how feasible inspiratory muscle training ( IMT ) is in the lung cancer population and explore changes in outcome variables . Material s and methods A pilot feasibility r and omised trial was conducted in patients with clinical ly stable lung cancer . The experimental group received training using a pressure threshold device . Patients were instructed to carry out five IMT sessions weekly for 12 weeks for a total of 30 mins/day . Patients in the control group received st and ard care . Outcome measures were completed at baseline and monthly for 3 months , and included : physiological parameters ( FEV1 , FVC ) ; perceived severity of breathlessness using six 10-point NRS ; modified Borg Scale ; quality of life using the short form Chronic Respiratory Disease Question naire ; Hospital Anxiety and Depression Scale , and safety . Results Forty-six patients ( M = 37 , F = 9 ) at a mean age of 69.5 years old and a mean of 16 months post-diagnosis who were not currently receiving chemotherapy and /or radiotherapy were recruited . Seventy-percent had NSCLC and advanced disease . Statistical ( area under the curve-AUC ) and clinical ly important differences were seen with regard to distress from breathlessness ( p = 0.03 ) , ability to cope with breathlessness ( p = 0.01 ) , satisfaction with breathlessness management ( p = 0.001 ) , fatigue ( p = 0.005 ) , emotional function ( p = 0.011 ) , breathlessness mastery ( p = 0.015 ) and depression ( p = 0.028 ) . The m-Borg difference between the two groups at 3 months was 0.80 , which is borderline clinical ly significant . Changes were more evident in the 3-month assessment where the effect of the intervention came to its peak . Conclusion This trial shows the IMT is feasible and potentially effective in patients with lung cancer . These findings warrant a fully powered larger r and omised controlled trial",
"BACKGROUND Thoracic procedures are currently performed by general and thoracic surgeons . Initial clinical outcome after training is a good measure of the quality of the surgical training received . METHODS We examined the morbidity and mortality for pneumonectomy , lobectomy and esophagectomy during one surgeon 's first 2 years of practice ; we collected data prospect ively . The results were based on the experience of the only dedicated thoracic surgeon ( 5 years of general surgery and 3 years of thoracic surgery training with certification from the Royal College of Physicians and Surgeons of Canada ) at the largest tertiary care hospital of Brown University School of Medicine . RESULTS During the 2-year period , 154 major pulmonary resections ( 20 pneumonectomies , 134 lobectomies ) and 25 esophagectomies ( 18 transhiatal , 4 Ivor-Lewis , 2 thoracoabdominal , one 3-incision ) were performed . Mortality for major lung resection was 1.9 % ( pneumonectomy 5 % , lobectomy 1.5 % ) , and morbidity was 27 % ( pneumonectomy 35 % , lobectomy 26 % ) . Mortality for esophagectomy was 4 % , and morbidity was 36 % ( anastamotic leak 12 % ) . CONCLUSIONS These results compare favourably with clinical outcomes published from several large series . Thoracic surgical training in Canada is adequate and prepares surgeons well to perform major thoracic procedures . A data base of the initial results from all graduates of thoracic surgery training in Canada is needed . Such a data base could be used to compare the initial results of thoracic procedures performed by general and thoracic surgery graduates from Canada and the United States",
"OBJECTIVE To evaluate the effect of 4 weeks of pulmonary rehabilitation ( PR ) versus chest physical therapy ( CPT ) on the preoperative functional capacity and postoperative respiratory morbidity of patients undergoing lung cancer resection . DESIGN R and omized single-blinded study . SETTING A teaching hospital . PARTICIPANTS Patients undergoing lung cancer resection ( N=24 ) . INTERVENTIONS Patients were r and omly assigned to receive PR ( strength and endurance training ) versus CPT ( breathing exercises for lung expansion ) . Both groups received educational classes . MAIN OUTCOME MEASURES Functional parameters assessed before and after 4 weeks of PR or CPT ( phase 1 ) , and pulmonary complications assessed after lung cancer resection ( phase 2 ) . RESULTS Twelve patients were r and omly assigned to the PR arm and 12 to the CPT arm . Three patients in the CPT arm were not su bmi tted to lung resection because of inoperable cancer . During phase 1 evaluation , most functional parameters in the PR group improved from baseline to 1 month : forced vital capacity ( FVC ) ( 1.47L [ 1.27 - 2.33L ] vs 1.71L [ 1.65 - 2.80L ] , respectively ; P=.02 ) ; percentage of predicted FVC ( FVC% ; 62.5 % [ 49%-71 % ] vs 76 % [ 65%-79.7 % ] , respectively ; P 6-minute walk test ( 425.5±85.3 m vs 475±86.5 m , respectively ; P maximal inspiratory pressure ( 90±45.9cmH(2)O vs 117.5±36.5cmH(2)O , respectively ; P and maximal expiratory pressure ( 79.7±17.1cmH(2)O vs 92.9±21.4cmH(2)O , respectively ; P lower incidence of postoperative respiratory morbidity ( P=.01 ) , a shorter length of postoperative stay ( 12.2±3.6d vs 7.8±4.8d , respectively ; P=.04 ) , and required a chest tube for fewer days ( 7.4±2.6d vs 4.5±2.9d , respectively ; P=.03 ) compared with the CPT arm . CONCLUSIONS These findings suggest that 4 weeks of PR before lung cancer resection improves preoperative functional capacity and decreases the postoperative respiratory morbidity ",
"OBJECTIVE To evaluate the effect of a combined hospital plus home exercise programme following curative surgery for non-small cell lung cancer ( NSCLC ) . DESIGN R and omised controlled trial . SETTING Teaching hospital . PARTICIPANTS One hundred and thirty-one subjects with NSCLC admitted for curative surgery . INTERVENTIONS Participants were r and omised to usual care or a hospital plus home exercise programme . OUTCOMES The primary outcome was the between-group difference in physical activity 4 weeks after surgery . Secondary outcomes were the difference in quadriceps strength , exercise tolerance and quality of life [ Short Form-36 ( SF-36 ) and European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-LC13 ] from pre-operatively ( baseline ) to 4 weeks after surgery . RESULTS The participants ( n=131 ) had a mean age of 68 [ st and ard deviation ( SD ) 11 ] years and mean forced expiratory volume in 1 second of 2.4 ( SD 1.1)l . There were no significant differences in physical activity between the groups 4 weeks after surgery [ mean difference adjusted for baseline 12minutes/day , 95 % confidence interval ( CI ) -20.2 to 44.1 ] . In addition , there were no significant differences in total SF-36 or EORTC QLQ-LC13 scores from baseline to 4 weeks after surgery . Both groups had recovered their pre-operative walking distance 4 weeks after surgery , and there were no differences between the groups ( mean difference in Incremental Shuttle Walk Test from baseline to 4 weeks after surgery ( -26 m , 95 % CI -94.2 to 42.3 ) . CONCLUSIONS A hospital plus home exercise programme showed little benefit in unselected patients with NSCLC following surgery . Regardless of group allocation , the patients had recovered their pre-operative exercise tolerance levels by 4 weeks after surgery",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"Introduction : Little is known about the effects of rehabilitation for patients with lung cancer after thoracotomy . The primary objective of this study was to evaluate the effect of a multidisciplinary rehabilitation program on quality of life ( QOL ) and secondary objectives were to determine its effects on pain and exercise capacity and the feasibility of combining rehabilitation with adjuvant chemotherapy . Methods : Patients who had undergone a thoracotomy for lung cancer were r and omized between rehabilitation and usual care . Rehabilitation consisted of twice-weekly training for 12 weeks starting 1 month after hospital discharge , scheduled visits to pain specialists , and medical social work . QOL and pain were measured with vali date d question naires at baseline and after 1 , 3 , 6 , and 12 months . Exercise tolerance was assessed at baseline and after 3 months with a 6-minute walking distance test . Results : The study closed prematurely because of the introduction of video-assisted thoracoscopic surgery . Of 57 r and omized patients , 49 patients ( 23 active and 26 control ) were analyzed . QOL was not significantly different between groups , although , the active group reported more pain after 3 and 6 months and more limitations because of physical problems after 3 months . In the active group , 6-minute walking distance improved by 35 m from preoperative baseline , as opposed to the control group that showed a decline by 59 m ( p = 0.024 for difference ) . Patients treated with adjuvant chemotherapy showed decreased attendance at training sessions . Conclusion : Rehabilitation did not result in a better QOL . Exercise tolerance improved at the cost of more pain and more limitations because of physical problems . We suggest that rehabilitation is better postponed for 3 to 4 months after hospital discharge"
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Cash transfers ( CTs ) are now high on the agenda of most governments in low- and middle-income countries . Within the field of health promotion , CTs constitute a healthy public policy initiative as they have the potential to address the social determinants of health ( SDoH ) and health inequalities . A systematic review was conducted to synthesis e the evidence on CTs ' impacts on SDoH and health inequalities in sub-Saharan Africa , and to identify the barriers and facilitators of effective CTs . Twenty-one electronic data bases and the websites of 14 key organizations were search ed in addition to grey literature and h and search ing of selected journals for quantitative and qualitative studies on CTs ' impacts on SDoH and health outcomes . Out of 182 full texts screened for eligibility , 79 reports that reported findings from 53 studies were included in the final review . The studies were undertaken within 24 CTs comprising 11 unconditional CTs ( UCTs ) , 8 conditional CTs ( CCTs ) and 5 combined UCTs and CCTs . The review found that CTs can be effective in tackling structural determinants of health such as financial poverty , education , household resilience , child labour , social capital and social cohesion , civic participation , and birth registration . The review further found that CTs modify intermediate determinants such as nutrition , dietary diversity , child deprivation , sexual risk behaviours , teen pregnancy and early marriage . In conjunction with their influence on SDoH , there is moderate evidence from the review that CTs impact on health and quality of life outcomes . The review also found many factors relating to intervention design features , macro-economic stability , household dynamics and community acceptance of programs that could influence the effectiveness of CTs . The external validity of the review findings is strong as the findings are largely consistent with those from Latin America . The findings thus provide useful insights to policy makers and managers and can be used to optimise CTs to reduce health inequalities
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"ABSTRACT This article reports on the impact on child schooling and work of the Government of Zambia ’s Child Grant Program ( CGP ) , an unconditional cash transfer programme targeted to households with children under age 3 years in three districts of the country . Although the CGP ’s focus is on very young children , we look to see if the programme has impacts on older children who are not the explicit target group . We use data from a large-scale social experiment involving 2519 households , half of whom were r and omised out to a delayed-entry control group , that was implemented to assess the impact of the programme . We find that the CGP has no discernible impact on school enrolment of children age 7–14 . However , when we break the sample by older ( 11–14 ) and younger ( 7–10 ) children – based on the grade structure of the Zambian schooling system – we find a significant impact among children age 11–14 , which coincides with the exact age range where a sharp drop-out begins to occur in Zambia with point estimates in the range of 7–8 percentage points . Finally , we provide evidence on the potential pathways through which the unconditional cash transfer impacts on enrolment . Households in the CGP spend more on education , and in particular on uniforms and shoes , two items cited as key barriers to school enrolment in study areas",
"Recent evidence suggests that conditional cash transfer programs for schooling are effective in raising school enrollment and attendance . However , there is also reason to believe that such programs can affect other outcomes , such as the sexual behavior of their young beneficiaries . Zomba Cash Transfer Program is a r and omized , ongoing conditional cash transfer intervention targeting young women in Malawi that provides incentives ( in the form of school fees and cash transfers ) to current schoolgirls and recent dropouts to stay in or return to school . An average offer of US$ 10/month conditional on satisfactory school attendance – plus direct payment of secondary school fees – led to significant declines in early marriage , teenage pregnancy , and self-reported sexual activity among program beneficiaries after just one year of program implementation . For program beneficiaries who were out of school at baseline , the probability of getting married and becoming pregnant declined by more than 40 percent and 30 percent , respectively . In addition , the incidence of the onset of sexual activity was 38 percent lower among all program beneficiaries than the control group . Overall , these results suggest that conditional cash transfer programs not only serve as useful tools for improving school attendance , but may also reduce sexual activity , teen pregnancy , and early marriage",
"Abstract We investigated ( 1 ) how household wealth affected the relationship between conditional cash transfers ( CCT ) and unconditional cash transfers ( UCT ) and school attendance , ( 2 ) whether CCT and UCT affected educational outcomes ( repeating a year of school ) , ( 3 ) if baseline school attendance and transfer conditions affected how much of the transfers participants spent on education and ( 4 ) if CCT or UCT reduced child labour in recipient households . Data were analysed from a cluster-r and omized controlled trial of CCT and UCT in 4043 households from 2009 to 2010 . Recipient households received $ 18 dollars per month plus $ 4 per child . CCT were conditioned on above 80 % school attendance , a full vaccination record and a birth certificate . In the poorest quintile , the odds ratio of above 80 % school attendance at follow-up for those with below 80 % school attendance at baseline was 1.06 ( p = .67 ) for UCT vs. CCT . UCT recipients reported spending slightly more ( 46.1 % ( 45.4–46.7 ) ) of the transfer on school expenses than did CCT recipients ( 44.8 % ( 44.1–45.5 ) ) . Amongst those with baseline school attendance of below 80 % , there was no statistically significant difference between CCT and UCT participants in the proportion of the transfer spent on school expenses ( p = .63 ) . Amongst those with above 80 % baseline school attendance , CCT participants spent 3.5 % less ( p = .001 ) on school expenses than UCT participants . UCT participants were no less likely than those in the control group to repeat a grade of school . CCT participants had .69 ( .60–.79 ) lower odds vs. control of repeating the previous school grade . Children in CCT recipient households spent an average of .31 fewer hours in paid work than those in the control group ( p UCT arm spent an average of .15 fewer hours in paid work each week than those in the control arm ( p = .06 )",
"There is promising evidence that poverty-targeted cash transfer programs can have positive impacts on adolescent transitions to adulthood in re source poor setting s , however existing research is typically from small scale programs in diverse geographic and cultural setting s. We provide estimates of the impact of a national unconditional cash transfer program , the Kenya Cash Transfer for Orphans and Vulnerable Children , on pregnancy and early marriage among females aged 12 to 24 , four years after program initiation . The evaluation was design ed as a clustered r and omized controlled trial and ran from 2007 to 2011 , capitalizing on the existence of a control group , which was delayed entry to the program due to budget constraints . Findings indicate that , among 1549 females included in the study , while the program reduced the likelihood of pregnancy by five percentage points , there was no significant impact on likelihood of early marriage . Program impacts on pregnancy appear to work through increasing the enrollment of young women in school , financial stability of the household and delayed age at first sex . The Kenyan program is similar in design to most other major national cash transfer programs in Eastern and Southern Africa , suggesting a degree of generalizability of the results reported here . Although the objective of the program is primarily poverty alleviation , it appears to have an important impact on facilitating the successful transition of adolescent girls into adulthood",
"The aim of this study is to assess whether the Government of Kenya 's Cash Transfer for Orphans and Vulnerable Children ( Kenya CT-OVC ) can reduce the risk of HIV among young people by postponing sexual debut . The program provides an unconditional transfer of US$ 20 per month directly to the main caregiver in the household . An evaluation of the program was implemented in 2007–2009 in seven districts . Fourteen Locations were r and omly assigned to receive the program and fourteen were assigned to a control arm . A sample of households was enrolled in the evaluation in 2007 . We revisited these households in 2011 and collected information on sexual activity among individuals between 15–25 years of age . We used logistic regression , adjusted for the respondent 's age , sex and relationship to caregiver , the age , sex and schooling of the caregiver and whether or not the household lived in Nairobi at baseline , to compare rates of sexual debut among young people living in program households with those living in control households who had not yet entered the program . Our results , adjusted for these covariates , show that the program reduced the odds of sexual debut by 31 percent . There were no statistically significant effects on secondary outcomes of behavioral risk such as condom use , number of partners and transactional sex . Since the CT-OVC provides cash to the caregiver and not to the child , and there are no explicit conditions associated with receipt , these impacts are indirect , and may have been achieved by keeping young people in school . Our results suggest that large-scale national social cash transfer programs with poverty alleviation objectives may have potential positive spillover benefits in terms of reducing HIV risk among young people in Eastern and Southern Africa",
"OBJECTIVE The primary goal was to examine whether Malawi Social Cash Transfer Pilot Scheme , initially implemented in a rural district in central Malawi , improved health outcomes for children aged 6 - 17 . Secondary goals were to examine the effects of individual child- ( orphan status and gender ) and household-level factors ( number of working-age adults and sick adults ) on health outcomes . Another secondary goal was to examine whether orphan status modified the cash transfer effect on health outcomes . METHODS This multilevel study used panel data collected in 2007 - 08 from a r and omized controlled evaluation study of phase one of the programme . The analyses included 1197 children aged 6 - 17 in 486 households . The four outcomes of interest were : illness in the past month , illness that stopped normal activities in the past month , missing school due to illness or injury in the past month and health care use for worst illness in the past year . FINDINGS Approximately two-thirds of children in cash transfer eligible households were orphans . Compared with children in non-beneficiary households , those in beneficiary households had a 37 % lower odds of child illness ( P illness that stopped normal activities ( P utilizing health services for a serious illness ( odds ratio=10.98 ; P household number of working-age adults was associated with 34 % lower odds of child illness ( P household number of sick adults increased the odds of child illness by 97 % ( P serious illness by 49 % ( P Unconditional cash transfer programmes to poor households have the potential to improve health outcomes for all vulnerable children aged 6 - 17",
"PURPOSE This study investigates the causal effect of Kenya 's unconditional cash transfer program on mental health outcomes of young people . METHODS Selected locations in Kenya were r and omly assigned to receive unconditional cash transfers in the first phase of Kenya 's Cash Transfer Program for orphans and Vulnerable Children . In intervention locations , low-income households and those with orphans and vulnerable childrens began receiving monthly cash transfers of $ 20 in 2007 . In 2011 , 4 years after program onset , data were collected on the psychosocial status for youth aged 15 - 24 years from households in intervention and control locations ( N = 1960 ) . The primary outcome variable was an indicator of depressive symptoms using the 10- question Center for Epidemiologic Studies Depression Scale . Secondary outcomes include an indicator for hopefulness and physical health measures . Logistic regression models that adjusted for individual and household characteristics were used to determine the effect of the cash transfer program . RESULTS The cash transfer reduced the odds of depressive symptoms by 24 percent among young persons living in households that received cash transfers . Further analysis by gender and age revealed that the effects were only significant for young men and were larger among men aged 20 - 24 years and orphans . CONCLUSIONS This study provides evidence that poverty-targeted unconditional cash transfer programs , can improve the mental health of young people in low-income countries",
"Summary Background Cash-transfer programmes can improve the wellbeing of vulnerable children , but few studies have rigorously assessed their effectiveness in sub-Saharan Africa . We investigated the effects of unconditional cash transfers ( UCTs ) and conditional cash transfers ( CCTs ) on birth registration , vaccination uptake , and school attendance in children in Zimbabwe . Methods We did a matched , cluster-r and omised controlled trial in ten sites in Manical and , Zimbabwe . We divided each study site into three clusters . After a baseline survey between July , and September , 2009 , clusters in each site were r and omly assigned to UCT , CCT , or control , by drawing of lots from a hat . Eligible households contained children younger than 18 years and satisfied at least one other criteria : head of household was younger than 18 years ; household cared for at least one orphan younger than 18 years , a disabled person , or an individual who was chronically ill ; or household was in poorest wealth quintile . Between January , 2010 , and January , 2011 , households in UCT clusters collected payments every 2 months . Households in CCT clusters could receive the same amount but were monitored for compliance with several conditions related to child wellbeing . Eligible households in all clusters , including control clusters , had access to parenting skills classes and received maize seed and fertiliser in December , 2009 , and August , 2010 . Households and individuals delivering the intervention were not masked , but data analysts were . The primary endpoints were proportion of children younger than 5 years with a birth certificate , proportion younger than 5 years with up-to- date vaccinations , and proportion aged 6–12 years attending school at least 80 % of the time . This trial is registered with Clinical Trials.gov , number NCT00966849 . Findings 1199 eligible households were allocated to the control group , 1525 to the UCT group , and 1319 to the CCT group . Compared with control clusters , the proportion of children aged 0–4 years with birth certificates had increased by 1·5 % ( 95 % CI −7·1 to 10·1 ) in the UCT group and by 16·4 % ( 7·8–25·0 ) in the CCT group by the end of the intervention period . The proportions of children aged 0–4 years with complete vaccination records was 3·1 % ( −3·8 to 9·9 ) greater in the UCT group and 1·8 % ( −5·0 to 8·7 ) greater in the CCT group than in the control group . The proportions of children aged 6–12 years who attended school at least 80 % of the time was 7·2 % ( 0·8–13·7 ) higher in the UCT group and 7·6 % ( 1·2–14·1 ) in the CCT group than in the control group . Interpretation Our results support strategies to integrate cash transfers into social welfare programming in sub-Saharan Africa , but further evidence is needed for the comparative effectiveness of UCT and CCT programmes in this region . Funding Wellcome Trust , the World Bank through the Partnership for Child Development , and the Programme of Support for the Zimbabwe National Action Plan for Orphans and Vulnerable Children",
"Céline Langendorf and colleagues conducted a pragmatic intervention study in Niger to assess whether distributions of supplementary foods in addition to household support by cash transfer effectively reduced malnutrition in children aged 6 to 23 months . Please see later in the article for the Editors '",
"The World Health Organization recommends four antenatal visits for pregnant women in developing countries . Cash transfers have been used to incentivize participation in health services . We examined whether modest cash transfers for participation in antenatal care would increase antenatal care attendance and delivery in a health facility in Kisoro , Ug and a. Twenty-three villages were r and omized into four groups : 1 ) no cash ; 2 ) 0.20 United States Dollars ( USD ) for each of four visits ; 3 ) 0.40 USD for a single first trimester visit only ; 4 ) 0.40 USD for each of four visits . Outcomes were three or more antenatal visits and delivery in a health facility . Chi-square , analysis of variance , and generalized estimating equation analyses were performed to detect differences in outcomes . Women in the 0.40 USD/visit group had higher odds of three or more antenatal visits than the control group ( OR 1.70 , 95 % CI : 1.13 - 2.57 ) . The odds of delivering in a health facility did not differ between groups . However , women with more antenatal visits had higher odds of delivering in a health facility ( OR 1.21 , 95 % CI : 1.03 - 1.42 ) . These findings are important in an area where maternal mortality is high , utilization of health services is low , and re sources are scarce",
"This paper evaluates an experiment in which individuals in rural Malawi were r and omly assigned monetary incentives to learn their HIV results after being tested . Distance to the HIV results centers was also r and omly assigned . Without any incentive , 34 percent of the participants learned their HIV results . However , even the smallest incentive doubled that share . Using the r and omly assigned incentives and distance from results centers as instruments for the knowledge of HIV status , sexually active HIV-positive individuals who learned their results are three times more likely to purchase condoms two months later than sexually active HIV-positive individuals who did not learn their results ; however , HIV-positive individuals who learned their results purchase only two additional condoms than those who did not . There is no significant effect of learning HIV-negative status on the purchase of condoms",
"BACKGROUND Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women . We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women . METHODS In this cluster r and omised trial , never-married women aged 13 - 22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and r and omly assigned with computer-generated r and om numbers by enumeration area ( 1:1 ) to receive cash payments ( intervention group ) or nothing ( control group ) . Intervention enumeration areas were further r and omly assigned with computer-generated r and om numbers to conditional ( school attendance required to receive payment ) and unconditional ( no requirements to receive payment ) groups . Participants in both intervention groups were r and omly assigned by a lottery to receive monthly payments ranging from US$ 1 to $ 5 , while their parents were independently assigned with computer-generated r and om numbers to receive $ 4 - 10 . Behavioural risk assessment s were done at baseline and 12 months ; serology was tested at 18 months . Participants were not masked to treatment status but counsellors doing the serologic testing were . The primary outcomes were prevalence of HIV and herpes simplex virus 2 ( HSV-2 ) at 18 months and were assessed by intention-to-treat analyses . The trial is registered , number NCT01333826 . FINDINGS 88 enumeration areas were assigned to receive the intervention and 88 as controls . For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data , weighted HIV prevalence at 18 month follow-up was 1·2 % ( seven of 490 participants ) in the combined intervention group versus 3·0 % ( 17 of 799 participants ) in the control group ( adjusted odds ratio [ OR ] 0·36 , 95 % CI 0·14 - 0·91 ) ; weighted HSV-2 prevalence was 0·7 % ( five of 488 participants ) versus 3·0 % ( 27 of 796 participants ; adjusted OR 0·24 , 0·09 - 0·65 ) . In the intervention group , we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence ( 3/235 [ 1 % ] vs 4/255 [ 2 % ] ) or weighted HSV-2 prevalence ( 4/233 [ 1 % ] vs 1/255 [ between intervention and control groups for weighted HIV prevalence ( 23/210 [ 10 % ] vs 17/207 [ 8 % ] ) or weighted HSV-2 prevalence ( 17/211 [ 8 % ] vs 17/208 [ 8 % ] ) . INTERPRETATION Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income setting s. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies . FUNDING Global Development Network , Bill & Melinda Gates Foundation , National Bureau of Economic Research Africa Project , World Bank 's Research Support Budget , and several World Bank trust funds ( Gender Action Plan , Knowledge for Change Program , and Spanish Impact Evaluation fund )",
"BACKGROUND Effective and scalable HIV prevention for adolescents in sub-Saharan Africa is needed . Cash transfers can reduce HIV incidence through reducing risk behaviours . However , questions remain about their effectiveness within national poverty-alleviation programmes , and their effects on different behaviours in boys and girls . METHODS In this case-control study , we interviewed South African adolescents ( aged 10 - 18 years ) between 2009 and 2012 . We r and omly selected census areas in two urban and two rural districts in two provinces in South Africa , including all homes with a resident adolescent . We assessed household receipt of state-provided child-focused cash transfers , incidence in the past year and prevalence of transactional sex , age-disparate sex , unprotected sex , multiple partners , and sex while drunk or after taking drugs . We used logistic regression after propensity score matching to assess the effect of cash transfers on these risky sexual behaviours . FINDINGS We interviewed 3515 participants ( one per household ) at baseline , and interviewed 3401 at follow-up . For adolescent girls ( n=1926 ) , receipt of a cash transfer was associated with reduced incidence of transactional sex ( odds ratio [ OR ] 0·49 , 95 % CI 0·26 - 0·93 ; p=0·028 ) , and age-disparate sex ( OR 0·29 , 95 % CI 0·13 - 0·67 ; p=0·004 ) , with similar associations for prevalence ( for transactional sex , OR 0·47 , 95 % CI 0·26 - 0·86 ; p=0·015 ; for age-disparate sex , OR 0·37 , 95 % CI 0·18 - 0·77 ; p=0·003 ) . No significant effects were shown for other risk behaviours . For boys ( n=1475 ) , no consistent effects were shown for any of the behaviours . INTERPRETATION National , child-focused cash transfers to alleviate poverty for households in sub-Saharan Africa can substantially reduce unsafe partner selection by adolescent girls . Child-focused cash transfers are of potential importance for effective combination strategies for prevention of HIV . FUNDING UK Economic and Social Research Council , South African National Research Foundation , Health Economics and AIDS Research Division at University of KwaZulu-Natal , South African National Department of Social Development , Claude Leon Foundation , John Fell Fund , Nuffield Foundation , and Regional Interagency Task Team for Children affected by AIDS-Eastern and Southern Africa",
"There is promising recent evidence that poverty-targeted social cash transfers have potential to improve maternal health outcomes ; however , questions remain surrounding design features responsible for impacts . In addition , virtually no evidence exists from the African region . This study explores the impact of Zambia 's Child Grant Program on a range of maternal health utilization outcomes using a r and omized design and difference-in-differences multivariate regression from data collected over 24 months from 2010 to 2012 . Results indicate that while there are no measurable program impacts among the main sample , there are heterogeneous impacts on skilled attendance at birth among a sample of women residing in households having better access to maternal health services . The latter result is particularly interesting because of the overall low level of health care availability in program areas suggesting that dedicated program design or matching supply-side interventions may be necessary to leverage unconditional cash transfers in similar setting s to impact maternal health",
"BACKGROUND Novel strategies are needed to increase retention in and uptake of prevention of mother-to-child HIV transmission ( PMTCT ) services in sub-Saharan Africa . We aim ed to determine whether small , increasing cash payments , which were conditional on attendance at scheduled clinic visits and receipt of proposed services can increase the proportions of HIV-infected pregnant women who accept available PMTCT services and remain in care . METHODS In this r and omised controlled trial , we recruited newly diagnosed HIV-infected women , who were 32 or less weeks pregnant , from 89 antenatal care clinics in Kinshasa , Democratic Republic of Congo , and r and omly assigned ( 1:1 ) them to either the intervention group or the control group using computer-based r and omisation with varying block sizes of four , six , and eight . The intervention group received compensation on the condition that they attended scheduled clinic visits and accepted offered PMTCT services ( US$ 5 , plus US$ 1 increment at every subsequent visit ) , whereas the control group received usual care . Outcomes assessed included retention in care at 6 weeks ' post partum and uptake of PMTCT services , measured by attendance of all scheduled clinic visits and acceptance of proposed services up to 6 weeks ' post partum . Analyses were by intention to treat . This trial is registered with Clinical Trials.org , number NCT01838005 . FINDINGS Between April 18 , 2013 , and Aug 30 , 2014 , 612 potential participants were identified , 545 were screened , and 433 were enrolled and r and omly assigned ; 217 to the control group and 216 to the intervention group . At 6 weeks ' post partum , 174 participants in the intervention group ( 81 % ) and 157 in the control group ( 72 % ) were retained in care ( risk ratio [ RR ] 1·11 ; 95 % CI 1·00 - 1·24 ) . 146 participants in the intervention group ( 68 % ) and 116 in the control group ( 54 % ) attended all clinic visits and accepted proposed services ( RR 1·26 ; 95 % CI 1·08 - 1·48 ) . Results were similar after adjustment for marital status , age , and education . INTERPRETATION Among women with newly diagnosed HIV , small , incremental cash incentives result ed in increased retention along the PMTCT cascade and uptake of available services . The cost-effectiveness of these incentives and their effect on HIV-free survival warrant further investigation . FUNDING President 's Emergency Plan for AIDS Relief and the National Institute of Health and Child Development",
"Background There is increasing pressure to address the social determinants of health ( SDoH ) and health inequities through the implementation of culturally acceptable interventions particularly in Sub-Saharan Africa ( SSA ) where health outcomes are generally poor . Available evaluation research on cash transfers ( CTs ) suggests that the programs may influence the wider determinants of health in SSA ; yet , there has been no attempt to synthesize the evidence regarding their contribution to tackling the SDoH and health inequalities . To date , nearly all the review s on CTs ' impact on health have predominantly featured evidence from Latin America with limited transferability to the social , cultural , and political environments in SSA . Therefore , the aim of this study is to undertake a systematic review to assess the role of CTs in tackling the wider determinants of health and health inequalities in SSA . Methods / design A systematic review of published and unpublished literature on CTs ’ impact on health and health determinants covering the period 2000–2016 will be undertaken . Studies will be considered for inclusion if they present quantitative or qualitative data , including all relevant study design s. The SDoH conceptual framework will be used to guide the data extraction process . EPPI Review er software will be used for data management and analysis . Studies included in the review will be analyzed by narrative synthesis and /or meta- analysis as appropriate for the nature of the data retrieved . Discussion This review will provide empirical evidence on the impact of CTs on SDoH to inform CT policy , implementation , and research in SSA . The protocol follows the Preferred Reporting Items for Systematic Review and Meta- Analysis Protocol s ( PRISMA -P ) . Systematic review registration This protocol has been registered with the PROSPERO international prospect i ve register of systematic review s , reference CRD42015025015",
"Abstract This paper reports the analysis of the impact of Kenya ’s Cash Transfer for Orphans and Vulnerable Children Programme on the household decisions on productive activities using data from a r and omised experimental design . Results show that the programme had a positive and significant impact on food consumption coming from home production , accumulation of productive assets , especially on the ownership of small livestock , and on formation of nonfarm enterprise , especially for females . The programme has provided more flexibility to families in terms of labour allocation decisions , particularly for those who are geographically isolated . The programme was also found to reduce child labour , an important objective of the programme . However , we find very little impact of the programme on direct indicators of crop production",
"BACKGROUND Cash transfers have been proposed as an intervention to reduce HIV-infection risk for young women in sub-Saharan Africa . However , scarce evidence is available about their effect on reducing HIV acquisition . We aim ed to assess the effect of a conditional cash transfer on HIV incidence among young women in rural South Africa . METHODS We did a phase 3 , r and omised controlled trial ( HPTN 068 ) in the rural Bushbuckridge subdistrict in Mpumalanga province , South Africa . We included girls aged 13 - 20 years if they were enrolled in school grade s 8 - 11 , not married or pregnant , able to read , they and their parent or guardian both had the necessary documentation necessary to open a bank account , and were residing in the study area and intending to remain until trial completion . Young women ( and their parents or guardians ) were r and omly assigned ( 1:1 ) , by use of numbered sealed envelopes containing a r and omisation assignment card which were numerically ordered with block r and omisation , to receive a monthly cash transfer conditional on school attendance ( ≥80 % of school days per month ) versus no cash transfer . Participants completed an Audio Computer-Assisted Self-Interview ( ACASI ) , before test HIV counselling , HIV and herpes simplex virus (HSV)-2 testing , and post-test counselling at baseline , then at annual follow-up visits at 12 , 24 , and 36 months . Parents or guardians completed a Computer-Assisted Personal Interview at baseline and each follow-up visit . A stratified proportional hazards model was used in an intention-to-treat analysis of the primary outcome , HIV incidence , to compare the intervention and control groups . This study is registered at Clinical Trials.gov ( NCT01233531 ) . FINDINGS Between March 5 , 2011 , and Dec 17 , 2012 , we recruited 10 134 young women and enrolled 2537 and their parents or guardians to receive a cash transfer programme ( n=1225 ) or not ( control group ; n=1223 ) . At baseline , the median age of girls was 15 years ( IQR 14 - 17 ) and 672 ( 27 % ) had reported to have ever had sex . 107 incident HIV infections were recorded during the study : 59 cases in 3048 person-years in the intervention group and 48 cases in 2830 person-years in the control group . HIV incidence was not significantly different between those who received a cash transfer ( 1·94 % per person-years ) and those who did not ( 1·70 % per person-years ; hazard ratio 1·17 , 95 % CI 0·80 - 1·72 , p=0·42 ) . INTERPRETATION Cash transfers conditional on school attendance did not reduce HIV incidence in young women . School attendance significantly reduced risk of HIV acquisition , irrespective of study group . Keeping girls in school is important to reduce their HIV-infection risk . FUNDING National Institute of Allergy and Infectious Diseases , National Institute of Mental Health of the National Institutes of Health",
"Summary . — The empowerment of women , broadly defined , is an often-cited objective and benefit of social cash transfer programs in developing countries . Despite the promise and potential of cash transfers to empower women , the evidence supporting this outcome is mixed . In addition , there is little evidence from programs at scale in sub-Saharan Africa . We conducted a mixed- methods evaluation of the Government of Zambia ’s Child Grant Program , a poverty-targeted , unconditional transfer given to mothers or primary caregivers of young children aged zero to five . The quantitative component was a four-year longitudinal clustered-r and omized control trial in three rural districts , and the qualitative component was a one-time data collection involving in-depth interviews with women and their partners stratified on marital status and program participation . Our study found that women in beneficiary households were making more sole or joint decisions ( across five out of nine domains ) ; however , impacts translated into relatively modest increases in the number of decision domains a woman is involved in , on average by 0.34 ( or a 6 % increase over a baseline mean of 5.3 ) . Qualitatively , we found that changes in intrahousehold relationships were limited by entrenched gender norms , which indicate men as heads of household and primary decision makers . However , women ’s narratives showed the transfer increased financial empowerment as they were able to retain control over transfers for household investment and savings for emergencies . We highlight method ological challenges in using intrahousehold decision making as the primary indicator to measure empowerment . Results show potential for unconditional cash transfer programs to improve the financial and intrahousehold status of female beneficiaries , however it is likely additional design components are need for transformational change"
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BACKGROUND Atrial fibrillation ( AF ) increases the risk of stroke , but this risk is not homogenous . Many risk factors contribute to stroke risk however , the evidence for female sex as a risk factor is less well-established . AIM To perform a systematic review and meta- analysis of the available evidence to establish if female sex is a risk factor for stroke/thromboembolism among patients with AF . METHODS A systematic literature search was conducted using Medline . The search term ' atrial fibrillation ' was used in combination with ' stroke risk ' , ' thromboembolism ' , ' female ' and ' gender differences ' and returned 735 articles , of which 17 were appraised and included . Females with AF were compared with males with AF for the outcome of stroke/thromboembolism . RESULTS Seventeen studies , 5 r and omized-controlled trials and 12 prospect i ve observational studies were included ; 10 demonstrated an increased risk of stroke in women . Meta- analysis of the 17 studies revealed a 1.31-fold ( 95 % confidence intervals ( CIs ) 1.18 - 1.46 ) elevated risk of stroke in women with AF ; the risk appearing greatest for women aged ≥75 years . Only three studies compared entirely anticoagulated population s ; stroke rates among these patients varied from 1.2 - 1.44 % per-patient year for men and 2.08 - 2.43 % per-patient year for women . Risk of stroke in women appeared similar regardless of oral anticoagulation therapy [ risk ratio ( 95 % CI 1.29 ( 1.09 - 1.52 ) and 1.49 ( 1.17 - 1.90 ) in non-anticogulated vs. anticoagulated/mixed cohorts , respectively ) . CONCLUSIONS Women with AF are at increased risk of stroke , particularly elderly women . Comprehensive stroke risk assessment , including sex as a risk factor , should be undertaken in all AF patients
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"BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P hypertension ( RR=2.0 , P systolic blood pressure > 160 mm Hg ( RR=2.3 , P prior stroke or transient ischemic attack ( RR=2.9 , P stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation",
"Background —Previous studies provide conflicting results about whether women are at higher risk than men for thromboembolism in the setting of atrial fibrillation ( AF ) . We examined data from a large contemporary cohort of AF patients to address this question . Methods and Results —We prospect ively studied 13 559 adults with AF and recorded data on patients ’ clinical characteristics and the occurrence of incident hospitalizations for ischemic stroke , peripheral embolism , and major hemorrhagic events through search ing vali date d computerized data bases and medical record review . We compared event rates by patient sex using multivariable log-linear regression , adjusting for clinical risk factors for stroke , and stratifying by warfarin use . We identified 394 ischemic stroke and peripheral embolic events during 15 494 person-years of follow-up off warfarin . After multivariable analysis , women had higher annual rates of thromboembolism off warfarin than did men ( 3.5 % versus 1.8 % ; adjusted rate ratio [ RR ] , 1.6 ; 95 % CI , 1.3 to 1.9 ) . There was no significant difference by sex in 30-day mortality after thromboembolism ( 23 % for both ) . Warfarin use was associated with significantly lower adjusted thromboembolism rates for both women and men ( RR , 0.4 ; 95 % CI , 0.3 to 0.5 ; and RR , 0.6 ; 95 % CI , 0.5 to 0.8 , respectively ) , with similar annual rates of major hemorrhage ( 1.0 % and 1.1 % , respectively ) . Conclusions —Women are at higher risk than men for AF-related thromboembolism off warfarin . Warfarin therapy appears be as effective in women , if not more so , than in men , with similar rates of major hemorrhage . Female sex is an independent risk factor for thromboembolism and should influence the decision to use anticoagulant therapy in persons with AF",
"Objective To compare the predictive power of the main existing and recently proposed schemes for stratification of risk of stroke in older patients with atrial fibrillation . Design Comparative cohort study of eight risk stratification scores . Setting Trial of thromboprophylaxis in stroke , the Birmingham Atrial Fibrillation in the Aged ( BAFTA ) trial . Participants 665 patients aged 75 or over with atrial fibrillation based in the community who were r and omised to the BAFTA trial and were not taking warfarin throughout or for part of the study period . Main outcome measures Events rates of stroke and thromboembolism . Results 54 ( 8 % ) patients had an ischaemic stroke , four ( 0.6 % ) had a systemic embolism , and 13 ( 2 % ) had a transient ischaemic attack . The distribution of patients classified into the three risk categories ( low , moderate , high ) was similar across three of the risk stratification scores ( revised CHADS2 , NICE , ACC/AHA/ESC ) , with most patients categorised as high risk ( 65 - 69 % , n=460 - 457 ) and the remaining classified as moderate risk . The original CHADS2 ( Congestive heart failure , Hypertension , Age ≥75 years , Diabetes , previous Stroke ) score identified the lowest number as high risk ( 27 % , n=180 ) . The incremental risk scores of CHADS2 , Rietbrock modified CHADS2 , and CHA2DS2-VASc ( CHA2DS2-Vascular disease , Age 65 - 74 years , Sex ) failed to show an increase in risk at the upper range of scores . The predictive accuracy was similar across the tested schemes with C statistic ranging from 0.55 ( original CHADS2 ) to 0.62 ( Rietbrock modified CHADS2 ) , with all except the original CHADS2 predicting better than chance . Bootstrapped paired comparisons provided no evidence of significant differences between the discriminatory ability of the schemes . Conclusions Based on this single trial population , current risk stratification schemes in older people with atrial fibrillation have only limited ability to predict the risk of stroke . Given the systematic undertreatment of older people with anticoagulation , and the relative safety of warfarin versus aspirin in those aged over 70 , there could be a pragmatic rationale for classifying all patients over 75 as “ high risk ” until better tools are available",
"BACKGROUND AND PURPOSE The risk of major vascular events after an initial episode of cerebral ischemia in patients with nonrheumatic atrial fibrillation ( NRAF ) varies from 2 % to 15 % in the first year and is approximately 5 % yearly thereafter . Few studies have reported on risk factors that can be used to identify high-risk subgroups within this patient population . METHODS We studied the predictive value of several easily obtainable clinical characteristics in a group of 375 placebo-treated patients with NRAF and a recent episode of transient or nondisabling cerebral ischemia who were entered in a multicenter clinical trial . The mean follow-up was 1.6 years . RESULTS By means of multivariate modeling , six independent variables were identified : history of previous thromboembolism , ischemic heart disease , enlarged cardiothoracic ratio on chest roentgenogram , systolic blood pressure greater than 160 mm Hg at study entry , NRAF for more than 1 year , and presence of an ischemic lesion on CT scan . These variables could also be used to stratify patients in low- , medium- , and high-risk subgroups for the other two arms of the trial , those treated with anticoagulation and aspirin . Patients older than 75 years with three or more risk factors seemingly benefited less from both aspirin and anticoagulant treatment . CONCLUSIONS Easily obtainable patient characteristics are helpful in estimating the potential effect of adequate secondary prevention in patients with NRAF who recently suffered a transient ischemic attack or minor ischemic stroke",
"Transesophageal echocardiography visualizes the left atrium and its appendage and is more sensitive than transthoracic echocardiography for diagnosing thrombi of the left atrium and the left atrial appendage and spontaneous echocardiographic contrast of the left atrium [ 1 - 3 ] . The left atrium and especially the left atrial appendage are the presumed sites of thrombus formation and sources of arterial emboli in patients with atrial fibrillation [ 4 ] . Patients with atrial fibrillation and a history of stroke or embolism were shown to have a higher prevalence of thrombi of the left atrium or the left atrial appendage , a higher prevalence of spontaneous echocardiographic contrast , and a larger left atrial appendage than patients with no history of stroke or embolism [ 2 , 5 , 6 ] . However , whether these abnormalities are predictors for stroke or embolism remains controversial [ 7 , 8 ] . Furthermore , no studies have determined whether transesophageal echocardiography helps to assess risk for stroke or embolism in out patients with atrial fibrillation who have no history of stroke or embolism or whether transesophageal echocardiography is useful in the decision to initiate anticoagulation . We therefore performed a prospect i ve , multicenter study of out patients with atrial fibrillation who had not recently had stroke . We sought to determine whether thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and size of the left atrial appendage are associated with stroke or embolism . Our hypothesis was that patients with thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and enlargement of the left atrial appendage have a higher rate of stroke or embolism than do patients without these abnormalities . The baseline clinical and echocardiographic characteristics of our study sample have been reported elsewhere [ 9 ] . Methods Patient Recruitment Our study was conducted in Austria and Slovakia . At the beginning of the study , general practitioners and internists from surrounding participating centers were informed about the study and were asked to refer patients who had constant or intermittent atrial fibrillation . At each patient 's first visit , a cardiologist recorded baseline data , associated illnesses , clinical characteristics ( definitions of which are listed in Appendix 2 ) , and the cause of atrial fibrillation . A 12-lead electrocardiogram was recorded on 2 separate days . We excluded patients with prosthetic valves and those who were already receiving anticoagulation . Current therapy with aspirin was not an exclusion criterion . Patients who had mitral valve stenosis or had recently had stroke were excluded because anticoagulation was indicated for such conditions . For the definition of recent stroke , we chose a cutoff value of 1 year because a previous study reported that the risk for recurrent stroke was increased in patients who had had an ischemic event in the previous year [ 10 ] . Echocardiography For transthoracic echocardiography , 2.5- or 3.5-MHz probes were used . For M-mode measurements , we applied the recommendations of the American Society of Echocardiography [ 11 ] . M-mode measurements were performed on-line and were documented on printouts . Regional wall-motion and valvular abnormalities were recorded . In patients without regional wall-motion abnormalities , left ventricular systolic function was assessed by calculation of left ventricular fractional shortening . For transesophageal echocardiography , biplane 5-MHz probes were used in 64 % of the patients and monoplane 5-MHz probes were used in 36 % . After local anesthesia with lidocaine spray was administered , the probe was introduced into the nonse date d patients , who lay on their left side . The entire study was recorded on S-VHS videotapes . The cardiac chambers and valves were investigated by using all obtainable views [ 12 , 13 ] . Special care was taken to visualize the whole cavity of the left atrium and its appendage from different planes , with the tip of the probe slightly flexed . The size of the left atrial appendage was measured off-line . A frame that best visualized the left atrial appendage with respect to its orifice , extension , and delineation of borders was selected just before the QRS complex . The length of the left atrial appendage was defined as the distance between the limbus of the left superior pulmonary vein and the apex of the left atrial appendage ; the width of the left atrial appendage was defined as the longest distance between the lateral and ventricular left atrial appendage wall , measured in a line perpendicular to the course of the left atrial appendage curvature ; and the left atrial appendage area was defined as described elsewhere [ 14 ] . For the assessment of intra- and interobserver deviations , left atrial appendage size was measured 1 year after the initial measurement in 20 r and omly selected video recordings by the same observer and in 60 r and omly selected video recordings by three observers from different centers . A thrombus of the left atrium or left atrial appendage was considered definite if at least three of the following five criteria were present : clear borders , echogenicity different from that of surrounding structures , independent mobility , longest diameter greater than 15 mm , and evidence of thrombus in more than one imaging plane [ 15 ] . A second observer from a different center review ed video recordings to confirm diagnosis of thrombus of the left atrium or left atrial appendage . A thrombus was considered probable if only two criteria were present or if the observers disagreed . Spontaneous echocardiographic contrast was diagnosed in the presence of dynamic smoke-like echoes within the left atrium or left atrial appendage with a characteristic swirling motion that was distinct from white noise artifact [ 16 ] . When spontaneous echocardiographic contrast was suspected , the gain setting s were decreased in a stepwise manner to exclude artifact caused by excessive gain . The compression and gain controls were then adjusted to ensure the best possible visualization . Spontaneous echocardiographic contrast was not quantified . A second observer from a different center checked the diagnosis of spontaneous echocardiographic contrast by review ing all video recordings . When the observers disagreed about the presence or absence of spontaneous echocardiographic contrast , the decision made at the time of examination was chosen . This was done because spontaneous echocardiographic contrast was not always visible on review of the video recordings . Outcome Events Primary events were stroke and embolism that extended to viscera or extremities . Stroke was defined as acute onset of a focal neurologic deficit that lasted more than 24 hours and was consistent with a vascular event . Severity and subtypes of stroke were assessed according to established criteria [ 17 ] . Embolism extending to viscera or extremities was defined as a sudden onset of pain that was associated with typical findings on Doppler ultrasonography , angiography , surgery , or autopsy . Secondary events were the need for anticoagulation during follow-up in patients who were primarily receiving aspirin and death not caused by stroke or embolism . Death not caused by stroke or embolism was classified as cardiac or noncardiac on the basis of information from the treating physician and the patient 's family . Follow-up Visits took place 3 , 6 , 12 , 18 , and 24 months after study entry . After a follow-up period of at least 2 years ( ending in February 1994 ) , it was evident that the number of primary outcome events was low . We therefore prolonged the follow-up period and planned further visits , one to be held in 1994 and one to be held in 1995 . Patients who were unwilling or unable to attend the visits were contacted by telephone . Medical records were obtained for patients who had been admitted to a hospital . If a patient had died , an autopsy report or death certificate was obtained . Treatment and Ethical Considerations Although our study was design ed to be observational , we recommended antithrombotic treatment to the patients because of ethical considerations . Because patients with thrombi of the left atrium or left atrial appendage are considered to have a high risk for embolism , we recommended that they receive anticoagulation . The target range for the international normalized ratio was 2.0 to 3.0 , and the treating physicians monitored the ratio [ 5 , 18 ] . We recommended that the remaining patients receive aspirin , 160 mg/d , because preliminary data indicated that aspirin reduces the risk for stroke or embolism in patients with atrial fibrillation [ 19 ] . The institutional review board of the participating centers approved the study . Patients were informed about the background and the procedures of the trial , and informed consent was obtained according to the rules of each center . Statistical Analysis For baseline data , group comparisons were done by analysis of variance for normally distributed data and by the nonparametric Kruskal-Wallis test for data that were not normally distributed . If appropriate , we used the Scheffe post hoc test . The Wilk-Shapiro test was used to check for normality . Contingency table methods , including the chi-square test and the Fisher exact test , were used to analyze categorical data . We used the Cox proportional-hazards model to obtain estimates of relative risk and 95 % CIs for all univariate and multivariate analyses of time-to-event data . All tests were two-sided . The level of significance assumed was an level of 0.05 . We used SAS software ( SAS Institute , Cary , North Carolina ) for analyses . Role of Funding Sources The funding sources had no role in the collection , analysis , or interpretation of the data ; did not review the manuscript at any time ; and were not involved in su bmi tting the paper for publication . Results Patients Patients were recruited between January 1990 and February 1992 . Of the 474",
"The efficacy of adjusted-dose oral anticoagulant treatment ( OAT ) in the prevention of stroke in atrial fibrillation ( AF ) is well documented . Available data show that AF patients are widely heterogeneous in terms of ischaemic stroke risk . The role of female gender as a predictor of stroke risk is inconsistent , in particular it is unclear if warfarin treatment is able to prevent stroke equally in both sexes . We performed a prospect i ve study on 780 AF patients on OAT , followed by an Anticoagulation Clinic , to evaluate if female gender is a risk factor for stroke among patients on OAT and if the quality of anticoagulation is different between genders . No difference was found in relation to the quality of anticoagulation between genders ( p=0.5 ) . During follow-up 33 patients had major bleedings ( rate 1.37 x 100 pt/yrs ) but no difference was found between genders in bleeding risk . Forty patients had ischaemic events [ rate 1.66 x 100 pt/yrs ; males rate 1.2 x 100 pt/yrs ; females rate 2.43 x 100 pt/yrs ; p=0.042 ; relative risk ( RR ) of females vs. males 2.0 ( 95 % confidence interval [ CI ] 1.3 - 3.1 ) ; p= 0.004 ] . The higher rate of ischaemic events in females with respect to males was confirmed at Cox regression analysis after correction for age ( p=0.009 ) . In addition , strokes occurring in females were more disabling , and RR for severe and fatal stroke , defined according to Modified Rankin scale , of females vs. males was 3.1 ( 95 % CI 1.3 - 6.5 ; p=0.001 ) . In conclusion , our data show a higher risk of stroke in anticoagulated AF females with respect to males , despite a similar quality of anticoagulation",
"AIMS We aim ed to investigate the prevalence and incidence of atrial fibrillation ( AF ) in a large European population -based study . METHODS AND RESULTS The study is part of the Rotterdam study , a population -based prospect i ve cohort study among subjects aged 55 years and above . The prevalence at baseline was assessed in 6808 participants . Incidence of AF was investigated during a mean follow-up period of 6.9 years in 6432 persons . We identified 376 prevalent and 437 incident cases . Overall prevalence was 5.5 % , rising from 0.7 % in the age group 55 - 59 years to 17.8 % in those aged 85 years and above . The overall incidence rate was 9.9/1000 person-years . The incidence rate in the age group 55 - 59 years was 1.1/1000 person-years , rose to 20.7/1000 person-years in the age group 80 - 84 years and stabilized in those aged 85 years and above . Prevalence and incidence were higher in men than in women . The lifetime risk to develop AF at the age of 55 years was 23.8 % in men and 22.2 % in women . CONCLUSION In this prospect i ve study in a European population , the prevalence and incidence of AF increased with age and were higher in men than in women . The high lifetime risk to develop AF was similar to North American epidemiological data"
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41164304-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE The objectives of this work were to fill the gap in the scientific literature and to evaluate the results of physical therapy treatments in individuals affected by chronic fatigue syndrome , considering only studies that employed a r and omized controlled trial . METHODS A systematic review was carried out according to PRISMA guidelines . Three bibliographic data bases were search ed : MEDLINE , Cochrane Library , and PEDro . The minimum prerequisites for papers to be included in the systematic review were that they had to ( a ) employ a r and omized controlled trial ; ( b ) be published in English ; and ( c ) be published during the last ten years ( 2007 - 2017 ) . The studies were evaluated according to Jadad score . RESULTS Four studies were included . This systematic review suggests that a treatment that is more effective than all the others can not be defined . This conclusion is related to the low number of investigated studies ; therefore , the collected results can not be generalized . CONCLUSION Chronic fatigue syndrome is not yet a well-understood pathology , and the physical mechanisms that influence the outcomes still need more study . Rehabilitation programs that promote physiotherapy techniques such as exercise , mobilization , and body awareness ( e.g. , MRT and GET ) are the most effective in reducing medium and long-term fatigue severity in CFS patients
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[
"OBJECTIVES The aim of this trial was to evaluate the difference in treatment effect , at 26 and 52 weeks after the start of treatment , between cognitive behavioural therapy ( CBT ) and multidisciplinary rehabilitation treatment ( MRT ) for patients with chronic fatigue syndrome ( CFS ) . DESIGN Multicentre , r and omized controlled trial of patients with CFS . Participants were r and omly assigned to MRT or CBT . SETTING Four rehabilitation centres in the Netherl and s. SUBJECTS A total of 122 patients participated in the trial . MAIN OUTCOME MEASURES Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36 . Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation . RESULTS A total of 114 participants completed the assessment at 26 weeks , and 112 completed the assessment at 52 weeks . MRT was significantly more effective than CBT in reducing fatigue at 52 weeks . The estimated difference in fatigue between the two treatments was -3.02 [ 95 % confidence interval ( CI ) -8.07 to 2.03 ; P = 0.24 ] at 26 weeks and -5.69 ( 95 % CI -10.62 to -0.76 ; P = 0.02 ) at 52 weeks . Patients showed an improvement in quality of life over time , but between-group differences were not significant . CONCLUSION This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS . Although implementation in comparable population s can be recommended based on clinical effectiveness , it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial",
"Background Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent , severe and debilitating medically unexplained fatigue , leading to impaired functioning and lower quality of life . Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients . Based on the self-regulation ( SR ) theory of behaviour change , we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills , the \" 4-STEPS to control your fatigue \" program . Methods / Design This is a multi-centre , r and omised controlled trial ( RCT ) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association . Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue ( ICF ) and Chronic Fatigue Syndrome ( CFS ) will be recruited and r and omly allocated to st and ard care ( SC ) or st and ard care plus a self-regulation based physical activity program ( 4-STEPS ) . Patients will be assessed at baseline , after the intervention ( 3 months ) and at 12 months follow-up . The primary outcome is fatigue severity . Discussion The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue . If the program proves to be effective , it may be considered as an adjunctive treatment for these patients .Trial Registration IS RCT N : IS RCT",
"BACKGROUND Stroke is one of the leading causes for disability worldwide . Exercise therapy is a key element of stroke rehabilitation but no evidence are present in literature . Moreover recently focal muscle vibrationis described as a useful therapeutic approach in the post stroke recovery . In this study the efficacy of the vibration therapy in association to progressive modular re balancing rehabilitative approach has been evaluated and compared to the conventional therapy alone and associated to the muscle vibration . METHODS A pilot r and omized controlled trial , using a pragmatic triple-blind , parallel-group study design in chronic stroke patients upper limb function . RESULTS Functional outcomes result ed increased in the group treated with vibration therapy and in particular in the group associated to progressive modular rebalancing approach . CONCLUSION The combining neurophysiologically-based rehabilitative technique and vibration therapy may improve functional recovery in chronic stroke patients",
"PURPOSE The objective of this study is to determine whether the typical exacerbation of symptoms in patients with chronic fatigue syndrome ( CFS ) after a bout of exercise differs between high-intensity interval training ( HIIT ) or continuous ( CONT ) aerobic exercise of the same duration and mechanical work . METHODS Participants with specialist-diagnosed CFS performed two 20-min bouts of cycling in a r and omized crossover study . The bouts were either moderate-intensity continuous ( 70 % age-predicted HR maximum ) or high-intensity interval exercise , separated by at least 2 wk . Self-report question naires capturing fatigue , the related symptoms , and actigraphy were collected across 2 d before and 4 d after the exercise . Comparisons between exercise bouts were made using paired sample t-tests . RESULTS Fourteen moderately affected participants who were unable to work , but not bed bound , completed the study ( nine female , 32 ± 10 yr , 67 ± 11 kg ) . Mechanical work was matched successfully between the exercise bouts ( HIIT , 83,037 , vs CONT , 83,348 J , P = 0.84 ) . Mean HR ( HIIT , 76 % ± 5 % , vs CONT , 73 % ± 6 % age-predicted HR maximum , P and RPE ( 6 - 20 ) in the legs ( HIIT , 15.4 ± 1.4 , vs CONT , 13.2 ± 1.2 , P exercise . Mean fatigue scores ( 0 - 10 ) were similar before each exercise challenge ( HIIT , 4.5 ± 1.8 , vs CONT , 4.1 ± 1.7 , P = 0.43 ) . Participants reported an increase in fatigue scores after both challenges ( mean difference : HIIT , 1.0 ± 1.3 , P these exacerbations in fatigue were not statistically or clinical ly different ( P = 0.20 ) . CONCLUSIONS High-intensity interval exercise did not exacerbate fatigue any more than continuous exercise of comparable workload . This finding supports evaluation of HIIT in grade d exercise therapy interventions for patients with CFS",
"Chronic fatigue syndrome ( CFS ) produces physical and neurocognitive disability that significantly affects health-related quality of life ( HRQL ) . Multidisciplinary treatment combining grade d exercise therapy ( GET ) cognitive behavioural therapy ( CBT ) and pharmacological treatment has shown only short-term improvements . To compare the effects on HRQL of ( 1 ) multidisciplinary treatment combining CBT , GET , and pharmacological treatment , and ( 2 ) usual treatment ( exercise counselling and pharmacological treatment ) at 12 months of follow-up . Prospect i ve , r and omized controlled trial with a follow-up of 12 months after the end of treatment . Patients consecutively diagnosed with CFS ( Fukuda criteria ) were r and omly assigned to intervention ( n = 60 ) or usual treatment ( n = 60 ) groups . HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form question naire ( SF-36 ) . Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Question naire ( HAQ ) and comorbidities . At baseline , the two groups were similar , except for lower SF-36 emotional role scores in the intervention group . At 12 months , the intervention did not improve HRQL scores , with worse SF-36 physical function and bodily pain scores in the intervention group . Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL . The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis",
"PURPOSE This paper is a first attempt analysis of h and and upper limb proprioception coordination induced by NeuroMuscular Taping ( NMT ) : application in a group of 5 participants with Down syndrome . MATERIAL S AND METHODS The participants underwent a drawing test with motion capture system acquisition before and after NMT application . Specific and descriptive parameters were computed and analysed in order to quantify the differences . RESULTS Results showed statistical differences between pre and post treatment sessions : the 5 participants with Down syndrome evidence d more reliance on proprioceptive signals in the post treatment session during the execution of the specific writing tasks . CONCLUSIONS Based on the hypothesis that modifications in proprioception should alter motor pathway mapping of the motor cortex , Neuromuscular taping may play a role in the treatment of dysgraphia and improving h and coordination following CNS impairment , even though a small treatment group was chosen for this pilot study the results lead to further discussion s concerning the role of different afferent signals in a pathological context",
"H and functioning is often impaired in patients with Systemic sclerosis . Neuromuscular Taping is a novel application of tape able to improve functioning . The aim of this study was to evaluate the possible role of this application in the h and functionality of patients with Systemic sclerosis . Women with a diagnosis of SSc has been recruited and evaluated using different scales before and immediately after NMT application and after one , three and six months . Fifty-three women has been evaluated and Cochin H and Functional Disability scale , H and Mobility in Sclerodermia , Modified Rodnan Skin Score and Dreiser Algo - Functional Index scores showed statistical significant differences during all the period ; moreover a reduction of pain and Raynaud Phenomenon 's and an improvement of finger flexion has been observed . Application of NMT in patients with Systemic sclerosis have showed beneficial effect and future studies are needed to confirm these results",
"Objective : To investigate the differential effects of aerobic grade d exercise and progressive resistance training on exercise tolerance , fatigue and quality of life in adolescent patients with chronic fatigue syndrome ( CFS ) . Design : Single-blind , r and omized controlled pilot trial . Setting : A major metropolitan hospital in Melbourne , Australia . Subjects : Twenty-two adolescents aged 13—18 years diagnosed with CFS and admitted to the inpatient chronic fatigue rehabilitation programme . Intervention : Patients were r and omized to either grade d aerobic exercise training or a progressive resistance training programme , for five days/week for four weeks . The grade d aerobic training consisted of 20—40 minutes of stationary cycling and treadmill exercise . The progressive resistance training involved 16 exercises performed with single set , moderate load and high repetitions . Main measures : Exercise tolerance ( time to fatigue ) measured on a grade d sub-maximal treadmill test , metabolic equivalents and quality of life , along with muscular strength ( maximium push-ups ) and endurance ( sit-to-st and ) and question naires evaluating depressive symptoms and fatigue severity . Results : No intervention was significantly better than the other for any outcome . However , physical capacity and quality of life significantly improved in both groups , while fatigue severity and symptoms of depression improved only with aerobic training . Conclusions : Resistance and aerobic training result ed in similar changes to physical capacity , quality of life and fatigue severity . Generally , patients who completed resistance training or aerobic training experienced significant improvements in outcomes from baseline when they entered the programme . Whether these improvements can be attributed to the treatment is unknown"
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41164340-06ff-11f0-808a-c43d1ab1c353
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Background The Paleolithic diet has been studied in the scope of prevention and control of chronic noncommunicable diseases ( CNCD ) . The objective of this study was to analyze the influence of the Paleolithic diet on the prevention and control of CNCD in humans , specifically on anthropometric markers , through a systematic review with meta- analysis . Methods What is the effect of the Paleolithic diet on anthropometric parameters ( weight , body mass index and waist circumference ) compared to other control diets based on recommendations in adults ? We included only r and omized studies with humans that used the Paleolithic Diet in the prevention and control of CNCD published in Portuguese , English or Spanish . The search period was until March 2019 , in the LILACS , PubMed , Scielo , Science Direct , Medline , Web of Science and Scopus data bases . The abstract s were evaluated by two research ers . We found 1224 articles , of which 24 were selected and 11 were included in the meta- analysis . The effect of dietary use on body weight , body mass index and waist circumference was evaluated . Results The summary of the effect showed a loss of − 3.52 kg in the mean weight ( CI 95 % : − 5.26 ; − 1.79 ; p relation to weight loss . The effect was significant on weight , body mass index and waist circumference . Conclusion The Paleolithic diet may assist in controlling weight and waist circumference and in the management of chronic diseases . However , more r and omized clinical studies with larger population s and duration are necessary to prove health benefits .Trial registration CRD42015027849
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"There is evidence for health benefits from ' Palaeolithic ' diets ; however , there are a few data on the acute effects of rationally design ed Palaeolithic-type meals . In the present study , we used Palaeolithic diet principles to construct meals comprising readily available ingredients : fish and a variety of plants , selected to be rich in fibre and phyto-nutrients . We investigated the acute effects of two Palaeolithic-type meals ( PAL 1 and PAL 2 ) and a reference meal based on WHO guidelines ( REF ) , on blood glucose control , gut hormone responses and appetite regulation . Using a r and omised cross-over trial design , healthy subjects were given three meals on separate occasions . PAL2 and REF were matched for energy , protein , fat and carbohydrates ; PAL1 contained more protein and energy . Plasma glucose , insulin , glucagon-like peptide-1 ( GLP-1 ) , glucose-dependent insulinotropic peptide ( GIP ) and peptide YY ( PYY ) concentrations were measured over a period of 180 min . Satiation was assessed using electronic visual analogue scale ( EVAS ) scores . GLP-1 and PYY concentrations were significantly increased across 180 min for both PAL1 ( P= 0·001 and P Concomitant EVAS scores showed increased satiety . By contrast , GIP concentration was significantly suppressed . Positive incremental AUC over 120 min for glucose and insulin did not differ between the meals . Consumption of meals based on Palaeolithic diet principles result ed in significant increases in incretin and anorectic gut hormones and increased perceived satiety . Surprisingly , this was independent of the energy or protein content of the meal and therefore suggests potential benefits for reduced risk of obesity",
"Background We found marked improvement of glucose tolerance and lower dietary energy intake in ischemic heart disease ( IHD ) patients after advice to follow a Paleolithic diet , as compared to a Mediterranean-like diet . We now report findings on subjective ratings of satiety at meals and data on the satiety hormone leptin and the soluble leptin receptor from the same study . Methods Twenty-nine male IHD patients with impaired glucose tolerance or diabetes type 2 , and waist circumference > 94 cm , were r and omized to ad libitum consumption of a Paleolithic diet ( n = 14 ) based on lean meat , fish , fruit , vegetables , root vegetables , eggs , and nuts , or a Mediterranean-like diet ( n = 15 ) based on whole grains , low-fat dairy products , vegetables , fruit , fish , and oils and margarines during 12 weeks . In parallel with a four day weighed food record the participants recorded their subjective rating of satiety . Satiety Quotients were calculated , as the intra-meal quotient of change in satiety during meal and consumed energy or weight of food and drink for that specific meal . Leptin and leptin receptor was measured at baseline and after 6 and 12 weeks . Free leptin index was calculated as the ratio leptin/leptin receptor . Results The Paleolithic group were as satiated as the Mediterranean group but consumed less energy per day ( 5.8 MJ/day vs. 7.6 MJ/day , Paleolithic vs. Mediterranean , p = 0.04 ) . Consequently , the quotients of mean change in satiety during meal and mean consumed energy from food and drink were higher in the Paleolithic group ( p = 0.03 ) . Also , there was a strong trend for greater Satiety Quotient for energy in the Paleolithic group ( p = 0.057 ) . Leptin decreased by 31 % in the Paleolithic group and by 18 % in the Mediterranean group with a trend for greater relative decrease of leptin in the Paleolithic group . Relative changes in leptin and changes in weight and waist circumference correlated significantly in the Paleolithic group ( p Changes in leptin receptor and free leptin index were not significant . Conclusions A Paleolithic diet is more satiating per calorie than a Mediterranean-like diet . Trial registration Clinical Trials.gov",
"Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240",
"Objective : It has been suggested that overweight is negatively associated with cognitive functions . The aim of this study was to investigate whether a reduction in body weight by dietary interventions could improve episodic memory performance and alter associated functional brain responses in overweight and obese women . Methods : 20 overweight postmenopausal women were r and omized to either a modified paleolithic diet or a st and ard diet adhering to the Nordic Nutrition Recommendations for 6 months . We used functional magnetic resonance imaging to examine brain function during an episodic memory task as well as anthropometric and biochemical data before and after the interventions . Results : Episodic memory performance improved significantly ( p = 0.010 ) after the dietary interventions . Concomitantly , brain activity increased in the anterior part of the right hippocampus during memory encoding , without differences between diets . This was associated with decreased levels of plasma free fatty acids ( FFA ) . Brain activity increased in pre-frontal cortex and superior/middle temporal gyri . The magnitude of increase correlated with waist circumference reduction . During episodic retrieval , brain activity decreased in inferior and middle frontal gyri , and increased in middle/superior temporal gyri . Conclusions : Diet-induced weight loss , associated with decreased levels of plasma FFA , improves episodic memory linked to increased hippocampal activity",
"Background We found marked improvement of glycemic control and several cardiovascular risk factors in patients with type 2 diabetes given advice to follow a Paleolithic diet , as compared to a diabetes diet . We now report findings on subjective ratings of satiety at meal times and participants ’ other experiences of the two diets from the same study . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes ( 3 women and 10 men ) , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts , and a diabetes diet design ed in accordance with dietary guidelines , during two consecutive 3-month periods . In parallel with a four-day weighed food record , the participants recorded their subjective rating of satiety . Satiety quotients were calculated as the intra-meal quotient of change in satiety during a meal and consumed energy or weight of food and drink for that specific meal . All participants answered the same three open-ended questions in a survey following each diet : “ What thoughts do you have about this diet ? ” , “ Describe your positive and negative experiences with this diet ” and “ How do you think this diet has affected your health ? ” . Results The participants were equally satiated on both diets . The Paleolithic diet result ed in greater satiety quotients for energy per meal ( p = 0.004 ) , energy density per meal ( p = 0.01 ) and glycemic load per meal ( p = 0.02 ) . The distribution of positive and negative comments from the survey did not differ between the two diets , and the comments were mostly positive . Among comments relating to recurring topics , there was no difference in distribution between the two diets for comments relating to tastelessness , but there was a trend towards more comments on the Paleolithic diet being satiating and improving blood sugar values , and significantly more comments on weight loss and difficulty adhering to the Paleolithic diet . Conclusions A Paleolithic diet is more satiating per calorie than a diabetes diet in patients with type 2 diabetes . The Paleolithic diet was seen as instrumental in weight loss , albeit it was difficult to adhere to . Trial registration Clinical Trials.gov :",
"Background / objectives : Formulas developed to estimate diet-dependent net acid excretion ( NAE ) generally agree with measured values for typical Western diets . Whether they can also appropriately predict NAE for ‘ Paleolithic-type ’ ( Paleo ) diets — which contain very high amounts of fruits and vegetables ( F&V ) and concurrent high amounts of protein is unknown . Here , we compare measured NAEs with established NAE estimates in subjects with Type 2 diabetes (T2D).Subjects/ methods : Thirteen subjects with well-controlled T2D were r and omized to either a Paleo or American Diabetes Association ( ADA ) diet for 14 days . Twenty-four hour urine collection s were performed at baseline and end of the diet period , and analyzed for titratable acid , bicarbonate and ammonium to calculate measured NAE . Three formulas for estimating NAE from dietary intake were used ; two ( NAE_diet R or L ) that include dietary mineral intake and sulfate- and organic acid ( OA ) production , and one that is empirically derived ( NAE_diet F ) only considering potassium and protein intake . Results : Measured NAE on the Paleo diet was significantly lower than on the ADA-diet ( + 31±22 vs 112±52 mEq/day , P=0.002 ) . Although all formula estimates showed similar and reasonable correlations ( r=0.52–0.76 ) with measured NAE , each one underestimated measured values . The formula with the best correlation did not contain an estimate of dietary OA production . Conclusions : Paleo-diets are lower in NAE than typical Western diets . However , commonly used formulas clearly underestimate NAE , especially for diets with very high F&V ( as the Paleo diet ) , and in subjects with T2D . This may be due to an inappropriate estimation of proton loads stemming from OAs , underlining the necessity for improved measures of OA-related proton sources",
"Background There is a lack of research about the experiences of participating in weight-reducing interventions . The aim of this study was to explore barriers and facilitators to weight-loss experienced by participants in a diet intervention for middle-aged to older women in the general population in Northern Sweden . Method In the intervention the women were r and omised to eat either a Palaeolithic-type diet or a diet according to Nordic Nutrition recommendations for 24 months . A strategic selection was made of women from the two intervention groups as well as from the drop-outs in relation to social class , civil status and age . Thematic structured interviews were performed with twelve women and analysed with qualitative content analyses . Results The results showed that the women in the dietary intervention experienced two main barriers – struggling with self ( related to difficulties in changing food habits , health problems , lack of self-control and insecurity ) and struggling with implementing the diet ( related to social relations and project-related difficulties ) – and two main facilitators– striving for self-determination ( related to having clear goals ) and receiving support ( from family/friends as well as from the project ) – for weight-loss . There was a greater emphasis on barriers than on facilitators . Conclusion It is important to also include drop-outs from diet interventions in order to fully underst and barriers to weight-loss . A gender-relational approach can bring new insights into underst and ing experiences of barriers to weight-loss . Trial registration Clinical Trials gov NCT00692536",
"Purpose We studied effects of diet-induced postmenopausal weight loss on gene expression and activity of proteins involved in lipogenesis and lipolysis in adipose tissue . Methods Fifty-eight postmenopausal women with overweight ( BMI 32.5 ± 5.5 ) were r and omized to eat an ad libitum Paleolithic-type diet ( PD ) aim ing for a high intake of protein and unsaturated fatty acids or a prudent control diet ( CD ) for 24 months . Anthropometry , plasma adipokines , gene expression of proteins involved in fat metabolism in subcutaneous adipose tissue ( SAT ) and lipoprotein lipase ( LPL ) activity and mass in SAT were measured at baseline and after 6 months . LPL mass and activity were also measured after 24 months . Results The PD led to improved insulin sensitivity ( P decreased circulating triglycerides ( P ) , lipogenesis-related factors , including LPL mRNA ( P , mass ( P and activity ( P as gene expressions of CD36 ( P fatty acid synthase , FAS ( P and diglyceride acyltransferase 2 , DGAT2 ( P ) . The LPL activity ( P 0.05 ) and gene expression of DGAT2 ( P and FAS ( P the PD group versus the CD group at 6 months and the LPL activity ( P the PD group compared to the CD group at 24 months . Conclusions Compared to the CD , the PD led to a more pronounced reduction of lipogenesis-promoting factors in SAT among postmenopausal women with overweight . This could have mediated the favorable metabolic effects of the PD on triglyceride levels and insulin sensitivity ",
"Abstract Background We have previously shown that a Palaeolithic diet consisting of the typical food groups that our ancestors ate during the Palaeolithic era , improves cardiovascular disease risk factors and glucose control compared to the currently recommended diabetes diet in patients with type 2 diabetes . To eluci date the mechanisms behind these effects , we evaluated fasting plasma concentrations of glucagon , insulin , incretins , ghrelin , C-peptide and adipokines from the same study . Methods In a r and omised , open-label , cross-over study , 13 patients with type 2 diabetes were r and omly assigned to eat a Palaeolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts , or a diabetes diet design ed in accordance with current diabetes dietary guidelines during two consecutive 3-month periods . The patients were recruited from primary health-care units and included three women and 10 men [ age ( mean ± SD ) 64 ± 6 years ; BMI 30 ± 7 kg/m2 ; diabetes duration 8 ± 5 years ; glycated haemoglobin 6.6 ± 0.6 % ( 57.3 ± 6 mmol/mol ) ] with unaltered diabetes treatment and stable body weight for 3 months prior to the start of the study . Outcome variables included fasting plasma concentrations of leptin , adiponectin , adipsin , visfatin , resistin , glucagon , insulin , C-peptide , glucose-dependent insulinotropic polypeptide , glucagon-like peptide-1 and ghrelin . Dietary intake was evaluated by use of 4-day weighed food records . Results Seven participants started with the Palaeolithic diet and six with the diabetes diet . The Palaeolithic diet result ed in a large effect size ( Cohen ’s d = −1.26 ) at lowering fasting plasma leptin levels compared to the diabetes diet [ mean difference ( 95 % CI ) , −2.3 ( −5.1 to 0.4 ) ng/ml , p = 0.023 ] . No statistically significant differences between the diets for the other variables , analysed in this study , were observed . Conclusions Over a 3-month study period , a Palaeolithic diet result ed in reduced fasting plasma leptin levels , but did not change fasting levels of insulin , C-peptide , glucagon , incretins , ghrelin and adipokines compared to the currently recommended diabetes diet . Trial registration : Clinical Trials.gov",
"This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence",
"Aims /hypothesisMost studies of diet in glucose intolerance and type 2 diabetes have focused on intakes of fat , carbohydrate , fibre , fruits and vegetables . Instead , we aim ed to compare diets that were available during human evolution with more recently introduced ones . Methods Twenty-nine patients with ischaemic heart disease plus either glucose intolerance or type 2 diabetes were r and omised to receive ( 1 ) a Palaeolithic ( ‘ Old Stone Age ’ ) diet ( n = 14 ) , based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; or ( 2 ) a Consensus ( Mediterranean-like ) diet ( n = 15 ) , based on whole grains , low-fat dairy products , vegetables , fruits , fish , oils and margarines . Primary outcome variables were changes in weight , waist circumference and plasma glucose AUC ( AUC Glucose0–120 ) and plasma insulin AUC ( AUC Insulin0–120 ) in OGTTs . Results Over 12 weeks , there was a 26 % decrease of AUC Glucose0–120 ( p = 0.0001 ) in the Palaeolithic group and a 7 % decrease ( p = 0.08 ) in the Consensus group . The larger ( p = 0.001 ) improvement in the Palaeolithic group was independent ( p = 0.0008 ) of change in waist circumference ( −5.6 cm in the Palaeolithic group , −2.9 cm in the Consensus group ; p = 0.03 ) . In the study population as a whole , there was no relationship between change in AUC Glucose0–120 and changes in weight ( r = −0.06 , p = 0.9 ) or waist circumference ( r = 0.01 , p = 1.0 ) . There was a tendency for a larger decrease of AUC Insulin0–120 in the Palaeolithic group , but because of the strong association between change in AUC Insulin0–120 and change in waist circumference ( r = 0.64 , p = 0.0003 ) , this did not remain after multivariate analysis . Conclusions /interpretationA Palaeolithic diet may improve glucose tolerance independently of decreased waist circumference",
"Recent research suggests that traditional grain-based heart-healthy diet recommendations , which replace dietary saturated fat with carbohydrate and reduce total fat intake , may result in unfavorable plasma lipid ratios , with reduced high-density lipoprotein ( HDL ) and an elevation of low-density lipoprotein ( LDL ) and triacylglycerols ( TG ) . The current study tested the hypothesis that a grain-free Paleolithic diet would induce weight loss and improve plasma total cholesterol , HDL , LDL , and TG concentrations in nondiabetic adults with hyperlipidemia to a greater extent than a grain-based heart-healthy diet , based on the recommendations of the American Heart Association . Twenty volunteers ( 10 male and 10 female ) aged 40 to 62 years were selected based on diagnosis of hypercholesterolemia . Volunteers were not taking any cholesterol-lowering medications and adhered to a traditional heart-healthy diet for 4 months , followed by a Paleolithic diet for 4 months . Regression analysis was used to determine whether change in body weight contributed to observed changes in plasma lipid concentrations . Differences in dietary intakes and plasma lipid measures were assessed using repeated- measures analysis of variance . Four months of Paleolithic nutrition significantly lowered ( P mean total cholesterol , LDL , and TG and increased ( P HDL , independent of changes in body weight , relative to both baseline and the traditional heart-healthy diet . Paleolithic nutrition offers promising potential for nutritional management of hyperlipidemia in adults whose lipid profiles have not improved after following more traditional heart-healthy dietary recommendations",
"BACKGROUND Multiple sclerosis is an autoimmune disease influenced by environmental factors . OBJECTIVES The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed . DESIGN / SETTING This was a single-arm , open-label intervention study in an outpatient setting . INTERVENTIONS A multimodal intervention including a modified paleolithic diet with supplements , stretching , strengthening exercises with electrical stimulation of trunk and lower limb muscles , meditation , and massage was used . OUTCOME MEASURES Adherence to each component of the intervention was calculated using daily logs . Side-effects were assessed from a monthly question naire and blood analyses . Fatigue was assessed using the Fatigue Severity Scale ( FSS ) . Data were collected at baseline and months 1 , 2 , 3 , 6 , 9 , and 12 . RESULTS Ten ( 10 ) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study . Of those 10 subjects , 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months . Over a 12-month period , average adherence to diet exceeded 90 % of days , and to exercise/muscle stimulation exceeded 75 % of days . Nutritional supplements intake varied among and within subjects . Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes . No adverse side-effects were reported . Group average FSS scores decreased from 5.7 at baseline to 3.32 ( p=0.0008 ) at 12 months . CONCLUSIONS In this small , uncontrolled pilot study , there was a significant improvement in fatigue in those who completed the study . Given the small sample size and completer rate , further evaluation of this multimodal therapy is warranted",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"Background / Objectives : Our objective was to investigate changes in liver fat and insulin sensitivity during a 2-year diet intervention . An ad libitum Paleolithic diet ( PD ) was compared with a conventional low-fat diet (LFD).Subjects/ Methods : Seventy healthy , obese , postmenopausal women were r and omized to either a PD or a conventional LFD . Diet intakes were ad libitum . Liver fat was measured with proton magnetic resonance spectroscopy . Insulin sensitivity was evaluated with oral glucose tolerance tests and calculated as homeostasis model assessment -insulin resistance (HOMA-IR)/liver insulin resistance ( Liver IR ) index for hepatic insulin sensitivity and oral glucose insulin sensitivity (OGIS)/Matsuda for peripheral insulin sensitivity . All measurements were performed at 0 , 6 and 24 months . Forty-one women completed the examinations for liver fat and were included . Results : Liver fat decreased after 6 months by 64 % ( 95 % confidence interval : 54–74 % ) in the PD group and by 43 % ( 27–59 % ) in the LFD group ( P months , liver fat decreased 50 % ( 25–75 % ) in the PD group and 49 % ( 27–71 % ) in the LFD group . Weight reduction between baseline and 6 months was correlated to liver fat improvement in the LFD group ( rs=0.66 , P Hepatic insulin sensitivity improved during the first 6 months in the PD group ( P A PD with ad libitum intake had a significant and persistent effect on liver fat and differed significantly from a conventional LFD at 6 months . This difference may be due to food quality , for example , a higher content of mono- and polyunsaturated fatty acids in the PD . Changes in liver fat did not associate with alterations in insulin sensitivity ",
"OBJECTIVE Abdominal fat accumulation after menopause is associated with low- grade inflammation and increased risk of metabolic disorders . Effective long-term lifestyle treatment is therefore needed . METHODS Seventy healthy postmenopausal women ( age 60 ± 5.6 years ) with BMI 32.5 ± 5.5 were r and omized to a Paleolithic-type diet ( PD ) or a prudent control diet ( CD ) for 24 months . Blood sample s and fat biopsies were collected at baseline , 6 months , and 24 months to analyze inflammation-related parameters . RESULTS And roid fat decreased significantly more in the PD group ( P = 0.009 ) during the first 6 months with weight maintenance at 24 months in both groups . Long-term significant effects ( P adipose gene expression were found for toll-like receptor 4 ( decreased at 24 months ) and macrophage migration inhibitory factor ( increased at 24 months ) in both groups . Serum interleukin 6 ( IL-6 ) and tumor necrosis factor α levels were decreased at 24 months in both groups ( P P = 0.022 ) . High-sensitivity C-reactive protein was decreased in the PD group at 24 months ( P = 0.001 ) . CONCLUSIONS A reduction of abdominal obesity in postmenopausal women is linked to specific changes in inflammation-related adipose gene expression"
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Dyslipidemia and hyperglycemia are associated with an increased risk of ischemic cardiovascular disease . Positive effects of a nutraceutical combination comprising red yeast rice , berberine , policosanol , astaxanthin , coenzyme Q10 and folic acid ( NComb ) on plasma lipid and glucose levels have been reported in some but not all clinical trials . To address this inconsistency , we tried to estimate the size of lipid- and glucose-lowering effects of NComb through a systematic review and meta- analysis of r and omized controlled trials . A systematic literature search in PubMed - Medline , SCOPUS and Google Scholar data bases was conducted to identify r and omized controlled trials investigating the effects of NComb on plasma lipids and glucose levels . Inverse variance-weighted mean differences ( WMDs ) and 95 % confidence intervals ( CIs ) were calculated for net changes in lipid and glucose levels using a r and om-effects model . R and om-effects meta-regression was performed to assess the effect of putative confounders on plasma lipid and glucose levels . Fourteen trials ( 1670 subjects in the NComb arm and 1489 subjects in the control arm ) met the eligibility criteria for lipid analysis and 10 trials ( 1014 subjects in the NComb arm and 962 subjects in the control arm ) for glucose analysis . Overall , WMDs were significant for the impact of NComb supplementation on plasma levels of total cholesterol ( -26.15mg/dL , p ( -23.85mg/dL , p ( 2.53mg/dL , p ( -13.83mg/dL , p ) and glucose ( -2.59mg/dL , p=0.010 ) . NComb-induced amelioration of lipid profile was not affected by duration of supplementation nor by baseline lipid levels ; conversely , a greater glucose-lowering effect of NComb was found with higher baseline glucose levels and longer duration s of supplementation . In conclusion , the present results suggest that NComb supplementation is associated with improvement of lipid and glucose profile . Short-term beneficial effects of NComb supplementation appear to be maintained in the long term
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"Background Statins are at the forefront of strategies to manage hypercholesterolemia . However 10 % to 15 % of patients are intolerant to any statin drugs , even at low daily doses and almost one-third of statin users discontinue therapy within 1 year . Some nutraceuticals are prescribed as lipid-lowering substances , but doubts remain about their efficacy and tolerability . Objectives We aim ed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract ( equivalent to 3 mg monacolins ) , 500 mg berberine , and 10 mg policosanols ( MBP-NC ) in patients with low-moderate risk hypercholesterolemia . Methods In this single centre , r and omized , double-blind , placebo-controlled study 60 consecutive out patients ( 29 men and 31 women ; age range = 18–60 years ) , with newly diagnosed primary hypercholesterolemia not previously treated , after a run-in period of 3 weeks on a stable hypolipidic diet , were r and omized to receive a pill of MBP-NC ( n = 30 ) or placebo ( n = 30 ) once a day after dinner , in addition to the hypolipidic diet . The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4 , 12 , and 24 weeks of treatment . Results In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 ( –30.3 % ± 33.9 % and –29.4 % ± 35.3 % , respectively ) that remained substantially unchanged at Week 12 ( –26.7 % ± 33.1 % and –25.6 % ± 31.5 % , respectively ) and at Week 24 ( –24.6 % ± 32.1 % and –23.7 % ± 32.6 % , respectively ) . The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C , fasting glucose , and triglyceride serum levels in either group . MBP-NC was also safe and well tolerated . Conclusions In patients with low- to moderate-risk hypercholesterolemia a nutraceutical combination in association with a hypolipidic diet significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets . Clinical Trials.gov identifier : NCT02078167",
"Patients with diabetes show an increased vascular morbidity and mortality that reduces their life expectancy by ~5–15 years ( depending on the age at diagnosis ) ( 1 ) . There is convincing evidence from epidemiological and pathophysiological studies that hyperglycemia per se is largely responsible for the harmful effects of the disease . As recently shown by clinical trials , treatment of this condition may reduce cardiovascular events and mortality , and several therapies should be considered : initiating early and individualized treatment and avoiding hypoglycemia . As shown in the Multiple Risk Factor Intervention Trial , at any given level of major cardiovascular risk factors , diabetes is associated with an odds ratio of 2–4 for cardiovascular mortality compared with nondiabetic subjects ( 2 ) . These results were confirmed by the European Prospect i ve Investigation of Cancer and Nutrition ( EPIC Norfolk ) study ( 3 ) and a recent analysis of the Atherosclerosis Risk in Communities ( ARIC ) study ( 4 ) . Furthermore , a recently published 18-year follow-up study from Finl and demonstrated a similar impact of type 1 and type 2 diabetes on cardiovascular mortality . The adjusted hazard ratios compared with age-matched subjects without diabetes were 5.2 and 4.9 for type 1 and type 2 diabetes , respectively ( 5 ) . Thus , today evidence exists on long-term follow-up population -based studies in patients with type 1 and type 2 diabetes . This evidence clearly suggests that hyperglycemia is a key risk factor not only for diabetes-related disease , but also for cardiovascular and all-cause mortality . On the basis of these long-term observations , one can assume an increment of cardiovascular disease per increase of 1 unit ( % ) A1C of ~18 % ( 6 ) . As shown in numerous prospect i ve studies , the deleterious effects of dysglycemia ( fasting and postpr and ial hyperglycemia ) develop before diabetes is diagnosed . In the Glucose Tolerance in Acute Myocardial Infa rct ion study of patients with acute coronary syndrome , abnormal glucose tolerance was the strongest independent",
"Berberine ( BERB ) and a combination ( COMB ) of berberine ( CAS 2086 - 83 - 1 ) with policosanol ( CAS 557 - 61 - 9 ) , red yeast extract ( containing monacolin , CAS 557 - 61 - 9 ) , folic acid and astaxanthin were orally administered daily for 4 weeks to 40 subjects with moderate dyslipidemias divided in two parallel groups each of 20 subjects . Total cholesterol ( TC ) , LDL , HDL , Non HDL , ApoB , ApoA , Lp(a ) and triglycerides ( TG ) were measured before and at the end of treatments . BERB and COMB significantly reduced TC ( respectively by 16 % and 20 % ) , LDL ( by 20 % and 25 % ) , ApoB ( by 15 % and 29 % ) and TG ( by 22 % and 26 % ) , and increased HDL ( by 6.6 % and 5.1 % ) . Adverse events or impairments of liver transaminases or of CPK were not observed . In conclusion , food supplements containing natural products such as berberine , policosanol , red yeast extracts , folic acid and astaxanthin could be a useful support to diet and life style changes to correct dyslipidemias and to reduce cardiovascular risk in subjects with moderate mixed dyslipidemias",
"BACKGROUND Astaxanthin has been reported to improve dyslipidemia and metabolic syndrome in animals , but such effects in humans are not well known . METHODS Placebo-controlled astaxanthin administration at doses of 0 , 6 , 12 , 18 mg/day for 12 weeks was r and omly allocated to 61 non-obese subjects with fasting serum triglyceride of 120 - 200mg/dl and without diabetes and hypertension , aged 25 - 60 years . RESULTS In before and after tests , body mass index ( BMI ) and LDL-cholesterol were unaffected at all doses , however , triglyceride decreased , while HDL-cholesterol increased significantly . Multiple comparison tests showed that 12 and 18 mg/day doses significantly reduced triglyceride , and 6 and 12 mg doses significantly increased HDL-cholesterol . Serum adiponectin was increased by astaxanthin ( 12 and 18 mg/day ) , and changes of adiponectin correlated positively with HDL-cholesterol changes independent of age and BMI . CONCLUSIONS This first-ever r and omized , placebo-controlled human study suggests that astaxanthin consumption ameliorates triglyceride and HDL-cholesterol in correlation with increased adiponectin in humans",
"Efficacy of a new patented proprietary combination of natural nutraceuticals ( PN ) containing natural hypolipidemic as red yeast , policosanol and berberine was tested in a large study on dyslipidemic patients in clinical practice . A parallel , controlled , r and omized , multicenter study was design ed . After 2 weeks on a stable dietary regimen , the patients were r and omized to PN 1 tablet/day associated with diet ( PN + D ) or diet alone ( D ) for 16 weeks . Entry criteria were : Tot-Chol > 200 mg/dL or LDL-Chol > 150 mg/dL without a clear indication for statins , or plasma triglycerides > 150 mg/dL. Lipid pattern and CV parameters were evaluated at baseline and monthly . 1,751 patients were enrolled in 248 Italian units , 933 patients on PN + D and 818 on D. The baseline lipid values were : Tot-Chol 255.4 versus 243.1 mg/dL , LDL-Chol 170.1 versus 162.2 mg/dL , HDL-Chol 50.0 versus 48.8 mg/dL , and TG 190.5 versus 184.4 mg/dL. PN constantly and significantly improved lipid parameters versus D group : at 16 weeks −19.1 versus −9.4 % for Tot-Chol ( p for LDL-Chol ( p HDL-Chol ( p TG ( p allows an effective improvement of blood lipids with a significant reduction of global CV risk , suggesting a role for PN in CHD prevention",
"A dietary supplement ( AP , Armolipid Plus ) that combines red yeast rice extract , policosanol , berberine , folic acid , coenzyme Q10 and asthaxantine can have beneficial effects on cardiovascular disease ( CVD ) biomarkers . The aim of this study was to assess whether the intake of AP , in combination with dietary recommendations , reduces serum low density lipoprotein cholesterol ( LDL-c ) concentrations and other CVD biomarkers in patients with hypercholesterolemia . Eligible patients were recruited from the outpatient clinics of six Spanish hospitals Hospital Virgen del Rocío ( Sevilla ) ; Hospital San Jorge ( Huesca ) ; Hospital San Pedro ( Logroño ) ; Hospital Gregorio Marañón ( Madrid ) , Hospital la Fe ( Valencia ) and Hospital Universitari Sant Joan ( Reus ) as recruiting and coordinating center . 102 participants ( mean age ± SD ; 50.91±11.61 ; 32 men ) with low CVD , with mild-to-moderately elevated LDL-c ( between 3.35 mmol/L and 4.88 mmol/L ) without hypolipemic therapy were r and omized in a double-blind , parallel , controlled , multicenter trial commencing January 2012 and ending December 2012 . Among the exclusion criteria were any concomitant chronic disease , triglycerides ( TG ) > 3.97 mmol/L , pregnant or lactating , and history of CVD . At 12 weeks , compared to placebo , AP reduced LDL-c by −6.9 % , apolipoprotein ( Apo ) B-100 by −6.6 % and total cholesterol/HDL-c ratio by −5.5 % , the ApoB/ApoA1 ratio by −8.6 % , while increasing ApoA1 by + 2.5 % ( p consumption was associated with modest mean weight loss of −0.93 kg ( 95%CI : -1.74 to -0.12 ; P = 0.02 ) compared with control group while dietary composition remained unchanged in the AP group . The AP product was well tolerated . In conclusion , AP , combined with dietary recommendations , reduced LDL-c levels as well as total cholesterol/HDL-c and ApoB/ApoA1 ratios , while increasing Apo A1 , all of which are improvements in CVD risk indicators . AP is a product which could benefit patients having moderate hyperlipidemia and excess body weight . Trial Registration Clinical Trials.gov",
"Introduction Statins are at the forefront of strategies to manage dyslipidemia , although they are not always well tolerated . At 6–7 months after the drug was supplied , discontinuation rates averaged 30 % . Alternate agents to statins have been studied . Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations . However , there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients . The purpose of this study was to examine the efficacy , safety , and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins . Methods This study was performed as a r and omized , prospect i ve , parallel group , single-blind study . Patients were included in the study if they had high total cholesterolemia , high low-density lipoprotein cholesterol ( LDL-C ) , > 75 years of age , statin-intolerant , and were refusing other pharmaceutical treatments for hypercholesterolemia . At the baseline visit , eligible patients were r and omized to either nutraceutical-combined pill ( containing berberine 500 mg , policosanol 10 mg , red yeast rice 200 mg , folic acid 0.2 mg , coenzyme Q10 2.0 mg , and astaxanthin 0.5 mg ) or placebo , and the first dose was dispensed . The efficacy , safety , and tolerability of the proposed treatment were fully assessed after 3 , 6 , and 12 months of treatment . Results Out of 106 consecutive patients screened , 80 eligible patients were r and omized to receive either nutraceutical-combined pill ( 40 patients ) or placebo ( 40 patients ) . No patients were lost and no deaths occurred during the follow-up . There was a statistically significant reduction in total cholesterolemia ( −20 % ) , LDL-C ( −31 % ) , and insulin resistance ( −10 % ) with nutraceutical treatment . No significant changes were detected for plasma high-density lipoprotein cholesterol ( HDL-C ) . Furthermore , no statistical differences were found between baseline and end- study safety parameters . Medication compliance and tolerability were high . Conclusion In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant . Combined nutraceuticals is also safe and well tolerated in these patients",
"BACKGROUND Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known . METHODS We conducted a double-blind , r and omized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter ( 1.3 to 2.6 mmol per liter ) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter ( 1.3 to 3.2 mmol per liter ) if they were not receiving lipid-lowering therapy . The combination of simvastatin ( 40 mg ) and ezetimibe ( 10 mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( 40 mg ) and placebo ( simvastatin monotherapy ) . The primary end point was a composite of cardiovascular death , nonfatal myocardial infa rct ion , unstable angina requiring rehospitalization , coronary revascularization ( ≥30 days after r and omization ) , or nonfatal stroke . The median follow-up was 6 years . RESULTS The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter ( 1.4 mmol per liter ) in the simvastatin-ezetimibe group , as compared with 69.5 mg per deciliter ( 1.8 mmol per liter ) in the simvastatin-monotherapy group ( P The Kaplan-Meier event rate for the primary end point at 7 years was 32.7 % in the simvastatin-ezetimibe group , as compared with 34.7 % in the simvastatin-monotherapy group ( absolute risk difference , 2.0 percentage points ; hazard ratio , 0.936 ; 95 % confidence interval , 0.89 to 0.99 ; P=0.016 ) . Rates of prespecified muscle , gallbladder , and hepatic adverse effects and cancer were similar in the two groups . CONCLUSIONS When added to statin therapy , ezetimibe result ed in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes . Moreover , lowering LDL cholesterol to levels below previous targets provided additional benefit . ( Funded by Merck ; IMPROVE-IT Clinical Trials.gov number , NCT00202878 . )",
"Statins are extensively used to treat dyslipidemia , but , because of their low tolerability profile , they are discontinued in a significant proportion of patients . Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated . A single-blind , single-center , r and omized , prospect i ve , and parallel group trial comparing a combination of nutraceuticals ( red yeast rice , policosanol , berberine , folic acid , coenzyme Q10 and astaxanthin ) , called Armolipid Plus , and ezetimibe for 3 months in terms of efficacy and tolerability . Patients who did not achieve their therapeutic target ( low-density lipoprotein cholesterol 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled ( ezetimibe n = 50 , nutraceutical n = 50 ) . Efficacy ( lipid profile ) and tolerability ( adverse events , transaminases , and creatine kinase ) were assessed after 3 and 12 months . After 3 months , 14 patients in the nutraceutical group achieved their therapeutic target , whereas none of the patients in the ezetimibe group did . At 1-year follow-up , 58 patients ( 72.5 % ) of the combined therapy group ( n = 86 ) and 14 ( 100 % ) of the nutraceutical group reached the therapeutic goal . No patients experienced important undesirable effects . In conclusion , nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease . Further studies are needed to assess long-term effects of nutraceuticals on mortality",
"Astaxanthin , a carotenoid , has antioxidant activity as well as many positive effects , such as anticancer and anti-inflammatory effects . We performed a r and omized , double-blind , placebo-controlled study to investigate the effects of astaxanthin on lipid profiles and oxidative stress in overweight and obese adults in Korea . In total , 27 subjects with body mass index > 25.0 kg/m2 were enrolled and r and omly assigned into two groups administered astaxanthin or placebo capsules for 12 weeks . Total cholesterol , triglycerides , high density lipoprotein ( HDL ) cholesterol , low density lipoprotein ( LDL ) cholesterol , apolipoprotein A1 ( ApoA1 ) , and apolipoprotein B ( ApoB ) were measured before and after intervention . Malondialdehyde ( MDA ) , isoprostane ( ISP ) , superoxide dismutase ( SOD ) , and total antioxidant capacity ( TAC ) , as oxidative stress biomarkers , were measured at baseline and at 4 , 8 , and 12 weeks after intervention . LDL cholesterol and ApoB were significantly lower after treatment with astaxanthin , compared with the start of administration , whereas none of the lipid profiles was changed in the placebo group . At the baseline , all four biomarkers were not significantly different between the two groups . Compared with the placebo group , MDA and ISP were significantly lower , but TAC was significantly higher in the astaxanthin group at 12 weeks . These results suggest that supplementary astaxanthin has positive effects by improving the LDL cholesterol , ApoB , and oxidative stress biomarkers",
"BACKGROUND The lowest dose of folic acid required to achieve effective reductions in homocysteine is controversial but important for food fortification policy given recent concerns about the potential adverse effects of overexposure to this vitamin . OBJECTIVE We compared the effectiveness of 0.2 mg folic acid/d with that of 0.4 and 0.8 mg/d at lowering homocysteine concentrations over a 6-mo period . DESIGN A r and omized dose-finding trial with folic acid was conducted . Of 203 participants screened , 101 patients with ischemic heart disease and 71 healthy volunteers completed the study . Participants were r and omly assigned to receive placebo or folic acid at doses of 0.2 , 0.4 , or 0.8 mg/d for 26 wk ; sub sample s of patients with ischemic heart disease were also examined at 6 or 12 wk . RESULTS Participants with higher baseline homocysteine concentrations had the greatest reductions in homocysteine in response to folic acid doses of 0.2 mg ( -20.6 % ) , 0.4 mg ( -20.7 % ) , and 0.8 mg ( -27.8 % ) ; in those with lower baseline homocysteine concentrations , the responses were -8.2 % , -8.9 % , and -8.3 % , respectively . No significant differences in homocysteine responses to the different doses were observed . In the patient group sample d at intervals during the intervention , the maximal homocysteine response appeared to be achieved by 6 wk in the 0.8-mg/d group and by 12 wk in the 0.4-mg/d group . However , the homocysteine response was suboptimal in the 0.2-mg/d group at both 6 and 12 wk compared with that at 26 wk . CONCLUSIONS A folic acid dose as low as 0.2 mg/d can , if administered for 6 mo , effectively lower homocysteine concentrations . Higher doses may not be necessary because they result in no further significant lowering , whereas doses even lower than 0.2 mg/d may be effective in the longer term . Previous trials probably overestimated the folic acid dose required because of a treatment duration that was too short . This trial was registered at clinical trials.gov as IS RCT N45296887",
"CONTEXT Recent r and omized trials among patients with preexisting cardiovascular disease ( CVD ) have failed to support benefits of B-vitamin supplementation on cardiovascular risk . Observational data suggest benefits may be greater among women , yet women have been underrepresented in published r and omized trials . OBJECTIVE To test whether a combination of folic acid , vitamin B6 , and vitamin B12 lowers risk of CVD among high-risk women with and without CVD . DESIGN , SETTING , AND PARTICIPANTS Within an ongoing r and omized trial of antioxidant vitamins , 5442 women who were US health professionals aged 42 years or older , with either a history of CVD or 3 or more coronary risk factors , were enrolled in a r and omized , double-blind , placebo-controlled trial to receive a combination pill containing folic acid , vitamin B6 , and vitamin B12 or a matching placebo , and were treated for 7.3 years from April 1998 through July 2005 . INTERVENTION Daily intake of a combination pill of 2.5 mg of folic acid , 50 mg of vitamin B6 , and 1 mg of vitamin B12 . MAIN OUTCOME MEASURES A composite outcome of myocardial infa rct ion , stroke , coronary revascularization , or CVD mortality . RESULTS Compared with placebo , a total of 796 women experienced a confirmed CVD event ( 406 in the active group and 390 in the placebo group ) . Patients receiving active vitamin treatment had similar risk for the composite CVD primary end point ( 226.9/10,000 person-years vs 219.2/10,000 person-years for the active vs placebo group ; relative risk [ RR ] , 1.03 ; 95 % confidence interval [ CI ] , 0.90 - 1.19 ; P = .65 ) , as well as for the secondary outcomes including myocardial infa rct ion ( 34.5/10,000 person-years vs 39.5/10,000 person-years ; RR , 0.87 ; 95 % CI , 0.63 - 1.22 ; P = .42 ) , stroke ( 41.9/10,000 person-years vs 36.8/10,000 person-years ; RR , 1.14 ; 95 % CI , 0.82 - 1.57 ; P = .44 ) , and CVD mortality ( 50.3/10,000 person-years vs 49.6/10,000 person-years ; RR , 1.01 ; 95 % CI , 0.76 - 1.35 ; P = .93 ) . In a blood sub study , geometric mean plasma homocysteine level was decreased by 18.5 % ( 95 % CI , 12.5%-24.1 % ; P of folic acid , vitamin B6 , and vitamin B12 did not reduce a combined end point of total cardiovascular events among high-risk women , despite significant homocysteine lowering . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000541",
"IMPORTANCE The value of measuring levels of glycated hemoglobin ( HbA1c ) for the prediction of first cardiovascular events is uncertain . OBJECTIVE To determine whether adding information on HbA1c values to conventional cardiovascular risk factors is associated with improvement in prediction of cardiovascular disease ( CVD ) risk . DESIGN , SETTING , AND PARTICIPANTS Analysis of individual-participant data available from 73 prospect i ve studies involving 294,998 participants without a known history of diabetes mellitus or CVD at the baseline assessment . MAIN OUTCOMES AND MEASURES Measures of risk discrimination for CVD outcomes ( eg , C-index ) and reclassification ( eg , net reclassification improvement ) of participants across predicted 10-year risk categories of low ( incident fatal and nonfatal CVD outcomes ( 13,237 coronary heart disease and 7603 stroke outcomes ) were recorded . In analyses adjusted for several conventional cardiovascular risk factors , there was an approximately J-shaped association between HbA1c values and CVD risk . The association between HbA1c values and CVD risk changed only slightly after adjustment for total cholesterol and triglyceride concentrations or estimated glomerular filtration rate , but this association attenuated somewhat after adjustment for concentrations of high-density lipoprotein cholesterol and C-reactive protein . The C-index for a CVD risk prediction model containing conventional cardiovascular risk factors alone was 0.7434 ( 95 % CI , 0.7350 to 0.7517 ) . The addition of information on HbA1c was associated with a C-index change of 0.0018 ( 0.0003 to 0.0033 ) and a net reclassification improvement of 0.42 ( -0.63 to 1.48 ) for the categories of predicted 10-year CVD risk . The improvement provided by HbA1c assessment in prediction of CVD risk was equal to or better than estimated improvements for measurement of fasting , r and om , or postload plasma glucose levels . CONCLUSIONS AND RELEVANCE In a study of individuals without known CVD or diabetes , additional assessment of HbA1c values in the context of CVD risk assessment provided little incremental benefit for prediction of CVD risk",
"Abstract Aim : The aim of this study was to test small dense LDL changes with Armolipid Plus treatment in patients with familial combined hyperlipidemia ( FCHL ) . Methods : After 4 weeks , 30 patients with FCHL were included in an 8-week , r and omized , double-blind study and were taking , in addition to the st and ard diet , either placebo or Armolipid Plus . Results : The placebo group showed no statistically significant differences in the studied parameters ; instead , in the Armolipid Plus group , statistically significant reduction differences were detected in BMI ( p = 0.010 ) , LDL score ( p = 0.035 ) and an increase in mean LDL particle diameter ( p = 0.040 ) . Conclusion : The combination of a st and ard diet with Armolipid Plus is able to reduce LDL score and increase LDL particle diameter in a group of FCHL after 8 weeks of treatment",
"BACKGROUND AND AIMS Some nutraceuticals are prescribed as lipid-lowering substances . However , doubts remain about their efficacy . We evaluated the effects of a nutraceutical combination ( NC ) , consisting of 500 mg berberine , 200 mg red yeast rice and 10 mg policosanols , on cholesterol levels and endothelial function in patients with hypercholesterolemia . METHODS AND RESULTS In this single centre , r and omized , double-blind , placebo-controlled study , 50 hypercholesterolemic patients ( 26 males and 24 females , mean age 55±7 years , total cholesterol 6.55±0.75 mmol/l , BMI 28±3.5 ) were r and omized to 6 weeks of treatment with a daily oral dose of NC ( 25 patients ) or placebo ( 25 patients ) . In a subsequent open-label extension of 4 weeks , the whole sample received NC . The main outcome measure was decrease total cholesterol ( C ) levels in the NC arm . Secondary outcome measures were decreased low-density lipoprotein cholesterol ( LDL-C ) and triglyceride levels , and improved endothelial-dependent flow-mediated dilation ( FMD ) and insulin sensitivity in relation to NC . Evaluation of absolute changes from baseline showed significant reductions in NC versus placebo for C and LDL-C ( C : -1.14±0.88 and -0.03±0.78 mmol/l , p significant improvement of FMD ( 3±4 % and 0±3 % respectively , p , triglyceride levels decreased significantly from 1.57±0.77 to 1.26±0.63 mmol/l , p and insulin sensitivity improved in a patient subgroup with insulin resistance at baseline ( HOMA : from 3.3±0.4 to 2.5±1.3 , p No adverse effect was reported . CONCLUSIONS This NC reduces cholesterol levels . The reduction is associated with improved endothelial function and insulin sensitivity "
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411643b8-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND A number of recent systematic review s have result ed in changes in international recommendations for children 's participation in physical activity ( PA ) for health . The World Health Authority ( WHO ) has recently released new recommendations . The WHO still recommends 60 min of moderate to vigorous physical activity ( MVPA ) , but also emphasises that these minutes should be on top of everyday physical activities . Everyday physical activities total around 30 min of MVPA in the quintile of the least active children , which means that the new recommendations constitute more activity in total compared with earlier recommendations . OBJECTIVE To summarise evidence justifying new PA recommendation for cardiovascular health in children . METHODS The results of recent systematic review s are discussed and supplemented with relevant literature not included in these review s. PubMed was search ed for the years 2006 - 2011 for additional topics not sufficiently covered by the review s. RESULTS PA was associated with lower blood pressure and a healthier lipid blood profile in children . The association was stronger when a composite risk factor score was analysed , and the associations between physical fitness and cardiovascular disease ( CVD ) risk factors were even stronger . Muscle strength and endurance exercise each had an effect on blood lipids and insulin sensitivity even if the effect was smaller for muscle strength than for aerobic exercise . New evidence suggests possible effects of PA on C-reactive protein . CONCLUSION There is accumulating evidence that PA can have beneficial effects on the risk factors of CVD in children . Public health policy to promote PA in children , especially the most sedentary children , may be a key element to prevent the onset of CVD later in the children 's lives
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"Background and design Few studies have investigated the association between maximal cardiorespiratory capacity ( fitness ) and the clustered cardiovascular disease ( CVD ) risk in children and youth from culturally diverse countries . This cross-sectional study examined the association between fitness and clustered CVD risk in children and adolescents from three European countries . Methods Participants were 2845 r and omly selected school children aged 9 or 15 years from Portugal ( n = 944 ) , Denmark ( n = 849 ) and Estonia ( n = 1052 ) . Cardiorespiratory fitness was determined during a maximal test on a cycle ergometer . CVD risk factors selected to assess the degree of clustering were the total cholesterol/high-density lipoprotein cholesterol ratio , plasma triglycerides , insulin resistance ( homeostasis model assessment ) , sum of four skinfolds , and systolic blood pressure . Results There was a strong association between cardiorespiratory fitness and the clustering of CVD risk factors . The odds ratios for clustering in each quartile of fitness , using the quartile with the highest fitness as reference , were 13.0 [ 95 % confidence interval ( CI ) 8.8 - 19.1 ] ; 4.8 ( 95 % CI 3.2 - 7.1 ) and 2.5 ( 95 % CI 1.6 - 3.8 ) , respectively , after adjusting for country , age , sex , socio-economic status , pubertal stage , family history of CVD and diabetes . In stratified analyses by age group , sex and country , similar strong patterns were observed . Conclusion Low cardiorespiratory fitness is strongly associated with the clustering of CVD risk factors in children independent of country , age and sex",
"The aim of the present study was to examine the effect of exercise training on adipokines , inflammatory markers , and oxidative stress in overweight children . Nineteen overweight children were r and omly assigned to an aerobic exercise training or sedentary control group for 8 weeks . Measurements included peak oxygen uptake ( V o(2)max ) , body weight and composition , adipokines ( C-reactive protein , interleukin 6 , tumor necrosis factor alpha , adiponectin , leptin , and resistin ) , and oxidative stress ( 8-isoprostane ) . There were no differences between groups for change in body weight or composition over the 8 weeks . Exercise training improved V o(2)max ( exercise group , 1.64 + /- 0.13 to 1.85 + /- 0.17L/min vs control group , 1.83 + /- 0.12 to 1.60 + /- 0.13 L/min , P measured adipokines or the marker of systemic oxidative stress , 8-isoprostane . These data suggest that in the absence of weight loss , exercise training alone does not improve the adipokine profile or levels of oxidative stress in overweight children",
"OBJECTIVES The aim of the study was to analyse changes in coronary heart disease ( CHD ) risk factors from adolescence to young adulthood , and how changes in risk factors relate to changes in lifestyle . DESIGN A r and omized sample of school children was tested in 1983 and followed-up 8 years later . In 1983 a dropout of 0.7 % was found and the sample was representative of 16 - 19-year-old Danes . SUBJECTS Subjects followed-up 8 years later ( two-thirds of the original sample ) were 88 male and 115 female 15 - 19-year-old school children attending 18 high schools , nine vocational and nine trade schools , throughout Denmark . MAIN OUTCOME MEASURES Height , body weight , body fat , occupation and coronary heart disease risk factors including physical activity ( PA ) , fitness , blood pressure ( BP ) , serum cholesterol , HDL cholesterol , triglyceride ( TG ) and smoking habits were assessed . RESULTS In males all risk factors increased : the increases in total cholesterol level and systolic and diastolic BP were large , 0.85 mmol l-1 and 11 mmHg , respectively . In females , the risk for some factors increased ( total cholesterol and BP ) , others decreased ( higher HDL cholesterol ) , and triglyceride did not change . Significant tracking was found in both sexes , with the highest correlation coefficients in men . A total risk score was calculated by categorizing risk factors into six groups--1 to 6 - - and then adding the scores . Pearson correlation between the total risk scores in 1983 and 1991 in men was r = 0.67 ( P total risk score in women . Nearly 50 % of the boys , who were initially in the upper quintile of risk , were still in the upper quintile 8 years later for most risk factors . In men , the changes in risk factors were related to social factors . Blue-collar workers and the unemployed had the highest increase in risk factors , and the largest decrease in VO2max ( ml min-1 kg-1 ) when analysed together . In both sexes the best relationship between 1983 and 1991 values was found in body mass index ( BMI ) . Leisure time physical activity ( PA ) and triglyceride ( TG ) had a low correlation between 1983 and 1991 values . Physical activity had a non-significant correlation over time for women , indicating that PA in 1983 did not predict PA in 1991 at all . CONCLUSION Coronary heart disease risk factors tracked in both males and females , but only in males was a strong relationship found for total risk from adolescence to young adulthood , indicating the influence of a poor lifestyle in high-risk men . Lower social status related to higher risk",
"OBJECTIVE --To examine the effect of physical training on physical fitness and blood pressure in children aged 9 - 11 years . DESIGN -- Prospect i ve r and omised controlled intervention study of a sample of children drawn from a population survey of coronary risk factors in children . SETTING --Odense , Denmark . SUBJECTS--69 children with mean blood pressure greater than or equal to 95th centile ( hypertensive group ) and 68 with mean blood pressure less than 95th centile ( normotensive group ) , r and omly selected from a population of 1369 children . INTERVENTION--67 children were r and omised to receive three extra lessons a week of an ordinary school physical education programme for eight months . MAIN OUTCOME MEASURES --Physical fitness assessed by calculation of maximum oxygen uptake and blood pressure recorded by one unblinded observer . RESULTS --After three months neither blood pressure nor physical fitness had changed significantly . After adjustment for values in weight , height , heart rate , and the variable in question before training physical fitness rose significantly at the end of eight months ' training , by 3.7 mlO2/kg/min ( 95 % confidence interval 2.2 to 5.3 ) in the normotensive training subgroup and by 2.1 mlO2/kg/min ( 0.1 to 4.2 ) in the hypertensive training subgroup compared with that in the controls . Systolic and diastolic blood pressures in the training subgroups fell significantly by 6.5 mm Hg ( 3.2 to 9.9 ) and 4.1 mm Hg ( 1.7 to 6.6 ) respectively in the normotensive group and by 4.9 mm Hg ( 0.7 to 9.2 ) and 3.8 mm Hg ( 0.9 to 6.6 ) respectively in the hypertensive group . CONCLUSIONS --Physical training lowers blood pressure and improves physical fitness in children and might have implication s for an important non-pharmacological approach to primary prevention of essential hypertension",
"Little is known about the relationship among training , energy expenditure , muscle volume , and fitness in prepubertal girls . Because physical activity is high in prepubertal children , we hypothesized that there would be no effect of training . Forty pre- and early pubertal ( mean age 9.1 + /- 0.1 yr ) nonobese girls enrolled in a 5 day/wk summer school program for 5 wk and were r and omized to control ( n = 20 ) or training groups ( n = 20 ; 1.5 h/day , endurance-type exercise ) . Total energy expenditure ( TEE ) was measured using doubly labeled water , thigh muscle volume using magnetic resonance imaging , and peak O(2 ) uptake ( VO(2 peak ) ) using cycle ergometry . TEE was significantly greater ( 17 % , P thigh muscle volume ( + 4.3 + /- 0.9 % , P VO(2 peak ) ( + 9.5 + /- 6 % , P adolescent girls using the same protocol ( Eliakim A , Barstow TJ , Brasel JA , Ajie H , Lee W-NP , Renslo R , Berman N , and Cooper DM , J Pediatr 129 : 537 - 543 , 1996 ) . We further compared these two sample population s : thigh muscle volume per weight was much lower in adolescent compared with prepubertal girls ( 17.0 + /- 0.3 vs. 27.8 + /- 0.6 ml/kg body mass ; P muscle volume ( 0.34 + /- 0.05 , P TEE ( 0.24 + /- 0 . 06 , P VO(2 peak ) ( 0.28 + /- 0.07 , P Muscle and cardiorespiratory functions were quite responsive to brief training in prepubertal girls . Moreover , a retrospective , cross-sectional analysis suggests that increases in muscle mass and VO(2 peak ) may be depressed in nonobese American girls as they mature",
"Objective To assess the effectiveness of a school based physical activity programme during one school year on physical and psychological health in young schoolchildren . Design Cluster r and omised controlled trial . Setting 28 classes from 15 elementary schools in Switzerl and r and omly selected and assigned in a 4:3 ratio to an intervention ( n=16 ) or control arm ( n=12 ) after stratification for grade ( first and fifth grade ) , from August 2005 to June 2006 . Participants 540 children , of whom 502 consented and presented at baseline . Intervention Children in the intervention arm ( n=297 ) received a multi-component physical activity programme that included structuring the three existing physical education lessons each week and adding two additional lessons a week , daily short activity breaks , and physical activity homework . Children ( n=205 ) and parents in the control group were not informed of an intervention group . For most outcome measures , the assessors were blinded . Main outcome measures Primary outcome measures included body fat ( sum of four skinfolds ) , aerobic fitness ( shuttle run test ) , physical activity ( accelerometry ) , and quality of life ( question naires ) . Secondary outcome measures included body mass index and cardiovascular risk score ( average z score of waist circumference , mean blood pressure , blood glucose , inverted high density lipoprotein cholesterol , and triglycerides ) . Results 498 children completed the baseline and follow-up assessment s ( mean age 6.9 ( SD 0.3 ) years for first grade , 11.1 ( 0.5 ) years for fifth grade ) . After adjustment for grade , sex , baseline values , and clustering within classes , children in the intervention arm compared with controls showed more negative changes in the z score of the sum of four skinfolds ( −0.12 , 95 % confidence interval −0.21 to −0.03 ; P=0.009 ) . Likewise , their z scores for aerobic fitness increased more favourably ( 0.17 , 0.01 to 0.32 ; P=0.04 ) , as did those for moderate-vigorous physical activity in school ( 1.19 , 0.78 to 1.60 ; P ( 0.44 , 0.05 to 0.82 ; P=0.03 ) , and total physical activity in school ( 0.92 , 0.35 to 1.50 ; P=0.003 ) . Z scores for overall daily physical activity ( 0.21 , −0.21 to 0.63 ) and physical quality of life ( 0.42 , −1.23 to 2.06 ) as well as psychological quality of life ( 0.59 , −0.85 to 2.03 ) did not change significantly . Conclusions A school based multi-component physical activity intervention including compulsory elements improved physical activity and fitness and reduced adiposity in children . Trial registration Current Controlled Trials IS RCT N15360785",
"OBJECTIVES The primary goals were to underst and the relationship among the inflammatory factors , C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and fibrinogen , and indices of obesity in normoglycemic , insulin-resistant adolescents and to investigate the impact of a lifestyle-only intervention on these nontraditional risk factors for cardiovascular disease ( CVD ) . STUDY DESIGN R and omized controlled lifestyle-only intervention study in adolescents . Of the 21 adolescents studied , 15 obese subjects ( body mass index [ BMI ] = 37.6 + /- 3.3 kg/m 2 ) were r and omized to either a lifestyle intervention program or usual care . The lean controls were studied only at baseline . Analysis of variance ( ANOVA ) for repeated measures was used to study intervention effect and t test , one-way ANOVA , and discriminant function analysis for baseline comparisons . RESULTS The intervention group maintained weight , whereas the control group gained weight ( P = .02 ) . A redistribution of body composition and a decrease in insulin resistance were observed . Elevated circulating concentrations of CRP , fibrinogen , and IL-6 were significantly reduced ( all P previously sedentary obese adolescents redistributes the parameters of body composition in the absence of weight loss and reverses , at least in part , the inflammatory state in association with an improvement of insulin resistance",
"BACKGROUND Atherosclerosis develops from early childhood ; physical activity could positively affect this process . This study 's aim was to assess the associations of objective ly measured physical activity with clustering of cardiovascular disease risk factors in children and derive guidelines on the basis of this analysis . METHODS We did a cross-sectional study of 1732 r and omly selected 9-year-old and 15-year-old school children from Denmark , Estonia , and Portugal . Risk factors included in the composite risk factor score ( mean of Z scores ) were systolic blood pressure , triglyceride , total cholesterol/HDL ratio , insulin resistance , sum of four skinfolds , and aerobic fitness . Individuals with a risk score above 1 SD of the composite variable were defined as being at risk . Physical activity was assessed by accelerometry . FINDINGS Odds ratios for having clustered risk for ascending quintiles of physical activity ( counts per min ; cpm ) were 3.29 ( 95 % CI 1.96 - 5.52 ) , 3.13 ( 1.87 - 5.25 ) , 2.51 ( 1.47 - 4.26 ) , and 2.03 ( 1.18 - 3.50 ) , respectively , compared with the most active quintile . The first to the third quintile of physical activity had a raised risk in all analyses . The mean time spent above 2000 cpm in the fourth quintile was 116 min per day in 9-year-old and 88 min per day in 15-year-old children . INTERPRETATION Physical activity levels should be higher than the current international guidelines of at least 1 h per day of physical activity of at least moderate intensity to prevent clustering of cardiovascular disease risk factors",
"OBJECTIVE : To determine the effect of exercise training ( ET ) on components of the insulin resistance syndrome ( IRS ) in obese children . DESIGN : R and omized , modified cross-over study , with subjects assigned to one of two conditions : ( 1 ) 4 months of ET followed by 4 months of no-ET ; or ( 2 ) 4 months of no-ET followed by 4 months of ET . Measurements were made at three time points : 0 , 4 and 8 months . SUBJECTS : 79 obese , but otherwise healthy children ( age : 7–11 y , percent fat ( % fat ) 27–61 % ) . MEASUREMENTS : Plasma lipid and lipoprotein concentrations , plasma insulin and glucose concentrations ; % fat ; submaximal heart rate ( HR ) as an index of fitness . EXERCISE TRAINING : ET was offered 5 d/week 40 min/d . For the 73 children who completed 4 months of ET , the mean attendance was 80 % ( that is , 4 d/week ) and the average HR during ET was 157 bpm . RESULTS : Significant ( P for plasma triglyceride ( TG ) and insulin concentrations and % fat . The average change for both groups , from just before ET to just after the 4 month ET was −0.24 mmolċl−1 for TG , −25.4 pmolċl−1 for insulin and −1.6 units for % fat . When Group 1 ceased ET , over the following 4 month period the average change for insulin was + 26.6 pmolċl−1 and for % fat + 1.3 units . CONCLUSION : Some components ( plasma TG , insulin , % fat ) of the IRS are improved as a result of 4 months of ET in obese children . However , the benefits of ET are lost when obese children become less active",
"OBJECTIVES We sought to assess the effects of a school-based intervention program on cardiovascular disease risk factors in urban girls . METHODS We compared heart health knowledge , health behaviors , cardiovascular risk factors , and physical fitness among a group of 442 multiethnic teenaged girls ( 310 experimental participants vs 132 control participants ) . Testing was conducted before and after a 12-week program of vigorous exercises integrated with lectures and discussion s on diet , exercise , stress , and smoking . RESULTS Significant differences in body fat , systolic and diastolic blood pressure , heart health knowledge , and whether breakfast was eaten were observed between experimental participants and control participants . CONCLUSIONS An integrated program of exercise and heart health-related lectures and discussion s had a beneficial effect on health knowledge , health behaviors , and onset of risk factors for coronary artery disease among urban girls",
" Sixteen postmenarcheal Type 1 diabetic adolescent girls were r and omized into training ( involving aerobic and strength exercises ) and nontraining groups . Body composition ( skinfold thickness ) , aerobic fitness ( PWC170 ) , plasma lipids , serum apolipoproteins , lipoprotein(a ) , leptin , and adiponectin were assessed before and after the 6-month period . After the 6-month period , fat mass and leptin increased significantly in the nontraining group but not in the training group . Conversely , in the latter group , fat-free mass increased ( P PWC170 improved and apolipoproteinB : apolipoproteinA-1 ratio decreased with physical training ( P physical training reduces cardiovascular risks and the increase of insulin resistance risk factors in diabetic adolescent girls",
"CONTEXT Risk factors for type 2 diabetes mellitus ( T2DM ) include obesity , family history , dyslipidemia , a proinflammatory state , impaired insulin secretory capacity , and insulin resistance . OBJECTIVE The aim of this study was to examine the effects of a 3- to 4-month school-based intervention consisting of health , nutrition , and exercise classes plus an aerobic exercise program on diabetes risk . DESIGN This study was a r and omized before/after controlled trial . METHODS Seventy-three eighth- grade students in a predominantly Hispanic New York City public school were divided into a control group ( studied twice without receiving the intervention ) and an experimental group ( studied before and after the intervention ) . OUTCOME MEASURES We measured body fatness ( bioelectrical impedance ) , insulin sensitivity , beta-cell function ( insulin release in response to an iv glucose load corrected for insulin sensitivity ) , lipid profiles , and circulating concentrations of IL-6 , C-reactive protein , adiponectin , and TNF-alpha . RESULTS Participation in the intervention was associated with significant reductions in body fatness , insulin resistance , and circulating concentrations of C-reactive protein and IL-6 , irrespective of somatotype on enrollment . CONCLUSION Short-term school-based health , nutrition , and exercise intervention is beneficial to all students and affects multiple diabetes risk factors",
"OBJECTIVES The present study aim ed to assess the effect of a 6-month exercise program in obese children on flow-mediated vasodilation ( FMD ) carotid intima-media thickness ( IMT ) and cardiovascular risk factors ( RF ) . BACKGROUND Childhood obesity contributes to adult obesity and subsequent cardiovascular disease . Physical inactivity is a major RF for obesity , endothelial dysfunction , and elevated carotid IMT , culminating in early atherosclerotic disease . METHODS Sixty-seven obese subjects ( age 14.7 + /- 2.2 years ) were r and omly assigned to 6 months ' exercise or non-exercise protocol . We examined the influence of exercises ( 1 h , 3 times/week ) on FMD , IMT , and cardiovascular risk profile . RESULTS Compared with lean control subjects , obese children demonstrated at baseline significantly impaired FMD ( 4.09 + /- 1.76 % vs. 10.65 + /- 1.95 % , p increased IMT ( 0.48 + /- 0.08 mm vs. 0.37 + /- 0.05 mm , p obesity-related cardiovascular RF . Significant improvements were observed in the exercise group for IMT ( 0.44 + /- 0.08 mm , p = 0.012 , -6.3 % ) and FMD ( 7.71 + /- 2.53 % , p body mass index st and ard deviation scores , body fat mass , waist/hip ratio , ambulatory systolic blood pressure , fasting insulin , triglycerides , low-density lipoprotein/high-density lipoprotein ratio , and low-degree inflammation ( C-reactive protein , fibrinogen ) . CONCLUSIONS The present study documented increased IMT , impaired endothelial function , and various elevated cardiovascular RF in young obese subjects . Regular exercise over 6 months restores endothelial function and improves carotid IMT associated with an improved cardiovascular risk profile in obese children",
"A longitudinal study of the effectiveness of the \" Know Your Body \" ( KYB ) program in reducing coronary heart disease risk factors was begun among black students in the District of Columbia in 1983 . Subjects were in grade s four through six at nine schools stratified on socioeconomic status and r and omized into one control and two intervention groups . At baseline , 1,041 students were measured for systolic and diastolic blood pressure , ponderosity , triceps skinfold thickness , postexercise pulse recovery rate , serum thiocyanate , serum total cholesterol , and serum HDL cholesterol . Significant net changes in individual values occurred in the favorable direction at one or all four annual follow-up reexaminations for systolic blood pressure , diastolic blood pressure , HDL cholesterol , HDL/total cholesterol ratio , serum thiocyanate , and fitness . Favorable changes in diastolic blood pressure and serum thiocyanate were observed at all reexaminations , and these were substantiated by analyses that used the school grade as the unit of analysis . Intervention students who were judged to have had the best KYB teachers showed significant favorable net changes in total serum cholesterol after one year . Results are consistent with other evaluations of the Know Your Body program suggesting that KYB may reduce chronic disease risk in diverse school population s , and that increased efforts should be made to improve implementation methods",
"BACKGROUND There is a need to find ways to increase the physical activity levels and improve the body composition and blood pressure of girls . METHODS Thirty 11-year-old girls were recruited from two after school programs in Houston Texas in Spring 2005 . Participants from one program ( 16 ) were r and omly assigned to intervention , the other ( 14 ) served as controls . BMI , BMI percentile , waist circumference and blood pressure were assessed before and after the intervention . Pilates classes were provided free of charge for an hour per day at the intervention site , 5 days a week , for 4 weeks . Four participants wore heart rate monitors during every session and completed enjoyment and perceived exertion question naires . Repeated measures analysis of variance with time ( within ) and group ( between ) as factors was performed . RESULTS Mean attendance was 75 % , mean heart rate 104 bpm , mean perceived exertion 5.9 ( 1 - 10 scale ) and enjoyment 4.4 ( 1 - 5 scale ) . There was a significant ( P = 0.039 ) time by group interaction for BMI percentile . Graphs indicated that this difference was influenced by large reductions in the BMI percentile of healthy girls . CONCLUSIONS Girls enjoyed Pilates , and participation for 4 weeks lowered BMI percentile . Pilates holds promise as a means of reducing obesity",
"BACKGROUND The rising prevalence of obesity in children and adolescents is implicated in the metabolic abnormalities that track into adulthood . The associated increased incidence of insulin resistance , metabolic syndrome and type 2 diabetes being identified in younger cohorts has given rise to a critical global health issue . Muscular strength is a vital component of metabolic fitness that provides protection from insulin resistance in adults , and we have recently shown this to be true in children as well . Targeting muscular strength deficiencies at an early age may be an effective preventative strategy for metabolic syndrome and type 2 diabetes . PURPOSE There is limited evidence -based best practice for progressive resistance training ( PRT ) , adiposity and metabolic fitness in children and adolescents . The purpose of this paper is to describe the methodology we utilized for implementing a PRT program to avoid publication bias , enable replication of the study and share a novel program that we have found safe and suitable for use with youth . METHODS We conducted the first r and omized controlled trial ( RCT ) prescribing high-intensity PRT to children and adolescents ( 10 - 15 years ) as a community-based primary prevention program to address adiposity and metabolic health . Participants were instructed to complete 2 sets of 8 repetitions of 11 exercises targeting all the major muscle groups twice a week at an RPE of 15 - 18 for 8 weeks . RESULTS Primary outcome was waist circumference ; secondary outcomes included insulin resistance , lipid levels , muscle strength , cardiorespiratory fitness , body composition , self-efficacy , self-concept , habitual physical activity , nutritional and sedentary behavior patterns . CONCLUSION The supervised PRT program that we used with children and adolescents has been described in detail . The efficacy of this modality of exercise for metabolic fitness and other health outcomes is now under investigation",
"The effects of regular aerobic exercise on blood concentrations on high‐density lipoprotein cholesterol and prostacyclin were studied in 18 healthy sedentary boys who exercised on a bicycle ergometer for 1 h , four times per week , for 2 months at 75 % of their physical working capacity . The results were compared with those of 10 control boys who did not participate in any specific program . The exercise group revealed a significantly higher mean high‐density lipoprotein cholesterol and 6‐keto‐PGF1a concentration at the end of the training program ( p that regular aerobic exercise has beneficial effects upon the high‐density lipoprotein cholesterol and 6‐keto‐PGF1a in healthy young boys and may be beneficial in the long term , by preventing atherosclerosis of coronary artery disease in adulthood",
"OBJECTIVE To assess the outcomes of health behavior interventions , focusing on the elementary school environment , classroom curricula , and home programs , for the primary prevention of cardiovascular disease . DESIGN A r and omized , controlled field trial at four sites with 56 intervention and 40 control elementary schools . Outcomes were assessed using prer and omization measures ( fall 1991 ) and follow-up measures ( spring 1994 ) . PARTICIPANTS A total of 5106 initially third- grade students from ethnically diverse background s in public schools located in California , Louisiana , Minnesota , and Texas . INTERVENTION Twenty-eight schools participated in a third- grade through fifth- grade intervention including school food service modifications , enhanced physical education ( PE ) , and classroom health curricula . Twenty-eight additional schools received these components plus family education . MAIN OUTCOME MEASURES At the school level , two primary end points were changes in the fat content of food service lunch offerings and the amount of moderate-to-vigorous physical activity in the PE programs . At the level of the individual student , serum cholesterol change was the primary end point and was used for power calculations for the study . Individual level secondary end points included psychological factors , recall measures of eating and physical activity patterns , and other physiologic measures . RESULTS In intervention school lunches , the percentage of energy intake from fat fell significantly more ( from 38.7 % to 31.9 % ) than in control lunches ( from 38.9 % to 36.2%)(P intensity of physical activity in PE classes during the Child and Adolescent Trial for Cardiovascular Health ( CATCH ) intervention increased significantly in the intervention schools compared with the control schools ( P Self-reported daily energy intake from fat among students in the intervention schools was significantly reduced ( from 32.7 % to 30.3 % ) compared with that among students in the control schools ( from 32.6 % to 32.2%)(P daily vigorous activity than controls ( 58.6 minutes vs 46.5 minutes ; P Blood pressure , body size , and cholesterol measures did not differ significantly between treatment groups . No evidence of deleterious effects of this intervention on growth or development was observed . CONCLUSION The CATCH intervention was able to modify the fat content of school lunches , increase moderate-to-vigorous physical activity in PE , and improve eating and physical activity behaviors in children during 3 school years",
"BACKGROUND No national policy for health education in schools exists to date in Greece . The first attempt to apply a school-based health education intervention program was launched in 1992 on all 4,171 pupils registered in the first grade in two counties of Crete . The 1,510 pupils registered in a third county served as controls . METHODS The school-based intervention and the seminars organized for parents were primarily aim ed at improving children 's diet , fitness , and physical activity . Pupils in the first grade in a representative sample of 40 schools were examined prior to the intervention program on a variety of health knowledge , dietary , physical activity , fitness , anthropometric , and biochemical indices . The same measurements were taken after 3 years of the program on 288 intervention group and 183 control group pupils . RESULTS Positive serum lipid level changes occurred to a greater extent in the intervention group than the control group . BMI increased less in the intervention group than for controls . The increase in health knowledge and physical activity and fitness levels occurred to a higher extent in the intervention group compared to controls . CONCLUSIONS The short-term changes observed in the present study are markedly encouraging and indicate great potential for progressive improvement . Continuation and expansion of such a program may prove to be beneficial in initiating long-term changes",
"OBJECTIVES To determine the relation of hemostatic markers to cardiovascular fitness and adiposity and the effect of physical training ( PT ) on these markers . STUDY DESIGN Seventy-four obese teenagers were r and omly assigned to 8 months of lifestyle education ( LSE ) , LSE plus moderate-intensity PT , or LSE plus high-intensity PT . Measures included fibrinogen , plasminogen activator inhibitor-1 ( PAI-1 ) , D-dimer , C-reactive protein ( CRP ) , fitness , percent body fat ( % BF ) , and visceral adiposity ( VAT ) . RESULTS At baseline , fibrinogen and CRP were significantly correlated with % BF and VAT ( 0.27 fitness ( r = -0.39 , r = -0.43 , respectively ) ; PAI-1 with % BF ( r = 0.30 ) and VAT ( r = 0.48 ) ; D-dimer with fitness ( r = -0.24 ) . Although PT produced significant changes in fitness and adiposity , there were no significant group differences in the hemostatic markers . Change in PAI-1 was significantly correlated with its baseline value ( r = -0.47 ) and change in % BF ( r = 0.38 ) . Changes in D-dimer and CRP were significantly correlated with their respective baseline values ( r = -0.68,r = -0.48 , respectively ) . CONCLUSIONS Unfavorable levels of fitness and adiposity were associated with higher levels of hemostatic markers , putting individuals with this profile at greater risk for future cardiovascular disease . No evidence was provided that 8 months of PT had a direct influence on these markers in obese youths",
"OBJECTIVES This study evaluated the effects of aerobic exercise physical education on blood pressure in high-risk , predominantly African-American , adolescent girls . METHODS Ninth- grade girls ( n = 99 ) with blood pressure above the 67th percentile were r and omized to 1 semester of aerobic exercise classes or st and ard physical education classes . RESULT The study was completed by 88 girls . At posttest , only members of the aerobic exercise group increased their estimated cardiorespiratory fitness . The aerobic exercise group had a greater decrease in systolic blood pressure than the st and ard physical education group ( P Aerobic exercise physical education is a feasible and effective health promotion strategy for high-risk adolescent girls",
"We conducted a study of the effectiveness of an educational intervention design ed to modify risk factors associated with coronary heart disease among 3388 children in 37 schools in two demographically dissimilar areas ( the Bronx and Westchester County ) in and around New York City . Schools within each area were r and omly assigned to either intervention or nonintervention groups . In schools targeted for intervention , children in the fourth through eighth grade s were taught a teacher-delivered curriculum focusing on diet , physical activity , and cigarette smoking . Risk-factor levels were measured in all schools at base line and at four follow-up points . A total of 1769 of the children qualified for analysis of the intervention effect . After five years , the net mean change in plasma levels of total cholesterol was -1.7 mg per deciliter per year ( -0.04 mmol per liter ) ( 95 percent confidence interval , -2.7 to -0.7 mg per deciliter [ -0.07 to -0.02 mmol per liter ] ) in the Westchester County schools , or -8.5 mg per deciliter ( -0.22 mmol per liter ) ( 5.1 percent ) over a period of five years . In the schools in the Bronx , the net mean change was -1.0 mg per deciliter per year ( -0.03 mmol per liter ) ( 95 percent confidence interval , -2.3 to + 0.3 mg per deciliter [ -0.06 to + 0.01 mmol per -2.3 to + 0.3 mg per deciliter [ -0.06 to + 0.01 mmol per liter ] ) , or -5.0 mg per deciliter ( -0.13 mmol per liter ) ( 2.9 percent ) over a period of five years . Favorable trends in dietary intake and health knowledge were also observed , whereas the other targeted risk factors were not significantly altered . If these findings can be replicated , this will suggest that educational programs to modify coronary risk factors are feasible and may have a favorable ( albeit small ) effect on blood levels of cholesterol in children",
"Physical activity during childhood and adolescence may influence the development of childhood obesity and cardiovascular disease later in life . Research focused prospect ively on the effects of training on lipid levels in nonobese subjects , and studies using noninvasive measurements of subcutaneous and intraabdominal fat are lacking . It was hypothesized in nonobese sedentary adolescent males that a brief endurance-type exercise training intervention would reduce body fat and improve lipid profiles . Thirty-eight healthy , nonobese sedentary adolescent males ( mean age 16 + /- 0.7 years old ; 18 controls , 20 trained ) completed a 5-week prospect i ve , r and omized , controlled study . Adiposity was measured using magnetic resonance images of the thigh and abdomen ( subcutaneous abdominal adipose tissue [ SAAT ] and intraabdominal adipose tissue [ IAAT ] ) . Lipid measurements included serum triglycerides ( TG ) , total cholesterol ( TC ) , HDL and LDL cholesterol . There was no change in body weight in either control or training groups . Training led to small but significant reductions in thigh fat ( -4.6 + /- 1.5 % , p SAAT% ( 1.7 + /- 0.8 % , p IAAT% . Unexpectedly in the control group there were significant increases in thigh fat ( 5.2 + /- 1.7 % , p SAAT% ( 1.8 + /- 0.6 , p IAAT% ( 4.5 + /- 1.1 , p changes in adiposity were not accompanied by changes in circulating lipids . In nonobese adolescent males a brief period of endurance training led to reductions in body fat depots without weight change while body fat increased rapidly in the control group . Exercise training did not change lipid levels , the latter may require more sustained alterations in patterns of physical activity",
"The epidemic of obesity-associated diabetes is a major crisis in modern societies , in which food is plentiful and exercise is optional . The biological basis of this problem has been explored from evolutionary and mechanistic perspectives . Evolutionary theories , focusing on the potential survival advantages of “ thrifty ” genes that are now maladaptive , are of great interest but are inherently speculative and difficult to prove . Mechanistic studies have revealed numerous fat-derived molecules and a link to inflammation that , together , are hypothesized to underlie the obesity-diabetes connection and thereby represent prospect i ve targets for therapeutic intervention",
"OBJECTIVE Our primary objective was to determine whether a novel ' active school ' model -- Action Schools ! BC -- improved the cardiovascular disease ( CVD ) risk profile in elementary-school children . Our secondary objective was to determine the percentage of children with elevated CVD risk factors . METHODS We undertook a cluster-r and omized controlled school-based trial with 8 elementary schools across 1 school year , in British Columbia , Canada , beginning in 2003 . Boys and girls ( n=268 , age 9 - 11 years ) were r and omly assigned ( by school ) to usual practice ( UP , 2 schools ) or intervention ( INT , 6 schools ) groups . We assessed change between groups in cardiovascular fitness ( 20-m Shuttle Run ) , blood pressure ( BP ) , and body mass index ( BMI , wt/ht(2 ) ) . We evaluated total cholesterol ( TC ) , total : high-density cholesterol ( TC : HDL-C ) , low-density lipoprotein , apolipoprotein B , C-reactive protein and fibrinogen on a subset of volunteers ( n=77 ) . RESULTS INT children had a 20 % greater increase in fitness and a 5.7 % smaller increase in BP compared with children attending UP schools ( P elevated risk factor ( fitness , BP or BMI ) at baseline . There were no significant differences between groups for change in BMI or in any of the blood variables . CONCLUSION Action Schools ! BC was an effective school-based physical activity model for improving the CVD risk profile of elementary-school children . Our multi-component intervention exposed children to fitness enhancing physical activity . It may be important for education stakeholders to adequately re source the delivery of the active school models if cardiovascular health benefits are to be achieved on a population basis"
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BACKGROUND Psychostimulant medication , most commonly the catecholamine agonist methylpheni date , is the most effective treatment for attention-deficit/hyperactivity disorder ( ADHD ) . However , relatively little is known on the mechanisms of action . Acute effects on brain function can eluci date underlying neurocognitive effects . We tested methylpheni date effects relative to placebo in functional magnetic resonance imaging ( fMRI ) during three disorder-relevant tasks in medication-naïve ADHD adolescents . In addition , we conducted a systematic review and meta- analysis of the fMRI findings of acute stimulant effects on ADHD brain function . METHODS The fMRI study compared 20 adolescents with ADHD under either placebo or methylpheni date in a r and omized controlled trial while performing stop , working memory , and time discrimination tasks . The meta- analysis was conducted search ing PubMed , ScienceDirect , Web of Knowledge , Google Scholar , and Scopus data bases . Peak coordinates of clusters of significant effects of stimulant medication relative to placebo or off medication were extracted for each study . RESULTS The fMRI analysis showed that methylpheni date significantly enhanced activation in bilateral inferior frontal cortex (IFC)/insula during inhibition and time discrimination but had no effect on working memory networks . The meta- analysis , including 14 fMRI data sets and 212 children with ADHD , showed that stimulants most consistently enhanced right IFC/insula activation , which also remained for a subgroup analysis of methylpheni date effects alone . A more lenient threshold also revealed increased putamen activation . CONCLUSIONS Psychostimulants most consistently increase right IFC/insula activation , which are key areas of cognitive control and also the most replicated neurocognitive dysfunction in ADHD . These neurocognitive effects may underlie their positive clinical effects
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"The aim of group fMRI studies is to relate contrasts of tasks or stimuli to regional brain activity increases . These studies typically involve 10 to 16 subjects . The average regional activity statistical significance is assessed using the subject to subject variability of the effect ( r and om effects analyses ) . Because of the relatively small number of subjects included , the sensitivity and reliability of these analyses is question able and hard to investigate . In this work , we use a very large number of subject ( more than 80 ) to investigate this issue . We take advantage of this large cohort to study the statistical properties of the inter-subject activity and focus on the notion of reproducibility by bootstrapping . We asked simple but important method ological questions : Is there , from the point of view of reliability , an optimal statistical threshold for activity maps ? How many subjects should be included in group studies ? What method should be preferred for inference ? Our results suggest that i ) optimal thresholds can indeed be found , and are rather lower than usual corrected for multiple comparison thresholds , ii ) 20 subjects or more should be included in functional neuroimaging studies in order to have sufficient reliability , iii ) non-parametric significance assessment should be preferred to parametric methods , iv ) cluster-level thresholding is more reliable than voxel-based thresholding , and v ) mixed effects tests are much more reliable than r and om effects tests . Moreover , our study shows that inter-subject variability plays a prominent role in the relatively low sensitivity and reliability of group studies",
"Stimulant medications , such as methylpheni date , which are effective treatments for attention deficit hyperactivity disorder ( ADHD ) , enhance brain dopamine signaling . However , the relationship between regional brain dopamine enhancement and treatment response has not been evaluated . Here , we assessed whether the dopamine increases elicited by methylpheni date are associated with long-term clinical response . We used a prospect i ve design to study 20 treatment-naive adults with ADHD who were evaluated before treatment initiation and after 12 months of clinical treatment with a titrated regimen of oral methylpheni date . Methylpheni date -induced dopamine changes were evaluated with positron emission tomography and [11C]raclopride ( D2/D3 receptor radiolig and sensitive to competition with endogenous dopamine ) . Clinical responses were assessed using the Conners ' Adult ADHD Rating Scale and revealed a significant reduction in symptoms of inattention and hyperactivity with long-term methylpheni date treatment . A challenge dose of 0.5 mg/kg intravenous methylpheni date significantly increased dopamine in striatum ( assessed as decreases in D2/D3 receptor availability ) . In the ventral striatum , these dopamine increases were associated with the reductions in ratings of symptoms of inattention with clinical treatment . Statistical parametric mapping additionally showed dopamine increases in prefrontal and temporal cortices with intravenous methylpheni date that were also associated with decreases in symptoms of inattention . Our findings indicate that dopamine enhancement in ventral striatum ( the brain region involved with reward and motivation ) was associated with therapeutic response to methylpheni date , further corroborating the relevance of the dopamine reward/motivation circuitry in ADHD . It also provides preliminary evidence that methylpheni date -elicited dopamine increases in prefrontal and temporal cortices may also contribute to the clinical response",
"The stimulant methylpheni date ( MPX ) and the nonstimulant atomoxetine ( ATX ) are the most commonly prescribed medications for attention deficit hyperactivity disorder ( ADHD ) . However , no functional magnetic resonance imaging ( fMRI ) study has as yet investigated the effects of ATX on inhibitory or any other brain function in ADHD patients or compared its effects with those of MPX . A r and omized , double-blind , placebo-controlled , crossover pharmacological design was used to compare the neurofunctional effects of single doses of MPX , ATX , and placebo during a stop task , combined with fMRI within 19 medication-naive ADHD boys , and their potential normalization effects relative to 29 age-matched healthy boys . Compared with controls , ADHD boys under placebo showed bilateral ventrolateral prefrontal , middle temporal , and cerebellar underactivation . Within patients , MPX relative to ATX and placebo significantly upregulated right ventrolateral prefrontal activation , which correlated with enhanced inhibitory capacity . Relative to controls , both drugs significantly normalized the left ventrolateral prefrontal underactivation observed under placebo , while MPX had a drug-specific effect of normalizing right ventrolateral prefrontal and cerebellar underactivation observed under both placebo and ATX . The findings show shared and drug-specific effects of MPX and ATX on performance and brain activation during inhibitory control in ADHD patients with superior upregulation and normalization effects of MPX",
"BACKGROUND Attention-deficit/hyperactivity disorder is a psychiatric disorder that starts in childhood . The mechanism of action of methylpheni date , the most common treatment for attention deficit hyperactivity disorder , is unclear . In vitro , the affinity of methylpheni date for the norepinephrine transporter ( NET ) is higher than that for the dopamine transporter ( DAT ) . The goal of this study was to use positron emission tomography to measure the occupancy of brain norepinephrine transporter by methylpheni date in vivo in humans . METHODS We used (S , S)-[¹¹C ] methylreboxetine ( [¹¹C]MRB ) to determine the effective dose 50 ( ED₅₀ ) of methylpheni date for NET . In a within-subject design , healthy subjects ( n = 11 ) received oral , single-blind placebo and 2.5 , 10 , and 40 mg of methylpheni date 75 min before [¹¹C]MRB injection . Dynamic positron emission tomography imaging was performed for 2 hours with the High Resolution Research Tomograph . The multilinear reference tissue model with occipital cortex as the reference region was used to estimate binding potential non-displaceable ( BP(ND ) ) in the thalamus and other NET-rich regions . RESULTS BP(ND ) was reduced by methylpheni date in a dose-dependent manner in thalamus and other NET-rich regions . The global ED₅₀ was estimated to be .14 mg/kg ; therefore , the average clinical maintenance dose of methylpheni date ( .35-.55 mg/kg ) produces 70 % to 80 % occupancy of NET . CONCLUSIONS For the first time in humans , we demonstrate that oral methylpheni date significantly occupies NET at clinical ly relevant doses . The ED₅₀ is lower than that for DAT ( .25 mg/kg ) , suggesting the potential relevance of NET inhibition in the therapeutic effects of methylpheni date in attention-deficit/hyperactivity disorder",
"CONTEXT Previous studies have reported hypofunction , structural abnormalities , and biochemical abnormalities of the dorsal anterior midcingulate cortex ( daMCC ) in attention-deficit/hyperactivity disorder ( ADHD ) . Stimulant medications are effective treatments for ADHD , but their neural effects have not been fully characterized . OBJECTIVE To determine whether the methylpheni date hydrochloride osmotic-release oral system ( OROS ) would increase functional magnetic resonance imaging ( fMRI ) activation , compared with placebo , in the daMCC and other frontoparietal regions subserving attention during the Multi- Source Interference Task ( MSIT ) . DESIGN R and omized , placebo-controlled , 6-week , before-after fMRI study . SETTING Academic medical center ambulatory clinic . PATIENTS Twenty-one adults with ADHD r and omized to 6 weeks of treatment with methylpheni date OROS ( n = 11 ) or placebo ( n = 10 ) . INTERVENTIONS Patients underwent fMRI twice while performing the MSIT ( scan 1 at baseline and scan 2 at 6 weeks ) . MAIN OUTCOME MEASURES Group-averaged , r and om-effects , repeated- measures , general linear model analyses were used to compare daMCC ( and whole-brain ) fMRI activation during the MSIT . Individual-based daMCC volume-of-interest confirmatory analyses and behavioral data are also presented . RESULTS Performance and baseline fMRI measures in the daMCC and other a priori brain regions did not differ between groups . Group comparisons showed a group x scan interaction and t test confirmation of higher activation in the daMCC at 6 weeks in the methylpheni date OROS group than in the placebo group ( P Individual daMCC volume-of-interest analyses confirmed group-averaged findings and suggested that daMCC activity might be related to clinical response . Methylpheni date OROS also produced higher activation in the dorsolateral prefrontal cortex and the parietal cortex at 6 weeks . CONCLUSION Methylpheni date OROS increased daMCC activation during the MSIT and may act , in part , by normalizing daMCC hypofunction in ADHD",
"We argue that impulsiveness is characterized by compromised timing functions such as premature motor timing , decreased tolerance to delays , poor temporal foresight and steeper temporal discounting . A model illustration for the association between impulsiveness and timing deficits is the impulsiveness disorder of attention-deficit hyperactivity disorder ( ADHD ) . Children with ADHD have deficits in timing processes of several temporal domains and the neural substrates of these compromised timing functions are strikingly similar to the neuropathology of ADHD . We review our published and present novel functional magnetic resonance imaging data to demonstrate that ADHD children show dysfunctions in key timing regions of prefrontal , cingulate , striatal and cerebellar location during temporal processes of several time domains including time discrimination of milliseconds , motor timing to seconds and temporal discounting of longer time intervals . Given that impulsiveness , timing abnormalities and more specifically ADHD have been related to dopamine dysregulation , we tested for and demonstrated a normalization effect of all brain dysfunctions in ADHD children during time discrimination with the dopamine agonist and treatment of choice , methylpheni date . This review together with the new empirical findings demonstrates that neurocognitive dysfunctions in temporal processes are crucial to the impulsiveness disorder of ADHD and provides first evidence for normalization with a dopamine reuptake inhibitor",
"OBJECTIVE While there has been considerable concern over possible adverse effects of psychostimulants on brain development , this issue has not been examined in a prospect i ve study . The authors sought to determine prospect ively whether psychostimulant treatment for attention deficit hyperactivity disorder ( ADHD ) was associated with differences in the development of the cerebral cortex during adolescence . METHOD Change in cortical thickness was estimated from two neuroanatomic MRI scans in 43 youths with ADHD . The mean age at the first scan was 12.5 years , and at the second scan , 16.4 years . Nineteen patients not treated with psychostimulants between the scans were compared with an age-matched group of 24 patients who were treated with psychostimulants . Further comparison was made against a template derived from 620 scans of 294 typically developing youths without ADHD . RESULTS Adolescents taking psychostimulants differed from those not taking psychostimulants in the rate of change of the cortical thickness in the right motor strip , the left middle/inferior frontal gyrus , and the right parieto-occipital region . The group difference was due to more rapid cortical thinning in the group not taking psychostimulants ( mean cortical thinning of 0.16 mm/year [ SD=0.17 ] , compared with 0.03 mm/year [ SD=0.11 ] in the group taking psychostimulants ) . Comparison against the typically developing cohort without ADHD showed that cortical thinning in the group not taking psychostimulants was in excess of age-appropriate rates . The treatment groups did not differ in clinical outcome , however . CONCLUSIONS These findings show no evidence that psychostimulants were associated with slowing of overall growth of the cortical mantle",
"CONTEXT Various anatomic brain abnormalities have been reported for attention-deficit/hyperactivity disorder ( ADHD ) , with varying methods , small sample s , cross-sectional design s , and without accounting for stimulant drug exposure . OBJECTIVE To compare regional brain volumes at initial scan and their change over time in medicated and previously unmedicated male and female patients with ADHD and healthy controls . DESIGN , SETTING , AND PARTICIPANTS Case-control study conducted from 1991 - 2001 at the National Institute of Mental Health , Bethesda , Md , of 152 children and adolescents with ADHD ( age range , 5 - 18 years ) and 139 age- and sex-matched controls ( age range , 4.5 - 19 years ) recruited from the local community , who contributed 544 anatomic magnetic resonance images . MAIN OUTCOME MEASURES Using completely automated methods , initial volumes and prospect i ve age-related changes of total cerebrum , cerebellum , gray and white matter for the 4 major lobes , and cau date nucleus of the brain were compared in patients and controls . RESULTS On initial scan , patients with ADHD had significantly smaller brain volumes in all regions , even after adjustment for significant covariates . This global difference was reflected in smaller total cerebral volumes ( -3.2 % , adjusted F(1,280 ) = 8.30 , P = .004 ) and in significantly smaller cerebellar volumes ( -3.5 % , adjusted F(1,280 ) = 12.29 , P = .001 ) . Compared with controls , previously unmedicated children with ADHD demonstrated significantly smaller total cerebral volumes ( overall F(2,288 ) = 6.65 ; all pairwise comparisons Bonferroni corrected , -5.8 % ; P = .002 ) and cerebellar volumes ( -6.2 % , F ( 2,288 ) = 8.97 , P total white matter volumes ( F(2,288 ) = 11.65 ) compared with controls ( -10.7 % , P Volumetric abnormalities persisted with age in total and regional cerebral measures ( P = .002 ) and in the cerebellum ( P = .003 ) . Cau date nucleus volumes were initially abnormal for patients with ADHD ( P = .05 ) , but diagnostic differences disappeared as cau date volumes decreased for patients and controls during adolescence . Results were comparable for male and female patients on all measures . Frontal and temporal gray matter , cau date , and cerebellar volumes correlated significantly with parent- and clinician-rated severity measures within the ADHD sample ( Pearson coefficients between -0.16 and -0.26 ; all P values were Developmental trajectories for all structures , except cau date , remain roughly parallel for patients and controls during childhood and adolescence , suggesting that genetic and /or early environmental influences on brain development in ADHD are fixed , nonprogressive , and unrelated to stimulant treatment",
"CONTEXT Attention-deficit/hyperactivity disorder ( ADHD ) is a highly prevalent and impairing psychiatric disorder that affects both children and adults . There are Food and Drug Administration-approved stimulant and nonstimulant medications for treating ADHD ; however , little is known about the mechanisms by which these different treatments exert their therapeutic effects . OBJECTIVE To contrast changes in brain activation related to symptomatic improvement with use of the stimulant methylpheni date hydrochloride vs the nonstimulant atomoxetine hydrochloride . DESIGN Functional magnetic resonance imaging before and after 6 to 8 weeks of treatment with methylpheni date ( n = 18 ) or atomoxetine ( n = 18 ) using a parallel-groups design . SETTING Specialized ADHD clinical research program at Mount Sinai School of Medicine , New York , New York . PARTICIPANTS Thirty-six youth with ADHD ( mean [ SD ] age , 11.2 [ 2.7 ] years ; 27 boys ) recruited from r and omized clinical trials . MAIN OUTCOME MEASURES Changes in brain activation during a go/no-go test of response inhibition and investigator-completed ratings on the ADHD Rating Scale-IV-Parent Version . RESULTS Treatment with methylpheni date vs atomoxetine was associated with comparable improvements in both response inhibition on the go/no-go test and mean ( SD ) improvements in ratings of ADHD symptoms ( 55 % [ 30 % ] vs 57 % [ 25 % ] ) . Improvement in ADHD symptoms was associated with common reductions in bilateral motor cortex activation for both treatments . Symptomatic improvement was also differentially related to gains in task-related activation for atomoxetine and reductions in activation for methylpheni date in the right inferior frontal gyrus , left anterior cingulate/supplementary motor area , and bilateral posterior cingulate cortex . These findings were not attributable to baseline differences in activation . CONCLUSIONS Treatment with methylpheni date and atomoxetine produces symptomatic improvement via both common and divergent neurophysiologic actions in frontoparietal regions that have been implicated in the pathophysiology of ADHD . These results represent a first step in delineating the neurobiological basis of differential response to stimulant and nonstimulant medications for ADHD",
"Even in the absence of an experimental effect , functional magnetic resonance imaging ( fMRI ) time series generally demonstrate serial dependence . This colored noise or endogenous autocorrelation typically has disproportionate spectral power at low frequencies , i.e. , its spectrum is (1/f)-like . Various pre-whitening and pre-coloring strategies have been proposed to make valid inference on st and ardised test statistics estimated by time series regression in this context of residually autocorrelated errors . Here we introduce a new method based on r and om permutation after orthogonal transformation of the observed time series to the wavelet domain . This scheme exploits the general whitening or decorrelating property of the discrete wavelet transform and is implemented using a Daubechies wavelet with four vanishing moments to ensure exchangeability of wavelet coefficients within each scale of decomposition . For (1/f)-like or fractal noises , e.g. , realisations of fractional Brownian motion ( fBm ) parameterised by Hurst exponent 0 wavelet-based estimates of the second order stochastic properties of the ( possibly nonstationary ) time series . Performance of the method is assessed empirically using (1/f)-like noise simulated by multiple physical relaxation processes , and experimental fMRI data . Nominal type 1 error control in brain activation mapping is demonstrated by analysis of 13 images acquired under None or resting conditions . Compared to autoregressive pre-whitening methods for computational inference , a key advantage of wavelet resampling seems to be its robustness in activation mapping of experimental fMRI data acquired at 3 Tesla field strength . We conclude that wavelet resampling may be a generally useful method for inference on naturally complex time series",
"We used resting-state functional magnetic resonance imaging ( RS-fMRI ) to investigate the acute effects of methylpheni date hydrochloride ( MPH ) on spontaneous brain activity in children with attention deficit hyperactivity disorder ( ADHD ) . In all , 23 boys with ADHD were scanned twice , under either 10 mg dose of MPH or placebo , in a r and omized , cross-over , counterbalanced placebo-controlled design . 32 Matched healthy controls were scanned once for comparison . Seven of the 23 ADHD boys participated in a follow-up 8-week MPH treatment . A regional homogeneity ( ReHo ) method was applied to characterize the local synchronization of spontaneous brain activity . ADHD boys under placebo compared with controls showed decreased ReHo in bilateral dorsolateral prefrontal cortices and increased ReHo in bilateral sensorimotor and parieto-visual cortices . Relative to placebo , MPH upregulated ReHo in bilateral ventral prefrontal cortices and cerebellar vermis , and downregulated ReHo in right parietal and visual areas that overlapped with the abnormally enhanced activities . When under MPH , ReHo differences between patients and controls were no longer observed . The preliminary prediction analysis revealed that the decreased ReHo in right parietal cortex after the acute MPH was positively correlated with the decreased symptom scores after the 8-week MPH treatment in the seven patients . We show that an acute dose of MPH normalized all fronto-parieto-cerebellar dysfunctions in boys with ADHD during the resting state . Preliminary findings furthermore suggest the potential of RS-fMRI as a prognostic imaging tool to identify response to MPH treatment",
"OBJECTIVE Recent studies have suggested that attention deficit hyperactivity disorder ( ADHD ) is associated with abnormalities in basal ganglia and prefrontal cortical functioning . However , these studies have primarily relied upon cognitive tasks that reflect impulse control rather than attentional mechanisms . METHOD The authors used functional magnetic resonance imaging to investigate the neural correlates of selective and divided attention in a r and omized , double-blind , placebo-controlled pharmacological challenge with methylpheni date in 15 adolescents with ADHD ( ages 14 - 17 ) , eight adolescents with reading disorder ( ages 12 - 17 ) , and four adolescents with both reading disorder and ADHD ( ages 14 - 18 ) who were scanned during both a methylpheni date and a placebo session . Fourteen healthy comparison subjects ( ages 12 - 20 ) who were not given methylpheni date served as the primary comparison group . RESULTS During the divided attention task , unmedicated subjects with ADHD or reading disorder recruited the left ventral basal ganglia significantly less than the healthy comparison subjects . Methylpheni date led to an increase in activation in this region but had no effect on task performance . Subjects with ADHD also recruited the middle temporal gyrus significantly less than the comparison subjects , but methylpheni date did not have a direct effect on activation in this region . CONCLUSIONS These results suggest that ADHD is associated with abnormal processing in attentional networks , with specific dysfunction in striatal circuitry . Methylpheni date may act to normalize activity within this network",
"BACKGROUND AND AIMS Children with attention deficit/hyperactivity disorder ( ADHD ) often show deficits in working memory performance . Methylpheni date ( MPH ) is an effective medication to improve these cognitive difficulties . This study aim ed to clarify which effect MPH induces on the underlying functional networks of working memory . METHODS Fourteen boys diagnosed with ADHD and 12 healthy controls were investigated using functional magnetic resonance imaging ( fMRI ) . Each patient was tested twice , once with medication and once without . The fMRI experiments consisted of three verbal N-back tasks with increasing difficulty . Functional images were acquired on a 3 Tesla head scanner . RESULTS On the behavioral level , medicated patients performed similar to healthy controls and significantly better than without medication . On the functional level , patients showed the expected frontal and parietal activations , which were more pronounced in the 2- and 3-back tasks . Healthy controls showed significantly more activation in these regions and additional activation in the cerebellum . Interestingly , patients showed an additional effect of laterality . Left-sided frontal and parietal activation in patients was significantly less pronounced than in controls . CONCLUSION Functional data indicate different activation patterns in verbal working memory tasks between healthy controls and patients with ADHD irrespective of medication condition . Intake of MPH led to a clear improvement on a behavioral level . However , this effect was not reflected by changes in functional brain organization . MPH-induced changes leading to better performance in verbal working memory tasks might be very subtle and therefore not detectable by fMRI",
"Debate still surrounds the nature of the role of the dorsolateral prefrontal gyrus ( DLPFC ) in time perception . This region is frequently associated with working memory and is thus implicated as a so-called \" accumulator \" within a hypothesized internal clock model . However , we hypothesized that this region may have a more primary role in time perception . To test this hypothesis we used functional magnetic resonance imaging ( fMRI ) to examine the neural correlates of relatively pure time perception with a temporal discrimination task where intervals of 1 s had to be discriminated from those of 1.3 , 1.4 , and 1.5 s. Time perception in this particular time domain within the \" perceived present \" has not previously been investigated using fMRI . By using relatively short time periods to be discriminated and also contrasting activation with an order judgment task , we aim ed to minimize the confounding aspects of sustained attention and working memory . In a group of 20 healthy right-h and ed adult males , neural activation associated with time discrimination was found in a predominantly right hemispheric network of right dorsolateral and inferior prefrontal cortices , right supplementary motor area , and left cerebellum . We conclude that right DLPFC , rather than having a purely working memory function , might be more central ly involved in time perception than previously thought",
"Inhibitory control and error detection are among the highest evolved human self-monitoring functions . Attempts in functional neuroimaging to effectively isolate inhibitory motor control from other cognitive functions have met with limited success . Different brain regions in inferior , mesial , and dorsolateral prefrontal cortices and parietal and temporal lobes have been related to inhibitory control in go/no-go and stop tasks . The widespread activation reflects the fact that the design s used so far have comeasured additional noninhibitory cognitive functions such as selective attention , response competition , decision making , target detection , and inhibition failure . Here we use rapid , mixed trial , event-related functional magnetic resonance imaging to correlate brain activation with an extremely difficult situation of inhibitory control in a challenging stop task that controls for noninhibitory functions . The difficulty of the stop task , requiring withholding of a triggered motor response , was assured by an algorithm that adjusted the task individually so that each subject only succeeded on half of all stop trials , failing on the other half . This design allowed to elegantly separate brain activation related to successful motor response inhibition and to inhibition failure or error detection . Brain activation correlating with successful inhibitory control in 20 healthy volunteers could be isolated in right inferior prefrontal cortex . Failure to inhibit was associated with activation in mesial frontopolar and bilateral inferior parietal cortices , presumably reflecting an attention network for error detection",
"Methylpheni date HCl ( Ritalin ) is often prescribed for the treatment of hyperactivity and is usually administered orally 30 minutes to 1 hour before meals , based on an assumption that meals may interfere with the absorption or metabolism of the drug . Seven boys who were taking methylpheni date regularly for the treatment of hyperactivity were hospitalized and given their established dose of the drug intravenously or orally , either with breakfast or in a fasted state . Blood sample s were taken to determine the pharmacokinetics of the drug in each condition . Few differences between the \" fed \" and \" fasted \" states were noted , but the statistically significant differences indicated that meals accelerate rather than impede the absorption of methylpheni date",
"Objective : To determine if there are differences in the volume of the cau date and anterior cingulate cortex ( ACC ) between children with attention deficit hyperactivity disorder ( ADHD ) and controls , and if such differences are related to the subjects ’ history of stimulant treatment . Methods : We performed a case-control study in an academic medical center . Twenty-one healthy controls , 16 children with ADHD , combined type with a history of stimulant treatment , and 14 children with ADHD , combined type treatment naïve , underwent structural MRI . All children with ADHD were medication-free at the time of the MRI . Regional hemispheric volumes ( in cm3 ) of cau date and anterior cingulate cortex were determined . Results : There were significant differences bilaterally on cau date volume for both ADHD groups vs controls , with no difference between the ADHD groups on either side . In contrast , the right ACC was significantly smaller for the ADHD-treatment naïve ( ADHD/TN ) group compared to the ADHD-treated ( ADHD/Rx ) and control group . The volume of left ACC approached significance contrast between ADHD/RX and ADHD/TN . There were no differences found between the ADHD/Rx and controls on the ACC volumes bilaterally . Conclusions : The results from this study indicate a relationship of previous treatment history with cau date and anterior cingulate volumetric changes in children with attention deficit hyperactivity disorder – combined type",
"BACKGROUND Children with Attention Deficit Hyperactivity Disorder ( ADHD ) have deficits in motivation and attention that can be ameliorated with the indirect dopamine agonist Methylpheni date ( MPH ) . We used functional magnetic resonance imaging ( fMRI ) to investigate the effects of MPH in medication-naïve children with ADHD on the activation and functional connectivity of \" cool \" attentional as well as \" hot \" motivation networks . METHODS 13 medication-naïve children with ADHD were scanned twice , under either an acute clinical dose of MPH or Placebo , in a r and omised , double-blind design , while they performed a rewarded continuous performance task that measured vigilant selective attention and the effects of reward . Brain activation and functional connectivity was compared to that of 13 healthy age-matched controls to test for normalisation effects of MPH . RESULTS MPH normalised performance deficits that were observed in children with ADHD compared to controls . Under placebo , children with ADHD showed reduced activation and functional inter-connectivity in bilateral fronto-striato-parieto-cerebellar networks during the attention condition , but enhanced activation in the orbitofrontal and superior temporal cortices for reward . MPH within children with ADHD enhanced the activation of fronto-striato-cerebellar and parieto-temporal regions . Compared to controls , MPH normalised differences during vigilant attention in parieto-temporal activation and fronto-striatal and fronto-cerebellar connectivity ; MPH also normalised the enhanced orbitofrontal activation in children with ADHD in response to reward . CONCLUSIONS MPH normalised attention differences between children with ADHD and controls by both up-regulation of dysfunctional fronto-striato-thalamo-cerebellar and parieto-temporal attention networks and down-regulation of hyper-sensitive orbitofrontal activation for reward processing . MPH thus shows context -dependent dissociative modulation of both motivational and attentional neuro-functional networks in children with ADHD"
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BACKGROUND Musculoskeletal conditions require particular management skills . Identification of interventions which are effective in equipping general practitioners ( GPs ) with such necessary skills could translate to improved health outcomes for patients and reduced healthcare and societal costs . OBJECTIVES To determine the effectiveness of professional interventions for GPs that aim to improve the management of musculoskeletal conditions in primary care . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) , 2010 , Issue 2 ; MEDLINE , Ovid ( 1950 - October 2013 ) ; EMBASE , Ovid ( 1980 - Ocotber 2013 ) ; CINAHL , EbscoHost ( 1980 - November 2013 ) , and the EPOC Specialised Register . We conducted cited reference search es using ISI Web of Knowledge and Google Scholar ; and h and search ed selected issues of Arthritis and Rheumatism and Primary Care-Clinics in Office Practice . The latest search was conducted in November 2013 . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) , non-r and omised controlled trials ( N RCTs ) , controlled before- and -after studies ( CBAs ) and interrupted time series ( ITS ) studies of professional interventions for GPs , taking place in a community setting , aim ing to improve the management ( including diagnosis and treatment ) of musculoskeletal conditions and reporting any objective measure of GP behaviour , patient or economic outcomes . We considered professional interventions of any length , duration , intensity and complexity compared with active or inactive controls . DATA COLLECTION AND ANALYSIS Two review authors independently abstract ed all data . We calculated the risk difference ( RD ) and risk ratio ( RR ) of compliance with desired practice for dichotomous outcomes , and the mean difference ( MD ) and st and ardised mean difference ( SMD ) for continuous outcomes . We investigated whether the direction of the targeted behavioural change affects the effectiveness of interventions . MAIN RESULTS Thirty studies met our inclusion criteria .From 11 studies on osteoporosis , meta- analysis of five studies ( high-certainty evidence ) showed that a combination of a GP alerting system on a patient 's increased risk of osteoporosis and a patient-directed intervention ( including patient education and a reminder to see their GP ) improves GP behaviour with regard to diagnostic bone mineral density ( BMD ) testing and osteoporosis medication prescribing ( RR 4.44 ; ( 95 % confidence interval ( CI ) 3.54 to 5.55 ; 3 studies ; 3,386 participants ) ) for BMD and RR 1.71 ( 95 % CI 1.50 to 1.94 ; 5 studies ; 4,223 participants ) for osteoporosis medication . Meta- analysis of two studies showed that GP alerting on its own also probably improves osteoporosis guideline -consistent GP behaviour ( RR 4.75 ( 95 % CI 3.62 to 6.24 ; 3,047 participants ) ) for BMD and RR 1.52 ( 95 % CI 1.26 to 1.84 ; 3.047 participants ) for osteoporosis medication ) and that adding the patient-directed component probably does not lead to a greater effect ( RR 0.94 ( 95 % CI 0.81 to 1.09 ; 2,995 participants ) ) for BMD and RR 0.93 ( 95 % CI 0.79 to 1.10 ; 2,995 participants ) for osteoporosis medication . Of the 10 studies on low back pain , seven showed that guideline dissemination and educational opportunities for GPs may lead to little or no improvement with regard to guideline -consistent GP behaviour . Two studies showed that the combination of guidelines and GP feedback on the total number of investigations requested may have an effect on GP behaviour and result in a slight reduction in the number of tests , while one of these studies showed that the combination of guidelines and GP reminders attached to radiology reports may result in a small but sustained reduction in the number of investigation requests . Of the four studies on osteoarthritis , one study showed that using educationally influential physicians may result in improvement in guideline -consistent GP behaviour . Another study showed slight improvements in patient outcomes ( pain control ) after training GPs on pain management . Of three studies on shoulder pain , one study reported that there may be little or no improvement in patient outcomes ( functional capacity ) after GP education on shoulder pain and injection training . Of two studies on other musculoskeletal conditions , one study on pain management showed that there may be worse patient outcomes ( pain control ) after GP training on the use of vali date d assessment scales . The 12 remaining studies across all musculoskeletal conditions showed little or no improvement in GP behaviour and patient outcomes .The direction of the targeted behaviour ( i.e. increasing or decreasing a behaviour ) does not seem to affect the effectiveness of an intervention . The majority of the studies did not investigate the potential adverse effects of the interventions and only three studies included a cost-effectiveness analysis .Overall , there were important method ological limitations in the body of evidence , with just a third of the studies reporting adequate allocation concealment and blinded outcome assessment s. While our confidence in the pooled effect estimate of interventions for improving diagnostic testing and medication prescribing in osteoporosis is high , our confidence in the reported effect estimates in the remaining studies is low . AUTHORS ' CONCLUSIONS There is good- quality evidence that a GP alerting system with or without patient-directed education on osteoporosis improves guideline -consistent GP behaviour , result ing in better diagnosis and treatment rates . Interventions such as GP reminder messages and GP feedback on performance combined with guideline dissemination may lead to small improvements in guideline -consistent GP behaviour with regard to low back pain , while GP education on osteoarthritis pain and the use of educationally influential physicians may lead to slight improvement in patient outcomes and guideline -consistent behaviour respectively . However , further studies are needed to ascertain the effectiveness of such interventions in improving GP behaviour and patient outcomes
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"Background Osteoporosis is a serious but treatable condition . However , appropriate therapy utilization of the disease remains suboptimal . Thus , the objective of the study was to change physicians ' therapy administration behavior in accordance with the Osteoporosis Canada 2002 guidelines . Methods The Project was a two year cohort study that consisted of five Quality Circle ( QC ) phases that included : 1 ) Training & Baseline Data Collection , 2 ) First Educational Intervention & First Follow-Up Data Collection 3 ) First Strategy Implementation Session , 4 ) Final Educational Intervention & Final Follow-up Data Collection , and 5 ) Final Strategy Implementation Session . A total of 340 family physicians formed 34 QCs and participated in the study . Physicians evaluated a total of 8376 , 7354 and 3673 r and omly selected patient charts at baseline , follow-up # 1 and the final follow-up , respectively . Patients were divided into three groups ; the high-risk , low-risk , and low-risk without fracture groups . The generalized estimating equations technique was utilized to model the change over time of whether physicians Results The odds of appropriate therapy was 1.29 ( 95 % CI : 1.13 , 1.46 ) , and 1.41 ( 95 % CI : 1.20 , 1.66 ) in the high risk group , 1.15 ( 95 % CI : 0.97 , 1.36 ) , and 1.16 ( 95 % CI : 0.93 , 1.44 ) in the low risk group , and 1.20 ( 95 % CI : 1.01 , 1.43 ) , and 1.23 ( 95 % CI : 0.97 , 1.55 ) in the low risk group without fractures at follow-up # 1 and the final follow-up , respectively . Conclusion QCs methodology was successful in increasing physicians ' appropriate use of osteoporosis medications in accordance with Osteoporosis Canada guidelines",
"Background : Postfracture care is suboptimal , and strategies to address this major gap in care are necessary . We investigated whether notifications sent by mail to physicians and patients would lead to improved postfracture care . Methods : We conducted a r and omized controlled trial ( Clinical Trials.gov identifier NCT00594789 ) in the province of Manitoba , Canada , from June 2008 to May 2010 . Using medical cl aims data , we identified 4264 men and women age 50 years or older who recently reported major fractures , and who had not undergone recent bone mineral density testing or treatment for osteoporosis . Participants were r and omized to three groups : group 1 received usual care ( n = 1480 ) , patients in group 2 had mailed notification of the fracture sent to their primary care physicians ( n = 1363 ) , and group 3 had notifications sent to both physicians and patients ( n = 1421 ) . Bone mineral density testing and the start of pharmacologic treatment for osteoporosis within the following 12 months were documented . Results : Among participants in group 1 ( usual care ) , 15.8 % of women and 7.6 % of men underwent testing for bone mineral density or started pharmacologic treatment for osteoporosis . Outcome measures improved among participants in group 2 ( 30.3 % of women and 19.0 % of men , both p end point of bone mineral density testing or pharmacologic treatment was 14.9 % ( 16.4 % among women , 11.8 % among men ) . The number needed to notify to change patient care was 7 ( 6 for women , 6 for men ) . The adjusted odds ratio ( OR ) to change patient care in group 2 was 2.45 ( 95 % confidence interval [ CI ] 2.01–2.98 ) ; for group 3 the OR was 2.82 ( 95 % CI 2.33–3.43 ) . Interpretation : This notification system provides a relatively simple way to enhance post-fracture care",
"AIM To investigate whether the effect of educational reminder messages for knee and lumbar spine radiographs varied over a 12 month period . MATERIAL S AND METHODS In a previous r and omized , controlled trial , educational reminder messages attached to x-ray reports were shown to be effective in reducing the number of radiograph requests by general practitioners for knee and lumbar spine radiographs . In this study , all radiology departments from the previous trial were asked for monthly referral records for the 12 month intervention period for knee and lumbar spine radiographs for each general practice . Poisson regression was used to test for a change over time in the number of referrals between control and intervention practice s. RESULTS Data were obtained for 66 % of the general practice s in the main trial . The number of referrals for both knee and lumbar spine radiographs remained consistently and statistically significantly lower in the educational reminder messages group compared with the control group ( relative risk=0.65 and 0.64 , respectively ) . There was no evidence that this difference increased or decreased throughout the 12 month period . CONCLUSIONS The effect of educational reminder messages was produced as soon as the intervention was delivered and maintained throughout the intervention period . There was no evidence of the effect of the intervention wearing off",
"OBJECTIVE To assess whether providing information on arthritis self-management through general practitioners ( GPs ) increases the quality of life in patients with osteoarthritis and whether additional case management provided by practice nurses shows better results . METHODS We conducted a pragmatic , cluster-r and omized , controlled , 3-arm trial that included 1,021 patients from 75 primary care practice s in Germany . GPs were r and omized to intervention group I , group II , or a control group . GPs of both intervention groups participated in 2 peer group meetings . In intervention group II , additional case management was conducted via telephone by a practice nurse . The primary outcome was change in quality of life , assessed by the German version of the Arthritis Impact Measurement Scales Short Form ( AIMS 2-SF ) . Secondary outcomes were health service utilization , prescriptions , and physical activity . Data were controlled for depression using the Patient Health Question naire 9 as a potential confounder . RESULTS Of 1,125 administered question naires , 1,021 were analyzed . Compared with the control group , no significant changes occurred in intervention group I with respect to the primary outcome . Performed radiographs decreased significantly ( P = 0.050 ) , whereas prescriptions of acetaminophen increased significantly ( P AIMS 2-SF dimensions social ( P symptom ( P = 0.048 ) , and lower body ( P = 0.049 ) were identified . Radiographs ( P = 0.031 ) and orthopedic referrals ( P = 0.044 ) decreased whereas prescriptions of pain relievers increased significantly . CONCLUSION Improving the quality of life in patients with arthritis using arthritis self-management seems challenging . Simply providing this information through GPs is not sufficient but combining it with case management seems to be a promising approach",
"Background Osteoporosis-related fractures are a significant public health concern . Interventions that increase detection and treatment of osteoporosis are underutilized . This pragmatic r and omised study was done to evaluate the impact of a multifaceted community-based care program aim ed at optimizing evidence -based management in patients at risk for osteoporosis and fractures . Methods This was a 12-month r and omized trial performed in Ontario , Canada . Eligible patients were community-dwelling , aged ≥55 years , and identified to be at risk for osteoporosis-related fractures . Two hundred and one patients were allocated to the intervention group or to usual care . Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing , patient education and patient-specific recommendations for osteoporosis treatment . The primary outcome was the implementation of appropriate osteoporosis management . Results 101 patients were allocated to intervention and 100 to control . Mean age of participants was 71.9 ± 7.2 years and 94 % were women . Pharmacological treatment ( alendronate , risedronate , or raloxifene ) for osteoporosis was increased by 29 % compared to usual care ( 56 % [ 29/52 ] vs. 27 % [ 16/60 ] ; relative risk [ RR ] 2.09 , 95 % confidence interval [ CI ] 1.29 to 3.40 ) . More individuals in the intervention group were taking calcium ( 54 % [ 54/101 ] vs. 20 % [ 20/100 ] ; RR 2.67 , 95 % CI 1.74 to 4.12 ) and vitamin D ( 33 % [ 33/101 ] vs. 20 % [ 20/100 ] ; RR 1.63 , 95 % CI 1.01 to 2.65 ) . Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care . Trial Registration This trial has been registered with clinical trials.gov ( ID : NCT00465387",
"OBJECTIVE To address the question whether general practitioners ( GPs ) should receive practical training in shoulder problems and to test whether cortisone injections are better than anaesthetic injections for rotator cuff problems . METHODS A pragmatic split-plot , r and omized trial with a cluster factorial design , conducted in general practice s across five centres across the United Kingdom . Ninety-one practice s were r and omized to receive additional training in diagnosing and injecting rotator cuff problems or no additional training . Two hundred patients consulting their general practice s with shoulder pain were then r and omized to receive either a corticosteroid or lignocaine injection . The main outcome was score on the British Shoulder Disability Question naire ( BSDQ ) . The Short-Form 36-item Health Survey and EuroQol at 12 months from entry to the trial were also scored . RESULTS Over the course of the trial there was a mean difference of 0.94 ( s.e . = 1.01 ) on the BSDQ score between the groups , with patients treated by the untrained group having a mean of 9.46 ( s.e . = 0.82 ) and those by the trained group having a mean of 8.51 ( s.e . = 0.60 ) . There were no statistically significant differences between the groups . Analysing by substance injected , there was a mean difference of 0.15 ( s.e . = 0.48 ) throughout the trial between the groups , with patients given the cortisone having a mean BSDQ of 9.67 ( s.e . = 0.39 ) and those given lignocaine , 9.82 ( s.e . = 0.39 ) . This was not statistically significantly different . CONCLUSIONS Training GPs in the diagnosis and treatment of shoulder disorders does not make any difference to the outcome , in terms of pain and disability , 1 yr later . Further , there is no advantage to injecting steroid in a group with predominant rotator cuff disorder . Trial registration . International St and ard R and omized Controlled Trial Number 58537244 . Trial steering committee comprised Prof. Paul Dieppe , Prof. Elaine Hay , Dr Brian Hazleman and Dr Kerenza Hood",
"Background Osteoarthritis ( OA ) has a high prevalence in primary care . Conservative , guideline orientated approaches aim ing at improving pain treatment and increasing physical activity , have been proven to be effective in several context s outside the primary care setting , as for instance the Arthritis Self management Programs ( ASMPs ) . But it remains unclear if these comprehensive evidence based approaches can improve patients ' quality of life if they are provided in a primary care setting . Methods / Design PraxArt is a cluster r and omised controlled trial with GPs as the unit of r and omisation . The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients ' quality of life . 75 GPs were r and omised either to intervention group I or II or to a control group . Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR.In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program . In intervention group II the same is provided , but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication . In the control group no intervention will be applied at all . Main outcome measurement for patients ' QoL is the GERMAN- AIMS 2-SF question naire . In addition data about patients ' satisfaction ( using a modified EUROPEP-tool ) , medication , health care utilization , comorbidity , physical activity and depression ( using PHQ-9 ) will be retrieved . Measurements ( pre data collection ) will take place in months I-III , starting in June 2005 . Post data collection will be performed after 6 months . Discussion Despite the high prevalence and increasing incidence , comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany . If the evaluation of the presented approach reveals a clear benefit it is planned to provide this GP-centred interventions on a much larger scale",
"Introduction This cluster r and omised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain ( LBP ) in general practice . Methods General practice s were r and omised to either access to a guideline for acute LBP ( control ) or facilitated interactive workshops ( intervention ) . We measured behavioural predictors ( e.g. knowledge , attitudes and intentions ) and fear avoidance beliefs . We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner ( GP ) level : behavioural simulation ( clinical decision about vignettes ) and rates of x-ray and CT-scan ( medical administrative data ) . All those not involved in the delivery of the intervention were blinded to allocation . Results 47 practice s ( 53 GPs ) were r and omised to the control and 45 practice s ( 59 GPs ) to the intervention . The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information ; a minimum of 38 GPs were available from the intervention group , and a minimum of 40 GPs from the control group . For the behavioural constructs , although effect estimates were small , the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral . For behavioural simulation , intervention group GPs were more likely to adhere to guideline recommendations about x-ray ( OR 1.76 , 95%CI 1.01 , 3.05 ) and more likely to give advice to stay active ( OR 4.49 , 95%CI 1.90 to 10.60 ) . Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear ; rate ratio 0.87 ( 95%CI 0.68 , 1.10 ) for x-ray or CT-scan . Conclusions The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence -based guideline , but it did not result in statistically significant changes in actual behaviour . Trial Registration Australian New Zeal and Clinical Trials Registry",
"Background Despite recommendations , osteoporosis screening rates among women aged 65 years and older remain low . We present results from a clustered , r and omized trial evaluating patient mailed reminders , alone and in combination with physician prompts , to improve osteoporosis screening and treatment . Methods Primary care clinics ( n = 15 ) were r and omized to usual care , mailed reminders alone , or mailed reminders with physician prompts . Study patients were females aged 65–89 years ( N = 10,354 ) . Using automated clinical and pharmacy data , information was collected on bone mineral density testing , pharmacy dispensings , and other patient characteristics . Unadjusted/adjusted differences in testing and treatment were assessed using generalized estimating equation approaches . Results Osteoporosis screening rates were 10.8 % in usual care , 24.1 % in mailed reminder , and 28.9 % in mailed reminder with physician prompt . Results adjusted for differences at baseline indicated that mailed reminders significantly improved testing rates compared to usual care , and that the addition of prompts further improved testing . This effect increased with patient age . Treatment rates were 5.2 % in usual care , 8.4 % in mailed reminders , and 9.1 % in mailed reminders with prompt . No significant differences were found in treatment rates between those receiving mailed reminders alone or in combination with physician prompts . However , women receiving usual care were significantly less likely to be treated . Conclusions The use of mailed reminders , either alone or with physician prompts , can significantly improve osteoporosis screening and treatment rates among insured primary care patients ( Clinical Trials.gov number NCT00139425 )",
"Background Despite accurate diagnostic tests and effective therapies , the management of osteoporosis has been observed to be suboptimal in many setting s. We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis . Design R and omized controlled trial . Participants Primary care physicians and their patients at-risk of osteoporosis , including women 65 years and over , men and women 45 and over with a prior fracture , and men and women 45 and over who recently used ≥90 days of oral glucocorticoids . InterventionA multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients . Outcome : Either undergoing a bone mineral density ( BMD ) testing or filling a prescription for a bone-active medication during the 10 months of follow-up . Results After the intervention , 144 ( 14 % ) patients in the intervention group and 97 ( 10 % ) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication . This represents a 4 % absolute increase and a 45 % relative increase ( 95 % confidence interval 9–93 % , p = 0.01 ) in osteoporosis management between the intervention and control groups . No differences between groups were observed in the incidence of fracture . Conclusion An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and /or filling prescriptions for osteoporosis medications . However , the absolute percentage of at-risk patients receiving osteoporosis management remained low",
"CONTEXT Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences . OBJECTIVE To implement the conservative , evidence -based approach to low-back pain recommended in national guidelines , with the anticipated effect of reducing population -based rates of surgery . DESIGN A r and omized , controlled trial . SETTING Ten communities in western Washington State with annual rates of back surgery above the 1990 national average ( 158 operations per 100,000 adults ) . PARTICIPANTS Spine surgeons , primary care physicians , patients who were surgical c and i date s , and hospital administrators . INTERVENTION The five communities r and omized to the intervention group received a package of six educational activities tailored to local needs by community planning groups . Surgeon study groups , primary care continuing medical education conferences , administrative consensus processes , videodisc-aided patient decision making , surgical outcomes management , and generalist academic detailing were serially implemented over a 30-month intervention period . OUTCOME MEASURE Quarterly observations of surgical rates . RESULTS After implementation of the intervention , surgery rates declined in the intervention communities but increased slightly in the control communities . The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000 , a relative reduction of 8.9 % ( P = 0.01 ) . CONCLUSION We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities",
"AIM To determine the impact and cost-effectiveness of telephone versus written access to magnetic resonance imaging ( MRI ) , and of different strategies for disseminating locally produced guidelines , upon requests by general practitioners ( GPs ) for knee and lumbar spine investigation . MATERIAL AND METHODS Two sequential pragmatic open cluster-r and omized trials were conducted within 39 general practice s. The outcome measure in each trial was concordance of request with local guidelines . Trial 1 : practice s requested MRI by telephone or in writing . Trial 2 : all practice s received guidelines , plus either : a practice -based seminar , practice -specific audit feedback , both seminar and feedback , or neither . RESULTS A total of 414 requests were assessed in the two trials . Trial 1 : telephone access cost pound4.86 more per request but rates of concordant requests were equivalent ( 65%/64 % : telephone/written ) . Trial 2 : compared to the control group , costs per practice were pound1911 higher in seminar group , pound1543 higher in feedback group and pound3578 higher for those receiving both . Concordance was greater following the intervention ( 74 % vs 65 % ; P concordance . Written access was more cost-effective . Seminars and feedback were no more effective in modifying practice than guidelines alone , which was thus the most cost-effective option",
"UNLABELLED We conducted a r and omized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries . Primary care physicians and their patients were r and omized to usual care , patient intervention only , physician intervention only , or both interventions . There was no difference in the probability of the primary composite endpoint ( BMD test or osteoporosis medication ) or in either of its components comparing the combined intervention group with usual care ( risk ratio = 1.04 ; 95 % CI , 0.85 - 1.26 ) . INTRODUCTION Fractures from osteoporosis are associated with substantial morbidity , mortality , and cost . However , only a minority of at-risk older adults receives screening and /or treatment for this condition . We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients , primary care physicians , or both . MATERIAL S AND METHODS We conducted a r and omized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries . Primary care physicians and their patients were r and omized to usual care , patient intervention only , physician intervention only , or both interventions . The at-risk patients were women > or=65 yr of age , men and women > or=65 yr of age with a prior fracture , and men and women > or=65 yr of age who used oral glucocorticoids . The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis . The secondary outcome was a hip , humerus , spine , or wrist fracture . RESULTS We r and omized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms . Physician and patient characteristics were very similar across all four groups . Across all four groups , the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups ( p = 0.5 ) . In adjusted Cox proportional hazards models , there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care ( risk ratio = 1.04 ; 95 % CI , 0.85 - 1.26 ) . There was also no difference in either of the components of the composite endpoint . The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment ( p = 0.9 ) . CONCLUSIONS In this trial , a relatively brief program of patient and /or physician education did not work to improve the management of osteoporosis . More intensive efforts should be considered for future quality improvement programs for osteoporosis",
"Background : Osteoporosis is a common disease characterized by decreased bone mass and increased fracture risk in postmenopausal women and the elderly . Hip fractures are among the most common consequences of osteoporosis and unfortunately usually occur late in the course of the disease . When a patient is admitted to the hospital with a fragility hip fracture , a unique opportunity for diagnosis and treatment presents itself . Fortunately , several medications have proven to be effective in lowering the risk of future fractures . The purpose s of the present study were to test the hypothesis that most fragility hip fractures go untreated and to determine whether educational efforts to raise physician awareness have led to an improvement in osteoporosis treatment rates . Methods : A retrospective cohort study was performed with use of the patient data bases at two university medical centers and one university-affiliated community hospital . The charts of 300 r and omly selected patients were sorted with use of ICD-9 ( International Classification of Diseases , Ninth Revision ) codes for femoral neck fractures . There were 100 patients from each center , with twenty-five patients from each year between 1997 and 2000 . The admitting diagnosis , mechanism of injury , admission medications , procedures performed during hospitalization , and discharge medications were then extracted and analyzed . During this period , the National Osteoporosis Foundation established guiding principles for the treatment of fragility fractures . Results : Of the seventy-five patients from all centers for each year from 1997 to 2000 , 11 % , 13 % , 24 % , and 29 % , respectively , were discharged with a prescription for some medication targeting osteopenia , either supplemental calcium or an antiosteoporotic medication ( estrogen , calcitonin , a bisphosphonate , or raloxifene ) . A trended chi-square analysis of this increase revealed a p value of prescription at the time of discharge . However , forty of these patients ( 13.3 % of the overall group ) received calcium and only eighteen ( 6.0 % of the overall group ) received a medication to actively prevent bone resorption and treat osteoporosis . In addition , no patient underwent a bone density scan while in the hospital . Conclusions : Elderly patients and postmenopausal women who are admitted to the hospital and diagnosed with a low-energy femoral neck fracture have been undertreated for osteoporosis . However , over the four years of the present study , there was a significant increase in the rate of treatment . It is hoped that treatment rates will continue to increase in the future with continued educational efforts",
"Objectives : To evaluate the impact of using pain assessment scales on the management of musculoskeletal chronic pain . Methods : Cluster-r and omized controlled multicentre trial in French general practice setting s. Practice s were r and omized by region before patient recruitment . The inclusion concerned patients suffering from musculoskeletal chronic pain . General practitioners assigned to the scale group used two vali date d assessment instruments ; those assigned to the control group cared for their patients according to their usual practice . The primary end-point was the level of relief obtained and the secondary changes in prescription of painkilling modalities . Results : A total of 155 general practitioners included 772 successive patients suffering from musculoskeletal chronic pain . The control group reported a mean level of relief of 50.7 % compared with one of 41.1 % in the scale group ( p prescription of level two painkillers . Conclusions . In general practice , the use of pain assessment scales is not associated with greater pain relief . The lesser level of pain relief obtained in the scale group does provide evidence that using pain assessment scales does not enhance the relief of chronic pain in patients in primary care . Guidelines which recommend the systematic use of scales for the assessment and monitoring of chronic pain are not tailored to either the context or the patients encountered in the primary care setting",
"Objective . To evaluate 2 incremental levels of intervention design ed to increase initiation of osteoporosis treatment by primary care physicians ( PCP ) following fragility fractures ( FF ) . Methods . Women and men over age 50 years were screened for incident FF in fracture clinics , and eligible out patients were r and omly assigned to st and ard care ( SC ) or to either minimal ( MIN ) or intensive ( INT ) interventions . The MIN and INT interventions were intended to educate and motivate both patients and PCP , but differed in their frequency of contact and information content . Delivery of osteoporosis medication was confirmed with pharmacists . Treatment rates were analyzed using an intention-to-treat approach . Results . At inclusion , 74.3 % of 881 out patients with FF were untreated . Followup at 12 months was completed in 92.3 % of patients . Up to 90 % of patients treated at inclusion remained treated at 12 months . Among patients who initially were untreated , 18.8 % in the SC group , 40.4 % in the MIN , and 53.2 % in the INT groups were treated at 12 months . Change in treatment rates ( adjusted for age and initial treatment ) increased significantly after both MIN and INT . Only the INT intervention significantly increased treatment rates in patients with previous fractures . Negative predictors of change in treatment status included non-major FF , age younger than 65 years , and male sex . Conclusion . Both interventions significantly increased initiation of osteoporosis treatment . Our multidisciplinary intervention builds on existing first-line structures and uses minimal specialized re sources . Iterative and systematic interventions in the context of clinical care may modify the approach of PCP to osteoporosis management after FF and narrow the care gap in the long term",
"OBJECTIVE To examine whether adherence to osteoporosis medications can be improved by educational interventions targeted at primary care physicians ( PCPs ) and patients . STUDY DESIGN Post hoc analysis of data collected as part of a prospect i ve r and omized controlled trial to improve initiation of osteoporosis management such as bone mineral density testing or osteoporosis drug initiation . METHODS The trial was conducted among patients at risk for osteoporosis enrolled in Horizon Blue Cross Blue Shield of New Jersey . For a 3-month period , r and omly selected PCPs and their patients received education about osteoporosis diagnosis and treatment . The PCPs received face-to-face education by trained pharmacists , while patients received letters and automated telephone calls . The control group received no education . We assessed medication adherence during 10 months following the start of the intervention using the medication possession ratio ( MPR ) , the ratio of available medication to the total number of days studied . RESULTS These analyses included 1867 patients ( 972 r and omized to the intervention group and 875 to the control group ) and their 436 PCPs . During 10 months following the intervention , the median MPRs were 74 % ( interquartile range [ IQR ] , 19%-93 % ) for the intervention group and 73 % ( IQR , 0%-93 % ) for the control group ( P = .18 ) . The median times until medication discontinuation after the intervention were 85 days ( IQR , 58 - 174 days ) for the intervention group and 79 days ( IQR , 31 - 158 days ) for the control group . CONCLUSION The educational intervention did not significantly improve medication compliance or persistence with osteoporosis drugs",
"OBJECTIVE : The effect of clinical guidelines on re source utilization for complex conditions with substantial barriers to clinician behavior change has not been well studied . We report the impact of a multifaceted guideline implementation intervention on primary care clinician utilization of radiologic and specialty services for the care of acute low back pain . DESIGN : Physician groups were r and omized to receive guideline education and individual feedback , supporting patient education material s , both , or neither . The impact on guideline adherence and re source utilization was evaluated during the 12-month period before and after implementation . PARTICIPANTS : Fourteen physician groups with 120 primary care physician and associate practitioners from 2 group model HMO practice s. INTERVENTIONS : Guideline implementation utilized an education/audit/feedback model with local peer opinion leaders . The patient education component included written and videotaped material s on the care of low back pain . MAIN RESULTS : The clinician intervention was associated with an absolute increase in guideline -consistent behavior of 5.4 % in the intervention group versus a decline of 2.7 % in the control group ( P=.04 ) . The patient education intervention produced no significant change in guideline -consistent behavior , but was poorly adopted . Patient characteristics including duration of pain , prior history of low back pain , and number of visits during the illness episode were strong predictors of service utilization and guideline -consistent behavior . CONCLUSIONS : Implementation of an education and feedback-supported acute low back pain care guideline for primary care clinicians was associated with an increase in guideline -consistent behavior . Patient education material s did not enhance guideline effectiveness . Implementation barriers could limit the utility of this approach in usual care setting ",
"Study Design . Back‐injured workers with high disability risk scores on a predictive question naire participated in a r and omized , controlled trial of physician notification , with outcomes follow‐up 3 months after injury . Objectives . To test whether physician intervention improves return to work and self‐ assessment outcomes for people at relatively high risk for disability . Summary of Background Data . Only a small number of back‐injured workers suffer significant disability . Ouick identification of these people would facilitate more efficient targeting and trials of interventions . Controlling variations in practice through practice guidelines has been recommended as a promising strategy for improving care and reducing disability . Methods . Workers filing back injury reports responded to a disability prediction question naire . Those with high risk scores were r and omly assigned to control or intervention groups . Patient‐ design ated physicians in the intervention group received two letters identifying the patient 's risk and making recommendations for care , including the Agency for Health Care Policy and Research 's algorithms for acute low back pain . Predictive accuracy of the question naire and efficacy of physician intervention were evaluated on the basis of work status and self‐ assessment s 3 months after injury . Results . Of the 268 workers completing the question naire portion of the study , 32 ( 12 % ) were out of work because of back pain 3 months after injury . The question naire 's predictive accuracy included maximum κ of 0.277 and a receiver operating curve area of 0.78 . Fifty‐three people completed the physician intervention trial . The intervention had no significant impact on return to work , self‐assessed pain , or satisfaction with health care . Conclusions . Stratification of back‐injured people according to disability risk can can increase intervention efficiency by identifying those who require treatment and sparing those who do not . The apparent failure of risk notification and practice guidelines to reduce disability in this study may be improved by different application methods in the future",
"BACKGROUND The Royal College of General Practitioners ( RCGP ) has produced guidelines for the management of acute low back pain in primary care . AIM To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners ( GPs ) . DESIGN OF STUDY Group r and omised controlled trial , using the health centre as the unit of r and omisation . SETTING Primary care teams in north-west Engl and . METHOD Twenty-four health centres were r and omly allocated to an intervention or control arm . Practice s in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain , as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms . RESULTS Twenty-four centres were r and omised . Two thous and , one hundred and eighty-seven eligible patients presented with acute low back pain during the study period : 1049 in the intervention group and 1138 in the control group . There were no significant differences between study groups in the proportion of patients who were referred for X-ray , issued with a sickness certificate , prescribed opioids or muscle relaxants , or who were referred to secondary care , but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit ( difference in proportion = 12.2 % , 95 % confidence interval [ CI ] = 2.8 % to 21.6 % ) . CONCLUSION The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs . An increase in referral to physiotherapy or educational programmes followed the provision of a triage service",
"Background The aim of this study was to assess the impact that Academic Detailing ( AD ) had on General Practitioners ' use of diagnostic imaging for shoulder complaints in general practice and their knowledge and confidence to manage shoulder pain . Methods One-to-one Academic Detailing ( AD ) for management of shoulder pain was delivered to 87 General Practitioners ( GPs ) in metropolitan Adelaide , South Australia , together with locally developed clinical guidelines and a video/DVD on how to examine the shoulder . Three months after the initial AD a further small group or an individual follow up session was offered . A 10-item question naire to assess knowledge about the shoulders was administered before , immediately after , and 3 months after AD , together with questions to assess confidence to manage shoulder complaints . The number of requests for plain film ( X-ray ) and ultrasound ( US ) imaging of the shoulder was obtained for the intervention group as well as a r and om comparison group of 90 GP 's from the same two Divisions . The change in the rate of requests was assessed using a log Poisson GEE with adjustment for clustering at the practice level . A linear mixed effects model was used to analyse changes in knowledge . Results In an average week 54 % of GPs reported seeing fewer than 6 patients with shoulder problems . Mean ( SD ) GP knowledge score before , immediately after and 3-months after AD , was 6.2/10 ( 1.5 ) ; 8.6/10 ( 0.96 ) and ; 7.2/10 ( 1.5 ) respectively ( p able to take a more meaningful history , more confident managing shoulder pain , and felt their management of shoulder pain had improved . Requests for ultrasound imaging were approximately 43.8 % higher in the period 2 years before detailing compared to six months after detailing ( p rate of requests from before to after AD for plain-radiographs ( p = 0.11 ) . No significant changes in the rate of requests over time were observed in the control groups . Conclusion These results provide evidence that AD together with education material s and guidelines can improve GPs ' knowledge and confidence to manage shoulder problems and reduce the use of imaging , at least in the short term",
"OBJECTIVES To assess the cost-effectiveness of providing practical training to general practitioners ( GPs ) in shoulder problems , and administering a local anaesthetic ( lignocaine ) vs steroidal ( cortisone ) injection . METHODS A cost-effectiveness analysis conducted alongside a cluster r and omized trial with a factorial design , in general practice s across five centres within the UK . A total of 155 participant GPs were r and omized to receive training or no training with 200 participants r and omized to either lignocaine or cortisone . Health care costs , quality -adjusted life years ( QALYs ) and incremental cost per QALY gained over 1 year estimated from a health system and a societal perspective were the main outcomes measured . RESULTS Over 1 year , training GPs costs on average an additional pound sterling 211 ( 95 % credibility interval - pound sterling 237 , pound sterling 661 ) than no training and produces higher mean QALYs ( 0.075 ; -0.004 , 0.154 ) per patient , yielding an incremental cost-effectiveness ratio of pound sterling 2813 per QALY gained for trained GPs . Over the same period of 1 year , lignocaine costs an average of pound sterling 122 more ( - pound sterling 232 , pound sterling 476 ) than cortisone and produces virtually no differential gain in mean QALYs ( 0.001 ; -0.068 , 0.070 ) , yielding an incremental cost per QALY gained of pound sterling 122,000 for lignocaine compared with cortisone . Across a range of cost-effectiveness thresholds , cortisone is as cost effective to inject as lignocaine . The probability that training is cost effective is above 0.95 at thresholds above pound sterling 20,000 . CONCLUSIONS Providing practical training to GPs about shoulder problems is cost effective and there is little uncertainty regarding this decision . The choice between lignocaine and cortisone is more uncertain and it is likely that there is significant value of further research to reduce this uncertainty . TRIAL REGISTRATION The International St and ard R and omised Controlled Trial Number is 58 537 244",
"Objectives : To evaluate the impact of two different modes of shoulder injection training on the level of confidence and number of injections performed by general practitioners ( GPs ) Methods : Demographic details , and information on referrals for shoulder problems , shoulder joint injection activity , and confidence in the six months before training were obtained for 40 GP principals at baseline . St and ardised training in the techniques of shoulder joint injection using rubber mannequins was given to all GPs . Twenty of these GPs were r and omly allocated to receive additional training on patients in hospital joint injection clinics . Six months after both forms of training the shoulder injection and referral activities of all GPs were reassessed . Results : Both training groups had comparable demographic characteristics and baseline clinical activity . GPs who had additional training with patients reported a marked increase in their level of confidence in performing shoulder injections and the number performed . The number of shoulder referrals did not differ between the groups Conclusion : Training on patients in addition to conventional training on mannequins increased GPs ’ shoulder injection activity and their level of confidence . Hospital injection clinics may provide a suitable setting in which to train GPs interested in developing their shoulder joint injection skills",
"BACKGROUND CONTEXT The process through which new scientific developments are incorporated into clinical practice is referred to as \" knowledge transfer \" and is currently the subject of great interest in many areas of clinical medicine . Family physicians managing patients with acute low back pain have been shown to have a poor overall rate of concordance with clinical practice guideline -recommended treatments . New methods need to be developed to help physicians bridge the guideline implementation gap . PURPOSE To determine the efficacy of a knowledge transfer method that communicates clinical practice guidelines to family physicians and their patients using patient-specific , physician-to-physician communications . STUDY DESIGN A prospect i ve r and omized controlled study . PATIENT SAMPLE 428 patients with acute mechanical low back pain and accepted Workers ' Compensation Board cl aims were studied . OUTCOME MEASURES Concordance with specific clinical practice guideline -derived history taking items , physical examination procedures and treatment recommendations was determined . METHODS Patients with acute mechanical back pain of less than 4 weeks duration and accepted Workers ' Compensation Board cl aims were r and omly assigned to one of three groups . In Group 1 ( control group ) neither the patients nor their family physicians received any information concerning the guidelines . In Group 2 , family physicians alone or as well as their patients ( Group 3 ) received a summary of clinical practice guidelines at approximately 2 weeks postinjury . In addition , both Groups 2 and 3 received reminders summarizing the recommended guidelines for patients at three specific stages of their clinical course . All guideline correspondence was addressed to a specific family physician or patient , signed by the study physician-investigators , and specified the patient by name . RESULTS Family physicians in the control and intervention groups demonstrated a high degree of concordance with the guideline -recommended history taking and physical examination procedures , but were generally highly discordant with guideline -recommended treatments . Significant improvement in guideline -concordant treatments was seen only with diminished recommendations of prolonged bed rest and passive therapies and an increase in recommended aerobic exercise . Concordance with guideline recommendations relating to the use of spinal manipulative therapy was poor in all study groups . CONCLUSIONS A knowledge transfer method that involved patient-specific , physician-to-physician communication to family physicians or their patients at three stages of the patient 's clinical course was largely unsuccessful in improving concordance with guideline treatment recommendations ",
"Introduction Older patients with fragility fractures are not commonly tested or treated for osteoporosis . Compared to usual care , a previously reported intervention led to 30 % absolute increases in osteoporosis treatment within 6 months of wrist fracture . Our objective was to examine longer-term outcomes , reproducibility , and cost-effectiveness of this intervention . Methods We conducted an extended analysis of a non-r and omized controlled trial with blinded ascertainment of outcomes that compared a multifaceted intervention to usual care controls . Patients > 50 years with a wrist fracture treated in two Emergency Departments in the province of Alberta , Canada were included ; those already treated for osteoporosis were excluded . Overall , 102 patients participated in this study ( 55 intervention and 47 controls ; median age : 66 years ; 78 % were women ) . The interventions consisted of faxed physician reminders that contained osteoporosis treatment guidelines endorsed by opinion leaders and patient counseling . Controls received usual care ; at 6-months post-fracture , when the original trial was completed , all controls were crossed-over to intervention . The main outcomes were rates of osteoporosis testing and treatment within 6 months ( original study ) and 1 year ( delayed intervention ) of fracture , and 1-year persistence with treatments started . From the perspective of the healthcare payer , the cost-effectiveness ( using a Markov decision-analytic model ) of the intervention was compared with usual care over a lifetime horizon . Results Overall , 40 % of the intervention patients ( vs. 10 % of the controls ) started treatment within 6 months post-fracture , and 82 % ( 95%CI : 67–96 % ) had persisted with it at 1-year post-fracture . Delaying the intervention to controls for 6 months still led to equivalent rates of bone mineral density ( BMD ) testing ( 64 vs. 60 % in the original study ; p = 0.72 ) and osteoporosis treatment ( 43 vs. 40 % ; p = 0.77 ) as previously reported . Compared with usual care , the intervention strategy was dominant – per patient , it led to a $ 13 Canadian ( U.S. $ 9 ) cost savings and a gain of 0.012 quality -adjusted life years . Base-case results were most sensitive to assumptions about treatment cost ; for example , a 50 % increase in the price of osteoporosis medication led to an incremental cost-effectiveness ratio of $ 24,250 Canadian ( U.S. $ 17,218 ) per quality -adjusted life year gained . Conclusions A pragmatic intervention directed at patients and physicians led to substantial improvements in osteoporosis treatment , even when delivered 6-months post-fracture . From the healthcare payer ’s perspective , the intervention appears to have led to both cost-savings and gains in life expectancy",
"OBJECTIVE The aim of the present study was to find out if a training programme adapted to family physicians with several years of clinical experience changes their behaviour when they deal with fibromyalgic patients in the sense of introducing the communication skills that define the ' patient-centred ' approach . METHODS A r and omized , and simple blind , educative study was carried out . Twenty full-time family physicians were invited to participate . They were allocated r and omly to two groups : an intervention and a control group . A total of 110 patients were recruited from people attending physicians ' surgeries for the first time and who complained of generalized pain that finally fulfilled criteria for generalized musculoskeletal chronic pain/fibromyalgia . This was done for an entire year . The intervention group received an 18 hour intensive course . One week after the course , all doctors carried out a video-recorded encounter with a patient who played the part of a typical fibromyalgia clinical case . The interviews were coded by an observer blind to the training status of the participants , using the GATHARES-CP question naire . All patients were contacted by telephone during a 1 - 2-month period by a different interviewer who was ' blinded ' to the patient 's experimental status . They were asked to respond to three questions that represent the key components of patient-centred style . RESULTS The average score on the GATHARES-CP question naire was 11.3 + /- 0.9 and 9 + /- 2.3 , for doctors from the intervention and control groups , respectively ( P patients ' answers to all three questions showed statistically significant differences in a positive direction for the trained doctors . CONCLUSIONS The doctors improved the use of strategies and skills for carrying out patient-centred consultations after they had received an interactive course . The doctors ' behaviour appeared to have changed as much in a more experimental situation as in the actual consultations . Moreover , the gain was observed immediately after the intervention was completed , and after having run for a variable period of time up to 1 year",
"BACKGROUND Fragility fractures are associated with a significant increase in the risk of future fracture , but the rates of evaluation to identify osteoporosis after such injuries are low . The purpose of this study was to determine the rates of evaluation and treatment of osteoporosis following distal radial fractures and to test two interventions in the outpatient clinic to improve evaluation and treatment rates . METHODS In the first part of the study , the medical records of 298 consecutive patients treated for a fragility fracture of the distal part of the radius were review ed . Primary outcome measures were a bone mineral density examination and treatment with osteoporosis medication within six months after the fracture . In the second part of the study , fifty patients with a fragility fracture of the distal part of the radius were prospect ively r and omized to receive one of two interventions . These consisted of ( 1 ) the orthopaedic surgeon ordering a bone mineral density examination and forwarding the results to the primary care physician or ( 2 ) the orthopaedic surgeon sending a letter to the primary care physician outlining guidelines for osteoporosis screening . Patients were contacted at six months after the fracture to determine the rates of evaluation and treatment for osteoporosis . RESULTS The first part of the study revealed that , following a distal radial fracture , 21.3 % of 240 patients had a bone mineral density examination and 78.7 % were never screened . Osteopenia was the most common diagnosis among those screened ( 57 % ) . Most ( 72.5 % ) of the 240 patients received no medication , whereas 6.7 % received calcium and vitamin D ; 11.3 % , bisphosphonates ; 2.5 % , hormone replacement therapy ; and 7.1 % , a combination regimen . The treatment rate for the patients who had undergone a bone mineral density examination was 2.5-fold higher than the rate for those who had not had bone mineral density testing ( 53 % compared with 21 % , p bone mineral density testing ( 93 % compared with 30 % , p discussion of osteoporosis with their primary care physician ( 89 % compared with 35 % , p initiation of osteoporosis therapy ( 74 % compared with 26 % , p Rates of evaluation and treatment for osteoporosis after fragility fractures remain low ( 21.3 % and 27.5 % , respectively ) . Patients who undergo a bone mineral density examination are more likely to receive treatment . Ordering a bone mineral density examination in the orthopaedic clinic can dramatically improve osteoporosis evaluation and treatment rates following fragility fractures of the distal part of the radius",
"OBJECTIVE To evaluate the effects of a short interactive training program for general practitioners ( GP ) on pain management in patients with osteoarthritis ( OA ) . METHODS A multicenter , parallel-group study . GP were r and omized to receive training on relationships and communication , pain evaluation , prescription , and negotiation of a patient contract or to a control group receiving a presentation about obtaining consent in trials . Outcomes were patient assessment s of pain and functional ability . We invited 1500 GP to take part in the study . Those who volunteered to receive the training recruited out patients from May 2001 to April 2002 . Patients participating in the evaluation of the effects of the general practitioners ' training had lower limb OA and pain on motion [ > or = 40 mm on a visual analog scale ( VAS ) ] and had indications for treatment with acetaminophen . The primary endpoint : sum of patient pain relief based on the daily VAS self-evaluation during the 2 weeks of the trial . RESULTS In total , 180 GP ( 84 trained , 96 nontrained ) enrolled 842 patients ( 414 and 428 , respectively ) . Mean baseline VAS pain was 63 + /- 14 mm . Patients in the trained-GP group had better overall pain relief ( 316 + /- 290 mm/day vs 265 + /- 243 mm ; p Lequesne and WOMAC scores ( p overall perception of treatment ( p = 0.002 ) . Acetaminophen use was slightly higher in the trained group ; however , the difference in pain relief remained statistically significant ( p = 0.0003 ) after adjustment for this difference . CONCLUSION This is the first study to demonstrate a positive effect of physician training on patients with a painful condition",
"Summary This study assessed whether osteoporosis diagnosis and treatment after an osteoporotic fracture can be increased by providing osteoporosis reading material to patients and family doctors or by watching a videocassette about osteoporosis . Educating patients about osteoporosis had little impact on whether a woman received an osteoporosis diagnosis or treatment . Introduction The purpose of this study was to investigate the impact of two education-based interventions on osteoporosis diagnosis and treatment in women ≥50 years of age after fragility fracture . Methods Six to eight months after fracture , women were r and omized into three groups : ( 1 ) control , ( 2 ) written material s , or ( 3 ) videocassette and written material s. Written material s for both the patient and physician detailed osteoporosis , fragility fracture , and available treatments ; written material s for physicians were provided through patients . The educational videocassette presented similar information as the written material , but in greater depth . Rates of osteoporosis diagnosis and treatment following intervention were compared among groups using survival analysis methods . Statistical significance was set at p At r and omization , 1,174 women were without osteoporosis diagnosis and treatment , and after follow-up , 12 % of the control group , 15 % of the written material s group ( p = 0.073 ) , and 16 % ( p = 0.036 ) of the videocassette and written material s group were diagnosed with osteoporosis ( statistical comparisons to control ) . Treatment rates were 8 % for the control group , 12 % for the written material s group ( p = 0.052 ) , and 11 % for the videocassette and written material s group ( p = 0.157 ) . At r and omization , 1,314 women were without treatment and after follow-up therapy was initiated in 10 % of the control group , 13 % of the written material s group ( p = 0.107 ) , and 13 % of the videocassette and written material s group ( p = 0.238 ) . Conclusions The educational interventions assessed in this trial were not satisfactory to increase osteoporosis diagnosis or treatment in recently fractured women to a clinical ly meaningful degree",
"BACKGROUND Radiological tests are often used by general practitioners ( GPs ) . These tests can be overused and contribute little to clinical management . We aim ed to assess two methods of reducing GP requests for radiological tests in accordance with the UK Royal College of Radiologists ' guidelines on lumbar spine and knee radiographs . METHODS We assessed audit and feedback , and educational reminder messages in six radiology departments and 244 general practice s that they served . The study was a before- and -after , pragmatic , cluster r and omised controlled trial with a 232 factorial design . A r and om subset of GP patients ' records were examined for concordance with the guidelines . The main outcome measure was number of radiograph requests per 1000 patients per year . Analysis was by intention to treat . FINDINGS The effect of educational reminder messages ( ie , the change in request rate after intervention ) was an absolute change of -1.53 ( 95 % CI -2.5 to -0.57 ) for lumbar spine and of -1.61 ( -2.6 to -0.62 ) for knee radiographs , both relative reductions of about 20 % . The effect of audit and feedback was an absolute change of -0.07 ( -1.3 to 0.9 ) for lumbar spine of 0.04 ( -0.95 to 1.03 ) for knee radiograph requests , both relative reductions of about 1 % . Concordance between groups did not differ significantly . INTERPRETATION 6-monthly feedback of audit data is ineffective but the routine attachment of educational reminder messages to radiographs is effective and does not affect quality of referrals . Any department of radiology that h and les referrals from primary care could deliver this intervention to good effect",
"Objectives : To identify the effect of a complex intervention ( educational outreach visits by pharmacists ) design ed to change general practitioners ' ( GPs ' ) prescribing on each step of a hypothesised pathway of change leading to the final primary trial outcome of change in prescribing . Method : The study was undertaken in six health authorities in the North of Engl and and six in London . We described three steps leading to this outcome : the general practice s agreeing to participate ; GPs in each practice attending the outreach visit conducted by the pharmacists ; and the GPs ' prescribing practice being influenced by these visits . The outcomes of each step were assessed using a combination of quantitative and qualitative methods . Results : Of the 102 practice s r and omly selected , 75 ( 73.5 % ) agreed to participate . The odds of all the doctors attending the outreach meeting in small practice s ( i.e. 1 - 2 partners ) was 6.7 ( 95 % CI : 4.4 - 23.5 ) compared with other practice s ( i.e. > 3 partners ) . Although the pharmacists reported that they had established a good rapport at 100 ( 72 % ) first visits and had agreed management plans for 110 ( 79 % ) of these visits , they were confident that the practice was likely to alter its prescribing in only 41 % of these visits . Pharmacists ' and GPs ' satisfaction with the outreach visits did not necessarily lead to prescribing changes after the practice visit , and the GPs ' knowledge of the guidelines promoted by the pharmacists did not necessarily translate into changes in clinical practice . The main barriers to the implementation of guidelines identified by the pharmacists at the follow-up visits were organisational difficulties , the GPs ' scepticism of the evidence presented to them and the doctors ' lack of interest in changing their prescribing behaviour . Conclusions : Although our study is limited by a post hoc rather than a pre hoc design , it provides a pragmatic approach to underst and ing the factors influencing the pathway of change in prescribing behaviour in response to academic outreach visits",
"OBJECTIVES Osteoporosis treatment rates after a fracture are low . This study evaluated methods to increase guideline -recommended osteoporosis care postfracture . DESIGN Participants were r and omly assigned to usual care or one of two interventions . Analysis of primary outcomes used electronic data and linear regression . SETTING A Pacific Northwest nonprofit health maintenance organization . PARTICIPANTS Female patients aged 50 to 89 who suffered a fracture in 1999 and had not received bone mineral density ( BMD ) measurement or medication for osteoporosis ( n=311 ) and their primary care providers ( n=159 ) . INTERVENTION Patient-specific clinical guideline advice to the primary care provider delivered by electronic medical record ( EMR ) message or electronic reminder to the provider plus an educational letter mailed to the patient . MEASUREMENTS BMD measurement and osteoporosis medication . RESULTS At 6 months , provider reminder result ed in 51.5 % of patients receiving BMD measurement or osteoporosis medication , provider reminder plus patient education result ed in 43.1 % , and usual care result ed in 5.9 % ( P Patients aged 60 to 69 were 18 % ( 95 % confidence interval=3 - 34 ) more likely to receive BMD measurement or an osteoporosis medication than those aged 80 to 89 . CONCLUSION Patient-specific postfracture advice to the provider through an EMR message significantly increased BMD measurement and osteoporosis medication . As EMRs become more widespread , this intervention could improve osteoporosis management for many postfracture patients . Future research should identify barriers to and facilitators of care for older , high-risk patients",
"Optimal information that should be included in ultrasound ( US ) heel bone mineral density ( BMD ) reports is not known . If additional information about further evaluation of patients with low heel BMD were included in reports , would responses for treatment improve ? We screened people at health fairs using the Sahara heel US machine . For those with a T-score of , letters were sent to their primary care physician notifying them of the result . Physicians were r and omly assigned to ( 1 ) a st and ard letter , which recommended central bone density screening ( dual X-ray absorptiometry [ DXA ] ) and treatment if the BMD was low ; or ( 2 ) an extended letter , which also outlined treatment strategies based on recommended subsequent central DXA scan results for a T-score of frequency of DXA testing from 30.1 to 37.2 % ( not a significant increase ) . Of 88 people with heel BMD , 25 of 45 ( 56 % ) were treated ( calcium , estrogens , bisphosphonates , or calcitonin or a combination ) after physicians received a st and ard letter and 30 of 43 ( 70 % ) after an extended letter ( one-sided p = 0.084 ) . Of people with T BMD results",
"Study Design . Cluster r and omized controlled trial for a multifaceted implementation strategy . Objectives . To assess the effectiveness of tailored interventions ( multifaceted implementation strategy ) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to guideline recommendations . Summary of Background Data . Guidelines for the management of low back pain in primary care have been developed in various countries , but little is known about the optimal implementation strategy . A multifaceted implementation strategy was developed to overcome identified barriers to the implementation of the Dutch low back pain guideline for general practitioners . Methods . General practitioners were r and omized to an intervention or a control group . The general practitioners in the intervention group ( n = 21 ) received tailored interventions consisting of the Dutch low back pain guideline for general practitioners , a 2-hour educational and clinical practice workshop ; two scientific articles on low back pain management ; the guideline for occupational physicians ; a tool for patient education ; and a tool for reaching agreement on low back care with physical , exercise , and manual therapists . The control group ( n = 20 ) received no intervention . The participating general practitioners were asked to recruit consecutive patients with a new episode of low back pain as the main reason for consultation . General practitioners completed registration forms of each individual consultation with regard to the main outcome measures : advice and information , referral to other health-care providers , and prescription of medication . Results . Forty-one of the 67 r and omized general practitioners reported on a total of 616 consultations for 531 patients with nonspecific low back pain . The advice and explanation provided by the general practitioners , the prescription of paracetamol or nonsteroidal anti-inflammatory drugs , and prescription of pain medication on atime contingent or a pain contingent basis showed no statistically significant differences between the intervention and control groups . There were also no differences in overall referral rate . However , in follow-up consultations fewer patients were referred to a physical or exercise therapist by the general practitioners in the intervention group than in the control group . Conclusions . The multifaceted intervention strategy modestly improved implementation ( for parts of the recommendations in ) the Dutch low back pain guideline by general practitioners and produced small concomitant changes in patient management . The implementation strategy produced fewer referrals to therapists during follow-up consultations",
"OBJECTIVE Musculoskeletal disorders ( MSD ) are a leading cause of morbidity in the population , yet their prominence seems to be insufficiently appreciated . We describe the ranking compared with other major body systems of the prevalence of MSD , including arthritis and rheumatism , and back/neck disorders , as a cause of chronic health problems , longterm disability , restricted activity days , consultation with health professionals , and use of both prescription and nonprescription drugs . METHODS We analyzed data from the 1990 Ontario Health Survey , a stratified r and om sample of the household dwelling population in Ontario , based on 45,650 individuals aged 16 years and over . RESULTS MSD ranked first in prevalence as the cause of chronic health problems , longterm disabilities , and consultations with a health professional and ranked 2nd for restricted activity days and use of both prescription and nonprescription drugs . No other body systems ranked invariably within the top 2 ranks for the morbidity indices examined . Even when compared to other major disease groups , arthritis and rheumatism ranked consistently in the top 3 and back/neck disorders also ranked high . MSD were mentioned as a reason for 40 % of all chronic conditions , 54 % of all longterm disability , 24 % of restricted activity days and almost 20 % of health care utilization . The impact of MSD was even greater in the 65 and over age group . CONCLUSIONS MSD have a major role in the health profile of the population . This high burden of illness should be considered in planning health care services and setting research priorities",
"Summary In a cluster r and omized trial , we evaluated the effect of a multifaceted intervention ( directed at both patient and primary care physician ) on the rates of testing and treatment of osteoporosis in postmenopausal women within six months of their wrist fracture . Compared to usual care , women in the intervention practice s were three times more likely to receive bone mineral density testing and prescribed osteoporosis treatments . Introduction Postmenopausal women with wrist fractures are at increased risk of future fragility fractures , yet they frequently do not receive evaluation and treatment for osteoporosis . We set out to evaluate a multifaceted intervention design ed to improve management of osteoporosis in older women with recent wrist fractures . Methods Cluster r and omized trial of 270 women cared for in 119 primary care practice s. We recruited postmenopausal women with an acute wrist fracture from the emergency departments of hospitals in southeastern Ontario , Canada . Family practice s were r and omly assigned to either the intervention or usual care . The intervention consisted of a mailed reminder with a summary of treatment guidelines and letter sent to the primary care physician , in addition to an educational package and letter to the women . The primary outcome was the proportion of women prescribed osteoporosis therapy within 6 months of their fracture . Results The mean age of women was 69(10.9 ) years . The intervention increased the proportion of women started on osteoporosis medications ( 28 % vs. 10 % ) of controls , adjusted OR 3.45 , 95 % CI , 1.58–7.56 , p = 0.002 ) and the proportion who had a bone mineral density ( BMD ) test ( 53.3 % vs. 26 % ) of controls , OR 3.38 , 95 % CI , 1.83–6.26 , p testing and treatment rates . Conclusion A multifaceted intervention significantly improved rates of osteoporosis treatment and BMD testing in postmenopausal women with wrist fractures",
"BACKGROUND The Royal College of Radiologists ( RCR ) have produced regularly up date d guidelines on radiological referrals since 1990 . A small study in 1992 showed postal distribution of guidelines reduced general practitioners ' referrals over the subsequent 9 weeks . However there have been no r and omized trials of the longer term effects of radiological guidelines and feedback on referral rates on X-ray requests from primary care . OBJECTIVES To see if the introduction of radiological guidelines into general practice s together with feedback on referral rates reduces the number of GP radiological requests over one year ; and to explore GPs'attitudes to the guidelines . METHODS Sixty-nine practice s referring patients to St George 's Healthcare Trust were r and omly allocated to intervention or control groups . In February 1995 a GP version of the RCR guidelines was sent to each GP in the 33 practice s in the intervention group . After 9 months intervention , practice s were sent revised guidelines with individual feedback on the number of examinations requested in the past 6 months . The total number of requests per practice was compared for the year before and the year after the introduction of the guidelines . Control practice s were sent the guidelines at the end of the study . All doctors were sent a question naire about the guidelines . RESULTS A total of 43 778 radiological requests were made during the two years 1994 - 1996 . In practice s receiving the guidelines there was a 20 % reduction in requests for spinal examinations compared with control practice s ( P total number of requests made , but due to wide inter practice variation in referral rates this failed to reach statistical significance . CONCLUSIONS Introduction of radiological guidelines together with feedback on referral rates was effective in reducing the number of requests for spinal examinations over one year . Wider use of GP-orientated guidelines with regular updating and feedback might save costs and reduce unnecessary irradiation of patients",
"PURPOSE We examined whether a continuing medical education intervention increased general practitioners ' ability to select the proper pharmacological treatment for patients with osteoarthritis . SUBJECTS AND METHODS Eight towns in Quebec , Canada were r and omly allocated to one of four intervention options , workshop and decision tree , workshop , decision tree , or no intervention . All general practitioners practicing in each town were eligible to participate . We evaluated all dispensed prescriptions for either a cyclooxygenase (COX)-2 inhibitor , nonselective nonsteroidal anti-inflammatory drug or acetaminophen written by eligible general practitioners between May 2000 and June 2001 to elderly patients suffering from osteoarthritis . We used a multi-level Bayesian hierarchical model to assess the impact of the interventions on prescription adequacy . RESULTS We analyzed 5318 dispensed prescriptions written by 249 general practitioners in the five-month preintervention period and 4610 dispensed prescriptions written by the same physicians in the five-month postintervention period . A score of zero or one was given to every prescription , with one indicating prescription adequacy according to guidelines provided during the interventions . Bayesian hierarchical models showed some improvement in scores in the post- versus preintervention periods in all four groups . The probability of an improvement in the towns allocated the workshop and decision tree over the control was 94 % , compared with 74 % in the workshop group and 55 % in the decision tree group . CONCLUSION An interactive approach offered by peers and complemented by easy to use guidelines may enhance the general practitioner 's ability to manage osteoarthritis patients",
"Study Design . Cluster r and omized controlled trial . Objective . To improve quality of care for patients with low back pain ( LBP ) a multifaceted general practitioner education alone and in combination with motivational counseling by practice nurses has been implemented in German general practice s. We studied effects on functional capacity ( main outcome ) , days in pain , physical activity , quality of life , or days of sick leave ( secondary outcomes ) compared with no intervention . Summary of Background Data . International research has lead to the development of the German LBP guideline for general practitioners . However , there is still doubt about the most effective implementation strategy . Although effects on process of care have been observed frequently , changes in patient outcomes are rarely seen . Methods . We recruited 1378 patients with LBP in 118 general practice s , which were r and omized to 1 of 3 study arms : a multifaceted guideline implementation ( GI ) , GI plus training of practice nurses in motivational counseling ( MC ) , and the postal dissemination of the guideline ( controls , C ) . Data were collected ( question naires and patient interviews ) at baseline and after 6 and 12 months . Multilevel mixed effects modeling was used to adjust for clustering of data and potential confounders . Results . After 6 months , functional capacity was higher in the intervention groups with a cluster adjusted mean difference of 3.650 between the MC group and controls ( 95 % CI = 0.320–6.979 , P = 0.032 ) and 2.652 between the GI group and controls ( 95 % CI = −0.704 to 6.007 , P = 0.120 ) . Intervention effects were more pronounced regarding days in pain per year with an average reduction of 16 ( GI ) to 17 days ( MC ) after 6 months ( 12 and 9 days after 12 months ) compared with controls . Conclusion . Active implementation of the German LBP guideline results in slightly better outcomes during 6 months follow-up than its postal dissemination . Results are more distinct when practice nurses are trained in motivational counseling",
"A survey of perceptions of continuing education -- content , methods and current provision -- was undertaken among all established general practitioners in one health region of the UK using a postal question naire . Interviews were conducted with a small r and om sample of respondents and with a larger sample of non-respondents to the question naire . Data from the question naire and interviews demonstrated overall a wide diversity of content and methods of continuing education perceived as appropriate , with duration of experience and involvement in undergraduate teaching or postgraduate training as significant determinants . The findings are used to review , critically , current provision of continuing education for general practice and to suggest ways in which future provision might reflect the range of educational need perceived by doctors",
"BACKGROUND Treatment of osteoporosis following a hip fracture has been notoriously poor . Many efforts have been made to improve treatment rates . The purpose of this study was to determine whether a perioperative inpatient intervention program , involving patient education and providing a list of questions for the primary care physician , increased the percentage of patients in whom osteoporosis was addressed following a hip fracture . METHODS A prospect i ve , r and omized trial involving eighty patients who had been admitted to an academic medical center with a low-energy hip fracture was conducted . During their hospitalization , the study group patients were engaged in a fifteen-minute discussion regarding the association between osteoporosis and hip fractures , the efficacy of dual-energy x-ray absorptiometry scans in the diagnosis of osteoporosis and of bisphosphonates in its treatment , and the importance of medical follow-up for osteoporosis management . These patients were also provided with five questions regarding osteoporosis treatment to be given to their primary medical physician , and they were reminded about the questions during a follow-up telephone call six weeks later . The patients in the control group received a brochure describing methods for preventing falls . Both groups were contacted by telephone at six months after discharge to determine whether osteoporosis had been addressed . Positive indicators of intervention included assessment of bone mineral density with dual-energy x-ray absorptiometry and initiation of antiresorptive therapy . RESULTS The average age in each group was eighty-two years , and 78 % of the patients were female . Four patients in each group did not survive through the six-month follow-up period and were excluded from the trial . Fifteen ( 42 % ) of the thirty-six patients who had been r and omized to the study group , compared with only seven ( 19 % ) of the thirty-six patients in the control group , had their osteoporosis addressed by their primary physician . This difference between the groups was significant ( p = 0.036 ) . CONCLUSIONS Patients who were provided with information and questions for their primary care physician about osteoporosis were more likely to receive appropriate therapeutic intervention than were patients who had not received the information and questions . Orthopaedic surgeons have a unique opportunity to improve the rate of osteoporosis treatment in the perioperative period following a hip fracture by educating patients and directing them toward channels for long-term osteoporosis management",
"BACKGROUND Primary care requests for radiographs of the lumbar spine have come under increasing scrutiny . Guidelines aim ing to reduce unnecessary radiographs by limiting referrals to patients at high risk of serious disease have been widely distributed . Trial evidence suggests that guidelines can reduce radiography referrals . It is not clear whether this reduction has been achieved in routine practice . AIM This study , using routine data , was conducted to measure trends in pnmary care referrals for lumbar spine radiography at two hospitals between 1994 and 1999 . DESIGN OF STUDY Analysis of primary care requests for lumbar spine radiography from computerised records . SETTING Addenbrooke 's Hospital , Cambridge ( 1 July 1994 to 30 June 1999 ) , and Ipswich General Hospital ( 1 July 1995 to 30 June 1999 ) , United Kingdom . METHOD All primary care requests for lumbar radiography were identified electronically from computerised information systems . A r and om sample of 2100 radiography reports were classified according to clinical importance . These classifications were used to examine whether the proportion of radiographs demonstrating potentially more serious findings had increased between 1994 and 1999 . RESULTS There was no evidence that primary care referrals for radiography of the lumbar spine had decreased between 1994 and 1999 at either hospital . General practitioners did not progressively refer more high-risk patients for lumbar radiography . Only a small proportion of patients had important radiographic findings that might warrant specialist referral or specific therapy . CONCLUSION The implementation of diagnostic guidelines offers much to the NHS . However in these two hospitals , the reduction in radiograph utilisation evident in trials was not achieved . Guideline development is a re source intensive process ; distribution must be supported by more effective implementation strategies",
"Background : Older patients who experience a fragility fracture are at high risk of future fractures but are rarely tested or treated for osteoporosis . We developed a multifaceted intervention directed at older patients with wrist fractures ( in the form of telephone-based education ) and their physicians ( in the form of guidelines endorsed by opinion leaders , supported by reminders ) to improve the quality of osteoporosis care . Methods : In a r and omized controlled trial with blinded ascertainment of outcomes , we compared our intervention with usual care ( provision of printed educational material s to patients ) . Eligible patients were those older than 50 years of age who had experienced a wrist fracture and were seen in emergency departments and fracture clinics ; we excluded those who were already being treated for osteoporosis . The primary outcome was bisphosphonate treatment within 6 months after the fracture . Secondary outcomes included bone mineral density testing , “ appropriate care ” ( consisting of bone mineral density testing with treatment if bone mass was low ) and quality of life . Results : We screened 795 patients for eligibility and r and omly assigned 272 to the intervention ( 137 patients ) or control ( 135 patients ) group . The median age was 60 years ; 210 ( 77 % ) of the subjects were women , and 130 ( 48 % ) reported a previous fracture as an adult . Six months after the fracture , 30 ( 22 % ) of the intervention patients , as compared with 10 ( 7 % ) of the control patients , were receiving bisphosphonate therapy for osteoporosis ( adjusted relative risk [ RR ] 2.6 , 95 % confidence interval [ CI ] 1.3–5.1 , p = 0.008 ) . Intervention patients were more likely than control patients to undergo bone mineral density testing ( 71/137 [ 52 % ] v. 24/135 [ 18 % ] ; adjusted RR 2.8 , 95 % CI 1.9–4.2 , p receive appropriate care ( 52/137 [ 38 % ] v. 15/135 [ 11 % ] ; adjusted RR 3.1 , 95 % CI 1.8–5.3 , p died , and 4 others experienced recurrent fracture . Interpretation : A multifaceted intervention directed at high-risk patients and their physicians substantially increased rates of testing and treatment for osteoporosis . Nevertheless , more than half of the patients in the intervention group were not receiving appropriate care 6 months after their fracture , which suggests that additional strategies should be explored . ( Clinical Trials.gov trial register no. NCT00152321 .",
"This article reports a controlled trial to investigate the effectiveness of patient education and a physician alerting system in altering secondary osteoporosis prevention after a low-trauma ( fragility ) wrist fracture and to record the current rate of osteoporosis investigation following such fractures . Fifty-one women and men aged 50 years or older with a low-trauma wrist fracture were identified ( 41 women and 10 men ; mean age [ 95 % CI ] , 71.51 [ 67.31 - 74.81 ] ) . The intervention group received a four-part intervention aim ed at both the patient and the family physician in addition to the usual care for the fracture . The control group only received usual care for the fracture . Data were collected for both groups at six weeks and six months . Results indicate that 92 % of the intervention subjects were investigated for osteoporosis , compared with the usual-care group , in which only 23 % were investigated . Early osteoporosis intervention has the potential to limit disease impact , and h and therapists can play a key role in early identification of osteoporosis",
"OBJECTIVE We assessed primary care clinician-provided guideline -concordant care as documented in patients ' medical records , predictors of documented guideline -concordant care , and its association with pain-related functioning . Patients were participants in a r and omized trial of collaborative care for chronic musculoskeletal pain . The intervention featured patient and primary care clinician education , symptom monitoring and feedback to clinicians by the intervention team . METHODS To assess concordance with the evidence -based treatment guidelines upon which our intervention was based , we developed an 8-item chart review tool , the Pain Process Checklist ( PPC ) . We then review ed electronic medical records for 365 veteran patients treated by 42 primary care clinicians over 12 months . Intervention status , demographic , and clinical variables were tested as predictors of PPC scores using generalized estimating equations ( GEE ) . GEE was also used to test whether PPC scores predicted treatment response ( ≥30 % decrease in Rol and -Morris Disability Question naire score ) . RESULTS Rates of documented guideline -concordant care varied widely among PPC items , from 94 % of patients having pain addressed to 17 % of patients on opioids having side effects addressed . Intervention status was unrelated to item scores , and PPC-7 totals did not differ significantly between intervention and treatment-as-usual patients ( 61.2 % , st and ard error [ SE ] = 3.3 % vs 55.2 % , SE = 2.6 % , P = 0.15 ) . In a multivariate model , higher PPC-7 scores were associated with receiving a prescription for opioids ( odds ratio [ OR ] = 1.07 , P = 0.007 ) and lower PPC-7 scores with patient age ( 10-year difference OR = 0.97 , P = 0.004 ) . Finally , intervention patients who received quantitative pain and depression assessment s were less likely to respond to treatment ( assessed vs not : 18 % vs 33 % , P = 0.008 , and 13 % vs 28 % , P = 0.001 , respectively ) . CONCLUSIONS As measured by medical record review , additional training and clinician feedback did not increase provision of documented guideline -concordant pain care , and adherence to guidelines by primary care clinicians did not improve clinical outcomes for patients with chronic musculoskeletal pain"
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Background / objectives Walking has well-established positive relationships with , and effects on , physical health . In contrast , while poor mental health contributes substantially to global health burden , an overview of the benefits from walking has not previously been published . We aim ed to scope the literature and present what is known , and highlight what is not known , about walking and mental health . Methods Design : Scoping review . Data sources : Ovid ( Medline ) , ProQuest , Web of Science . Screening and reporting : 13 014 records were identified and screened by a team of research ers . Included full texts were analysed and reported according to mental health outcome . Results For the 8 mental health outcomes ( identified a priori ) , there were a total of 5 systematic review s and 50 individual papers included . Depression had the most evidence and existing systematic review s were reported . Evidence for anxiety , psychological stress , psychological well-being , subjective well-being and social isolation and loneliness varied in volume and effectiveness , but no harmful effects were identified . There were no studies for walking and resilience . The setting and context of walking seems to be important variables . Conclusion The evidence base that suggests walking benefits mental health is growing , but remains fragmented and incomplete for some important outcomes . Policy and national guidelines should promote the known mental health benefits of increased walking and future research should directly address the gaps we have identified
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"Tai Chi , a moving meditation , is examined for its efficacy in post-stressor recovery . Forty-eight male and 48 female Tai Chi practitioners were r and omly assigned to four treatment groups : Tai Chi , brisk walking , mediation and neutral reading . Mental arithmetic and other difficult tests were chosen as mental challenges , and a stressful film was used to produce emotional disturbance . Tai Chi and the other treatments were applied after these stressors . After all treatments , the salivary cortisol level dropped significantly , and the mood states were also improved . In general the stress-reduction effect of Tai Chi characterized moderate physical exercise . Heart rate , blood pressure , and urinary catecholamine changes for Tai Chi were found to be similar to those for walking at a speed of 6 km/hr . Although Tai Chi appeared to be superior to neutral reading in the reduction of state anxiety and the enhancement of vigour , this effect could be partially accounted for by the subjects ' high expectations about gains from Tai Chi . Approaches controlling for expectancy level are recommended for further assessment",
"Background . The aim of this r and omized , controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress . Methods . Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were r and omized to 8 sessions of mindful walking in 4 weeks ( each 40 minutes walking , 10 minutes mindful walking , 10 minutes discussion ) or to no study intervention ( waiting group ) . Primary outcome parameter was the difference to baseline on Cohen 's Perceived Stress Scale ( CPSS ) after 4 weeks between intervention and control . Results . Seventy-four participants were r and omized in the study ; 36 ( 32 female , 52.3 ± 8.6 years ) were allocated to the intervention and 38 ( 35 female , 49.5 ± 8.8 years ) to the control group . Adjusted CPSS differences after 4 weeks were −8.8 [ 95 % CI : −10.8 ; −6.8 ] ( mean 24.2 [ 22.2 ; 26.2 ] ) in the intervention group and −1.0 [ −2.9 ; 0.9 ] ( mean 32.0 [ 30.1 ; 33.9 ] ) in the control group , result ing in a highly significant group difference ( P in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention . Further studies should include an active treatment group and a long-term follow-up",
"Background Despite Internet-based interventions that incorporate pedometers with appropriate goal - setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior , few have incorporated all of these key features or assessed maintenance of behavior change . Objective The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts , combined with an interactive support website for step counts , health parameters and motivation over 12 and 24 weeks . Methods Low active participants ( mean [ SD ] 46.2 [ 11.2 ] years ) were r and omly assigned to the Stepwise ( SW ) intervention group ( n=49 ) or a comparison ( CP ) group ( n=48 ) . SW received a pedometer , step goal walking program and access to the SW website ( containing interactive self-monitoring and goal feedback tools , motivational messages and action and coping planning strategies ) . CP received a pedometer and locally available physical activity information . Step counts , BMI , resting heart rate , blood pressure and glucose , cholesterol and triglyceride levels , psychological well-being , perceived health , self-efficacy and self-determined motivation were measured at baseline , 12 and 24 weeks . Results Linear mixed model analysis found that both groups ’ step counts increased from baseline to week 12 ( β = 11,002 , CI 5739 - 16,266 , P Group step counts were significantly different at week 24 with SW taking 8939 ( CI 274 - 17604 , P=.04 ) more steps compared to CP . Compared to baseline , both groups had improved triglyceride levels ( 0.14 mmol/L , CI -0.25 to -0.02 , P=.02 ) at week 12 , decreased diastolic blood pressure ( 4.22 mmHg , CI -6.73 to -1.72 ) at weeks 12 and 24 ( 3.17 mmHg , CI -5.55 to -0.78 ) , improved positive ( β = .21 , CI 0.03 - 0.38 , P=.02 ) and negative affect ( β = -.15 , CI -0.28 to -0.03 , P=.02 ) at week 12 , and perceived health at week 12 ( β = 6.37 , CI 2.10 - 10.65 , P=.004 ) and 24 ( β = 8.52 , CI 3.98 - 13.06 , P increased at week 12 ( 0.26 mmol/L , CI 0.099 - 0.423 , P=.006 ) and week 24 ( 0.38 mmol/L , CI 0.20 - 0.56 , P ) . Repeated measures ANOVA found motivation for walking improved from baseline with higher task self-efficacy ( P and autonomous motivation ( P decreased controlled motivation ( P=.004 , η2=.08 ) at week 24 . Conclusions Both groups had similar improvements in step counts and physical and psychological health after 12 weeks but only the SW group successfully maintained the increased step-counts 24 weeks post-intervention . This suggests the step- goal based walking program combined with Internet-based behavior change tools were important for sustained behavior change",
"Introduction Affective responses during physical activity ( PA ) are important for engagement in PA programs and for adherence to a physically active lifestyle . Little is known about the affective responses to PA bouts lasting longer than 45 minutes . Therefore , the aims of the present study were to analyse acute effects on affective responses of a three-hour outdoor PA intervention ( mountain hiking ) compared to a sedentary control situation and to an indoor treadmill condition . Methods Using a r and omized crossover design , 42 healthy participants were r and omly exposed to three different conditions : outdoor mountain hiking , indoor treadmill walking , and sedentary control situation ( approximately three hours each ) . Measures included the Feeling Scale , Felt Arousal Scale and a Mood Survey Scale . Repeated measures ANOVAs were used to analyse differences between the conditions . Results Compared to the control situation , the participants showed a significant increase in affective valence ( d = 1.21 , p .001 ) , activation ( d = 0.81 , p = .004 ) , elation ( d = 1.07 , p .001 ) , and calmness ( d = 0.84 , p = .004 ) , and a significant decrease in fatigue ( d = -1.19 , p anxiety ( d = -.79 , p on affective valence , activation , and fatigue compared to indoor treadmill walking . Discussion The results indicate that a three-hour PA intervention ( mountain hiking ) elicits higher positive and lower negative affective responses compared to a sedentary control situation and to an indoor PA condition . Outdoor mountain hiking can be recommended by health professionals as a form of PA with the potential to positively influence affective responses . Trial registration Clinical Trials.gov NCT02853760 . https:// clinical trials.gov/. Date of registration : 08/02/2016 ( retrospectively registered ) . Date of enrolment of the first participant to the trial : 05/01/2014",
"Physical activity has long been considered beneficial to health and regular exercise is purported to relieve stress . However empirical evidence demonstrating these effects is limited . In this study , we compared psychophysiological responses to an acute psychosocial stressor between individuals who did , or did not , report regular physical exercise . Healthy men and women ( N = 111 ) participated in two experimental sessions , one with the Trier Social Stress Test ( TSST ) and one with a non-stressful control task . We measured heart rate , blood pressure , cortisol , and self-reported mood before and at repeated times after the tasks . Individuals who reported physical exercise at least once per week exhibited lower heart rate at rest than non-exercisers , but the groups did not differ in their cardiovascular responses to the TSST . Level of habitual exercise did not influence self-reported mood before the tasks , but non-exercisers reported a greater decline in positive affect after the TSST in comparison to exercisers . These findings provide modest support for cl aims that regular exercise protects against the negative emotional consequences of stress , and suggest that exercise has beneficial effects in healthy individuals . These findings are limited by their correlational nature , and future prospect i ve controlled studies on the effects of regular exercise on response to acute stress are needed",
"Purpose . To examine the effects of walking and yoga on multidimensional self-esteem and roles played by self-efficacy , body composition , and physical activity ( PA ) in changes in esteem . Design . Four-month r and omized controlled exercise trial with three arms : walking , yoga , and control . Subjects . Previously low-active middle-aged women ( n = 164 ; M age = 49.9 ; SD = 3.6 ) . Intervention . Structured and supervised walking program meeting three times per week for 1 hour and supervised yoga program meeting twice per week for 90 minutes . Measures . Body composition , fitness assessment , and battery of psychologic measures . Analysis . Panel analysis within a structural equation modeling framework using Mplus 3.0 . Results . The walking and yoga interventions failed to enhance global or physical self-esteem but improved subdomain esteem relative to physical condition and strength ( for walking ) and body attractiveness ( for both walking and yoga ) . Over time the effects of PA , self-efficacy , and body fat on changes in physical self-esteem and global esteem were mediated by changes in physical condition and body attractiveness subdomain esteem . Women reporting greater levels of self-efficacy and PA with lower body fat also reported greater enhancements in subdomain esteem . Conclusion . These results provide support for the hierarchic and multidimensional nature of self-esteem and indicate that middle-aged women may enhance certain aspects of physical self-esteem by participating in PA",
"A r and omized controlled trial examined the growth and form of multidimensional self-esteem over a 12-month period ( 6-month exercise intervention and 6-month follow-up ) in 174 older adults engaged in either a walking or stretching/toning program . The extent to which changes in physical fitness parameters and physical self-efficacy were related to changes in perceptions of attractive body , strength , physical conditioning , and physical self-worth was also determined . Latent growth curve analyses showed a curvilinear pattern of growth in esteem with significant increases at all levels of self-esteem upon completion of the intervention followed by significant declines at 6 months poistintervention in both groups . Frequency of activity and changes in physical fitness , body fat , and self-efficacy were related to improvements in esteem perceptions relative to attractive body , strength , and physical condition . Model fitting procedures suggested that the best fit of the data was to a model in which the influence of changes in efficacy and physical parameters on physical self-worth were mediated by perceptions of attractive body and physical conditions",
"OBJECTIVES Yoga and exercise have beneficial effects on mood and anxiety . γ-Aminobutyric acid (GABA)-ergic activity is reduced in mood and anxiety disorders . The practice of yoga postures is associated with increased brain GABA levels . This study addresses the question of whether changes in mood , anxiety , and GABA levels are specific to yoga or related to physical activity . METHODS Healthy subjects with no significant medical/psychiatric disorders were r and omized to yoga or a metabolically matched walking intervention for 60 minutes 3 times a week for 12 weeks . Mood and anxiety scales were taken at weeks 0 , 4 , 8 , 12 , and before each magnetic resonance spectroscopy scan . Scan 1 was at baseline . Scan 2 , obtained after the 12-week intervention , was followed by a 60-minute yoga or walking intervention , which was immediately followed by Scan 3 . RESULTS The yoga subjects ( n = 19 ) reported greater improvement in mood and greater decreases in anxiety than the walking group ( n = 15 ) . There were positive correlations between improved mood and decreased anxiety and thalamic GABA levels . The yoga group had positive correlations between changes in mood scales and changes in GABA levels . CONCLUSIONS The 12-week yoga intervention was associated with greater improvements in mood and anxiety than a metabolically matched walking exercise . This is the first study to demonstrate that increased thalamic GABA levels are associated with improved mood and decreased anxiety . It is also the first time that a behavioral intervention ( i.e. , yoga postures ) has been associated with a positive correlation between acute increases in thalamic GABA levels and improvements in mood and anxiety scales . Given that pharmacologic agents that increase the activity of the GABA system are prescribed to improve mood and decrease anxiety , the reported correlations are in the expected direction . The possible role of GABA in mediating the beneficial effects of yoga on mood and anxiety warrants further study",
"Both physical activity and relaxation have stress-relieving potential . This study investigates their combined impact on the relaxation response while considering participants ' initial stress level . In a r and omized cross-over trial , 81 healthy adults completed 4 types of short-term interventions for stress reduction , each lasting for 1 hr : ( 1 ) physical activity ( walking ) combined with resting , ( 2 ) walking combined with balneotherapy , ( 3 ) combined resting and balneotherapy , and ( 4 ) resting only . Saliva cortisol , blood pressure , state of mood , and relaxation were measured preintervention and postintervention . Stress levels were determined by vali date d question naires . All interventions were associated with relaxation responses in the variables saliva cortisol , blood pressure , state of mood , and subjective relaxation . No significant differences were found regarding the reduction of salivary cortisol ( F = 1.30 ; p = .281 ) . The systolic blood pressure was reduced best when walking was combined with balneotherapy or resting ( F = 7.34 ; p high stress levels ( n = 25 ) felt more alert after interventions including balneotherapy , whereas they reported an increase of tiredness when walking was combined with resting ( F = 3.20 ; p = .044 ) . Results suggest that combining physical activity and relaxation ( resting or balneotherapy ) is an advantageous short-term strategy for stress reduction as systolic blood pressure is reduced best while similar levels of relaxation can be obtained",
"Introduction . Physical activity is important for health and well-being ; however , rates of postnatal physical activity can be low . This paper reports the secondary outcomes of a trial aim ed at increasing physical activity among postnatal women . Methods . More Active MuMs in Stirling ( MAMMiS ) was a r and omised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women . Data were collected on postnatal weight , body composition , general well-being , and fatigue . Participants were also interviewed regarding motivations and perceived benefits of participating in the trial . Results . There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up . There was a significant but inconsistent difference in fatigue between groups . Qualitative data highlighted a number of perceived benefits to weight , body composition , and particularly well-being ( including improved fatigue ) which were not borne out by objective data . Discussion . The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women",
"OBJECTIVES To evaluate the efficacy of a municipality-led walking program under the Japanese public Long-Term Care Insurance Act to prevent mental decline . DESIGN R and omized controlled trial . SETTING The city of Takasaki . PARTICIPANTS One hundred fifty community members aged 72.0 ± 4.0 were r and omly divided into intervention ( n = 75 ) and control ( n = 75 ) groups . INTERVENTION A walking program was conducted once a week for 90 minutes for 3 months . The program encouraged participants to walk on a regular basis and to increase their steps per day gradually . The intervention was conducted in small groups of approximately six , so combined benefits of exercise and social interaction were expected . MEASUREMENTS Cognitive function was evaluated focusing on nine tests in five domains : memory , executive function , word fluency , visuospatial abilities , and sustained attention . Quality of life ( QOL ) , depressive state , functional capacity , range of activities , and social network were assessed using question naires , and motor function was evaluated . RESULTS Significant differences between the intervention and control groups were shown in word fluency related to frontal lobe function ( F(1 , 128 ) = 6.833 , P = .01 ) , QOL ( F(1,128 ) = 9.751 , P = .002 ) , functional capacity including social interaction ( F(1,128 ) = 13.055 , P .001 ) , and motor function ( Timed Up and Go Test : F(1,127 ) = 10.117 , P = .002 ) . No significant differences were observed in other cognitive tests . CONCLUSION Walking programs may provide benefits in some aspects of cognition , QOL , and functional capacity including social interaction in elderly community members . This study could serve as the basis for implementation of a community-based intervention to prevent mental decline",
"This 12-month , 2 arm , single blind r and omized controlled exercise trial examined relationships among changes in multidimensional self-esteem as a function of intervention mode ( i.e. , walking vs. flexibility-toning-balance ) . Data were collected on three equidistant occasions ( baseline , 6 and 12 months ) . One-hundred seventy-nine older adults ( Mage = 66.38 ) began the study and 145 completed assessment s at all time points . Participants completed measures of physical and global self-esteem as well as demographic information . There were no significant group differences at baseline on these demographic indicators or esteem variables . Data were analyzed using linear and parallel process growth modeling procedures . Results supported the position that across both groups , domain-level ( i.e. , physical self-worth ) was dependent upon sub-domain-level ( i.e. , perceived attractiveness , strength , and condition ) esteem change . Furthermore , greater improvements were observed in the flexibility-toning-balance group , in terms of perceived strength and attractiveness esteem , compared to the walking group . Our findings support theoretically-based predictions and extend the literature showing unique psychological responses conditional on specific types of physical activities",
"Background . Physical activity can positively influence health for older adults . Primary care is a good setting for physical activity promotion . Objective . To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations . Methods . Design : Two-arm ( intervention/control ) 12-week r and omized controlled trial with a 12-week follow-up for the intervention group . Setting : One general practice in Glasgow , UK . Participants : Participants were aged ≥65 years . The intervention group received two 30-minute physical activity consultations from a trained practice nurse , a pedometer and a walking programme . The control group continued as normal for 12 weeks and then received the intervention . Both groups were followed up at 12 and 24 weeks . Outcome measures : Step counts were measured by sealed pedometers and an activPALTM monitor . Psychosocial variables were assessed and focus groups conducted . Results . The response rate was 66 % ( 187/284 ) , and 90 % of those r and omized ( 37/41 ) completed the study . Qualitative data suggested that the pedometer and nurse were helpful to the intervention . Step counts ( activPAL ) showed a significant increase from baseline to week 12 for the intervention group , while the control group showed no change . Between weeks 12 and 24 , step counts were maintained in the intervention group , and increased for the control group after receiving the intervention . The intervention was associated with improved quality of life and reduced sedentary time . Conclusions . It is feasible to recruit and retain older adults from primary care and help them increase walking . A larger trial is necessary to confirm findings and consider cost-effectiveness",
"A group r and omized trial of adding a home-based walking program to a st and ard group cognitive behavioral therapy ( GCBT+EX ) was compared with groups receiving GCBT and educational sessions ( GCBT+ED ) . The study was implemented in an outpatient clinic providing GCBT for clients diagnosed with panic disorder , generalized anxiety disorder or social phobia . Pre- and post-treatment measures included the self-report depression , anxiety , and stress scale ( DASS-21 ) and measures of physical activity . From January 2004 to May 2005 , six groups were allocated to GCBT+EX ( n=38 ) and five to GCBT+ED ( n=36 ) . Analysis of covariance for completed cases ( GCBT+EX , n=21 ; GCBT+ED , n=20 ) , adjusting for the group design , baseline DASS-21 scores , and anxiety diagnosis showed significant effect for GCBT+EX on depression , anxiety , and stress ( regression coefficients=-6.21 , -3.41 , and -5.14 , respectively , p GCBT+ED . The potential of exercise interventions as adjunct to GCBT for anxiety disorder needs to be further explored",
"Background Although physical activity is associated with health-related quality of life ( HRQL ) , the nature of the dose – response relationship remains unclear . Objectives To examine the concurrent and prospect i ve dose – response relationships between total physical activity ( TPA ) and ( only ) walking with HRQL in two age cohorts of women . Methods Participants were 10 698 women born in 1946–1951 and 7646 born in 1921–1926 , who completed three mailed surveys for the Australian Longitudinal Study on Women 's Health . They reported weekly TPA minutes ( sum of walking , moderate and vigorous minutes ) . HRQL was measured with the Medical Outcomes Study Short-Form 36 Health Status Survey ( SF-36 ) . Linear mixed models , adjusted for socio-demographic and health-related variables , were used to examine associations between TPA level ( none , very low , low , intermediate , sufficient , high and very high ) and SF-36 scores . For women who reported walking as their only physical activity , associations between walking and SF-36 scores were also examined . Results Curvilinear trends were observed between TPA and walking with SF-36 scores . Concurrently , HRQL scores increased significantly with increasing TPA and walking , in both cohorts , with increases less marked above sufficient activity levels . Prospect ively , associations were attenuated although significant and meaningful improvements in physical functioning and vitality were observed across most TPA and walking categories above the low category . Conclusion For women in their 50s–80s without clinical depression , greater amounts of TPA are associated with better current and future HRQL , particularly physical functioning and vitality . Even if walking is their only activity , women , particularly those in their 70s–80s , have better HRQL",
"OBJECTIVES To determine the effect of walking on incident depressive symptoms in elderly Japanese-American men with and without chronic disease . DESIGN Prospect i ve cohort study . SETTING The Honolulu-Asia Aging Study . PARTICIPANTS Japanese-American men aged 71 to 93 at baseline . MEASUREMENTS Physical activity was assessed according to self-reported distance walked per day . Depressive symptoms were measured using an 11- question version of the Centers for Epidemiologic Studies Depression Scale ( CES-D 11 ) at the fourth examination ( n=3,196 ) and at the seventh examination 8 years later ( 1999/00 , n=1,417 ) . Presence of incident depressive symptoms was defined as a CES-D 11 score of 9 or greater or taking antidepressants at Examination 7 . Subjects with prevalent depressive symptoms at baseline were excluded . RESULTS Age-adjusted 8-year incident depressive symptoms were 13.6 % , 7.6 % , and 8.5 % for low ( 1.5 miles/day ) walking groups at baseline ( P=0.008 ) . Multiple logistic regression analyses , adjusted for age , education , marital status , cardiovascular risk factors , prevalent diseases , and functional impairment , showed that those in the intermediate and highest walking groups had significantly lower odds of developing 8-year incident depressive symptoms ( odds ratio (OR)=0.52 , 95 % confidence interval (CI)=0.32 - 0.83 , P=.006 and OR=0.61 , 95 % CI= 0.39 - 0.97 , P=.04 , respectively ) . Analysis found that this association was significant only in participants without chronic diseases ( coronary heart disease , cerebrovascular accident , cancer , Parkinson 's disease , dementia , or cognitive impairment ) at baseline . CONCLUSION Daily physical activity ( ≥0.25 mile/day ) is significantly associated with lower risk of 8-year incident depressive symptoms in elderly Japanese-American men without chronic disease at baseline",
"Although physical activity ( PA ) has been inversely associated with depressive symptoms , it is not clear whether regular PA and television watching are associated with clinical depression risk . The authors conducted a prospect i ve analysis involving 49,821 US women from the Nurses ' Health Study who were free from depressive symptoms at baseline ( 1996 ) . Information on PA was obtained from vali date d question naires completed in 1992 , 1994 , 1996 , 1998 , and 2000 ; analyses were conducted using the cumulative average of PA ( minutes/day ) with a 2-year latency period applied . Participants were asked about television-watching habits in 1992 . Cox proportional hazards regression models adjusted for multiple risk factors were used to estimate relative risks of clinical depression ( self-reported physician-diagnosed depression or use of antidepressants ) . During 10 years of follow-up ( 1996 - 2006 ) , 6,505 incident cases of depression were documented . Higher levels of PA were associated with lower depression risk . The multivariate relative risk comparing the highest level of PA ( ≥ 90 minutes/day ) with the lowest ( contrast , the risk of depression increased with increasing television-watching time . The multivariate relative risk comparing women who spent 21 hours/week or more watching television with those who spent 0 - 1 hour/week was 1.13 ( 95 % confidence interval : 1.00 , 1.27 ; P(trend ) = 0.01 ) . Analyses simultaneously considering PA and television watching suggested that both contributed independently to depression risk ",
"Abstract Objectives : To establish the effect of an educational intervention for general practitioners on the health behaviours and wellbeing of elderly patients . Design : R and omised controlled trial with 1 year follow up . Setting : Metropolitan general practice s in Melbourne , Australia . Subjects : 42 general practitioners and 267 of their patients aged over 65 years . Intervention : Educational and clinical practice audit programme for general practitioners on health promotion for elderly people . Main outcome measures : Patients ' physical activity , functional status , self rated health , immunisation status , social contacts , psychological wellbeing , drug usage , and rate of influenza vaccination . Primary efficacy variables were changes in outcome measures over 1 year period . Results : Patients in the intervention group had increased ( a ) walking by an average of 88 minutes per fortnight , ( b ) frequency of pleasurable activities , and ( c ) self rated health compared with the control group . No change was seen in drug usage , rate of influenza vaccination , functional status , or psychological wellbeing as a result of the intervention . Extrapolations of the known effect of these changes in behaviour suggest mortality could be reduced by 22 % if activity was sustained for 5 years . Conclusions : Education of the general practitioners had a positive effect on health outcomes of their elderly patients . General practitioners may have considerable public health impact in promotion of health for elderly patients . Key messages Few educational interventions for doctors have shown benefit to the health of patients Elderly people were identified in the UK health initiatives as in need of additional attention , and levels of health protective behaviours were low in community surveys A multifaceted educational intervention for general practitioners was effective in improving walking behaviour , self rated health status , and the frequency of social contacts in elderly patients General practitioners are effective in improving health and health behaviours in their elderly",
"PURPOSE To compare the effects of different patterns of regular brisk walking on fitness , risk factors for cardiovascular disease , and psychological well-being in previously sedentary adults . METHODS Twenty-one subjects ( 14 women ) , aged 44.5 + /- 6.1 yr ( mean + /- SD ) were r and omly assigned to two different , 6-wk programs of brisk walking in a cross-over design , with an interval of 2 wk . One program comprised one 30-min walk per day , 5 d.wk(-1 ) ( long bout ) and the other three 10-min walks per day , also 5 d.wk(-1 ) ( short bouts ) . All walking was at 70 - 80 % of predicted maximal heart rate . Maximal oxygen uptake ( (.)VO(2max ) ) , body composition , resting arterial blood pressure , fasting plasma lipoprotein variables , and psychological parameters were assessed before and after each program . RESULTS Overall , subjects completed 88.2 + /- 1.1 % and 91.3 + /- 4.1 % of prescribed total walking time in the short- and long-bout programs , respectively . Both programs increased plasma concentrations of high-density lipoprotein cholesterol , and decreased concentrations of triacylglycerol and total cholesterol ( all body mass , but the sum of four skinfolds , waist circumference , and hip circumference were decreased after both walking programs ( all P Predicted (.)VO(2max ) increased with both programs ( P tension/anxiety ( P brisk walking accumulated throughout the day are at least as effective as one continuous bout of equal total duration in reducing cardiovascular risk and improving aspects of mood in previously sedentary individuals",
"PURPOSE To determine whether individuals participating in a program design ed to accumulate 10,000 steps/ day demonstrate health , fitness and psychological benefits . METHODS Sedentary individuals ( 22 F , 7 M ; age 59.8 + /- 5.78 yr ) were r and omly assigned into a walking ( W , n = 14 ) or control ( C , n = 15 ) group . Following baseline assessment , the W group was given a daily plan to reach 10,000 steps/day within 3 weeks and asked to maintain this level for 12 weeks ; the C group was asked to maintain their current activity . Participants were evaluated for cardiovascular endurance , resting and postexercise HR , functional ability , cholesterol , psychological well-being , and exercise self-efficacy before and following the 15-week program . RESULTS Significant changes over time were noted between groups ( G x T ; P postexercise HR ( -6.51 % ) , total cholesterol ( TC : -7.74 % ) , and personal growth ( 2.53 % ) . While not statistically significant , the W group also demonstrated improvements in 6 min walk distance ( 2.32 % ) , total/HDL ratio ( -10.09 % ) , 8 foot up- and -go time ( -3.35 % ) , chair st and s ( 6.17 % ) , flexibility ( 128 % ) , and environmental mastery ( 4.54 % ) . CONCLUSION A 15-week program aim ed at accumulating 10,000 steps/day improves cardiovascular performance and personal growth and also positively influences many variables that are indicators of health , fitness and psychological well-being",
"OBJECTIVES to assess longitudinal relationships between habitual levels of physical activity and indices of psychological wellbeing in older people . DESIGN baseline assessment with 4- and 8-year follow-ups . SUBJECTS 1042 people originally aged 65 and over r and omly sample d from general practitioner lists in Nottingham , UK . METHODS logistic regression analysis of selected T1 ( 1985 ) and T2 ( 1989 ) variables , with depression at T2 as dependent ; multiple regression analyses of selected T1 , T2 and T3 ( 1993 ) variables , with life satisfaction at T2 ( model 1 ) or T3 ( model 2 ) as dependent . MAIN OUTCOME MEASURES question naire-assessed levels of physical activity ; 14-item Symptoms of Anxiety and Depression scale ; 13-item Life Satisfaction Index ; health , demographic and social activity variables . RESULTS in the logistic regression model , depression at T2 was most strongly associated with depression [ odds ratio ( OR ) = 7.13 ; 95 % confidence interval ( CI ) = 3.25 - 15.64 ; P lower physical health status ( OR = 1.26 per unit change in score ; 95 % CI = 1.17 - 1.42 ; P outdoor/leisure activities at T1 were also associated with some increased risk of depression 4 years later ( OR = 0.92 per hour of activity ; 95 % CI = 0.85 - 0.99 ; P of life satisfaction , social engagement and health accounted for most of the explained variance in life satisfaction ( R2 = 0.42 for model 1 ; R2 = 0.35 for model 2 ) . Again , however , earlier levels of physical activity ( as walking and housework ) did contribute significantly , although modestly , to longitudinal changes in morale . CONCLUSIONS while the results provide some support for the conclusion that physical activity contributes independently to the promotion and maintenance of psychological wellbeing in later life , this contribution is , at best , extremely modest",
"Few controlled studies describe the psychological effects of a walking program on non clinical , premenopausal women . This experiment measured the effects of an 8–wk . walking program on female volunteers ( N = 27 ) age 29 to 50 years ( M = 37.4 ) r and omly assigned to a supervised walking group vs a nonwalking group . A repeated- measures , multivariate design was used to analyze blood pressure , resting heart rate , timed mile walk , and scores on self-esteem , depression , and attributional style . The walking group showed significant improvement in the timed mile walk , diastolic blood pressure , and rated self-esteem",
"BACKGROUND A r and omized controlled trial was conducted to examine : ( a ) the effect of two physical activity modes on changes in subjective well-being ( SWB ) over the course of a 12-month period in older , formerly sedentary adults ( N = 174 , M age = 65.5 years ) and ( b ) the role played by physical activity participation and social support in changes in SWB over time . METHOD Participants were r and omized into either an aerobic activity group or a stretching and toning group . Structural equation modeling was employed to conduct multiple sample latent growth curve analyses of individual growth in measures of SWB ( happiness , satisfaction with life , and loneliness ) over time . RESULTS A curvilinear growth pattern was revealed with well-being significantly improving over the course of the intervention followed by significant declines at the 6-month follow-up . Subsequent structural analyses were conducted showing that frequency of exercise participation was a significant predictor of improvement in satisfaction with life , whereas social relations were related to increases in satisfaction with life and reductions in loneliness . Improvements in social relations and exercise frequency also helped to buffer the declines in satisfaction with life at follow-up . CONCLUSIONS It appears that social relations integral to the exercise environment are significant determinants of subjective well-being in older adults . Findings are discussed in terms of how physical activity environments might be structured to maximize improvements in more global well-being constructs such as satisfaction with life",
"Recent physical activity recommendations call for activities that are of moderate intensity and can be performed intermittently during the day , such as walking . These proclamations were based partly on the assumption that moderate activities are generally more enjoyable than physically dem and ing ones , and they are , therefore , also more likely to be continued over the long haul . However , little is actually known about the affective outcomes of short bouts of walking and extant findings are equivocal . Four experimental studies examined the affective responses associated with short ( 10- to 15-min ) bouts of walking using a dimensional conceptual model of affect , namely , the circumplex . Results consistently showed that walking was associated with shifts toward increased activation and more positive affective valence . Recovery from walking for 10–15 min was associated with a return toward calmness and relaxation . This pattern was robust across different self-report measures of the circumplex affective dimensions , across ecological setting s ( field and laboratory ) , across time , and across sample",
"BACKGROUND The current physical activity ( PA ) and health-related quality of life ( HRQoL ) literature warrants further investigation with general population sample s. The exploratory-focused purpose of this study was to compare total PA-HRQoL and walking-HRQoL relations , include a measure of general happiness , and to evaluate potential activity-HRQoL demographic moderators . METHODS A r and om sample of 351 adults completed an adapted Godin Leisure Time Question naire , the SF-36 , and the Satisfaction with Life Scale . RESULTS Partial correlations revealed small-to-moderate associations between walking/total PA and general health , vitality , and social functioning after controlling for key demographics ( P walking and PA as equally related to vitality and social functioning . Multiple regression revealed annual income as a moderator of the total PA/walking-social functioning relationship [ F(3,315 ) = 9.71 and F(3,316 ) = 12.03 , P HRQoL may be considered with walking interventions and annual income . The contribution of PA to overall happiness appears to be minor",
"The relationship between moderate exercise training ( five 45 min sessions/week , brisk walking at 62 beta + /- 2 % VO2max for 15 weeks , psychological well-being and mood state was investigated in a group of 35 sedentary , mildly obese women . A 2 ( exercise ( EX ) ( N = 18 ) , and nonexercise ( NEX ) ( N = 17 ) groups ) x 3 ( baseline , 6-week , 15-week testing sessions ) factorial design was used with data analyzed using repeated measures ANOVA . Four psychological tests were administered : Daily Hassles Scale ( DHS ) , General Well-being Schedule ( GWB ) , Spielberger State Anxiety Inventory ( S-Anxiety ) , and Profile of Mood States ( POMS ) . The EX and NEX groups had significantly different patterns of change over time for GWB total scores [ F(2,66 ) = 5.72 , p = 0.005 ] and the GWB subscales ' energy level ' and ' freedom from health concern or worry ' . Scores for the EX group were elevated at both 6 and 15 weeks . General well-being total scores and subscale ' energy level ' scores were significantly correlated with improvement in submaximal cardiorespiratory fitness ( r = -0.41 , p = 0.014 ; r = -0.40 , p = 0.017 , respectively ) . Exercise training also had a significant effect on frequency but not intensity of DHS scores , and S-Anxiety , with a significant decrease seen in the EX group at 6 weeks but not 15 weeks . Profile of Mood States scores were not significantly related to exercise training . These data support the results of other studies that have reported improvement in general psychological well-being with exercise training",
"ISSUE ADDRESSED Women with children under five are the least physically active population group . We provided postpartum women living in western Sydney with the opportunity to participate in weekly pram walking groups and evaluated the effect of the intervention on self-reported physical activity , mental health and social indicators . METHODS Mothers living in the intervention area ( Blacktown LGA ) and control area ( Holroyd and Parramatta LGAs ) completed a baseline question naire . Women in the intervention community were invited to participate in a pram walking group starting in the next month . The control group ( n = 60 ) were also invited to participate in a pram walking group starting six months later . A follow-up question naire was completed by all mothers . RESULTS There was no significant increase in the proportion of mothers in the intervention or control groups engaging in adequate physical activity from baseline to follow-up . However , intervention mothers increased their sessions of vigorous exercise and control mothers increased the amount of time spent walking . There were no significant differences at baseline or follow-up between the intervention and control groups in frequency of social contact or size of social networks . Nor was there a significant difference in satisfaction with social contact at baseline between the two groups . However , at follow-up women in the intervention group were more satisfied with the quality of their social contacts than the controls . CONCLUSIONS Providing organised , community-based pram walking was not sufficient to increase overall physical activity levels among this group of postpartum women . The results suggest that the friendships formed in the pram walking group boosted mothers ' satisfaction with social contact and possibly their mental health",
"ABSTRACT Objectives : To assess the effects of a 12-week pedometer-based intervention on the physical activity behavior , health-related quality of life ( HRQOL ) , and psychological well-being of first-year university students . Participants : First-year university students ( N = 184 ) were recruited during September 2012 and r and omly assigned to an intervention or a control group . Methods : Intervention participants were provided with a pedometer , monthly tracking logs , and follow-up e-mails . Control participants received no intervention . Physical activity , HRQOL , and psychological well-being were measured at baseline and post intervention . Data were analyzed using multivariate/univariate analysis of variance ( MANOVA/ANOVA ) . Results : All participants experienced an increase in mild physical activity ( p for physical activity ( p = .28 ) , HRQOL ( p = .80 ) , or psychological well-being ( p = .72 ) . Psychological well-being ( p ) , vigorous physical activity ( p = .04 ) , and mental health status ( p physical activity behavior change",
"Psychological changes associated with 16-wk moderate and low intensity exercise training programs , two of which possessed a cognitive component , were evaluated . Subjects were healthy , sedentary adults , 69 women ( mean age = 54.8 + /- 8.3 yr ) and 66 men ( mean age = 50.6 + /- 8.0 yr ) . Participants were r and omly assigned to a control group ( C ) , moderate intensity walking group ( MW ) , low intensity walking group ( LW ) , low intensity walking plus relaxation response group ( LWR ) , or mindful exercise ( ME ) group-a Tai Chi type program . Women in the ME group experienced reductions in mood disturbance ( tension , P depression , P anger , P confusion , P total mood disturbance , P general mood ( P satisfaction with physical attributes ( body cathexis , P positive affect ( P mood , self-esteem , personality , or life satisfaction . Equivocal support is provided for the hypothesis that exercise plus cognitive strategy training programs are more effective than exercise programs lacking a structured cognitive component in promoting psychological benefits",
"Objective Insomnia , anxiety , and depression are some psychological symptoms associated with menopause . The aim of this study was to evaluate the effect of pedometer-based walking on anxiety , insomnia , and depression among postmenopausal women . Methods In this r and omized , controlled trial , 106 postmenopausal women were r and omly assigned to two groups ( n = 53 in each group ) . Their anxiety , insomnia , and depression levels were assessed using the GHQ-28 and Beck question naires in the 4th , 8th , and 12th weeks of intervention . The depression level was assessed in the beginning , and in the 12th week of the trial . The members of the intervention group each received a pedometer and were asked to increase their steps by 500 per week . Data were analyzed using the independent t-test , χ2 and repeated- measures tests . Results The levels of anxiety and insomnia decreased in the 8th ( 4.2 ± 2.1 vs. 5.4 ± 2.3 , p = 0.007 ) and 12th week ( 4.3 ± 2.8 vs. 7.2 ± 2.6 , p . The depression intensity decreased in the intervention group , compared with the control group , after 12 weeks ( 13.7 ± 5 vs. 19.6 ± 4.79 , p their step count from 76 377 steps per month in the first month , to 106 398 in the 3rd month ( p showed that pedometer-based walking had a positive effect on depression , insomnia and anxiety among postmenopausal women . A walking training program can be considered for postmenopausal women in Iran",
"Background / objectives Walking pace is associated with risk of premature mortality . However , whether this relationship is independent of total volume of physical activity and highest physical activity intensity remains unclear . We examined the associations between walking pace and cause-specific mortality , investigating the potential modifying effect of factors such as total physical activity volume , highest physical activity intensity , age , sex and body mass index ( BMI ) . Methods Prospect i ve pooled analysis of 11 population -based baseline surveys in Engl and and Scotl and between 1994 and 2008 that were linked with mortality records . Multivariate-adjusted Cox proportional hazards models examined associations between walking pace ( slow , average , brisk/fast ) and all-cause , cancer and cardiovascular disease ( CVD ) mortality . Results 50 225 walkers were entered in the core analyses . Among participants who did not experience an event in the first 2 years of follow-up ( n=49 731 ) , walking at an average or brisk/fast pace was associated with a reduced risk of all-cause ( 20 % ( 95 % CI 12 % to 28 % ) and 24 % ( 95 % CI 13 % to 33 % ) , respectively ) and CVD mortality ( 24 % ( 95 % CI 9 % to 36 % ) and 21 % ( 95 % CI 1 % to 38 % ) , respectively ) , compared with reporting walking at a slow pace . In stratified analyses , such associations were evident among those over 50 years , those not meeting the physical activity recommendations and those who did not undertake vigorous-intensity activity . There were no interactions by sex or BMI . No associations were seen between pace and cancer mortality . Conclusion Walking benefits health . Assuming causality , these analyses suggest that increasing walking pace could reduce risk for all-cause and CVD mortality . Walking pace could be emphasised in public health messages , especially in situations when increase in walking volume or frequency is less feasible"
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411644b2-06ff-11f0-808a-c43d1ab1c353
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Background Elective surgeries can be associated with significant harm to older adults . The present study aim ed to identify the prognostic factors associated with the development of postoperative complications among older adults undergoing elective surgery . Methods Medline , EMBASE , CINAHL , Cochrane Central Register of Controlled Trials , and AgeLine were search ed for articles published between inception and April 21 , 2016 . Prospect i ve studies reporting prognostic factors associated with postoperative complications ( composite outcome of medical and surgical complications ) , functional decline , mortality , post-hospitalization discharge destination , and prolonged hospitalization among older adults undergoing elective surgery were included . Study characteristics and prognostic factors associated with the outcomes of interest were extracted independently by two review ers . R and om effects meta- analysis models were used to derive pooled effect estimates for prognostic factors and incidences of adverse outcomes . Results Of the 5692 titles and abstract s that were screened for inclusion , 44 studies ( 12,281 patients ) reported on the following adverse postoperative outcomes : postoperative complications ( n = 28 ) , postoperative mortality ( n = 11 ) , length of hospitalization ( n = 21 ) , functional decline ( n = 6 ) , and destination at discharge from hospital ( n = 13 ) . The pooled incidence of postoperative complications was 25.17 % ( 95 % confidence interval ( CI ) 18.03–33.98 % , number needed to follow = 4 ) . The geriatric syndromes of frailty ( odds ratio ( OR ) 2.16 , 95 % CI 1.29–3.62 ) and cognitive impairment ( OR 2.01 , 95 % CI 1.44–2.81 ) were associated with developing postoperative complications ; however , there was no association with traditionally assessed prognostic factors such as age ( OR 1.07 , 95 % CI 1.00–1.14 ) or American Society of Anesthesiologists status ( OR 2.62 , 95 % CI 0.78–8.79 ) . Besides frailty , other potentially modifiable prognostic factors , including depressive symptoms ( OR 1.77 , 95 % CI 1.22–2.56 ) and smoking ( OR 2.43 , 95 % CI 1.32–4.46 ) , were also associated with developing postoperative complications . Conclusion Geriatric syndromes are important prognostic factors for postoperative complications . We identified potentially modifiable prognostic factors ( e.g. , frailty , depressive symptoms , and smoking ) associated with developing postoperative complications that can be targeted preoperatively to optimize care
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"Background and objectives : Postoperative confusion and delirium is a common complication in the elderly with a poorly understood pathophysiology . The aim of this study was to examine whether the type of anaesthesia ( general or regional ) plays a role in the development of cognitive impairment in elderly patients during the immediate postoperative period . Methods : Forty‐seven patients > 60 yr of age and undergoing major surgery were r and omly allocated to receive either regional or general anaesthesia . The mental status of the patients was assessed preoperatively and during the first three postoperative days with the Mini Mental State Examination . The incidence of delirium was also examined during the same period with the use of DSM III criteria . Results : Overall , during the first three postoperative days , the mean Mini Mental State Examination score decreased significantly ( P general anaesthesia ( P anaesthesia . Nine patients developed delirium but the type of anaesthesia did not affect its incidence . The only important factor for the development of delirium was pre‐existing cardiovascular disease irrespective of anaesthesia type ( P Elderly patients subjected to general anaesthesia displayed more frequent cognitive impairment during the immediate postoperative period in comparison to those who received a regional technique",
"Background : There is no single generally accepted clinical definition of frailty . Previously developed tools to assess frailty that have been shown to be predictive of death or need for entry into an institutional facility have not gained acceptance among practising clinicians . We aim ed to develop a tool that would be both predictive and easy to use . Methods : We developed the 7-point Clinical Frailty Scale and applied it and other established tools that measure frailty to 2305 elderly patients who participated in the second stage of the Canadian Study of Health and Aging ( CSHA ) . We followed this cohort prospect ively ; after 5 years , we determined the ability of the Clinical Frailty Scale to predict death or need for institutional care , and correlated the results with those obtained from other established tools . Results : The CSHA Clinical Frailty Scale was highly correlated ( r = 0.80 ) with the Frailty Index . Each 1-category increment of our scale significantly increased the medium-term risks of death ( 21.2 % within about 70 mo , 95 % confidence interval [ CI ] 12.5%–30.6 % ) and entry into an institution ( 23.9 % , 95 % CI 8.8%–41.2 % ) in multivariable models that adjusted for age , sex and education . Analyses of receiver operating characteristic curves showed that our Clinical Frailty Scale performed better than measures of cognition , function or comorbidity in assessing risk for death ( area under the curve 0.77 for 18-month and 0.70 for 70-month mortality ) . Interpretation : Frailty is a valid and clinical ly important construct that is recognizable by physicians . Clinical judgments about frailty can yield useful predictive information",
"BACKGROUND Preoperative risk assessment is important yet inexact in older patients because physiologic reserves are difficult to measure . Frailty is thought to estimate physiologic reserves , although its use has not been evaluated in surgical patients . We design ed a study to determine if frailty predicts surgical complications and enhances current perioperative risk models . STUDY DESIGN We prospect ively measured frailty in 594 patients ( age 65 years or older ) presenting to a university hospital for elective surgery between July 2005 and July 2006 . Frailty was classified using a vali date d scale ( 0 to 5 ) that included weakness , weight loss , exhaustion , low physical activity , and slowed walking speed . Patients scoring 4 to 5 were classified as frail , 2 to 3 were intermediately frail , and 0 to 1 were nonfrail . Main outcomes measures were 30-day surgical complications , length of stay , and discharge disposition . Multiple logistic regression ( complications and discharge ) and negative binomial regression ( length of stay ) were done to analyze frailty and postoperative outcomes associations . RESULTS Preoperative frailty was associated with an increased risk for postoperative complications ( intermediately frail : odds ratio [ OR ] 2.06 ; 95 % CI 1.18 - 3.60 ; frail : OR 2.54 ; 95 % CI 1.12 - 5.77 ) , length of stay ( intermediately frail : incidence rate ratio 1.49 ; 95 % CI 1.24 - 1.80 ; frail : incidence rate ratio 1.69 ; 95 % CI 1.28 - 2.23 ) , and discharge to a skilled or assisted-living facility after previously living at home ( intermediately frail : OR 3.16 ; 95 % CI 1.0 - 9.99 ; frail : OR 20.48 ; 95 % CI 5.54 - 75.68 ) . Frailty improved predictive power ( p risk index ( ie , American Society of Anesthesiologists , Lee , and Eagle scores ) . CONCLUSIONS Frailty independently predicts postoperative complications , length of stay , and discharge to a skilled or assisted-living facility in older surgical patients and enhances conventional risk models . Assessing frailty using a st and ardized definition can help patients and physicians make more informed decisions",
"BACKGROUND Elders undergo approximately 40 % of more than 1 million major abdominal operations annually . Yet evidence about recovery to preoperative levels of functional independence is limited . This study details course and predictors of functional recovery after elective major abdominal operations in the elderly . STUDY DESIGN This was a prospect i ve cohort of 372 consecutive patients , 60 years old or more , enrolled from surgeons in private practice and two university-affiliated hospitals , assessed preoperatively and postoperatively at 1 , 3 , and 6 weeks , 3 and 6 months , using self-report and performance-based measures ( Activities of Daily Living [ ADL ] , Instrumental Activities of Daily Living [ IADL ] , Medical Outcomes Study Short Form-36 Physical Component and Mental Component Scales [ PCS , MCS ] , Geriatric Depression Scale [ GDS ] , Folstein Mini-Mental State Exam [ MMSE ] , timed walk , functional reach , h and grip strength ) . RESULTS Mean age was 69 + /- 6 years with 56 % men , 47 % nonHispanic Caucasian , and 42 % Mexican American ; hospital distribution was 49 % private , 51 % university-affiliated . Maximum functional declines ( 95 % CI ) occurred 1 week postoperatively : ADL , 2.8 points ( 2.4 to 3.2 ) ; IADL , 7.6 points ( 7 to 8.3 ) ; SF-36 PCS , 6.5 points ( 5.4 to 7.6 ) ; Mini-Mental State Exam , 0.5 points ( 0.2 to 0.7 ) ; timed walk , 6.8 seconds ( 5.2 to 8.4 ) ; functional reach , 1.7 inches ( 1.2 to 2.2 ) ; grip strength , 2 kilograms ( 1.3 to 2.7 ) ( p SF-36 mental component scale and Geriatric Depression Scale scores did not worsen . Mean recovery times were : Mini-Mental State Exam , 3 weeks ; timed walk , 6 weeks ; ADL , SF-36 PCS , and functional reach , 3 months ; and IADL , 6 months . Mean grip strength did not return to preoperative status by 6 months . The incidence of persistent disability at 6 months , compared with preoperative status , was : ADL , 9 % ; IADL , 19 % ; PCS , 16 % ; mental component scale , 17 % ; timed walk , 39 % ; functional reach , 58 % ; and grip strength , 52 % . Potentially modifiable independent predictors of ADL and IADL recovery were preoperative physical conditioning and depression plus serious postoperative complications . CONCLUSIONS The clinical course of functional recovery varied across different measures . Protracted disability at 6 months after operation was substantial . Several potentially modifiable factors consistently predicted recovery",
"Objective To determine the predictive value of the “ Timed Up & Go ” ( TUG ) , a vali date d assessment tool , on a prospect i ve cohort study and to compare these findings to the ASA classification , an instrument commonly used for quantifying patients ’ physical status and anesthetic risk . Background In the onco-geriatric surgical population it is important to identify patients at increased risk of adverse post-operative outcome to minimize the risk of over- and under-treatment and improve outcome in this population . Methods 263 patients ≥70 years undergoing elective surgery for solid tumors were prospect ively recruited . Primary endpoint was 30-day morbidity . Pre-operatively TUG was administered and ASA-classification was registered . Data were analyzed using multivariable logistic regression analyses to estimate odds ratios ( OR ) and 95 % confidence intervals ( 95%-CI ) . Absolute risks and area under the receiver operating characteristic curves ( AUC ’s ) were calculated . Results 164 ( 62.4 % ) patients ( median age : 76 ) underwent major surgery . 50 ( 19.5 % ) patients experienced major complications . 50.0 % of patients with high TUG and 24.8 % of patients with ASA≥3 experienced major complications ( absolute risks ) . TUG and ASA were independent predictors of the occurrence of major complications ( TUG : OR 3.43 ; 95%-CI = 1.13–10.36 . ASA1 vs. 2:OR 5.67 ; 95%-CI = 0.86–37.32 . ASA1 vs. 3&4:OR 11.75 ; 95%-CI = 1.62–85.11 ) . AUCTUG was 0.66 ( 95%-CI = 0.57–0.75 , p ) and AUCASA was 0.58 ( 95%-CI = 0.49–0.67 , p = 0.09 ) . Conclusions Twice as many onco-geriatric patients at risk of post-operative complications , who might benefit from pre-operative interventions , are identified using TUG than when using ASA",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"This prospect i ve cohort study sought to identify predictors of functional decline in patients aged 65 years or older who underwent major , nonemergent abdominal or thoracic surgery in our tertiary hospital from 2006 to 2008 . We used the Stanford Health Assessment Question naire – Disability Index ( HAQ-DI ) to evaluate functional decline ; a 0.1 or greater increase was used to indicate a clinical ly significant decline . The preoperative Duke Activity Status Index ( DASI ) and a physical function score ( PFS ) , assessing gait speed , grip strength , balance , and st and ing speed , were evaluated as predictors of decline . We enrolled 215 patients ( 71.2 ± 5.2 years ; 56.7 % female ) ; 204 completed follow-up HAQ assessment s ( 71.1 ± 5.3 years ; 57.8 % female ) . A significant number of patients had functional decline out to 1 year . Postoperative HAQ-DI increases of 0.1 or greater occurred in 45.3 per cent at 1 month , 30.1 per cent at 3 months , and 28.3 per cent at 1 year . Pre-operative DASI and PFS scores were not predictors of functional decline . Male sex at 1 month ( odds ratio [ OR ] , 3.05 ; 95 % confidence interval [ CI ] , 1.41 to 6.85 ) ; American Society of Anesthesiologists class ( OR , 3.41 ; 95 % CI , 1.31 to 8.86 ) , smoking ( OR , 3.15 ; 95 % CI , 1.27 to 7.85 ) , and length of stay ( OR , 1.09 ; 95 % CI , 1.01 to 1.16 ) at 3 months ; and cancer diagnosis at 1 year ( OR , 2.6 ; 95 % CI , 1.14 to 5.96 ) were associated with functional decline",
"OBJECTIVES Delirium is a common complication in elderly patients after cardiac surgery and is associated with adverse outcomes including prolonged hospital stay and increased mortality . Therefore , prevention or early detection of delirium is indicated . Our objective was to identify preoperative and operative characteristics that could predict delirium after cardiac surgery in elderly patients . METHODS We conducted a prospect i ve cohort study in which we analysed 201 patients of 70 years and older who underwent cardiac surgery , for developing a delirium . Patients were assessed daily using the Confusion Assessment Method -Intensive Care Unit . RESULTS Sixty-three patients ( 31 % ) developed a delirium after cardiac surgery . The Mini-Mental State Examination ( MMSE ) score prior to surgery was lower in the delirious patients when compared with the non-delirious patients ( 27 vs. 28 , P = 0.026 ) , creatinine level was higher ( 98 vs. 88 μmol/l , P = 0.003 ) and extracorporeal circulation ( ECC ) time was longer ( 145 vs. 113 min , P ) . Mortality during the first 30 days after surgery in patients with delirium was significantly higher than that in the non-delirious patients ( 14 vs. 0 % , P Low MMSE score and high creatinine level prior to surgery as well as increased ECC time are important independent predictors of delirium . In addition , delirium is an important predictor of 30-day mortality . Patients with a substantial risk for delirium should be c and i date s for interventions to reduce postoperative delirium and to potentially improve overall surgical outcomes",
"OBJECTIVES Delirium ( or acute confusional state ) affects 35 % to 65 % of patients after hip-fracture repair , and has been independently associated with poor functional recovery . We performed a r and omized trial in an orthopedic surgery service at an academic hospital to determine whether proactive geriatrics consultation can reduce delirium after hip fracture . DESIGN Prospect i ve , r and omized , blinded . SETTING Inpatient academic tertiary medical center . PARTICIPANTS 126 consenting patients 65 and older ( mean age 79 + /- 8 years , 79 % women ) admitted emergently for surgical repair of hip fracture . MEASUREMENTS Detailed assessment through interviews with patients and design ated proxies and review of medical records was performed at enrollment to ascertain prefracture status . Subjects were then r and omized to proactive geriatrics consultation , which began preoperatively or within 24 hours of surgery , or \" usual care . \" A geriatrician made daily visits for the duration of the hospitalization and made targeted recommendations based on a structured protocol . To ascertain study outcomes , all subjects underwent daily , blinded interviews for the duration of their hospitalization , including the Mini-Mental State Examination ( MMSE ) , the Delirium Symptom Interview ( DSI ) , and the Memorial Delirium Assessment Scale ( MDAS ) . Delirium was diagnosed using the Confusion Assessment Method ( CAM ) algorithm . RESULTS The 62 patients r and omized to geriatrics consultation were not significantly different ( P>.1 ) from the 64 usual-care patients in terms of age , gender , prefracture dementia , comorbidity , type of hip fracture , or type of surgical repair . Sixty-one percent of geriatrics consultation patients were seen preoperatively and all were seen within 24 hours postoperatively . A mean of 10 recommendations were made throughout the duration of the hospitalization , with 77 % adherence by the orthopedics team . Delirium occurred in 20 /62 ( 32 % ) intervention patients , versus 32 / 64 ( 50 % ) usual-care patients ( P = .04 ) , representing a relative risk of 0.64 ( 95 % confidence interval ( CI ) = 0.37 - 0.98 ) for the consultation group . One case of delirium was prevented for every 5.6 patients in the geriatrics consultation group . There was an even greater reduction in cases of severe delirium , occurring in 7/ 60 ( 12 % ) of intervention patients and 18 / 62 ( 29 % ) of usual-care patients , with a relative risk of 0.40 ( 95 % CI = 0.18 - 0.89 ) . Despite this reduction in delirium , length of stay did not significantly differ between intervention and usual-care groups ( median + /- interquartile range = 5 + /- 2 days in both groups ) , likely because protocol s and pathways predetermined length of stay . In subgroup analyses , geriatrics consultation was most effective in reducing delirium in patients without prefracture dementia or activities of daily living ( ADL ) functional impairment . CONCLUSIONS Proactive geriatrics consultation was successfully implemented with good adherence after hip-fracture repair . Geriatrics consultation reduced delirium by over one-third , and reduced severe delirium by over one-half . Our trial provides strong preliminary evidence that proactive geriatrics consultation may play an important role in the acute hospital management of hip-fracture patients",
"OBJECTIVES In elderly patients with mild cognitive impairment , noncompliance with respiratory exercises , ineffective expectoration , reluctance in mobilization , and difficulty in learning the use of drugs such as inhalers were observed in the early postoperative period after coronary artery bypass graft surgery . It was hypothesized that respiratory complications may be more frequent in these patients , and so the postoperative respiratory complications in patients with preoperative mild cognitive impairment were compared with the postoperative respiratory complications of a control group . DESIGN A prospect i ve cohort control . SETTING A university hospital . PARTICIPANTS Patients undergoing elective coronary artery bypass graft surgery . INTERVENTIONS Investigators separated 48 patients > 70 years old who were scheduled for elective coronary artery bypass graft surgery into two groups : patients with preoperative mild cognitive impairment ( group A , n = 25 ) and patients with no cognitive impairment ( control group ; group B , n = 23 ) . The patients ' cognitive status was evaluated preoperatively by the Montreal Cognitive Assessment test . MEASUREMENTS AND MAIN RESULTS Pulmonary functions and respiratory complications were evaluated via chest x-rays and spirometry tests preoperatively and postoperatively . A significant difference was observed between the groups , particularly with regard to atelectasis and prolonged ventilation ( p impairment was observed in the spirometry tests of the control group . However , a significant deterioration was observed in the postoperative spirometry tests of patients with preoperative mild cognitive impairment . CONCLUSIONS This study suggested that mild cognitive impairment was associated with pulmonary complications after coronary artery bypass graft surgery",
"Purpose This r and omized controlled , clinical prospect i ve interventional trial was aim ed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients . Methods This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany . The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal , genitourinary , and thoracic cancer . The patients were r and omly assigned to the intervention group , i.e. patient empowerment through information booklet and diary keeping , or to the control group , which received st and ard care . R and omization was done by block r and omization in blocks of four in order of enrollment . The primary outcome were 1,postoperative length of hospital stay ( LOS ) and 2 . long-term global health-related quality of life ( HRQoL ) one year postoperatively . HRQoL was assessed using the EORTC QLQ C30 question naire . Secondary outcomes encompassed postoperative stress and complications . Further objectives were the identification of predictors of LOS , and HRQoL at 12 months . Results Overall 652 patients were included . The mean age was 72 ± 4.9 years , and the majority of patients were male ( 68.6 % , n = 447 ) . The ^median of postoperative length of stay was 9 days ( IQR 7–14 day ) . There were no significant differences between the intervention and the control groups in postoperative LOS ( p = 0.99 ) or global HRQoL after one year ( women : p = 0.54 , men : p = 0.94 ) . While overall complications and major complications occurred in 74 % and 24 % of the cases , respectively , frequency and severity of complications did not differ significantly between the groups . Patients in the intervention group reported significantly less postoperative pain ( p = 0.03 ) than the control group . Independent predictors for LOS were identified as severity of surgery , length of anesthesia , major postoperative complications , nutritional state , and pre-operative physical functional capacity measured by the Timed Up and Go-test by multiple robust regressions . Conclusion Patient empowerment through information booklet and diary keeping did not shorten the postoperative LOS in elderly onco-surgical patients , but improved quality of care regarding postoperative pain . Postoperative length of stay is influenced by pre-operative nutritional state , pre-operative functional impairment , severity of surgery , and length of anesthesia . Trial Registration Clinical trials.gov . Identifier",
"Primary arthroplasty may be denied to very elderly patients based upon the perceived outcome and risks associated with surgery . This prospect i ve study compared the outcome , complications , and mortality of total hip ( TKR ) and total knee replacement ( TKR ) in a prospect ively selected group of patients aged ≥ 80 years with that of a control group aged between 65 and 74 years . There were 171 and 495 THRs and 185 and 492 TKRs performed in the older and control groups , respectively . No significant difference was observed in the mean improvement of Oxford hip and knee scores between the groups at 12 months ( 0.98 , ( 95 % confidence interval ( CI ) -0.66 to 2.95 ) , p = 0.34 and 1.15 ( 95 % CI -0.65 to 2.94 ) , p = 0.16 , respectively ) . The control group had a significantly ( p = 0.02 and p = 0.04 , respectively ) greater improvement in the physical well being component of their SF-12 score , but the older group was more satisfied with their THR ( p = 0.047 ) . The older group had a longer hospital stay for both THR ( 5.9 versus 9.0 days , p p 0.0001 ) . The rates of post-operative complications and mortality were increased in the older group",
"OBJECTIVES This study sought to evaluate the impact of frailty in older adults undergoing transcatheter aortic valve replacement ( TAVR ) for symptomatic aortic stenosis . BACKGROUND Frailty status impacts prognosis in older adults with heart disease ; however , the impact of frailty on prognosis after TAVR is unknown . METHODS Gait speed , grip strength , serum albumin , and activities of daily living status were collected at baseline and used to derive a frailty score among patients who underwent TAVR procedures at a single large-volume institution . The cohort was dichotomized on the basis of median frailty score into frail and not frail groups . The impact of frailty on procedural outcomes ( stroke , bleeding , vascular complications , acute kidney injury , and mortality at 30 days ) and 1-year mortality was evaluated . RESULTS Frailty status was assessed in 159 subjects who underwent TAVR ( age 86 ± 8 years , Society of Thoracic Surgery Risk Score 12 ± 4 ) . Baseline frailty score was not associated with conventionally ascertained clinical variables or Society of Thoracic Surgery score . Although high frailty score was associated with a longer post-TAVR hospital stay when compared with lower frailty score ( 9 ± 6 days vs. 6 ± 5 days , respectively , p = 0.004 ) , there were no significant crude associations between frailty status and procedural outcomes , suggesting adequacy of the st and ard selection process for identifying patients at risk for periprocedural complications after TAVR . Frailty status was independently associated with increased 1-year mortality ( hazard ratio : 3.5 , 95 % confidence interval : 1.4 to 8.5 , p = 0.007 ) after TAVR . CONCLUSIONS Frailty was not associated with increased periprocedural complications in patients selected as c and i date s to undergo TAVR but was associated with increased 1-year mortality after TAVR . Further studies will evaluate the independent value of this frailty composite in older adults with aortic stenosis",
"Objective : To describe and evaluate an inpatient geriatric trauma consultation service ( GTCS ) . Background : Delays in recognizing the special needs of older trauma patients may result in suboptimal care . The GTCS is a proactive geriatric consultation model aim ed at preventing and managing age-specific complications and discharge planning for all patients 60 years or older admitted to the St Michael 's Hospital Trauma Service . Methods : This was a before and after case series of patients admitted pre-GTCS ( March 2005–August 2007 ) and post-GTCS ( September 2007–March 2010 ) . Study data were derived from a review of the medical records and from the St Michael 's Hospital trauma registry . Abstract ed data included demographics , type of geriatric issues addressed , rate of adherence to recommendations made by the GTCS , geriatric-specific clinical outcomes , trauma quality indicators , consultation requests , and discharge destinations . Results : A total of 238 pre-GTCS patients and 248 post-GTCS patients were identified . The rate of adherence to recommendations made by the GTCS team was 93.2 % . There were fewer consultation requests made to Internal Medicine and Psychiatry in the post-GTCS group ( N = 31 vs N = 18 , P = 0.04 ; and N = 33 vs N = 18 , P = 0.02 ; respectively ) . There were no differences in any of the prespecified complications except delirium ( 50.5 % pre-GTCS vs 40.9 % post- GTCS , P = 0.05 ) . Among patients admitted from home , fewer were discharged to long-term care facilities among the post-GTCS group ( 6.5 % pre-GTCS vs 1.7 % post-GTCS , P = 0.03 ) . Conclusions : A proactive geriatric consultation model for elderly trauma patients may decrease delirium and discharges to long-term care facilities . Future studies should include a multicenter r and omized trial of this model of care",
"BACKGROUND The prevalence of comorbidities and functional impairment among elderly patients may enhance the risk of operation-related complications , but the importance of these conditions in elderly patients undergoing thoracic surgery remains unclear . METHODS One hundred twenty patients > /= 60 years of age who underwent thoracic surgery were registered prospect ively and examined . A comprehensive geriatric assessment ( CGA ) that evaluated such diverse areas as functional status ( ie , performance status and activities of daily living [ ADLs ] using the Barthel index ) , comorbidity , nutrition ( ie , body mass index , arm-muscle circumference , albumin level , transferrin level , lymphocyte count , and cholinesterase level ) , and cognitive function ( ie , mini-mental state examination [ MMSE ] and negative emotions for operation ) was performed in the 2 weeks before patients underwent the operation . RESULTS The diseases of the 120 patients were as follows : lung cancer , 85 patients ; mediastinal tumor , 14 patients ; bullas , 12 patients ; and other diseases , 9 patients . Postoperative complications developed in 20 patients ( 16.7 % ) . The patients with dependence for performing the ADLs , and dementia were more likely to develop postoperative complications ( p = 0.041 , and p = 0.0065 , respectively ) . The patients who experienced longer operation times ( ie , > /= 300 min ; p = 0.018 ) were more likely to have complications . The incidence of prolonged air leak in the patients with malnutrition increased seven-fold ( p = 0.045 ) and that of postoperative infectious diseases in those patients with obesity increased 24-fold ( p = 0.0013 ) , while all patients who developed delirium had low scores in the MMSE preoperatively ( p = 0.0003 ) . Using multiple logistic regression , the best model was obtained with a combination of MMSE ( p = 0.031 ) and the Barthel index ( p = 0.04 ) . When the operation variables were added to this model , the operation time had the strongest effect ( p = 0.016 ) . CONCLUSIONS Dependence for the performance of ADLs and impaired cognitive conditions are important predictors of postoperative complications , especially when the operation time is long . CGA is necessary in addition to the conventional cardiopulmonary functional assessment in elderly patients",
"OBJECTIVE To develop and vali date a clinical prediction rule for postoperative delirium using data available to clinicians preoperatively . DESIGN Prospect i ve cohort study . SETTING General surgery , orthopedic surgery , and gynecology services at Brigham and Women 's Hospital , Boston , Mass. PATIENTS Consenting patients older than 50 years admitted for major elective noncardiac surgery between November 1 , 1990 , and March 15 , 1992 ( N = 1341 ) . MEASUREMENTS All patients underwent preoperative evaluations , including a medical history , physical examination , laboratory tests , and assessment s of physical and cognitive function using the Specific Activity Scale and the Telephone Interview for Cognitive Status . Postoperative delirium was diagnosed using the Confusion Assessment Method or using data from the medical record and the hospital 's nursing intensity index . Patients were followed up for the duration of hospitalization to determine major complication rates , length of stay , and discharge disposition . RESULTS Postoperative delirium occurred in 117 ( 9 % ) of the 1341 patients studied . Independent correlates included age 70 years or older ; self-reported alcohol abuse ; poor cognitive status ; poor functional status ; markedly abnormal preoperative serum sodium , potassium , or glucose level ; noncardiac thoracic surgery ; and aortic aneurysm surgery . Using these seven preoperative factors , a simple predictive rule was developed . In an independent population , the rule stratified patients into groups with low ( 2 % ) , medium ( 8 % , 13 % ) , and high ( 50 % ) rates of postoperative delirium . Patients who developed delirium had higher rates of major complications , longer lengths of stay , and higher rates of discharge to long-term care or rehabilitative facilities . CONCLUSIONS Using data available preoperatively , clinicians can stratify patients into risk groups for the development of delirium . Since delirium is associated with a variety of adverse outcomes , patients with substantial risk for this complication could be c and i date s for interventions to reduce the incidence of postoperative delirium and potentially improve overall surgical outcomes",
"BACKGROUND : Previous studies have shown that women are at higher risk than men for stroke after coronary artery bypass graft ( CABG ) surgery , but gender differences in systemic atherosclerosis have not been studied adequately . We investigated gender differences in the incidence of craniocervical and ascending aortic atherosclerosis and other risk factors for stroke in elderly patients ( age ≥60 yr ) undergoing CABG surgery . METHODS : Data were prospect ively collected on 720 patients ( 31.8 % women ) undergoing CABG surgery . All patients underwent preoperative brain magnetic resonance imaging and angiography to assess for prior cerebral infa rct ions , carotid artery stenosis , and intracranial arterial stenosis . Epiaortic ultrasound was performed at the time of surgery to assess for atherosclerosis of the ascending aorta . Cognitive status was measured using the Hasegawa-dementia score in all patients before surgery and on the seventh postoperative day . RESULTS : Women were older and had more hypertension and intracranial arterial stenosis than did men . Men had significantly higher rates of hyperlipidemia , peripheral vascular disease , abdominal aortic aneurysm , smoking history , severe carotid artery stenosis , and severe aortic atherosclerosis than did women . Although there were no differences in prior cerebral infa rct ion or preoperative cognitive impairment , the rate of perioperative stroke was marginally higher in men than in women ( 3.9 % vs 1.3 % , P = 0.066 ) . Univariate predictors of perioperative stroke were prior cerebral infa rct ions , ascending aortic atherosclerosis , preexisting cognitive impairment , and peripheral vascular disease . Stepwise logistic regression analysis demonstrated that significant independent predictors of perioperative stroke were prior cerebral infa rct ions and aortic atherosclerosis . CONCLUSIONS : These data suggest that men are more likely than women to have risk factors for stroke , including severe carotid artery stenosis , severe aortic atherosclerosis , and peripheral vascular disease . The rates of prior cerebral infa rct ion and preoperative cognitive impairment were similar between genders",
"OBJECTIVES The Nutrition Screening Initiative is a national collaborative effort committed to the identification and treatment of nutritional problems in older persons . METHODS A 14-item checklist of characteristics associated with nutritional status was administered to a r and om sample of Medicare beneficiaries , aged 70 years and older , in New Engl and . Regression analysis was used to derive item weights that would predict poor nutrient intakes and low perceived health status . Sensitivity and specificity values were review ed to define low , moderate , and high nutritional risk scores . RESULTS A revised checklist containing 10 yes/no items was adopted . Scores of 6 or more points defined persons at high nutritional risk . Twenty-four percent of the Medicare population was estimated to be at high nutritional risk according to the checklist . Among those in the high-risk group , 56 % perceived their health to be \" fair \" or \" poor \" and 38 % had dietary intakes below 75 % of the recommended dietary allowances for three or more nutrients . CONCLUSIONS The Nutrition Screening Initiative Checklist is a brief , easily scored instrument that can accurately identify noninstitutionalized older persons at risk for low nutrient intake and health problems",
"BACKGROUND A number of elderly cancer patients do not receive st and ard surgery for solid tumors because they are considered unfit for treatment as a consequence of inaccurate estimation of the operative risk . To tailor treatment to onco-geriatric series , oncologists are now beginning to use a comprehensive geriatric assessment ( CGA ) . This study investigates the value of an extended CGA in assessing the suitability of elderly patients for surgical intervention . PATIENTS AND METHODS Preoperative assessment of cancer in the elderly ( PACE ) incorporates vali date d instruments including the CGA , an assessment of fatigue and performance status and an anaesthesiologist 's evaluation of operative risk . An international prospect i ve study was conducted using 460 consecutively recruited elderly cancer patients who received PACE prior to elective surgery . Mortality , post-operative complications ( morbidity ) and length of hospital stay were recorded up to 30 days after surgery . RESULTS Poor health in relation to disability ( assessed using the instrumental activities of daily living ( IADL ) ) , fatigue and performance status ( PS ) were associated with a 50 % increase in the relative risk of post-operative complications . Multivariate analysis identified moderate/severe fatigue , a dependent IADL and an abnormal PS as the most important independent predictors of post-surgical complications . Disability assessed by activities of daily living ( ADL ) , IADL and PS were associated with an extended hospital stay . CONCLUSION PACE represents a valuable tool in enhancing the decision process concerning the c and idacy of elderly cancer patients for surgical intervention and can reduce inappropriate age-related inequity in access to surgical intervention . It is recommended that PACE be used routinely in surgical practice",
"OBJECTIVES Delirium is a common and critical clinical syndrome in older patients . We examined whether abnormalities in the brain that could be assessed by magnetic resonance imaging predisposed patients to develop delirium after coronary artery bypass graft surgery . We also analysed the association between delirium and cognitive dysfunction after coronary artery bypass graft surgery . METHODS Data were collected prospect ively on 153 patients aged 60 years or older who consecutively underwent elective isolated coronary artery bypass graft surgery . All patients were assessed for prior cerebral infa rct ions and craniocervical artery stenosis by magnetic resonance imaging ( MRI ) and angiography of their brains . Atherosclerosis of the ascending aorta was examined by epiaortic ultrasound at the time of surgery . Individual cognitive status was measured using four tests in all the patients before surgery and on the seventh postoperative day . A single psychiatrist diagnosed delirium using the Diagnostic and Statistical Manual of Mental Disorders 4th edition IV criteria . RESULTS Postoperative delirium occurred in 16 patients ( 10.5 % ) . Compared with patients who did not develop postoperative delirium , delirious patients had significantly higher rates of peripheral artery disease , preoperative decline in global cognitive function and pre-existing multiple cerebral infa rct ions on MRI . In addition , 9 ( 56 % ) of the delirious patients suffered postoperative cognitive dysfunction . Stepwise logistic regression analysis found significant independent predictors of postoperative delirium to be preoperative cerebral infa rcts on MRI ( odds ratio [ OR ] , 2.26 ; 95 % confidence interval [ CI ] 1.10 - 4.78 ) , preoperative decline in global cognitive function ( OR 4.54 ; 95 % CI 1.21 - 16.51 ) and atherosclerosis of the ascending aorta ( OR 2.44 ; 95 % CI 1.03 - 5.62 ) . CONCLUSIONS Our findings suggested that postoperative delirium was associated with pre-existing multiple cerebral infa rct ions on MRI , preoperative decline in global cognitive function and ascending aortic atherosclerosis in elderly patients undergoing coronary artery bypass graft surgery and increased risk of postoperative cognitive dysfunction",
"The present study examined the association between patient-reported anxiety and postcardiac surgery mortality and major morbidity . Frailty Assessment Before Cardiac Surgery was a prospect i ve multicenter cohort study of elderly patients undergoing cardiac surgery ( coronary artery bypass surgery and /or valve repair or replacement ) at 4 tertiary care hospitals from 2008 to 2009 . The patients were evaluated a mean of 2 days preoperatively with the Hospital Anxiety and Depression Scale , a vali date d question naire assessing depression and anxiety in hospitalized patients . The primary predictor variable was a high level of anxiety , defined by a Hospital Anxiety and Depression Scale score of ≥ 11 . The main outcome measure was all-cause mortality or major morbidity ( e.g. , stroke , renal failure , prolonged ventilation , deep sternal wound infection , or reoperation ) occurring during the index hospitalization . Multivariable logistic regression analysis examined the association between high preoperative anxiety and all-cause mortality/major morbidity , adjusting for the Society of Thoracic Surgeons predicted risk , age , gender , and depression symptoms . A total of 148 patients ( mean age 75.8 ± 4.4 years ; 34 % women ) completed the Hospital Anxiety and Depression Scale . High levels of preoperative anxiety were present in 7 % of patients . No differences were found in the type of surgery and Society of Thoracic Surgeons predicted risk across the preoperative levels of anxiety . After adjusting for potential confounders , high preoperative anxiety was remained independently predictive of postoperative mortality or major morbidity ( odds ratio 5.1 , 95 % confidence interval 1.3 to 20.2 ; p = 0.02 ) . In conclusion , although high levels of anxiety were present in few patients anticipating cardiac surgery , this conferred a strong and independent heightened risk of mortality or major morbidity ",
"We investigate age and sex differences in acute myocardial infa rct ion ( AMI ) after cardiac surgery in a prospect i ve study of 2038 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass . An age of ≥ 70 years implied changes in the type of AMI from the ST-segment elevation myocardial infa rct ion ( STEMI ) to non-ST-segment elevation myocardial infa rct ion ( non-STEMI ) . Men were more likely than women to suffer from AMI after cardiac surgery ( 11.8 % vs. 5.6 % ) , as a result of the higher frequency of STEMI ( 6 % of men vs. 1.8 % of women ; P groups . A troponin-I ( Tn-I ) peak was significantly higher in patients ≥ 70 years old . In-hospital mortality was higher in patients ≥ 70 ( 7.3 % ) than in those increased mortality observed in men with non-AMI ( 2.1 % vs. 6.3 % ) and women with STEMI ( 0 % vs. 28.6 % ) and non-STEMI ( 0 % vs. 36.8 % , P frequency of non-STEMI , Tn-I peak , mortality and length of stay in the intensive care unit ( ICU ) . Regardless of age , men more often suffer from AMI ( particularly STEMI ) . AMI in women had a notable impact on excess mortality and ICU stay observed in patients ≥ 70 years of age . Clinical and Tn-I peak differences are expected in relation to age and gender after AMI post-cardiac surgery",
"Background Frailty is a phenotype characterized by complex and challenging medical problems and higher susceptibility to adverse health outcomes . It can be derived at by a multidimensional process known as comprehensive geriatric assessment ( CGA ) , which assesses the functional reserves of the elderly . In this study we report for the first time on a prospect i ve evaluation of the association between CGA and postoperative complications after elective laparoscopic cholecystectomy for biliary disease . Methods Fifty-seven patients older than 65 years who were to undergo elective laparoscopic cholecystectomy for uncomplicated biliary disease were prospect ively examined . Preoperative CGA was performed and the patients were categorized as fit or frail . The main outcome of the study was the rate of any postoperative complication within 30 days of surgery . Results There were 29 women ( 50.9 % ) and the median ( interquartile range ) age of the cohort was 73 ( 8.8 ) years . Thirty-two patients ( 56.1 % ) were categorized as frail and 25 ( 43.9 % ) as fit . The overall incidence of postoperative complications was 23.7 % , most of which were grade I and II ( 18.8 % ) . Frail patients , according to the CGA assessment , experienced a significantly higher incidence of postoperative complications compared to their fit counterparts ( 84.6 vs. 15.4 % , p = 0.023 ) . Frail patients experienced a significantly higher frequency of prolonged ( more than 2 days ) postoperative hospital stay compared with their fit counterparts ( p = 0.023 ) . Conclusions Preoperative CGA may predict postoperative complications and prolonged postoperative hospital stay of elderly patients who undergo elective laparoscopic cholecystectomy . Larger-scale studies independently assessing this association are warranted",
"To determine which preoperative factors might affect the development of cardiac complications after major noncardiac operations , we prospect ively studied 1001 patients over 40 years of age . By multivariate discriminant analysis , we identified nine independent significant correlates of life-threatening and fatal cardiac complications : preoperative third heart sound or jugular venous distention ; myocardial infa rct ion in the preceding six months ; more than five premature ventricular contractions per minute documented at any time before operation ; rhythm other than sinus or presence of premature atrial contractions on preoperative electrocardiogram ; age over 70 years ; intraperitoneal , intrathoracic or aortic operation ; emergency operation ; important valvular aortic stenosis ; and poor general medical condition . Patients could be separated into four classes of significantly different risk . Ten of the 19 postoperative cardiac fatalities occurred in the 18 patients at highest risk . If vali date d by prospect i ve application , the multifactorial index may allow preoperative estimation of cardiac risk independent of direct surgical risk",
"OBJECTIVE The geriatric assessment ( GA ) has proven to be of great value for clinicians treating older patients . However , a clear consensus on the optimal set of GA instruments is lacking , particularly for surgical patients . Therefore , the aim of this prospect i ve study was to compare the prevalence of frailty , depending on the number of incorporated GA domains , and to evaluate its accuracy in predicting postoperative outcome . MATERIAL S AND METHODS Seventy-five patients aged 65 years and older , qualified for abdominal surgery due to solid cancer , were enrolled . The GA included a wide variety of vali date d tools that evaluate functional , mobility , nutritional , co-morbidity , polypharmacy , and psychosocial domains . RESULTS Depending on the number of incorporated GA domains the frequency of frailty was 23 - 97 % . The cumulative score rather than individual components of the GA , turned out to be an independent risk factor of 30-day postoperative morbidity . In predicting 30-day \" any \" and \" major \" morbidities , the area under the curve was 0.67 - 0.72 and 0.70 - 0.82 ( model including the severity of the surgery ) vs. 0.57 - 0.66 and 0.50 - 0.65 ( model not including the severity of the surgery ) , respectively . CONCLUSION The number of incorporated GA domains has a great influence on the prevalence of frailty and on adequate surgical risk assessment . The summary deficit score based on Pre-operative Assessment of Cancer in the Elderly ( PACE ) or the GA consisting of functional , mobility , cognitive , depression , nutritional , co-morbidity , polypharmacy , and social support assessment domains can predict 30-day postoperative morbidity . However , only models with addition of the severity of surgery show moderate to good predictive value",
"PURPOSE To determine the association between self-reported exercise tolerance and the risk of unanticipated postoperative nursing home placement in adults undergoing major surgery . METHODS Consecutive community-dwelling adults ( N = 586 ) referred to a medical clinic for evaluation before undergoing major nonemergent surgery at a tertiary care academic medical center were prospect ively followed between 1995 and 1997 . The main outcome measure was unanticipated postoperative nursing home placement . RESULTS Overall , 12 % ( 40/324 ) of patients with poor preoperative exercise tolerance ( inability to walk four blocks and climb two flights of stairs without symptomatic limitation ) had unanticipated nursing home placement compared with 4 % ( 10/262 ) of patients with good exercise tolerance . Patient and surgical characteristics associated with nursing home placement in univariate analyses included poor preoperative exercise tolerance , increasing age , living alone , history of heart failure , taking five or more preoperative medications , longer anesthesia duration , and orthopedic surgery . Patients who were married were at lower risk . After adjusting for all other patient and surgical factors , poor preoperative exercise tolerance ( odds ratio [ OR ] = 2.8 ; 95 % confidence interval [ CI ] : 1.3 to 6.2 ) and serious postoperative complications ( OR = 4.7 ; 95 % CI : 2.1 to 10.5 ) remained associated with postoperative nursing home placement . CONCLUSION Poor preoperative exercise tolerance was an independent predictor of unanticipated nursing home placement following major nonemergent surgery",
"Background The number of elderly patients proposed for brain tumor removal is increasing . Only few data on long-term functional prognosis after intracranial surgery are available . Material s and Methods Prospect i ve , observational study of all patients greater than 70 year of age operated for intracranial tumors . Two scales for health status evaluation were used : Karnofsky Performance Scale ( KPS ) and Activities of Daily Living ( ADL ) score . Data were expressed as medians ( first to third quartiles ) . The primary endpoint was the probability to remain nondependant ( ADL>3 and KPS≥70 % ) after 1 year . Results Between 2003 and 2007 , 90 patients were included : 46 ( 51.1 % ) meningioma , 17 ( 18.9 % ) high- grade glioma , and 11 ( 12.2 % ) metastasis . At hospital admission , age was 73.50 years ( 71.25 - 76.00 ) , American Society of Anesthesiology score 2 ( 2 to 3 ) , KPS 80 % ( 70–90 ) , ADL 5.5 ( 4.5 to 6.0 ) . Two patients died during the first 28 days , 3 others during the first year . Both KPS and ADL decreased after 1 year : KPS 80 % ( 70 to 90 ; mean : 80 % ) at hospital admission versus 80 % ( 60 to 90 ) at 1 year ( mean : 70 % ) , P=0.003 ; ADL 5.5 ( 4.5 to 6.0 ) at hospital admission versus 5.0 ( 3.25 to 5.50 ) at 1 year , P=0.001 . In multivariate analysis , 2 preoperative parameters were associated with autonomy at 1 year : the ADL at hospital admission and meningioma as histologic type . Conclusions In this series of elderly patients , intracranial tumor surgery was associated with low 1-year mortality . Meningioma was associated with a better postoperative functional outcome . Preoperative ADL score was a predictive of functional evolution 1 year after the surgery",
"BACKGROUND No tool currently exists to rapidly allow surgeons to objective ly quantify surgical risk in geriatric patients . The goal of our prospect i ve study was to determine if individual questions extracted from vali date d screens for common geriatric syndromes would have predictive value for surgical risk in geriatric patients with thoracic neoplasms . METHODS Patients ≥ 70 y old were recruited to participate in a prospect i ve , IRB-approved study involving the preoperative administration of vali date d screening tests . Patients were given the geriatric depression scale ( GDS ) , nutrition screening initiative nutritional health checklist ( NSI NHC ) , mini mental status exam ( MMSE ) , brief fatigue inventory ( BFI ) , and assessed for activities of daily living ( ADLs ) and instrumental activities of daily living ( IADLs ) . All patients enrolled in this study were scheduled for thoracic surgery . RESULTS Patients who responded to having a dependency in the IADL \" shopping \" were more likely to have major complications and to be discharged to a non-home location than those without a dependency ( P = 0.011 , 0.003 ) . Patients who answered \" yes \" to questions 1 , 9 , and 10 of the NSI NHC had a longer mean length of stay compared with patients who answered \" no \" ( P = 0.039 , 0.010 , 0.031 ) . Answering \" yes \" to GDS question 2 correlated with the incidence of major complications ( r = 0.270 P = 0.037 ) . Answering \" yes \" to GDS question 12 increased the likelihood of being discharged to a non-home location postoperatively ( odds ratio = 11.64 , 95 % CI , 0.68 - 202.86 , P = 0.047 ) . CONCLUSIONS Our data indicate that an abbreviated , rapid presurgical assessment can be developed for estimating operative risk , length of stay , and discharge destination in geriatric patients with thoracic malignancies using individual questions from previously vali date d screening tools",
"BACKGROUND The purpose of this prospect i ve study was to identify risk factors for adverse outcomes or increased re source utilization after abdominal cancer surgery in geriatric patients . METHODS Baseline clinical and geriatric assessment variables including functional status , nutritional status , comorbidity index , mental status , depression scale score , fatigue inventory scale , and polypharmacy scale were prospect ively recorded for patients age ≥65 undergoing intra-abdominal oncologic surgery . Outcome variables included morbidity , mortality , discharge to nursing facility , prolonged hospital stay , and readmission . RESULTS Of 111 patients , surgery type was colorectal in 40 % , hepatopancreatobiliary in 30 % , and gastric/duodenal in 14 % . Variables associated with discharge to a nursing facility on multivariate analysis included weight loss ≥10 % ( OR 6.52 [ 95 % CI : 1.43 - 29.76 ] , P = 0.02 ) , ASA score ≥2 ( OR 5.08 [ 1.13 - 22.77 ] , P = 0.03 ) , and ECOG score ≥2 ( OR 4.51 [ 1.03 - 19.71 ] , P = 0.04 ) . Variables independently associated with prolonged hospital stay included weight loss ≥10 % ( OR 4.03 [ 1.13 - 14.43 ] , P = 0.03 ) , the presence of polypharmacy ( OR 2.45 [ 1.09 - 5.48 ] , P = 0.03 ) , and distant disease ( OR 0.37 [ 0.15 - 0.91 ] , P = 0.03 ) . No variables were associated with morbidity or readmission . CONCLUSIONS Pre-operative clinical and geriatric assessment tools can help predict the need for discharge to a nursing facility or increased length of stay . Future studies will be required to identify patients suitable for interventions to decrease hospital and post-discharge re source utilization ",
"Predictors of perioperative complications , including cardiac death , ventricular tachycardia or fibrillation , and heart failure or myocardial infa rct ion , were assessed in an initial study of 100 patients aged 65 years or older scheduled for elective abdominal or noncardiac thoracic surgery . Preoperative history , results of physical examination , chest roentgenogram , electrocardiogram , laboratory data , Dripps ( American Society of Anesthesiologists ) class , and Goldman cardiac risk index were compared with rest and exercise radionuclide ventriculograms . Thirteen patients had perioperative cardiac complications , and 6 died . Multivariate analysis showed that an inability to do 2 minutes of bicycle exercise in the supine position to raise the heart rate above 99 beats/min ( sensitivity 85 % , specificity 64 % ) gave predictive information not available from clinical or radionuclide data . On prospect i ve testing involving 55 additional geriatric patients , inability to exercise was the only independent predictor of perioperative complications ( p less than 0.05 ) . Data from rest and exercise radionuclide ventriculography added little information for predicting perioperative cardiac risk",
"BACKGROUND & AIMS Little is known about the impact of preoperative protein or energy intake in relation to the occurrence of postoperative complications in patients who are not undernourished but can not keep up their daily protein or energy requirements prior to cardiac surgery . Therefore , a prospect i ve study on intake in preoperatively well-nourished , non-hospitalized cardiac surgery patients ( > or= 65 y ) was carried out . METHODS Between December 2004 and November 2005 preoperative protein and energy intake and postoperative outcome data were collected from 100 consecutive patients undergoing cardiac surgery . RESULTS Comparison of low protein intake ( 0.98 g/kg/d ) showed a low protein intake did not result in more complications or prolonged length of stay . In low-risk operation patients in particular , a high-energy intake ( > 22 kcal/kg/d ) result ed in more postoperative complications than a low energy intake ( preoperative protein intake energy intake low protein or energy intake is of no clinical relevance in the well-nourished , non-hospitalized elderly cardiac surgery patients . Caloric overfeeding may be associated with an increased complication rate",
"Objective : To establish reliable st and ards for surgical application to elderly patients 75 years old or older with gastric or colorectal cancer with special reference to the postoperative recovery of activities of daily living ( ADL ) and quality of life ( QOL ) . Summary Background Data : ADL and QOL are important outcomes of surgery for the elderly . However , there has been only limited evidence on the natural course of recovery of functional independence . Methods : Two hundred twenty-three patients 75 years old or older with gastric or colorectal cancer were prospect ively examined . Physical conditions , ADL , and QOL were evaluated preoperatively and at the first , third , and sixth postoperative month . Results : The mortality and morbidity rates were 0.4 % and 28 % , respectively . Twenty-four percent of patients showed a decrease in ADL at 1 month postoperatively , but most patients recovered from this transient reduction , with only 3 % showing a decline at the sixth postoperative month ( 6POM ) . ADL of these patients was likely to decrease after discharge from the hospital . QOL of the patients showed a recovery to an extent equal to or better than their average preoperative scores . Conclusions : Of the patients 75 years old or older who underwent elective surgery for gastric or colorectal cancer , only a few showed a protracted decline in ADL and most exhibited better QOL after surgery . This indicates that surgical treatment should be considered , whenever needed , for elderly patients 75 years old or older with gastric or colorectal cancer . Estimation of Physical Ability and Surgical Stress is useful for predicting postoperative declines in ADL and protracted disability ; this could aid in establishing a directed rehabilitation program for preventing protracted disability in elderly patients",
"BACKGROUND The clinical syndrome of frailty identified through the assessment of weight loss , gait speed , grip strength , physical activity , and physical exhaustion has been used to identify patients with reduced reserves . We hypothesized that frailty is useful in predicting adverse outcomes in optimized elective elderly colorectal surgery patients . METHODS A prospect i ve study was conducted at 2 centers ( Singapore and Japan ) . All patients over 75 years of age undergoing colorectal resection were assessed for the presence of the syndrome of frailty . All these patients had already had their comorbidities optimized for surgery . The outcome measure was postoperative major complications ( defined as Clavien-Dindo type II and above complications ) . RESULTS Eighty-three patients were studied from February 2008 to April 2010 . The mean age was 81.5 years ( range 75 - 93 years ) . The mean comorbidity index was 3.37 ( range 0 - 11 ) . Twenty-six ( 31.3 % ) patients were an American Society of Anesthesiologists ( ASA ) score of 3 and above . Chi-square analysis revealed that the odds ratio of postoperative major complications was 4.083 ( 95 % confidence interval , 1.433 - 11.638 ) when the patient satisfied the criteria for frailty . Albumin ASA > 3 , comorbidity index > 5 , and Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity ( POSSUM ) scores were not predictive of postoperative major complications . CONCLUSIONS Preliminary findings show that frailty is a potent adjunctive tool of predicting postoperative morbidity . Frailty can be used to identify elderly patients needing further optimization before major surgery",
"BACKGROUND Preoperative risk stratification is commonly performed by assessing end-organ function ( such as cardiac and pulmonary ) to define postoperative risk . Little is known about impaired preoperative cognition and outcomes . The purpose of this study was to evaluate the impact of baseline impaired cognition on postoperative outcomes in geriatric surgery patients . STUDY DESIGN Subjects 65 years and older undergoing a planned elective operation requiring postoperative ICU admission were recruited prospect ively . Preoperative baseline cognition was assessed using the vali date d Mini-Cog test . Impaired cognition was defined as a Mini-Cog score of ≤ 3 . Delirium was assessed using the Confusion Assessment Method -ICU by a trained research team . Adverse outcomes were defined using the Veterans Affairs Surgical Quality Improvement Program definitions . RESULTS One hundred and eighty-six subjects were included , with a mean age of 73 ± 6 years . Eighty-two subjects ( 44 % ) had baseline impaired cognition . The impaired cognition group had the following unadjusted outcomes : increased incidence of 1 or more postoperative complications ( 41 % vs 24 % ; p = 0.011 ) , higher incidence of delirium ( 78 % vs 37 % ; p , longer hospital stays ( 15 ± 14 vs 9 ± 9 days ; p = 0.001 ) , higher rate of discharge institutionalization ( 42 % vs 18 % ; p = 0.001 ) , and higher 6-month mortality ( 13 % vs 5 % ; p = 0.040 ) . Adjusting for potential confounders determined by univariate analysis , logistic regression found impaired cognition was still associated with the occurrence of 1 or more postoperative complications ( odds ratio = 2.401 ; 95 % CI , 1.185 - 4.865 ; p = 0.015 ) . Kaplan-Meier survival analysis revealed higher mortality in the impaired cognition group ( log-rank p = 0.008 ) . CONCLUSIONS Baseline cognitive impairment in older adults undergoing major elective operations is related to adverse postoperative outcomes including increased complications , length of stay , and long-term mortality . Improved underst and ing of baseline cognition and surgical outcomes can aid surgical decision making in older adults"
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411644f8-06ff-11f0-808a-c43d1ab1c353
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The present study aims to identify the range of eating behavior self- assessment tools reported in the adult bariatric surgery literature and evaluate the measurement properties of these tools using pre-established criteria . This systematic review follows the Preferred Reporting Items for Systematic Review s and Meta- analysis ( PRISMA ) guidelines . This review revealed the use of 20 distinct tools ; however , evidence for measurement properties specific to bariatric surgery population s was limited to only ten of these tools , as reported in 14 papers . Validity varied extensively and there was a widespread lack of information regarding measurement of change over time and patient burden . According to the evaluation criteria , there was adequate support for two tools . Several other tools show potential but would benefit from additional investigation of their measurement properties prior to continued use with bariatric surgery patients
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"Previous research has found similarities between addiction to psychoactive substances and excessive food consumption . Further exploration is needed to evaluate the concept of \" food addiction , \" as there is currently a lack of psychometrically vali date d measurement tools in this area . The current study represents a preliminary exploration of the Yale Food Addiction Scale ( YFAS ) , design ed to identify those exhibiting signs of addiction towards certain types of foods ( e.g. , high fat and high sugar ) . Survey data were collected from 353 respondents from a stratified r and om sample of young adults . In addition to the YFAS , the survey assessed eating pathology , alcohol consumption and other health behaviors . The YFAS exhibited adequate internal reliability , and showed good convergent validity with measures of similar constructs and good discriminant validity relative to related but dissimilar constructs . Additionally , the YFAS predicted binge-eating behavior above and beyond existing measures of eating pathology , demonstrating incremental validity . The YFAS is a sound tool for identifying eating patterns that are similar to behaviors seen in classic areas of addiction . Further evaluation of the scale is needed , especially due to a low response rate of 24.5 % and a non- clinical sample , but confirmation of the reliability and validity of the scale has the potential to facilitate empirical research on the concept of \" food addiction \"",
"OBJECTIVE : To evaluate the construct validity of the Three-Factor Eating Question naire ( TFEQ ) in obese men and women . SUBJECTS : A total of 4377 middle-aged , obese subjects in the Swedish Obese Subjects ( SOS ) study . METHODS : The total sample was r and omly split into two data subsets and psychometric testing was performed separately in each sample . Multitrait/multi-item analysis was conducted to test scaling assumptions and factor analysis was used to test the factor structure . Measures of mental well-being ( MACL , HAD ) were used for testing criterion-based validity . RESULTS : The Cognitive Restraint factor was consistently reproduced and scaling analysis demonstrated strong item-scale discriminant validity , while the item-scale convergent validity was unsatisfactory . The internal structure of the Disinhibition scale was weak . Most Disinhibition and Hunger items grouped in one global factor labeled Uncontrolled Eating . A third cluster containing items on Emotional Eating was also identified . The obtained three-factor structure was cross-vali date d and replicated across subgroups by gender , age and BMI . CONCLUSION : The original TFEQ factor structure was not replicated . A short , revised 18-item instrument was constructed , representing the derived factors of Cognitive Restraint , Uncontrolled Eating and Emotional Eating . The most efficient items were used to boost both the convergent and discriminant validity of the scales",
"The purpose of this study was to conduct an assessment of binge eating severity among obese persons . Two question naires were developed . A 16-item Binge Eating Scale was constructed describing both behavioral manifestations ( e.g. , eating large amounts of food ) and feeling/cognitions surrounding a binge episode ( e.g. , guilt , fear of being unable to stop eating ) . An 11-item Cognitive Factors Scale was developed measure two cognitive phenomena thought to be related to binge eating : the tendency to set unrealistic st and ards for a diet ( e.g. , eliminating \" favorite foods \" ) and low efficacy expectations for sustaining a diet . The results showed that the Binge Eating Scale successfully discriminated among persons judged by trained interviewers to have either no , moderate or severe binge eating problems . Significant correlation between the scales were obtained such that severe bingers tended to set up diets which were unrealistically strict while reporting low efficacy expectations to sustain a diet . The discussion highlighted the differences among obese persons on binge eating severity and emphasized the role of cognitions in the relapse of self control of eating",
"Underst and ing why people select certain food items in everyday life is crucial for the creation of interventions to promote normal eating and to prevent the development of obesity and eating disorders . The Eating Motivation Survey ( TEMS ) was developed within a frame of three different studies . In Study 1 , a total of 331 motives for eating behavior were generated on the basis of different data sources ( previous research , nutritionist interviews , and expert discussion s ) . In Study 2 , 1250 respondents were provided with a set of motives from Study 1 and the Eating Motivation Survey was finalized . In Study 3 , a sample of 1040 participants filled in the Eating Motivation Survey . Confirmatory factor analysis with fifteen factors for food choice yielded a satisfactory model fit for a full ( 78 items ) and brief survey version ( 45 items ) with RMSEA .048 and .037 , 90 % CI .047-.049 and .035-.039 , respectively . Factor structure was generally invariant across r and om selected groups , gender , and BMI , which indicates a high stability for the Eating Motivation Survey . On the mean level , however , significant differences in motivation for food choice associated with gender , age , and BMI emerged . Implication s of the fifteen distinct motivations to choose foods in everyday life are discussed",
"Behavioral obesity research ers are increasingly concerned with thorough assessment of obesity . The present report describes the preliminary testing and refinement of the Master Question naire ( MQ ) , a true-false scale developed expressly for use in obesity research . It was initially divided into four subscales : Spouse Support , Energy Balance Habits , Cognitive Factors , and Energy Balance Knowledge , and was intended for use as an outcome measure and as a predictor of change in obesity status . Its stability , internal consistency , sensitivity to treatment-related change , and predictive validity were examined . Test-retest reliability and sensitivity to treatment-related change were each found to be acceptable for three out of four subscales . Two subscales , Energy Balance Knowledge and Cognitive Factors , predicted outcome . The major weakness of the subscales was a lack of unidimensionality which would limit their utility . Cluster and factor analyses were used to develop five new subscales with acceptable levels of internal consistency . While some additional development and validation is still needed , the available evidence suggests that we have the nucleus of a strong assessment tool for obesity research",
"The Spinal Cord Injury Rehabilitation Evidence ( SCIRE ) is a synthesis of the research evidence underlying rehabilitation interventions to improve the health of people living with SCI . SCIRE covers a comprehensive set of topics and in this issue we present six papers relevant to SCI rehabilitation clinicians ( SCI inpatient rehabilitation practice s , gait strategies , upper extremity reconstructive surgery , spasticity treatments , cardiovascular health and bone health ) . The SCIRE used a systematic and well-defined protocol to assess and synthesize the evidence . Each article was scored for its method ological quality using either the Physiotherapy Evidence Data base ( PEDro ) Score for r and omized controlled trials or the Downs and Black Tool for other types of studies . Following the individual study assessment , conclusions were drawn about the accumulated studies for each topic of interest based on the levels of evidence , quality of studies and concurring evidence . The SCIRE project was design ed for health professionals to inform them of best practice",
"OBJECTIVE This study examined the clinical significance of loss of control ( LOC ) over eating in bariatric surgery patients over 24 months of prospect i ve , multiwave follow-ups . METHOD Three hundred sixty-one gastric bypass surgery patients completed a battery of assessment s before surgery and at 6 , 12 , and 24 months following surgery . In addition to weight loss and LOC over eating , the assessment s targeted eating disorder psychopathology , depression levels , and quality of life . The study was conducted between January 2002 and February 2008 . RESULTS Prior to surgery , 61 % of patients reported general LOC ; postsurgery , 31 % reported LOC at 6-month follow-up , 36 % reported LOC at 12-month follow-up , and 39 % reported LOC at 24-month follow-up . Preoperative LOC did not predict postoperative outcomes . In contrast , mixed models analyses revealed that postsurgery LOC was predictive of weight loss outcomes : patients with LOC postsurgery lost significantly less weight at 12-month ( 34.6 % vs 37.2 % BMI loss ) and 24-month ( 35.8 % vs 39.1 % BMI loss ) postsurgery follow-ups . Postsurgery LOC also significantly predicted eating disorder psychopathology , depression , and quality of life at 12- and 24-month postsurgery follow-ups . CONCLUSIONS Preoperative LOC does not appear to be a negative prognostic indicator for postsurgical outcomes . Postoperative LOC , however , significantly predicts poorer postsurgical weight loss and psychosocial outcomes at 12 and 24 months following surgery . Since LOC following bariatric surgery significantly predicts attenuated postsurgical improvements , it may signal a need for clinical attention"
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41164548-06ff-11f0-808a-c43d1ab1c353
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OBJECT Chiari malformation Type I ( CM-I ) is a common and often debilitating neurological disease . Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes . To underst and current approaches and lay a foundation for future research , the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. METHODS The authors search ed PubMed , Embase , the Cumulative Index to Nursing and Allied Health Literature , Clinical Trials.gov , and Cochrane data bases to identify publications between January 2003 and August 2013 that met the following criteria : 1 ) reported clinical outcomes in patients treated for CM-I ; 2 ) were original research articles ; 3 ) included at least 10 patients or , if a comparative study , at least 5 patients per group ; and 4 ) were restricted to patients with CM-I. RESULTS Among the 74 papers meeting inclusion criteria , there was wide variation in the outcome methods used . However , all approaches were broadly grouped into 3 categories : 1 ) " gestalt " impression of overall symptomatic improvement ( n=45 papers ) ; 2 ) postoperative change in specific signs or symptoms ( n=20 ) ; or 3 ) results of various st and ardized assessment scales ( n=22 ) . Among st and ardized scales , 11 general function measures were used , compared with 6 disease-specific tools . Only 3 papers used scales vali date d in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches , the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably , only 7 articles incorporated patient-response instruments when reporting outcome , and only 22 articles explicitly assessed quality of life . CONCLUSIONS The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable , complicating efforts to analyze results across studies . Development , validation , and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients
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"Objective Many patients with symptomatic Chiari I malformation experience symptom recurrence after surgical decompression . Improved radiographic predictors of outcome are needed to better select patients most likely to benefit from surgical intervention . We examined whether ventral or dorsal cerebrospinal fluid ( CSF ) flow dynamics assessed by cine phase-contrast MRI scans could predict response to posterior fossa decompression for Chiari I malformation . Methods Forty-four consecutive pediatric patients undergoing pre-operative cine phase-contrast MRI followed by posterior fossa decompression for Chiari I malformation were retrospectively review ed . The association of pre-operative ventral or dorsal CSF flow abnormalities at the foramen magnum with symptom-free survival after surgical decompression was assessed via Kaplan – Meier plots and log-rank analysis . Results Mean ± SD age at time of surgery was 8 ± 6 years . Sixteen ( 36 % ) patients demonstrated decreased CSF flow dorsal to the cervico-medullary brainstem alone . Fourteen ( 32 % ) patients demonstrated abnormal CSF flow both ventral and dorsal to the cervico-medullary brainstem . Fourteen ( 32 % ) had normal hindbrain CSF flow . Overall , 13 ( 30 % ) patients experienced some degree of symptom recurrence by last follow-up ( mean of 27 ± 16 months post-operatively ) . Symptom recurrence did not differ as a function of degree of tonsilar ectopia ( p = 0.55 ) . Abnormal CSF flow dorsal to the cervico-medullary brainstem was not associated with symptom recurrence after surgical decompression ( p = 0.10 ) . However , combined pre-operative ventral and dorsal CSF flow abnormality was associated with a significant reduction ( 2.6-fold ) in the risk of post-operative symptom recurrence ( p experienced symptom recurrence 3.5 years after surgery versus 12 ( 40 % ) patients without ventral CSF flow pathology . There were otherwise no differences in baseline clinical , radiological , or operative variables between patients with abnormal versus normal ventral CSF flow . Conclusion The presence of decreased CSF flow both ventral and dorsal to the cervico-medullary brainstem was associated with improved response to hindbrain decompression for Chiari I malformation in children . Cine phase-contrast MRI may be a useful tool for surgical risk stratification and identifying patients that may be optimal surgical c and i date s. Combined ventral and dorsal hindbrain CSF flow pathology may better predict response to posterior fossa decompression compared to dorsal CSF flow pathology alone",
"OBJECT There is little information about the long-term effectiveness and complications following decompressive surgery for syringomyelia related to Chiari malformation Type I ( CM-I ) . METHODS Examining long-term clinical and radiological follow-up , the authors studied a mixed retrospective and prospect i ve single-institution cohort of 109 consecutive surgically treated adult patients with syringomyelia and CM-I. All patients underwent a st and ardized surgical protocol : decompression of the craniocervical junction , arachnoid exploration , and shrinkage of the cerebellar tonsils . Factors predicting outcome were investigated . RESULTS The retrospective arm consisted of 41 cases treated between 1990 and 1994 , and the prospect i ve arm comprised 68 patients treated between 1994 and 2001 . The mean overall age was 45.9 years , and 58.8 % of the population was female . The median follow-up period was 12.7 years . The most frequent initial symptoms were pain and sensory and gait disturbances . There was no perioperative death or neurological deterioration . The comprehensive perioperative complication rate was approximately 11 % , with 3 cases ( 2.7 % ) of CSF leakage . Regression analysis showed that the best combination of clinical and radiological outcome predictors was age and duration of symptoms . Clinical follow-up confirmed surgical result stability with clinical improvement of greater than 90 % of the spinal and cranial manifestations over a long-term period . Two patients had radiological recurrences of syringomyelia without clinical signs 85 and 124 months after surgery . CONCLUSIONS Certain clinical predictors of poor clinical and radiological prognosis were identified-namely , age at time of surgery and symptom duration . The results of the study provide additional long-term data that support the effectiveness and safety of relieving CSF block at the craniocervical junction in CM-I-related syringomyelia",
"Background : This study compared the use of two commonly utilized dural closure techniques used in augmentation duraplasty for Chiari malformation I ( CM I ) and evaluated their efficacy and outcome in terms of quality of life assessment s. Methods : This prospect i ve r and omized study compared sutureless ( DuraGen ) and suturable ( Dura-Guard ) techniques in CM I decompression . Clinical parameters , cost analysis , and SF-36 Quality of Life Question naire ( QLQ ) were utilized to assess outcome . Results : Thirty-four patients were enrolled . Average age was 38.7 ± 12.2 years ( mean ± SD ( St and ard Deviation ) ) and 82 % of patients were female . Sixteen patients received DuraGen and 18 Dura-Guard . Age and gender were similar among groups . Postoperative complications did not differ between groups . Operative cost and time were less for DuraGen , whereas hospital stay was less with Dura-Guard , neither was statistically significant . Average QLQ scores at months 1 , 2 , and 3 improved in both groups . Dura-Guard patients showed greater improvement in quality of life at month 2 ( P All patient 's physical health ( P 0.005 ) and function ( P in quality of life at final survey . All patients showed significant improvement in physical function , physical health , and outcome following surgery . With all variables being equal the choice of duraplasty material may be based upon surgeon 's preference",
"OBJECT The choice of surgical technique for decompressive surgery in patients with Chiari I malformation is controversial . Good preliminary postoperative outcomes have been achieved in patients with Chiari I malformation ( without syringomyelia ) after using a dura-splitting technique . The authors evaluated safety , re source use , and early outcome after this surgery in patients without syringomyelia and compared the findings associated with duraplasty in patients with syringomyelia . METHODS A prospect i ve series of 24 patients with Chiari I malformation ( 12 with a syrinx ) underwent decompression of the craniocervical junction ( CCJ ) . An allograft-augmented duraplasty was performed in patients with syringomyelia . Intraoperative ultrasonography confirmed adequate tonsillar decompression after lysis of the periosteal b and s at the foramen magnum and C-1 arch as well as partial resection of the outer leaf of the dura in patients without syringomyelia . Patients in each group were of similar mean age ( syringomyelia 10.8 years and no syringomyelia 7.6 years old ; p = 0.07 ) and functional status . The mean follow-up period was 15.3 months ( range 3 - 30 months ) . Dura-splitting decompression required significantly less mean operative time ( 99 minutes compared with 169 minutes , respectively ; p total operating room time ( 166 minutes compared with 249 minutes , respectively ; p duration of hospitalization ( 3 days compared with 3.75 days , respectively ; p perioperative charges ( $ 3615 compared with $ 5538 , respectively ; p overall hospital charges ( $ 7705 compared with $ 9759 , respectively ; p Mean clinical outcome scores were similar ( syringomyelia 1.53 of 2 ; no syringomyelia 1.67 of 2 ; not statistically significant ) . CONCLUSIONS Dura-splitting CCJ decompression in pediatric patients with Chiari I malformation and without syringomyelia is safe , provides good early clinical results , and significantly reduces re source use . A r and omized controlled trial of dura-splitting decompression in a uniform population of patients with Chiari I malformation is indicated",
"Summary Background . This prospect i ve study , conducted in patients with Chiari I malformation ( C I ) related syringomyelia who underwent posterior decompression and duroplasty , utilizes radionuclide cisternography in order to study the cerebrospinal fluid ( CSF ) dynamics at the foramen magnum and to predict the clinical outcome following surgery . Methods . 17 consecutive patients of C I with syringomyelia ( but without hydrocephalus or fixed atlanto-axial dislocation ) , underwent a detailed neurological examination and were assigned a clinical disability score based on the modified Klekamp and Samii score . A radionuclide cisternography ( using Tc99m-DTPA ) was performed via the lumbar route and the ascent of the tracer was followed utilizing a gamma camera immediately after injection and then sequentially after 1 , 2 , 4 , 6 and 24 hours . After posterior decompression and duroplasty , the modified Klekamp and Samii score was repeated at follow-up visits ( range : 3 months to one year ) along with radionuclide cisternography at 3 months , and MR imaging at 6 months . Findings . Three patterns of tracer flow were observed : a ) rapid flow ( n=7 ) ; b ) supratentorial subarachnoid delay ( n=7 ) ; and , c ) foramen magnum block ( n=3 ) . The patients having foramen magnum block had the poorest clinical scores on admission . At follow up , there was an improvement in the clinical scores so that the mean scores in all three categories reached nearly the same level . Following posterior decompression , the radionuclide cisternography performed in 10 patients showed a rapid flow of the tracer without any obstruction . The syrinx resolved in 4 of the 11 patients in whom an MRI was done . Interpretation . The patients with C I with syringomyelia may often have a free flow of tracer across the FM . Posterior decompression and duroplasty provides maximum clinical relief in patients with a demonstrable foramen magnum block on radionuclide cisternography while those with a normal flow have less relief . The symptomatology related to brain-stem compression immediately responds to the surgical procedure but the syrinx-induced signs and symptoms of spinal cord dysfunction persist",
"OBJECT Craniocervical decompression for Chiari malformation Type I ( CM-I ) and syringomyelia has been reported to fail in 10%-40 % of patients . The present prospect i ve clinical study was design ed to test the hypothesis that in cases in which syringomyelia persists after surgery , craniocervical decompression relieves neither the physiological block at the foramen magnum nor the mechanism of syringomyelia progression . METHODS The authors prospect ively evaluated and treated 16 patients with CM-I who had persistent syringomyelia despite previous craniocervical decompression . Testing before surgery included the following : 1 ) clinical examination ; 2 ) evaluation of the anatomy using T1-weighted MR imaging ; 3 ) assessment of the syrinx and CSF velocity and flow using cine phase-contrast MR imaging ; and 4 ) appraisal of the lumbar and cervical subarachnoid pressures at rest , during a Valsalva maneuver , during jugular compression , and following the removal of CSF ( CSF compliance measurement ) . During surgery , ultrasonography was performed to observe the motion of the cerebellar tonsils and syrinx walls ; pressure measurements were obtained from the intracranial and lumbar intrathecal spaces . The surgical procedure involved enlarging the previous craniectomy and performing an expansile duraplasty with autologous pericranium . Three to 6 months after surgery , clinical examination , MR imaging , and CSF pressure recordings were repeated . Clinical examination and MR imaging studies were then repeated annually . RESULTS Before reexploration , patients had a decreased size of the CSF pathways and a partial blockage in CSF transmission at the foramen magnum . Cervical subarachnoid pressure and pulse pressure were abnormally elevated . During surgery , ultrasonographic imaging demonstrated active pulsation of the cerebellar tonsils , with the tonsils descending during cardiac systole and concomitant narrowing of the upper pole of the syrinx . Three months after reoperation , patency of the CSF pathways was restored and pressure transmission was improved . The flow of syrinx fluid and the diameter of the syrinx decreased after surgery in 15 of 16 patients . CONCLUSIONS Persistent blockage of the CSF pathways at the foramen magnum result ed in increased pulsation of the cerebellar tonsils , which acted on a partially enclosed cervical subarachnoid space to create elevated cervical CSF pressure waves , which in turn affected the external surface of the spinal cord to force CSF into the spinal cord through the Virchow-Robin spaces and to propel the syrinx fluid caudally , leading to syrinx progression . A surgical procedure that reestablished the CSF pathways at the foramen magnum reversed this pathophysiological mechanism and resolved syringomyelia . Elucidating the pathophysiology of persistent syringomyelia has implication s for its primary and secondary treatment",
"Pain experienced by patients who have syringomyelia associated with Chiari I malformation ( SACM ) includes headache , cervicalgia and radiculalgia . We studied the correlation of clinical and imaging factors with the evolution of pain and surgical outcome at 12 months . We performed a prospect i ve study of 13 patients who presented with SACM and who underwent suboccipital decompression , C1 laminectomy , tonsillar coagulation and duraplasty . The Bidzinski Outcome Scale was used . Post-operatively , pain improvement was observed in 11 patients and the syrinx resolved in 6 patients and reduced in 7 . Eleven patients had a good or very good outcome , while 2 patients had a poor outcome . A post-operative medullary axial occupation of the syrinx less than 75 % of the spinal canal was associated with improved post-operative pain . Longer duration of symptomatology was associated with a poor outcome and failed pain control . The size and form of the syrinx , as well as early surgical treatment , are the factors that most influence the control of pain post-surgery in patients with SACM",
"To facilitate statistical analysis of the clinical course of patients with spinal lesions such as tumours , dysraphic malformations , inflammation , or syringomyelia , we have developed a score system for each of the following symptoms and signs : sensory deficits , dysaesthesiae , pain , motor weakness , gait , bladder and bowel function . For each a score between 0 and 5 is given . The grading is design ed in such a way that levels of functional significance receive separate scores : 0 = no function , 1 = severely disabled , 2 = disabled , 3 = severely compromised but function preserved , 4 = slightly compromised , and 5 = normal function . In general , scores between 0 and 2 indicate insufficient functional capacity and an unsatisfactory condition . Scores between 3 and 5 represent levels of function which should be the aim of treatment . We have used this scoring system for evaluation of almost 500 patients with spinal lesions both retrospectively and prospect ively with good results in terms of reproducibility and validity",
"Objective : The Chiari Symptom Profile ( CSP ) was developed to provide a quantitative assessment of self-reported Chiari (CMI)-related symptoms and their impact on the individual ’s quality of life . Methods : The instrument was developed in three phases . Phase I consisted of instrument development using exploratory item analysis from the literature and direct patient evaluations . The item pool was then analyzed and tested on a convenience sample of eight CMI patients . Interitem correlation matrix suggested redundancy of 13 questions . These items were discarded , result ing in a final question naire consisting of 57 items , measuring four realms : physical , functional , psychological , and social . Phases II and III tested the reliability and validity of the instrument using a large sample of patients diagnosed with Chiari/syringomyelia . Results : Statistical analysis confirmed that the CSP has excellent validity and reliability with a Cronbach ’s alpha of .958 ( p = .0001 ) and factor loadings ranging from .784 to .321 . Conclusion : The CSP is a self-reported , Chiari-/syringomyelia-specific instrument intended to provide a quantitative analysis of symptoms and their impact on the individual ’s quality of life . The CSP has shown statistically significant content validity , internal consistency , and test – retest reliability . The CSP will enhance the provider ’s underst and ing of Chiari-/syringomyelia-related symptoms , quantify the impact of self-reported symptoms on quality of life , help to determine if interventions are of benefit , and allow comparison of symptomatic improvement/ outcome following different surgical techniques",
"Background There have been few reports about the relation between the morphology of syrinxes and body pain in syringomyelia associated with Chiari I malformation . To investigate this phenomenon , the relation between the location of the syrinx and body pain before and after foramen magnum decompression ( FMD ) were evaluated . Methods The subjects were 20 patients with Chiari I malformation associated with syringomyelia who underwent FMD . The morphology of the syrinxes was classified into three types — enlarged type , which was a distended syrinx at the central spinal cord ; deviated type , which was a deviated syrinx posterolaterally within the spinal cord ; central type , which was a small syrinx at the central canal of the spinal cord — based on axial magnetic resonance imaging ( MRI ) . Preoperative and postoperative clinical symptoms and the body pain were evaluated by the Japanese Orthopaedic Association ( JOA ) score and a visual analogue scale ( VAS ) prospect ively . Results Preoperative and postoperative JOA scores showed no statistically significant differences between the three syrinx types . Intensity of body pain evaluated by the VAS showed that patients with a deviated-type syrinx on pre- and postoperative MRI tended to be associated with more intense pain than the other two types . Conclusions It was indicated that pain before and after surgery is more intense when the syrinx is deviated toward the spinal dorsal horn as seen on MRI",
"& NA ; Intraoperative electrophysiologic monitoring can diminish the risk of neurologic injury by enabling the detection of injury at a time when it can be reversed or minimized . Although it is clear that in patients with cervical spine disease monitoring during surgery reduces the incidence of neurologic injury , almost no data are available regarding its utility in patients undergoing suboccipital decompression for Chiari I malformation . Patients with Chiari I malformation have caudal displacement of the cerebellar tonsils below the skull base , thereby creating a tight foramen magnum and cervical canal . Although the majority of pediatric neurosurgeons perform a bony decompression with duraplasty for symptomatic patients , there is much controversy regarding the amount of bony decompression required for clinical improvement and whether a duraplasty is essential . The authors therefore conducted a prospect i ve , observational study using intraoperative brainstem auditory evoked potentials ( BAEPs ) and somatosensory evoked potentials in pediatric patients undergoing suboccipital decompressions for Chiari I malformations to determine whether there were consistent changes in intraoperative BAEPs that could help the operating surgeon decide how extensive a decompression was needed in these patients , and whether changes in BAEPs or somatosensory evoked potentials occurred during operative positioning that could be modified to reduce the risk of neurologic injury ",
"BACKGROUND Treatment options for Chiari I malformations include posterior fossa decompression ( PFD ) with additional techniques including laminectomy , intradural exploration , and duraplasty . Neuroimaging findings of cisterna magna volume , syringomyelia , and intraoperative ultrasonography may tailor surgical intervention . METHODS We developed an algorithm classifying symptomatic Chiari I patients into three groups to define minimum operation . Without syringomyelia , the presence of cisterna magna defined Group A and the absence defined Group B. Patients with syrinx formed Group C. Mild structural pathology ( Group A ) or adequate space following PFD ( Group B , normal intraoperative ultrasound ( IOUS ) ) should be treated by PFD alone . Conversely , presence of syringomyelia ( Group C ) or inadequate space following PFD ( Group B , abnormal IOUS ) should additionally have duraplasty . We applied this algorithm to patients treated at a single institution over 16 years . RESULTS Twenty-four symptomatic Chiari I malformation patients were divided into three groups that did not differ by age , gender , or extent of tonsillar ectopia . All patients treated by this algorithm experienced clinical and radiographic improvement . This included eight Group B patients who underwent PFD only ( n=6 ) or additional duraplasty ( n=2 ) decided by IOUS . CONCLUSION Treatment of symptomatic Chiari I malformation may have inadequate outcome with conservative strategy or complications with aggressive strategy . This algorithm utilizes preoperative neuroimaging and intraoperative ultrasound to tailor intervention , with excellent clinical outcome and radiographic syrinx resolution on application to 24 patients . Further validation requires prospect i ve multicenter evaluation with larger patient population",
"OBJECT The aim of this paper was to measure the posterior fossa ( PF ) volume increase result ing from a given-sized occipital craniectomy in Chiari malformation Type I surgery and to analyze its correlations with the PF size and the treatment response , with the perspective of tailoring the amount of bone removal to the patient-specific PF dimensions . METHODS Between January 2005 and June 2006 , 11 adult patients with symptomatic Chiari malformation Type I underwent a st and ardized PF decompression . A prospect i ve evaluation with clinical examination , functional grading , and MR imaging measurement protocol s was performed pre- and postoperatively . A method is reported for the measurement of PF volume ( PFV ) after surgery . The degree of PFV increase was compared with the preoperative size of the PF and with the clinical outcome . RESULTS All 11 patients improved postoperatively , with complete and partial recovery in 4 and 7 patients , respectively . No postoperative complication occurred after a mean follow-up period of 45 months . The mean relative increase in PFV accounted for 10 % ( range 1.5%-19.7 % ) of the initial PFV ; the increase was greater in cases in which the PF was small ( r = -0.52 , p = 0.09 ) and the basiocciput was short ( r = -0.37 , p = 0.2 ) . A statistically significant positive correlation was found between the degree of PFV increase and the treatment response ( p = 0.014 ) ; complete recovery was observed with a PFV increase of 15 % and partial recovery with an increase of 7 % . CONCLUSIONS The treatment response is significantly influenced by the degree of PFV increase , which is dependent on the size of the PF and the extent of the craniectomy , suggesting that the optimal patient-specific PFV increase could be predicted on the basis of preoperative MR imaging and enhancing the perspective that the craniectomy size could be tailored to the individual PFV",
"BACKGROUND Foramen magnum decompression is widely accepted as the treatment of choice for Chiari I malformation . However , important surgical details of the procedure are controversial . OBJECTIVE This study analyzes 371 decompressions focusing on intraoperative findings , analysis of complications , and long-term outcomes . METHODS Among 644 patients between 1985 and 2010 , 359 patients underwent 371 decompressions . Surgery for symptomatic patients consisted of suboccipital craniectomy , C1 laminectomy , arachnoid dissection , and duraplasty . Short-term results were determined after 3 months ; long-term outcomes were evaluated with Kaplan-Meier statistics . RESULTS The mean age was 40 ± 16 years ; mean follow-up was 49 ± 56 months ; 75.8 % demonstrated syringomyelia . The complication rate was 21.8 % with permanent surgical morbidity of 3.2 % and surgical mortality of 1.3 % . Of the patients , 73.6 % reported improvement after 3 months ; 21 % were unchanged . Overall , 14.3 % demonstrated a neurological deterioration within 5 years and 15.4 % within 10 years . The severity of neurological symptoms correlated with the grade of arachnoid pathology . Outcome data correlated with the number of previous decompressions , severity of arachnoid pathology , h and ling of the arachnoid , type of duraplasty , and surgical experience . First-time decompressions with arachnoid dissection and an alloplastic duraplasty result ed in surgical morbidity for 2.0 % , a 0.9 % mortality rate , postoperative improvement after 3 months for 82 % , and neurological recurrence rates of 7 % after 5 years and 8.7 % after 10 years . CONCLUSION Arachnoid pathology in Chiari I malformation has an impact on clinical symptoms and postoperative results . Decompressions with arachnoid dissection and an alloplastic duraplasty performed by surgeons experienced with this pathology offer a favorable long-term prognosis",
"Objective The aim of this prospect i ve study was to define the role of cardiac gated phase-contrast ciné magnetic resonance imaging in deciding the therapeutic strategy in patients with Chiari I malformation . Material s and methods Twenty-one patients operated on between February 2000 and July 2002 were enrolled in the study . All patients underwent a detailed preoperative neurological examination . MRI of the craniovertebral junction and the whole spine was done , followed by cardiac gated phase contrast ciné magnetic resonance imaging . Results Signs and symptoms of syringomyelia were noted in 15 patients and cerebellar signs in 11 patients . Three of them had trigeminal nerve involvement , and 4 had ninth and tenth cranial nerve involvement . The sixth and accessory nerves were involved in 1 patient each . Preoperative CSF flow studies revealed obstructive flow both anteriorly and posteriorly in 6 patients and only posterior block in 15 patients . One patient investigated for failed foramen magnum decompression revealed obstruction to CSF flow ventrally . Foramen magnum decompression with duroplasty was done in all these cases . The patient who had a persistent ventral flow block underwent odontoidectomy . Patients were followed up for a maximum of 36 months , with a mean of 18 months . MRI CSF flow studies revealed established flow dorsally in all cases . Seventeen patients showed clinical improvement and 2 of them did not show any neurological changes . Two patients deteriorated following an initial period with a shunt . Conclusion MRI CSF flow study is an effective tool for deciding the type of surgery to be performed and also for monitoring patients postoperatively",
"OBJECT The purpose of this prospect i ve study was to determine if there was a difference in the self-perceived quality of life ( QOL ) before and after surgery among patients with Chiari I malformations with or without syringomyelia . Most patients with Chiari I malformations report improvement in their QOL after decompression surgery ; however , specific outcome data have not been empirically studied in this patient population . METHODS One hundred seventy-two consecutive patients who underwent posterior fossa decompression based on neuroimaging evidence of a Chiari I malformation with or without syringomyelia were prospect ively offered participation in the study . The Sickness Impact Profile ( SIP ) was chosen as the instrument for data collection . Completed question naires were returned by 112 patients . A statistically significant improvement ( p SIP scores ( self-reported QOL ) was noted in 84 % of participants after decompression surgery . Patient age , amount of tonsillar herniation , and evidence of syringomyelia before surgery did not correlate with or adversely affect outcomes . Among 16 participants who reported worsening in their QOL , anecdotal information revealed extraneous factors unrelated to the Chiari I malformation that they perceived as negatively influencing their outcome . Among the extraneous variables noted by the participants were general health status , unrelated injury , other illnesses , and significant stress . CONCLUSIONS The majority of participants who underwent posterior fossa surgery for a Chiari I malformation reported significant improvement in their QOL after surgery",
"AIM This study was design ed to determine the hemodynamics of cerebrospinal fluid flow in syringomyelia patients associated with Chiari I malformation using phase-contrast velocity-encoded-cine MRI and also to find out whether treatment outcomes may be predicted by these flow measurements . MATERIAL AND METHODS Eighteen consecutive symptomatic patients with syringomyelia associated with Chiari 1 malformation were included . The PC VEC MRI was performed at the level of foramen magnum and syrinx cavity both preoperatively and 6 months postoperatively . Following surgery , the modified Asgari score was calculated , and the association between CSF flow pattern and clinical outcome was assessed . RESULTS Evaluation of clinical symptoms at postoperative 6th month revealed improvement in 11 ( 61 % ) patients and stabilization in 5 ( 28 % ) patients whereas results were poor in 2 ( 11 % ) patients . Preoperative cine MRI flow studies showed a heterogeneous pattern at the foramen magnum level in all of the patients . Postoperative cine MR flow studies demonstrated the change from heterogeneous pattern to sinusoidal pattern in 11 patients and a decrease in heterogeneity in 7 patients . CONCLUSION Our results indicate that CSF flow measurements using PC VEC MRI can give important information regarding the prognosis and follow-up of the patients with Chiari I malformation",
"BACKGROUND There has been a transition to using patient-reported outcome instruments ( PROi ) to assess surgical effectiveness . However , none of these instruments have been vali date d for outcomes of adult Chiari I malformation ( CMI ) . OBJECTIVE The aim of this study was to determine the relative validity and responsiveness of various PROi in measuring outcomes after surgery for CMI . METHODS Fifty patients undergoing suboccipital craniotomy for adult CMI were prospect ively followed for 1 year . Baseline and 1-year patient-reported outcomes ( visual analog scale for head pain and visual analog scale for neck pain , Neck Disability Index [ NDI ] , Headache Disability Index , SF-12 , Zung Self-Rating Depression Scale , and EuroQol-5D [ EQ-5D ] ) were assessed . A level of improvement in general health after surgery was defined as meaningful improvement . Receiver-operating characteristic curves were generated to assess the validity of PROi to discriminate between meaningful improvement and not . The difference between st and ardized response means ( SRMs ) in patients reporting meaningful improvement vs not as calculated to determine the relative responsiveness of each outcome instrument . RESULTS For pain and disability , the NDI was the most accurate discriminator of meaningful effectiveness ( area under the curve : 0.90 ) and also most responsive to postoperative improvement ( st and ardized response means difference : 1.87 ) . For general health and quality of life , the SF-12 PCS , EQ-5D , and Zung Self-Rating Depression Scale were all accurate discriminators ; however , SF-12 Physical Component Scale ( SF-12 PCS ) and EQ-5D were most accurate . SF-12 PCS was also most responsive . CONCLUSION For pain and disability , NDI is the most valid and responsive measure of improvement after surgery for CMI . For health-related quality of life , SF-12 PCS and EQ-5D are the most valid and responsive measures . NDI with SF-12 or EQ-5D is the most valid in patients with CMI and should be considered in cost-effectiveness studies"
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Introduction : There are various studies looking at the effects of formocresol ( FC ) and mineral trioxide aggregate ( MTA ) on pulpotomy of primary molars . This is a systematic review of literature comparing the success rates of MTA and FC in pulpotomy of primary molars . Material s and Methods : The study list was obtained using PubMed , EMBASE , Scopus , Science Citation Index , Iran Medex , Google Scholar , the Cochrane Library , and also some h and search es contains through dental journals approved by the Iranian Ministry of Health . Papers which met the inclusion were accepted . The quality of studies for the meta- analysis was assessed by a series of validity criteria according to Jadad 's scale . Eight qualified studies met the criteria . Terms of clinical outcomes and radiographic findings were evaluated in all studies to assess clinical success and root resorption . Fixed model was applied to aggregate the data of homogenous studies . A r and om effect model was carried out for measuring the effect size of heterogeneous studies . Results : The overall clinical and radiographic success rates based on the data suggested that MTA was superior to FC ( P=0.004 ) with the Odds Ratio=3.535 and 95 % confidence interval ( 1.494 - 8.369 ) . Conclusion : Primary molars pulpotomy with MTA have better clinical and radiographic success rates than FC . ( Iranian Endodontic Journal 2008;3:45 - 9
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"PURPOSE The objective of this study was to assess the effect of mineral trioxide aggregate ( MTA ) as pulp dressing material following pulpotomy in primary molars with carious pulp exposure and compare them to those of formocresol ( FC ) . METHODS Of 33 children , primary molars treated via a conventional pulpotomy technique were r and omly assigned to the MTA group ( 33 teeth ) or FC group ( 29 teeth ) . Clinical and radiographic follow-up ranged between 4 and 74 months . The mean follow-up time was 38 months , with no difference between the groups . Twenty-nine teeth were followed until uneventful shedding ( mean=33 months ) . Failures were detected after a mean period of 16 months ( range=4 to 30 ) . RESULTS The success rate of pulpotomy was 97 % for MTA ( 1 failure ) and 83 % for FC ( 5 failures ) . Eight teeth presented internal resorption . In 4 of them ( 2 of each group ) , progress of the resorption process stopped and the pulp tissue was replaced by a radioopaque calcified tissue . Pulp canal obliteration was observed in 58 % of the MTA group and in 52 % of the FC group ( total=55 % ) . CONCLUSIONS MTA showed a higher ( though not statistically significant ) long-term clinical and radiographic success rate than formocresol , and can be recommended as its replacement as , unlike FC , MTA does not induce undesirable responses",
"AIM To compare the outcome after 6 months of the application of formocresol ( FC ) or mineral trioxide aggregate ( MTA ) during pulpotomy in primary molar teeth . METHODOLOGY A maximum of 126 children ( aged 5 - 9 years ) with carious primary teeth that required pulpotomy were selected . Following r and omization , a st and ard pulpotomy preparation was undertaken , and the coronal pulp removed and bleeding arrested . In the FC group , cotton balls , soaked in FC , were placed for 5 min , and then the pulp chamber was filled with Zonalin , a pulpotomy agent . In the MTA group , a 1-mm-thick paste of MTA was used as a pulpotomy agent . The crowns in both groups were restored with amalgam or glass ionomer . The teeth of 100 patients were evaluated and compared clinical ly and radiographically after 3 and 6 months . RESULTS No signs of clinical failure were observed at the 3- and 6-month follow-up appointments in either group . There were no significant differences in the radiographic findings of the teeth and surrounding tissue at the 3-month follow-up . However , at the 6-month follow-up , significantly more cases ( P = 0.036 ) with root resorption were seen in the FC group ; no cases of resorption occurred amongst the MTA cases . The surrounding tissue showed radiographic signs of post-treatment disease in four FC cases ; none was seen in the MTA cases . CONCLUSION After 6 months , pulpotomy with MTA was associated with fewer cases of root resorption and post-treatment disease . MTA appears to be a reliable alternative material for pulpotomy in primary molar teeth",
"PURPOSE The aim of this study was to compare the effect of mineral trioxide aggregate ( MTA ) to that of formocresol ( FC ) as pulp dressing agents in pulpotomized primary molars with carious pulp exposure . METHODS Forty-five primary molars of 26 children were treated by a conventional pulpotomy technique . The teeth were r and omly assigned to the MTA ( experimental ) or FC ( control ) group by a toss of a coin . Following removal of the coronal pulp and hemostasis the pulp stumps were covered with an MTA paste in the experimental group . In the control group , FC was placed with a cotton pellet over the pulp stumps for 5 minutes and removed ; the pulp stumps were then covered by zinc oxide-eugenol ( ZOE ) paste . The teeth of both groups were restored with stainless steel crowns . Eighteen children with 32 teeth arrived for clinical and radiographic follow-up evaluation ranging from 6 to 30 months . RESULTS The follow-up evaluations revealed only one failure ( internal resorption detected at a 17 months postoperative evaluation ) in a molar treated with formocresol . None of the MTA-treated teeth showed any clinical or radiographic pathology . Pulp canal obliteration was observed in 9 of 32 ( 28 % ) evaluated molars . This finding was detected in 2 out of the 15 teeth treated with FC ( 13 % ) and in 7 out of the 17 treated with MTA ( 41 % ) . CONCLUSION MTA showed clinical and radiographic success as a dressing material following pulpotomy in primary teeth and seems to be a suitable replacement for formocresol in primary teeth",
"Seventy primary molar teeth , carious exposed , symptom free , without any sign of root resorption in children aged from 3 to 6 years ( main age 4.3 yr ) were treated with conventional pulpotomy procedures . Ferric sulfate 15.5 % solution ( applied for 15 second for 35 teeth ) and formocresol solution ( five minute procedure of Buckley 's formula for next 35 teeth ) have been used as pulpotomy agents . In both groups , pulp stumps were covered with zinc-oxide eugenol paste . Permanent restorations were stainless steel crowns . Clinical check up was every three-months and radiographic follow-up time was six and twenty months after treatment . Our results within this period revealed 100 % clinical success rate in both groups . Radiographic success rate was in both groups 97.2 % , while in 2.8 % cases has shown internal root resorption . On the basis of these results , we can recommend ferric sulfate as a pulpotomy agent in primary teeth in substitution for formocresol at the moment",
"PURPOSE The aim of this study was to use clinical , radiographic , and histologic examinations to compare the relative success of gray mineral trioxide aggregate ( MTA ) , white MTA , and formocresol as pulp dressings in pulpotomized primary teeth . METHODS Twenty-four children , each with at least 3 primary molars requiring pulpotomy , were selected for this study 's clinical and radiographic portion . An additional 15 carious primary teeth planned for serial extraction were selected for this study 's histologic portion . All selected teeth were evenly divided into 3 test groups and treated with pulpotomies . Gray MTA was used as the pulp dressing for one third of the teeth , white MTA was the dressing for one third , and the remaining one third were treated with formocresol . The treated teeth selected for the clinical and radiographic evaluations were monitored periodically for 12 months . The treated teeth selected for histologic study were monitored periodically and extracted 6 months postoperatively . RESULTS Four children with 12 pulpotomized teeth failed to return for any follow-up evaluations in the clinical and radiographic study . Of the remaining 60 teeth in 20 patients , 1 tooth ( gray MTA ) exfoliated normally and 6 teeth ( 4 white MTA and 2 formocresol ) failed due to abscesses . The remaining 53 teeth appeared to be clinical ly and radiographically successful 12 months postoperatively . Pulp canal obliteration was a radiographic finding in 11 teeth treated with gray MTA and 1 tooth treated with white MTA . In the histologic study , both types of MTA successfully induced thick dentin bridge formation at the amputation sites , while formocresol induced thin , poorly calcified dentin . Teeth treated with gray MTA demonstrated pulp architecture nearest to normal pulp by preserving the odontoblastic layer and delicate fibrocellular matrix , yet few inflammatory cells or isolated calcified bodies were seen . Teeth treated with white MTA showed a denser fibrotic pattern , with more isolated calcifications in the pulp tissue along with secondary dentin formation . CONCLUSIONS Gray MTA appears to be superior to white MTA and formocresol as a pulp dressing for pulpotomized primary teeth",
"UNLABELLED The aim of the present study was to compare , clinical ly and radiographically , the mineral trioxide aggregate ( MTA ) to formocresol ( FC ) when used as medicaments in pulpotomized vital human primary molars . METHODS The sample consisted of 120 primary molars , all teeth were treated with the same conventional pulpotomy technique . Sixty molars received FC and 60 received MTA throughout a r and om selection technique . RESULTS At the end of 24-month evaluation period , 74 molars ( 36 FC , 38 MTA ) were available for clinical and radiographic evaluation . None of the MTA treated teeth showed any clinical or radiographic pathology , while the FC group showed a success rate of 86.8 % radiographically and 98.6 % clinical ly . The difference between the two groups in the radiographic outcomes was statistically significant . It was concluded that MTA treated molars demonstrated significantly greater success . MTA seems to be a suitable replacement for formocresol in pulpotomized primary teeth",
"The clinical success and effect upon the age at which teeth exfoliated was prospect ively observed in 175 primary molars that had received formoceresol pulpotomies performed by one operator . The success rate among 142 vital teeth was 99.3 % and among 33 non-vital teeth 84.8 % . There was no significant effect upon age at exfoliation after either type of pulpal treatment"
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411645d4-06ff-11f0-808a-c43d1ab1c353
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This review aims to : Identify the effectiveness of nurse-led care in general practice in comparison to general practitioner care on clinical outcomes such as systolic and diastolic blood pressure , weight , BMI , HbA1c , and cholesterol in adults ( > 18 years of age ) with type 2 diabetes . Criteria for considering studies for this review Types of participants Participants will be adults ( aged > 18 years ) , with type 2 diabetes attending a general/family practice . Types of intervention Studies will be considered for inclusion in the review if they compare nurse-led care and general practitioner-led care of patients with type 2 diabetes in general practice . Types of outcome of interest The primary outcomes of interest to this systematic review are : • Clinical outcomes for adult patients of general/family practice with type 2 diabetes . It is envisioned that these may be measured by : oChanges in systolic and diastolic blood pressure oChanges in BMI oChanges in cholesterol levels oChanges in HbA1c Studies will not be required to address all of these outcomes to be eligible for inclusion
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"BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans",
"Background The Health Improvement and Prevention Study ( HIPS ) study aims to evaluate the capacity of general practice to identify patients at high risk for developing vascular disease and to reduce their risk of vascular disease and diabetes through behavioural interventions delivered in general practice and by the local primary care organization . Methods / Design HIPS is a stratified r and omized controlled trial involving 30 general practice s in NSW , Australia . Practice s are r and omly allocated to an ' intervention ' or ' control ' group . General practitioners ( GPs ) and practice nurses ( PNs ) are offered training in lifestyle counselling and motivational interviewing as well as practice visits and patient educational re sources . Patients enrolled in the trial present for a health check in which the GP and PN provide brief lifestyle counselling based on the 5As model ( ask , assess , advise , assist , and arrange ) and refer high risk patients to a diet education and physical activity program . The program consists of two individual visits with a dietician or exercise physiologist and four group sessions , after which patients are followed up by the GP or PN . In each practice 160 eligible patients aged between 40 and 64 years are invited to participate in the study , with the expectation that 40 will be eligible and willing to participate . Evaluation data collection consists of ( 1 ) a practice question naire , ( 2 ) GP and PN question naires to assess preventive care attitudes and practice s , ( 3 ) patient question naire to assess self-reported lifestyle behaviours and readiness to change , ( 4 ) physical assessment including weight , height , body mass index ( BMI ) , waist circumference and blood pressure , ( 5 ) a fasting blood test for glucose and lipids , ( 6 ) a clinical record audit , and ( 7 ) qualitative data collection . All measures are collected at baseline and 12 months except the patient question naire which is also collected at 6 months . Study outcomes before and after the intervention is compared between intervention and control groups after adjusting for baseline differences and clustering at the level of the practice . Discussion This study will provide evidence of the effectiveness of a primary care intervention to reduce the risk of cardiovascular disease and diabetes in general practice patients . It will inform current policies and programs design ed to prevent these conditions in Australian primary health care . Trial Registration",
"Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms ",
"A decision support system for the management of oral hypoglycaemic therapy in type II diabetes was evaluated . The ruleset contained therein forms the basis of a prototype computer programme , but in order to assess the robustness of the individual rules , it was decided it was necessary to use a paper-based form of the ruleset . A nurse with no previous experience of managing type II diabetes was trained to use the system and then undertook the exclusive management of half of all new type II diabetics , from a district population of 300,000 , over a 16-month period . General practice s within this area were divided into two groups , study and control , matching for size , geographical area and st and ards of existing diabetes care . Patients ( n = 102 ) from the study group practice s were then assigned to her care . Those patients ( n = 116 ) in the control group of practice s were treated according to their normal procedures . The decision support system for oral hypoglycaemic therapy was based on the following criteria : the current type of treatment ( six levels ) ; current glycaemic control ( HbA1 and FBS)-whether improving , steady or worsening ; and weight-%IBW , whether rising , steady or falling . Each of these parameters was carefully defined on the basis of established practice and clinical experience . Patients after initial education were seen at their usual clinic by the nurse only , on a monthly basis , until satisfactory glycaemic control was established and thereafter review ed 3 monthly . She was also responsible for ensuring the organisation of Diabetes Annual Review procedures . The medical records of the control group patients were examined at the end of the study and data on glycaemic control and Annual Review s extracted . In the study group 98 % patients achieved HbA1 levels within the normal range and all patients had full annual review s performed . The control practice s achieved much poorer degrees of metabolic control ( P frequency of clinical hypoglycaemia consequent upon better blood sugar control . No exceptions to the ruleset , as initially defined , were detected . In conclusion , this decision support system was successful at achieving st and ards of diabetes control and care equal to or better than conventional structures of diabetes care . Implementation of such a system , on a simple computer platform , could greatly assist and possibly improve diabetes management in general practice",
"OBJECTIVE To determine whether diabetes care directed by nurses following detailed protocol s and algorithms and supervised by a diabetologist results in meeting the evidence -based American Diabetes Association ( ADA ) process and outcome measures more often than care directed under usual care in a minority population . RESEARCH DESIGN AND METHODS Studies were mainly conducted in two Los Angeles County clinics . In clinic A , nurse-directed diabetes care was provided to 252 patients ( 92 % Hispanic and 2 % African-American ) referred by their primary care providers . These patients were hierarchically matched with 252 diabetic patients in clinic B ( 79 % Hispanic and 19 % African American ) . When nurse-directed care was abruptly discontinued in clinic A for administrative reasons , it was reestablished in clinic B. Those patients were r and omly selected from a teaching clinic , and the outcomes in 114 patients who completed 1 year were compared with outcomes derived the year before receiving nurses ' care . The following process and outcome measures were assessed in the study : 1 ) number of visits , 2 ) diabetes education , 3 ) nutritional counseling , 4 ) HbA(1c ) , 5 ) lipid profiles , 6 ) eye exams , 7 ) foot exams , 8) renal evaluations , and 9 ) ACE inhibitor therapy in appropriate patients . RESULTS For patients under nurse-directed diabetes care in both clinics A and B , almost all process measures were carried out significantly more frequently than for the appropriate control patients . Under the care of nurses in clinic A , HbA(1c ) levels fell 3.5 % from 13.3 to 9.8 % in the 120 patients who were followed for at least 6 months , as compared with a 1.5 % fall from 12.3 to 10.8 % under usual ( physician-directed ) care in clinic B. During the year before enrolling in nurse-directed care in clinic B , mean HbA(1c ) levels decreased from 10.0 to 8.5 % . At the end of a year under the nurses ' care , the values fell further to 7.1 % . The median value fell from 8.3 to 6.6 % . CONCLUSIONS Specially trained nurses who follow detailed protocol s and algorithms under the supervision of a diabetologist can markedly improve diabetes outcomes in a minority population . This approach could help blunt the increased morbidity and mortality noted in minority population",
"Background In the presence of type 2 diabetes ( T2DM ) or coronary heart disease ( CHD ) , depression is under diagnosed and under treated despite being associated with worse clinical outcomes . Our earlier pilot study demonstrated that it was feasible , acceptable and affordable for practice nurses to extend their role to include screening for and monitoring of depression alongside biological and lifestyle risk factors . The current study will compare the clinical outcomes of our model of practice nurse-led collaborative care with usual care for patients with depression and T2DM or CHD . Methods This is a cluster-r and omised intervention trial . Eighteen general practice s from regional and metropolitan areas agreed to join this study , and were allocated r and omly to an intervention or control group . We aim to recruit 50 patients with co-morbid depression and diabetes or heart disease from each of these practice s. In the intervention group , practice nurses ( PNs ) will be trained for their enhanced roles in this nurse-led collaborative care study . Patients will be invited to attend a practice nurse consultation every 3 months prior to seeing their usual general practitioner . The PN will assess psychological , physiological and lifestyle parameters then work with the patient to set management goals . The outcome of this assessment will form the basis of a GP Management Plan document . In the control group , the patients will continue to receive their usual care for the first six months of the study before the PNs undergo the training and switch to the intervention protocol . The primary clinical outcome will be a reduction in the depression score . The study will also measure the impact on physiological measures , quality of life and on patient attitude to health care delivered by practice nurses . Conclusion The strength of this programme is that it provides a sustainable model of chronic disease management with monitoring and self-management assistance for physiological , lifestyle and psychological risk factors for high-risk patients with co-morbid depression , diabetes or heart disease . The study will demonstrate whether nurse-led collaborative care achieves better outcomes than usual care",
"BACKGROUND Patients with depression and poorly controlled diabetes , coronary heart disease , or both have an increased risk of adverse outcomes and high health care costs . We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients . METHODS We conducted a single-blind , r and omized , controlled trial in 14 primary care clinics in an integrated health care system in Washington State , involving 214 participants with poorly controlled diabetes , coronary heart disease , or both and coexisting depression . Patients were r and omly assigned to the usual-care group or to the intervention group , in which a medically supervised nurse , working with each patient 's primary care physician , provided guideline -based , collaborative care management , with the goal of controlling risk factors associated with multiple diseases . The primary outcome was based on simultaneous modeling of glycated hemoglobin , low-density lipoprotein ( LDL ) cholesterol , and systolic blood-pressure levels and Symptom Checklist-20 ( SCL-20 ) depression outcomes at 12 months ; this modeling allowed estimation of a single overall treatment effect . RESULTS As compared with controls , patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels ( difference , 0.58 % ) , LDL cholesterol levels ( difference , 6.9 mg per deciliter [ 0.2 mmol per liter ] ) , systolic blood pressure ( difference , 5.1 mm Hg ) , and SCL-20 depression scores ( difference , 0.40 points ) ( P adjustments of insulin ( P=0.006 ) , antihypertensive medications ( P antidepressant medications ( P better quality of life ( P greater satisfaction with care for diabetes , coronary heart disease , or both ( P with care for depression ( P usual care , an intervention involving nurses who provided guideline -based , patient-centered management of depression and chronic disease significantly improved control of medical disease and depression . ( Funded by the National Institute of Mental Health ; Clinical Trials.gov number , NCT00468676 . )",
"Background : National guidelines for managing diabetes set st and ards for care . We sought to determine whether a 1-year intensive multitherapy program result ed in greater goal attainment than usual care among patients with poorly controlled type 2 diabetes mellitus . Methods : We identified patients with poorly controlled type 2 diabetes receiving outpatient care in the community or at our hospital . Patients 30–70 years of age with a hemoglobin A1c concentration of 8 % or greater were r and omly assigned to receive intensive multitherapy ( n = 36 ) or usual care ( n = 36 ) . Results : The average hemoglobin A1c concentration at entry was 9.1 % ( st and ard deviation [ SD ] 1 % ) in the intensive therapy group and 9.3 % ( SD 1 % ) in the usual therapy group . By 12 months , a higher proportion of patients in the intensive therapy group than in the control group had achieved Canadian Diabetes Association ( CDA ) goals for hemoglobin A1c concentrations ( goal ≤ 7.0 % : 35 % v. 8 % ) , diastolic blood pressure ( goal , low-density lipoprotein cholesterol ( LDL-C ) levels ( goal and triglyceride levels ( goal targets for fasting plasma glucose levels , systolic blood pressure or total cholesterol : high-density lipoprotein cholesterol ratio . None of the patients reached all CDA treatment goals . By 18 months , differences in goal attainment were no longer evident between the 2 groups , except for LDL-C levels . Quality of life , as measured by a specific question naire , increased in both groups , with a greater increase in the intensive therapy group ( 13 % [ SD 10 % ] v. 6 % [ SD 13 % ] , p Interpretation : Intensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association . However , 6 months after intensive therapy stopped and patients returned to usual care , the benefits had vanished",
"OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients",
"Background : First Nations people with diabetes mellitus and hypertension are at greater risk of renal and cardiovascular complications than are non-native patients because of barriers to health care services . We conducted this r and omized controlled trial to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes . Methods : We compared 2 community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes . In the intervention group , a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy . In the control group , treatment decisions were made by each subject 's primary care physician . The primary outcome measure was the difference between the 2 groups in the change in systolic blood pressure after 12 months . Secondary outcome measures were the change in diastolic blood pressure over time , the change in urine albumin status and the incidence of adverse events . Results : Both groups experienced a significant reduction in systolic blood pressure by the final visit ( by 24.0 [ st and ard deviation ( SD ) 13.5 ] mm Hg in the intervention group and by 17.0 [ SD 18.6 ] mm Hg in the control group ) ; p diastolic blood pressure over time than did those in the control group ( by 11.6 [ SD 10.6 ] mm Hg v. 6.8 [ SD 11.1 ] mm Hg respectively ; p = 0.05 ) . The groups did not differ significantly in terms of changes in urine albumin excretion or incidence of adverse events . Interpretation : High rates of blood pressure control in the community were achieved in both groups in the DREAM 3 study . The addition of a home care nurse to implement a treatment strategy for blood pressure control was more effective in lowering diastolic than systolic blood pressure compared with home care visits for blood pressure monitoring alone and follow-up treatment by a family physician",
"Background Type 2 diabetes mellitus is a complex , progressive disease which requires a variety of quality improvement strategies . Limited information is available on the feasibility and effectiveness of interdisciplinary diabetes care teams ( IDCT ) operating on the interface between primary and specialty care . A first study hypothesis was that the implementation of an IDCT is feasible in a health care setting with limited tradition in shared care . A second hypothesis was that patients who make use of an IDCT would have significantly better outcomes compared to non-users of the IDCT after an 18-month intervention period . A third hypothesis was that patients who used the IDCT in an Advanced quality Improvement Program ( AQIP ) would have significantly better outcomes compared to users of a Usual Quality Improvement Program ( UQIP ) . Methods This investigation comprised a two-arm cluster r and omized trial conducted in a primary care setting in Belgium . Primary care physicians ( PCPs , n = 120 ) and their patients with type 2 diabetes mellitus ( n = 2495 ) were included and subjects were r and omly assigned to the intervention arms . The IDCT acted as a cornerstone to both the intervention arms , but the number , type and intensity of IDCT related interventions varied depending upon the intervention arm . Results Final registration included 67 PCPs and 1577 patients in the AQIP and 53 PCPs and 918 patients in the UQIP . 84 % of the PCPs made use of the IDCT . The expected participation rate in patients ( 30 % ) was not attained , with 12,5 % of the patients using the IDCT . When comparing users and non-users of the IDCT ( irrespective of the intervention arm ) and after 18 months of intervention the use of the IDCT was significantly associated with improvements in HbA1c , LDL-cholesterol , an increase in statins and anti-platelet therapy as well as the number of targets that were reached . When comparing users of the IDCT in the two intervention arms no significant differences were noted , except for anti-platelet therapy . Conclusion IDCT 's operating on the interface between primary and specialty care are associated with improved outcomes of care . More research is required on what team and program characteristics contribute to improvements in diabetes care . Trial registration NTR 1369",
"OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes . We hypothesized that structured care would reduce renal complications in type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were r and omly assigned to receive structured care ( n = 104 ) or usual care ( n = 101 ) for 2 years . The structured care group was managed according to a prespecified protocol with the following treatment goals : blood pressure renin-angiotensin blockers . The primary end point was death and /or renal end point ( creatinine > 500 μmol/l or dialysis ) . RESULTS Of these 205 patients ( mean ± SD age 65 ± 7.2 years ; disease duration 14 ± 7.9 years ) , the structured care group achieved better control than the usual care group ( diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg , respectively , P = 0.02 ; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6 % , P structured care ( 23.1 % , n = 24 ) and usual care ( 23.8 % , n = 24 ; NS ) groups had similar end points , but more patients in the structured care group attained ≥3 treatment goals ( 61 % , n = 63 , vs. 28 % , n = 28 ; P had reduced risk of the primary end point ( 14 vs. 34 ; relative risk 0.43 [ 95 % CI 0.21–0.86 ] compared with that of those who attained ≤2 targets ( n = 114 ) . CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes . In addition to protocol , audits and feedback are needed to improve outcomes",
"We studied the impact of nurse case management ( NCM ) on blood pressure ( BP ) , hemoglobin A1C , lipids , and diabetes complication screening . A 1-year r and omized-controlled trial was conducted in two primary care clinics of the Penn State Hershey Medical Center . Diabetes patients were r and omized to control group ( CG ) ( n=182 ) who received usual care by their primary care provider and intervention group ( IG ) ( n=150 ) who received additional NCM care , including self-management education , and implementation of diabetes guidelines . Primary outcomes included BP , A1C , lipid , process measures , and secondary outcome was diabetes-related emotional distress as assessed by Problem Areas in Diabetes ( PAID ) . BP significantly decreased from 137/77 to 129/72 in IG as compared to an increase from 136/77 to 138/79 in CG after 1 year . PAID scores improved significantly in IG ( from 23 to 10 ) due to reduced emotional stress . A1C ( 7.4 ) and LDL ( 105 ) were unaffected . Complications screening significantly improved in IG compared to CG : opthalmologic exam 26 to 68 % , foot exam 47 to 64 % , and nephropathy screening 34 to 72 % . NCM improved BP , diabetes-related emotional distress , and process measures in primary care . Unchanged A1C and lipids might be due to a threshold effect . Intervention based upon initial risk assessment may prove more cost-effective ",
"OBJECTIVE To compare the effectiveness of a nurse-led hypertension clinic with conventional community care in general practice in the management of uncontrolled hypertension in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS We studied 120 men and women outpatient attendees ( 61 % non-Caucasian ) with type 2 diabetes and a seated blood pressure ( BP ) > or=140/80 mmHg . All patients were being treated for hypertension , and 71 % had increased urinary albumin excretion ( UAE ) . Patients were allocated to either a nurse-led hypertension clinic or conventional primary care . The primary outcome measure was a change in systolic BP . Secondary outcome measures were total cholesterol , HDL cholesterol , total triglycerides , HbA(1c ) , UAE , serum creatinine , and changes in absolute stroke and coronary heart disease ( CHD ) risk scores . RESULTS The mean ( 95 % CI ) difference in the decrement of systolic BP was 12.6 mmHg ( 5.9 - 19.3 ) ( P = 0.000 ) in favor of the nurse-led group , whose patients were three times more likely to a reach target systolic BP 10-year CHD ( P = 0.004 ) and stroke risk ( P = 0.000 ) scores occurred only in the nurse-led group . There were no significant differences in the reduction of diastolic BP or any of the other secondary outcome measures at 6 months . CONCLUSIONS Compared with conventional care , a nurse-led hypertension clinic is a more effective intervention for patients with type 2 diabetes and uncontrolled hypertension . A target systolic BP < 140 mmHg is more readily achieved and may be associated with significant reductions in 10-year cardiovascular disease risk scores",
"OBJECTIVE To evaluate the effectiveness of a nurse-managed smoking cessation intervention in diabetic patients . RESEARCH DESIGN AND METHODS This r and omized controlled clinical trial involved 280 diabetic smokers ( age range 17 - 84 years ) who were r and omized either into control ( n = 133 ) or intervention ( n = 147 ) groups at 12 primary care centers and 2 hospitals located in Navarre , Spain . The intervention consisted of a 40-min nurse visit that included counseling , education , and contracting information ( a negotiated cessation date ) . The follow-up consisted of telephone calls , letters , and visits . The control group received the usual care for diabetic smokers . Baseline and 6-month follow-up measurements included smoking status ( self-reported cessation was verified by urine cotinine concentrations ) , mean number of cigarettes smoked per day , and stage of change . RESULTS At the 6-month follow-up , the smoking cessation incidence was 17.0 % in the intervention group compared with 2.3 % in the usual care group , which was a 14.7 % difference ( 95 % CI 8.2 - 21.3 % ) . Among participants who continued smoking , a significant reduction was evident in the average cigarette consumption at the 6-month follow-up . The mean number of cigarettes per day decreased from 20.0 at baseline to 15.5 at 6 months for the experimental group versus from 19.7 to 18.1 for the control group ( P structured intervention managed by a single nurse was shown to be effective in changing the smoking behavior of diabetic patients",
"AIM OF THE STUDY Assessment of effects on quality of care , in terms of patient outcomes , when tasks in the care for out patients with stable type 2 diabetes are transferred from internist to nurse specialist and from outpatient clinic to general practice . BACKGROUND For the management of chronic diseases with a high prevalence and requiring current monitoring , it is suggested that substitution of care may be an appropriate solution to safeguard high quality care . DESIGN AND METHODS A 12-month nonequivalent control group design was used . General practitioners ( GPs ) referring diabetes patients to the University Hospital Maastricht were asked to choose for the traditional model or the nurse specialist model . Informed consent was obtained from patients with stable diabetes type 2 attending these practice s. All patients received care according to the model chosen by their GP . Identified outcomes were : clinical status , health status , self-care behaviour , knowledge of diabetes , patient satisfaction , and consultation with care-providers . RESULTS In the control group ( n=47 ) no patients were treated with oral hypoglycaemic agents ( OHA ) only . The control group was compared with an intervention subgroup ( n=52 ) also without patients receiving OHA only . Clinical data were available for all patients . Patients without complete data from question naires had better mean concentration of HbA1c than patients with complete data ( P=0.004 ) . The traditional care model and the nurse specialist model achieved equal outcomes , while glycaemic control of patients in the nurse specialist model improved ( from 8.6 % to 8.3 % ) but deteriorated in the traditional model ( from 8.6 % to 8.8 % ; P-value between groups=0.001 ) . CONCLUSIONS The model with nurse specialists taking on roles and tasks beyond those traditionally regarded as their remit as well as new ones , is effective for the care of stable diabetic out patients",
"OBJECTIVE To examine baseline renal screening practice s and the effect of nurse case management of patients with diabetes in a group model health maintenance organization ( HMO ) . RESEARCH DESIGN AND METHODS We performed both 1-year retrospective and 1-year prospect i ve studies of renal assessment practice s and ACE inhibitor usage in a cohort of 133 diabetic patients enrolled in a r and omized controlled trial of a diabetes nurse case management program in a group model HMO . In accordance with American Diabetes Association recommendations , urine dipstick and quantitative protein and microalbuminuria testing rates were calculated . RESULTS At baseline , 77 % of patients were screened for proteinuria with dipsticks or had quantitative urine testing . Of patients with negative dipstick findings , 30 % had appropriate quantitative protein or microalbumin follow-up at baseline . Baseline ACE inhibitor usage was associated with decreased follow-up testing ( relative risk = 0.47 ) . Nurse case management was associated with increased quantitative protein or or microalbumin testing and increased follow-up testing ( relative risk = 1.65 and 1.60 , respectively ) . CONCLUSIONS We found a higher degree of adherence to recommendations for renal testing than has been reported previously . Nurse case management intervention further increased renal screening rates . The inverse association between ACE inhibitor usage and microalbumin testing highlights a potentially ambiguous area of current clinical pathways",
"Nurses with advanced training — diabetes re source nurses (DRNs)—can improve care for people with diabetes in capitated payment setting s. Their effectiveness in fee-for-service setting s has not been investigated . We conducted a 12-month practice -r and omized trial involving 22 practice s in a fee-for-service metropolitan network with 92 primary care physicians caring for 1891 Medicare patients ≥65 years with diabetes mellitus . Each practice was r and omized to one of three intervention groups : physician feedback on process measures using Medicare cl aims data ; Medicare cl aims feedback plus feedback on clinical measures from medical record ( MR ) abstract ion ; or both types of feedback plus a practice -based DRN . The primary endpoint investigated was hemoglobin A1c level . Other measures were low-density lipoprotein ( LDL ) cholesterol level , blood pressure , annual hemoglobin A1c testing , annual LDL screening , annual eye exam , annual foot exam , and annual renal assessment . Data were collected from medical chart abstract ion and Medicare cl aims . The number of patients with hemoglobin A1c % increased by 4 ( 0.9 % ) in the Cl aims group ; 9 ( 2.1 % ) in the Cl aims + MR group ( comparison with Cl aims : P = 0.97 ) ; and 16 ( 3.8 % ) in the DRN group ( comparison with Cl aims : P = 0.31 ) . Results were similar for the other clinical outcomes , with no differences significant at P = 0.10 . For process of care measures , decreases were seen in all groups , with no significant differences in change scores . Quality improvement strategies must be evaluated in the appropriate setting . Initiatives that have been effective in capitated systems may not be effective in fee-for-service environments",
"BACKGROUND Delivery of high- quality , evidence -based health care to deprived sectors of the community is a major goal for society . We investigated the effectiveness of a culturally sensitive , enhanced care package in UK general practice s for improvement of cardiovascular risk factors in patients of south Asian origin with type 2 diabetes . METHODS In this cluster r and omised controlled trial , 21 inner-city practice s in the UK were assigned by simple r and omisation to intervention ( enhanced care including additional time with practice nurse and support from a link worker and diabetes-specialist nurse [ nine practice s ; n=868 ] ) or control ( st and ard care [ 12 practice s ; n=618 ] ) groups . All adult patients of south Asian origin with type 2 diabetes were eligible . Prescribing algorithms with clearly defined targets were provided for all practice s. Primary outcomes were changes in blood pressure , total cholesterol , and glycaemic control ( haemoglobin A1c ) after 2 years . Analysis was by intention to treat . This trial is registered , number IS RCT N 38297969 . FINDINGS We recorded significant differences between treatment groups in diastolic blood pressure ( 1.91 [ 95 % CI -2.88 to -0.94 ] mm Hg , p=0.0001 ) and mean arterial pressure ( 1.36 [ -2.49 to -0.23 ] mm Hg , p=0.0180 ) , after adjustment for confounders and clustering . We noted no significant differences between groups for total cholesterol ( 0.03 [ -0.04 to 0.11 ] mmol/L ) , systolic blood pressure ( -0.33 [ -2.41 to 1.75 ] mm Hg ) , or HbA1c ( -0.15 % [ -0.33 to 0.03 ] ) . Economic analysis suggests that the nurse-led intervention was not cost effective ( incremental cost-effectiveness ratio pound28 933 per QALY gained ) . Across the whole study population over the 2 years of the trial , systolic blood pressure , diastolic blood pressure , and cholesterol decreased significantly by 4.9 ( 95 % CI 4.0 - 5.9 ) mm Hg , 3.8 ( 3.2 - 4.4 ) mm Hg , and 0.45 ( 0.40 - 0.51 ) mmol/L , respectively , and we recorded a small and non-significant increase for haemoglobin A1c ( 0.04 % [ -0.04 to 0.13 ] ) , p=0.290 ) . INTERPRETATION We recorded additional , although small , benefits from our culturally tailored care package that were greater than the secular changes achieved in the UK in recent years . Stricter targets in general practice and further measures to motivate patients are needed to achieve best possible health-care outcomes in south Asian patients with diabetes",
"OBJECTIVE To determine the effectiveness of specialist nurse-led clinics for hypertension and hyperlipidemia provided for diabetic patients receiving hospital-based care . RESEARCH DESIGN AND METHODS This study was a r and omized controlled implementation trial at Hope Hospital , Salford , U.K. The subjects consisted of 1,407 subjects presenting for annual review with raised blood pressure(>or=140/80 mmHg ) , raised total cholesterol ( > or=5.0 mmol/l ) , or both . Individuals with diabetes were r and omized to usual care or usual care with subsequent invitation to attend specialist nurse-led clinics . Nurses provided clinics for participants , with attendance every 4 - 6 weeks , until targets were achieved . Lifestyle advice and titration of drug therapies were provided according to the locally agreed upon guidelines . Patients with both conditions were eligible for enrollment in either or both clinics . At subsequent annual review , blood pressure and total cholesterol values were obtained from the Salford electronic diabetes register . Data relating to deaths were obtained from the national strategic tracing service . The primary outcome was the odds ratio of achieving targets in hypertension and hyperlipidemia , attributable to the specialist nurse-led intervention . RESULTS Overall , specialist nurse-led clinics were associated with a significant improvement in patients achieving the target after 1 year ( odds ratio [ OR ] 1.37 [ 95 % CI 1.11 - 1.69 ] , P = 0.003 ) . This primary analysis revealed a borderline difference in effect between the two types of clinics ( test for interaction between groups : P = 0.06 ) . Secondary analysis , consistent with the prior beliefs of the health care professionals involved , suggested that targets were achieved more frequently in patients enrolled in the specialist nurse-led clinic for hyperlipidemia ( OR 1.69 [ 1.25 - 2.29 ] , P = 0.0007 ) than for hypertension ( OR 1.14 [ 0.86 - 1.51 ] , P = 0.37 ) . Intervention ( enrolled to either or both clinics ) was associated with a reduction in all-cause mortality ( OR 0.55 [ 0.32 - 0.92 ] , P = 0.02 ) . CONCLUSIONS This study provides good evidence to support the use of specialist nurse-led clinics as an effective adjunct to hospital-based care of patients with diabetes . If the st and ards of care recommended in the National Service Framework for Diabetes are to be achieved , then such proven methods for delivering care must be adopted",
"The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group who were taking insulin received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to",
"The purpose of this study is to examine effects of a nurse-physician collaborative approach to care of patients with type 2 diabetes and to determine possible effect sizes for use in computing sample sizes for a larger study . Forty patients from a family practice clinic with type 2 diabetes were r and omly assigned to control or experimental groups . The control group received st and ard care , whereas the experimental group received st and ard care plus home visits from a nurse , as well as consultation with an exercise specialist and /or nutritionist . Follow-up continued for 3 months . Clinical end points included st and ard measures of diabetes activity as well as quality -of-life indicators . Focus group interviews were used to explore patients ’ responses to the program . Although findings were not statistically significant , a trend toward small to moderate positive effect sizes was found in glycosylated hemoglobin and blood pressure . Quality oflife measures also showed a trend toward small to moderate , but nonsignificant , improvements in physical functioning , bodily pain , vitality , social and global functioning , energy , impact of diabetes , and health distress . Focus group interviews indicated a very positive response from patients , who expressed feelings of empowerment . In this study , patients treated with nurse-physician collaboration demonstrated small , but nonsignificant , improvements in blood chemistry after only 3 months . Physical and social functioning , energy , and bodily pain also showed a small improvement . Changes in awareness of effects of diabetes on health and an expressed sense of self-efficacy suggest that effects could be sustainable over the longer term",
"Brief , cost-effective interventions to promote diabetes self-management are needed . This study evaluated the effects of a brief , regular , proactive , telephone “ coaching ” intervention delivered by paraprofessionals on diabetes adherence , glycemic control , diabetes-related medical symptoms , and depressive symptoms . Therapeutic mechanisms underlying the intervention ’s effect on the primary outcomes were also examined . Adults diagnosed with type 2 diabetes ( N = 62 ) were r and omly assigned to receive the “ coaching ” intervention and treatment as usual , or only treatment as usual . The intervention increased frequency of exercise and feet inspection , improved diet , reduced diabetes medical symptoms , and lowered depressive symptoms . Self-efficacy , reinforcement , and awareness of self-care goals mediated the treatment effect on depression , exercise , and feet inspection , respectively . A brief telephone intervention delivered by paraprofessionals had positive effects on type 2 diabetes patients",
"OBJECTIVE To compare usual care with nurse-directed care for patients with diabetes . STUDY DESIGN R and omized before-after trial . METHODS Diabetic patients were r and omly selected for a diabetes managed care program ( DMCP ) , in which a specially trained registered nurse , supervised by an endocrinologist , followed detailed treatment algorithms . Process and outcome measures during the year before DMCP entry were compared with those during the first year of DMCP enrollment . RESULTS A total of 367 patients completed a full year in the DMCP . Data from the prior year were available for 331 patients . Among a subset of Latino patients , 95 % earned less than 25,000 US dollars and 73 % had an education of 6th grade or less . Process measures recommended by the American Diabetes Association ( ADA ) were met 98 % of the time during the DMCP year compared with 54 % of the time during the prior year ( P Mean glycosylated hemoglobin ( A1C ) levels fell from 9.3 % to 8.7 % in the year before entry into the DMCP and to 7.0 % by the end of the first DMCP year ( P ADA A1C goal of ADA low-density lipoprotein cholesterol goal at entry into the DMCP compared with 82 % at the end of the year . CONCLUSION A nurse making clinical decisions based on detailed treatment algorithms did a better job of achieving ADA-recommended process and outcome measures than physicians providing usual care",
"Research ers at Johns Hopkins University conducted a r and omized clinical trial to test the effect of nurse case management and community health worker interventions on diabetes control among inner city African Americans . The results demonstrated that the greatest improvement occurred when nurse case managers and community health workers worked together . This study has implication s for how nurse/home health aide collaboration can enhance diabetes management in home care",
"Background The aim of this research was to determine whether an intensive , nurse-led clinic could achieve recommended vascular risk reduction targets in patients with type 2 diabetes as compared to st and ard diabetes management . Method Two hundred patients with type 2 diabetes were recruited to receive either intensive nurse-led or st and ard diabetes care in a 1-year open study . Results In each group 94 patients completed the study . The groups were matched for age and baseline HbA1c , blood pressure and lipid profiles . More patients in the intensive group achieved vascular risk targets than in the st and ard group : SBP ( DBP ( cholesterol ( LDL ( HbA1c ( intensive nurse-led clinic is more successful in achieving vascular risk targets than st and ard diabetes care",
"OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities . HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits",
"OBJECTIVE To improve clinical diabetes care , patient knowledge , and treatment satisfaction and to reduce health-adverse culture-based beliefs in underserved and underinsured population s with diabetes . RESEARCH DESIGN AND METHODS A total of 153 high-risk patients with diabetes recruited from six community clinic sites in San Diego County , California were enrolled in a nurse case management ( NCM ) and peer education/empowerment group . Baseline and 1-year levels of HbA(1c ) , lipid parameters , systolic and diastolic blood pressure , knowledge of diabetes , culture-based beliefs in ineffective remedies , and treatment satisfaction were prospect ively measured . The NCM and peer education/empowerment group was compared with 76 individuals in a matched control group ( CG ) derived from patients referred but not enrolled in Project Dulce . RESULTS After 1 year in Project Dulce , the NCM and peer education/empowerment group had significant improvements in HbA(1c ) ( 12.0 - 8.3 % , P total cholesterol ( 5.82 - 4.86 mmol/l , P LDL cholesterol ( 3.39 - 2.79 mmol/l , P diastolic blood pressure ( 80 - 76 mmHg , P diabetes care , knowledge of diabetes ( P = 0.024 ) , treatment satisfaction ( P = 0.001 ) , and culture-based beliefs ( P = 0.001 ) were also improved . CONCLUSIONS A novel , culturally appropriate , community-based , nurse case management/peer education diabetes care model leads to significant improvement in clinical diabetes care , self-awareness , and underst and ing of diabetes in underinsured population",
"This r and omized , controlled trial tested the effectiveness of a nurse-run , telephone-based intervention to improve lipid control in patients with diabetes . Our patient population is predominantly low-income and Latino . Using our diabetes registry , we r and omly assigned 381 patients to continue with their usual care and 381 to participate in our nurse-run program . Three registered nurses learned algorithms for diabetes care . These algorithms address management of lipids , glycemic control , blood pressure , nephropathy , aspirin use , eye screening , pneumovax and influenza vaccines , obesity , and cigarette smoking . The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management . The primary goal was to improve lipid control in our diabetic population . Secondary outcomes address blood pressure control , glycemic control , renal function , and medication adherence . In addition , a cost-effective analysis is being performed . This article summarizes the design of the intervention",
"Background : Logistic support to general practitioners improves the care processes for patients with diabetes but is not sufficient to meet all criteria . Aim : To introduce patient-oriented interventions by a practice nurse in general practice s which already use logistic support to improve the care processes for patients with diabetes . Design of study : A controlled before – after study with delayed intervention in the control group . Setting : 51 practice s ( n = 23 for the intervention and n = 28 for the control group ) in the south of The Netherl and s and 900 of their patients with type 2 diabetes . Methods : Data were collected on the results of the checkups ( fasting blood glucose , glycosylated haemoglobin ( HbA1C ) , cholesterol , cholesterol/high-density lipoprotein ratio , triglycerides , creatinine , blood pressure , fundus photo , foot exam and body mass index ) , smoking status , physical activity and medication use . The effect of the patient-oriented intervention was analysed in a mixed model with repeated measurement covariance structure . Results : The HbA1C improved in the intervention group ( from 7.3 to 7.1 ) , while that of the control group deteriorated ( from 7.2 to 7.3 ) . The percentage of patients with an HbA1C ⩾8.5 was halved after the intervention ( from 13 to 6 ) . Patients in the intervention group started to exercise more besides their daily activities compared with the control group . The need for medication increased more in the control group than in the intervention group ( more changes to insulin and more defined daily dose ( DDD ) oral medication ) . Conclusion : Patient-oriented interventions in addition to logistic support have a positive effect on diabetic patient outcomes",
"Effective control of diabetes is known to delay or prevent the end-organ complications of this disease . Can telemedicine improve a patient 's ability to self-manage diabetes ? Twenty-eight patients entered a study comparing home telemedicine consultation with st and ard outpatient care . A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician , who contacted the telemedicine group once a month . Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study . The hemoglobin A1c ( HbA1c ) and total body weight improved significantly in the intervention ( telemedicine ) group , as shown by a 16 % reduction in mean HbA1c level ( from 9.5 to 8.2 % ) and a 4 % mean weight reduction ( from 214.3 to 206.7 pounds ) . Based on our experience , we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies",
"OBJECTIVES To explore changes in mortality and hospital usage for chronically ill seniors enrolled in a multidisease care management program , Care Management Plus ( CMP ) . DESIGN Controlled clinical trial with seven intervention and six control clinics with additional patient-level matching . SETTING Intermountain Health Care , a large health system in Utah ; seven intervention and six control clinics . PARTICIPANTS Three thous and four hundred thirty-two senior patients ( > or=65 ) enrolled in Medicare . INTERVENTION The intervention employed nurse care managers supported by specialized information technology in primary care to manage chronically ill patients ( 2002 - 2005 ) . MEASUREMENTS Mortality and hospitalization data were collected from clinical records and Medicare billing . RESULTS One thous and one hundred forty-four intervention patients were matched to 2,288 controls . Average age was 76.2 ; average comorbidity score was 2.3+/-1.1 ; 75 % of patients had two or more chronic diseases . Survival analyses showed lower mortality and slightly more emergency department visits for care managed patients than for controls . In patients with diabetes mellitus , the intervention result ed in significantly lower mortality at 1 year ( 6.2 % , vs 10.6 % for controls ) and at 2 years ( 12.9 % vs 18.2 % ) . Hospitalization rate was lower ( 21.0 % , vs. 24.2 % for controls ) at 1 year and substantially more so at the 2-year follow-up . CONCLUSION CMP was successful in reducing death for all patients . For complex patients with diabetes mellitus in the intervention group , death and hospital usage were lower . Per clinic , hypothesized savings from decreased hospitalizations was $ 17,384 to $ 70,349",
"Background The diabetes of many patients is managed in general practice ; healthcare providers aim to promote healthful behaviors , such as healthful diet , adequate physical activity , and smoking cessation . These measures may decrease insulin resistance , improve glycemic control , lipid abnormalities , and hypertension . They may also prevent cardiovascular disease and complications of diabetes . However , professionals do not adhere optimally to guidelines for lifestyle counseling . Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling . Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice . The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses ' training on patient outcomes . Methods / Design A cluster , r and omized , controlled trial involving 70 general practice s ( 35 practice s in the intervention arm and 35 in the control arm ) starting in March 2007 . A total of 700 patients with type 2 diabetes will be recruited . The patients in the intervention arm will receive care from the primary care nurse , who will receive training in an implementation strategy with motivational interviewing as the core component . Other components of this strategy will be adaptation of the diabetes protocol to local circumstances , introduction of a social map for lifestyle support , and educational and supportive tools for sustaining motivational interviewing . The control arm will be encouraged to maintain usual care . The effect measures will be the care process , metabolic parameters ( glycosylated hemoglobin , blood pressure and lipids ) , lifestyle ( diet , physical activity , smoking , and alcohol ) , health-related quality of life , and patients ' willingness to change behaviors . The measurements will take place at baseline and after 14 months . Discussion Applying motivational interviewing for patients with diabetes in primary care has been studied , but to our knowledge , no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice . If this intervention proves to be effective and cost-effective , large-scale implementation of this nurse-oriented intervention will be considered and anticipated . Trial registration Current Controlled Trials IS RCT N68707773"
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41164610-06ff-11f0-808a-c43d1ab1c353
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( 1 ) Aim : To perform a systematic review of the literature on the biocompatibility of root canal sealers that encompasses the various types of sealers that are commercially available as well as both in vitro and in vivo evidence . ( 2 ) Methods : This systematic review has been registered in PROSPERO ( ID 140445 ) and was carried out according to PRISMA guidelines using the following data bases : PubMed , Cochrane Library , Clinical Trials.gov , Science Direct , and Web of Science Core Collection . Studies published between 2000 and 11 June 2019 that evaluated cytotoxicity ( cell viability/proliferation ) and biocompatibility ( tissue response ) of root canal sealers were included . ( 3 ) Results : From a total of 1249 studies , 73 in vitro and 21 in vivo studies were included . In general , studies suggest that root canal sealers elicit mild to severe toxic effects and that several factors may influence biocompatibility , e.g. , material setting condition and time , material concentration , and type of exposure . Bioactive endodontic sealers seem to exhibit a lower toxic potential in vitro . ( 4 ) Conclusions : The available evidence shows that root canal sealers exhibit variable toxic potential at the cellular and tissue level . However , the method ological heterogeneity among studies included in this systematic review and the somewhat conflicting results do not allow a conclusion on which type of sealer presents higher biocompatibility . Further research is crucial to achieve a better underst and ing of the biological effects of root canal sealers
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"INTRODUCTION : The purpose of this study was to compare the subcutaneous tissue responses of freshly mixed or set endodontic root canal sealers ( i.e. RoekoSeal , AH26 , AH Plus ) in Wistar Albino rats . MATERIAL S AND METHODS : Seventy-two male albino rats weighing 200 - 250 g were used . The animals were r and omly divided into six groups of 12 rats each . Root canal sealers were implanted in subcutaneous tissue in both freshly mixed and set conditions . The animals were sacrificed after 7 , 14 , and , 60 days . After histological preparation and Hematoxylin and Eosin ( H&E ) staining , the specimens were evaluated for capsule thickness , severity and extent of inflammation , and necrosis . Results were statistically analyzed using Multivariate ANOVA test . RESULTS : Differences between set and freshly mixed root canal sealers were significant ( P=0.014 ) , but not significant between test material s and controls , except for capsule thickness and extent of inflammation between control and AH26 ( P=0.019 and P=0.006 respectively ) . The interaction between the type of material and setting condition was significant for capsule thickness and severity of inflammation in AH26 specimens at 14 and 60 days ( P=0.001 ) . CONCLUSION : Based on the results of this study assessing the biocompatibility , both set and freshly mixed states can be used . [ Iranian Endodontic Journal 2009;4(4):152 - 7",
"The purpose of this study was to compare ISO st and ards versus a new technique for in vitro evaluation of cytotoxicity of root canal sealers . The cytotoxicity of AH Plus , Cortisomol , and Sealapex was first recorded according to ISO st and ards on L 929 fibroblasts by the MTT assay . In parallel , 30 single-rooted teeth were cut at the cementum enamel junction ( CEJ ) , and the roots were prepared and sterilized before filling with the lateral condensation using one of three sealers ( n = 10 ) . The apexes of the roots were dipped into 1 ml of minimum essential medium for 1 , 2 , and 30 days renewing the medium every other day . After 24-h contact between the medium and the filled roots , the medium was used to measure the cytotoxicity on L 929 with the MTT assay . ISO st and ards always gave a statistically higher cytotoxicity than the root-dipping technique ( p noncytotoxic , Cortisomol showed a high cytotoxicity decreasing over time ( p Sealapex displayed a high cytotoxicity that did not decrease over time ( NS ) . The new technique showed statistically significant differences among the sealers ( p = 0.001 ) , but the differences were so small that they were likely not clinical ly relevant . The high cytotoxicity of Sealapex decreased over time but the cytotoxicity of AH Plus and Cortisomol did not . The results show that the ISO st and ards may strongly over-evaluate the cytotoxicity of the endodontic sealers , emphasize the difference among the sealers , and may clinical ly correspond to a large overfilling . The new technique reduces the discrimination of the test and may clinical ly correspond to a classical filling . Therefore , both methods might be considered as clinical ly relevant , corresponding to classical and overfilling conditions",
"In vitro pre- clinical research is an important aspect of the development of new dental material s and techniques , because it can provide essential information for further testing of therapeutic approaches in clinical trials . These pre- clinical experiments should therefore be reported with the same rigor as studies involving humans . The objectives of this paper were twofold : ( a ) to search and assess existing guidelines for reporting in vitro studies in dentistry , and ( b ) to present a methodology for reporting these studies , based on the CONSORT checklist for reporting r and omized clinical trials . After a comprehensive search in PubMed data base , no guidelines for reporting in vitro studies in dentistry were found . The proposed methodology is presented and the rationale for the choice of fourteen guidelines for producing the different sections of such papers is described in detail . The assessment of a sample of in vitro studies using the proposed guidelines showed that the st and ards of reporting should be improved . Good st and ards of reporting of studies are necessary for improvement of efficiency in dental research . The guidelines presented are the first st and ards for reporting in vitro studies in dentistry . As with the original CONSORT document , the modified checklist is evolving . It should , therefore , be further tested by research ers and the results of these assessment s should be used for further improvement of this tool",
"INTRODUCTION This study analyzed bone tissue reactions to MTA Fillapex ( Ângelus Industria de Produtos Odontológicos Ltda , Londrina , Brazil ) compared with an epoxy resin-based material in the femur of Wistar rats . METHODS Bone tissue reactions were evaluated in 15 animals after 7 , 30 , and 90 days ( n = 5 per period ) . Three surgical cavities were prepared on the femur and filled with 0.2 mL MTA Fillapex , AH Plus ( Dentsply DeTrey GmbH , Konstanz , Germany ) , or no sealer ( negative control ) . By the end of each experimental period , 5 animals were r and omly euthanized . The sample s were histologically processed and analyzed using a light microscope . The presence of inflammatory cells , fibers , and hard tissue barrier formation was evaluated . Differences among the groups and between the 3 experimental periods were evaluated by using 2-way analysis of variance followed by the Bonferroni post hoc test ( P ≤ .05 ) . RESULTS MTA Fillapex scored significantly higher for neutrophils at 7 days than at 90 . At 7 days , the same occurred when comparing MTA Fillapex with AH Plus . The presence of lymphocytes/plasmocytes significantly decreased over time in all groups . Macrophages , giant cells , eosinophils , and fiber condensation presented no differences among groups and periods . Within 90 days , all groups presented complete hard tissue barrier formation . CONCLUSIONS The presence of mineral trioxide aggregate in MTA Fillapex composition did not improve the bone tissue repair . The presence of sealers provided the re-establishment of the original bone tissue structure and the inflammatory response decreased over time , so they can be considered biocompatible",
"Clinicians often witness impressive treatment results in practice and may wish to pursue research to formally explore their anecdotal experiences . The potential to further new knowledge both within the profession and to the greater healthcare system is compelling . An obvious next step for a practitioner considering research is to connect with experienced research ers to convey their idea for a study , who may in turn ask , “ What is your research question ? ” With limited underst and ing of how to respond , this interaction may result in the first and last experience these clinicians will have with the research community . It has been estimated that between 1 % and 7 % of the chiropractic profession in Canada is engaged in research . 1,2 Arguably , this low engagement could be the result of practitioners ’ perceived importance of research and levels of research literacy and capacity . However , increasing dem and s for evidence -based approaches across the health system puts pressure on all clinicians to base their decisions on the best available scientific evidence . Lack of clinician representation in research has the probable effect of limiting growth and new developments for the profession . Furthermore , lack of clinician involvement in research complicates the transfer of study findings into practical setting s. The Canadian Institutes of Health Research describes integrated knowledge translation as a process that involves collaboration between research ers and knowledge users at all stages of a research project.3 This necessitates involvement of clinicians to help in forming a research question , interpreting the results , and moving research findings into practice . This shared effort between clinicians and research ers increases the likelihood that research initiatives will be relevant to practice .3 Conversely , it has been reported that there is a growing communication gap between clinicians and academics in chiropractic . 4 Clinicians have important practice -related questions to ask , but many may lack the ability to map out their research strategy , specifically in communicating their question in a manner required to develop a research protocol . David L. Sackett , Officer of the Order of Canada and the founding Chair of Canada ’s first Department of Clinical Epidemiology & Biostatistics at McMaster University , highlights the importance of mapping one ’s research strategy in exploration of the research question : “ one-third of a trial ’s time between the germ of your idea and its publication in the New Engl and Journal of Medicine should be spent fighting about the research question . ” ( personal communication , November 30 , 2011 ) We describe a r and omized controlled trial ( RCT ) example to highlight how clinicians may use existing literature and the PICOT format to formulate a research question on treatment efficacy",
"AIM The aim of this study was to evaluate pigmentation and tissue response to four endodontic sealers placed in the oral mucosa of rabbits by either submucous injection or implant in polyethylene tubes . METHODOLOGY Thirty white New Zeal and rabbits were divided r and omly into two groups of eight for N-Rickert and AH-26 , and two groups of seven for Fillcanal and Sealer 2 6 . On the right side of the filter , corresponding to the gingivo-labial sulcus in humans , the sealer was injected ; on the left side the sealer was placed within a polyethylene tube and implanted . Direct clinical observations were made at 30 , 60 and 90 days . The animals were then sacrificed for histological analysis . RESULTS After 60 days of observation N-Rickert and AH-26 produced tattoos that became larger by 90 days . Submucous injection produced larger and more numerous pigmentation , when compared to implant in polyethylene tubes . N-Rickert sealer displayed larger and more numerous tattoos when compared to AH-26 . Histological analysis showed no differences between the two methods of implantation . All sealers elicited some kind of inflammatory response ; the most irritant was Fillcanal , followed by N-Rickert and AH-26 . Sealer 26 elicited a mild reaction only . CONCLUSIONS Under the conditions of this study there was no relationship between the method of implantation and the tissue response ; the silver-containing sealers produced pigmentation , and the concentration of silver influenced the quantity and size of the tattoos . The sealers elicited various responses when in direct contact with the surrounding tissues : the calcium hydroxide-containing sealer had enhanced healing when compared to the other sealers",
"In regard to biological properties of endodontic sealers , there are many characteristics that should be considered . The aim of this study was to examine the biological effects of new calcium phosphate-based root canal sealers , CAPSEAL I and CAPSEAL II ( CPS ) , on human periodontal fibroblast cells by examining the expression levels of inflammatory mediators and to compare the effects of CPS on the viability and osteogenic potential of human osteoblast MG63 cells compared to those of other commercially available calcium phosphate sealers [ Apatite Root Sealer type I ( ARS I ) and Apatite Root Sealer III ( ARS III ) ; Sankin Kogyo , Tokyo , Japan ] and a zinc oxide eugenol-based sealer ( Pulp Canal Sealer EWT [ PCS EWT ] ; Kerr , Detroit , MI ) . The levels of IL-6 in the new CPS group ( CAPSEAL I , II ) were higher than those in the control and all experimental groups at all time points after 2 h. TGF-β1 and FGF-1 levels decreased at 72 h compared to the levels in the control , in cells treated with every sealers except ARS I. The new CPS sealers showed low cytotoxicity . Reverse transcription polymerase chain reaction showed that CAPSEAL I , II , and Apatite Root Sealer type III induced expression of early stage markers of differentiation ( alkaline phosphatase and osteopontin ) at 7 days . Also , new CPS showed higher mineralized nodule formation at 28 days . These results suggest that CAPSEAL I and II facilitate the periapical dentoalveolar and alveolar healing by controlling cellular mediators from PDL cells and osteoblast differentiation of precursor cells",
"Background Systematic Review s ( SRs ) of experimental animal studies are not yet common practice , but awareness of the merits of conducting such SRs is steadily increasing . As animal intervention studies differ from r and omized clinical trials ( RCT ) in many aspects , the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies . The Cochrane Collaboration developed a Risk of Bias ( RoB ) tool to establish consistency and avoid discrepancies in assessing the method ological quality of RCTs . A similar initiative is warranted in the field of animal experimentation . Methods We provide an RoB tool for animal intervention studies ( SYRCLE ’s RoB tool ) . This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies . To enhance transparency and applicability , we formulated signalling questions to facilitate judgment . Results The result ing RoB tool for animal studies contains 10 entries . These entries are related to selection bias , performance bias , detection bias , attrition bias , reporting bias and other biases . Half these items are in agreement with the items in the Cochrane RoB tool . Most of the variations between the two tools are due to differences in design between RCTs and animal studies . Shortcomings in , or unfamiliarity with , specific aspects of experimental design of animal studies compared to clinical studies also play a role . Conclusions SYRCLE ’s RoB tool is an adapted version of the Cochrane RoB tool . Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies . This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the method ological quality of animal studies"
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This evidence base up date examines the level of empirical support for interventions for children with autism spectrum disorder ( ASD ) younger than 5 years old . It focuses on research published since a previous review in this journal ( Rogers & Vismara , 2008 ) . We identified psychological or behavioral interventions that had been manualized and evaluated in either ( a ) experimental or quasi-experimental group studies or ( b ) systematic review s of single-subject studies . We extracted data from all studies that met these criteria and were published after the previous review . Interventions were categorized across two dimensions . First , primary theoretical principles included applied behavior analysis ( ABA ) , developmental social-pragmatic ( DSP ) , or both . Second , practice elements included scope ( comprehensive or focused ) , modality ( individual intervention with the child , parent training , or classrooms ) , and intervention targets ( e.g. , spoken language or alternative and augmentative communication ) . We classified two interventions as well-established ( individual , comprehensive ABA and teacher-implemented , focused ABA + DSP ) , 3 as probably efficacious ( individual , focused ABA for augmentative and alternative communication ; individual , focused ABA + DSP ; and focused DSP parent training ) , and 5 as possibly efficacious ( individual , comprehensive ABA + DSP ; comprehensive ABA classrooms ; focused ABA for spoken communication ; focused ABA parent training ; and teacher-implemented , focused DSP ) . The evidence base for ASD interventions has grown substantially since 2008 . An increasing number of interventions have some empirical support ; others are emerging as potentially efficacious . Priorities for future research include improving outcome measures , developing interventions for understudied ASD symptoms ( e.g. , repetitive behaviors ) , pinpointing mechanisms of action in interventions , and adapting interventions for implementation with fidelity by community providers
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"This study extends findings on the effects of intensive applied behavior analytic treatment for children with autism who began treatment at a mean age of 5.5 years . The behavioral treatment group ( n = 13 , 8 boys ) was compared to an eclectic treatment group ( n = 12 , 11 boys ) . Assignment to groups was made independently based on the availability of qualified supervisors . Both behavioral and eclectic treatment took place in public kindergartens and elementary schools for typically developing children . At a mean age of 8 years , 2 months , the behavioral treatment group showed larger increases in IQ and adaptive functioning than did the eclectic group . The behavioral treatment group also displayed fewer aberrant behaviors and social problems at follow-up . Results suggest that behavioral treatment was effective for children with autism in the study",
"This study reports results of a r and omized controlled trial aim ed at joint attention ( JA ) and symbolic play ( SP ) in preschool children with autism , with prediction to language outcome 12 months later . Participants were 58 children ( 46 boys ) with autism between 3 and 4 years of age . Children were r and omized to a JA intervention , an SP intervention , or control group . Interventions were conducted 30 min daily for 5 - 6 weeks . Assessment s of JA skills , SP skills , mother-child interactions , and language development were collected at 4 time points : pre- and postintervention and 6 and 12 months postintervention by independent testers . Results indicate that expressive language gains were greater for both treatment groups compared with the control group , and results could not be explained by differences in other interventions in which children participated . For children beginning treatment with the lowest language levels , the JA intervention improved language outcome significantly more than did the SP or control interventions . These findings suggest clinical ly significant benefits of actively treating JA and SP skills in young children with autism",
"BACKGROUND Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development",
"OBJECTIVE A previously published r and omized clinical trial indicated that a developmental behavioral intervention , the Early Start Denver Model ( ESDM ) , result ed in gains in IQ , language , and adaptive behavior of children with autism spectrum disorder . This report describes a secondary outcome measurement from this trial , EEG activity . METHOD Forty-eight 18- to 30-month-old children with autism spectrum disorder were r and omized to receive the ESDM or referral to community intervention for 2 years . After the intervention ( age 48 to 77 months ) , EEG activity ( event-related potentials and spectral power ) was measured during the presentation of faces versus objects . Age-matched typical children were also assessed . RESULTS The ESDM group exhibited greater improvements in autism symptoms , IQ , language , and adaptive and social behaviors than the community intervention group . The ESDM group and typical children showed a shorter Nc latency and increased cortical activation ( decreased α power and increased θ power ) when viewing faces , whereas the community intervention group showed the opposite pattern ( shorter latency event-related potential [ ERP ] and greater cortical activation when viewing objects ) . Greater cortical activation while viewing faces was associated with improved social behavior . CONCLUSIONS This was the first trial to demonstrate that early behavioral intervention is associated with normalized patterns of brain activity , which is associated with improvements in social behavior , in young children with autism spectrum disorder",
"OBJECTIVE This study reports 12-month follow-up data from a r and omized controlled trial of preschool-based social communication treatment for young children with autism . METHOD A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been r and omized either to 8 weeks of preschool-based social communication treatment in addition to st and ard preschool program ( n = 34 ) or to st and ard preschool program only ( n = 27 ) . Significant short-term effects on targeted social communication skills have previously been published . Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Question naire . RESULTS Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up . However , no effects were detected on language and global ratings of social functioning and communication . The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect . CONCLUSIONS This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinical ly important long-term changes in social communication in young children with autism . The treatment did not affect language and global ratings of social functioning and communication . More studies are needed to better underst and whether treatment effects may be improved by increasing the intensity and duration of the treatment . Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http:// clinical trials.gov/ ; NCT00378157",
"The current study is a r and omized clinical trial evaluating the efficacy of Focused Playtime Intervention ( FPI ) in a sample of 70 children with Autism Spectrum Disorder . This parent-mediated intervention has previously been shown to significantly increase responsive parental communication ( Siller et al. in J Autism Dev Disord 43:540–555 , 2013a ) . The current analyses focus on children ’s attachment related outcomes . Results revealed that children who were r and omly assigned to FPI showed bigger increases in attachment-related behaviors , compared to children assigned to the control condition . Significant treatment effects of FPI were found for both an observational measure of attachment-related behaviors elicited during a brief separation-reunion episode and a question naire measure evaluating parental perceptions of child attachment . The theoretical and clinical implication s of these findings are discussed",
"OBJECTIVE : To conduct a r and omized , controlled trial to evaluate the efficacy of the Early Start Denver Model ( ESDM ) , a comprehensive developmental behavioral intervention , for improving outcomes of toddlers diagnosed with autism spectrum disorder ( ASD ) . METHODS : Forty-eight children diagnosed with ASD between 18 and 30 months of age were r and omly assigned to 1 of 2 groups : ( 1 ) ESDM intervention , which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years ; or ( 2 ) referral to community providers for intervention commonly available in the community . RESULTS : Compared with children who received community-intervention , children who received ESDM showed significant improvements in IQ , adaptive behavior , and autism diagnosis . Two years after entering intervention , the ESDM group on average improved 17.6 st and ard score points ( 1 SD : 15 points ) compared with 7.0 points in the comparison group relative to baseline scores . The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children . In contrast , over the 2-year span , the comparison group showed greater delays in adaptive behavior . Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder , not otherwise specified , than the comparison group . CONCLUSIONS : This is the first r and omized , controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis . Results of this study underscore the importance of early detection of and intervention in autism",
"Children with autism exhibit significant deficits in imitation skills . Reciprocal Imitation Training ( RIT ) , a naturalistic imitation intervention , was developed to teach young children with autism to imitate during play . This study used a r and omized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21 young children with autism . Results found that children in the treatment group made significantly more gains in elicited and spontaneous imitation , replicating previous single-subject design studies . Number of spontaneous play acts at pre-treatment was related to improvements in imitation during the intervention , suggesting that children with a greater play repertoire make greater gains during RIT",
"PURPOSE This r and omized group experiment compared the efficacy of 2 communication interventions ( Responsive Education and Prelinguistic Milieu Teaching [ RPMT ] and the Picture Exchange Communication System [ PECS ] ) on spoken communication in 36 preschoolers with autism spectrum disorders ( ASD ) . METHOD Each treatment was delivered to children for a maximum total of 24 hr over a 6-month period . Spoken communication was assessed in a rigorous test of generalization at pretreatment , posttreatment , and 6-month follow-up periods . RESULTS PECS was more successful than RPMT in increasing the number of nonimitative spoken communication acts and the number of different nonimitative words used at the posttreatment period . Considering growth over all 3 measurement periods , an exploratory analysis showed that growth rate of the number of different nonimitative words was faster in the PECS group than in the RPMT group for children who began treatment with relatively high object exploration . In contrast , analogous slopes were steeper in the RPMT group than in the PECS group for children who began treatment with relatively low object exploration",
"This study aim ed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism . The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later . Compared to caregivers and toddlers r and omized to the waitlist control group the immediate treatment ( IT ) group made significant improvements in targeted areas of joint engagement . The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention . These are among the first r and omized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism . Clinical Trials # : NCT00065910",
"In 2002 , the National Institutes of Health sponsored a meeting concerning method ological challenges of research in psychosocial interventions in Autism Spectrum Disorders . This paper provides a summary of the presentations and the discussion s that occurred during this meeting . Recommendations to federal and private agencies included the need for r and omized clinical trials of comprehensive interventions for autism as the highest , but not the sole priority . Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics , st and ardized documentation and methods of diagnosis , development of outcome measures , establishment of st and ards in research ; and the need for innovative treatment design s , including application of design s from other research areas to the study of interventions in ASD",
"Objective : To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only . Methods : Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were r and omized in two 1-year cohorts . Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction . CS included speech/ language and occupational therapy and public education services . Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms . Secondary outcomes included parent stress and depression and home consultant fidelity . Data were collected pre- and post-intervention . Results : Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales . Child language and developmental quotient did not differ over time by group , although functional development improved significantly . PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) . PLAY caregivers ' stress did not increase , and depressive symptomatology decreased . Home consultants administered the intervention with fidelity . Conclusions : PLAY intervention demonstrated substantial changes in parent-child interaction without increasing parents ' stress/depression . ADOS findings must be interpreted cautiously because results do not align with clinical experience . PLAY offers communities a relatively inexpensive effective intervention for children with ASD and their parents",
"Summary Background Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children . We therefore investigated the efficacy of such an intervention in a larger trial . Methods Children with core autism ( aged 2 years to 4 years and 11 months ) were r and omly assigned in a one-to-one ratio to a parent-mediated communication-focused ( Preschool Autism Communication Trial [ PACT ] ) intervention or treatment as usual at three specialist centres in the UK . Those assigned to PACT were also given treatment as usual . R and omisation was by use of minimisation of probability in the marginal distribution of treatment centre , age ( ≤42 months or > 42 months ) , and autism severity ( Autism Diagnostic Observation Schedule-Generic [ ADOS-G ] algorithm score 12–17 or 18–24 ) . Primary outcome was severity of autism symptoms ( a total score of social communication algorithm items from ADOS-G , higher score indicating greater severity ) at 13 months . Complementary secondary outcomes were measures of parent-child interaction , child language , and adaptive functioning in school . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N58133827 . Results 152 children were recruited . 77 were assigned to PACT ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=25 ] ) ; and 75 to treatment as usual ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=23 ] ) . At the 13-month endpoint , the severity of symptoms was reduced by 3·9 points ( SD 4·7 ) on the ADOS-G algorithm in the group assigned to PACT , and 2·9 ( 3·9 ) in the group assigned to treatment as usual , representing a between-group effect size of −0·24 ( 95 % CI −0·59 to 0·11 ) , after adjustment for centre , sex , socioeconomic status , age , and verbal and non-verbal abilities . Treatment effect was positive for parental synchronous response to child ( 1·22 , 0·85 to 1·59 ) , child initiations with parent ( 0·41 , 0·08 to 0·74 ) , and for parent-child shared attention ( 0·33 , −0·02 to 0·68 ) . Effects on directly assessed language and adaptive functioning in school were small . Interpretation On the basis of our findings , we can not recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms ; however , a clear benefit was noted for parent-child dyadic social communication . Funding UK Medical Research Council , and UK Department for Children , Schools and Families",
"BACKGROUND With rates of autism diagnosis continuing to rise , there is an urgent need for effective and efficient service delivery models . Pivotal Response Treatment ( PRT ) is considered an established treatment for autism spectrum disorder ( ASD ) ; however , there have been few well-controlled studies with adequate sample size . The aim of this study was to conduct a r and omized controlled trial to evaluate PRT parent training group ( PRTG ) for targeting language deficits in young children with ASD . METHODS Fifty-three children with autism and significant language delay between 2 and 6 years old were r and omized to PRTG ( N = 27 ) or psychoeducation group ( PEG ; N = 26 ) for 12 weeks . The PRTG taught parents behavioral techniques to facilitate language development . The PEG taught general information about ASD ( clinical trial NCT01881750 ; http://www . clinical trials.gov ) . RESULTS Analysis of child utterances during the structured laboratory observation ( primary outcome ) indicated that , compared with children in the PEG , children in the PRTG demonstrated greater improvement in frequency of utterances ( F(2 , 43 ) = 3.53 , p = .038 , d = 0.42 ) . Results indicated that parents were able to learn PRT in a group format , as the majority of parents in the PRTG ( 84 % ) met fidelity of implementation criteria after 12 weeks . Children also demonstrated greater improvement in adaptive communication skills ( Vinel and -II ) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG . CONCLUSIONS This is the first r and omized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date . The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children , especially in functional and adaptive communication skills . Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms",
"This study evaluated the effectiveness of low intensity behavioral treatment ( on average 6.5h per week ) supplementing preschool services in 3 - 6-year-old children with autism spectrum disorder and severe to mild intellectual disability . Treatment was implemented in preschools ( i.e. , daycare centers ) and a discrete trial teaching approach was used . Twelve children in the treatment group were compared to 22 children receiving regular intervention . At pre-treatment , both groups did not differ on chronological age , developmental age , diagnosis and level of adaptive skills . Eight months into treatment , children receiving behavioral treatment displayed significantly higher developmental ages and made more gains in adaptive skills than children from the control group . No significant differences between groups were found on autistic symptom severity and emotional and behavioral problems",
"Twenty-four children with autism were r and omly assigned to a clinic-directed group , replicating the parameters of the early intensive behavioral treatment developed at UCLA , or to a parent-directed group that received intensive hours but less supervision by equally well-trained supervisors . Outcome after 4 years of treatment , including cognitive , language , adaptive , social , and academic measures , was similar for both groups . After combining groups , we found that 48 % of all children showed rapid learning , achieved average posttreatment scores , and at age 7 , were succeeding in regular education classrooms . Treatment outcome was best predicted by pretreatment imitation , language , and social responsiveness . These results are consistent with those reported by Lovaas and colleagues ( Lovaas , 1987 ; McEachin , Smith , & Lovaas , 1993 )",
"Although applied behavior analysts often say they engage in evidence -based practice , they express differing views on what constitutes “ evidence ” and “ practice . ” This article describes a practice as a service offered by a provider to help solve a problem presented by a consumer . Solving most problems ( e.g. , increasing or decreasing a behavior and maintaining this change ) requires multiple intervention procedures ( i.e. , a package ) . Single-subject studies are invaluable in investigating individual procedures , but research ers still need to integrate the procedures into a package . The package must be st and ardized enough for independent providers to replicate yet flexible enough to allow individualization ; intervention manuals are the primary technology for achieving this balance . To test whether the package is effective in solving consumers ’ problems , research ers must evaluate outcomes of the package as a whole , usually in group studies such as r and omized controlled trials . From this perspective , establishing an evidence -based practice involves more than analyzing the effects of discrete intervention procedures on behavior ; it requires synthesizing information so as to offer thorough solutions to problems . Recognizing the need for synthesis offers behavior analysts many promising opportunities to build on their existing research to increase the quality and quantity of evidence -based practice",
"BACKGROUND This prospect i ve study compared outcome for pre-school children with autism spectrum disorders ( ASD ) receiving autism-specific nursery provision or home-based Early Intensive Behavioural Interventions ( EIBI ) in a community setting . METHODS Forty-four 23- to 53-month-old children with ASD participated ( 28 in EIBI home-based programmes ; 16 in autism-specific nurseries ) . Cognitive , language , play , adaptive behaviour skills and severity of autism were assessed at intake and 2 years later . RESULTS Both groups showed improvements in age equivalent scores but st and ard scores changed little over time . At follow-up , there were no significant group differences in cognitive ability , language , play or severity of autism . The only difference approaching significance ( p = .06 ) , in favour of the EIBI group , was for Vinel and Daily Living Skills st and ard scores . However , there were large individual differences in progress , with intake IQ and language level best predicting overall progress . CONCLUSIONS Home-based EIBI , as implemented in the community , and autism-specific nursery provision produced comparable outcomes after two years of intervention",
"OBJECTIVE This study was carried out to examine the efficacy of a 12-week , low-intensity ( 1-hour/wk of therapist contact ) , parent-delivered intervention for toddlers at risk for autism spectrum disorders ( ASD ) aged 14 to 24 months and their families . METHOD A r and omized controlled trial involving 98 children and families was carried out in three different sites investigating the efficacy of a parent delivery of the Early Start Denver model ( P-ESDM ) , which fosters parental use of a child-centered responsive interaction style that embeds many teaching opportunities into play , compared to community treatment as usual . Assessment s were completed at baseline and 12 weeks later , immediately after the end of parent coaching sessions . RESULTS There was no effect of group assignment on parent-child interaction characteristics or on any child outcomes . Both groups of parents improved interaction skills , and both groups of children demonstrated progress . Parents receiving P-ESDM demonstrated significantly stronger working alliances with their therapists than did the community group . Children in the community group received significantly more intervention hours than those in the P-ESDM group . For the group as a whole , both younger child age at the start of intervention and a greater number of intervention hours were positively related to the degree of improvement in children 's behavior for most variables . CONCLUSIONS Parent-implemented intervention studies for early ASD thus far have not demonstrated the large effects seen in intensive-treatment studies . Evidence that both younger age and more intervention hours positively affect developmental rates has implication s for clinical practice , service delivery , and public policy",
"Imitation is an early skill thought to play a role in social development , leading some to suggest that teaching imitation to children with autism should lead to improvements in social functioning . This study used a r and omized controlled trial to evaluate the effect of a focused imitation intervention on initiation of joint attention and social-emotional functioning in 27 young children with autism . Results indicated the treatment group made significantly more gains in joint attention initiations at post-treatment and follow-up and social-emotional functioning at follow-up than the control group . Although gains in social functioning were associated with treatment , a mediation analysis did not support imitation as the mechanism of action . These findings suggest the intervention improves social functioning in children with ASD",
"BACKGROUND This r and omized controlled trial compared Hanen 's ' More than Words ' ( HMTW ) , a parent-implemented intervention , to a ' business as usual ' control group . METHODS Sixty-two children ( 51 boys and 11 girls ; M age = 20 months ; SD = 2.6 ) who met criteria for autism spectrum disorders ( ASD ) and their parents participated in the study . The HMTW intervention was provided over 3.5 months . There were three measurement periods : prior to r and omization ( Time 1 ) and at 5 and 9 months post enrollment ( Times 2 and 3 ) . Children 's communication and parental responsivity were measured at each time point . Children 's object interest , a putative moderator , was measured at Time 1 . RESULTS There were no main effects of the HMTW intervention on either parental responsivity or children 's communication . However , the effects on residualized gains in parental responsivity from Time 1 to both Times 2 and 3 yielded noteworthy effect sizes ( Glass 's Δ = .71 , .50 respectively ) . In contrast , there were treatment effects on child communication gains to Time 3 that were moderated by children 's Time 1 object interest . Children with lower levels of Time 1 object interest exhibited facilitated growth in communication ; children with higher levels of object interest exhibited growth attenuation . CONCLUSIONS The HMTW intervention showed differential effects on child communication depending on a baseline child factor . HMTW facilitated communication in children with lower levels of Time 1 object interest . Parents of children who evidence higher object interest may require greater support to implement the HMTW strategies , or may require different strategies than those provided by the HMTW curriculum",
"This study was design ed to evaluate 1 year of intensive treatment for 4- to 7-year-old children with autism . An independent clinician assigned children to either behavioral treatment ( n = 13 ) or eclectic treatment ( n = 12 ) . Assignment was based on availability of personnel to supervise treatment and was not influenced by child characteristics or family preference . The two treatment groups received similar amounts of treatment ( M = 28.52 hours per week at the child ’s school ) . Children in the behavioral treatment group made significantly larger gains on st and ardized tests than did children in the eclectic treatment group . Results suggest that some 4- to 7-year-olds may make large gains with intensive behavioral treatment , that such treatment can be successfully implemented in school setting s , and that specific aspects of behavioral treatment ( not just its intensity ) may account for favorable outcomes",
"This r and omized group experiment compared the efficacy of 2 communication interventions ( Responsive Education and Prelinguistic Milieu Teaching [ RPMT ] and the Picture Exchange Communication System [ PECS ] ) in 36 preschoolers with autism spectrum disorders . Each treatment was delivered 3 times per week , in 20-min sessions , for 6 months . The results revealed that the RPMT facilitated the frequency of generalized turn taking and generalized initiating joint attention more than did the PECS . The latter effect occurred only for children who began treatment with at least some initiating joint attention . In contrast , the PECS facilitated generalized requests more than the RPMT in children with very little initiating joint attention prior to treatment . These effect sizes were large",
"This r and omized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone . The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. ( Eur Child Adolesc Psychiatr 11:266–272 , 2002 ) . Seventy-five toddlers with autism spectrum disorder ( 65 autism , 10 PDD-NOS , mean age = 34.4 months , SD = 6.2 ) were enrolled . Analyses were conducted on a final sample of 67 children ( lost to follow-up = 8) . No significant intervention effects were found for any of the primary ( language ) , secondary ( global clinical improvement ) , or mediating ( child engagement , early precursors of social communication , or parental skills ) outcome variables , suggesting that the ‘ Focus parent training ’ was not of additional value to the more general care-as-usual",
"OBJECTIVE The vast majority of children with an autism spectrum disorder ( ASD ) attend public preschools at some point in their childhood . Community preschool practice s often are not evidence based , and almost none target the prelinguistic core deficits of ASD . This study investigated the effectiveness of public preschool teachers implementing a vali date d intervention ( the Joint Attention and Symbolic Play/Engagement and Regulation intervention ; JASP/ER ) on a core deficit of autism , initiating joint attention . METHOD Sixteen dyads ( preschoolers with ASD and the public school teachers who worked in the child 's classroom ) were r and omly assigned to the 6-week JASP/ER intervention or a control group . RESULTS At the end of the intervention , JASP/ER teachers used more JASP/ER strategies than the control teachers , and JASP/ER preschoolers used more joint attention in their classroom than control children . Additionally , JASP/ER children spent more time in supported engagement and less time in object engagement than control preschoolers on a taped play interaction . CONCLUSIONS Findings suggest that teachers were able to improve a core deficit of children with ASD in a public preschool context ",
"& NA ; This study reports on the results of a r and omized controlled trial that evaluated a caregiverbased intervention program for children with autism in community day‐care centers . Thirty‐five preschool children with a DSM III‐R diagnosis of autism or pervasive developmental disorder were r and omized to an experimental or control group . Children in the experimental group were enrolled in day care and their parents and child care workers received a 12‐week intervention consisting of lectures and on‐site consultations to day‐care centers . In addition , supportive work was undertaken with families . Control subjects received day care alone . In the experimental group , there were greater gains in language abilities , significant increases in caregivers ' knowledge about autism , greater perception of control on the part of mothers , and greater parent satisfaction . We conclude that this research design demonstrated that the intervention was significantly superior to day care alone",
"Young children with pervasive developmental disorder were r and omly assigned to intensive treatment or parent training . The intensive treatment group ( 7 with autism , 8 with pervasive developmental disorder not otherwise specified -- NOS ) averaged 24.52 hours per week of individual treatment for one year , gradually reducing hours over the next 1 to 2 years . The parent training group ( 7 with autism , 6 with pervasive developmental disorder NOS ) received 3 to 9 months of parent training . The groups appeared similar at intake on all measures ; however , at follow-up the intensive treatment group outperformed the parent training group on measures of intelligence , visual-spatial skills , language , and academics , though not adaptive functioning or behavior problems . Children with pervasive developmental disorder NOS may have gained more than those with autism",
"Introduction Accurate and full reporting of evaluation of interventions in health research is needed for evidence synthesis and informed decision-making . Evidence suggests that biases and incomplete reporting affect the assessment of study validity and the ability to include this data in secondary research . The Transparent Reporting of Evaluations with Non-r and omised Design s ( TREND ) reporting guideline was developed to improve the transparency and accuracy of the reporting of behavioural and public health evaluations with non-r and omised design s. Evaluations of reporting guidelines have shown that they can be effective in improving reporting completeness . Although TREND occupies a niche within reporting guidelines , and despite it being 8 years since publication , no study yet has assessed its impact on reporting completeness or investigated what factors affect its use by authors and journal editors . This protocol describes two studies that aim to redress this . Methods and analysis Study 1 will use an observational design to examine the uptake and use of TREND by authors , and by journals in their instructions to authors . A comparison of reporting completeness and study quality of papers that do and do not use TREND to inform reporting will be made . Study 2 will use a cross-sectional survey to investigate what factors inhibit or facilitate authors ’ and journal editors ’ use of TREND . Semistructured interviews will also be conducted with a subset of authors and editors to explore findings from study 1 and the surveys in greater depth . Ethics and dissemination These studies will generate evidence of how implementation and dissemination of the TREND guideline has affected reporting completeness in studies with experimental , non-r and omised design s within behavioural and public health research . The project has received ethics approval from the Research Ethics Committee of the Peninsula College of Medicine and Dentistry , Universities of Exeter and Plymouth",
"Presently there is no consensus on the specific behavioral treatment of choice for targeting language in young nonverbal children with autism . This r and omized clinical trial compared the effectiveness of a verbally-based intervention , Pivotal Response Training ( PRT ) to a pictorially-based behavioral intervention , the Picture Exchange Communication System ( PECS ) on the acquisition of spoken language by young ( 2–4 years ) , nonverbal or minimally verbal ( ≤9 words ) children with autism . Thirty-nine children were r and omly assigned to either the PRT or PECS condition . Participants received on average 247 h of intervention across 23 weeks . Dependent measures included overall communication , expressive vocabulary , pictorial communication and parent satisfaction . Children in both intervention groups demonstrated increases in spoken language skills , with no significant difference between the two conditions . Seventy-eight percent of all children exited the program with more than 10 functional words . Parents were very satisfied with both programs but indicated PECS was more difficult to implement",
"This r and omized field trial comparing Strategies for Teaching based on Autism Research and Structured Teaching enrolled educators in 33 kindergarten-through-second- grade autism support classrooms and 119 students , aged 5–8 years in the School District of Philadelphia . Students were assessed at the beginning and end of the academic year using the Differential Ability Scales . Program fidelity was measured through video coding and use of a checklist . Outcomes were assessed using linear regression with r and om effects for classroom and student . Average fidelity was 57 % in Strategies for Teaching based on Autism Research classrooms and 48 % in Structured Teaching classrooms . There was a 9.2-point ( st and ard deviation = 9.6 ) increase in Differential Ability Scales score over the 8-month study period , but no main effect of program . There was a significant interaction between fidelity and group . In classrooms with either low or high program fidelity , students in Strategies for Teaching based on Autism Research experienced a greater gain in Differential Ability Scales score than students in Structured Teaching ( 11.2 vs 5.5 points and 11.3 vs 8.9 points , respectively ) . In classrooms with moderate fidelity , students in Structured Teaching experienced a greater gain than students in Strategies for Teaching based on Autism Research ( 10.1 vs 4.4 points ) . The results suggest significant variability in implementation of evidence -based practice s , even with supports , and also suggest the need to address challenging issues related to implementation measurement in community setting",
"This study evaluated the impact of intensive behavioral treatment on the development of young autistic children . The treatment reported in this study was home based and was implemented by parents of autistic children with the assistance of community-based clinicians . Although treatment was unable to be observed directly , parents reported that therapy was based on methods developed by Lovaas et al. ( 1981 ) . Treatment differed from that described in previous reports of intensive behavior therapy for this population in that it was implemented outside an academic setting and for a shorter period . In addition , children received fewer hours per week of therapy than in previous reports . Children in the experimental treatment group were pairwise matched to children in a control group ( who received conventional school-based and brief one-on-one interventions ) on the basis of pretreatment chronological and mental age , diagnosis ( autism vs. PDD ) , and length of treatment . The groups did not differ on pretreatment IQ . Children receiving the experimental treatment had significantly higher posttreatment IQ scores . Smaller , but still statistically significant effects on symptom severity were also found , though experimental subjects still met diagnostic criteria for autism or PDD",
"The study investigated the impact of mastery of the Picture Exchange Communication System ( PECS ) to Phase III , on the communications of children with autism . Children aged between 3 and 7 years , formed a PECS intervention group and a non-intervention control group . The intervention group received 15 h of PECS teaching over 5 weeks . Three 2-h classroom observations recorded communications between the children and their teachers . These occurred : 6 weeks before teaching ; during the week immediately prior to teaching ; during the week immediately following teaching . For the control group , two 2-h observations were separated by a 5-week interval without PECS teaching . Communicative initiations and dyadic interactions increased significantly between the children and teachers in the PECS group but not for the control group",
"Evidence from recent meta-analytic and narrative review suggests that early intensive behavioral intervention ( EIBI ) may improve life chances of preschool children with autism . Unfortunately , there are few data indicating whether early gains are maintained after intervention ceases . The purpose of the present study was to establish the 2-year follow-up outcome for children with autism ( N = 41 ) who had participated in an earlier 2-year controlled comparison of EIBI . Twenty-three children in the intervention group ( 100 % of original sample ) and 18 in the treatment-as-usual comparison group ( 86 % of original sample ) were located and retested . Group differences favoring intervention substantially diluted in this period but varied significantly between subgroups who had received university-supervised and parent-commissioned interventions , favoring the latter . These groups differed in terms of their baseline characteristics and intensity of intervention . Results strongly suggest a need for better characterization of those children who would benefit from more active maintenance programs",
"BACKGROUND Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness . R and omised controlled trial ( RCT ) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder . We aim ed to test a new theoretically based social communication intervention targeting parental communication in a r and omised design against routine care alone . METHODS The intervention was given in addition to existing care and involved regular monthly therapist contact for 6 months with a further 6 months of 2-monthly consolidation sessions . It aim ed to educate parents and train them in adapted communication tailored to their child 's individual competencies . Twenty-eight children with autism were r and omised between this treatment and routine care alone , stratified for age and baseline severity . Outcome was measured at 12 months from commencement of intervention , using st and ardised instruments . RESULTS All cases studied met full Autism Diagnostic Interview ( ADI ) criteria for classical autism . Treatment and controls had similar routine care during the study period and there were no study dropouts after treatment had started . The active treatment group showed significant improvement compared with controls on the primary outcome measure -- Autism Diagnostic Observation Schedule ( ADOS ) total score , particularly in reciprocal social interaction-- and on secondary measures of expressive language , communicative initiation and parent-child interaction . Suggestive but non-significant results were found in Vinel and Adaptive Behaviour Scales ( Communication Sub-domain ) and ADOS stereotyped and restricted behaviour domain . CONCLUSIONS A R and omised Treatment Trial design of this kind in classical autism is feasible and acceptable to patients . This pilot study suggests significant additional treatment benefits following a targeted ( but relatively non-intensive ) dyadic social communication treatment , when compared with routine care . The study needs replication on larger and independent sample s. It should encourage further RCT design s in this area",
"Aim : To determine the effect of parent education on adaptive behaviour , autism symptoms and cognitive/ language skills of young children with autistic disorder . Method : A r and omised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample . Two rural and two metropolitan regions were r and omly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . Parents from autism assessment services in the intervention regions were r and omly allocated to parent education and behaviour management ( n = 35 ) or parent education and counselling ( n = 35 ) . Results : Parent education and behaviour management result ed in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour . Parent education and behaviour management was superior to parent education and counselling . We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children",
"The inability to imitate is a salient diagnostic marker for autism . It has been suggested that for children with autism , imitation may be a prerequisite skill that can assist in the development of various skills . Using a multiple baseline design across subjects , the purpose of this research was to determine if two interventions , reciprocal imitation training and video modeling were effective in promoting imitation acquisition in young children with autism . Six boys were matched across various features ( i.e. , age , language , autism severity ) and r and omly placed in a treatment condition . Results indicated that all six participants increased their imitation skills to varying degrees in both conditions , and imitation maintained and generalized at higher than baseline levels post treatment",
"OBJECTIVE To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System ( PECS ) . METHOD DESIGN Group r and omised , controlled trial ( 3 groups : immediate treatment , delayed treatment , no treatment ) . PARTICIPANTS 84 elementary school children , mean age 6.8 years . TREATMENT A 2-day PECS workshop for teachers plus 6 half-day , school-based training sessions with expert consultants over 5 months . OUTCOME MEASURES Rates of : communicative initiations , use of PECS , and speech in the classroom ; Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) domain scores for Communication and Reciprocal Social Interaction ; scores on formal language tests . RESULTS Controlling for baseline age , developmental quotient ( DQ ) and language ; rates of initiations and PECS usage increased significantly immediately post-treatment ( Odds Ratio ( OR ) of being in a higher ordinal rate category 2.72 , 95 % confidence interval 1.22 - 6.09 , p in frequency of speech , or improvements in ADOS-G ratings or language test scores . CONCLUSIONS The results indicate modest effectiveness of PECS teacher training/consultancy . Rates of pupils ' initiations and use of symbols in the classroom increased , although there was no evidence of improvement in other areas of communication . TREATMENT effects were not maintained once active intervention ceased",
"BACKGROUND Social and communication impairments are core deficits and prognostic indicators of autism . We evaluated the impact of supplementing a comprehensive intervention with a curriculum targeting socially synchronous behavior on social outcomes of toddlers with autism spectrum disorders ( ASD ) . METHODS Fifty toddlers with ASD , ages 21 to 33 months , were r and omized to one of two six-month interventions : Interpersonal Synchrony or Non-Interpersonal Synchrony . The interventions provided identical intensity ( 10 hours per week in classroom ) , student-to-teacher ratio , schedule , home-based parent training ( 1.5 hours per month ) , parent education ( 38 hours ) , and instructional strategies , except the Interpersonal Synchrony condition provided a supplementary curriculum targeting socially engaged imitation , joint attention , and affect sharing ; measures of these were primary outcomes . Assessment s were conducted pre-intervention , immediately post-intervention , and , to assess maintenance , at six-month follow-up . R and om effects models were used to examine differences between groups over time . Secondary analyses examined gains in expressive language and nonverbal cognition , and time effects during the intervention and follow-up periods . RESULTS A significant treatment effect was found for socially engaged imitation ( p = .02 ) , with more than doubling ( 17 % to 42 % ) of imitated acts paired with eye contact in the Interpersonal Synchrony group after the intervention . This skill was generalized to unfamiliar context s and maintained through follow-up . Similar gains were observed for initiation of joint attention and shared positive affect , but between-group differences did not reach statistical significance . A significant time effect was found for all outcomes ( p toddlers to identify an active ingredient for enhancing socially engaged imitation . Adding social engagement targets to intervention improves short-term outcome at no additional cost to the intervention . The social , language , and cognitive gains in our participants provide evidence for plasticity of these developmental systems in toddlers with ASD . http://www . clinical trials.gov/ct2/show/NCT00106210?term = l and a&rank = 3",
"In this pilot study , we tested the effects of a novel intervention ( JASPER , Joint Attention Symbolic Play Engagement and Regulation ) on 3 to 5 year old , minimally verbal children with autism who were attending a non-public preschool . Participants were r and omized to a control group ( treatment as usual , 30 h of ABA-based therapy per week ) or a treatment group ( substitution of 30 min of JASPER treatment , twice weekly during their regular program ) . A baseline of 12 weeks in which no changes were noted in core deficits was followed by 12 weeks of intervention for children r and omized to the JASPER treatment . Participants in the treatment group demonstrated greater play diversity on a st and ardized assessment . Effects also generalized to the classroom , where participants in the treatment group initiated more gestures and spent less time unengaged . These results provide further support that even brief , targeted interventions on joint attention and play can improve core deficits in minimally verbal children with ASD",
"Longitudinal research has demonstrated that responsive parental behaviors reliably predict subsequent language gains in children with autism spectrum disorder . To investigate the underlying causal mechanisms , we conducted a r and omized clinical trial of an experimental intervention ( Focused Playtime Intervention , FPI ) that aims to enhance responsive parental communication ( N = 70 ) . Results showed a significant treatment effect of FPI on responsive parental behaviors . Findings also revealed a conditional effect of FPI on children ’s expressive language outcomes at 12-month follow up , suggesting that children with baseline language skills below 12 months ( n = 24 ) are most likely to benefit from FPI . Parents of children with more advanced language skills may require intervention strategies that go beyond FPI ’s focus on responsive communication",
"The study evaluates a social-communication-based approach to autism intervention aim ed at improving the social interaction skills of children with autism spectrum disorder . We report preliminary results from an ongoing r and omized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months . Participants were assigned to either a target treatment or community treatment group . Families in the target treatment group were given 2 hours of therapy and coaching each week in an intervention emphasizing social-interaction and the parent-child relationship . Children in the community treatment group received a variety of services averaging 3.9 hours per week . After 12 months , outcomes were measured to determine changes in the groups in social interaction and communication . In addition , a regression analysis was conducted to determine whether changes in social interaction skills were associated with language development . Results suggest that children in the treatment group made significantly greater gains in social interaction skills in comparison to the community treatment group , but no between-group differences were found for st and ard language assessment s. Initiation of joint attention , involvement , and severity of language delay were found to be significantly associated with improvement of language skills in children with autism . Finally caregiver skills targeted by the intervention were found to be significantly associated with changes in children ’s interaction skills",
"Although early intensive behavior interventions have been efficient in producing positive behavior outcome in young children with Autism Spectrum Disorder , there is a considerable variety in the children 's progress . Research has suggested that parental and treatment factors are likely to affect children 's response to treatment . The purpose of the current study was to examine the interrelating factors that impact children 's progress , highlighting the influence of parent inclusion in treatment provision captured by parental stress , how faithfully the parents followed the treatment protocol s and the intensity of treatment provided at home . Twenty-four children received cross- setting staff- and parent-mediated EIBI , including continuous parent training and supervision . A comparison group of 20 children received eclectic intervention . St and ardized tests were carried out by independent examiners at intake and after six months . The intervention group outperformed the eclectic group in measures of autism severity , developmental and language skills . Parent training and constant parent-mediated treatment provision led to reduced challenging behaviors from the children , increased treatment fidelity and child direct behavior change as measured by performance in correct responding on behavior targets . Variables of treatment progress and potential predictors of child outcome were analyzed in detail and mapped with regard to their relationships drawn from multiple regression analysis . Particularly , the study highlights an association between parental stress and staff treatment fidelity that interferes with decision making in treatment planning and consequently with positive behavior outcome . Such results provide important scientific and clinical information on parental and treatment factors likely to affect a child 's response to treatment",
"BACKGROUND Deficits in joint attention ( JA ) and joint engagement ( JE ) represent a core problem in young children with autism as these affect language and social development . Studies of parent-mediated and specialist-mediated JA-intervention suggest that such intervention may be effective . However , there is little knowledge about the success of the intervention when done in preschools . AIM Assess the effects of a preschool-based JA-intervention . METHODS 61 children ( 48 males ) with autistic disorder ( 29 - 60 months ) were r and omized to either 8 weeks of JA-intervention , in addition to their preschool programs ( n = 34 ) , or to preschool programs only ( n = 27 ) . The intervention was done by preschool teachers with weekly supervision by trained counselors from Child and Adolescent Mental Health Clinics ( CAMHC ) . Changes in JA and JE were measured by blinded independent testers using Early Social Communication Scale ( ESCS ) and video taped preschool teacher-child and mother-child play at baseline and post-intervention . CLINICAL TRIALS REGISTRATION Clinical trials.gov : NCT00378157 . RESULTS Intention-to-treat analysis showed significant difference between the intervention and the control group , with the intervention group yielding more JA initiation during interaction with the preschool teachers . The effect generalized to significantly longer duration of JE with the mothers . CONCLUSIONS This is the first r and omized study to show positive and generalized effects of preschool-based JA-intervention",
"Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials",
"Abstract . Few attempts have been made to conduct r and omised control trials ( RCTs ) of interventions for pre-school children with autism . We report findings of a pilot RCT for a parent training intervention with a focus on the development of joint attention skills and joint action routines . Twenty-four children meeting ICD-10 criteria for childhood autism ( mean age = 23 months ) were identified using the CHAT screen and r and omised to the parent training group or to local services only . A follow-up was conducted 12 months later ( mean age = 35 months ) . There was some evidence that the parent training group made more progress in language development than the local services group . However , the present pilot study was compromised by several factors : a reliance on parental report to measure language , non-matching of the groups on initial IQ , and a lack of systematic checking regarding the implementation of the parent training intervention . Furthermore , three parents in the local services group commenced intensive , home-based behavioural intervention during the course of the study . The difficulties encountered in the conduct of RCTs for pre-school children with autism are discussed . Method ological challenges and strategies for future well- design ed RCTs for autism interventions are highlighted"
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PURPOSE Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis . Non-steroidal anti-inflammatory drugs ( NSAIDs ) are associated with various side effects . Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration . The present systematic review aim ed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis ( OA ) . METHODS A systematic literature review was performed . The electronic data bases EMBASE , MEDLINE , HealthStar and PubMed were search ed from 1946 to June 2016 . A screen of the reference sections of the included studies was also performed . Two blinded review ers search ed , screened , abstract ed and evaluated the data quality using the Jadad scale . Studies were included if they contained : at least 50 % of participants with knee OA , topical ketoprofen , human subjects and participants from North America or Europe . Study outcomes had to include patient-reported functional outcome scores . RESULTS Five studies were included , with a total of 3619 participants , and a mean Jadad score of 3.4/5 . Western Ontario McMaster Universities ( WOMAC ) Osteoarthritis Index was the only outcome measure consistent across all of the r and omized controlled trials included in the present review ( four of the five included studies ) . All topical ketoprofen in Transfersome gel groups ( 25 mg , 50 mg and 100 mg ) had improvements in pain that were superior to all other treatment arms , and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms . The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders , with erythema being the most common . The average of all adverse events and gastrointestinal ( GI ) adverse events was highest in the oral celecoxib group ( 47.1 % and 15.1 % , respectively ) . The average frequency of GI adverse events in the topical ketoprofen groups was comparable with that in the topical placebo treatment arm . A meta- analysis was not feasible due to the heterogeneity among the studies . CONCLUSIONS Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA , and is superior to oral celecoxib , oral placebo and topical placebo . The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders . Furthermore , as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib , and had rates of GI adverse events comparable with those of topical placebo , it may be ideal for those who are unable to take oral NSAIDs
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"Objective To evaluate the safety and efficacy of ketoprofen in Transfersome ® gel ( IDEA-033 ) in comparison with a ketoprofen-free vehicle ( TDT 064 ) for the treatment of osteoarthritis ( OA ) of the knee . Methods Patients with knee OA ( N = 866 ) were r and omly assigned to receive topical IDEA-033 containing 100 , 50 , or 25 mg ketoprofen , or TDT 064 twice daily for 12 weeks , in a double-blind trial . The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities ( WOMAC ® ) Osteoarthritis Index pain subscale score . The co primary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy . The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International ( OARSI ) responder rates . Results The WOMAC pain scores were reduced by approximately 50 % or more in all four groups . The 100 and 50 mg ketoprofen groups , but not the 25 mg group , showed a superior reduction in the WOMAC pain score versus the TDT 064 group ( 100 mg : −57.4 % [ P = 0.0383 ] ; 50 mg : −57.1 % [ P = 0.0204 ] ; and 25 mg : −53.4 % [ P = 0.3616 ] versus TDT 064 : −49.5 % ) . The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score , whereas the patient global assessment of 50 mg ketoprofen group , but not the 100 or 25 mg group , was superior to that of the TDT 064 group ( P = 0.0283 ) . Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group , but were high in all groups ( 100 mg : 88.6 % ; 50 mg : 86.8 % ; 25 mg : 88.6 % ; and TDT 064 : 77.5 % ) . Dermal reactions were the only relevant drug-related adverse events in all four groups . Conclusion The 50 and 100 mg ketoprofen doses of IDEA-033 were only marginally superior to TDT 064 for reducing pain associated with knee OA . The study indicates a high treatment response to the topical ketoprofen-free vehicle TDT 064",
"OBJECTIVE To assess the efficacy and safety of 12-week treatment with ketoprofen in ultradeformable phospholipid vesicles in patients with OA knee pain and to compare the efficacy with that of ketoprofen-free vehicle and celecoxib . METHODS ; A multicentre , double-blind controlled study in which patients with knee OA and moderate pain were r and omized to one of the six arms : topical ketoprofen 50 or 100 mg in ultradeformable vesicles ( IDEA-033 ) , 2.2 or 4.4 g ketoprofen-free vehicle ( TDT 064 ) , oral celecoxib 100 mg or matching oral placebo , all bd . The primary outcome was change from baseline in the WOMAC pain subscale at week 12 . RESULTS A total of 1395 patients received treatment . Baseline mean WOMAC pain scores ranged from 4.7 to 4.8 across groups . The mean reduction in WOMAC pain score at week 12 was -1.9 ( -40.8 % ) for ketoprofen 50 mg , -1.9 ( -40.9 % ) for ketoprofen 100 mg , -1.9 ( -39.8 % ) for 2.2 g TDT 064 , -1.8 ( -37.8 % ) for 4.4 g TDT 064 , -1.9 ( -40.4 % ) for celecoxib and -1.4 ( -29.3 % ) for oral placebo . IDEA-033 was not statistically superior to TDT 064 . All topical treatments were statistically superior to oral placebo and non-inferior to celecoxib . The most frequent types of treatment-related adverse events reported were gastrointestinal for oral ( 15.9 % for celecoxib ) and dermal for topical applications ( 12.2 % for ketoprofen 100 mg ) . CONCLUSION IDEA-033 was not superior to ketoprofen-free vehicle , but both formulations were superior to oral placebo and non-inferior to celecoxib in reducing OA knee pain . TRIAL REGISTRATION Clinical Trials.gov , http:// clinical trials.gov/ , NCT00716547",
"Objective To investigate the effect of epicutaneously applied Diractin ® ( ketoprofen in Transfersome ® gel ) on pain induced by eccentric muscle contractions . Methods Three pilot studies which were subsequently pooled for a meta- analysis compared the efficacy of a single application of 25 mg ketoprofen in Diractin ® to 25 mg oral ketoprofen and placebo for the treatment of pain induced by 50 eccentric contractions of the elbow flexor muscles . In addition , the effect of multiple usage of up to 100 mg ketoprofen in Diractin ® bid over seven days on pain induced by walking down stairs with a total altitude of 200 meters was investigated . Results A single dose of 25 mg ketoprofen in Diractin ® after the elbow flexion exercise was significantly superior to placebo from 5 to 12 hours after treatment and also to oral ketoprofen at some time points after treatment . In contrast , oral ketoprofen was not different to placebo at any time after treatment . Multiple doses of up to 100 mg ketoprofen Diractin ® provided significant more pain relief than placebo on muscle pain induced by walking down stairs . Conclusions Eccentric exercise-induced muscle soreness was shown to be an appropriate acute pain model to evaluate the efficacy of nonsteroidal anti-inflammatory drugs applied epicutaneously with Transfersome ® carriers . Diractin ® proved to be efficacious in relieving pain from eccentric muscle contractions and muscle overexercise , respectively . The effect needs to be confirmed in a larger prospect i ve clinical trial",
"BACKGROUND Orally administrated nonsteroidal anti-inflammatory drugs are effective in the treatment of a variety of acute and chronic pain conditions but their use may be associated with serious systemic adverse effects which are correlated with the therapeutic plasma levels of the drug . In order to minimize the incidence of drug related systemic events , topical formulations of the nonsteroidal anti-inflammatory drugs have been developed . A recently performed review of the evidence from r and omized , double-blind , placebo controlled trials with topically applied NSAIDs in the treatment of acute pain confirmed the previously described pain relief effectiveness . For all topical nonsteroidal anti-inflammatory drugs combined , in comparison to placebo , the number needed to treat ( NNT ) to achieve a clinical ly meaningful pain relief of 50 % was 4.5 ( 3.9 to 5.3 ) for treatment periods of 6 to 14 days . Local skin reactions were generally mild and transient , and did not differ from placebo . OBJECTIVES The present is an observational , multicenter , open-label , non-interventional , post-authorization safety study as it is defined by Article 21 of the European Clinical Trials Directive 2001/20/EC . The main objective of this study was to evaluate the local tolerability and the therapeutic efficacy of static and pain on movement intensity reduction of Ketospray ® 10 % cutaneous spray solution administered in accordance with the terms of the marketing authorization and last version of summary of product characteristics approved by National Medicines Agency of Romania . METHODS In compliance with the Post-marketing study type , the assignment of the patient to a particular therapeutic strategy fell within current practice . The prescription of the medicine was not subject to compliance with predefined patients ' characteristics . No specific , out of the daily practice routine diagnostic , monitoring , instrumental or laboratory assessment s were foreseen by the study protocol . Patients ' data were collected into respective case report forms . Study medication , Ketoprofen 10 % Cutaneous Spray Solution was administered to the affected area at the dose of 3 - 6 spray puffs , 2 - 3 times a day , for 7 days . According to the study type , descriptive statistical methods were applied . Since almost half of the patients were treated with combination of the pain relieving medications , sizing of the pain relieving effects , as NNT , between the two groups was made . FINDINGS There were 2020 study subjects in safety and ITT analysis population and 1802 ( 89 % ) in PP efficacy analysis population . There were 4 types of injuries : non-complicated strain-sprain ( 555 ) , soft tissue contusion ( 323 ) , low back pain ( 461 ) and osteoarthritis ( 681 patients ) . Ten patients reported 13 side effects of which 10 were recognized by investigators as adverse drug reactions . All side effects were non-serious , listed , application site skin changes . Remarkable reductions of static and pain on movement intensity were experienced by patients irrespective of the type of the injury and the type of the treatment . However , a clinical ly meaningful benefit of the concomitantly prescribed pain relieving medications was not observed for any type of pain . The lowest NNT ( 14 ) was obtained for the reduction of pain at rest in patients with strain-sprain or soft tissue contusions . The highest NNT ( 283 ) was for pain at rest in patients treated for the exacerbation of the chronic pain . CONCLUSIONS The results of the current post-authorization study confirm beneficial pain intensity reducing efficacy of Ketospray 10 % associated with good local tolerability of 7 days treatment course . Concomitant administration of systemic pain relieving medication did not substantially contribute neither to the relief of pain at rest nor of pain on movement among the subjects of respective study population",
"Objective To determine whether older patients with chronic knee pain should be advised to use topical or oral non-steroidal anti-inflammatory drugs ( NSAIDs ) . Design R and omised controlled trial and patient preference study . Setting 26 general practice s. Participants People aged ≥50 with knee pain : 282 in r and omised trial and 303 in preference study . Interventions Advice to use topical or oral ibuprofen . Primary outcome measures WOMAC ( Western Ontario and McMaster Universities ) osteoarthritis index , major and minor adverse effects . Results Changes in global WOMAC scores at 12 months were equivalent . In the r and omised trial the difference ( topical minus oral ) was two points ( 95 % confidence interval −2 to 6 ) ; in the preference study , it was one point ( −4 to 6 ) . There were no differences in major adverse effects in the trial or study . The only significant differences in secondary outcomes were in the r and omised trial . The oral group had more respiratory adverse effects ( 17 % v 7%,95 % confidence interval for difference −17 % to −2 % ) , the change in serum creatinine was 3.7 mmol/l less favourable ( 0.9 µmol/l to 6.5 µmol/l ) ; and more participants changed treatments because of adverse effects ( 16 % v 1 % , −16 % to −5 % ) . In the topical group more participants had chronic pain grade III or IV at three months , and more participants changed treatment because of ineffectiveness . Conclusions Advice to use oral or topical preparations has an equivalent effect on knee pain over one year , and there are more minor side effects with oral NSAIDs . Topical NSAIDs may be a useful alternative to oral NSAIDs . Trial registration IS RCT N 79353052",
"Objective . This r and omized , double-blind , phase III study evaluated the efficacy and safety of ketoprofen in an ultradeformable vesicle gel compared with ketoprofen-free gel in osteoarthritis ( OA ) knee pain . Methods . Patients with American College of Rheumatology-defined OA of the knee and moderate pain were r and omized to receive 100 mg ketoprofen in 4.4 g transfersome gel ( IDEA-033 ) or 4.4 g ketoprofen-free vehicle ( TDT 064 ) topically , twice daily , for 12 weeks . The primary endpoint was mean change in Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain subscale score from baseline to Week 12 . Results . Patients ( n = 555 ) were r and omized and treated . Mean baseline WOMAC pain scores were 5.2 ( SD 1.0 ) for IDEA-033 and 5.3 ( SD 1.0 ) for TDT 064 . Mean change in WOMAC pain scores from baseline to Week 12 was 38.6 % for IDEA-033 and 44.6 % for TDT 064 ( Mann-Whitney estimator 0.4505 ; p = 0.022 ) . Both groups reported progressive decreases in pain and improvements in function and stiffness . Mean baseline WOMAC function scores decreased from 5.4 to 3.4 with IDEA-033 and 3.1 with TDT 064 at Week 12 . The proportion of patients achieving ≥ 50 % decrease in WOMAC pain score from baseline at Week 12 was 41.2 % ( 95 % CI 0.35–0.47 ) with IDEA-033 and 50.5 % ( 95 % CI 0.45–0.57 ) with TDT 064 . Mild skin and subcutaneous tissue disorders were the most frequently reported treatment-related adverse events ( AE ) . Conclusions . IDEA-033 was inferior to drug-free gel ( TDT 064 ) in relieving moderate OA knee pain and improving joint function ( Clinical Trials NCT00722852 )",
"Low quality clinical trials have a possibility to have errors in the process of deriving the results and therefore distort the study . Quality assessment of clinical trial is necessary in order to prevent any clinical application erroneous results is important . R and omized controlled trial ( RCT ) is a design for evaluate the effectiveness of medical procedure . This study was conducted by extracting the RCTs from the original articles published in the Journal of Korean Medical Science ( JKMS ) from 1986 to 2011 and conducting a qualitative analysis using three types of analysis tools : Jadad scale , van Tulder scale and Cochrane Collaboration risk of bias Tool . To compare the quality of articles of JKMS , quality analysis of the RCTs published in Yonsei Medical Journal ( YMJ ) and Korean Journal of Internal Medicine was also conducted . In the JKMS , YMJ and Korean Journal of Internal Medicine , the quantitative increase of RCT presented over time was observed but no qualitative improvement of RCT was observed over time . From the results of this study , it is required for the research ers to plan for and perform higher quality studies",
"The risk of oral NSAID including Cox-2 inhibitors to cause gastrointestinal , renal or cardiovascular adverse events related to systemic drug exposure could be reduced by local application . But only few long-term studies have been published to show safety and efficacy for long-term use of topical NSAID s. Diractin ( formerly IDEA-033 ) is a viscous , aqueous formulation for epicutaneous application of ketoprofen based on ultra-deformable , self-regulating carrier ( Transfersome ) . This multiple-dose , open label study with treatment periods up to 18 months included 402 patients with joint pain , musculoskeletal pain , stiffness or soft tissue inflammation ( age of 61.4+/-11.5 years ) . Most of the patients suffered from osteoarthritis ( OA ) of the knee ( 68.9 % ) . Diractin was applied epicutaneously up to twice daily with a maximum dose of 220 mg ketoprofen per a maximum of 2 application sites . The mean pain score at baseline was 5.4+/-.4 on a 10 point categorical scale . During the study the pain score progressively improved up to week 36 ( 3.5+/-1.9 ) without a substantial further change during the rest of observation period of up to 18 months . The reduction of pain scores between week 0 ( baseline ) and at all later visits was statistically significant ( P quality of life on the EUROQoL. The majority of treatment related adverse events were skin and subcutaneous tissue disorders with the highest frequency reported for erythema ( 16.7 % ) and pruritus ( 2.0 % ) . Systemic ketoprofen exposure remained low throughout the study period with plasma concentrations of less than 1 % of what was reported for a single , st and ard oral dose of 200 mg ketoprofen . There were no occurrences of treatment related serious adverse events and no remarkable changes in laboratory values or vital signs . In summary , Diractin provided adequate pain relief with a good safety and tolerability profile when used for up to 18 months ( 72 weeks )",
"Objective : To compare epicutaneous ketoprofen in Transfersome ( ultra-deformable vesicles , IDEA-033 ) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis . Methods : This was a multicentre , r and omised , double-blind , controlled trial ; 397 patients with knee osteoarthritis participated and 324 completed the trial . They were r and omly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo ( n = 138 ) , 100 mg oral celecoxib plus placebo gel ( n = 132 ) , or both placebo formulations ( n = 127 ) twice daily for 6 weeks . Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index pain subscale , physical function subscale and patient global assessment ( PGA ) of response . Results : The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 ( 95 % confidence interval −22.1 to −14.3 ) , 20.3 ( −24.3 to −16.2 ) and 9.9 ( −13.9 to −5.8 ) in the IDEA-033 , celecoxib and placebo groups , respectively , and the physical function subscale score by 14.6 ( −18.1 to −11.0 ) , 16.6 ( −20.2 to −13.0 ) and 10.2 ( −13.8 to −6.6 ) , respectively . The mean PGA of response scores were 1.8 ( 1.6 to 2.1 ) , 1.7 ( 1.5 to 1.9 ) and 1.3 ( 1.1 to 1.5 ) , respectively . The differences in change between IDEA-033 and placebo were statistically significant for pain subscale ( p of response ( p events for IDEA-033 were similar to placebo . Conclusion : IDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis",
"The clinical efficacy of the two topical analgesics , ketoprofen hydroalcoholic gel ( Fastum gel ) and diclofenac emulgel , for osteoarthritis of the knee was studied . There were 85 patients who underwent the trial . They were r and omly allocated into 2 groups , the diclofenac group , 42 patients ( 4 males and 38 females ) receiving the diclofenac emulgel at the painfull site four times a day for 4 weeks , and the ketoprofen group , 43 patients ( 9 males and 34 females ) receiving the ketoprofen hydroalcoholic gel four times a day for 4 weeks at the painful knee . Golberg 's knee scoring was used to evaluate the patients before the trial , at the end of the first , second and fourth weeks . The ketoprofen group had poorer a score before the trial , however , both groups had improvement in their knee functions , knee score and pain . There was no significant difference between the groups at the end of the study . There was no serious side effect in both groups . Ketoprofen hydroalcoholic gel gave persuasive results in the treatment of knee arthrosis stage I and II",
"BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients"
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411646c4-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To present a summary of the 2016 version of the European Association of Urology ( EAU ) - European Society for Radiotherapy & Oncology ( ESTRO ) - International Society of Geriatric Oncology ( SIOG ) Guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly localised prostate cancer ( PCa ) . EVIDENCE ACQUISITION The working panel performed a literature review of the new data ( 2013 - 2015 ) . The guidelines were up date d and the levels of evidence and /or grade s of recommendation were added based on a systematic review of the evidence . EVIDENCE SYNTHESIS BRCA2 mutations have been added as risk factors for early and aggressive disease . In addition to the Gleason score , the five-tier 2014 International Society of Urological Pathology grading system should now be provided . Systematic screening is still not recommended . Instead , an individual risk-adapted strategy following a detailed discussion and taking into account the patient 's wishes and life expectancy must be considered . An early prostate-specific antigen test , the use of a risk calculator , or one of the promising biomarker tools are being investigated and might be able to limit the overdetection of insignificant PCa . Breaking the link between diagnosis and treatment may lower the overtreatment risk . Multiparametric magnetic resonance imaging using st and ardised reporting can not replace systematic biopsy , but robustly nested within the diagnostic work-up , it has a key role in local staging . Active surveillance always needs to be discussed with very low-risk patients . The place of surgery in high-risk disease and the role of lymph node dissection have been clarified , as well as the management of node-positive patients . Radiation therapy using dose-escalated intensity-modulated technology is a key treatment modality with recent improvement in the outcome based on increased doses as well as combination with hormonal treatment . Moderate hypofractionation is safe and effective , but longer-term data are still lacking . Brachytherapy represents an effective way to increase the delivered dose . Focal therapy remains experimental while cryosurgery and HIFU are still lacking long-term convincing results . CONCLUSIONS The knowledge in the field of diagnosis , staging , and treatment of localised PCa is evolving rapidly . The 2016 EAU-ESTRO-SIOG Guidelines on PCa summarise the most recent findings and advice for the use in clinical practice . These are the first PCa guidelines endorsed by the European Society for Radiotherapy and Oncology and the International Society of Geriatric Oncology and reflect the multidisciplinary nature of PCa management . A full version is available from the EAU office and online ( http://uroweb.org/ guideline /prostate-cancer/ ) . PATIENT SUMMARY The 2016 EAU-STRO-IOG Prostate Cancer ( PCa ) Guidelines present up date d information on the diagnosis , and treatment of clinical ly localised prostate cancer . In Northern and Western Europe , the number of men diagnosed with PCa has been on the rise . This may be due to an increase in opportunistic screening , but other factors may also be involved ( eg , diet , sexual behaviour , low exposure to ultraviolet radiation ) . We propose that men who are potential c and i date s for screening should be engaged in a discussion with their clinician ( also involving their families and caregivers ) so that an informed decision may be made as part of an individualised risk-adapted approach
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"Background : Many men with elevated prostate-specific antigen ( PSA ) levels in serum do not have aggressive prostate cancer and undergo unnecessary biopsy . Retrospective studies using cryopreserved serum suggest that four kallikrein markers can predict biopsy outcome . Methods : Free , intact and total PSA , and kallikrein-related peptidase 2 were measured in cryopreserved blood from 6129 men with elevated PSA ( ≥3.0ng/mL ) participating in the prospect i ve , r and omized trial Prostate Testing for Cancer and Treatment . Marker levels from 4765 men providing anticoagulated plasma were incorporated into statistical models to predict any- grade and high- grade ( Gleason score ≥7 ) prostate cancer at 10-core biopsy . The models were corrected for optimism by 10-fold cross validation and independently vali date d using markers measured in serum from 1364 men . All statistical tests were two-sided . Results : The four kallikreins enhanced prostate cancer detection compared with PSA and age alone . Area under the curve ( AUC ) for the four kallikreins was 0.719 ( 95 % confidence interval [ CI ] = 0.704 to 0.734 ) vs 0.634 ( 95 % CI = 0.617 to 0.651 , P reduce the need for biopsy in 428 men , detect 119 high- grade cancers , and delay diagnosis of 14 of 133 high- grade cancers . Models exhibited excellent discrimination on independent validation among men with only serum sample s available for analysis . Conclusions : A statistical model based on kallikrein markers was vali date d in a large prospect i ve study and reduces unnecessary biopsies while delaying diagnosis of high- grade cancers in few men",
"PURPOSE To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months . According to the 1997-American Society for Therapeutic Radiology and Oncology definition , the 5-year biochemical relapse rate was 39 % and 28 % in the 70- and 80-Gy arms , respectively ( p = .036 ) . Using the Phoenix definition , the 5-year biochemical relapse rate was 32 % and 23.5 % , respectively ( p = .09 ) . The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level > 15 ng/mL. At the last follow-up date , 26 patients had died , 10 of their disease and none of toxicity , with no differences between the two arms . According to the Radiation Therapy Oncology Group scale , the Grade 2 or greater rectal toxicity rate was 14 % and 19.5 % for the 70- and 80-Gy arms ( p = .22 ) , respectively . The Grade 2 or greater urinary toxicity was 10 % at 70 Gy and 17.5 % at 80 Gy ( p = .046 ) . Similar results were observed using the LENT-SOMA scale . Bladder toxicity was more frequent at 80 Gy than at 70 Gy ( p = .039 ) . The quality -of-life question naire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms . CONCLUSION High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity",
"BACKGROUND It is not known whether short-term and rogen-deprivation therapy ( ADT ) before and during radiotherapy improves cancer control and overall survival among patients with early , localized prostate adenocarcinoma . METHODS From 1994 through 2001 , we r and omly assigned 1979 eligible patients with stage T1b , T1c , T2a , or T2b prostate adenocarcinoma and a prostate-specific antigen ( PSA ) level of 20 ng per milliliter or less to radiotherapy alone ( 992 patients ) or radiotherapy with 4 months of total and rogen suppression starting 2 months before radiotherapy ( radiotherapy plus short-term ADT , 987 patients ) . The primary end point was overall survival . Secondary end points included disease-specific mortality , distant metastases , biochemical failure ( an increasing level of PSA ) , and the rate of positive findings on repeat prostate biopsy at 2 years . RESULTS The median follow-up period was 9.1 years . The 10-year rate of overall survival was 62 % among patients receiving radiotherapy plus short-term ADT ( the combined-therapy group ) , as compared with 57 % among patients receiving radiotherapy alone ( hazard ratio for death with radiotherapy alone , 1.17 ; P=0.03 ) . The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8 % to 4 % ( hazard ratio for radiotherapy alone , 1.87 ; P=0.001 ) . Biochemical failure , distant metastases , and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT . Acute and late radiation-induced toxic effects were similar in the two groups . The incidence of grade 3 or higher hormone-related toxic effects was less than 5 % . Re analysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients , with no significant reductions among low-risk patients . CONCLUSIONS Among patients with stage T1b , T1c , T2a , or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less , the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival . According to post hoc risk analysis , the benefit was mainly seen in intermediate-risk , but not low-risk , men . ( Funded by the National Cancer Institute ; RTOG 94 - 08 Clinical Trials.gov number , NCT00002597 . )",
"BACKGROUND The European R and omised study of Screening for Prostate Cancer ( ERSPC ) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up , but screening is controversial because of adverse events such as overdiagnosis . We provide up date d results of mortality from prostate cancer with follow-up to 2010 , with analyses truncated at 9 , 11 , and 13 years . METHODS ERSPC is a multicentre , r and omised trial with a predefined central ised data base , analysis plan , and core age group ( 55 - 69 years ) , which assesses prostate-specific antigen ( PSA ) testing in eight European countries . Eligible men aged 50 - 74 years were identified from population registries and r and omly assigned by computer generated r and om numbers to screening or no intervention ( control ) . Investigators were masked to group allocation . The primary outcome was prostate cancer mortality in the core age group . Analysis was by intention to treat . We did a secondary analysis that corrected for selection bias due to non-participation . Only incidence and no mortality data at 9 years ' follow-up are reported for the French centres . This study is registered with Current Controlled Trials , number IS RCT N49127736 . FINDINGS With data truncated at 13 years of follow-up , 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group . The rate ratio of prostate cancer incidence between the intervention and control groups was 1·91 ( 95 % CI 1·83 - 1·99 ) after 9 years ( 1·64 [ 1·58 - 1·69 ] including France ) , 1·66 ( 1·60 - 1·73 ) after 11 years , and 1·57 ( 1·51 - 1·62 ) after 13 years . The rate ratio of prostate cancer mortality was 0·85 ( 0·70 - 1·03 ) after 9 years , 0·78 ( 0·66 - 0·91 ) after 11 years , and 0·79 ( 0·69 - 0·91 ) at 13 years . The absolute risk reduction of death from prostate cancer at 13 years was 0·11 per 1000 person-years or 1·28 per 1000 men r and omised , which is equivalent to one prostate cancer death averted per 781 ( 95 % CI 490 - 1929 ) men invited for screening or one per 27 ( 17 - 66 ) additional prostate cancer detected . After adjustment for non-participation , the rate ratio of prostate cancer mortality in men screened was 0·73 ( 95 % CI 0·61 - 0·88 ) . INTERPRETATION In this up date the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA , with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years . Despite our findings , further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening . FUNDING Each centre had its own funding responsibility",
"Summary Background Prostate cancer might have high radiation-fraction sensitivity that would give a therapeutic advantage to hypofractionated treatment . We present a pre-planned analysis of the efficacy and side-effects of a r and omised trial comparing conventional and hypofractionated radiotherapy after 5 years follow-up . Methods CHHiP is a r and omised , phase 3 , non-inferiority trial that recruited men with localised prostate cancer ( pT1b – T3aN0M0 ) . Patients were r and omly assigned ( 1:1:1 ) to conventional ( 74 Gy delivered in 37 fractions over 7·4 weeks ) or one of two hypofractionated schedules ( 60 Gy in 20 fractions over 4 weeks or 57 Gy in 19 fractions over 3·8 weeks ) all delivered with intensity-modulated techniques . Most patients were given radiotherapy with 3–6 months of neoadjuvant and concurrent and rogen suppression . R and omisation was by computer-generated r and om permuted blocks , stratified by National Comprehensive Cancer Network ( NCCN ) risk group and radiotherapy treatment centre , and treatment allocation was not masked . The primary endpoint was time to biochemical or clinical failure ; the critical hazard ratio ( HR ) for non-inferiority was 1·208 . Analysis was by intention to treat . Long-term follow-up continues . The CHHiP trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N97182923 . Findings Between Oct 18 , 2002 , and June 17 , 2011 , 3216 men were enrolled from 71 centres and r and omly assigned ( 74 Gy group , 1065 patients ; 60 Gy group , 1074 patients ; 57 Gy group , 1077 patients ) . Median follow-up was 62·4 months ( IQR 53·9–77·0 ) . The proportion of patients who were biochemical or clinical failure free at 5 years was 88·3 % ( 95 % CI 86·0–90·2 ) in the 74 Gy group , 90·6 % ( 88·5–92·3 ) in the 60 Gy group , and 85·9 % ( 83·4–88·0 ) in the 57 Gy group . 60 Gy was non-inferior to 74 Gy ( HR 0·84 [ 90 % CI 0·68–1·03 ] , pNI=0·0018 ) but non-inferiority could not be cl aim ed for 57 Gy compared with 74 Gy ( HR 1·20 [ 0·99–1·46 ] , pNI=0·48 ) . Long-term side-effects were similar in the hypofractionated groups compared with the conventional group . There were no significant differences in either the proportion or cumulative incidence of side-effects 5 years after treatment using three clinician-reported as well as patient-reported outcome measures . The estimated cumulative 5 year incidence of Radiation Therapy Oncology Group ( RTOG ) grade 2 or worse bowel and bladder adverse events was 13·7 % ( 111 events ) and 9·1 % ( 66 events ) in the 74 Gy group , 11·9 % ( 105 events ) and 11·7 % ( 88 events ) in the 60 Gy group , 11·3 % ( 95 events ) and 6·6 % ( 57 events ) in the 57 Gy group , respectively . No treatment-related deaths were reported . Interpretation Hypofractionated radiotherapy using 60 Gy in 20 fractions is non-inferior to conventional fractionation using 74 Gy in 37 fractions and is recommended as a new st and ard of care for external-beam radiotherapy of localised prostate cancer . Funding Cancer Research UK , Department of Health , and the National Institute for Health Research Cancer Research Network",
"BACKGROUND Studies have reported a low α/β ratio for prostate cancer , suggesting that hypofractionation could enhance the biological tumour dose without increasing genitourinary and gastrointestinal toxicity . In the multicentre phase 3 , HYpofractionated irradiation for PROstate cancer ( HYPRO ) trial , hypofractionated radiotherapy was compared with conventionally fractionated radiotherapy for treatment of prostate cancer . We have previously reported acute and late incidence of genitourinary and gastrointestinal toxicity ; here we report protocol -defined 5-year relapse-free survival outcomes . METHODS We did an open-label , r and omised , phase 3 trial at seven Dutch radiotherapy centres . We enrolled patients with intermediate-risk to high-risk T1b-T4NX-N0MX-M0 localised prostate cancer , a prostate-specific antigen concentration of 60 μg/L or less , and a WHO performance status of 0 - 2 . We used a web-based application to r and omly assign ( 1:1 ) patients to either hypofractionated radiotherapy of 64·6 Gy ( 19 fractions of 3·4 Gy , three fractions per week ) or conventionally fractionated radiotherapy of 78·0 Gy ( 39 fractions of 2·0 Gy , five fractions per week ) . Based on an estimated α/β ratio for prostate cancer of 1·5 Gy , the equivalent total dose in fractions of 2·0 Gy was 90·4 Gy for hypofractionation compared with 78·0 Gy for conventional fractionation . The primary endpoint was relapse-free survival . All analyses were done on an intention-to-treat basis in all eligible patients . The HYPRO trial completed recruitment in 2010 and follow-up is ongoing . This trial is registered with IS RCT N , number IS RCT N85138529 . FINDINGS Between March 19 , 2007 , and Dec 3 , 2010 , 820 patients were enrolled , of whom 804 were eligible and assessable for intention-to-treat analyses . Of these , 407 were assigned hypofractionated radiotherapy and 397 were allocated conventionally fractionated radiotherapy . 537 ( 67 % ) of 804 patients received concomitant and rogen deprivation therapy for a median duration of 32 months ( IQR 10 - 44 ) . Median follow-up was 60 months ( IQR 51 - 69 ) . Treatment failure was reported in 169 ( 21 % ) of 804 patients , 80 ( 20 % ) in the hypofractionation group and 89 ( 22 % ) in the conventional fractionation group . 5-year relapse-free survival was 80·5 % ( 95 % CI 75·7 - 84·4 ) for patients assigned hypofractionation and 77·1 % ( 71·9 - 81·5 ) for those allocated conventional fractionation ( adjusted hazard radio 0·86 , 95 % CI 0·63 - 1·16 ; log-rank p=0·36 ) . There were no treatment-related deaths . INTERPRETATION Hypofractionated radiotherapy was not superior to conventional radiotherapy with respect to 5-year relapse-free survival . Our hypofractionated radiotherapy regimen can not be regarded as the new st and ard of care for patients with intermediate-risk or high-risk prostate cancer . FUNDING Dutch Cancer Society",
"BACKGROUND It has been shown that organized screening decreases prostate cancer ( PC ) mortality , but the effect of opportunistic screening is largely unknown . OBJECTIVE To compare the ability to reduce PC mortality and the risk of overdiagnosis between organized and opportunistic screening . DESIGN , SETTING , AND PARTICIPANTS The Göteborg screening study invited 10 000 r and omly selected men for prostate-specific antigen ( PSA ) testing every 2 yr since 1995 , with a prostate biopsy recommended for men with PSA ≥2.5 ng/ml . The control group of 10 000 men not invited has been exposed to a previously reported increased rate of opportunistic PSA testing . Both groups were followed until December 31 , 2012 . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Observed cumulative PC incidence and mortality rates in both groups were calculated using the actuarial method . Using historical data from 1990 - 1994 ( pre-PSA era ) , we calculated expected PC incidence and mortality rates in the absence of any PSA testing . The number needed to invite ( NNI ) and the number needed to diagnose ( NND ) were calculated by comparing the expected versus observed incidence and mortality rates . RESULTS AND LIMITATIONS At 18 yr , 1396 men were diagnosed with PC and 79 men died of PC in the screening group , compared to 962 and 122 , respectively , in the control group . In the screening group , the observed cumulative PC incidence/mortality was 16%/0.98 % compared to expected values of 6.8%/1.7 % . The corresponding values for the control group were 11%/1.5 % and 6.9%/1.7 % . Organized screening was associated with an absolute PC-specific mortality reduction of 0.72 % ( 95 % confidence interval [ CI ] 0.50 - 0.94 % ) and relative risk reduction of 42 % ( 95 % CI 28 - 54 % ) . There was an absolute reduction in PC deaths of 0.20 % ( 95 % CI -0.06 % to 0.47 % ) and a relative risk reduction of 12 % ( 95 % CI -5 to 26 % ) associated with opportunistic PSA testing . NNI and NND were 139 ( 95 % CI 107 - 200 ) and 13 for organized biennial screening and 493 ( 95 % CI 213- -1563 ) and 23 for opportunistic screening . The extent of opportunistic screening could not be measured ; incidence trends were used as a proxy . CONCLUSIONS Organized screening reduces PC mortality but is associated with overdiagnosis . Opportunistic PSA testing had little if any effect on PC mortality and result ed in more overdiagnosis , with almost twice the number of men needed to be diagnosed to save one man from dying from PC compared to men offered an organized biennial screening program . PATIENT SUMMARY Prostate-specific antigen ( PSA ) screening within the framework of an organized program seems more effective than unorganized screening",
"BACKGROUND Robot-assisted laparoscopic radical prostatectomy ( RALP ) has become widely used without high- grade evidence of superiority regarding long-term clinical outcomes compared with open retropubic radical prostatectomy ( RRP ) , the gold st and ard . OBJECTIVE To compare patient-reported urinary incontinence and erectile dysfunction 12 mo after RALP or RRP . DESIGN , SETTING , AND PARTICIPANTS This was a prospect i ve , controlled , nonr and omised trial of patients undergoing prostatectomy in 14 centres using RALP or RRP . Clinical -record forms and vali date d patient question naires at baseline and 12 mo after surgery were collected . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES Odds ratios ( ORs ) were calculated with logistic regression and adjusted for possible confounders . The primary end point was urinary incontinence ( change of pad less than once in 24h vs one time or more per 24h ) at 12 mo . Secondary end points were erectile dysfunction at 12 mo and positive surgical margins . RESULTS AND LIMITATIONS At 12 mo after RALP , 366 men ( 21.3 % ) were incontinent , as were 144 ( 20.2 % ) after RRP . The unadjusted OR was 1.08 ( 95 % confidence interval [ CI ] , 0.87–1.34 ) . Erectile dysfunction was observed in 1200 men ( 70.4 % ) 12 mo after RALP and 531 ( 74.7 % ) after RRP . The unadjusted OR was 0.81 ( 95 % CI , 0.66–0.98 ) . CONCLUSIONS In a Swedish setting , RALP for prostate cancer was modestly beneficial in preserving erectile function compared with RRP , without a statistically significant difference regarding urinary incontinence or surgical margins . PATIENT SUMMARY We compared patient-reported urinary incontinence after prostatectomy with two types of surgical technique . There was no statistically significant improvement in the rate of urinary leakage , but there was a small improvement regarding erectile function after robot-assisted operation",
"BACKGROUND Radical prostatectomy reduces mortality among men with localized prostate cancer ; however , important questions regarding long-term benefit remain . METHODS Between 1989 and 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012 . The primary end points in the Sc and inavian Prostate Cancer Group Study Number 4 ( SPCG-4 ) were death from any cause , death from prostate cancer , and the risk of metastases . Secondary end points included the initiation of and rogen-deprivation therapy . RESULTS During 23.2 years of follow-up , 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died . Of the deaths , 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer ; the relative risk was 0.56 ( 95 % confidence interval [ CI ] , 0.41 to 0.77 ; P=0.001 ) , and the absolute difference was 11.0 percentage points ( 95 % CI , 4.5 to 17.5 ) . The number needed to treat to prevent one death was 8 . One man died after surgery in the radical-prostatectomy group . And rogen-deprivation therapy was used in fewer patients who underwent prostatectomy ( a difference of 25.0 percentage points ; 95 % CI , 17.7 to 32.3 ) . The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age ( relative risk , 0.45 ) and in those with intermediate-risk prostate cancer ( relative risk , 0.38 ) . However , radical prostatectomy was associated with a reduced risk of metastases among older men ( relative risk , 0.68 ; P=0.04 ) . CONCLUSIONS Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy ; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk . A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment . ( Funded by the Swedish Cancer Society and others . )",
"BACKGROUND The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen ( PSA ) testing is not known . METHODS From November 1994 through January 2002 , we r and omly assigned 731 men with localized prostate cancer ( mean age , 67 years ; median PSA value , 7.8 ng per milliliter ) to radical prostatectomy or observation and followed them through January 2010 . The primary outcome was all-cause mortality ; the secondary outcome was prostate-cancer mortality . RESULTS During the median follow-up of 10.0 years , 171 of 364 men ( 47.0 % ) assigned to radical prostatectomy died , as compared with 183 of 367 ( 49.9 % ) assigned to observation ( hazard ratio , 0.88 ; 95 % confidence interval [ CI ] , 0.71 to 1.08 ; P=0.22 ; absolute risk reduction , 2.9 percentage points ) . Among men assigned to radical prostatectomy , 21 ( 5.8 % ) died from prostate cancer or treatment , as compared with 31 men ( 8.4 % ) assigned to observation ( hazard ratio , 0.63 ; 95 % CI , 0.36 to 1.09 ; P=0.09 ; absolute risk reduction , 2.6 percentage points ) . The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age , race , coexisting conditions , self-reported performance status , or histologic features of the tumor . Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter ( P=0.04 for interaction ) and possibly among those with intermediate-risk or high-risk tumors ( P=0.07 for interaction ) . Adverse events within 30 days after surgery occurred in 21.4 % of men , including one death . CONCLUSIONS Among men with localized prostate cancer detected during the early era of PSA testing , radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality , as compared with observation , through at least 12 years of follow-up . Absolute differences were less than 3 percentage points . ( Funded by the Department of Veterans Affairs Cooperative Studies Program and others ; PIVOT Clinical Trials.gov number , NCT00007644 . )",
"PURPOSE Nowadays , advanced irradiation techniques make it possible to escalate safely the dose in prostate cancer . We studied the effect of a higher dose on tumor control in a r and omized trial with a median follow-up of 110 months . PATIENTS AND METHODS Patients with T1b-T4N0 prostate cancer ( n=664 ) were r and omized between 78 Gy and 68 Gy . Primary endpoint was biochemical and /or clinical failure ( BCF ) according to the American Society for Therapeutic Radiology and Oncology ( ASTRO ) guidelines ( 3 consecutive rises ) , and to Phoenix ( nadir plus 2 μg/L ) . Secondary endpoints were clinical failure ( CF ) , local failure ( LF ) , prostate cancer death ( PCD ) , and overall survival ( OS ) . Explorative subgroup analyses were performed . RESULTS BCF rate ( HR=0.8 ; 20 % less events ) and LF rate ( HR=0.5 ; 50 % less events ) were significantly lower in the 78 Gy arm ( p ) . CF , PCD and OS were similar in both arms . A significant heterogeneity of treatment effect was found for PSA cutoffs between 7 and 10 μg/L. CONCLUSION We observed significantly less BCF and LF in the high-dose arm . This suggests improvement of the therapeutic ratio . However , we observed similar rates of CF and PCD at the current up date . More follow-up is needed to investigate which patients benefit in terms of prolonged OS",
"IMPORTANCE Targeted magnetic resonance (MR)/ultrasound fusion prostate biopsy has been shown to detect prostate cancer . The implication s of targeted biopsy alone vs st and ard extended-sextant biopsy or the 2 modalities combined are not well understood . OBJECTIVE To assess targeted vs st and ard biopsy and the 2 approaches combined for the diagnosis of intermediate- to high-risk prostate cancer . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1003 men undergoing both targeted and st and ard biopsy concurrently from 2007 through 2014 at the National Cancer Institute in the United States . Patients were referred for elevated level of prostate-specific antigen ( PSA ) or abnormal digital rectal examination results , often with prior negative biopsy results . Risk categorization was compared among targeted and st and ard biopsy and , when available , whole-gl and pathology after prostatectomy as the \" gold st and ard . \" INTERVENTIONS Patients underwent multiparametric prostate magnetic resonance imaging to identify regions of prostate cancer suspicion followed by targeted MR/ultrasound fusion biopsy and concurrent st and ard biopsy . MAIN OUTCOMES AND MEASURES The primary objective was to compare targeted and st and ard biopsy approaches for detection of high-risk prostate cancer ( Gleason score ≥ 4 + 3 ) ; secondary end points focused on detection of low-risk prostate cancer ( Gleason score 3 + 3 or low-volume 3 + 4 ) and the biopsy ability to predict whole-gl and pathology at prostatectomy . RESULTS Targeted MR/ultrasound fusion biopsy diagnosed 461 prostate cancer cases , and st and ard biopsy diagnosed 469 cases . There was exact agreement between targeted and st and ard biopsy in 690 men ( 69 % ) undergoing biopsy . Targeted biopsy diagnosed 30 % more high-risk cancers vs st and ard biopsy ( 173 vs 122 cases , P The predictive ability of targeted biopsy for differentiating low-risk from intermediate- and high-risk disease in 170 men with whole-gl and pathology after prostatectomy was greater than that of st and ard biopsy or the 2 approaches combined ( area under the curve , 0.73 , 0.59 , and 0.67 , respectively ; P men undergoing biopsy for suspected prostate cancer , targeted MR/ultrasound fusion biopsy , compared with st and ard extended-sextant ultrasound-guided biopsy , was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer . Future studies will be needed to assess the ultimate clinical implication s of targeted biopsy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00102544",
"Purpose We have previously reported that radiotherapy ( RT ) added to and rogen-deprivation therapy ( ADT ) improves survival in men with locally advanced prostate cancer . Here , we report the prespecified final analysis of this r and omized trial . Patients and Methods NCIC Clinical Trials Group PR.3/Medical Research Council PR07/Intergroup T94 - 0110 was a r and omized controlled trial of patients with locally advanced prostate cancer . Patients with T3 - 4 , N0/Nx , M0 prostate cancer or T1 - 2 disease with either prostate-specific antigen ( PSA ) of more than 40 μg/L or PSA of 20 to 40 μg/L plus Gleason score of 8 to 10 were r and omly assigned to lifelong ADT alone or to ADT+RT . The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone . Overall survival was compared using a log-rank test stratified for prespecified variables . Results One thous and two hundred five patients were r and omly assigned between 1995 and 2005 , 602 to ADT alone and 603 to ADT+RT . At a median follow-up time of 8 years , 465 patients had died , including 199 patients from prostate cancer . Overall survival was significantly improved in the patients allocated to ADT+RT ( hazard ratio [ HR ] , 0.70 ; 95 % CI , 0.57 to 0.85 ; P .001 ) . Deaths from prostate cancer were significantly reduced by the addition of RT to ADT ( HR , 0.46 ; 95 % CI , 0.34 to 0.61 ; P on ADT+RT reported a higher frequency of adverse events related to bowel toxicity , but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT . Conclusion This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer",
"BACKGROUND We report the long-term results of a trial of immediate postoperative irradiation versus a wait- and -see policy in patients with prostate cancer extending beyond the prostate , to confirm whether previously reported progression-free survival was sustained . METHODS This r and omised , phase 3 , controlled trial recruited patients aged 75 years or younger with untreated cT0 - 3 prostate cancer ( WHO performance status 0 or 1 ) from 37 institutions across Europe . Eligible patients were r and omly assigned central ly ( 1:1 ) to postoperative irradiation ( 60 Gy of conventional irradiation to the surgical bed for 6 weeks ) or to a wait- and -see policy until biochemical progression ( increase in prostate-specific antigen > 0·2 μg/L confirmed twice at least 2 weeks apart ) . We analysed the primary endpoint , biochemical progression-free survival , by intention to treat ( two-sided test for difference at α=0.05 , adjusted for one interim analysis ) and did exploratory analyses of heterogeneity of effect . This trial is registered with Clinical Trials.gov , number NCT00002511 . FINDINGS 1005 patients were r and omly assigned to a wait- and -see policy ( n=503 ) or postoperative irradiation ( n=502 ) and were followed up for a median of 10·6 years ( range 2 months to 16·6 years ) . Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait- and -see policy ( 198 [ 39·4 % ] of 502 patients in postoperative irradiation group vs 311 [ 61·8 % ] of 503 patients in wait- and -see group had biochemical or clinical progression or died ; HR 0·49 [ 95 % CI 0·41 - 0·59 ] ; p ( any type of any grade ) were more frequent in the postoperative irradiation group than in the wait- and -see group ( 10 year cumulative incidence 70·8 % [ 66·6 - 75·0 ] vs 59·7 % [ 55·3 - 64·1 ] ; p=0.001 ) . INTERPRETATION Results at median follow-up of 10·6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait- and -see policy , supporting results at 5 year follow-up ; however , improvements in clinical progression-free survival were not maintained . Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins , but could have a detrimental effect in patients aged 70 years or older . FUNDING Ligue Nationale contre le Cancer ( Comité de l'Isère , Grenoble , France ) and the European Organisation for Research and Treatment of Cancer ( EORTC ) Charitable Trust",
"OBJECTIVES Transperineal and transrectal prostate biopsy are both used for prostate cancer detection . However , which approach is superior remains unknown . In this study , we performed a prospect i ve r and omized study to compare the efficacy of transperineal versus transrectal 12-core initial prostate biopsy . METHODS From May 2003 to October 2005 , a prospect i ve r and omized study of transperineal versus transrectal 12-core biopsy ( 126 and 120 patients , respectively ) was conducted in 246 patients with a prostate-specific antigen level of 4.0 to 20.0 ng/mL. All procedures were performed with the patient in the lithotomy position , with the transperineal and transrectal approach performed with spinal anesthesia ( 0.5 % bupivacaine ) or a caudal block ( 1 % lidocaine ) , respectively . With both approaches , eight biopsy specimens were obtained systematic ally from the peripheral zone , including the apex , and four from the transition zone . RESULTS The cancer detection rate was 42.1 % ( 53 of 126 patients ) with the transperineal approach and 48.3 % ( 58 of 120 patients ) with the transrectal approach ( P = 0.323 ) . For all patients undergoing transperineal and transrectal biopsy , the cancer core rate ( cancer core number/biopsy core number ) was 13.7 % ( 207 of 1512 cores ) and 14.4 % ( 208 of 1440 cores ) , respectively ( P = 0.566 ) . Apart from headache , presumably related to the spinal anesthesia , no significant differences were found in the complications between the two groups . CONCLUSIONS No significant differences were found in the cancer detection rate , cancer core rate , or complications between the two approaches . We believe that the preferred approach as an initial prostate biopsy is the transrectal approach , which does not require spinal anesthesia or another burdensome process",
"OBJECTIVES To assess whether the proportion of men with clinical ly significant prostate cancer ( PCa ) is higher among men r and omized to multiparametric magnetic resonance imaging (mp-MRI)/biopsy vs. those r and omized to transrectal ultrasound (TRUS)-guided biopsy . METHODS In total , 1,140 patients with symptoms highly suggestive of PCa were enrolled and divided in 2 groups of 570 patients to follow 2 different diagnostic algorithms . Group A underwent a TRUS-guided r and om biopsy . Group B underwent an mp-MRI and a TRUS-guided targeted+r and om biopsy . The accuracy of mp-MRI in the diagnosis of PCa was calculated using prostatectomy as the st and ard of reference . RESULTS In group A , PCa was detected in 215 patients . The remaining 355 patients underwent an mp-MRI : the findings were positive in 208 and unremarkable in 147 patients . After the second r and om+targeted biopsy , PCa was detected in 186 of the 208 patients . In group B , 440 patients had positive findings on mp-MRI , and PCa was detected in 417 at first biopsy ; 130 group B patients had unremarkable findings on both mp-MRI and biopsy . In the 130 group B patients with unremarkable findings on mp-MRI and biopsy , a PCa Gleason score of 6 or precancerous lesions were detected after saturation biopsy . mp-MRI showed an accuracy of 97 % for the diagnosis of PCa . CONCLUSIONS The proportion of men with clinical ly significant PCa is higher among those r and omized to mp-MRI/biopsy vs. those r and omized to TRUS-guided biopsy ; moreover , mp-MRI is a very reliable tool to identify patients to schedule in active surveillance",
"The aim of this study is to eluci date the diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy for prostate cancer . We prospect ively r and omized 200 consecutive men into two groups to undergo systematic prostate biopsy . Overall positivity for cancer was similar ( 47 % by transperineal and 53 % by transrectal ; P=0.480 ) . However , in case with ‘ gray zone ’ PSA ( from 4.1 to 10.0 ng/ml ) , significantly more cores were positive when approach was transperineal , especially among transition zone cores . Therefore , urologist preferences are sufficient for choosing an approach , except for a possible small advantage of transperineal biopsy when PSA is in gray zone",
"PURPOSE Conventional radiotherapy ( C-RT ) treatment schedules for patients with prostate cancer typically require 40 to 45 treatments that take place from > 8 to 9 weeks . Pre clinical and clinical research suggest that hypofractionation-fewer treatments but at a higher dose per treatment-may produce similar outcomes . This trial was design ed to assess whether the efficacy of a hypofractionated radiotherapy ( H-RT ) treatment schedule is no worse than a C-RT schedule in men with low-risk prostate cancer . PATIENTS AND METHODS A total of 1,115 men with low-risk prostate cancer were r and omly assigned 1:1 to C-RT ( 73.8 Gy in 41 fractions over 8.2 weeks ) or to H-RT ( 70 Gy in 28 fractions over 5.6 weeks ) . This trial was design ed to establish ( with 90 % power and an α of .05 ) that treatment with H-RT results in 5-year disease-free survival ( DFS ) that is not worse than C-RT by more than 7.65 % ( H-RT/C-RT hazard ratio [ HR ] A total of 1,092 men were protocol eligible and had follow-up information ; 542 patients were assigned to C-RT and 550 to H-RT . Median follow-up was 5.8 years . Baseline characteristics were not different according to treatment assignment . The estimated 5-year DFS was 85.3 % ( 95 % CI , 81.9 to 88.1 ) in the C-RT arm and 86.3 % ( 95 % CI , 83.1 to 89.0 ) in the H-RT arm . The DFS HR was 0.85 ( 95 % CI , 0.64 to 1.14 ) , and the predefined noninferiority criterion that required that DFS outcomes be consistent with HR P were increased ( HR , 1.31 to 1.59 ) in patients who were treated with H-RT . CONCLUSION In men with low-risk prostate cancer , the efficacy of 70 Gy in 28 fractions over 5.6 weeks is not inferior to 73.8 Gy in 41 fractions over 8.2 weeks , although an increase in late GI/genitourinary adverse events was observed in patients treated with H-RT",
"PURPOSE To test the hypothesis that increasing radiation dose delivered to men with early-stage prostate cancer improves clinical outcomes . PATIENTS AND METHODS Men with T1b-T2b prostate cancer and prostate-specific antigen were r and omly assigned to a total dose of either 70.2 Gray equivalents ( GyE ; conventional ) or 79.2 GyE ( high ) . No patient received and rogen suppression therapy with radiation . Local failure ( LF ) , biochemical failure ( BF ) , and overall survival ( OS ) were outcomes . Results A total of 393 men were r and omly assigned , and median follow-up was 8.9 years . Men receiving high-dose radiation therapy were significantly less likely to have LF , with a hazard ratio of 0.57 . The 10-year American Society for Therapeutic Radiology and Oncology BF rates were 32.4 % for conventional-dose and 16.7 % for high-dose radiation therapy ( P recurrence after conventional dose compared with 6 % after high dose ( P = .047 ) . There remains no difference in OS rates between the treatment arms ( 78.4 % v 83.4 % ; P = .41 ) . Two percent of patients in both arms experienced late grade > /= 3 genitourinary toxicity , and 1 % of patients in the high-dose arm experienced late grade > /= 3 GI toxicity . CONCLUSION This r and omized controlled trial shows superior long-term cancer control for men with localized prostate cancer receiving high-dose versus conventional-dose radiation . This was achieved without an increase in grade > /= 3 late urinary or rectal morbidity",
"PURPOSE Radiation Therapy Oncology Group protocol 85 - 31 was design ed to evaluate the effectiveness of adjuvant and rogen suppression , using goserelin , in unfavorable prognosis carcinoma of the prostate treated with definitive radiotherapy ( RT ) . METHODS AND MATERIAL S Eligible patients were those with palpable primary tumor extending beyond the prostate ( clinical Stage T3 ) or those with regional lymphatic involvement . Patients who had undergone prostatectomy were eligible if penetration through the prostatic capsule to the margin of resection and /or seminal vesicle involvement was documented histologically . Stratification was based on histologic differentiation , nodal status , acid phosphatase status , and prior prostatectomy . The patients were r and omized to either RT and adjuvant goserelin ( Arm I ) or RT alone followed by observation and application of goserelin at relapse ( Arm II ) . In Arm I , the drug was to be started during the last week of RT and was to be continued indefinitely or until signs of progression . RESULTS Between 1987 and 1992 , when the study was closed , 977 patients were entered : 488 to Arm I and 489 to Arm II . As of July 2003 , the median follow-up for all patients was 7.6 years and for living patients was 11 years . At 10 years , the absolute survival rate was significantly greater for the adjuvant arm than for the control arm : 49 % vs. 39 % , respectively ( p = 0.002 ) . The 10-year local failure rate for the adjuvant arm was 23 % vs. 38 % for the control arm ( p corresponding 10-year rates for the incidence of distant metastases and disease-specific mortality was 24 % vs. 39 % ( p patients with unfavorable prognosis carcinoma of the prostate , and rogen suppression applied as an adjuvant after definitive RT was associated not only with a reduction in disease progression but in a statistically significant improvement in absolute survival . The improvement in survival appeared preferentially in patients with a Gleason score of 7 - 10",
"PURPOSE To report long-term failure patterns and survival in a r and omized radiotherapy dose escalation trial for prostate cancer . MATERIAL S AND METHODS A total of 301 patients with Stage T1b-T3 prostate cancer treated to 70 Gy versus 78 Gy now have a median follow-up of 9 years . Failure patterns and survival were compared between dose levels . The cumulative incidence of death from prostate cancer versus other causes was examined and regression analysis was used to establish predictive factors . RESULTS Patients with pretreatment prostate-specific antigen ( PSA ) > 10 ng/mL or high-risk disease had higher biochemical and clinical failures rates when treated to 70 Gy . These patients also had a significantly higher risk of dying of prostate cancer . Patients at treatment died of prostate cancer nearly three times more frequently than of other causes when they were radiated to 70 Gy , whereas those treated to 78 Gy died of other causes more frequently . Patients age 70 or older treated to 70 Gy died of prostate cancer as often as other causes , and those receiving 78 Gy never died of prostate cancer within 10 years of follow-up . In regression analysis , factors predicting for death from prostate cancer were pretreatment PSA > 10.5 ng/mL , Gleason score 9 and 10 , recurrence within 2.6 years of radiation , and doubling time of biochemical and clinical failure as well as prostate cancer death in patients with pretreatment PSA > 10 ng/mL or high-risk disease ",
"Objectives The Swedish Family-Cancer Data base has been the major source of population -based prospect i ve data on familial risks on most cancers , including prostate cancer . In the present review , I focus on three lines of family studies with novel results . Methods The covered studies originate from the same data base with publication date s spanning a period of somewhat over 3 years . Age-specific hazard ratios ( HRs ) of incident prostate cancer and fatal prostate cancer were determined according to the number of affected relatives . Cumulative risks for incidence and death were calculated for the various types of families . Finally , data on the familial association of prostate cancer with some other cancers were review ed . Results If the father had prostate cancer , the HR for sons was 2.1 and it increased to 17.7 when three brothers were affected . The highest HR ( 23 ) was observed for men before age 60 years with three affected brothers . The patterns for fatal familial prostate cancer were similar . Other review ed sets of data showed evidence for the familial concordance of good and poor survival in prostate cancer . Familial risks were somewhat higher for fatal than for incident prostate cancer , suggesting that fatal prostate cancers may be a genetic subgroup . Conclusions Considering the high familial risks in fatal prostate cancer , family history remains an important prognostic piece of information useful for clinical genetic counseling . Obviously , preventive measures for at-risk men are needed but these are beyond the present paper . Starting screening before any prostate cancers are diagnosed in a family appears counterproductive",
"BACKGROUND Prostate biopsy guided by computer-assisted fusion of magnetic resonance imaging ( MRI ) and transrectal ultrasound ( TRUS ) images ( MRI group ) has not yet been compared with 12-core r and om biopsy ( RB ; control group ) in a r and omized controlled trial ( RCT ) . OBJECTIVE To compare the rate of detection of clinical ly significant prostate cancer ( csPCa ) between the two groups . DESIGN , SETTING , AND PARTICIPANTS This RCT included 175 biopsy-naïve patients with suspicion for prostate cancer , r and omized to an MRI group ( n=86 ) and a control group ( n=89 ) between September 2011 and June 2013 . INTERVENTION In the MRI group , two-core targeted biopsy ( TB ) guided by computer-assisted fusion of MRI/TRUS images of MRI-suspicious lesions was followed by 12-core RB . In the control group , both two-core TB for abnormal digital rectal examination ( DRE ) and /or TRUS-suspicious lesions and 12-core RB were performed . In patients with normal MRI or DRE/TRUS , only 12-core RB was performed . OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS The detection rates for any cancer and csPCa were compared between the two groups and between TB and RB . RESULTS AND LIMITATIONS Detection rates for any cancer ( MRI group 51/86 , 59 % ; control group 48/89 , 54 % ; p=0.4 ) and csPCa ( 38/86 , 44 % vs 44/89 , 49 % ; p=0.5 ) did not significantly differ between the groups . Detection of csPCa was comparable between two-core MRI/TRUS-TB ( 33/86 , 38 % ) and 12-core RB in the control group ( 44/89 , 49 % ; p=0.2 ) . In a subset analysis of patients with normal DRE , csPCa detection was similar between two-core MRI/TRUS-TB ( 14/66 , 21 % ) and 12-core RB in the control group ( 15/60 , 25 % ; p=0.7 ) . Among biopsy-proven csPCas in MRI group , 87 % ( 33/38 ) were detected by MRI/TRUS-TB . The definition of csPCa was only based on biopsy outcomes . CONCLUSION Overall csPCa detection was similar between the MRI and control groups . Two-core MRI/TRUS-TB was comparable to 12-core RB for csPCa detection . PATIENT SUMMARY Our r and omized controlled trial revealed a similar rate of prostate cancer detection between targeted biopsy guided by magnetic resonance imaging ( MRI ) and transrectal ultrasound ( TRUS ) and 12-core r and om biopsy . The traditional 12-core r and om biopsy may be replaced by two-core MRI/TRUS targeted biopsy for detection of clinical ly significant prostate cancer",
"PURPOSE To compare the subjective Likert score to the Prostate Imaging Reporting and Data System ( PIRADS ) and morphology-location-signal intensity ( MLS ) scores for categorization of prostate lesions as benign or malignant at multiparametric magnetic resonance ( MR ) imaging . MATERIAL S AND METHODS Two hundred fifteen patients who underwent T2-weighted , diffusion-weighted , and dynamic contrast material -enhanced multiparametric MR imaging of the prostate before radical prostatectomy were included in a prospect i ve data base after they signed the institutional review board-approved forms . Senior readers 1 and 2 prospect ively noted the location , shape , and signal intensity of lesions on MR images from individual pulse sequences and scored each for likelihood of malignancy by using a Likert scale ( range , 1 - 5 ) . A junior reader ( reader 3 ) retrospectively review ed the data base and did the same analysis . The MLS score ( range , 1 - 13 ) was computed by using the readers ' descriptions of the lesions . Then , the three readers again scored the lesions they described by using the PIRADS score ( range , 3 - 15 ) . MLS and PIRADS scores were compared with the Likert score by using their areas under the receiver operating characteristic curves . RESULTS Areas under the receiver operating characteristic curves of the Likert , MLS , and PIRADS scores were 0.81 , 0.77 ( P = .03 ) , and 0.75 ( P = .01 ) for reader 1 ; 0.88 , 0.74 ( P MLS score for reader 3 . Weighted κ values were 0.470 - 0.524 , 0.405 - 0.430 , and 0.378 - 0.441 for the Likert , MLS , and PIRADS scores , respectively . CONCLUSION The Likert score allowed significantly more accurate categorization of prostate lesions on MR images than did the MLS and PIRADS scores",
"BACKGROUND Appropriate timing of and rogen deprivation treatment ( ADT ) for prostate cancer is controversial . Our aim was to determine whether immediate ADT extends survival in men with node-positive prostate cancer who have undergone radical prostatectomy and pelvic lymphadenectomy compared with those who received ADT only once disease progressed . METHODS Eligible patients from 36 institutes in the USA were r and omly assigned in 1988 - 93 to receive immediate ADT ( n=47 ) or to be observed ( n=51 ) , with ADT to be given on detection of distant metastases or symptomatic recurrences . Patients were followed up every 3 months for the first year and every 6 months thereafter . The primary endpoint was progression-free survival ; secondary endpoints were overall and disease-specific survival . Analysis was by intention to treat . To ensure that the treatment groups were comparable , we did a retrospective central pathology review of slides and re grade d the Gleason scores for available sample s. This trial pre date s the requirement for clinical trial registration . FINDINGS At median follow-up of 11.9 years ( range 9.7 - 14.5 for surviving patients ) , men assigned immediate ADT had a significant improvement in overall survival ( hazard ratio 1.84 [ 95 % CI 1.01 - 3.35 ] , p=0.04 ) , prostate-cancer-specific survival ( 4.09 [ 1.76 - 9.49 ] , p=0.0004 ) , and progression-free survival ( 3.42 [ 1.96 - 5.98 ] , p ADT , 30 observation ) , 16 were down grade d from the original Gleason score ( between groups or = 8) and five were up grade d. We recorded similar proportions of score changes in each group ( p=0.68 ) , and no difference in score distribution by treatment ( p=0.38 ) . After adjustment for score , associations were still significant between treatment and survival ( overall , p=0.02 ; disease-specific , p=0.002 ; progression-free survival , p ADT benefits patients with nodal metastases who have undergone prostatectomy and lymphadenectomy , compared with those who receive deferred treatment . The beneficial effects of early ADT , rather than an imbalance in risk factors , are likely to explain the differences in outcomes between treatments",
"PURPOSE We explored the impact of magnetic resonance imaging-ultrasound fusion prostate biopsy on the prediction of final surgical pathology . MATERIAL S AND METHODS A total of 54 consecutive men undergoing radical prostatectomy at UCLA after fusion biopsy were included in this prospect i ve , institutional review board approved pilot study . Using magnetic resonance imaging-ultrasound fusion , tissue was obtained from a 12-point systematic grid ( mapping biopsy ) and from regions of interest detected by multiparametric magnetic resonance imaging ( targeted biopsy ) . A single radiologist read all magnetic resonance imaging , and a single pathologist independently re review ed all biopsy and whole mount pathology , blinded to prior interpretation and matched specimen . Gleason score concordance between biopsy and prostatectomy was the primary end point . RESULTS Mean patient age was 62 years and median prostate specific antigen was 6.2 ng/ml . Final Gleason score at prostatectomy was 6 ( 13 % ) , 7 ( 70 % ) and 8 - 9 ( 17 % ) . A tertiary pattern was detected in 17 ( 31 % ) men . Of 45 high suspicion ( image grade 4 - 5 ) magnetic resonance imaging targets 32 ( 71 % ) contained prostate cancer . The per core cancer detection rate was 20 % by systematic mapping biopsy and 42 % by targeted biopsy . The highest Gleason pattern at prostatectomy was detected by systematic mapping biopsy in 54 % , targeted biopsy in 54 % and a combination in 81 % of cases . Overall 17 % of cases were up grade d from fusion biopsy to final pathology and 1 ( 2 % ) was down grade d. The combination of targeted biopsy and systematic mapping biopsy was needed to obtain the best predictive accuracy . CONCLUSIONS In this pilot study magnetic resonance imaging-ultrasound fusion biopsy allowed for the prediction of final prostate pathology with greater accuracy than that reported previously using conventional methods ( 81 % vs 40 % to 65 % ) . If confirmed , these results will have important clinical implication",
"BACKGROUND Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule . Three prospect ively r and omized trials demonstrated an advantage for adjuvant radiotherapy ( ART ) compared with a wait- and -see ( WS ) policy . OBJECTIVE To determine the efficiency of ART after a 10-yr follow-up in the ARO 96 - 02 study . DESIGN , SETTING , AND PARTICIPANTS After RP , 388 patients with pT3 pN0 prostate cancer ( PCa ) were r and omized to WS or three-dimensional conformal ART with 60 Gy . The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP ( ITT2 population ) --that is , 159 WS plus 148 ART men . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary end point of the study was progression-free survival ( PFS ) ( events : biochemical recurrence , clinical recurrence , or death ) . Outcomes were compared by log-rank test . Cox regression analysis served to identify variables influencing the course of disease . RESULTS AND LIMITATIONS The median follow-up was 111 mo for ART and 113 mo for WS . At 10 yr , PFS was 56 % for ART and 35 % for WS ( p 307 ITT2 patients , 15 died from PCa , and 28 died for other or unknown reasons . Neither metastasis-free survival nor overall survival was significantly improved by ART . However , the study was underpowered for these end points . The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity . No grade 4 events occurred . CONCLUSIONS Compared with WS , ART reduced the risk of ( biochemical ) progression with a hazard ratio of 0.51 in pT3 PCa . With only one grade 3 case of late toxicity , ART was safe . PATIENT SUMMARY Pre caution ary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors",
"BACKGROUND Early risk-stratified chemotherapy is a st and ard treatment for breast , colorectal , and lung cancers , but not for high-risk localised prostate cancer . Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer . We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer . METHODS We did this r and omised phase 3 trial at 26 hospitals in France . We enrolled patients with treatment-naive prostate cancer and at least one risk factor ( ie , stage T3-T4 disease , Gleason score of ≥8 , prostate-specific antigen concentration > 20 ng/mL , or pathological node-positive ) . All patients underwent a staging pelvic lymph node dissection . Patients were r and omly assigned ( 1:1 ) to either and rogen deprivation therapy ( ADT ; goserelin 10·8 mg every 3 months for 3 years ) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2 ) and estramustine 10 mg/kg per day on days 1 - 5 , every 3 weeks , or ADT only . The r and omisation was done central ly by computer , stratified by risk factor . Local treatment was administered at 3 months . Neither patients nor investigators were masked to treatment allocation . The primary endpoint was relapse-free survival in the intention-to-treat population . Follow-up for other endpoints is ongoing . This study is registered with Clinical Trials.gov , number NCT00055731 . FINDINGS We r and omly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group . Median follow-up was 8·8 years ( IQR 8·1 - 9·7 ) . 88 ( 43 % ) of 207 patients in the ADT plus docetaxel and estramustine group had an event ( relapse or death ) versus 111 ( 54 % ) of 206 in the ADT only group . 8-year relapse-free survival was 62 % ( 95 % CI 55 - 69 ) in the ADT plus docetaxel and estramustine group versus 50 % ( 44 - 57 ) in the ADT only group ( adjusted hazard ratio [ HR ] 0·71 , 95 % CI 0·54 - 0·94 , p=0·017 ) . Of patients who were treated with radiotherapy and had data available , 31 ( 21 % ) of 151 in the ADT plus docetaxel and estramustine group versus 26 ( 18 % ) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect ( p=0·61 ) . We recorded no excess second cancers ( 26 [ 13 % ] of 207 vs 22 [ 11 % ] of 206 ; p=0·57 ) , and there were no treatment-related deaths . INTERPRETATION Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer . Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival . FUNDING Ligue Contre le Cancer , Sanofi-Aventis , AstraZeneca , Institut National du Cancer",
"Objective To determine the relative risks of prostate cancer incidence , metastasis , and mortality associated with screening by serum prostate specific antigen ( PSA ) levels at age 60 . Design Population based cohort study . Setting General male population of Sweden taking part in a screening trial in Gothenburg or participating in a cardiovascular study , the Malmö Preventive Project . Participants The screened group consisted of 1756 men aged 57.5 - 62.5 participating in the screening arm of the Gothenburg r and omized prostate cancer screening trial since 1995 . The unscreened group consisted of 1162 men , born in 1921 , participating in the Malmö Preventive Project , with PSA levels measured retrospectively in stored blood sample s from 1981 . Intervention PSA screening versus no screening . Main outcome measures Incidence rate ratios for the effect of screening on prostate cancer diagnosis , metastasis , and death by PSA levels at age 60 . Results The distribution of PSA levels was similar between the two cohorts . Differences in benefits by baseline PSA levels were large . Among men with baseline levels measured , 71.7 % ( 1646/2295 ) had a PSA level incidence of 767 cases per 10 000 without a decrease in prostate cancer mortality . For men with PSA levels ≥2 ng/mL , the reduction in cancer mortality was large , with only 23 men needing to be screened and six diagnosed to avoid one prostate cancer death by 15 years . Conclusions The ratio of benefits to harms of PSA screening varies noticeably with blood PSA levels at age 60 . For men with a PSA level 2 ng/mL at age 60 is beneficial , with the number needed to screen and treat being extremely favourable . Screening men with a PSA level of 1 - 2 ng/mL is an individual decision to be based on a discussion between patient and doctor",
"OBJECTIVES More-extensive pelvic lymph node dissection ( PLND ) may be associated with a higher rate of complications and a longer hospital stay than more limited PLND . METHODS Before radical retropubic prostatectomy , PLNDs were performed in 963 patients . Of these , 767 ( 79.6 % ) had > or=10 lymph nodes removed and examined ( extended PLND [ ePLND ] ) , while 1 - 9 nodes ( limited PLND [ lPLND ] ) were removed in the remaining 196 ( 20.4 % ) . Limits included external iliac , obturator , internal iliac , and iliac bifurcation . PLND-related complications and the length of hospital stay were recorded prospect ively and analyzed according to the extent of PLND . RESULTS In patients subjected to ePLND , the overall rate of complications was 19.8 % versus 8.2 % in those treated with lPLND ( p lymphocele rate was significantly higher after ePLND ( 10.3 % vs 4.6 % ; p=0.01 ) . Similarly , ePLND translated into a longer hospital stay ( 9.9 vs 8.2 d ; p complication rates and longer hospital stay . These detriments need to be taken into account when the staging benefit associated with ePLND is considered",
"CONTEXT The most recent summary of the European Association of Urology ( EAU ) guidelines on prostate cancer ( PCa ) was published in 2011 . OBJECTIVE To present a summary of the 2013 version of the EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined PCa . EVIDENCE ACQUISITION A literature review of the new data emerging from 2011 to 2013 has been performed by the EAU PCa guideline group . The guidelines have been up date d , and levels of evidence and grade s of recommendation have been added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. EVIDENCE SYNTHESIS A full version of the guidelines is available at the EAU office or online ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . Systematic prostate biopsies under ultrasound guidance and local anesthesia are the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . A biopsy progression indicates the need for active intervention , whereas the role of PSA doubling time is controversial . In men with locally advanced PCa for whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) , with equivalent oncologic efficacy . Active treatment is recommended mostly for patients with localized disease and a long life expectancy , with radical prostatectomy ( RP ) shown to be superior to WW in prospect i ve r and omized trials . Nerve-sparing RP is the approach of choice in organ-confined disease , while neoadjuvant ADT provides no improvement in outcome variables . Radiation therapy should be performed with ≥ 74 Gy in low-risk PCa and 78 Gy in intermediate- or high-risk PCa . For locally advanced disease , adjuvant ADT for 3 yr results in superior rates for disease-specific and overall survival and is the treatment of choice . Follow-up after local therapy is largely based on PSA and a disease-specific history , with imaging indicated only when symptoms occur . CONCLUSIONS Knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarize the most recent findings and put them into clinical practice . PATIENT SUMMARY A summary is presented of the 2013 EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined prostate cancer ( PCa ) . Screening continues to be done on an individual basis , in consultation with a physician . Diagnosis is by prostate biopsy . Active surveillance is an option in low-risk PCa and watchful waiting is an alternative to and rogen-deprivation therapy in locally advanced PCa not requiring immediate local treatment . Radical prostatectomy is the only surgical option . Radiation therapy can be external or delivered by way of prostate implants . Treatment follow-up is based on the PSA level",
"PURPOSE Although there is no evidence that testosterone therapy increases the risk of prostate cancer , there is a paucity of long-term data . We determined whether the incidence of prostate cancer is increased in hypogonadal men receiving long-term testosterone therapy . MATERIAL S AND METHODS In 3 parallel , prospect i ve , ongoing , cumulative registry studies 1,023 hypogonadal men received testosterone therapy . Two study cohorts were treated by urologists ( since 2004 ) and 1 was treated at an academic and rology center ( since 1996 ) . Patients were treated when total testosterone was 12.1 nmol/l or less ( 350 ng/dl ) and symptoms of hypogonadism were present . Maximum followup was 17 years ( 1996 to 2013 ) and median followup was 5 years . Mean baseline patient age in the urological setting s was 58 years and in the and rology setting it was 41 years . Patients received testosterone undecanoate injections in 12-week intervals . Pretreatment examination of the prostate and monitoring during treatment were performed . Prostate biopsies were performed according to EAU guidelines . RESULTS Numbers of positive and negative biopsies were assessed . The incidence of prostate cancer and post-prostatectomy outcomes was studied . A total of 11 patients were diagnosed with prostate cancer in the 2 urology setting s at proportions of 2.3 % and 1.5 % , respectively . The incidence per 10,000 patient-years was 54.4 and 30.7 , respectively . No prostate cancer was reported by the and rology center . Limitations are inherent in the registry design without a control group . CONCLUSIONS Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer . If guidelines for testosterone therapy are properly applied , testosterone treatment is safe in hypogonadal men",
"PURPOSE We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen ( PSA ) , or histologic progression as treatment indications for clinical ly localized prostate cancer . PATIENTS AND METHODS This was a prospect i ve , single-arm , cohort study . Patients were managed with an initial expectant approach . Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years , Gleason score progression ( to 4 + 3 or greater ) , or unequivocal clinical progression . Survival analysis and Cox proportional hazard model were applied to the data . Results A total of 450 patients have been observed with active surveillance . Median follow-up was 6.8 years ( range , 1 to 13 years ) . Overall survival was 78.6 % . The 10-year prostate cancer actuarial survival was 97.2 % . Overall , 30 % of patients have been reclassified as higher risk and have been offered definitive therapy . Of 117 patients treated radically , the PSA failure rate was 50 % , which was 13 % of the total cohort . PSA doubling time of 3 years or less was associated with an 8.5-times higher risk of biochemical failure after definitive treatment compared with a doubling time of more than 3 years ( P hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years . CONCLUSION We observed a low rate of prostate cancer mortality . Among the patients who were reclassified as higher risk and who were treated , PSA failure was relatively common . Other-cause mortality accounted for almost all of the deaths . Additional studies are warranted to improve the identification of patients who harbor more aggressive disease despite favorable clinical parameters at diagnosis",
"PURPOSE We determined whether the characteristics of patients undergoing prostate needle biopsies and prostate needle biopsy results changed after the U.S. Preventive Services Task Force recommendation in 2012 against prostate specific antigen based screening for prostate cancer for men of any age . MATERIAL S AND METHODS A prospect i ve data base of patients undergoing prostate needle biopsies at Virginia Mason from 2004 to 2014 was review ed . Welch 's t-test and chi-square tests were used to compare patients seen before to those seen after the USPSTF recommendation . Relative risks and corresponding confidence intervals were estimated by general linear regression . RESULTS Patients in the post-USPSTF group ( 310 ) had a higher prostate specific antigen ( p absolute number of biopsies performed decreased by 31 % , with the majority of the decrease occurring in the detection of intermediate risk tumors . CONCLUSIONS In the 2 and a half years after the USPSTF recommendation against prostate specific antigen based screening , patients undergoing prostate needle biopsies were significantly more likely to be diagnosed with high risk disease . However , a reduction in the number of prostate needle biopsies performed occurred concomitantly with a decrease in the detection of intermediate risk , potentially curable prostate cancer . Future focus on informed application of screening techniques may prevent the reversal of decades of improvement in the prostate cancer mortality rate",
"PURPOSE This trial was design ed to test the hypothesis that total and rogen suppression and whole pelvic radiotherapy ( WPRT ) followed by a prostate boost improves progression-free survival ( PFS ) by > or = 10 % compared with total and rogen suppression and prostate only RT ( PORT ) . This trial was also design ed to test the hypothesis that neoadjuvant hormonal therapy ( NHT ) followed by concurrent total and rogen suppression and RT improves PFS compared with RT followed by adjuvant hormonal therapy ( AHT ) by > or = 10 % . METHODS AND MATERIAL S Patients eligible for the study included those with clinical ly localized adenocarcinoma of the prostate and an elevated prostate-specific antigen level of 15 % . RESULTS The difference in overall survival for the four arms was statistically significant ( p = 0.027 ) . However , no statistically significant differences were found in PFS or overall survival between NHT vs. AHT and WPRT compared with PORT . A trend towards a difference was found in PFS ( p = 0.065 ) in favor of the WPRT + NHT arm compared with the PORT + NHT and WPRT + AHT arms . CONCLUSIONS Unexpected interactions appear to exist between the timing of hormonal therapy and radiation field size for this patient population . Four Phase III trials have demonstrated better outcomes when NHT was combined with RT compared with RT alone . The Radiation Therapy Oncology Group 9413 trial results have demonstrated that when NHT is used in conjunction with RT , WPRT yields a better PFS than does PORT . It also showed that when NHT + WPRT results in better overall survival than does WPRT + short-term AHT . Additional studies are warranted to determine whether the failure to demonstrate an advantage for NHT + WPRT compared with PORT + AHT is chance or , more likely , reflects a previously unrecognized biologic phenomenon"
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OBJECTIVE To identify the strategies used in the development of planned and scientifically documented physical activity , as well as the results achieved with those interventions in children with Autism Spectrum Disorder ( ASD ) . METHODS Systematic analysis of scientific articles regarding the use of physical activity as a therapeutic tool for children with ASD . Articles published between 2006 and 2016 were included in the review . Participants in the selected articles had to be children diagnosed with ASD ; the interventions carried out had to involve some kind of physical activity , and their effects had to be clearly exposed . RESULTS Six intervention strategies with autistic children were found . DISCUSSION Physical activity has a positive impact on the health and wellness of human beings , as well as a major role in the prevention of several chronic pathologies . Planned and correctly directed physical activity allows developing motor skills and generating positive psychological context s and behavioral changes in children with ASD
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"This study evaluated the effects of therapeutic horseback riding on social functioning in children with autism . We hypothesized that participants in the experimental condition ( n = 19 ) , compared to those on the wait-list control ( n = 15 ) , would demonstrate significant improvement in social functioning following a 12-weeks horseback riding intervention . Autistic children exposed to therapeutic horseback riding exhibited greater sensory seeking , sensory sensitivity , social motivation , and less inattention , distractibility , and sedentary behaviors . The results provide evidence that therapeutic horseback riding may be a viable therapeutic option in treating children with autism spectrum disorders",
"Imitation is an early skill thought to play a role in social development , leading some to suggest that teaching imitation to children with autism should lead to improvements in social functioning . This study used a r and omized controlled trial to evaluate the effect of a focused imitation intervention on initiation of joint attention and social-emotional functioning in 27 young children with autism . Results indicated the treatment group made significantly more gains in joint attention initiations at post-treatment and follow-up and social-emotional functioning at follow-up than the control group . Although gains in social functioning were associated with treatment , a mediation analysis did not support imitation as the mechanism of action . These findings suggest the intervention improves social functioning in children with ASD",
"This study evaluated the efficacy of a 9-month treadmill walking ( TW ) program on exercise capacity and body mass index ( BMI ) for adolescents with severe autism . Ten youth residing in a residential/school treatment facility were assigned to either a supplemental treadmill walking ( TW ) or control group . Both groups continued to participate in their regular physical education curriculum . Monthly records were maintained for the following : ( a ) TW progression in frequency , duration , speed and elevation ; ( b ) caloric expenditure ; and ( c ) BMI . The TW program result ed in significant increases in mean monthly TW frequency , speed , elevation , and calories expended coupled with a reduction in BMI"
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4116473c-06ff-11f0-808a-c43d1ab1c353
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Summary This review summarizes evidence regarding the effects of patient education in osteoporosis prevention and treatment . The included studies reveal mixed results on a variety of endpoints . Method ological improvem ent of future RCTs ( e.g. with regard to r and omization and duration of follow-up ) might yield more conclusive evidence on the effects of patient education in osteoporosis Introduction This review aims to evaluate the effects of patient education on osteoporosis prevention and treatment results . Methods Multiple data bases including PubMed and Embase were search ed until February 2016 . R and omised controlled trials ( RCTs ) were eligible if they included adults diagnosed with or at risk of osteoporosis and assessed patient education interventions ( group- or individual-based ) . Outcomes regarding osteoporosis management including initiation of and adherence to pharmacological therapy , physical activity , calcium and vitamin D intake , changes in smoking behaviour , fractures , quality of life ( QoL ) and osteoporosis knowledge were evaluated . The Cochrane collaboration ’s tool for assessing the risk of bias was used to assess the internal validity of included trials . Results Fifteen articles ( 13 different studies ) published between 2001 and 2013 were included ( group-based education = 7 , individual-based education = 5 , both = 1 ) . The general risk of bias was considered as moderate to high . The effects on ‘ bone mineral density ( BMD ) testing and /or pharmacological therapy ’ ( composite endpoint ) , ‘ calcium intake ’ and ‘ vitamin D intake ’ as well as ‘ osteoporosis knowledge ’ were statistically significant in favour of the intervention in ≥50 % of the studies analysing these outcomes . Differences between the intervention and the control group regarding ‘ pharmacological therapy ’ , ‘ medication adherence ’ , ‘ physical activity ’ , ‘ fractures ’ and ‘ QoL ’ were found to be statistically significant in patient education is beneficial and whether it has a significant and clinical ly relevant impact on osteoporosis management results . Educational programmes for osteoporosis require further investigation within the context of well-conducted RCTs
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"Background Adherence to anti-osteoporosis treatments is poor , exposing treated women to increased fracture risk . Determinants of poor adherence are poorly understood . The study aims to determine physician- and patient- rated treatment compliance with osteoporosis treatments and to evaluate factors influencing compliance . Methods This was an observational , cross-sectional pharmacoepidemiological study with a r and omly-selected sample of 420 GPs , 154 rheumatologists and 110 gynaecologists practicing in France . Investigators included post-menopausal women with a diagnosis of osteoporosis and a treatment initiated in the previous six months . Investigators completed a question naire on clinical features , treatments and medical history , and on patient compliance . Patients completed a question naire on sociodemographic features , lifestyle , attitudes and knowledge about osteoporosis , treatment compliance , treatment satisfaction and quality of life . Treatment compliance was evaluated with the Morisky Medication-taking Adherence Scale . Variables collected in the question naires were evaluated for association with compliance using multivariate logistic regression analysis . Results 785 women were evaluated . Physicians considered 95.4 % of the sample to be compliant , but only 65.5 % of women considered themselves compliant . The correlation between patient and physician perceptions of compliance was low ( κ : 0.11 [ 95 % CI : 0.06 to 0.16 ] ) . Patient-rated compliance was highest for monthly bisphosphonates ( 79.7 % ) and lowest for hormone substitution therapy ( 50.0 % ) . Six variables were associated with compliance : treatment administration frequency , perceptions of long-term treatment acceptability , perceptions of health consequences of osteoporosis , perceptions of knowledge about osteoporosis , exercise and mental quality of life . Conclusion Compliance to anti-osteoporosis treatments is poor . Reduction of dosing regimen frequency and patient education may be useful ways of improving compliance",
"Introduction : Specific pharmacological treatment reduces the incidence of fractures significantly in patients with osteoporosis . Unfortunately , compliance with such therapy is low in clinical practice and is inversely related to educational level . We hypothesized that patients ' knowledge of osteoporosis may be increased by a group-based multidisciplinary education programme . Methods : Three hundred patients , aged 45—81 years , recently diagnosed with osteoporosis and started on specific treatment , were r and omized to either the \" school ' ' or \" control ' ' group . Teaching was performed by nurses , physiotherapists , dieticians , and doctors , and design ed to increase the patient 's empowerment . The patient 's knowledge of osteoporosis was tested at study entry and at 3 months using a vali date d question naire . Results : At study entry , no differences in age or score ( 22 ( 18—24 ) ( median ( 25—75 percentiles ) ) vs. 22 ( 18—24 ) ) were seen between the school and control groups . The change in knowledge during the study , however , differed significantly between the two groups ( p the increase in knowledge score correlated inversely with the level of education ; that is , the lower the education level , the higher the gain in knowledge during the course ( Rho=-0.25 , p group-based multidisciplinary education programme significantly increases patients ' knowledge of the disease",
"Summary European observational 1-year study assessed osteoporosis and fracture patterns in 3,402 postmenopausal women prescribed osteoporosis medication . Almost 40 % of patients had a previous fracture , while 25 % had neither fracture nor dual energy X-ray absorptiometry ( DXA ) diagnosis and were prescribed medication , probably due to other risk factors . Introduction This analysis assessed osteoporosis and fracture prevalence in postmenopausal women prescribed osteoporosis treatment in the Prospect i ve Observational Study Investigating Bone Loss Experience in Europe(POSSIBLE EU ® ) . Methods Women in this observational , multicenter 1-year study were categorized by fracture history and location at baseline . Baseline characteristics were analyzed according to no DXA and DXA diagnosis ( osteoporosis or osteopenia ) . Fractures occurring during the 1-year follow-up period were recorded . Results Of the 3,402 women enrolled , 39 % had a previous fracture , of whom 30 % had ≥2 fractures . One thous and seven hundred and eighty-four ( 52 % ) patients had a DXA diagnosis ( osteoporosis 68 % , osteopenia 31 % , and unknown 1 % ) . Among the osteoporosis patients , 37 % had a previous fracture ( hip 2.9 % , vertebral 8.8 % , and non-hip , non-vertebral 25 % ) and 35 % had fractures associated with major trauma . Of the 3,402 women , 1,476 ( 43 % ) had no DXA diagnosis ; of these , 57 % had no fracture ( 25 % of all women ) . Risk factors varied across patients with and without DXA diagnosis . During the 1-year follow-up period , the fracture incidence in patients with or without a previous fracture at baseline was 4.7 % and 1.6 % , respectively . Conclusion Almost 40 % of patients prescribed osteoporosis medication had a previous fracture , highlighting a population with advanced disease . In contrast , 25 % of patients had neither a previous fracture nor DXA diagnosis and were prescribed treatment , probably due to other risk factors . There is a need for continued improvement of disease management in European women",
"Background Osteoporosis-related fractures are a significant public health concern . Interventions that increase detection and treatment of osteoporosis are underutilized . This pragmatic r and omised study was done to evaluate the impact of a multifaceted community-based care program aim ed at optimizing evidence -based management in patients at risk for osteoporosis and fractures . Methods This was a 12-month r and omized trial performed in Ontario , Canada . Eligible patients were community-dwelling , aged ≥55 years , and identified to be at risk for osteoporosis-related fractures . Two hundred and one patients were allocated to the intervention group or to usual care . Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing , patient education and patient-specific recommendations for osteoporosis treatment . The primary outcome was the implementation of appropriate osteoporosis management . Results 101 patients were allocated to intervention and 100 to control . Mean age of participants was 71.9 ± 7.2 years and 94 % were women . Pharmacological treatment ( alendronate , risedronate , or raloxifene ) for osteoporosis was increased by 29 % compared to usual care ( 56 % [ 29/52 ] vs. 27 % [ 16/60 ] ; relative risk [ RR ] 2.09 , 95 % confidence interval [ CI ] 1.29 to 3.40 ) . More individuals in the intervention group were taking calcium ( 54 % [ 54/101 ] vs. 20 % [ 20/100 ] ; RR 2.67 , 95 % CI 1.74 to 4.12 ) and vitamin D ( 33 % [ 33/101 ] vs. 20 % [ 20/100 ] ; RR 1.63 , 95 % CI 1.01 to 2.65 ) . Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care . Trial Registration This trial has been registered with clinical trials.gov ( ID : NCT00465387",
"Alp A , Kanat E , Yurtkuran M : Efficacy of a self-management program for osteoporotic subjects . Am J Phys Med Rehabil 2007;86:633–640 . Objective : This study is based on whether the self-management program choices For Better Bone Health is effective to promote behavioral strategies for improving bone health , life quality , pain perception , physical function , and balance in osteoporotic subjects . Design : In this single-blind , r and omized controlled study , a total of 50 sedentary women with postmenopausal and idiopathic osteoporosis were selected from the out patients of Atatürk Balneotherapy and Rehabilitation Center according to their physical activity level and T scores of dual-energy x-ray absorptiometry as the inclusion criteria . Fifty sedentary women with BMD T scores of −2.5 or lower were r and omized into two groups ( self-management group : group 1 ; and control group : group 2 ) and enrolled in a 6-mo study . Participants attended self-management class once a week for 5 wks . Evaluations were done at baseline , at the end of the fifth week , and at the sixth month . Pain-intensity evaluation by Visual Analogue Scale ( VAS ) , life- quality assessment s by SF-36 , balance testing by Sensitized Romberg Test ( SRT ) , and functional assessment by Timed Sit to St and test ( TSS ) and a simple question naire were the outcome measures . Results : When the groups were compared by change scores and percentages of change , improvements observed in pain intensity by VAS ( P , SF-36 Physical Function ( P , SF-36 Physical Role Limitations ( P 0.001 ) , SF-36 Social Function ( P ) , SF-36 Mental Health ( P , SF-36 Vitality ( P ) , SF-36 Pain ( P 0.001 ) , SF-36 General Health Perceptions ( P ) , SF-36 Emotional Role Limitations ( P , SRT eyes open ( P SRT eyes closed ( P , and TSS ( P medications and dietary calcium intake . Fifty-seven percent of them formed personal plans for preventing traumas , whereas 8 % of the subjects in group 2 experienced new falls but no fractures . Conclusion : It is determined that the self-management class led to improvements in functional , balance , and life- quality outcomes and to reductions in pain perception",
"Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field",
"Objective To assess whether osteoporosis education , with and without bone mineral density ( BMD ) testing , increases the initiation of lifestyle changes and pharmaceutical treatment to prevent osteoporosis . Design A total of 508 women , aged 54–65 , from a large managed care organization who were not on osteoporosis prevention therapy participated in an intervention study . Participants were r and omly assigned to either an education class on osteoporosis ( n = 301 ) or education plus BMD ( n = 207 ) . A control group of 187 women receiving no intervention were also surveyed to serve as comparison . Group differences and differences based on BMD test result were compared 6 months after education regarding self-reported changes in health behaviors using & khgr;2 tests and logistic regression analyses . Results Of the 508 intervention participants , 455 ( 90 % ) responded to the follow-up survey . Initiation of hormone replacement therapy was reported by 9 % , with 5 % reporting starting alendronate . More than half reported changes in diet , exercise , or calcium intake . Forty-three percent increased their vitamin D intake . There were no significant group differences in behavior except with regard to pharmaceutical therapy ; subjects with education plus BMD were three times more likely than those receiving education only to report starting hormone replacement therapy ( p = 0.004 ) . Low BMD scores were associated with increasing vitamin D intake ( p = 0.03 ) and starting medication ( p = 0.001 ) . Women in the intervention groups were significantly more likely to report modifying their diet ( p 0.001 ) , calcium ( p 0.01 ) , and vitamin D intake ( p < 0.0001 ) than women in the control group , not exposed to education . Conclusion Education regarding osteoporosis prevention seems to encourage women to make lifestyle changes . The inclusion of BMD testing enhances the likelihood that women will consider pharmaceutical therapy",
"Introduction Adherence to treatment in osteoporosis remains poor . The aim of this study was to evaluate the effects of an educational leaflet on adherence to medication and to assess the association between adherence and health-related quality of life ( HRQOL ) . Methods A naturalistic , observational , multi-center , prospect i ve study of 12 months ’ follow-up was performed . Consecutive post-menopausal women aged 50 years to 86 years starting treatment with raloxifene according to daily practice were enrolled from 126 primary care offices in Spain . The women were assigned to two study groups . Group A received an educational leaflet with general information about osteoporosis ; group B followed current practice . To assess adherence to medication and HRQOL , the Morisky test and the EuroQoL question naire were administered . A total of 745 post-menopausal women ( group A , n=366 ; group B n=379 ) , with a mean age of 62 years , were included . Results Most patients in both study groups showed high adherence to raloxifene at the 3-month visit : 56.3 % vs 62.7 % for groups A and B , respectively ; this proportion at the 12-month visit was 47.4 % ( P=0.15 ) and 52.5 % ( P=0.02 ) , respectively . At baseline , “ pain/discomfort ” was the dimension showing the highest percentage of women reporting problems : 86.4 % vs 83.2 % in groups A and B , respectively ( P=0.22 ) . HRQOL improved in both groups throughout the study , with an overall mean increment in the EuroQoL visual analog scale ( EQ VAS ) of 9.2 at 12 months ( P adherence and HRQOL were weak . After receiving an educational leaflet , young post-menopausal women suffering osteoporosis did not show improvement in adherence to therapy . HRQOL improved at 12-month follow-up under treatment . Conclusion No consistent correlation between adherence and HRQOL was found",
"Long-term patient adherence to osteoporosis treatment is poor despite proven efficacy . In this study , we aim ed to assess the impact of active patient training on treatment compliance and persistence in patients with postmenopausal osteoporosis . In the present national , multicenter , r and omized controlled study , postmenopausal osteoporosis patients ( 45 - 75 years ) who were on weekly bisphosphonate treatment were r and omized to active training ( AT ) and passive training ( PT ) groups and followed-up by 4 visits after the initial visit at 3 months interval during 12 months of the treatment . Both groups received a bisphosphonate usage guide and osteoporosis training booklets . Additionally , AT group received four phone calls ( at 2nd , 5th , 8th , and 11th months ) and participated to four interactive social/training meetings held in groups of 10 patients ( at 3rd , 6th , 9th , and 12th months ) . The primary evaluation criteria were self-reported persistence and compliance to the treatment and the secondary evaluation criteria was quality life of the patients assessed by 41-item Quality of Life European Foundation for Osteoporosis ( QUALEFFO-41 ) question naire .. Of 448 patients ( mean age 62.4±7.7 years ) , 226 were r and omized to AT group and 222 were r and omized to PT group . Among the study visits , the most common reason for not receiving treatment regularly was forgetfulness ( 54.9 % for visit 2 , 44.3 % for visit 3 , 51.6 % for visit 4 , and 43.8 % for visit 5 ) , the majority of the patients always used their drugs regularly on recommended days and dosages ( 63.8 % for visit 2 , 60.9 % for visit 3 , 72.1 % for visit 4 , and 70.8 % for visit 5 ) , and most of the patients were highly satisfied with the treatment ( 63.4 % for visit 2 , 68.9 % for visit 3 , 72.4 % for visit 4 , and 65.2 % for visit 5 ) and wanted to continue to the treatment ( 96.5 % for visit 2 , 96.5 % for visit 3 , 96.9 % for visit 4 , and 94.4 % for visit 5 ) . QUALEFFO scores of the patients in visit 1 significantly improved in visit 5 ( 37.7±25.4 vs. 34.0±14.6 , p persistence and compliance of the patients for bisphosphonate treatment",
"Summary Osteoporosis is an increasing burden on individuals and health re sources . The Osteoporosis Prevention and Self-Management Course ( OPSMC ) was design ed to assist individuals to prevent and manage osteoporosis ; however , it had not been evaluated in an Australian setting . This r and omised controlled trial showed that the course increased osteoporosis knowledge . Introduction and hypothesisOsteoporosis is a major and growing public health concern . An OPSMC was design ed to provide individuals with information and skills to prevent or manage osteoporosis , but its effectiveness has not previously been evaluated . This study aim ed to determine whether OPSMC attendance improved osteoporosis knowledge , self-efficacy , self-management skills or behaviour . Material s and methods Using a wait list r and omised controlled trial design , 198 people ( 92 % female ) recruited from the community and aged over 40 ( mean age = 63 ) were r and omised into control ( n = 95 ) and intervention ( n = 103 ) groups . The OPSMC consists of four weekly sessions which run for 2 h and are led by two facilitators . The primary outcome were osteoporosis knowledge , health-directed behaviour , self-monitoring and insight and self-efficacy . Results The groups were comparable at baseline . At 6-week follow-up , the intervention group showed a significant increase in osteoporosis knowledge compared with the control group ; mean change 3.5 ( p health-directed behaviour , mean change 0.16 ( p < 0.05 ) , on a measure of 0–6 . Conclusion The results indicate that the OPSMC is an effective intervention for improving underst and ing of osteoporosis and some aspects of behaviour in the short term",
"Background Osteoporosis-related fractures are a significant public health concern . Interventions that increase detection and treatment of osteoporosis , as well as prevention of fractures and falls , are substantially underutilized . This paper outlines the protocol for a pragmatic r and omised trial of a multifaceted community-based care program aim ed at optimizing the evidence -based management of falls and fractures in patients at risk . Design 6-month r and omised controlled study . Methods This population -based study was completed in the Algoma District of Ontario , Canada a geographically vast area with Sault Ste Marie ( population 78 000 ) as its main city . Eligible patients were allocated to an immediate intervention protocol ( IP ) group , or a delayed intervention protocol ( DP ) group . The DP group received usual care for 6 months and then was crossed over to receive the interventions . Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada , and falls risk assessment and treatment . Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management . Secondary outcomes included quality of life and the number of falls , fractures , and hospital admissions over a twelve-month period . The patient is the unit of allocation and analysis . Analyses will be performed on an intention to treat basis . Discussion This paper outlines the protocol for a pragmatic r and omised trial of a multi-faceted , community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis . Trial Registration This trial has been registered with clinical trials.gov ( ID : NCT00465387",
"Summary Guidelines suggest identification of women at fracture risk by bone density measurement and subsequently pharmacotherapy . However , most women who sustain a hip fracture do not have osteoporosis in terms of bone density . The present non-pharmacological intervention among elderly women unselected for osteoporosis reduced hip fracture risk by 55 % providing an alternative approach to fracture prevention . Introduction Hip fractures are expensive for society and cause disability for those who sustain them . We studied whether a multifactorial non-pharmacological prevention program reduces hip fracture risk in elderly women . Methods A controlled trial concerning 60- to 70-year-old community-dwelling Finnish women was undertaken . A r and om sample was drawn from the Population Information System and assigned into the intervention group ( IG ) and control group ( CG ) . Of the 2,547 women who were invited to the IG , 1,004 ( 39 % ) and of the 2,120 invited to the CG , 1,174 ( 55 % ) participated . The IG participated in a fracture prevention program for 1 week at a rehabilitation center followed by review days twice . The CG received no intervention . During the 10-year follow-up , both groups participated in survey question naire by mail . Outcome of interest was occurrence of hip fractures and changes in bone – health-related lifestyle . Results During the follow-up , 12 ( 1.2 % ) women in the IG and 29 ( 2.5 % ) in the CG sustained a hip fracture ( P = 0.039 ) . The determinants of hip fractures by stepwise logistic regression were baseline smoking ( odds ratio ( OR ) 4.32 ( 95 % confidence interval [ CI ] 2.14–8.71 ) , age OR 1.15/year ( 95 % CI 1.03–1.28 ) , fall history OR 2.7 ( 95 % CI 1.24–5.9 ) , stroke history OR 2.99 ( 95 % CI 1.19–7.54 ) and participating in this program OR 0.45 ( 95 % CI 0.22–0.93 ) . Starting vitamin D and calcium supplement use was more common in the IG compared with the CG . Conclusions The results suggest that this non-pharmacological fracture prevention program may reduce the risk of hip fractures in elderly Finnish women",
"OBJECTIVE Non-adherence to pharmacological treatment in osteoporosis is a well-recognized problem . We hypothesized that a group-based educational programme would increase patients ' knowledge and level of adherence with medical treatment . METHODS A total of 300 patients ( 32 men aged 65 ± 9 years and 268 women aged 63 ± 8 years ) , recently diagnosed with osteoporosis , were r and omised to either an osteoporosis school programme ( four classes of 8 - 12 participants over four weeks ) or a control group . Teaching was multidisciplinary , based on patients ' experiences and background and design ed to encourage empowerment . Patients ' knowledge about osteoporosis and adherence to treatment was assessed with self-completed question naires at baseline and after 3 , 12 , and 24 months . RESULTS There were no significant differences at baseline between the two groups with respect to knowledge score or level of adherence . At two years ' follow-up , the improvement in knowledge score was 2 [ 0 - 4 ] points ( median [ 25 - 75 percentiles ] ) in the school group and 0 [ -2 to 2 ] in controls ( p ) and self-reported adherence to pharmacological therapy was significantly higher in the school group ( 92 % ) compared to the control group ( 80 % ) , p programme increased knowledge about osteoporosis and increased self-reported adherence to pharmacological treatment over a period of two years",
"An 8-week , bone-health community program addressed risks/lifestyle changes within the Health Belief Model and Theory of Reasoned Action frameworks in a r and omized format ( treatment group n = 35 ; control group n = 34 ) . Median week 1 values for calcium ( control , 963 mg ; treatment , 1023 mg ) and vitamin D ( 81 IU both groups ) were below recommendations , increasing throughout the program for both control ( 1023 mg calcium , 128 IU vitamin D ) and treatment ( 1005 mg calcium , 122 IU vitamin D ) groups . There was limited response to the exercise outcome variables , with many not participating in that section of the program . Psychosocial variables were positive for both control and treatment groups at week 1 , with no significant difference at postintervention . Regression analysis indicated that those with a positive attitude about calcium intake and belief that they could choose calcium-fortified foods were more likely to have higher calcium intake . Intention to exercise was modified by peer and family support . Community-based programs can translate and use clinical trial key topics and outcomes , but participation bias makes impact results difficult to interpret the effectiveness of the program",
"BACKGROUND Treatment of osteoporosis following a hip fracture has been notoriously poor . Many efforts have been made to improve treatment rates . The purpose of this study was to determine whether a perioperative inpatient intervention program , involving patient education and providing a list of questions for the primary care physician , increased the percentage of patients in whom osteoporosis was addressed following a hip fracture . METHODS A prospect i ve , r and omized trial involving eighty patients who had been admitted to an academic medical center with a low-energy hip fracture was conducted . During their hospitalization , the study group patients were engaged in a fifteen-minute discussion regarding the association between osteoporosis and hip fractures , the efficacy of dual-energy x-ray absorptiometry scans in the diagnosis of osteoporosis and of bisphosphonates in its treatment , and the importance of medical follow-up for osteoporosis management . These patients were also provided with five questions regarding osteoporosis treatment to be given to their primary medical physician , and they were reminded about the questions during a follow-up telephone call six weeks later . The patients in the control group received a brochure describing methods for preventing falls . Both groups were contacted by telephone at six months after discharge to determine whether osteoporosis had been addressed . Positive indicators of intervention included assessment of bone mineral density with dual-energy x-ray absorptiometry and initiation of antiresorptive therapy . RESULTS The average age in each group was eighty-two years , and 78 % of the patients were female . Four patients in each group did not survive through the six-month follow-up period and were excluded from the trial . Fifteen ( 42 % ) of the thirty-six patients who had been r and omized to the study group , compared with only seven ( 19 % ) of the thirty-six patients in the control group , had their osteoporosis addressed by their primary physician . This difference between the groups was significant ( p = 0.036 ) . CONCLUSIONS Patients who were provided with information and questions for their primary care physician about osteoporosis were more likely to receive appropriate therapeutic intervention than were patients who had not received the information and questions . Orthopaedic surgeons have a unique opportunity to improve the rate of osteoporosis treatment in the perioperative period following a hip fracture by educating patients and directing them toward channels for long-term osteoporosis management",
"Summary This study evaluated the effect of a multifaceted intervention ( screening and patient education ) by community pharmacists on testing or treatment of osteoporosis . One hundred and twenty-nine patients r and omized to receive the intervention were compared to 133 patients who did not receive the intervention . Twice as many patients who got the intervention received further testing or treatment for osteoporosis . Introduction The objective of this study was to determine the effect of a community pharmacist screening program on testing and treatment of osteoporosis . Methods In this r and omized , controlled trial , 262 patients meeting bone mineral density ( BMD ) testing guidelines [ men or women aged ≥ 65 years or 50–64 years with one major risk factor including previous fracture , family history of osteoporosis , glucocorticoids for > 3 months , or early menopause ] were allocated to intervention ( 129 ) or control ( 133 ) . Intervention consisted of printed material s , education , and quantitative ultrasound . Primary outcome was a composite endpoint of BMD or prescription for osteoporosis medication within 4 months . Results Primary endpoint of BMD or osteoporosis treatment was achieved by 28 intervention patients ( 22 % ) compared with 14 controls ( 11 % ) ( RR 2.1 , 95 % CI 1.1–3.7 ) . This was driven by BMD testing ( 28 ( 22 % ) vs. 13 ( 10 % ) for controls , p = 0.011 ) . Calcium intake increased more among intervention patients than controls ( 30 % vs. 19 % , RR 1.6 , 95 % CI 1.0–2.5 ) . There was no effect on knowledge or quality of life . Conclusion A pharmacist screening program doubled the number of patients tested for osteoporosis . Nevertheless , many patients eligible for BMD did not receive appropriate care suggesting more intensive interventions are needed",
"UNLABELLED The impact of clinical risk factor-based absolute risk methods on the prevalence of high risk for osteoporotic fracture is unknown . We applied absolute risk methods to 6646 subjects and found that the prevalence of elderly women deemed to be at high risk increased substantially , whereas the overall prevalence was highly dependent on the threshold used to design ate high risk . INTRODUCTION Many groups have advocated using absolute risk methods that incorporate clinical risk factors to target patients for osteoporosis therapy . We examined how the application of such absolute risk classification systems influences the prevalence of those considered to be at high risk for osteoporotic fracture and compared these systems to one based solely on BMD . MATERIAL S AND METHODS Using 6646 subjects from the Canadian Multicentre Osteoporosis Study ( CaMos ) , a prospect i ve , r and omly selected , population -based cohort , we assessed three different systems for determining prevalence of high risk for osteoporotic fracture : a BMD-based system ; a simplified risk factor system incorporating age , sex , BMD , and two clinical risk factors ; and a comprehensive system , incorporating age , sex , BMD , and seven clinical risk factors . The 10-year absolute risks of incident fragility fracture were compared across systems using three different high-risk thresholds . RESULTS The prevalence of a T score -2.5 was 18.8 % ( 95 % CI : 17.7 - 19.9 % ) in women and 3.9 % ( 95 % CI : 3.0 - 4.7 % ) in men . Using a 15 % 10-year risk of fracture threshold , the prevalence of women at high risk increased to 46.9 % ( 95 % CI : 45.4 - 48.4 ) and 42.5 % ( 95 % CI : 41.1 - 43.9 ) when the comprehensive and simplified risk factor classification systems were used , respectively . Using a 25 % 10-year absolute risk threshold , the prevalence of high risk was similar to that of the BMD-based system , whereas the 20 % threshold gave intermediate rates . All thresholds analyzed result ed in an increased prevalence of older women at high risk for fracture , whereas only the 15 % 10-year risk of fracture threshold result ed in an increase in the prevalence of men at high risk . CONCLUSIONS The application of risk factor-based systems results in an increased prevalence of older women at high risk . The prevalence of individuals at high risk may increase with changes to the methods used to determine those who are eligible for therapy . These data have important implication s for the pattern of care and costs of treating osteoporotic fractures",
"Background and aims : Given the high risk of subsequent fracture among elderly persons with fracture , it is important to initiate secondary treatment for osteoporosis . Acute rehabilitation centers may offer a unique opportunity to introduce treatment . Therefore , we evaluated willingness-to-participate and compliance with evidence -based interventions for the secondary prevention of osteoporotic fracture in a non-r and omized study conducted in the acute rehabilitation setting . We also described differences in baseline characteristics between study participants and non- participants . Methods : All consecutive , community-dwelling admissions to an acute rehabilitation unit ( Boston , MA ) with the diagnosis of fracture were screened for enrollment . Eligible subjects were offered a free , 6-month supply of alendronate/cholecalciferol ( 70 mg/2800 IU weekly ) , calcium and vitamin D supplements , and fall prevention strategies . Six-month compliance ( ≥75 % consumption of medication or supplement ) with the interventions was determined at a home visit . Results : Among 62 eligible subjects , 25 agreed to participate . Non- participants were older than participants ( 86 vs 80 yrs , p . There was no significant difference between other characteristics of participants and non- participants including sex , weight , type of fracture , cognitive status , and functional status . The most common reason for non-participation was reluctance to take another medication . Among participants , only 52 % were compliant with alendronate and 58 % were compliant with calcium and vitamin D supplementation at 6 months . Conclusions : Willingness-to-participate and compliance with secondary prevention strategies for osteoporosis was low in the acute rehabilitation setting , even when medications were provided free of cost . Educating individuals with fracture and their families on the consequences and treatment of osteoporosis may help to decrease the risk of sustaining a second fracture by accepting secondary preventive measures",
"In a r and omized trial , we demonstrated that a community pharmacist osteoporosis screening intervention doubled the rates of bone mineral density ( BMD ) testing in high-risk patients . The purpose of this secondary analysis was to evaluate the potentially modifiable factors associated with BMD testing . From 2005 to 2007 , 15 pharmacies r and omized 262 patients to intervention ( education , pamphlets , point-of-care quantitative heel ultrasound [ QUS ] ) or usual care . The main outcome was BMD testing within 4mo . Multivariate regression was used to determine independent correlates of BMD testing . The median age of the cohort was 62yr , 65 % were women , and 49 % ( n=129 ) were r and omized to intervention . Compared with patients who were not tested , those with BMD were more likely to be women ( p=0.007 ) and have excellent or very good health ( p BMD test were intervention ( p=0.017 ) , greater osteoporosis knowledge ( p=0.004 ) , and osteoporosis-specific physician visits ( p osteoporosis-specific visits ( aOR : 3.2 ; 95 % CI : 1.4 - 7.8 ) were independently associated with BMD testing . In analyses restricted to intervention patients , abnormal QUS ( aOR : 3.7 , 95 % CI : 1.4 - 9.1 ) was the only independent predictor of BMD test . Future interventions should incorporate the finding that osteoporosis-specific visits and abnormal QUS results were strongly associated with getting a BMD testing and should give greater attention to men"
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41164778-06ff-11f0-808a-c43d1ab1c353
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CONTEXT Being physically active during the early years ( age 0 - 6 years ) is vital for healthy development . Identifying correlates and determinants of physical activity ( PA ) is crucial to guide effective interventions . This systematic review synthesized studies investigating potential correlates and determinants of PA during the early years , accounting for different types of PA assessment . EVIDENCE ACQUISITION Nine electronic data bases were search ed from inception year ( 1900 ) until September 2014 ; data were analyzed/interpreted in April 2015 . The following inclusion criteria were used : written in English , published in peer- review ed journals , participants not in statutory/school education , and an observational design investigating associations between an exposure/variable , and a quantitative measure of PA . Correlates/determinants of total , moderate to vigorous , and light PA were reported using an ecologic model . EVIDENCE SYNTHESIS Of 22,045 identified studies , 130 were included . All took place in high-income countries and few ( 6 % ) were of high quality . Correlates of total PA were sex ( male , + + ) ; parental PA ( + ) ; parental support ( + ) ; and time outdoors ( + ) . Determinants of total PA were sex ( + ) and time spent playing with parents ( + ) . The only correlate of moderate to vigorous PA was sex ( male , + + ) . No determinants of moderate to vigorous or light PA were found . PA correlates/determinants were relatively consistent between objective and subjective PA measures . CONCLUSIONS Numerous studies investigated potential correlates and determinants of PA , but overall quality was low . A small number of demographic/biological and social/cultural factors were associated with PA . There is a need for high- quality studies exploring correlates/determinants across all domains of the ecologic model
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"Asthma is a severe problem among inner city children , and recent evidence suggests that both allergen exposure and lifestyle can impact the disease early in childhood . This study was design ed to investigate the association between physical activity and wheezing among a population of inner city children enrolling in Head Start . The parents of children aged 3 - 5 years responded to a question naire ( N = 144 ) to determine the presence and severity of wheezing and asthma . Information was also gathered regarding home environment , food frequency , and presence of other allergic diseases . Serum was obtained to measure total IgE and specific IgE levels to common allergens . Height and weight for body mass index were recorded . Lastly , motion sensor wristwatches ( Actiwatch ) were worn continuously by a subset of these children ( n = 54 ) for 6 or 7 days . Physical activity measured with the motion sensor was decreased among children with a history of wheezing . The significant differences involved those measures of activity relating to prolonged or sustained physical activity . The correlates of asthma associated with decreased levels of physical activity included : 1 ) a history of wheezing in the last 12 months , 2 ) the diagnosis of asthma , and 3 ) presentation to the emergency room in the last 12 months for wheezing or asthma . In a preschool-age population , decreased physical activity was observed among children with a history of asthma or wheezing . Decreased physical activity could contribute to persistence of asthma or put children at higher risk for obesity and other chronic diseases",
"Background Little is known about preschool-aged children ’s levels of physical activity ( PA ) over the course of the day . Using time-stamped data , we describe the levels and patterns of PA in a population -based sample of four-year-old British children . Methods Within the Southampton Women ’s Survey the PA levels of 593 4-year-old children ( 51 % female ) were measured using ( Actiheart ) accelerometry for up to 7 days . Three outcome measures : minutes spent sedentary ( in light ( LPA : ≥20 – 399 cpm ) and in moderate-to-vigorous activity ( MVPA : ≥400 cpm ) were derived . Average daily activity levels were calculated and then segmented across the day ( morning , afternoon and evening ) . MVPA was log-transformed . Two-level r and om intercept models were used to analyse associations between activity level and temporal and demographic factors . Results Children were active for 67 % ( mean 568.5 SD 79.5 minutes ) of their daily registered time on average , with 88 % of active time spent in LPA . All children met current UK guidelines of 180 minutes of daily activity . There were no differences in children ’s average daily levels of sedentary activity and LPA by temporal and demographic factors : differences did emerge when activity was segmented across the day . Sex differences were largest in the morning , with girls being more sedentary , spending fewer minutes in LPA and 18 % less time in MVPA than boys . Children were more sedentary and less active ( LPA and MVPA ) in the morning if they attended childcare full-time compared to part-time , and on weekend mornings compared to weekdays . The reverse was true for weekend afternoons and evenings . Children with more educated mothers were less active in the evenings . Children were less sedentary and did more MVPA on summer evenings compared to winter evenings . Conclusions Preschool-aged children meet current physical activity guidelines , but with the majority of their active time spent in LPA , investigation of the importance of activity intensity in younger children is needed . Activity levels over the day differed by demographic and temporal factors , highlighting the need to consider temporality in future interventions . Increasing girls ’ morning activity and providing opportunities for daytime activity in winter months may be worthwhile",
"Background : The aim of this study was to examine in detail levels and patterns of physical activity in preschool children and the effects of gender and BMI on this activity . Methods : Two hundred and fifty-three children aged 5 y participating in the Copenhagen Prospect i ve Studies on Asthma in Childhood wore an accelerometer day and night over a 4-wk period . The main outcome measure was level of physical activity using the raw data . A secondary measure was time spent in moderate to vigorous physical activity ( MVPA ) . A Fourier series analysis was applied to study in detail patterns over time . Results : Activity profiles throughout the year were unique for each sex , with boys being overall more active than girls except for winter months . Preschool children also showed distinct patterns of physical activity during weekdays as compared with weekends and were most active during weekdays . Preschool children in the highest tertile of BMI had a flat yearly activity profile and tended to be less active as compared with those in the lowest tertile . Conclusion : Preschool children showed significant gender differences in physical activity , with distinct patterns throughout the year as well as between weekdays and weekends . A high BMI tended to be associated with lower levels of physical activity",
"OBJECTIVE : To identify correlates of objective ly measured moderate and vigorous physical activity ( MVPA ) in children during preschool attendance . METHODS : This cross-sectional study included data from 426 apparently healthy Danish children ( 49.5 % boys ) , 5 to 6 years of age enrolled in 42 r and omly selected preschools . The percentage of time spent in MVPA ( ≥574 counts/15 second ) during preschool attendance was measured using ActiGraph accelerometers over 4.3 preschool days in May and June in 2009 . Thirty-seven potential correlates across the child , preschool staff , and preschool environment domains were tested for associations with MVPA . RESULTS : The final multivariate model identified 9 significant correlates of MVPA . Preterm birth , vegetation on the playground , and rainy days were negatively associated with MVPA , whereas child motor coordination , location of preschool building on the playground , gender ( boys ) , percentage afternoon hours , and size of indoor area per child were positively associated with MVPA . The direction of the significant association with the parental mean education level was unclear . CONCLUSIONS : We identified a number of new modifiable correlates of MVPA during preschool attendance . The positive association with size of indoor area per child and location of the preschool building on the playground seem important correlates to be targeted in future studies",
"Early childhood is a critical time for promoting physical activity . Few studies have investigated the effect of interventions in this population . The aim of this study was to investigate the effect of a school-based active play intervention on preschool children 's sedentary time and physical activity . Preschool children were recruited from r and omly selected preschools . Schools were r and omly assigned to an intervention or comparison group . One teacher per intervention school received training from active play professionals in the delivery of a 6-week active play programme . Comparison schools continued their usual practice . Children wore a uni-axial accelerometer for 7 days at baseline , immediately after and at 6-month post-intervention . No significant intervention effects were observed for sedentary time or physical activity . However , sex and hours spent at school were significant predictors of physical activity . Children who spent fewer hours ( half-day children ) at school were significantly more active than their full-day counterparts . Physical activity during the intervention classes was high even though neither daily physical activity nor sedentary time changed . Notably children who spent more time at preschool were less active suggesting that preschool was not as conducive to physical activity engagement as other environments",
"Background Low levels of physical activity are characteristic in preschoolers . To effectively promote physical activity , it is necessary to underst and factors that influence young children 's physical activity . The present study aim ed to investigate how physical activity levels are influenced by environmental factors during recess in preschool . Methods Preschool playground observations and pedometry during recess were carried out in 39 r and omly selected preschools ( 415 boys and 368 girls ; 5.3 ± 0.4 years old ) . In order to examine the contribution of playground variables to physical activity levels , taking adjustment for clustering of subjects within preschools into account , multilevel analyses were conducted . Results During recess boys took significantly more steps per minute than girls ( 65 ± 36 versus 54 ± 28 steps/min ) . In both genders higher step counts per minute were significantly associated with less children per m2 and with shorter recess times . Only in boys a hard playground surface was a borderline significant predictor for higher physical activity levels . In girls higher step counts were associated with the presence of less supervising teachers . Playground markings , access to toys , the number of playing or aim ing equipment pieces and the presence of vegetation or height differences were not significant physical activity predictors in both genders . Conclusion In preschool children physical activity during outdoor play is associated with modifiable playground factors . Further study is recommended to evaluate if the provision of more play space , the promotion of continued activity by supervisors and the modification of playground characteristics can increase physical activity levels in preschoolers",
"Background Early childhood provides a window of opportunity for the promotion of physical activity . Given the limited effectiveness of interventions to date , new approaches are needed . Socio-ecological models suggest that involving parents as intervention targets may be effective in fostering healthier lifestyles in children . This study describes the effectiveness of a family-focused ‘ Active Play ’ intervention in decreasing sedentary time and increasing total physical activity in preschool children . MethodS eventy-seven families were recruited from 8 r and omly selected SureStart children ’s centres in the North West of Engl and . Centres were r and omly assigned to either an intervention ( n = 4 ) or a comparison group ( n = 4 ) . Parents and children in the intervention group received a 10-week active play programme delivered by trained active play professionals ; this included an activity and educational component . Families in the comparison group were asked to maintain their usual routine . Each participating parent and child wore a uni-axial accelerometer for 7 days at baseline and post-test . Week and weekend day sedentary time and total physical activity adjusted for child- and home- level covariates were analysed using multilevel analyses . Results Significant intervention effects were observed for sedentary time and physical activity for both week and weekend days . Children in the intervention group engaged in 1.5 % and 4.3 % less sedentary time during week and weekend days , respectively and 4.5 % and 13.1 % more physical activity during week and weekend days , respectively than children in the comparison group . Parent ’s participation in sport and their physical activity levels , child ’s sex , availability of media in the home and attendance at organised activities were significant predictors of sedentary time and physical activity in this age group . Conclusion A 10-week family focused active play intervention produced positive changes in sedentary time and total physical activity levels in preschool children . Specific covariates were identified as having a significant effect on the outcome measures . Moreover , children whose parents were active engaged in less sedentary time and more physical activity suggesting that parent ’s activity habits are mediators of physical activity engagement in this age group",
"OBJECTIVE To report dietary intake and physical activity among preschool-aged children living in rural American Indian communities before participation in a family-based healthy lifestyle intervention and to compare data to current age-specific recommendations . SUBJECTS/ DESIGN One hundred thirty-five preschool-aged children , living in rural American Indian communities , provided diet and physical activity data before participating in a 2-year r and omized healthy lifestyle intervention . Three 24-hour dietary recalls assessed nutrient and food and added sugar intake , which were compared to the National Academy of Science 's Dietary Reference Intakes , the US Department of Agriculture 's MyPyramid , and American Heart Association recommendations . Time watching television and moderate plus vigorous activity was compared to MyPyramid and American Academy of Pediatrics recommendations . STATISTICAL ANALYSIS Nutrient , food group , added sugar intake , and time watching television and in moderate or vigorous activity were compared to recommendations by computing the percent of recommendations met . Nonparametric tests identified differences in diet and physical activity among age groups and normal and overweight children ( body mass index or = 85th percentile ) . RESULTS Average nutrient intakes met recommendations whereas food group intakes did not . Mean fruit and vegetable intakes for 2- to 3-year-olds were 0.36 c/day fruit and 0.45 c/day vegetables and , for 4- to 5-year-olds , 0.33 c/day fruit and 0.48 c/day vegetables . Both age groups reported consuming more than 50 g added sugar , exceeding the recommendation of 16 g. Overweight vs normal weight children reported significantly more sweetened beverage intake ( 8.0+/-0.10 vs 5.28+/-0.08 oz/day , P watching television 2.0 hours/day and significant differences were observed for total television viewing and nonviewing time between overweight and normal weight children ( 8.52+/-0.6 vs 6.54+/-0.6 hours/day , P 20 minutes/day of moderate or vigorous activity . CONCLUSIONS Overall , children in this sample did not meet MyPyramid recommendations for fruits or vegetables and exceed added sugar intake recommendations . Television viewing time and time when the television was on in the home was highly prevalent along with low levels of moderate or vigorous activity . The Healthy Children Strong Families intervention we studied has potential for improving nutrition and physical activity among preschool-aged children living in rural American Indian communities",
"Alarm about the increasing prevalence of childhood obesity has focussed attention on individual lifestyle behaviours that may contribute to unhealthy weight . More distal predictors such as maternal employment may also be implicated since working mothers have less time to supervise children 's daily activities . The research reported here used two waves of data from the Longitudinal Study of Australian Children to investigate whether mothers ' hours in paid work shape young children 's television viewing , snacking and physical activity , and through those lifestyle behaviours , children 's weight at ages 4 - 5 years and 6 - 7 years . At both ages , children 's lifestyle behaviours were interrelated and associated with weight status . Cross-sectional analysis confirmed small , direct associations between longer hours of maternal employment and child weight at age 4 - 5 years , but not with child 's weight measured two years later . In both the cross-sectional and prospect i ve analyses , the children of mothers who worked part-time watched less television and were less likely to be overweight than children of mothers who were not employed or who worked full-time . While associations were small , they remained significant after adjustment for maternal weight , household income and other factors . The combination of direct and indirect relationships between mothers ' work hours and the weight status of their young children provides additional support to calls for family-friendly work policies as an important means for promoting healthy family lifestyles and early childhood wellbeing",
"Objective : To evaluate energy balance and physical activity in obese preschool children attending day-care centres . Design : Cross-sectional study .Subjects : Twenty-four 3–5 years old obese children selected at r and om from four different day-care centres in Santiago City , Chile . Total energy expenditure ( TEE ) was measured by doubly labelled water and physical activity as recorded by TRITRAC R3D motion sensor . Energy intake was assessed by measuring food intake while at the centre , along with the recording of additional food intake in the home . Results : Obese children had a 5.4 % higher weighed energy intake than their energy requirements 2001 . Energy intake during the week was 7716±1092 kJ/day and 7401±1023 kJ/day in boys and girls , respectively . Minimal activity was higher in the day-care centres ( 62 % ) compared to 52 % during the weekend at home . Light activity was higher during the weekend at home than during the week ( 25 versus 20 % ) , but moderate-intense activity was similar ( 3–5 % ) . Conclusions : Reduction in dietary energy provided at the day-care centres helps to balance energy requirements during the week . Obese children had marked sedentary characteristics with regards to physical activity , although children are more active at home in weekends . This situation suggests that educators and parents need to improve children 's physical activity levels and nutrition habits",
"PURPOSE To test for relationships between objective ly measured habitual physical activity and fundamental movement skills in a relatively large and representative sample of preschool children . METHODS Physical activity was measured over 6 d using the Computer Science and Applications ( CSA ) accelerometer in 394 boys and girls ( mean age 4.2 , SD 0.5 yr ) . Children were scored on 15 fundamental movement skills , based on the Movement Assessment Battery , by a single observer . RESULTS Total physical activity ( r=0.10 , P percent time spent in moderate to vigorous physical activity ( MVPA ) ( r=0.18 , P total movement skills score . Time spent in light-intensity physical activity was not significantly correlated with motor skills score ( r=0.02 , P>0.05 ) . CONCLUSIONS In this sample and setting , fundamental movement skills were significantly associated with habitual physical activity , but the association between the two variables was weak . The present study questions whether the widely assumed relationships between motor skills and habitual physical activity actually exist in young children",
"Objectives : Decreased physical activity levels in children may partly explain the rising prevalence of functional constipation in childhood . The aim of the present study , therefore , was to examine the association between physical activity and functional constipation during the preschool period . Methods : This study was embedded in the Generation R study , a large prospect i ve birth-cohort study in Rotterdam , The Netherl and s. Physical activity was measured by an Actigraph accelerometer in 347 children ( 182 boys , 165 girls ; mean age 25.1 months ) and data were expressed as counts per minute . Data were categorized into light activity ( 302–614 counts/15 seconds ) , moderate activity ( 615–1230 counts/15 seconds ) , and vigorous activity ( ≥1231 counts/15 seconds ) . Functional constipation in the third and fourth year of life was defined according to the Rome II criteria . Results : Children spending time in the highest tertile of light ( adjusted odds ratio [ OR ] 0.34 ; 95 % confidence interval [ CI ] 0.13–0.87 ) , moderate ( adjusted OR 0.37 ; 95 % CI 0.14–0.97 ) , and total activity ( adjusted OR 0.37 ; 95 % CI 0.15–0.92 ) at the age of 2 years had significantly less functional constipation in the fourth year of life . For functional constipation in the third year of life , the results were in similar direction but not statistically significant . Additionally , children with physical activity of more than the WHO recommendation of 60 min/day had significantly less functional constipation in the fourth year of life ( adjusted OR 0.48 ; 95 % CI 0.24–0.97 ) . Conclusions : Physical activity is associated with a decreased risk of functional constipation in the preschool period , but this may be time dependent",
"UNLABELLED The aim of this study was to examine the relationship between motor proficiency and pedometer-determined physical activity in 5 - 6 year-old children . Participants ( n = 232 ) were r and omly recruited and assessed from 30 kindergartens in Northern Greece . Two trained research ers administered the measurements for the assessment of children 's motor proficiency by using the BOTMP-SF . Physical activity was assessed by OMRON pedometers . Significant relationships between BOTMP-SF st and ard score and steps ( S ) , aerobic walking time ( AWT ) and aerobic steps ( AS ) , ( p for AWT , S and AS ( p Young children with high levels of motor proficiency were more active in contrast to their peers with lower motor proficiency . The findings add to the growing body of literature that considers motor skills/abilities as important elements of physical activity participation . ( ABBREVIATIONS S-steps per day ; AS-aerobic steps per day ; AWT-aerobic walking time ( minutes·day(-1 ) ) ; BOTMP-SF-Bruininks-Oseretsky Test of Motor Proficiency-Short Form ( st and ard score ) ) ",
"Little is known about the frequency‐intensity patterns of naturally occurring physical activity in children . A data set obtained previously by direct observation of physical activity in 8 girls and 7 boys ( all prepubertal , ages 6–10 ) was analyzed with spectral analysis to detect significant frequency‐intensity relationships . Pulse detection algorithms were used to characterize the number of exercise bouts , their duration and relative intensity . Spectral analysis revealed that physical activity bouts were frequent , pulsatile , and r and om with no significant frequencies detected during many 24‐min periods of observation . An average of 83 ± 11 bouts per hour were observed in boys and 89 ± 12 bouts per hour in girls , and the mean duration of an exercise bout was 21 ± 5 sec for boys and 20 ± 4 sec for girls ( NS ) . While high‐intensity exercise bouts comprised less than 20 % of the time spent in physical activity , duration of high intensity exercise bouts tended to be longer and accounted for about 40 % of the energy expenditure associated with physical activity . Spontaneous physical activity in prepubertal children is characterized by frequent bouts of brief , mostly low intensity exercise , r and omly interspersed with less frequent , but metabolically substantial high intensity bouts . These findings are potentially useful in assessing the impact of disease on quality of life in children , investigating the relationship between physical activity and mechanisms of growth and development , and creating new approaches for in‐laboratory exercise testing in children . Am . J. Hum . Biol . 10:289–297 , 1998 . © 1998 Wiley‐Liss ,"
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Independent systematic review s of the totality of the evidence by governments and international agencies throughout the world uniformly conclude that population -wide interventions to reduce salt are beneficial for health . However , some scientists continue to produce and cite studies with paradoxical findings that conflict with the evidence base used to develop national and World Health Organization ( WHO ) guidelines on salt reduction.[1 - 5 ] While conflicting studies are not uncommon in any area of research , [ 6 ] in the case of salt , such studies attract widespread attention in the media ; misinform program leaders , clinicians , and the general public ; and impede program implementation . Such impediments to progress have occurred despite the fact that the design s and methods of studies with paradoxical findings have been criticized by international experts who highlight the fact that the results are not valid.[7 - 9
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"BACKGROUND High US sodium intake and national reduction efforts necessitate developing a feasible and valid monitoring method across the distribution of low-to-high sodium intake . OBJECTIVE We examined a statistical approach using timed urine voids to estimate the population distribution of usual 24-h sodium excretion . METHODS A sample of 407 adults , aged 18 - 39 y ( 54 % female , 48 % black ) , collected each void in a separate container for 24 h ; 133 repeated the procedure 4 - 11 d later . Four timed voids ( morning , afternoon , evening , overnight ) were selected from each 24-h collection . We developed gender-specific equations to calibrate total sodium excreted in each of the one-void ( e.g. , morning ) and combined two-void ( e.g. , morning + afternoon ) urines to 24-h sodium excretion . The calibrated sodium excretions were used to estimate the population distribution of usual 24-h sodium excretion . Participants were then r and omly assigned to modeling ( n = 160 ) or validation ( n = 247 ) groups to examine the bias in estimated population percentiles . RESULTS Median bias in predicting selected percentiles ( 5th , 25th , 50th , 75th , 95th ) of usual 24-h sodium excretion with one-void urines ranged from -367 to 284 mg ( -7.7 to 12.2 % of the observed usual excretions ) for men and -604 to 486 mg ( -14.6 to 23.7 % ) for women , and with two-void urines from -338 to 263 mg ( -6.9 to 10.4 % ) and -166 to 153 mg ( -4.1 to 8.1 % ) , respectively . Four of the 6 two-void urine combinations produced no significant bias in predicting selected percentiles . CONCLUSIONS Our approach to estimate the population usual 24-h sodium excretion , which uses calibrated timed-void sodium to account for day-to-day variation and covariance between measurement errors , produced percentile estimates with relatively low biases across low-to-high sodium excretions . This may provide a low-burden , low-cost alternative to 24-h collection s in monitoring population sodium intake among healthy young adults and merits further investigation in other population subgroups ",
"Background : According to traditional underst and ing of sodium homeostasis , nearly all of daily sodium intake is excreted in urine , with intraindividual variability attributed to variability in dietary sodium intake and urine collection errors . Objective : To analyze the variability of urinary sodium in excretion from a balance study with fixed sodium intakes . Methods : Daily 24-h urine collection s were assessed for sodium , potassium , and creatinine in 22 black and 13 white adolescent girls ( 11–15 year , BMI 15–29 kg/m2 ) in a r and omized , crossover design with controlled diets containing either low ( 57 mmol/day ) or high ( 167 mmol/day ) sodium , each fed for 3 weeks . Results : Coefficient of variation analysis indicated higher variation in urinary sodium excretion about the mean on low ( vs high ) sodium ( 40 vs 32 % , P = 0.02 ) and in black ( vs white ) girls ( 42 vs 30 % , P interaction . Urinary sodium excretion was not correlated with urinary potassium or creatinine excretion . Excretion of 65 mmol/day ( adequate intake ) or less was documented on 16 % on the days during the high-sodium diet . Reliability of the mean of several urine sodium sample s varied from 23 % for one sample to 75 % for 10 sample s for the high-sodium diet . Conclusion : The high intraindividual variability in urinary sodium excretion on a fixed diet highlights the potential for substantial error in ( a ) using a single 24-h urine collection to estimate an individual 's usual sodium intake and ( b ) relating sodium excretion from a single 24-h collection with outcomes . Further research is warranted to underst and the causes of such variation",
"Objective Having found no definite relationship between blood pressure ( BP ) and 24h sodium excretion in women aged 48–56 years ( in contrast to the results in men of the same age ) in the WHO Cardiovascular Diseases and Alimentary Comparison ( WHO-CARDIAC ) Study , we analyzed the data to investigate whether the sodium – BP association differed between pre- and post-menopausal women . Design and methods The WHO-CARDIAC is a multi-center cross-sectional study , involving , as of July 2000 , 60 collaborating centers in 25 countries . In each center , 100 men and 100 women aged 48–56 years were selected r and omly from the general population of the area . In this report , 2212 women in 21 centers located in 17 countries worldwide , who had data on menopausal status , were studied . Results After adjustment for age , body mass index ( BMI ) and 24h urinary potassium excretion , 24h sodium excretion was positively and significantly associated with systolic blood pressure ( SBP ) [ pooled regression coefficient : 0.037 ( SE 0.01 ) , P diastolic blood pressure ( DBP ) [ 0.023 ( 0.006 ) , P of sodium – BP association were not significant in pre-menopausal women ( P with SBP and DBP in both pre- and post-menopausal women , and this positive association between sodium excretion and SBP was significant in post-menopausal women ( R2 = 0.23 , P = 0.029 ) . Conclusion Different associations between sodium and BP were observed in women with pre- and post-menopausal status . There may be a tendency for salt sensitivity to increase at the menopause",
"BACKGROUND In patients who have vascular disease or high-risk diabetes without heart failure , angiotensin-converting-enzyme ( ACE ) inhibitors reduce mortality and morbidity from cardiovascular causes , but the role of angiotensin-receptor blockers ( ARBs ) in such patients is unknown . We compared the ACE inhibitor ramipril , the ARB telmisartan , and the combination of the two drugs in patients with vascular disease or high-risk diabetes . METHODS After a 3-week , single-blind run-in period , patients underwent double-blind r and omization , with 8576 assigned to receive 10 mg of ramipril per day , 8542 assigned to receive 80 mg of telmisartan per day , and 8502 assigned to receive both drugs ( combination therapy ) . The primary composite outcome was death from cardiovascular causes , myocardial infa rct ion , stroke , or hospitalization for heart failure . RESULTS Mean blood pressure was lower in both the telmisartan group ( a 0.9/0.6 mm Hg greater reduction ) and the combination-therapy group ( a 2.4/1.4 mm Hg greater reduction ) than in the ramipril group . At a median follow-up of 56 months , the primary outcome had occurred in 1412 patients in the ramipril group ( 16.5 % ) , as compared with 1423 patients in the telmisartan group ( 16.7 % ; relative risk , 1.01 ; 95 % confidence interval [ CI ] , 0.94 to 1.09 ) . As compared with the ramipril group , the telmisartan group had lower rates of cough ( 1.1 % vs. 4.2 % , P angioedema ( 0.1 % vs. 0.3 % , P=0.01 ) and a higher rate of hypotensive symptoms ( 2.6 % vs. 1.7 % , P rate of syncope was the same in the two groups ( 0.2 % ) . In the combination-therapy group , the primary outcome occurred in 1386 patients ( 16.3 % ; relative risk , 0.99 ; 95 % CI , 0.92 to 1.07 ) ; as compared with the ramipril group , there was an increased risk of hypotensive symptoms ( 4.8 % vs. 1.7 % , P syncope ( 0.3 % vs. 0.2 % , P=0.03 ) , and renal dysfunction ( 13.5 % vs. 10.2 % , P CONCLUSIONS Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema . The combination of the two drugs was associated with more adverse events without an increase in benefit . ( Clinical Trials.gov number , NCT00153101 [ Clinical Trials.gov ] . )",
"Background — Recent studies have raised the possibility of adverse effects of low sodium , particularly disease ; however , these paradoxical findings might have result ed from suboptimal measurement of sodium and potential biases related to indication or reverse causation . Methods and Results — Phases 1 and 2 of the Trials of Hypertension Prevention ( TOHP ) collected multiple 24-hour urine specimens among prehypertensive individuals . During extended posttrial surveillance , 193 cardiovascular events or cardiovascular disease deaths occurred among 2275 participants not in a sodium reduction intervention with 10 ( TOHP II ) or 15 ( TOHP I ) years of posttrial follow-up . Median sodium excretion was 3630 mg/d , with 1.4 % of the participants having intake sodium excretion of 3600 to sodium in sodium ( P=0.05 ) . Spline curves supported a linear association of sodium with cardiovascular events , which continued to decrease from 3600 to 2300 and 1500 mg/d , although the data were sparse at the lowest levels . Controlling for creatinine levels had little effect on these results . Conclusions — Results from the TOHP studies , which overcome the major method ological challenges of prior studies , are consistent with overall health benefits of reducing sodium intake to the 1500 to 2300 mg/d range in the majority of the population , in agreement with current dietary guidelines",
"24-h urinary sodium excretion is the gold st and ard for evaluating dietary sodium intake , but it is often not feasible in large epidemiological studies due to high participant burden and cost . Three methods —Kawasaki , INTERSALT , and Tanaka — have been proposed to estimate 24-h urinary sodium excretion from a spot urine sample , but these methods have not been vali date d in the general Chinese population . This aim of this study was to assess the validity of three methods for estimating 24-h urinary sodium excretion using spot urine sample s against measured 24-h urinary sodium excretion in a Chinese sample population . Data are from a sub study of the Prospect i ve Urban Rural Epidemiology ( PURE ) study that enrolled 120 participants aged 35 to 70 years and collected their morning fasting urine and 24-h urine specimens . Bias calculations ( estimated values minus measured values ) and Bl and -Altman plots were used to assess the validity of the three estimation methods . 116 participants were included in the final analysis . Mean bias for the Kawasaki method was -740 mg/day ( 95 % CI : -1219 , 262 mg/day ) , and was the lowest among the three methods . Mean bias for the Tanaka method was -2305 mg/day ( 95 % CI : -2735 , 1875 mg/day ) . Mean bias for the INTERSALT method was -2797 mg/day ( 95 % CI : -3245 , 2349 mg/day ) , and was the highest of the three methods . Bl and -Altman plots indicated that all three methods underestimated 24-h urinary sodium excretion . The Kawasaki , INTERSALT and Tanaka methods for estimation of 24-h urinary sodium excretion using spot urines all underestimated true 24-h urinary sodium excretion in this sample of Chinese adults . Among the three methods , the Kawasaki method was least biased , but was still relatively inaccurate . A more accurate method is needed to estimate the 24-h urinary sodium excretion from spot urine for assessment of dietary sodium intake in China",
"Objectives To determine the relationship between the reduction in salt intake that occurred in Engl and , and blood pressure ( BP ) , as well as mortality from stroke and ischaemic heart disease ( IHD ) . Design Analysis of the data from the Health Survey for Engl and . Setting and participants Engl and , 2003 N=9183 , 2006 N=8762 , 2008 N=8974 and 2011 N=4753 , aged ≥16 years . Outcomes BP , stroke and IHD mortality . Results From 2003 to 2011 , there was a decrease in mortality from stroke by 42 % ( p fall in BP of 3.0±0.33/1.4±0.20 mm Hg ( p mmol/L ( p , a reduction in smoking prevalence from 19 % to 14 % ( p increase in fruit and vegetable consumption ( 0.2±0.05 portion/day , p increase in body mass index ( BMI ; 0.5±0.09 kg/m2 , p , decreased by 1.4 g/day ( p treatments of BP , cholesterol and cardiovascular disease , contributed to the falls in stroke and IHD mortality . In individuals who were not on antihypertensive medication , there was a fall in BP of 2.7±0.34/1.1±0.23 mm Hg ( p Although salt intake was not measured in these participants , the fact that the average salt intake in a r and om sample of the population fell by 15 % during the same period suggests that the falls in BP would be largely attributable to the reduction in salt intake rather than antihypertensive medications . Conclusions The reduction in salt intake is likely to be an important contributor to the falls in BP from 2003 to 2011 in Engl and . As a result , it would have contributed substantially to the decreases in stroke and IHD mortality",
"BACKGROUND The effect of dietary composition on blood pressure is a subject of public health importance . We studied the effect of different levels of dietary sodium , in conjunction with the Dietary Approaches to Stop Hypertension ( DASH ) diet , which is rich in vegetables , fruits , and low-fat dairy products , in persons with and in those without hypertension . METHODS A total of 412 participants were r and omly assigned to eat either a control diet typical of intake in the United States or the DASH diet . Within the assigned diet , participants ate foods with high , intermediate , and low levels of sodium for 30 consecutive days each , in r and om order . RESULTS Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg ( P reductions of 4.6 mm Hg during the control diet ( P participants with and in those without hypertension , blacks and those of other races , and women and men . The DASH diet was associated with a significantly lower systolic blood pressure at each sodium level ; and the difference was greater with high sodium levels than with low ones . As compared with the control diet with a high sodium level , the DASH diet with a low sodium level led to a mean systolic blood pressure that was 7.1 mm Hg lower in participants without hypertension , and 11.5 mm Hg lower in participants with hypertension . CONCLUSIONS The reduction of sodium intake to levels below the current recommendation of 100 mmol per day and the DASH diet both lower blood pressure substantially , with greater effects in combination than singly . Long-term health benefits will depend on the ability of people to make long-lasting dietary changes and the increased availability of lower-sodium foods",
"CONTEXT Dietary sodium is positively associated with blood pressure , and ecological and animal studies both have suggested that high dietary sodium intake increases stroke mortality . OBJECTIVE To examine the risk of cardiovascular disease associated with dietary sodium intake in overweight and nonoverweight persons . DESIGN Prospect i ve cohort study . SETTING The first National Health and Nutrition Examination Survey Epidemiologic Follow-up Study , conducted in 1982 - 1984 , 1986 , 1987 , and 1992 . PARTICIPANTS Of those aged 25 to 74 years when the survey was conducted in 1971 -1975 ( 14407 participants ) , a total of 2688 overweight and 6797 nonoverweight persons were included in the analysis . MAIN OUTCOME MEASURES Dietary sodium and energy intake were estimated at baseline using a single 24-hour dietary recall method . Incidence and mortality data for cardiovascular disease were obtained from medical records and death certificates . RESULTS For overweight and nonoverweight persons , over an average of 19 years of follow-up , the total number of documented cases were as follows : 680 stroke events ( 210 fatal ) , 1727 coronary heart disease events ( 614 fatal ) , 895 cardiovascular disease deaths , and 2486 deaths from all causes . Among overweight persons with an average energy intake of 7452 kJ , a 100 mmol higher sodium intake was associated with a 32 % increase ( relative risk [ RR ] , 1.32 ; 95 % confidence interval [ CI ] , 1.07 - 1.64 ; P = .01 ) in stroke incidence , 89 % increase ( RR , 1.89 ; 95 % CI , 1.31 - 2.74 ; P stroke mortality , 44 % increase ( RR , 1.44 ; 95 % CI , 1.14 - 1.81 ; P = .002 ) in coronary heart disease mortality , 61 % increase ( RR , 1.61 ; 95 % CI , 1.32 - 1.96 ; P cardiovascular disease mortality , and 39 % increase ( RR , 1.39 ; 95 % CI , 1.23 - 1.58 ; P mortality from all causes . Dietary sodium intake was not significantly associated with cardiovascular disease risk in nonoverweight persons . CONCLUSIONS Our analysis indicates that high sodium intake is strongly and independently associated with an increased risk of cardiovascular disease and all-cause mortality in overweight persons",
"OBJECTIVE To provide a firmer basis for preventing high blood pressure ( BP ) , we tested interventions to promote weight loss , dietary sodium reduction , and their combination for lowering diastolic BP , systolic BP , and the incidence of hypertension during a 3- to 4-year period . METHODS We conducted a r and omized , 2 x 2 factorial , clinical trial , with BP levels measured by blinded observers . Nine academic medical centers recruited 2382 men and women ( age range , 30 - 54 years ) not taking antihypertensive drugs , with a diastolic BP of 83 to 89 mm Hg , a systolic BP lower than 140 mm Hg , and a body mass index ( the weight in kilograms divided by the square of the height in meters ) representing 110 % to 165 % of desirable body weight . Counseling aim ed at helping participants achieve their desirable weight or a 4.5-kg or more weight reduction ( in the weight loss and combined groups ) and /or sodium intake of 80 mmol/d ( in the sodium reduction and combined groups ) was provided . RESULTS From baseline , participants ' weight decreased by 4.3 to 4.5 kg at 6 months and by approximately 2 kg at 36 months in the weight loss and combined groups compared with weight changes in the usual care group ( all groups , P Sodium excretion decreased 50 and 40 mmol/d at 6 and 36 months , respectively , in the sodium reduction group and about 15 mmol/d less at each time point in the combined group compared with the usual care group ( all groups , P care group , BP decreased 3.7/2.7 mm Hg in the weight loss group , 2.9/1.6 mm Hg in the sodium reduction group , and 4.0/2.8 mm Hg in the combined group at 6 months ( all groups , P BP decreases remained greater in the active intervention groups than in the usual care group ( weight loss group , 1.3/0.9 mm Hg ; sodium reduction group , 1.2/0.7 mm Hg ; combined group , 1.1/0.6 mm Hg ) . Differences were statistically significant for systolic and diastolic BP in the weight loss group and for systolic BP in the sodium reduction group . Through 48 months , the incidence of hypertension ( BP > or = 140 mm Hg systolic or > or = 90 mm Hg diastolic or the use of antihypertensive drugs ) was significantly less in each active intervention group than the usual care group ( average relative risks , 0.78 - 0.82 ) . CONCLUSIONS In overweight adults with high-normal BP , weight loss and reduction in sodium intake , individually and in combination , were effective in lowering systolic and diastolic BP , especially in the short-term ( 6 months ) . Although the effects on average BP declined over time , reductions in hypertension incidence were achieved",
"Extensive research supports the harmful effects of high dietary sodium.[1 - 11 ] In several animal species , including chimpanzees , diets with added sodium result in increased blood pressure ( BP ) , and , in all setting s , sodium-induced hypertension is harmful.[12 ] Further , in several animal models , increased dietary sodium directly causes inflammation and vascular , cardiac , and renal target organ damage independent of BP.[1 , 13 ] Increased dietary sodium is a procarcinogen for gastric cancer in animal studies and a probable procarcinogen in humans , as shown in epidemiological studies that have found close associations between sodium intake and gastric cancer.[14 , 15 ] Reducing dietary sodium decreases BP in adults and children,[1 ] with a linear relationship down to the lowest levels of sodium intake tested in r and omized controlled trials ( about 1200 mg/d of sodium ) . Increased dietary sodium is also associated with increased vascular events in healthy population s and was estimated to cause more than 3 million sodium-related deaths in 2010 ( http://viz.healthmetrics and evaluation.org/gbd-compare/ ) . Reducing dietary sodium is projected to be one of the most effective ( and cost-effective ) interventions to improve health.[16 ] Major health and scientific organizations around the world have recommended that dietary sodium levels be reduced",
"Across population s , the level of blood pressure , the incremental rise in blood pressure with age , and the prevalence of hypertension are directly related to sodium intake . Observational studies and r and omized controlled trials document a consistent effect of sodium consumption on blood pressure . The majority of sodium consumption in the United States is derived from amounts added during food processing and preparation . Leading scientific organizations and governmental agencies advise limiting sodium intake to 2400 mg or less daily ( approximately 6000 mg of salt ) . Substantial public health benefits accrue from small reductions in the population blood pressure distribution . A 1.3-g/d lower lifetime sodium intake translates into an approximately 5-mm Hg smaller rise in systolic blood pressure as individuals advance from 25 to 55 years of age , a reduction estimated to save 150,000 lives annually . With an appropriate food industry response , combined with consumer education and knowledgeable use of food labels , the average consumer should be able to choose a lower-sodium diet without inconvenience or loss of food enjoyment . In the continued absence of voluntary measures adopted by the food industry , new regulations will be required to achieve lower sodium concentrations in processed and prepared foods",
"BACKGROUND The evidence that high salt intake increases the risk of cardiovascular disease has been challenged . We aim ed to find out whether salt intake , measured by 24 h urinary sodium excretion , is an independent risk factor for cardiovascular disease frequency and mortality , and all-cause mortality . METHODS We prospect ively followed 1173 Finnish men and 1263 women aged 25 - 64 years with complete data on 24 h urinary sodium excretion and cardiovascular risk factors . The endpoints were an incident coronary and stroke event , and death from coronary heart disease , cardiovascular disease , and any cause . Each endpoint was analysed separately with the Cox proportional hazards model . FINDINGS The hazards ratios for coronary heart disease , cardiovascular disease , and all-cause mortality , associated with a 100 mmol increase in 24 h urinary sodium excretion , were 1.51 ( 95 % CI 1.14 - 2.00 ) , 1.45 ( 1.14 - 1.84 ) , and 1.26 ( 1.06 - 1.50 ) , respectively , in both men and women . The frequency of acute coronary events , but not acute stroke events , rose significantly with increasing sodium excretion . When analyses were done separately for each sex , the risk ratios were significant in men only . There was a significant interaction between sodium excretion and body mass index for cardiovascular and total mortality ; sodium predicted mortality in men who were overweight . Correction for the regression dilution bias increased the hazards ratios markedly . INTERPRETATION High sodium intake predicted mortality and risk of coronary heart disease , independent of other cardiovascular risk factors , including blood pressure . These results provide direct evidence of the harmful effects of high salt intake in the adult population",
"BACKGROUND The relationship between lower sodium intake and total mortality remains controversial . OBJECTIVES This study examined the relationship between well-characterized measures of sodium intake estimated from urinary sodium excretion and long-term mortality . METHODS Two trials , phase I ( 1987 to 1990 ) , over 18 months , and phase II ( 1990 to 1995 ) , over 36 months , were undertaken in TOHP ( Trials of Hypertension Prevention ) , which implemented sodium reduction interventions . The studies included multiple 24-h urine sample s collected from pre-hypertensive adults 30 to 54 years of age during the trials . Post-trial deaths were ascertained over a median 24 years , using the National Death Index . The associations between mortality and the r and omized interventions as well as with average sodium intake were examined . RESULTS Among 744 phase I and 2,382 phase II participants r and omized to sodium reduction or control , 251 deaths occurred , representing a nonsignificant 15 % lower risk in the active intervention ( hazard ratio [ HR ] : 0.85 ; 95 % confidence interval [ CI ] : 0.66 to 1.09 ; p = 0.19 ) . Among 2,974 participants not assigned to an active sodium intervention , 272 deaths occurred . There was a direct linear association between average sodium intake and mortality , with an HR of 0.75 , 0.95 , and 1.00 ( references ) and 1.07 ( p trend = 0.30 ) for The HR per unit increase in sodium/potassium ratio was 1.13 ( 95 % CI : 1.01 to 1.27 ; p = 0.04 ) . CONCLUSIONS We found an increased risk of mortality for high-sodium intake and a direct relationship with total mortality , even at the lowest levels of sodium intake . These results are consistent with a benefit of reduced sodium and sodium/potassium intake on total mortality over a 20-year period"
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Background There is a large quality of care gap for patients with osteoporosis . As a fragility fracture is a strong indicator of underlying osteoporosis , it offers an ideal opportunity to initiate investigation and treatment . However , studies of post-fracture population s document screening and treatment rates below 20 % in most setting s. This is despite the fact that bone mineral density ( BMD ) scans are effective at identifying patients at high risk of fracture , and effective drug treatments are widely available . Effective interventions are required to remedy this incongruity in current practice . Methods This study review ed r and omised controlled trials ( RCT ) involving fully qualified healthcare professionals caring for patients with a fragility fracture in all healthcare setting s. Any intervention design ed to modify the behaviour of healthcare professionals or implement a service delivery change was considered . The main outcomes were BMD scanning and osteoporosis treatment with anti-resorptive therapy . The electronic data bases Medline and Embase were search ed from 1994 to June 2010 to identify relevant articles in English . Post-intervention risk differences ( RDs ) were calculated for the main outcomes and any additional study primary outcomes ; the trials were meta-analysed . Results A total of 2814 potentially relevant articles were sifted ; 18 were assessed in full text . Nine RCTs evaluating ten interventions met the inclusion criteria for the review . All were from North America . Four studies focused on patients with a hip fracture , three on fractures of the wrist/distal forearm , and two included several fracture sites consistent with a fragility fracture . All studies reported positive effects of the intervention for the main study outcomes of BMD scanning and osteoporosis treatment . For BMD scanning the overall risk ratio ( 95 % CI ) was 2.8 ( 2.16 to 3.64 ) ; the RD was 36 % ( 21 % to 50 % ) . For treatment with anti-resorptive therapy the overall risk ratio ( 95 % CI ) was 2.48 ( 1.92 to 3.2 ) ; the RD was 20 % ( 10 % to 30 % ) . Conclusions All interventions produced positive effects on BMD scanning and osteoporosis treatment rates post-fracture . Despite sizeable increases , investigation and treatment rates remain sub-optimal . Long-term compliance with osteoporosis medications needs to be addressed , as the majority of studies reported treatment rates at six-month follow up only . Studies would be more informative if treatment criteria were defined a priori to facilitate underst and ing of whether patients were being treated appropriately and integrated economic analyses would be helpful for informing policy implementation decisions
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"Appendicular bone mass is inversely related to the risk of hip fracture in short-term prospect i ve studies , but hip fractures typically occur about 30 years after menopause . We developed a model that estimates a woman 's lifetime risk of hip fracture based on measurement of radial bone mass at age 50 using short-term prospect i ve data relating bone mass to hip fracture , the correlation between bone mass at age 50 and later years , the age-specific incidence of hip fracture and mortality , and prospect i ve data about bone mass and mortality . We estimate that a 50-year-old white woman has a 19 % lifetime risk of hip fracture if her radial bone mass is at the 10th percentile for her age and an 11 % lifetime risk if her bone mass is at the 90th percentile . Improved measurement techniques that have a higher predictive value for hip fracture in short-term studies could substantially increase this gradient of lifetime risk and therefore be more clinical ly useful",
"The objectives of this study were to determine information needs of family physicians around issues in the management of osteoporosis and preferences for dissemination of this information . A mailed survey was sent to a stratified r and om sample of 1000 family physicians in Ontario in May 2001 . Female physicians and those practicing in rural communities were over- sample d from the College of Family Physicians ' data base . Among the 505 respondents , 364 were still practicing ( 182 males and 182 females ) and completed the full question naire . There were no statistically significant differences in responses by sex or region of practice . Over 80 % of family physicians wanted to be more informed about bone density testing and the pharmacological and non-pharmacological management of osteoporosis . The presence of risk factors was one of the most influential factors ( 72 % ) for ordering bone density testing . Information in peer- review ed journals was thought to be the most credible , with 80 % rating the CMAJ as very credible compared to 47 % for the Osteoporosis Society of Canada ( OSC ) . Sixty-two percent found the OSC guidelines ( 1996 ) to be useful even though much of that information is now out of date . Almost 70 % had not read the more recently published treatment guidelines from the Ontario Program for Optimal Therapeutics ( 2000 ) . Over 80 % were interested in a decision aid , which incorporates information on risk factors , fracture risk and a treatment algorithm . The perceived need and the lack of availability of clinical ly useful information on osteoporosis for the family practice setting highlights the failure of the current guideline implementation process and provides insight into where the process has to be improved",
"BACKGROUND Although osteoporosis is strongly associated with hip fractures , the initiation of osteoporosis treatment following hip fractures occurs at surprisingly low rates of between 5 % and 30 % . Currently , most patients receiving treatment have been referred back to their primary care physician for osteoporosis management . The purpose of this study was to compare the effect of osteoporosis management initiated by the orthopaedic team and osteoporosis management initiated by the primary care physician on the rates of treatment at six months . METHODS A prospect i ve r and omized trial was conducted to assess the difference in the rate of osteoporosis treatment when an in-house assessment of osteoporosis was initiated by the orthopaedic surgeon and follow-up was conducted in a specialized orthopaedic osteoporosis clinic compared with osteoporosis education and \" usual \" care . RESULTS Sixty-two patients were enrolled in the study . Thirty-one patients each were in the control and intervention groups . The percentage of patients who were on pharmacologic treatment for osteoporosis at six months after the fracture was significantly greater when the evaluation was initiated by the orthopaedic surgeon and was managed in a specialized orthopaedic osteoporosis clinic ( 58 % ) than when treatment was managed by a primary care physician ( 29 % ) ( p = 0.04 ) . CONCLUSIONS An active role by orthopaedic surgeons in the management of osteoporosis improves the rate of treatment at six months following a hip fracture",
"BACKGROUND In a r and omized trial of patients with hip fractures , we previously demonstrated that a hospital-based case manager could increase rates of appropriate osteoporosis treatment to 51 % compared with 22 % for usual care ( P Patients with hip fractures were r and omized to usual care ( n = 110 ) or a case manager ( n = 110 ) and followed up for 1 year . Time-motion studies were used to determine intervention costs . From a third-party health care payer perspective and over the patient 's remaining lifetime , a Markov decision-analytic model was constructed to determine cost-effectiveness of the intervention compared with usual care . Costs and benefits were discounted at 3 % and expressed in 2006 Canadian dollars . RESULTS The intervention cost CaD $ 56 per patient . Compared with usual care , the intervention strategy was dominant : for every 100 patients case managed , 6 fractures ( 4 hip fractures ) were prevented , 4 quality -adjusted life-years were gained , and CaD $ 260 000 was saved by the health care system . Irrespective of the number of patients case managed , the intervention reached a break-even threshold within 2 years . The intervention dominated usual care over the entire spectrum of 1-way sensitivity analyses and was cost-saving in 82 % of probabilistic model simulations . CONCLUSIONS Compared with usual care , we found that using a case manager for patients with hip fractures increased rates of appropriate osteoporosis treatment . The intervention dominated usual care , and the analysis suggests that systems implementing an intervention similar to ours should expect to see a reduction in fractures , gains in life expectancy , and substantial cost savings . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00175175",
"Background Despite accurate diagnostic tests and effective therapies , the management of osteoporosis has been observed to be suboptimal in many setting s. We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis . Design R and omized controlled trial . Participants Primary care physicians and their patients at-risk of osteoporosis , including women 65 years and over , men and women 45 and over with a prior fracture , and men and women 45 and over who recently used ≥90 days of oral glucocorticoids . InterventionA multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients . Outcome : Either undergoing a bone mineral density ( BMD ) testing or filling a prescription for a bone-active medication during the 10 months of follow-up . Results After the intervention , 144 ( 14 % ) patients in the intervention group and 97 ( 10 % ) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication . This represents a 4 % absolute increase and a 45 % relative increase ( 95 % confidence interval 9–93 % , p = 0.01 ) in osteoporosis management between the intervention and control groups . No differences between groups were observed in the incidence of fracture . Conclusion An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and /or filling prescriptions for osteoporosis medications . However , the absolute percentage of at-risk patients receiving osteoporosis management remained low",
"BACKGROUND Despite its association with disability , death , and increased medical costs , osteoporosis in men has been relatively neglected as a subject of study . There have been no large , controlled trials of treatment in men . METHODS In a two-year double-blind trial , we studied the effect of 10 mg of alendronate or placebo , given daily , on bone mineral density in 241 men ( age , 31 to 87 years ; mean , 63 ) with osteoporosis . Approximately one third had low serum free testosterone concentrations at base line ; the rest had normal concentrations . Men with other secondary causes of osteoporosis were excluded . All the men received calcium and vitamin D supplements . The main outcome measures were the percent changes in lumbar-spine , hip , and total-body bone mineral density . RESULTS The men who received alendronate had a mean ( + /-SE ) increase in bone mineral density of 7.1+/-0.3 percent at the lumbar spine , 2.5+/-0.4 percent at the femoral neck , and 2.0+/-0.2 percent for the total body ( P placebo had an increase in lumbar-spine bone mineral density of 1.8+/-0.5 percent ( P femoral-neck or total-body bone mineral density . The increase in bone mineral density in the alendronate group was greater than that in the placebo group at all measurement sites ( P incidence of vertebral fractures was lower in the alendronate group than in the placebo group ( 0.8 percent vs. 7.1 percent , P=0.02 ) . Men in the placebo group had a 2.4-mm decrease in height , as compared with a decrease of 0.6 mm in the alendronate group ( P=0.02 ) . Alendronate was generally well tolerated . CONCLUSIONS In men with osteoporosis , alendronate significantly increases spine , hip , and total-body bone mineral density and helps prevent vertebral fractures and decreases in height",
"BACKGROUND Previous studies have shown that alendronate can increase bone mineral density ( BMD ) and prevent radiographically defined ( morphometric ) vertebral fractures . The Fracture Intervention Trial aim ed to investigate the effect of alendronate on the risk of morphometric as well as clinical ly evident fractures in postmenopausal women with low bone mass . METHODS Women aged 55 - 81 with low femoral-neck BMD were enrolled in two study groups based on presence or absence of an existing vertebral fracture . Results for women with at least one vertebral fracture at baseline are reported here . 2027 women were r and omly assigned placebo ( 1005 ) or alendronate ( 1022 ) and followed up for 36 months . The dose of alendronate ( initially 5 mg daily ) was increased ( to 10 mg daily ) at 24 months , with maintenance of the double blind . Lateral spine radiography was done at baseline and at 24 and 36 months . New vertebral fractures , the primary endpoint , were defined by morphometry as a decrease of 20 % ( and at least 4 mm ) in at least one vertebral height between the baseline and latest follow-up radiograph . Non-spine clinical fractures were confirmed by radiographic reports . New symptomatic vertebral fractures were based on self-report and confirmed by radiography . FINDINGS Follow-up radiographs were obtained for 1946 women ( 98 % of surviving participants ) . 78 ( 8.0 % ) of women in the alendronate group had one or more new morphometric vertebral fractures compared with 145 ( 15.0 % ) in the placebo group ( relative risk 0.53 [ 95 % Cl 0.41 - 0.68 ] ) . For clinical ly apparent vertebral fractures , the corresponding numbers were 23 ( 2.3 % ) alendronate and 50 ( 5.0 % ) placebo ( relative hazard 0.45 [ 0.27 - 0.72 ] ) . The risk of any clinical fracture , the main secondary endpoint , was lower in the alendronate than in the placebo group ( 139 [ 13.6 % ] vs 183 [ 18.2 % ] ; relative hazard 0.72 [ 0.58 - 0.90 ] ) . The relative hazards for hip fracture and wrist fracture for alendronate versus placebo were 0.49 ( 0.23 - 0.99 ) and 0.52 ( 0.31 - 0.87 ) . There was no significant difference between the groups in numbers of adverse experiences , including upper-gastrointestinal disorders . INTERPRETATION We conclude that among women with low bone mass and existing vertebral fractures , alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures , as well as other clinical fractures",
"UNLABELLED We conducted a r and omized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries . Primary care physicians and their patients were r and omized to usual care , patient intervention only , physician intervention only , or both interventions . There was no difference in the probability of the primary composite endpoint ( BMD test or osteoporosis medication ) or in either of its components comparing the combined intervention group with usual care ( risk ratio = 1.04 ; 95 % CI , 0.85 - 1.26 ) . INTRODUCTION Fractures from osteoporosis are associated with substantial morbidity , mortality , and cost . However , only a minority of at-risk older adults receives screening and /or treatment for this condition . We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients , primary care physicians , or both . MATERIAL S AND METHODS We conducted a r and omized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries . Primary care physicians and their patients were r and omized to usual care , patient intervention only , physician intervention only , or both interventions . The at-risk patients were women > or=65 yr of age , men and women > or=65 yr of age with a prior fracture , and men and women > or=65 yr of age who used oral glucocorticoids . The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis . The secondary outcome was a hip , humerus , spine , or wrist fracture . RESULTS We r and omized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms . Physician and patient characteristics were very similar across all four groups . Across all four groups , the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups ( p = 0.5 ) . In adjusted Cox proportional hazards models , there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care ( risk ratio = 1.04 ; 95 % CI , 0.85 - 1.26 ) . There was also no difference in either of the components of the composite endpoint . The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment ( p = 0.9 ) . CONCLUSIONS In this trial , a relatively brief program of patient and /or physician education did not work to improve the management of osteoporosis . More intensive efforts should be considered for future quality improvement programs for osteoporosis",
"Progressive bone loss in osteoporosis results from bone resorption in excess of bone formation . We conducted a double-blind study in 66 women with postmenopausal osteoporosis of therapy with etidronate , a diphosphonate compound that reduces bone resorption by inhibiting osteoclastic activity . The patients were r and omly assigned in equal numbers to receive oral etidronate ( 400 mg per day ) or placebo for 2 weeks , followed by a 13-week period in which no drugs were given . This sequence was repeated 10 times , for a total of 150 weeks . Daily oral supplementation with calcium and vitamin D was given throughout the study to both groups . Vertebral bone mineral content was measured by dual-photon absorptiometry ; spinal radiographs were assessed to identify new vertebral fractures . Vertebral bone mineral content increased significantly ( P less than 0.01 ) after 150 weeks of etidronate therapy ( 5.3 percent ; 95 percent confidence interval , 2.0 to 8.6 ; n = 20 ) but decreased with placebo ( -2.7 percent ; 95 percent confidence interval , -7.3 to 1.9 ; n = 20 ) . The difference between groups was 8.0 percentage points ( P less than 0.01 ; 95 percent confidence interval , 2.4 to 13.6 ) . The rates of fracture were significantly different for the period from week 60 to week 150 between the etidronate and placebo groups ( 6 vs. 54 fractures per 100 patient-years ; P = 0.023 ) . No adverse clinical , biochemical , or bone histomorphometric effects of treatment were observed . We conclude that at the end of nearly three years , etidronate therapy for postmenopausal osteoporosis results in significant increases in vertebral bone mineral content and , after approximately one year of treatment , a significant decrease in the rate of new vertebral fractures",
"CONTEXT Risedronate , a potent bisphosphonate , has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases but , to our knowledge , it has not been evaluated in the treatment of established postmenopausal osteoporosis . OBJECTIVE To test the efficacy and safety of daily treatment with risedronate to reduce the risk of vertebral and other fractures in postmenopausal women with established osteoporosis . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 2458 ambulatory postmenopausal women younger than 85 years with at least 1 vertebral fracture at baseline who were enrolled at 1 of 110 centers in North America conducted between December 1993 and January 1998 . INTERVENTIONS Subjects were r and omly assigned to receive oral treatment for 3 years with risedronate ( 2.5 or 5 mg/d ) or placebo . All subjects received calcium , 1000 mg/d . Vitamin D ( cholecalciferol , up to 500 IU/d ) was provided if baseline levels of 25-hydroxyvitamin D were low . MAIN OUTCOME MEASURES Incidence of new vertebral fractures as detected by quantitative and semiquantitative assessment s of radiographs ; incidence of radiographically confirmed nonvertebral fractures and change from baseline in bone mineral density as determined by dual x-ray absorptiometry . RESULTS The 2.5 mg/d of risedronate arm was discontinued after 1 year ; in the placebo and 5 mg/d of risedronate arms , 450 and 489 subjects , respectively , completed all 3 years of the trial . Treatment with 5 mg/d of risedronate , compared with placebo , decreased the cumulative incidence of new vertebral fractures by 41 % ( 95 % confidence interval [ CI ] , 18%-58 % ) over 3 years ( 11.3 % vs 16.3 % ; P= .003 ) . A fracture reduction of 65 % ( 95 % CI , 38%-81 % ) was observed after the first year ( 2.4 % vs 6.4 % ; P cumulative incidence of nonvertebral fractures over 3 years was reduced by 39 % ( 95 % CI , 6%-61 % ) ( 5.2 % vs 8.4 % ; P = .02 ) . Bone mineral density increased significantly compared with placebo at the lumbar spine ( 5.4 % vs 1.1 % ) , femoral neck ( 1.6 % vs -1.2 % ) , femoral trochanter ( 3.3 % vs -0.7 % ) , and midshaft of the radius ( 0.2 % vs -1.4 % ) . Bone formed during risedronate treatment was histologically normal . The overall safety profile of risedronate , including gastrointestinal safety , was similar to that of placebo . CONCLUSIONS These data suggest that risedronate therapy is effective and well tolerated in the treatment of women with established postmenopausal osteoporosis",
"Introduction Osteoporosis represents a growing public health concern ; however , current rates of management are sub-optimal . The aim of our study was to assess , in a r and omized controlled trial , the effect of a mailed educational intervention on older adults ’ knowledge , attitudes , and preventive behaviors regarding osteoporosis . The setting was a large publicly funded state pharmacy benefits program . The patients were 31,715 Medicare beneficiaries from Pennsylvania who participated in a drug benefits program for low-to-moderate income elderly people . Methods All women aged over 65 years , and all men and women with a history of fracture or long-term oral use of glucocorticoid , were included . Approximately half of the participants ( intervention group ) were r and omly selected to receive three mailings aim ed at improving knowledge of osteoporosis and enhancing preventive activities , such as using calcium and vitamin D , reducing fall risks in the home , obtaining a bone mineral density ( BMD ) test , and taking medications when necessary . The other participants did not receive the intervention mailings and served as controls . We surveyed a sample of intervention and control subjects to determine the effects of the intervention on knowledge , attitudes , self-efficacy ( confidence in one ’s ability to perform specific activities ) , and behavior regarding osteoporosis prevention and treatment . Six hundred r and omly selected participants in the intervention group and an equal number in the control group were invited to participate . Results Twenty-six had died and 636 of the remaining 1,185 ( 54 % ) completed the survey . Respondents and non-respondents did not differ significantly with respect to measured sociodemographic factors . All scales had good reliability ( all Cronbach ’s alphas > 0.65 ) . Knowledge of osteoporosis was generally very good and did not differ between intervention ( mean = 65 % correct responses ) and control subjects ( mean = 67 % correct ; P=0.4 ) . Perceived susceptibility to osteoporosis was relatively high and similar across groups ( P=0.4 ) . Self-efficacy for participating in osteoporosis prevention and treatment was very strong in both the intervention ( mean = 4.3 on a 0–5 scale ) and control ( mean = 4.2 , P=0.03 ) groups . On average , subjects in the intervention group reported participating in 3.5 of 6 preventive osteoporosis activities compared with 3.4 in the control group ( P=0.5 ) . Conclusions Compared with the controls , a mailed educational intervention for osteoporosis was not associated with better knowledge , higher perceived susceptibility , or performance of preventive measures among the at-risk older adults that we studied . The intervention group demonstrated a small increase in self-efficacy . More intensive patient interventions or intervention aim ed at other aspects of the care process may be required to bring about changes that lead to a reduction in fractures",
"BACKGROUND Interventions to improve the fracture prevention in nursing homes are needed . METHODS Cluster-r and omized , single-blind , controlled trial of a multi-modal quality improvement intervention . Nursing homes ( n=67 ) with > or = 10 residents with a diagnosis of osteoporosis or recent hip fracture ( n=606 ) were r and omized to receive an early or delayed intervention consisting of audit and feedback , educational modules , teleconferences , and academic detailing . Medical record abstract ion and the Minimum Data Set were used to measure the prescription of osteoporosis therapies before and after the intervention period . Analysis was at the facility-level and Generalized Estimating Equation modeling was used to account for clustering . RESULTS No significant improvements were observed in any of the quality indicators . The use of osteoporosis pharmacotherapy or hip protectors improved by 8.0 % in the intervention group and 0.6 % in the control group , but the difference was not statistically significant ( P=.72 ) . Participation in the intervention activities was low , but completion of the educational module ( odds ratio [ OR ] 4.8 , 95 % confidence interval [ CI ] , 1.9 - 12.0 ) and direct physician contact by an academic detailer ( OR 4.5 , 95 % CI , 1.1 - 18.2 ) were significantly associated with prescription of osteoporosis pharmacotherapy or hip protectors in multivariable models . CONCLUSIONS Audit-feedback and education interventions were ineffective in improving fracture prevention in the nursing home setting , although results may have been tempered by low participation in the intervention activities",
"Case- selection strategies have been advocated for identifying patients who would benefit from primary care to prevent osteoporosis . However , the effectiveness of this approach is unclear . To address this question , we performed a r and omized control trial to determine whether a case- selection strategy to identify patients with clinical risk factors for osteoporosis , combined with open access to dual X-ray absorptometry ( DXA ) scans , influences bisphosphonate prescribing in ten GP practice s in Avon . Practice s were r and omized to two groups : the first identified women aged 45–75 years at high risk of osteoporosis and provided open access to DXA scans for 12 months ; the second had no case-finding strategy and no DXA scan access . Bisphosphonate prescribing was ascertained by search ing computerized patient records every 3 months during the intervention and a subsequent 6-month follow-up period . Overall , the number of subjects in each practice who were prescribed bisphosphonates increased by 50 % ( p proportion of bisphosphonates prescribed as aminobisphosphonates increased 3-fold ( p magnitude of these changes was similar in both groups . However , of the patients prescribed bisphosphonates , approximately twice as many in group 1 , as compared with group 2 , had a previously documented low-trauma fracture , as assessed at the end of the 12-month intervention period ( p=0.01 ) . Furthermore , at study ’s end , of the 30 patients in group 1 receiving bisphosphonates who had received DXA scans , 80 % had osteoporosis as defined by t-score bisphosphonate therapy to those at high risk of osteoporotic fractures . In contrast , the overall rate of bisphosphonate prescribing is unaffected by this intervention",
"UNLABELLED The level of recognition and treatment of osteoporosis is not well characterized in primary care . In data from a large sample of postmenopausal women attending 927 primary care physicians , 29 % of women reported one or more fractures after menopause . The great majority ( 72 % ) were not on any osteoporosis-specific therapy . INTRODUCTION Osteoporosis is often first recognized at the time of a low-trauma fracture . However , by this stage , the risk of subsequent fractures has already risen substantially . Moreover , in many countries , only a small proportion of women , who have already sustained fractures , receive a treatment shown to reduce this increased risk of further fractures . MATERIAL S AND METHODS This project was initiated to examine the prevalence of osteoporotic fractures , risk factors for osteoporosis , and use of antifracture therapy among postmenopausal Australian women . More than 88,000 women from 927 primary care physicians returned over 69,358 surveys . Of these , 57,088 reported the presence of a postmenopausal fracture or risk factors . RESULTS Among these r and omly selected postmenopausal women , 29 % reported having had one or more low-trauma fractures after menopause ( 44 % substantiated in current records ) . One-third of these women reported multiple fractures . The prevalence of all types of fractures , except rib and ankle , increased with age and low body weight . Those who reported fractures were also more likely to report early menopause , corticosteroid use , and a family history of osteoporosis . Moreover , those with vertebral fractures were more likely to record height loss , kyphosis , and back pain . Physical inactivity , low calcium intake , and smoking had no consistent relationship with any fracture outcome . Of the women who reported a fracture after menopause , only 28 % were on any specific therapy for osteoporosis , and 7 % were on calcium alone . Of those who had been told they had osteoporosis by a doctor , 40 % were receiving specific osteoporosis therapy . CONCLUSIONS In this large study of postmenopausal Australian women attending primary care physicians , 29 % reported at least one low-trauma fracture after menopause . Less than one-third of these women were on specific treatment for osteoporosis , and only 40 % were ever told they had osteoporosis . Therefore , osteoporotic fractures are common in postmenopausal Australian women , and few , despite their substantially increased risk of further fractures , are on any specific anti-osteoporotic therapy . These data support the need for more effective education for the community and medical practitioners of the clinical significance of osteoporotic fractures and alternatives for treatment",
"BACKGROUND Fragility fractures are associated with a significant increase in the risk of future fracture , but the rates of evaluation to identify osteoporosis after such injuries are low . The purpose of this study was to determine the rates of evaluation and treatment of osteoporosis following distal radial fractures and to test two interventions in the outpatient clinic to improve evaluation and treatment rates . METHODS In the first part of the study , the medical records of 298 consecutive patients treated for a fragility fracture of the distal part of the radius were review ed . Primary outcome measures were a bone mineral density examination and treatment with osteoporosis medication within six months after the fracture . In the second part of the study , fifty patients with a fragility fracture of the distal part of the radius were prospect ively r and omized to receive one of two interventions . These consisted of ( 1 ) the orthopaedic surgeon ordering a bone mineral density examination and forwarding the results to the primary care physician or ( 2 ) the orthopaedic surgeon sending a letter to the primary care physician outlining guidelines for osteoporosis screening . Patients were contacted at six months after the fracture to determine the rates of evaluation and treatment for osteoporosis . RESULTS The first part of the study revealed that , following a distal radial fracture , 21.3 % of 240 patients had a bone mineral density examination and 78.7 % were never screened . Osteopenia was the most common diagnosis among those screened ( 57 % ) . Most ( 72.5 % ) of the 240 patients received no medication , whereas 6.7 % received calcium and vitamin D ; 11.3 % , bisphosphonates ; 2.5 % , hormone replacement therapy ; and 7.1 % , a combination regimen . The treatment rate for the patients who had undergone a bone mineral density examination was 2.5-fold higher than the rate for those who had not had bone mineral density testing ( 53 % compared with 21 % , p bone mineral density testing ( 93 % compared with 30 % , p discussion of osteoporosis with their primary care physician ( 89 % compared with 35 % , p initiation of osteoporosis therapy ( 74 % compared with 26 % , p Rates of evaluation and treatment for osteoporosis after fragility fractures remain low ( 21.3 % and 27.5 % , respectively ) . Patients who undergo a bone mineral density examination are more likely to receive treatment . Ordering a bone mineral density examination in the orthopaedic clinic can dramatically improve osteoporosis evaluation and treatment rates following fragility fractures of the distal part of the radius",
"Although osteoporosis is common in older adults , it is often under-diagnosed and under-treated . We developed community-based patient- and physician-directed interventions for fracture prevention and compared them in a 2 x 2 factorial r and omized controlled trial . The study population included older adults who were enrolled in a state-run pharmacy benefits program ( The Pharmaceutical Assistance Contract for the Elderly in Pennsylvania ) for Medicare beneficiaries . We r and omly assigned 826 primary care physicians and their 31,715 patients to one of four trial arms -- no patient and no physician intervention , patient but no physician intervention , physician but no patient intervention , both patient and physician interventions . The patient intervention consisted of targeted communication about fall and fracture prevention and osteoporosis diagnosis and treatment . It was delivered through several mailings . The physician intervention entailed one-on-one academic detailing encounters covering the same topics . The composite primary endpoint consisted of use of osteoporosis medication or a bone mineral density test . Other endpoints included patient 's knowledge and attitudes towards fractures and osteoporosis , use of lower extremity strengthening to prevent falls , and the occurrence of fractures . All outcomes will be analyzed using r and om effects models accounting for clustering of subjects within physicians ' practice",
"Abstract : This r and omized , double-masked , placebo-controlled trial evaluated the safety , tolerability and effects on bone mineral density ( BMD ) of alendronate in a large , multinational population of postmenopausal women with low bone mass . At 153 centers in 34 countries , 1908 otherwise healthy , postmenopausal women with lumbar spine BMD 2 st and ard deviations or more below the premenopausal adult mean were r and omly assigned to receive oral alendronate 10 mg ( n = 950 ) or placebo ( n = 958 ) once daily for 1 year . All patients received 500 mg elemental calcium daily . Baseline characteristics of patients in the two treatment groups were similar . At 12 months , mean increases in BMD were significantly ( p≤0.001 ) greater in the alendronate than the placebo group by 4.9 % ( 95 % confidence interval 4.6 % to 5.2 % ) at the lumbar spine , 2.4 % ( 2.0 % to 2.8 % ) at the femoral neck , 3.6 % ( 3.2 % to 4.1 % ) at the trochanter and 3.0 % ( 2.6 % to 3.4 % ) for the total hip . The incidence of nonvertebral fractures was significantly lower in the alendronate than the placebo group ( 19 vs 37 patients with fractures ) , representing a 47 % risk reduction for nonvertebral fracture for alendronate-treated patients ( 95 % confidence interval 10 % to 70 % ; p= 0.021 ) . Incidences of adverse events , including upper gastrointestinal adverse events , were similar in the two groups . Therefore , for postmenopausal women with low bone mass , alendronate is well tolerated and produces significant , progressive increases in BMD at the lumbar spine and hip in addition to significant reduction in the risk of nonvertebral fracture",
"OBJECTIVES Osteoporosis treatment rates after a fracture are low . This study evaluated methods to increase guideline -recommended osteoporosis care postfracture . DESIGN Participants were r and omly assigned to usual care or one of two interventions . Analysis of primary outcomes used electronic data and linear regression . SETTING A Pacific Northwest nonprofit health maintenance organization . PARTICIPANTS Female patients aged 50 to 89 who suffered a fracture in 1999 and had not received bone mineral density ( BMD ) measurement or medication for osteoporosis ( n=311 ) and their primary care providers ( n=159 ) . INTERVENTION Patient-specific clinical guideline advice to the primary care provider delivered by electronic medical record ( EMR ) message or electronic reminder to the provider plus an educational letter mailed to the patient . MEASUREMENTS BMD measurement and osteoporosis medication . RESULTS At 6 months , provider reminder result ed in 51.5 % of patients receiving BMD measurement or osteoporosis medication , provider reminder plus patient education result ed in 43.1 % , and usual care result ed in 5.9 % ( P Patients aged 60 to 69 were 18 % ( 95 % confidence interval=3 - 34 ) more likely to receive BMD measurement or an osteoporosis medication than those aged 80 to 89 . CONCLUSION Patient-specific postfracture advice to the provider through an EMR message significantly increased BMD measurement and osteoporosis medication . As EMRs become more widespread , this intervention could improve osteoporosis management for many postfracture patients . Future research should identify barriers to and facilitators of care for older , high-risk patients",
"Introduction Despite the high risk for subsequent fracture following an initial osteoporotic fracture , the majority of subjects with minimal trauma fractures receive no treatment for osteoporosis . The primary aim of this investigation was to determine whether an information-based intervention could change post-fracture management of osteoporosis . A secondary aim was to define participant- and doctor-related barriers to osteoporosis management . Methods Consecutive fracture patients ( n=254 ) from the outpatient fracture clinic at St Vincent ’s Hospital , Sydney were interviewed over a 15-month period ( February 2002–July 2003 ) . Fracture risk factors , prior investigation and treatment for osteoporosis were collected at baseline . Participants were initially contacted after 3 months to ascertain follow-up management . All those not investigated or treated by their primary care physician were then r and omized to either a personalized letter or the same letter plus an offer of a free bone mineral density ( BMD ) test . Participants were contacted after 9 months to record further investigations or treatment for osteoporosis . Results Less than 20 % of the participants had a primary care physician follow-up 3 months after the fracture , leaving 159 who were r and omized to a personalized letter ( n=79 ) and a personalized letter plus the offer of a free BMD test ( n=80 ) . There was a significant increase in the number of people investigated for osteoporosis in the group receiving the letter plus BMD offer [ 38 % ( letter + BMD ) vs. 7 % ( letter only ) ; p=0.001 ) . A high proportion of those tested had low BMD ( 49 % osteopenia and 17 % osteoporosis ) . However , the rates of treatment in both groups were very low ( 6 % ) . Furthermore , even among the few individuals ( 23 % ) who contacted their primary care physician , only 25 % were recommended treatment . The belief that the fracture was osteoporotic was an independent predictor of having a BMD test , a primary care physician follow-up and treatment . Other independent predictors were age over 50 years for a primary care physician follow-up , female sex for having a BMD test and having had a BMD test for treatment . Conclusion This study demonstrates that an information-based intervention led to a modest increase in the proportion of people investigated for osteoporosis ; however . there was no significant effect on treatment rates . The offer of a free BMD assessment was associated with a significantly higher rate of investigation than a personalized letter alone ( odds ratio : 8.5 ; 95 % confidence interval : 3.1–24.5 ) , but this investigation did not affect treatment rate . The low uptake of either a BMD or a visit to a primary care physician together with low rates of treatment recommendation even among people who contacted their primary care physician reflects significant participant and doctor-related barriers to osteoporosis management",
"OBJECTIVE To assess current osteoporosis treatment guidelines , studies of osteoporosis treatment , and interventions to improve osteoporosis treatment . METHODS We search ed the medical literature for articles published between January 1 , 1992 , and December 31 , 2003 , and assessed all relevant articles using a structured data abstract ion process . Because of substantial heterogeneity in study design , no attempt was made to summarize the data using meta-analytic techniques . RESULTS Seventy-six articles met criteria for inclusion . Eighteen practice guidelines were studied . Most guidelines were consistent in key treatment recommendations . Among 18 studies of treatment rates in patients who had fractures , the weighted average varied from 22 % for nonhormonal treatment to 19 % for calcium . We found slightly higher treatment rates for patients taking oral glucocorticoids or for those older than 65 years . There were no consistent correlates of which patients received treatment . Six studies that examined treatment frequencies after bone densitometry all found that patients with lower bone mineral density were more likely to receive treatment . Most of the 8 interventions design ed to improve osteoporosis treatment showed improvement in treatment rates ; however , only 3 were r and omized , and these showed the smallest effects . CONCLUSIONS Frequency of treatment of osteoporosis in at-risk population s is low . However , our assessment of the literature revealed no clear and consistent predictors of undertreatment . Few carefully controlled interventions have been reported",
"PURPOSE We conducted a 5-year , double-blind , r and omized , placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis . SUBJECTS AND METHODS A total of 1,255 postmenopausal women with established osteoporosis were r and omly assigned to receive salmon calcitonin nasal spray ( 100 , 200 , or 400 IU ) or placebo daily . All participants received elemental calcium ( 1,000 mg ) and vitamin D ( 400 IU ) daily . Vertebral fractures were assessed with lateral radiographs of the spine . The primary efficacy endpoint was the risk of new vertebral fractures in the salmon calcitonin nasal spray 200-IU group compared with the placebo group . RESULTS During 5 years , 1,108 participants had at least one follow-up radiograph . A total of 783 women completed 3 years of treatment , and 511 completed 5 years . The 200-IU dose of salmon calcitonin nasal spray significantly reduced the risk of new vertebral fractures by 33 % compared with placebo [ 200 IU : 51 of 287 , placebo : 70 of 270 , relative risk ( RR ) = 0.67 , 95 % confidence interval ( CI ) : 0.47- to 0.97 , P = 0.03 ] . In the 817 women with one to five prevalent vertebral fractures at enrollment , the risk was reduced by 36 % ( RR = 0.64 , 95 % CI : 0.43- to 0.96 , P = 0.03 ) . The reductions in vertebral fractures in the 100-IU ( RR = 0.85 , 95 % CI : 0.60- to 1.21 ) and the 400-IU ( RR = 0.84 , 95 % CI : 0.59- to 1.18 ) groups were not significantly different from placebo . Lumbar spine bone mineral density increased significantly from baseline ( 1 % to 1 . 5 % , P Bone turnover was inhibited , as shown by suppression of serum type-I collagen cross-linked telopeptide ( C-telopeptide ) by 12 % in the 200-IU group ( P placebo . CONCLUSION Salmon calcitonin nasal spray at a dose of 200 IU daily significantly reduces the risk of new vertebral fractures in postmenopausal women with osteoporosis",
"Summary In a cluster r and omized trial , we evaluated the effect of a multifaceted intervention ( directed at both patient and primary care physician ) on the rates of testing and treatment of osteoporosis in postmenopausal women within six months of their wrist fracture . Compared to usual care , women in the intervention practice s were three times more likely to receive bone mineral density testing and prescribed osteoporosis treatments . Introduction Postmenopausal women with wrist fractures are at increased risk of future fragility fractures , yet they frequently do not receive evaluation and treatment for osteoporosis . We set out to evaluate a multifaceted intervention design ed to improve management of osteoporosis in older women with recent wrist fractures . Methods Cluster r and omized trial of 270 women cared for in 119 primary care practice s. We recruited postmenopausal women with an acute wrist fracture from the emergency departments of hospitals in southeastern Ontario , Canada . Family practice s were r and omly assigned to either the intervention or usual care . The intervention consisted of a mailed reminder with a summary of treatment guidelines and letter sent to the primary care physician , in addition to an educational package and letter to the women . The primary outcome was the proportion of women prescribed osteoporosis therapy within 6 months of their fracture . Results The mean age of women was 69(10.9 ) years . The intervention increased the proportion of women started on osteoporosis medications ( 28 % vs. 10 % ) of controls , adjusted OR 3.45 , 95 % CI , 1.58–7.56 , p = 0.002 ) and the proportion who had a bone mineral density ( BMD ) test ( 53.3 % vs. 26 % ) of controls , OR 3.38 , 95 % CI , 1.83–6.26 , p testing and treatment rates . Conclusion A multifaceted intervention significantly improved rates of osteoporosis treatment and BMD testing in postmenopausal women with wrist fractures",
"OBJECTIVE We aim ed to determine whether a novel Patient Empowerment and Physician Alerting ( PEPA ) intervention would improve the proportion of seniors who were investigated and treated for osteoporosis after hip fracture . METHODS We undertook a 6-month r and omized controlled trial ( RCT ) in 48 women and men > /= 60 years old who had suffered a hip fracture and were admitted to a tertiary-care university hospital . The primary outcome measure was the proportion of participants offered one or more osteoporosis-specific ' best practice s ' measured using the Diagnosis and Management Question naire ( DMQ ) . Participant responses were vali date d in part by physician report . RESULTS In the PEPA intervention group , 19 ( 68 % ) were offered one or more components of best practice care compared with 7 ( 35 % ) in the ' usual care ' group ( p PEPA group , 15 ( 54 % ) ( p bisphosphonate therapy , 8 ( 29 % ) ( p bone mineral density scan , 11 ( 39 % ) were prescribed calcium and vitamin D ( p = .32 ) , and 9 ( 32 % ) ( p exercise . In the usual care group , 0 ( 0 % ) were prescribed bisphosphonate therapy , a bone mineral density assessment , or exercise and 6 ( 30 % ) were prescribed calcium and vitamin D. CONCLUSIONS This simple , inexpensive PEPA intervention result ed in far superior clinical management than did usual care in a population at high risk of future hip fracture",
"Context Many patients who sustain fragility fractures do not receive subsequent testing and treatment for osteoporosis . Contribution This study shows that faxed reminders to physicians , treatment guidelines endorsed by opinion leaders , and patient education about osteoporosis can increase the testing and therapy for osteoporosis among patients who present to an emergency department with wrist fracture . Caution s This study did not r and omly assign persons to the intervention group and did not examine improvements in bone density or repeated fractures . The Editors Osteoporosis , a chronic and progressive condition that leads to decreased bone mass and skeletal fragility , may result in fractures , disability , pain , deformity , and even death ( 1 - 3 ) . The condition is common , affecting an estimated 1.4 million Canadians and 10 million Americans ( 1 , 2 ) . These figures represent 25 % of women and 12 % of men older than 50 years of age ( 1 , 2 ) . In the United States , the annual cost of treating osteoporosis and its sequelae has been estimated at $ 13.8 billion ( 2 ) , compared with $ 7.5 billion for congestive heart failure and $ 6.2 billion for asthma ( 3 ) . Without better preventive strategies , the rate of osteoporotic fractures is expected to double over the next 15 years ( 4 ) . Several experts ( 5 ) and guidelines ( 1 , 2 ) suggest a preventive strategy of identifying people with typical osteoporosis-related fractures ( for example , fractures of the hip , spine , or wrist [ often called fragility fractures ] ) and targeting them for treatment . They recommend this strategy because this population is at the greatest risk for subsequent fracture and may derive the greatest absolute benefit from treatment . Numerous safe and effective treatments can reduce the risk for recurrent fracture by 40 % to 60 % ( 1 - 3 , 6 ) . In addition , with the use of bisphosphonates and raloxifene , all subgroups of examined patients may obtain beneficial effects ( 3 , 7 - 9 ) within a year ( 7 , 8) . People 50 years of age and older with a fracture of the wrist may be particularly well suited to a strategy of case finding and secondary prevention . Fractures of the wrist are the most common symptomatic fracture related to osteoporosis ( 3 ) , and 70 % to 80 % of persons with wrist fractures have low bone mass ( 10 , 11 ) . Observational studies suggest that a wrist fracture is a sentinel event in the natural history of osteoporosis because this type of fracture forecasts an increased risk for fractures of the hip and spine over the next 10 to 20 years ( 12 - 14 ) . Best practice ( clinical practice consistent with current evidence and expert consensus ) would be to identify people 50 years of age or older with a fragility fracture of the wrist , to measure their bone mineral density , and to treat those with low bone mass or osteoporosis ( 1 , 2 , 5 ) . However , the gap between best practice and everyday clinical practice is wide . Over the past 5 to 10 years , studies from the United States ( 3 , 15 , 16 ) , Canada ( 17 , 18 ) , and elsewhere ( 5 , 19 ) report that rates of testing for and treating osteoporosis a year or longer after a fracture of the wrist are less than 10 % to 20 % . This is an important failure in the process of knowledge translation and indicates that benefits within our reach are not being achieved . We design ed a pragmatic , multifaceted osteoporosis intervention strategy directed at people 50 years of age or older with a fracture of the wrist and at their primary care physicians . The intervention consisted of physician reminders , treatment guidelines endorsed by local opinion leaders , and patient education . Our primary objective was to examine whether this intervention improved the diagnosis and treatment of osteoporosis in this high-risk population . Secondary objectives included examining the effect of this intervention on patients ' knowledge , satisfaction , and quality of life . Methods Setting and Participants Capital Health ( Edmonton , Alberta ) is one of the largest integrated health service delivery organizations in Canada ( 20 ) . It provides comprehensive health services for about 1 million people and has an annual budget of almost $ 2 billion ( Canadian ) ( 20 ) . Primary care is delivered by approximately 900 fee-for-service physicians . We enrolled participants from the 2 largest emergency departments in the region : the University of Alberta Hospital ( a university-based teaching hospital ) and the Royal Alex and ra Hospital ( a university-affiliated community teaching hospital ) . These emergency departments provide most of the fracture care and emergency orthopedic services to the region . Consecutive patients presenting to the emergency department with a wrist fracture were potentially eligible . Inclusion criteria were as follows : age 50 years or older ; any simple , closed fracture of the distal forearm ; and discharge home . We excluded patients who were already taking prescription treatments for osteoporosis . Because we did not ask patients whether they had a diagnosis of osteoporosis until study closeout , a patient with a history of osteoporosis who was not being treated with prescription medication was potentially eligible for inclusion . We also excluded patients who were unable to provide consent , were unwilling to participate , were admitted to the hospital , resided in a long-term care facility , resided outside the Capital Health region , or could not read and converse in English . Study Design and Patient Enrollment We conducted a prospect i ve controlled trial with blinded ascertainment of outcomes . To allocate patients to the intervention or usual care control groups , we adapted and modified an onoff 1-site study design for 2 sites ( 21 ) . For 1 month at a time , in sequential order , the intervention was on at 1 emergency department while it was off at the other . At the end of each month , research nurses alternated intervention status from on to off or vice versa . Patients with wrist fractures were treated , as appropriate , by emergency department physicians and then approached by research nurses or orthopedic technicians for enrollment in the study before discharge home . We obtained informed consent from each patient , and all data were maintained outside the emergency departments in a central ized secure file system . The University of Alberta Health Research Ethics Board approved the study . Intervention We design ed an intervention to overcome the many barriers that exist for primary care physicians who are trying to adopt evidence -based treatments for their patients with osteoporosis . Each of the 3 components of the intervention had published evidence of effectiveness ( 22 - 24 ) . Physician Reminders A reminder was generated for each patient and faxed to the primary care physician of record . The reminder notified physicians that their patient had recently been seen and treated in the emergency department for a wrist fracture and reminded them that their patient was now considered to be at increased risk for osteoporosis . Generating and sending the personalized and patient-specific reminder took about 6 minutes for each patient . Treatment Guidelines Generated and Endorsed by Opinion Leaders As part of the reminder , we provided brief evidence -based treatment recommendations . These guidelines were design ed to fit on the same page and emphasized 3 points : 1 ) The patient is at very high risk for osteoporosis and needs a bone mineral density measurement if one has not been performed in the past year ; 2 ) without treatment , the patient may be at increased risk for another fracture within the year ; and 3 ) bisphosphonate treatment will reduce the patient 's risk for fracture by about 50 % . Bisphosphonate alternatives ( for example , calcitonin , raloxifene , and hormone therapy ) were mentioned as second-line approved treatments because , at the time of study design , only the bisphosphonates had been demonstrated to prevent both vertebral and nonvertebral fractures . Using previously vali date d methods ( 25 , 26 ) , we recruited 5 osteoporosis opinion leaders who had been nominated by local primary care providers . The opinion leaders helped develop and then endorsed the guidelines by attaching their names and signatures . Patient Education We provided patients in the intervention group with a tailored , single-page summary of osteoporosis information that mirrored the physician material s described in the preceding paragraph . We reinforced these written material s with a brief telephone counseling session that took place within 1 week of the fracture . This counseling ( approximately 4 minutes per session ) reiterated the content of the written material s and encouraged patients to seek further information and counseling from their primary care physician . We did not provide intervention patients with any written material s or counseling regarding fall prevention or home safety . Control Patients ( Usual Care ) On the basis of surveys and in-depth interviews with emergency department physicians in Canada and the United States , the current st and ard of care for patients treated for a wrist fracture usually consists of 1 ) notification to the primary care physician of record that the patient was seen and treated and 2 ) information on follow-up plans . We ensured that such notifications occurred for all control patients . In addition , we enhanced usual care by ensuring that control patients received educational material s and telephone counseling regarding fall prevention and home safety . During the call , patients were encouraged to visit their primary care physician for more detailed advice and a medication review . They did not receive any counseling or educational material s about osteoporosis . Thus , control patients received the same amount of attention and care as the intervention patients . After the main study was completed , all control patients were crossed over to the osteoporosis intervention , and all intervention patients were provided with counseling regarding fall prevention and home safety . Outcomes and Measurements The primary study outcome was",
"BACKGROUND Treatment of osteoporosis following a hip fracture has been notoriously poor . Many efforts have been made to improve treatment rates . The purpose of this study was to determine whether a perioperative inpatient intervention program , involving patient education and providing a list of questions for the primary care physician , increased the percentage of patients in whom osteoporosis was addressed following a hip fracture . METHODS A prospect i ve , r and omized trial involving eighty patients who had been admitted to an academic medical center with a low-energy hip fracture was conducted . During their hospitalization , the study group patients were engaged in a fifteen-minute discussion regarding the association between osteoporosis and hip fractures , the efficacy of dual-energy x-ray absorptiometry scans in the diagnosis of osteoporosis and of bisphosphonates in its treatment , and the importance of medical follow-up for osteoporosis management . These patients were also provided with five questions regarding osteoporosis treatment to be given to their primary medical physician , and they were reminded about the questions during a follow-up telephone call six weeks later . The patients in the control group received a brochure describing methods for preventing falls . Both groups were contacted by telephone at six months after discharge to determine whether osteoporosis had been addressed . Positive indicators of intervention included assessment of bone mineral density with dual-energy x-ray absorptiometry and initiation of antiresorptive therapy . RESULTS The average age in each group was eighty-two years , and 78 % of the patients were female . Four patients in each group did not survive through the six-month follow-up period and were excluded from the trial . Fifteen ( 42 % ) of the thirty-six patients who had been r and omized to the study group , compared with only seven ( 19 % ) of the thirty-six patients in the control group , had their osteoporosis addressed by their primary physician . This difference between the groups was significant ( p = 0.036 ) . CONCLUSIONS Patients who were provided with information and questions for their primary care physician about osteoporosis were more likely to receive appropriate therapeutic intervention than were patients who had not received the information and questions . Orthopaedic surgeons have a unique opportunity to improve the rate of osteoporosis treatment in the perioperative period following a hip fracture by educating patients and directing them toward channels for long-term osteoporosis management",
"OBJECTIVES Osteoporosis is a major cause of morbidity and cost . Patients sustaining one osteoporotic fracture are at increased risk of having another fracture . The objective of this study was to examine the use of “ bone drugs ” for the prevention of further osteoporotic fractures among patients who have had a “ typical ” osteoporotic fracture . METHODS This study took a r and om sample of 300 women aged 50 and over who had sustained either a vertebral , hip or Colles fracture in 1995 from the General Practice Research Data base ( GPRD ) and compared their use of bone drugs with 300 age and practice matched controls . RESULTS Compared with age and practice matched control patients only vertebral fracture patients showed a statistically significant increase in the use of bone drugs in the year after fracture ( 39 % and 2 % for cases and controls respectively ; 95 % CI of difference 27 % to 47 % ) . Etidronate was the most commonly used compound . CONCLUSION The majority of patients sustaining an osteoporotic fracture are not prescribed any pharmaceutical agents for the secondary prevention of fracture one year after a primary fracture",
"Background : Older patients who experience a fragility fracture are at high risk of future fractures but are rarely tested or treated for osteoporosis . We developed a multifaceted intervention directed at older patients with wrist fractures ( in the form of telephone-based education ) and their physicians ( in the form of guidelines endorsed by opinion leaders , supported by reminders ) to improve the quality of osteoporosis care . Methods : In a r and omized controlled trial with blinded ascertainment of outcomes , we compared our intervention with usual care ( provision of printed educational material s to patients ) . Eligible patients were those older than 50 years of age who had experienced a wrist fracture and were seen in emergency departments and fracture clinics ; we excluded those who were already being treated for osteoporosis . The primary outcome was bisphosphonate treatment within 6 months after the fracture . Secondary outcomes included bone mineral density testing , “ appropriate care ” ( consisting of bone mineral density testing with treatment if bone mass was low ) and quality of life . Results : We screened 795 patients for eligibility and r and omly assigned 272 to the intervention ( 137 patients ) or control ( 135 patients ) group . The median age was 60 years ; 210 ( 77 % ) of the subjects were women , and 130 ( 48 % ) reported a previous fracture as an adult . Six months after the fracture , 30 ( 22 % ) of the intervention patients , as compared with 10 ( 7 % ) of the control patients , were receiving bisphosphonate therapy for osteoporosis ( adjusted relative risk [ RR ] 2.6 , 95 % confidence interval [ CI ] 1.3–5.1 , p = 0.008 ) . Intervention patients were more likely than control patients to undergo bone mineral density testing ( 71/137 [ 52 % ] v. 24/135 [ 18 % ] ; adjusted RR 2.8 , 95 % CI 1.9–4.2 , p receive appropriate care ( 52/137 [ 38 % ] v. 15/135 [ 11 % ] ; adjusted RR 3.1 , 95 % CI 1.8–5.3 , p died , and 4 others experienced recurrent fracture . Interpretation : A multifaceted intervention directed at high-risk patients and their physicians substantially increased rates of testing and treatment for osteoporosis . Nevertheless , more than half of the patients in the intervention group were not receiving appropriate care 6 months after their fracture , which suggests that additional strategies should be explored . ( Clinical Trials.gov trial register no. NCT00152321 .",
"Women with low bone density in the radius or calcaneus are at increased risk of hip fracture . To see whether bone density of the hip measured by dual X-ray absorptiometry is a better predictor of hip fracture than measurements of other bones , we assessed bone density at several sites in 8134 women aged 65 years or more . 65 women had hip fractures during a mean follow-up of 1.8 years . Each SD decrease in femoral neck bone density increased the age-adjusted risk of hip fracture 2.6 times ( 95 % CL 1.9 , 3.6 ) . Women with bone density in the lowest quartile had an 8.5-fold greater risk of hip fracture than those in the highest quartile . Bone density of the femoral neck was a better predictor than measurements of the spine ( p radius ( p Low hip bone density is a stronger predictor of hip fracture than bone density at other sites . Efforts to prevent hip fractures should focus on women with low hip bone density",
"BACKGROUND Patients who survive hip fracture are at high risk of recurrent fractures , but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10 % to 20 % . We have developed an osteoporosis case manager intervention . The case manager educated patients , arranged bone mineral density tests , provided prescriptions , and communicated with primary care physicians . The intervention was compared with usual care in a r and omized controlled trial . METHODS We recruited from all hospitals that participate in the Capital Health system ( Alberta , Canada ) , including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility . Primary outcome was bisphosphonate therapy 6 months after fracture ; secondary outcomes included bone mineral density testing , appropriate care ( bone mineral density testing and treatment if bone mass was low ) , and intervention costs . RESULTS We screened 2219 patients and allocated 220 , as follows : 110 to the intervention group and 110 to the control group . Median age was 74 years , 60 % were women , and 37 % reported having had previous fractures . Six months after hip fracture , 56 patients in the intervention group ( 51 % ) were receiving bisphosphonate therapy compared with 24 patients in the control group ( 22 % ) ( adjusted odds ratio , 4.7 ; 95 % confidence interval , 2.4 - 8.9 ; P Bone mineral density tests were performed in 88 patients in the intervention group ( 80 % ) vs 32 patients in the control group ( 29 % ) ( P bone mineral density testing , 25 ( 21 % ) had normal bone mass . Patients in the intervention group were more likely to receive appropriate care than were patients in the control group ( 67 % vs 26 % ; P intervention cost was $ 50.00 per patient . CONCLUSION For a modest cost , a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures",
"Recognizing Osteoporosis and its Consequences in Quebec ( ROCQ ) is an ongoing patient health-management programme aim ed at evaluating the diagnostic and treatment care gaps for osteoporosis following a fragility fracture , and subsequently initiating and measuring interventions to decrease these gaps in women 50 years of age and over . Hospitals servicing approximately half of the population of the Province of Quebec ( Canada ) are participating in the ROCQ programme . Women with fragility and traumatic fractures are approached during their visit to a cast or outpatient clinic and are subsequently contacted by telephone 0 to 16 weeks after their fracture ( phase 1 ) . During the first phone contact , they are invited to answer a question naire aim ed at identifying the specific circumstances of their fracture and asked to participate in an observational study that could last up to 18 months . Based on this initial question naire , patients are classified as having either experienced a fragility or traumatic fracture . During the first phone contact , there is no reference about the possible association between the fracture and osteoporosis and no investigation or intervention is proposed . Six to eight months after the fracture event ( phase 2 ) , women are again contacted by phone to complete a question naire that evaluates the diagnostic and treatment rates for osteoporosis . At this phase of the programme , women with fragility fractures are r and omized to one of the three following intervention groups : 1 ) Educational Video Group , 2 ) Documentation Group and 3 ) Control Group . Participants are contacted 12 to 14 months after the intervention ( phase 3 ) to evaluate the efficacy of the interventions on the diagnosis and treatment rates of osteoporosis . All participants with fragility or traumatic fractures who consent will be followed for 20 years using data from the Québec Ministry of Health data base to measure the association between the index fracture and future fracture risk",
"OBJECTIVE We previously demonstrated that a case manager intervention improved osteoporosis ( OP ) treatment within 6 months of hip fracture compared with usual care . The second phase of the r and omized trial compared a less intensive intervention , facilitated bone mineral density ( BMD ) testing , with usual care and the case manager intervention . METHODS We initially r and omized 220 hip fracture patients to either an OP case manager intervention or usual care . After completing the original trial at 6 months postfracture , usual care patients were reallocated to facilitated BMD testing ; BMD tests were arranged and results sent to primary care physicians . Main outcomes ( bisphosphonate treatment , BMD tests , receipt of appropriate care ) were reascertained 1 year following hip fracture and compared with outcomes achieved by the OP case manager intervention and usual care . RESULTS Compared with usual care , facilitated BMD testing increased testing from 29 % to 68 % ( P bisphosphonate use from 22 % to 38 % ( P of appropriate care from 26 % to 45 % ( P OP case manager intervention led to significantly higher bisphosphonate use ( 54 % versus 38 % ; P = 0.03 ) , receipt of appropriate care ( 71 % versus 45 % ; P BMD testing ( 80 % versus 68 % ; P = 0.06 ) than usual care followed by facilitated BMD testing . CONCLUSION Compared with usual care , 2 different inexpensive interventions result ed in significant increases in appropriate management of OP after hip fracture . The magnitude of improvements achieved was directly related to the intensity of the interventions"
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OBJECTIVE To assess whether respiratory physiotherapy prevents pulmonary complications after cardiac surgery . DATA SOURCES Search es through Medline , Embase , Cinahl , the Cochrane library , and bibliographies , for r and omised trials comparing any type of prophylactic respiratory physiotherapy with another type or no intervention after cardiac surgery , with a follow up of at least two days , and reporting on respiratory outcomes . REVIEW METHODS Investigators assessed trial validity independently . Information on study design , population , interventions , and end points was abstract ed by one investigator and checked by the others . RESULTS 18 trials ( 1457 patients ) were identified . Most were of low quality . They tested physical therapy ( 13 trials ) , incentive spirometry ( eight ) , continuous positive airway pressure ( five ) , and intermittent positive pressure breathing ( three ) . The maximum follow up was six days . Four trials only had a no intervention control ; none showed any significant benefit of physiotherapy . Across all trials and interventions , average values postoperatively were : incidence of atelectasis , 15 - 98 % ; incidence of pneumonia , 0 - 20 % ; partial pressure of arterial oxygen per inspired oxygen fraction , 212 - 329 mm Hg ; vital capacity , 37 - 72 % of preoperative values ; and forced expiratory volume in one second , 34 - 72 % . No intervention showed superiority for any end point . For the most labour intensive intervention , continuous positive airway pressure , the average cost of labour for each patient day was 27 euro ( pound 19 ; 32 dollars ) . CONCLUSIONS The usefulness of respiratory physiotherapy for the prevention of pulmonary complications after cardiac surgery remains unproved . Large r and omised trials are needed with no intervention controls , clinical ly relevant end points , and reasonable follow up periods
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"One hundred twenty patients undergoing coronary artery surgery completed a r and omized controlled study design ed to investigate whether prophylactic chest physiotherapy affected the incidence of postoperative pulmonary complications . Group 1 patients received no preoperative or postoperative chest physiotherapy . Group 2 patients received preoperative education and instruction in breathing and coughing exercises and postoperative supervision and assistance in performing the same . These exercises were supervised by a physiotherapist twice per day on the first 2 postoperative days and once per day on the 3rd and 4th postoperative days . Physiotherapy for group 3 patients was the same as for group 2 patients except that patients were seen by a physiotherapist 4 times per day on the first 2 postoperative days and twice per day on the 3rd and 4th postoperative days . Group 2 and 3 patients were instructed to practice breathing and coughing exercises every hour . Overall , an incidence of clinical ly significant postoperative pulmonary complications of 7.5 percent was demonstrated . In general , these patients demonstrated lower levels of preoperative pulmonary function and very low early postoperative oxygenation compared with those who did not develop pulmonary complications . There was no indication that the incidence or severity of fever , hypoxemia , chest roentgenologic abnormalities or clinical ly significant postoperative pulmonary complications was different between groups . These results suggest that the necessity for prophylactic chest physiotherapy after routine coronary artery surgery should be review ed",
"Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size",
"OBJECTIVE : Internists frequently evaluate preoperative cardiopulmonary risk and comanage cardiac and pulmonary complications , but the comparative incidence and clinical importance of these complications are not clearly delineated . This study evaluated incidence and length of stay for both cardiac and pulmonary complications after elective laparotomy . DESIGN : Nested case-control . SETTING : University-affiliated Department of Veterans Affairs Hospital . PATIENTS : Computerized registry of all 2,291 patients undergoing elective abdominal operations from 1982 to 1991.MEASUREMENT AND MAIN RESULTS : Strategy for ascertainment and verification of complications was systematic and explicit . The charts of all 116 patients identified by the registry as having complications and 412 ( 19 % ) r and omly selected from 2,175 remaining patients were review ed to verify presence or absence of cardiac or pulmonary complications , using explicit criteria and independent abstract ion of pre- and postoperative components of charts . From these 528 vali date d cases and controls ( 23 % of the cohort ) , 96 cases and 96 controls were matched by operation type and age within ten years . Hospital and intensive care unit stays were significantly longer ( p deaths occurred among the cases . Among the cases , pulmonary complications occurred significantly more often than cardiac complications ( p longer hospital stays ( 22.7 vs 10.4 days , p=0.001 ) . Combined cardiopulmonary complications occurred among 26 % of the cases . Misclassification-corrected incidence rates for the entire cohort were 9.6 % ( 95 % CI 7.2–12.0 ) for pulmonary and 5.7 % ( 95 % CI 3.8–7.7 ) for cardiac complications . CONCLUSIONS : For noncardiac surgery , previous research has focused on cardiac risk . In this study , pulmonary complications were more frequent , were associated with longer hospital stay , and occurred in combination with cardiac complications in a substantial proportion of cases . These results suggest that further research is needed to fully characterize the clinical epidemiology of postoperative cardiac and pulmonary complications and better guide preoperative risk assessment",
"The object of the investigation was to compare the effect of three different physiotherapy masks on the incidence of postoperative complications after thoracic surgery . It was carried out as a prospect i ve , consecutive , r and omized comparison at a Department of Thoracic and Heart Surgery at a University Hospital . The therapy was performed by experienced and specially trained physiotherapists . One hundred and sixty patients were evaluated ; 60 patients undergoing heart surgery , 59 patients having pulmonary resection , and 41 patients with exploratory thoracotomy . In each operative category the patients were treated with one of three face mask systems used in addition to routine chest physiotherapy . These were either continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , or inspiratory resistance -- positive expiratory pressure ( IR-PEP ) . Postoperative pulmonary complications were assessed by forced vital capacity ( FVC ) , arterial oxygen tension ( PaO2 ) , and chest X-ray examination , all parameters were measured preoperatively and on the fourth and ninth postoperative day . The patients filled in a question naire concerning their opinions about their mask treatment . IR-PEP showed a lesser decrease in PaO2 on day nine . Otherwise there was an equal decrease in FVC and PaO2 , and equal frequency of atelectasis in the three mask treatments . It is therefore concluded that any of the three therapies : continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , and inspiratory resistance -- positive expiratory pressure ( IR-PEP ) may be used as supplement to st and ard chest physiotherapy",
"BACKGROUND The purpose of this study was to assess the value of tracheal aspirate as a predictor of pneumonia after coronary artery bypass grafting and to evaluate the efficacy of prolonged perioperative antibiotic prophylaxis . METHODS Tracheal aspirates of 500 patients undergoing coronary artery bypass grafting were taken immediately after intubation and analyzed for microorganisms by Gram stain and semiquantitative microbiologic cultures . All patients received 2 g ceftriaxone as a single-dose perioperative antibiotic prophylaxis before operation . Results of Gram stains were available before the patients were transferred to the intensive care unit . After the results were known , both groups of patients ( positive Gram stain , group 1 ; negative Gram stain , group 2 ) were r and omly assigned to either conventional antibiotic prophylaxis ( A ) , consisting of ceftriaxone 2 g on postoperative day 1 , or prolonged antibiotic prophylaxis ( B ) , with ticarcillin + clavulanic acid 3 x 5.2 g during 72 hours . RESULTS From 500 patients , 91 had a positive Gram stain whereas 409 had a negative one . The incidence of pneumonia was significantly higher in patients with preoperative positive tracheal aspirates ( 15.3 % ) than in patients with a negative one ( 3.6 % ; p rate of postoperative pneumonia , which was as high as 13 % in untreated positive patients versus 17 % in treated positive patients , and 2 % in untreated negative patients versus 4 % in treated patients . In patients who had pneumonia , there was a high correlation between the microorganisms found in preoperative aspirates and those observed when aspirates were repeated ( 100 % correlation in patients with conventional antibiotic prophylaxis and 87 % in those with prolonged prophylaxis ) . CONCLUSIONS Early postoperative pneumonia ( perioperative antibiotic prophylaxis has no efficacy in reducing the incidence of pulmonary infections",
" Forty-nine adults who had undergone cardiopulmonary bypass surgery were r and omly assigned to one of three exercise programs to determine if either maximal inspiratory breathing exercises or incentive spirometry offered a therapeutic advantage over early mobilization alone . After extubation , the patients started their assigned exercise programs . A physical examination and pulmonary function tests were performed preoperatively , at the start of the exercise program , and 24 and 48 hours after the start of the program . The results showed a significant decrease ( approximately 50 % ) in lung volumes but no airflow obstruction in patients who had coronary artery bypass graft . In those patients who had valve replacement , lung volumes fell , and in addition , mild airflow obstruction occurred . A majority of patients had postoperative pulmonary complications . There were no significant differences among the exercise programs in improving lung volumes and airflow or in preventing postoperative complications . We conclude that maximal inspiratory breathing exercises or incentive spirometry , when used in addition to early mobilization , offers no therapeutic advantage over early mobilization alone after cardiopulmonary bypass surgery",
"Objective An investigation into the incidence of post-operative complications after thoracic surgery with 3 different physiotherapy masks . Design A prospect i ve , consecutive , r and omized comparison . Setting Department of Thoracic and Heart Surgery at a University Hospital . The treatments were performed by experienced and specially trained physiotherapists . Patients 160 patients were evaluated . 60 patients undergoing heart surgery , 59 patients having pulmonary resection , and 41 patients with exploratory thoractomy . Interventions In each operative category the patients were treated with one of three face mask systems used in addition to routine chest physiotherapy . These were either continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , or inspiratory resistance — positive expiratory pressure ( IR-PEP ) . Measurements and results Post-operative pulmonary complications were assessed by forced vital capacity ( FVC ) , arterial oxygen tension ( PaO2 ) , and chest X-ray examination , all measured pre-operatively and on the fourth and ninth post-operative day . The patients filled in a question naire expressing their opinion about their mask treatment . There was an equal decrease in FVC , FVC% , and PaO2 , and equal frequency of atelectasis in the 3 mask treatments . More patients with the PEP mask favoured their system than did those with the other 2 systems . Conclusion There was no statistically significant difference between the treatments : continuous positive airway pressure ( CPAP ) , positive expiratory pressure ( PEP ) , and inspiratory resistance — positive expiratory pressure ( IR-PEP ) on post-operative complications . Any of the three treatments may be used as supplement to st and ard chest physiotherapy",
"One hundred and ten men undergoing coronary artery bypass grafting took part in a prospect i ve r and omised study comparing three physiotherapy protocol s. All patients were taught self supported huffing and coughing by a physiotherapist and encouraged to move about . This comprised the sole treatment for the 37 control patients ( group 3 ) . Additional physiotherapy included breathing exercises for the 35 patients in group 1 and use of an incentive spirometer for the 38 patients in group 2 . Functional residual capacity ( FRC ) was measured daily at the bedside until the fifth postoperative day and arterial blood gas tensions were measured on the second and fourth postoperative days . After surgery patients developed a severe restrictive ventilatory defect and profound arterial hypoxaemia . There were no differences between the three groups . Mean FRC on day 2 was 1.90 litres ( 61 % of the preoperative value ) , increasing to 2.32 1 by day 5 ( 76 % of the preoperative value ) . The mean arterial oxygen tension was 7.37 kPa on day 2 and 8.58 kPa on day 4 . Four patients in group 1 , two in group 2 , and five in group 3 developed a chest infection . It is concluded that the addition of breathing exercises or incentive spirometry to a regimen of early mobilisation and huffing and coughing confers no extra benefit after uncomplicated coronary artery bypass grafting",
"BACKGROUND AND PURPOSE The purpose of this study was to determine whether the addition of incentive spirometry ( IS ) to postoperative pulmonary physical therapy is more effective than physical therapy alone in reducing postoperative pulmonary complications in high-risk patients after coronary artery bypass grafting ( CABG ) . Patients were given the spirometer and instructed in its use , as often occurs in clinical setting s. SUBJECTS Patients with chronic airflow limitation following CABG ( N = 185 ) participated . METHODS Subjects were r and omly assigned to receive either postoperative pulmonary physical therapy ( breathing exercises , secretion removal , mobility ) or physical therapy combined with IS . RESULTS No difference was found between the two groups in atelectasis , spirometry , oxygen saturation , pulmonary infection , or hospital stay . CONCLUSION AND DISCUSSION Incentive spirometry combined with physical therapy is no more effective than postoperative physical therapy alone in reducing atelectasis for this population . Use of the spirometer , however , was not monitored , and although the study mimicked practice as it often occurs , the effectiveness of the spirometer can not be fully evaluated",
"The objective of this prospect i ve , consecutive , r and omized , controlled study was to investigate the effects of mask physiotherapy on postoperative complications after heart surgery . Sixty-six low-risk male patients undergoing coronary artery by-pass graft surgery were evaluated . The patients were treated with routine chest physiotherapy alone or supplied with either positive expiratory pressure ( PEP ) , or inspiratory resistance-positive expiratory pressure ( IR-PEP ) . Postoperative pulmonary complications were assessed by forced vital capacity ( FVC ) , arterial oxygen tension ( PaO2 ) , and chest X-ray examination . There was an almost equal decrease and subsequent rise in spirometric and blood gas values in all three groups , but patients treated with the PEP mask had a borderline significantly higher increase in PaO2 from day three to day six compared with patients treated with no mask . There was an almost equal frequency of atelectasis in the three treatment groups . It is concluded that no significant differences in outcome were found between the three groups",
"Objective Investigate the effects of mask physiotherapy on post-operative complications after thoracic surgery . Design A prospect i ve , consecutive , r and omized , controlled study . Setting Department of Thoracic and Heart Surgery at a University Hospital . The treatments were performed by experienced and specially trained physiotherapists . Patients 97 low-risk male patients undergoing coronary artery by-pass graft surgery were evaluated . 66 patients completed the study . Interventions The patients were treated with routine chest physiotherapy alone or supplied with either positive expiratory pressure ( PEP ) , or inspiratory resistance-positive expiratory pressure ( IR-PEP ) . Measurements and results Post-operative pulmonary complications were assessed by forced vital capacity ( FVC ) , arterial oxygen tension ( PaO2 ) , and chest X-ray examination , all measured pre-operatively and on the third and sixth post-operative day . There was an almost equal decrease and subsequent rise in spirometric and blood gas values , but patients treated with the PEP mask had a borderly significantly higher increase in PaO2 from day 3 to day 6 compared with patients treated with no mask . There was an almost equal frequency of atelectasis in the 3 treatments . The patients filled in a question aire expressing their opinion about their treatment . Most patients liked their treatment and found it helpful but a little less so in the IR-PEP group . Conclusion We did not find any significant difference between the three groups ; however , a tendency to decreased risk of having post-operative complications was observed in the groups having positive expiratory pressure ( PEP ) and inspiratory resistance-positive expiratory pressure ( IR-PEP )",
"This is a prospect i ve study of 500 consecutive patients having coronary artery bypass surgery ; mean hospital charge from time of surgery to discharge was + 11,900 + /- 12,700 . Multiple regression analysis was performed using preoperative variables and postoperative complications . No preoperative clinical feature was a significant predictor of higher average charge . Sternal wound infection ( p = 0.0001 ) , respiratory failure ( p = 0.0001 ) and left ventricular failure ( p = 0.017 ) were associated with higher average hospital charge . The absence of any complication predicted a lower average charge , and postoperative death ( 4.4 + /- 4.5 days after surgery ) was also associated with lower average charge . A cost equation was developed : hospital charge equalled $ 11,217 + $ 41,559 of sternal wound infection , + $ 28,756 for respiratory failure , + $ 5,186 for left ventricular failure , - $ 1,798 for no complication and - $ 6,019 for death . Recognition of the influence of complications on charges suggests that low average charges can only be achieved by surgical programs with a low complication rate",
"Background : Coronary artery bypass graft ( CABG ) surgery with the use of mammary arteries is associated with severe alteration of lung function parameters . The purpose of the present study was to compare the effect on lung function tests of conventional physiotherapy using incentive spirometry ( IS ) with non‐invasive ventilation on continuous positive airway pressure ( CPAP ) and with non‐invasive ventilation on bilevel positive airway pressure ( BiPAP or NIV‐2P )",
"Pulmonary oxygen transfer , defined by PaO2/FIO2 , and radiologic presence of atelectasis were measured pre- , intra- , and postoperatively to postoperative day 9 in elective cardiac aortocoronary bypass surgical patients , who were r and omly allocated either to receive 18 h PEEP while on the ventilator followed by 12 h of nasal continuous positive airway pressure ( nasal CPAP ) or to be control subjects . The two groups were comparable in age , sex , forced expiratory volume in 1 sec ( FEV1 ) , the ratio of FEV1 over forced vital capacity ( FVC ) , time on pump , units of blood transfused , New York Heart Association grading , and cardiac performance indices . The PaO2/FIO2 was significantly ( p less than .05 ) better from half an hour after extubation until 24 h postextubation in the nasal CPAP group , but was decreased for the remainder of the study in both groups . Incidence of atelectasis/consolidation was not different in both groups during the study period . We conclude that nasal CPAP is well tolerated as a treatment of hypoxemia in the immediate postoperative period of aortocoronary bypass patients . CPAP does not change the course of postoperative atelectasis",
"The effectiveness of three deep breathing techniques was evaluated in 98 male patients after coronary artery bypass graft surgery in a r and omized trial . The techniques examined were deep breathing with a blow bottle-device , an inspiratory resistance-positive expiratory pressure mask ( IR-PEP ) and performed with no mechanical device . Pulmonary function and roentgenological changes were evaluated . Four days post-operatively there were significantly decreased vital capacity , inspiratory capacity , forced expiratory volume in 1 second , functional residual capacity , total lung capacity and single-breath carbon monoxide diffusing capacity in all three groups ( p pulmonary function tended to be less marked using the blow bottle technique . The Blow bottle group had significantly less reduction in total lung capacity ( p = 0.01 ) compared to the Deep breathing group , while the IR-PEP group did not significantly differ from the other two groups",
"In a prospect i ve , r and omized study , the effectiveness of chest physiotherapy ( CPT ) was evaluated in preventing postoperative atelectasis in children after heart surgery . Postoperative clinical variables and chest x-ray findings of atelectasis were compared in two groups : 19 patients receiving CPT and 25 patients not receiving CPT ( NCPT ) . Chest physiotherapy was associated with significantly more frequent ( p less than 0.01 ) and more severe ( p less than 0.01 ) atelectasis than NCPT . Atelectasis was not significantly associated with temperature elevation , age , or presence of preoperative left-to-right shunt",
" Fifty-two patients were r and omized to receive either incentive spirometry ( IS ) or intermittent positive pressure breathing ( IPPB ) in addition to conventional chest physical therapy following coronary artery bypass grafting . Slow vital capacity and peak expiratory flow readings decreased rapidly and to an equal extent in both groups after surgery , and partly recovered by the sixth postoperative day ( POP ) . Arterial PO2 values were similar for the groups on the first three POPs . On the POPs 2 , 3 , and 6 , the number of chest films showing atelectases as well as the number of individual patients having atelectases revealed no statistically significant differences between the two groups . Based on the three variables studied , we consider both devices equal in efficiency after coronary surgery",
"Thirty patients who underwent coronary artery bypass grafting were r and omized to receive 30 % oxygen by mask either with an ambient airway pressure or with 7.4 mmHg ( 1 kPa ) continuous positive airway pressure ( CPAP ) for 8 h after extubation . Arterial blood oxygen tension ( Pao2 ) decreased remarkably in the control group after extubation ( from 19.2± 5.3 kPa to 12.4 ± 2.7 kPa ) but less in the CPAP group ( from 16.4 ± 3.3 kPa to 14.0 ± 2.1 kPa ) . On the second postoperative morning Pao2 was equally low in both groups ( control : 8.4 ± 1.5 kPa , CPAP : 8.9 ± 1.9 kPa ) . Atelectatic areas were seen with similar frequency in both groups , 17 % ( whole material ) on the first and 50 % on the second postoperative morning . Atelectasis was more common in patients with internal thoracic artery grafting and /or pleural drainage . In conclusion , CPAP therapy was well tolerated , and minimized the decrease in Pao2 after extubation , but could not prevent the poor oxygenation or the late development of atelectatic areas on the second postoperative day",
"STUDY OBJECTIVE To determine whether higher personnel intensive chest physical therapy can prevent the atelectasis that routinely follows cardiac valve surgery . DESIGN R and omized , controlled trial . SETTING Tertiary care hospital . PATIENTS Seventy-eight patients undergoing elective cardiac valve surgery between October 1991 and April 1993 were enrolled . INTERVENTIONS Patients were r and omized in an unmasked fashion to receive early mobilization and sustained maximal inflations ( lower-intensity treatment ) or to receive early mobilization , sustained maximal inflations , and single-h and ed percussions ( higher-intensity treatment . ) MEASUREMENTS AND RESULTS Clinical efficacy was determined by extent of atelectasis , length of ICU stay , total length of hospital stay , and personnel costs . The extent of postoperative atelectasis was similar in both groups on the fifth postoperative day . Postoperative values of FVC and FEV1 were reduced to a similar extent in both groups . Hospital stays and ICU stays were similar regardless of treatment . Physical therapy costs were highest in the higher-intensity therapy group . CONCLUSIONS Postoperative respiratory dysfunction is common but does not usually cause significant morbidity or prolong hospital stay . The routine prescription of high-intensity physical therapy does not improve patient outcomes but does add significantly to patient costs",
"Of 38 patients undergoing median sternotomy for cardiac operations all developed profound restrictive defects in pulmonary function during the first 72 h after tracheal extubation . Although decreased lung volumes were refractory to correction by vigorous , aggressive pulmonary therapy during this period , frequent and supervised treatment may prevent further deterioration in pulmonary function . The overall incidence of pneumonia was only 3 % ( 1/38 ) . Continuous positive airway pressure delivered by mask proved to be a nearly effortless form of postoperative respiratory therapy that was less painful than incentive spirometry or coughing and deep breathing , and therefore may be preferable",
" Following cardiac operations , 145 patients were treated with either intermittent positive-pressure breathing ( IPPB ) , blod bottles , or an incentive spirometer in an attempt to alter the incidence of atelectasis . Pulmonary complications occurred in 30 % of the patients receiving IPPB , 15 % of those using an incentive spirometer , and 8 % of those using blow bottles . Gastrointestinal side-effects occurred in 20 % of the IPPB group and were rare in other groups . The cost of IPPB is also considerably greater than either incentive spirometry or blow bottles . IPPB is not essential to prevention of atelectasis in postoperative cardiac surgical patients and may be inferior to other methods",
"Intestinal ischemia should be suspected in any patient following aortic surgery who has pain out of keeping with the operation , postoperative diarrhea ( with or without bleeding ) or an unexplained metabolic acidosis . Ten such cases of intestinal ischemia were identified during a 10-year period at the Toronto General and Toronto Western hospitals . Six occurred following repair of a ruptured abdominal aneurysm , one followed elective aneurysmectomy and three followed elective bypass for occlusive disease . The overall mortality was 70 % . Transmural bowel infa rct ion was found in six patients ( all died ) , while four patients had partial-thickness injury ( one died , three had late strictures ) . Potentially preventable factors in each patient , either single or multiple , were identified and are discussed . Emphasis on early diagnosis is stressed , because once transmural necrosis has occurred the prognosis is poor",
"Coronary artery bypass surgery is frequently complicated by postoperative atelectasis . Although routinely prescribed , the efficacy of any specific chest physical therapy is not well established . We studied patients at a university center undergoing elective coronary artery bypass surgery . Based upon chest X-ray criteria at extubation , patients ( n = 228 ) were classified as demonstrating greater or lesser degrees of atelectasis . Those with a lesser degree of atelectasis were r and omized to receive either early mobilization or sustained maximal inflations ( SMI ) . Those with greater a degree of atelectasis were separately r and omized to receive either SMI or single-h and ed percussions ( SSP ) . We found the extent of atelectasis at extubation did not predict the risk of developing pneumonia . Hospital stays and intensive care unit stays were similar regardless of treatment . Physical therapy costs were highest in the most labor-intensive therapy group ( SSP ) . We conclude that postoperative respiratory dysfunction is common but does not commonly cause significant morbidity or prolong hospital stay . Adding SMI to patients with minimal atelectasis at extubation does not improve clinical outcomes . Similarly , adding SSP to patients with marked atelectasis does not improve outcomes over those obtained with SMI and early ambulation",
"OBJECTIVE To compare st and ard nurse-based pain therapy with a patient-controlled analgesia ( PCA ) regimen . DESIGN Prospect i ve , r and omized study . SETTING Single-institutional , clinical investigation in an urban , university-affiliated hospital . PARTICIPANTS Sixty patients undergoing elective first-time cardiac surgery were included . INTERVENTIONS In 30 patients , a st and ard analgesic regimen was used , and in 30 patients , a PCA regimen was used . The perioperative and postoperative management was similar for all patients . MEASUREMENTS AND MAIN RESULTS Degree of sedation , satisfaction , and pain ( by visual analog scale [ VAS ] ) was assessed within the first 3 postoperative days . Vital capacity ( VC ) and forced expiratory volume in 1 second ( FEV1 ) were measured using a portable spirometry system . Cortisol and troponin T ( TnT ) plasma levels were also measured . The expectation of pain was similar in both groups , and the postoperative pain score was significantly lower in the PCA than in the st and ard group throughout the study period . Significantly more piritramid was used in the PCA ( total , 75.6 + /- 33.4 mg ) than in the st and ard group ( total , 20.1 + /- 31.9 mg ) . VC and FEV1 were significantly lower in the st and ard group compared with the PCA patients . Cortisol and TnT plasma levels were similar in both groups . Frequency of side effects were similar for both groups . CONCLUSION Because of the beneficial effects with regard to degree of pain and satisfaction , pain management using PCA systems can be recommended for cardiac surgery patients . It appears to be superior to st and ard nurse-based pain therapy"
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41164868-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Evidence from systematic review s of observational studies suggests that hormone therapy may have beneficial effects in reducing the incidence of cardiovascular disease events in post-menopausal women , however the results of r and omised controlled trials ( RCTs ) have had mixed results . This is an up date d version of a Cochrane review published in 2013 . OBJECTIVES To assess the effects of hormone therapy for the prevention of cardiovascular disease in post-menopausal women , and whether there are differential effects between use in primary or secondary prevention . Secondary aims were to undertake exploratory analyses to ( i ) assess the impact of time since menopause that treatment was commenced ( ≥ 10 years versus of trial participants at baseline as a proxy ( ≥ 60 years of age versus ) ; and ( ii ) assess the effects of length of time on treatment . SEARCH METHODS We search ed the following data bases on 25 February 2014 : Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library , MEDLINE , EMBASE and LILACS . We also search ed research and trials registers , and conducted reference checking of relevant studies and related systematic review s to identify additional studies . SELECTION CRITERIA RCTs of women comparing orally administered hormone therapy with placebo or a no treatment control , with a minimum of six months follow-up . DATA COLLECTION AND ANALYSIS Two authors independently assessed study quality and extracted data . We calculated risk ratios ( RRs ) with 95 % confidence intervals ( CIs ) for each outcome . We combined results using r and om effects meta-analyses , and undertook further analyses to assess the effects of treatment as primary or secondary prevention , and whether treatment was commenced more than or less than 10 years after menopause . MAIN RESULTS We identified six new trials through this up date . Therefore the review includes 19 trials with a total of 40,410 post-menopausal women . On the whole , study quality was good and generally at low risk of bias ; the findings are dominated by the three largest trials . We found high quality evidence that hormone therapy in both primary and secondary prevention conferred no protective effects for all-cause mortality , cardiovascular death , non-fatal myocardial infa rct ion , angina , or revascularisation . However , there was an increased risk of stroke in those in the hormone therapy arm for combined primary and secondary prevention ( RR 1.24 , 95 % CI 1.10 to 1.41 ) . Venous thromboembolic events were increased ( RR 1.92 , 95 % CI 1.36 to 2.69 ) , as were pulmonary emboli ( RR 1.81 , 95 % CI 1.32 to 2.48 ) on hormone therapy relative to placebo . The absolute risk increase for stroke was 6 per 1000 women ( number needed to treat for an additional harmful outcome ( NNTH ) = 165 ; mean length of follow-up : 4.21 years ( range : 2.0 to 7.1 ) ) ; for venous thromboembolism 8 per 1000 women ( NNTH = 118 ; mean length of follow-up : 5.95 years ( range : 1.0 to 7.1 ) ) ; and for pulmonary embolism 4 per 1000 ( NNTH = 242 ; mean length of follow-up : 3.13 years ( range : 1.0 to 7.1)).We performed subgroup analyses according to when treatment was started in relation to the menopause . Those who started hormone therapy less than 10 years after the menopause had lower mortality ( RR 0.70 , 95 % CI 0.52 to 0.95 , moderate quality evidence ) and coronary heart disease ( composite of death from cardiovascular causes and non-fatal myocardial infa rct ion ) ( RR 0.52 , 95 % CI 0.29 to 0.96 ; moderate quality evidence ) , though they were still at increased risk of venous thromboembolism ( RR 1.74 , 95 % CI 1.11 to 2.73 , high quality evidence ) compared to placebo or no treatment . There was no strong evidence of effect on risk of stroke in this group . In those who started treatment more than 10 years after the menopause there was high quality evidence that it had little effect on death or coronary heart disease between groups but there was an increased risk of stroke ( RR 1.21 , 95 % CI 1.06 to 1.38 , high quality evidence ) and venous thromboembolism ( RR 1.96 , 95 % CI 1.37 to 2.80 , high quality evidence ) . AUTHORS ' CONCLUSIONS Our review findings provide strong evidence that treatment with hormone therapy in post-menopausal women overall , for either primary or secondary prevention of cardiovascular disease events has little if any benefit and causes an increase in the risk of stroke and venous thromboembolic events
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"The effect of oral oestriol ( 3 mg/day for 4 weeks followed by 2 mg/day for a further 6 weeks ) on the vaginal bacterial flora , vaginal cytology and urogenital symptoms was assessed in a double-blind , placebo-controlled study in 35 women with symptoms of the urogenital oestrogen deficiency syndrome . No significant differences were observed with regard to the occurrence or severity of urogenital symptoms , vaginal pH , karyopyknotic index ( KPI ) or the baseline results of vaginal bacterial cultures in the 18 patients ( mean age 71.6 + /- 1.0 years ) treated with oestriol and the 17 women ( mean age 72.6 + /- 1.4 years ) who received placebo tablets . A decrease in both vaginal pH ( P less than 0.001 ) and the proportion of faecal-type bacteria ( P less than 0.05 ) , and an increase in the KPI ( P less than 0.01 ) and the proportion of lactobacilli ( P less than 0.001 ) were recorded after 10 weeks of treatment with oral oestriol . At the end of the following 10 medication-free weeks all of these parameters except vaginal pH had returned to values that were not significantly altered from the corresponding baseline levels . In the patients treated with placebo no significant changes occurred in vaginal pH , KPI or the proportion of lactobacilli in vaginal cultures during the course of this study . Urogenital symptoms improved in both groups after medication ( and even after the medication-free period ) in relation to the baseline assessment , which reflects the latter 's subjective nature",
"Objective —The effects of hormone replacement therapy ( HRT ) can affect many aspects relevant to cardiovascular disease , including vasomotor function , inflammation , and hemostasis . Recent studies have demonstrated that current doses of HRT exert a mixture of both protective and adverse effects . In the current study , we compared the effects of lower doses of HRT ( L-HRT ) and conventional doses of HRT ( C-HRT ) on a variety of relevant cardiovascular parameters . Methods and Results —This r and omized , double-blind , crossover study included 57 women who received micronized progesterone 100 mg with either conjugated equine estrogen 0.625 mg ( C-HRT ) or 0.3 mg ( L-HRT ) daily for 2 months . L-HRT showed comparable effects to C-HRT on high-density lipoprotein cholesterol and triglyceride levels , but not on low-density lipoprotein cholesterol levels . C-HRT and L-HRT significantly improved the percent flow-mediated dilator response to hyperemia from baseline values ( both P C-HRT significantly increased high-sensitivity C-reactive protein ( hsCRP ) levels from baseline values ( P L-HRT did not significantly change hsCRP ( P = 0.874 ) . C-HRT and L-HRT significantly decreased antithrombin III from baseline values ( P C-HRT significantly increased prothrombin fragment 1 + 2 ( F1 + 2 ) from baseline values ( P L-HRT did not significantly change F1 + 2 ( P = 0.558 ) . Of interest , the effects of C-HRT and L-HRT on hsCRP , antithrombin III , and F1 + 2 were significantly different ( all P C-HRT and L-HRT significantly reduced plasma PAI-1 antigen levels from baseline values ( P = 0.002 and P = 0.038 , respectively ) to a similar degree ( P = 0.184 ) . Conclusions —Compared with C-HRT , L-HRT has comparable effects on lipoproteins , flow-mediated dilation , and PAI-1 antigen levels . However , L-HRT did not increase hsCRP or F1 + 2 levels , and it decreased antithrombin III less than C-HRT",
"Background and Purpose — Raloxifene , a selective estrogen receptor modulator , reduces risk of invasive breast cancer and osteoporosis , but the effect on risk for stroke and venous thromboembolism in different patient subgroups is not established . The purpose of this analysis was to evaluate the effect of raloxifene on the incidence of all strokes , stroke deaths , and venous thromboembolic events according to participant subgroups . Methods — This was a secondary end point analysis of an international , r and omized , placebo-controlled clinical trial of 10 101 postmenopausal women with or at increased risk of coronary heart disease followed a median of 5.6 years . Strokes , venous thromboembolic events , and deaths were adjudicated by expert central ized committees . Strokes were categorized as ischemic , hemorrhagic , or undetermined and venous thromboembolic events were subclassified . Results — The incidences of all strokes did not differ between raloxifene ( incidence rate per 100 woman-years=0.95 ) and placebo ( incidence rate=0.86 ) treatment groups ( P=0.30 ) . In women assigned raloxifene versus placebo , there was a higher incidence of fatal strokes ( incidence rates=0.22 and 0.15 , respectively , P=0.0499 ) and venous thromboembolic events ( incidence rates=0.39 and 0.27 , respectively , P=0.02 ) . No significant subgroup interactions were found except that there was a higher incidence of stroke associated with raloxifene use among current smokers . Conclusions — In postmenopausal women at increased risk for coronary events , the incidences of venous thromboembolism and fatal stroke but not all strokes were higher in those assigned raloxifene versus placebo . Raloxifene ’s effect did not differ across subgroups , except that the risk of stroke differed by smoking status . Treatment decisions about raloxifene should be based on a balance of projected absolute risks and benefits",
"Background — The Women ’s Health Initiative ( WHI ) Estrogen Alone trial assessed the balance of benefits and risks of hormone use in healthy postmenopausal women . The trial was stopped prematurely because there was no benefit for coronary heart disease and an increased risk of stroke . This report provides a thorough analysis of the stroke finding using the final results from the completed trial data base . Methods and Results — The WHI Estrogen Alone hormone trial is a multicenter , double-blind , placebo-controlled , r and omized clinical trial in 10 739 women aged 50 to 79 years who were given daily conjugated equine estrogen ( CEE ; 0.625 mg ; n=5310 ) or placebo ( n=5429 ) . During an average follow-up of 7.1 years , there were 168 strokes in the CEE group and 127 in the placebo group ; 80.3 % of strokes were ischemic . For all stroke the intention-to-treat hazard ratio [ HR ] ( 95 % CI ) for CEE versus placebo was 1.37 ( 1.09 to 1.73 ) . The HR ( 95 % CI ) was 1.55 ( 1.19 to 2.01 ) for ischemic stroke and 0.64 ( 0.35 , 1.18 ) for hemorrhagic stroke . The HRs indicate excess risk of ischemic stroke was apparent in all categories of baseline stroke risk , including younger and more recently menopausal women and in women with prior or current use of statins or aspirin . Conclusions — CEE increases the risk of ischemic stroke in generally healthy postmenopausal women . The excess risk appeared to be present in all subgroups of women examined , including younger and more recently menopausal women . There was no convincing evidence to suggest that CEE had an effect on the risk of hemorrhagic stroke",
"Abstract —Postmenopausal hormone replacement therapy ( HRT ) is associated with low cardiovascular morbidity and mortality in epidemiological studies . Yet , no r and omized trial has examined whether HRT is effective for prevention of coronary heart disease ( CHD ) in women with increased risk . The objective of this study was to determine whether HRT can slow progression of atherosclerosis , measured as intima-media thickness ( IMT ) in carotid arteries . Carotid IMT is an appropriate intermediate end point to investigate clinical ly relevant effects on atherogenesis . This r and omized , controlled , observer-blind , clinical , single-center trial enrolled 321 healthy postmenopausal women with increased IMT in ≥1 segment of the carotid arteries . For a period of 48 weeks , subjects received either 1 mg/d 17&bgr;-estradiol continuously plus 0.025 mg gestodene for 12 days every month ( st and ard-progestin group ) , or 1 mg 17&bgr;-estradiol plus 0.025 mg gestodene for 12 days every third month ( low-progestin group ) , or no HRT . Maximum IMT in 6 carotid artery segments ( common , bifurcation , and internal , both sides ) was measured by B-mode ultrasound before and after intervention . HRT did not slow IMT progression in carotid arteries . Mean maximum IMT in the carotid arteries increased by 0.02±0.05 mm in the no HRT group and by 0.03±0.05 and 0.03±0.05 mm , respectively , in the HRT groups ( P > 0.2 ) . HRT significantly decreased LDL cholesterol , fibrinogen , and follicle-stimulating hormone . In conclusion , 1 year of HRT was not effective in slowing progression of sub clinical atherosclerosis in postmenopausal women at increased risk",
"Objective To assess the effect of combined hormone replacement therapy ( HRT ) on health related quality of life . Design R and omised placebo controlled double blind trial . Setting General practice s in United Kingdom ( 384 ) , Australia ( 94 ) , and New Zeal and ( 24 ) . Participants Postmenopausal women aged 50 - 69 at r and omisation ; 3721 women with a uterus were r and omised to combined oestrogen and progestogen ( n=1862 ) or placebo ( n=1859 ) . Data on health related quality of life at one year were available from 1043 and 1087 women , respectively . Interventions Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year . Main outcome measures Health related quality of life and psychological wellbeing as measured by the women ’s health question naire . Changes in emotional and physical menopausal symptoms as measured by a symptoms question naire and depression by the Centre for Epidemiological Studies depression scale ( CES-D ) . Overall health related quality of life and overall quality of life as measured by the European quality of life instrument ( EuroQol ) and visual analogue scale , respectively . Results After one year small but significant improvements were observed in three of nine components of the women ’s health question naire for those taking combined HRT compared with those taking placebo : vasomotor symptoms ( P sexual functioning ( P sleep problems ( P combined HRT group reported hot flushes ( P night sweats ( P aching joints and muscles ( P=0.001 ) , insomnia ( P vaginal dryness ( P placebo group , but greater proportions reported breast tenderness ( P vaginal discharge ( P Hot flushes were experienced in the combined HRT and placebo groups by 30 % and 29 % at trial entry and 9 % and 25 % at one year , respectively . No significant differences in other menopausal symptoms , depression , or overall quality of life were observed at one year . Conclusions Combined HRT started many years after the menopause can improve health related quality of life . Trial registration IS RCT N 63718836",
"Estrogen deficiency and declining calcium absorption due to reduced calcitriol levels or intestinal resistance to calcitriol , are important factors in the pathogenesis of age-related bone loss . The main objective of this study was to examine the effect of estrogen and 1,25-dihydroxyvitamin D therapy given individually or in combination on bone loss in elderly women . Four hundred eighty-nine elderly women with normal bone density for their age , aged 65 - 77 yr , were entered into a r and omized double blind , placebo-controlled trial . Women were r and omized to one of four groups : conjugated estrogens ( 0.625 mg , daily ) to women without a uterus ( estrogen replacement therapy ) plus medroxyprogesterone acetate ( 2.5 mg , daily ) to women with a uterus ( hormone replacement therapy ) , calcitriol ( 0.25 microg twice daily ) , a combination of hormone replacement therapy/estrogen replacement therapy plus calcitriol , or placebos for 3 yr . The primary outcome was the change in bone mineral density of the femoral neck and spine . In the intent to treat analysis , hormone therapy ( hormone replacement therapy/estrogen replacement therapy ) produced a mean ( + /-1 SD ) increase in bone mineral density of 2.98 % ( + /-5.45 % ) at the femoral neck ( P total hip and trochanter bone mineral density . Calcitriol increased bone mineral density 0.10 % ( + /- 4.27 % ) at the femoral neck ( P = 0.57 ) and 1.65 % ( + /- 4.83 % ) at the spine ( P of hormone replacement therapy/estrogen replacement therapy + calcitriol increased bone mineral density 3.80 % ( + /-4.95 % ) at the femoral neck ( P hip and trochanter . All three treatment groups differed significantly from placebo at the spine and for the hormone replacement therapy/estrogen replacement therapy groups at the femoral neck , spine , total hip and trochanter . There were no significant differences between combination therapy and hormone replacement therapy/estrogen replacement therapy alone on bone mineral density at any site in the intent to treat analysis . In a secondary analysis of the effect in women who were adherent to treatment , calcitriol had a more significant effect on spine ( P = 0.003 ) and total hip ( P = 0.004 ) . The increase in bone mineral density in the adherent groups of women was always higher compared with the intent to treat groups . Combination therapy compared with hormone replacement therapy/estrogen replacement therapy alone produced a significantly greater response in trochanter ( P = 0.007 ) and total hip bone mineral density ( P = 0.0017 ) . In summary , hormone replacement therapy/estrogen replacement therapy alone and in combination with calcitriol therapy was highly effective in reducing bone resorption and increasing bone mineral density at the hip and other clinical ly relevant sites in a group of elderly women , with normal bone density for their age . Calcitriol was effective in increasing spine bone mineral density . In the adherent women , combination therapy with hormone replacement therapy/estrogen replacement therapy and calcitriol increased bone mineral density significantly more in the total hip and trochanter than did hormone replacement therapy/estrogen replacement therapy alone",
"BACKGROUND Administration of estrogen or etidronate has been shown to increase bone mineral density in postmenopausal women . This 4-year , prospect i ve , r and omized study was carried out to monitor any added beneficial effect on bone mineral density when hormone-replacement therapy ( HRT ) was combined with etidronate . PATIENTS AND METHODS Fifty-eight early postmenopausal women attending metabolic bone disease outpatient clinics were r and omly allocated into four treatment groups and monitored for up to 4 years . All patients received 1.0 g/d of elemental calcium . In addition , group 1 received percutaneously administered HRT ( n = 15 ) ; group 2 , intermittent cyclical etidronate ( ICE ) ( n = 14 ) ; group 3 , HRT and ICE ( n = 15 ) ; and group 4 , calcium alone ( n = 14 ) . The bone mineral density ( measured by dual-energy x-ray absorptiometry ) , biochemical variables of bone turnover , including bone-specific alkaline phosphatase , and urinary hydroxyproline : creatinine ratios were measured before treatment and at 2 and 4 years after treatment . RESULTS In patients who received the combined therapy , bone mineral density was increased in the vertebrae by 10.9 % ( P ICE , the increase was 6.79 % ( P HRT , 6.78 % ( P bone mineral density in vertebrae and femora . Patients who received no specific therapy lost 8.58 % ( P bone mineral density in both vertebrae ( P HRT , or ICE , alone . Three of 9 patients ( 33 % ) in the ICE group developed osteomalacia , as shown by bone histomorphometry , whereas in women who received combined HRT and ICE therapies , none of the 11 patients tested had evidence of bone mineralization defects . CONCLUSION This 4-year , prospect i ve , r and omized study in early postmenopausal women showed an additive effect of ICE and HRT on the bone mineral density in both vertebrae and the hip . Furthermore , the combined therapy prevented the occurrence of osteomalacia associated with etidronate . This is the first study to demonstrate the effects of etidronate in early postmenopausal women , and the additive beneficial effects of HRT and ICE on bone mineral density ",
"CONTEXT Postmenopausal hormone therapy increases the risk of venous thrombosis . It is not known whether other factors influencing thrombosis add to this risk . OBJECTIVE To report final data on incidence of venous thrombosis in the Women 's Health Initiative Estrogen Plus Progestin clinical trial and the association of hormone therapy with venous thrombosis in the setting of other thrombosis risk factors . DESIGN , SETTING , AND PARTICIPANTS Double-blind r and omized controlled trial of 16,608 postmenopausal women between the ages of 50 and 79 years , who were enrolled in 1993 through 1998 at 40 US clinical centers with 5.6 years of follow up ; and a nested case-control study . Baseline gene variants related to thrombosis risk were measured in the first 147 women who developed thrombosis and in 513 controls . INTERVENTION R and om assignment to 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate , or placebo . MAIN OUTCOME MEASURES Central ly vali date d deep vein thrombosis and pulmonary embolus . RESULTS Venous thrombosis occurred in 167 women taking estrogen plus progestin ( 3.5 per 1000 person-years ) and in 76 taking placebo ( 1.7 per 1000 person-years ) ; hazard ratio ( HR ) , 2.06 ( 95 % confidence interval [ CI ] , 1.57 - 2.70 ) . Compared with women between the ages of 50 and 59 years who were taking placebo , the risk associated with hormone therapy was higher with age : HR of 4.28 ( 95 % CI , 2.38 - 7.72 ) for women aged 60 to 69 years and 7.46 ( 95 % CI , 4.32 - 14.38 ) for women aged 70 to 79 years . Compared with women who were of normal weight and taking placebo , the risk associated with taking estrogen plus progestin was increased among overweight and obese women : HR of 3.80 ( 95 % CI , 2.08 - 6.94 ) and 5.61 ( 95 % CI , 3.12 - 10.11 ) , respectively . Factor V Leiden enhanced the hormone-associated risk of thrombosis with a 6.69-fold increased risk compared with women in the placebo group without the mutation ( 95 % CI , 3.09 - 14.49 ) . Other genetic variants ( prothrombin 20210A , methylenetetrahydrofolate reductase C677 T , factor XIII Val34Leu , PAI-1 4G/5 G , and factor V HR2 ) did not modify the association of hormone therapy with venous thrombosis . CONCLUSIONS Estrogen plus progestin was associated with doubling the risk of venous thrombosis . Estrogen plus progestin therapy increased the risks associated with age , overweight or obesity , and factor V Leiden",
"In the 1990s , two r and omised clinical trials started in Sc and inavia addressing whether hormone replacement therapy ( HRT ) is safe for women with previous breast cancer . We report the findings of the safety analysis in HABITS ( hormonal replacement therapy after breast cancer -- is it safe ? ) , an open r and omised clinical trial with allocation to either HRT or best treatment without hormones . The main endpoint was any new breast cancer event . All analyses were done according to intention-to-treat . Until September , 2003 , 434 women were r and omised ; 345 had at least one follow-up report . After a median follow-up of 2.1 years , 26 women in the HRT group and seven in the non-HRT group had a new breast-cancer event . All women with an event in the HRT group and two of those in the non-HRT group were exposed to HRT and most women had their event when on treatment . We decided that these findings indicated an unacceptable risk for women exposed to HRT in the HABITS trial , and the trial was terminated on Dec 17 , 2003",
"The authors further analyzed results from the Women 's Health Initiative r and omized trials ( 1993 - 2004 ) of conjugated equine estrogens , with or without medroxyprogesterone acetate , focusing on health benefits versus risks among women who initiated hormone therapy soon after menopause . Data from the Women 's Health Initiative observational study ( 1993 - 2004 ) were included in some analyses for additional precision . Results are presented here for incident coronary heart disease , stroke , venous thromboembolism , breast cancer , colorectal cancer , endometrial cancer , or hip fracture ; death from other causes ; a summary global index ; total cancer ; and total mortality . Hazard ratios for breast cancer and total cancer were comparatively higher ( P women who initiated hormone therapy soon after menopause , for both regimens . Among these women , use of conjugated equine estrogens appeared to produce elevations in venous thromboembolism and stroke and a reduction in hip fracture . Estrogen plus progestin results among women who initiated use soon after menopause were similar for venous thromboembolism , stroke , and hip fracture but also included evidence of longer-term elevations in breast cancer , total cancer , and the global index . These analyses provide little support for the hypothesis of favorable effects among women who initiate postmenopausal estrogen use soon after menopause , either for coronary heart disease or for health benefits versus risk indices considered",
"Recent observational studies suggest a 2 - 4 fold increased risk of venous thromboembolism ( VTE ) in women taking hormone replacement therapy ( HRT ) . The present study was started before publication of these studies , and the aim was to determine if HRT alters the risk of VTE in high risk women . The study was a r and omized . double-blind , and placebo-controlled clinical trial with a double-triangular sequential design . Females with previously verified VTE were r and omized to 2 mg estradiol plus 1 mg norethisterone acetate , 1 tablet daily ( n = 71 ) or placebo ( n = 69 ) . The primary outcome was recurrent deep venous thrombosis ( DVT ) or pulmonary embolism ( PE ) . Between 1996 and 1998 a total of 140 women were included . The study was terminated prematurely based on the results of circumstantial evidence emerging during the trial . Eight women in the HRT group and one woman in the placebo group developed VTE . The incidence of VTE was 10.7 % in the HRT group and 2.3 % in the placebo group . In the HRT group , all events happened within 261 days after inclusion . The sequential design did not stop the study , but strongly indicated a difference between the two groups . Our data strongly suggests that women who have previously suffered a VTE have an increased risk of recurrence on HRT . This treatment should therefore be avoided in this patient group if possible . The results also support those of recent epidemiological studies , which also indicate increased risk of VTE in non-selected female population s during HRT",
"Objective : The aim of this study was to examine interactions between hot flushes , estrogen plus progestogen therapy ( EPT ) , and coronary heart disease ( CHD ) events in postmenopausal women with CHD . Methods : We analyzed data from the Heart and Estrogen/Progestin Replacement Study , a r and omized , placebo-controlled trial of 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate in 2,763 postmenopausal women with CHD . Hot flushes were assessed at baseline using self-administered question naires ; women reporting bothersome hot flushes \" some \" to \" all \" of the time were considered to have clinical ly significant flushing . Cox regression models were used to examine the effect of EPT on risk of CHD events among women with and without significant flushing at baseline . Results : The mean age of participants was 66.7 ± 6.8 years , and 89 % ( n = 2,448 ) were white . Sixteen percent ( n = 434 ) of participants reported clinical ly significant hot flushes at baseline . Among women with baseline flushing , EPT increased risk of CHD events nine-fold in the first year compared with placebo ( hazard ratio = 9.01 ; 95 % CI , 1.15 - 70.35 ) ; among women without baseline flushing , treatment did not significantly affect CHD event risk in the first year ( hazard ratio = 1.32 ; 95 % CI , 0.86 - 2.03 ; P = 0.07 for interaction of hot flushes with treatment ) . The trend toward differential effects of EPT on risk for CHD among women with and without baseline flushing did not persist after the first year of treatment . Conclusions : Among older postmenopausal women with CHD , EPT may increase risk of CHD events substantially in the first year of treatment among women with clinical ly significant hot flushes but not among those without hot flushes",
"The effect of natural oestrogens on serum cholesterol and serum triglyceride levels was studied in a controlled double‐blind clinical trial . No statistically significant changes were found in the blood lipids when comparing the patients treated with oestradiol , 2 mg , and oestriol , 1 mg , and those given placebo",
"The Women 's Health Initiative ( WHI ) is a large and complex clinical investigation of strategies for the prevention and control of some of the most common causes of morbidity and mortality among postmenopausal women , including cancer , cardiovascular disease , and osteoporotic fractures . The WHI was initiated in 1992 , with a planned completion date of 2007 . Postmenopausal women ranging in age from 50 to 79 are enrolled at one of 40 WHI clinical centers nationwide into either a clinical trial ( CT ) that will include about 64,500 women or an observational study ( OS ) that will include about 100,000 women . The CT is design ed to allow r and omized controlled evaluation of three distinct interventions : a low-fat eating pattern , hypothesized to prevent breast cancer and colorectal cancer and , secondarily , coronary heart disease ; hormone replacement therapy , hypothesized to reduce the risk of coronary heart disease and other cardiovascular diseases and , secondarily , to reduce the risk of hip and other fractures , with increased breast cancer risk as a possible adverse outcome ; and calcium and vitamin D supplementation , hypothesized to prevent hip fractures and , secondarily , other fractures and colorectal cancer . Overall benefit-versus-risk assessment is a central focus in each of the three CT components . Women are screened for participation in one or both of the components -- dietary modification ( DM ) or hormone replacement therapy (HRT)--of the CT , which will r and omize 48,000 and 27,500 women , respectively . Women who prove to be ineligible for , or who are unwilling to enroll in , these CT components are invited to enroll in the OS . At their 1-year anniversary of r and omization , CT women are invited to be further r and omized into the calcium and vitamin D ( CaD ) trial component , which is projected to include 45,000 women . The average follow-up for women in either CT or OS is approximately 9 years . Concerted efforts are made to enroll women of racial and ethnic minority groups , with a target of 20 % of overall enrollment in both the CT and OS . This article gives a brief description of the rationale for the interventions being studied in each of the CT components and for the inclusion of the OS component . Some detail is provided on specific study design choices , including eligibility criteria , recruitment strategy , and sample size , with attention to the partial factorial design of the CT . Some aspects of the CT monitoring approach are also outlined . The scientific and logistic complexity of the WHI implies particular leadership and management challenges . The WHI organization and committee structure employed to respond to these challenges is also briefly described",
"Female hormones are known in influence serum lipoproteins . In post-menopausal women oestrogens decrease the concentration of low-density lipoprotein ( LDL ) and increase that of high-density lipoprotein ( HDL ) , while progestogens may have the opposite effect . The risk of coronary heart disease ( CHD ) should consequently be decreased by oestrogens and increased by progestogens . We report here the changes observed in serum total cholesterol , triglycerides , and lipoproteins in post-menopausal women during sequential oestrogen/progestogen treatment . Oestriol and 17 beta-oestradiol were given alone for the first 12 days , in combination with norethisterone acetate ( 1 mg/day ) for the next 10 days , and then in reduced amounts for the last 6 days of the 28-day cycle . Three different doses of the oestrogens were investigated ( high , medium and low ) . A total of 177 normal post-menopausal women volunteered for r and om allocation to treatment or placebo groups . Blood sample s were taken every 3 mth during the progestogen phase of the cycle . Serum total cholesterol was found to be 10 - 13 % lower over a 3-yr period on the high oestrogen dose and 5 and 3 % lower on the medium and low doses , respectively . No significant changes were seen in serum triglycerides . Determination of lipoprotein fractions showed that the reduction in total cholesterol was due to reduced LDL-cholesterol , the HDL-cholesterol levels remaining virtually unchanged",
"PURPOSE To determine whether baseline serum uric acid ( UA ) levels and estrogen-progestin (E+P)-associated change in serum UA in postmenopausal women with coronary disease are associated with recurrent coronary heart disease ( CHD ) events . METHODS 2763 postmenopausal women enrolled in the Heart and Estrogen-Progestin Replacement Study ( HERS ) were r and omly assigned to take conjugated E+P or placebo in a secondary CHD prevention study . The primary outcome for these analyses was nonfatal myocardial infa rct ion or CHD death during a mean follow up of 4.1 years . RESULTS The baseline serum UA for the cohort was 5.4 mg/dl and , compared with placebo , E+P on average lowered serum UA levels slightly ( 0.2 mg/dl ) at one year of follow up ( p Baseline serum UA levels were associated in simple proportional hazards models with CHD events ; each st and ard deviation increase ( 1.3 mg/dl ) was associated with a 22 % increased risk of primary CHD events ( p=.0001 ) . This association , however , was no longer statistically significant after multivariable adjustment ( p=0.36 ) . There was no association between on- study change in serum UA level and any CHD outcome . CONCLUSION Treatment with E+P lowered serum UA levels slightly , but neither baseline UA nor change in UA affected CHD risk",
"CONTEXT The Heart and Estrogen/progestin Replacement Study ( HERS ) found no overall reduction in risk of coronary heart disease ( CHD ) events among postmenopausal women with CHD . However , in the hormone group , findings did suggest a higher risk of CHD events during the first year , and a decreased risk during years 3 to 5 . OBJECTIVE To determine if the risk reduction observed in the later years of HERS persisted and result ed in an overall reduced risk of CHD events with additional years of follow-up . DESIGN AND SETTING R and omized , blinded , placebo-controlled trial of 4.1 years ' duration ( HERS ) and subsequent unblinded follow-up for 2.7 years ( HERS II ) conducted at outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 postmenopausal women with CHD and average age of 67 years at enrollment in HERS ; 2321 women ( 93 % of those surviving ) consented to follow-up in HERS II . INTERVENTION Participants were r and omly assigned to receive 0.625 mg/d of conjugated estrogens and 2.5 mg of medroxyprogesterone acetate ( n = 1380 ) , or placebo ( n = 1383 ) during HERS ; open-label hormone therapy was prescribed at personal physicians ' discretion during HERS II . The proportions with at least 80 % adherence to hormones declined from 81 % ( year 1 ) to 45 % ( year 6 ) in the hormone group , and increased from 0 % ( year 1 ) to 8 % ( year 6 ) in the placebo group . MAIN OUTCOME MEASURES The primary outcome was nonfatal myocardial infa rct ion and CHD death . Secondary cardiovascular events were coronary revascularization , hospitalization for unstable angina or congestive heart failure , nonfatal ventricular arrhythmia , sudden death , stroke or transient ischemic attack , and peripheral arterial disease . RESULTS There were no significant decreases in rates of primary CHD events or secondary cardiovascular events among women assigned to the hormone group compared with the placebo group in HERS , HERS II , or overall . The unadjusted relative hazard ( RH ) for CHD events in HERS was 0.99 ( 95 % confidence interval [ CI ] , 0.81 - 1.22 ) ; HERS II , 1.00 ( 95 % CI , 0.77 - 1.29 ) ; and overall , 0.99 ( 0.84 - 1.17 ) . The overall RHs were similar after adjustment for potential confounders and differential use of statins between treatment groups ( RH , 0.97 ; 95 % CI , 0.82 - 1.14 ) , and in analyses restricted to women who were adherent to r and omized treatment assignment ( RH , 0.96 ; 95 % CI , 0.77 - 1.19 ) . CONCLUSIONS Lower rates of CHD events among women in the hormone group in the final years of HERS did not persist during additional years of follow-up . After 6.8 years , hormone therapy did not reduce risk of cardiovascular events in women with CHD . Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD",
"Use of conjugated equine estrogens ( CEE ) has been linked to smaller regional brain volumes in women aged ≥65 years ; however , it is unknown whether this results in a broad-based characteristic pattern of effects . Structural magnetic resonance imaging was used to assess regional volumes of normal tissue and ischemic lesions among 513 women who had been enrolled in a r and omized clinical trial of CEE therapy for an average of 6.6 years , beginning at ages 65 - 80 years . A multivariate pattern analysis , based on a machine learning technique that combined R and om Forest and logistic regression with L(1 ) penalty , was applied to identify patterns among regional volumes associated with therapy and whether patterns discriminate between treatment groups . The multivariate pattern analysis detected smaller regional volumes of normal tissue within the limbic and temporal lobes among women that had been assigned to CEE therapy . Mean decrements ranged as high as 7 % in the left entorhinal cortex and 5 % in the left perirhinal cortex , which exceeded the effect sizes reported previously in frontal lobe and hippocampus . Overall accuracy of classification based on these patterns , however , was projected to be only 54.5 % . Prescription of CEE therapy for an average of 6.6 years is associated with lower regional brain volumes , but it does not induce a characteristic spatial pattern of changes in brain volumes of sufficient magnitude to discriminate users and nonusers",
"The postmenopausal hormone therapy ( PHT ) component of the Women ’s Health Initiative ( WHI ) is composed of two r and omized , placebo-controlled , double-blind trials in postmenopausal women aged 50 to 79 years at initial screening , testing the effects of estrogen alone ( E-alone ) and estrogen plus progestin ( E P ) on coronary heart disease ( CHD ) as the primary outcome , hip and other fractures and colorectal cancer as secondary outcomes , and pulmonary embolism , breast and endometrial cancers as potential risks . The design and rationale of the PHT trials , including general eligibility and exclusion criteria and considerations regarding sample size and statistical power , have been described previously ( 1 ) . Postmenopausal hormones have been initiated in menopausal women for the treatment of vasomotor symptoms , mood disturbances , vaginal dryness , and prevention of rapid bone loss for several decades . Despite a paucity of data on effects of initiating hormone use in older women , postmenopausal hormones have also been promoted for the prevention of CHD , osteoporotic fractures , and other diseases that occur years after menopause ( 2 ) . It is generally recommended ( 2 ) that women with a uterus be prescribed a combination of estrogen and progestin to prevent",
"We prospect ively examined the prognostic significance of silent myocardial ischemia detected by ambulatory electrocardiogram ( ECG ) monitoring during daily life in 107 patients with long-term stable angina who were symptomatically controlled on conventional antianginal agents . Forty-six patients ( group 1 ) demonstrated one or more episodes ( 87 % silent ) of myocardial ischemia ; the remaining 61 patients ( group 2 ) had no ischemic ST segment changes . During the mean follow-up period of 23 + /- 8 months , 11 cardiac deaths ( five sudden and six nonsudden ) occurred in group 1 , and five cardiac deaths ( all nonsudden ) occurred in group 2 . Kaplan-Meier survival analysis between the groups confirmed that patients with silent ischemia ( group 1 ) had worse prognoses during the follow-up period ( p = 0.023 ) . Although the higher incidence of hypertension , smoking , hypercholesterolemia , and diabetes in our patients might reflect a more sickly population of stable angina patients , the multivariate Cox 's hazard function analysis of these and other variables including Q waves on ECG , exercise parameters , and ambulatory ECG findings revealed presence of silent ischemia during daily life as the most powerful and independent predictor of cardiac mortality ( p = 0.01 ) . These data indicate that , in such patients with stable angina , silent myocardial ischemia occurs frequently during treatment with conventional antianginal drugs and identifies a subset of patients who are at high risk of cardiac death",
"Markers of inflammation , such as C-reactive protein ( CRP ) and fibrinogen , are associated with the risk of atherothrombosis . Plasma levels of these markers of inflammation are affected by hormone replacement therapy ( HRT ) and modulated by smoking . We studied whether genetic variation in the estrogen receptor- 1 ( ESR1 ) , CRP and fibrinogen-beta genes influences the plasma levels of inflammation markers after HRT . Plasma CRP and fibrinogen were measured after five years follow-up in healthy postmenopausal women ( per- protocol group ) who were r and omised to hormone therapy ( n=187 ) or no treatment ( n=249 ) . The effect of HRT , smoking and genetic variations in ESR1 ( PvuII and XbaI ) , CRP ( 1444C/T ) and fibrinogen-beta ( FGB , -455G/A ) were determined . The plasma concentration of CRP was higher in the HRT group than in the control group ( 2.03 mg/l and 1.41 mg/l , respectively ; p concentration of fibrinogen was lower in the HRT group than in the control group ( 3.02 g/l and 3.20 g/l , respectively ; p smoking and HRT on the fibrinogen ( p=0.02 ) , but not on the CRP concentration ( n.s . ) . Genetic polymorphisms in ESR1 , CRP and fibrinogen were not associated with an effect of HRT on the CRP and fibrinogen plasma levels , and no significant interaction with smoking was observed . In conclusion , higher plasma levels of CRP and lower plasma levels of fibrinogen were observed in women using HRT ; however , genetic polymorphisms in ESR1 , CRP and FGB were not associated with these effects of HRT",
"Pulse pressure , an index of large artery stiffness , has been associated with coronary events . However , mechanisms for this association remain unclear . In this study , we examined the relationship between pulse pressure and the progression of coronary atherosclerosis and the effects of hormone replacement therapy ( HRT ) on pulse pressure in postmenopausal women with angiographically confirmed coronary disease followed for 3.2 years in the Estrogen Replacement in Atherosclerosis ( ERA ) trial . In the ERA trial , 309 postmenopausal women ( mean age 66±7 years ) with coronary disease were r and omized to estrogen , estrogen plus progestin , or placebo , and followed for 3.2 years . Ten st and ardized epicardial segments were measured for minimal diameter values at baseline and follow-up using quantitative coronary angiography . For this study , mixed-model analysis of covariance was used to : ( 1 ) test the association between pulse pressure and change in mean minimum diameter ( MMD ) adjusted for baseline MMD and ( 2 ) the effect of HRT on follow-up pulse pressure . After adjustment for potential confounders , there was a significant grade d increase in progression of coronary stenosis with increasing quartiles of baseline pulse pressure ( P test for trend=0.0001 ) . The progression rate in women with the highest quartile of baseline pulse pressure was 5-fold higher than in women in the lowest quartile ( P postmenopausal women with coronary disease , increased levels of baseline pulse pressure are associated with subsequent progression of coronary atherosclerosis in postmenopausal women . HRT had no detectable effect on pulse pressure ",
"Whether to take hormone therapy is one of the most difficult medical decisions that healthy postmenopausal women face . The apparent coronary benefits ( 1 ) of hormone use are an important part of that decision . Although the data appear consistent in suggesting long-term coronary benefits , the Heart and Estrogen/progestin Replacement Study ( 2 ) showed an increased risk for coronary events during the first year of therapy in women with existing heart disease ; we also found such an elevated risk in an examination of secondary prevention in the Nurses ' Health Study ( 3 ) . More recently , a report from the Women 's Health Initiative , an ongoing r and omized clinical trial of hormone therapy for primary prevention of cardiovascular disease , suggested similar findings in healthy women ( National Institutes of Health . Press release ) . However , additional data on short-term effects of hormone use in women without previous cardiovascular disease are sparse . Many further questions also remain . Among them is the cardiovascular effect of daily doses lower than the st and ard 0.625 mg of oral conjugated estrogen . Recent studies suggest that lower doses of hormone therapy provide bone benefits ( 4 ) and , compared with higher doses , might decrease the risk for thromboembolism ( 5 ) and reduce endometrial hyperplasia ( 4 ) . However , few data are currently available on the relation between low-dose estrogen and primary prevention of heart disease and stroke . In an earlier report , we examined the relation between postmenopausal hormone therapy and primary prevention of cardiovascular disease based on 16 years of follow-up from the Nurses ' Health Study ( 6 ) . In the current analysis , we have almost 50 % more follow-up time among women taking daily doses less than 0.625 mg and more than 800 additional cases of cardiovascular disease , allowing more precise assessment of specific associations . Thus , we now report on the relation among low-dose estrogen , short-term hormone use , and cardiovascular events in 70 533 postmenopausal women with no previous cardiovascular disease who were followed for up to 20 years . We also provide additional information on the effects of estrogen combined with progestin . Methods The Nurses ' Health Study Cohort The Nurses ' Health Study began in 1976 when 121 700 female nurses 30 to 55 years of age completed a mailed question naire about their postmenopausal hormone use and medical history , including cardiovascular disease and its risk factors . We up date information with biennial follow-up question naires . Dietary and physical activity question naires were added in 1980 . Cohort follow-up is greater than 90 % . Ascertainment of Hormone Use In 1976 , women were asked about use and duration of hormone therapy after menopause . Beginning in 1978 , we collected information on type of hormones taken , and starting in 1980 , we asked about the dose of oral conjugated estrogen . All information is up date d biennially . Identification of Cardiovascular Disease We identified first occurrences of nonfatal myocardial infa rct ion , fatal coronary disease , and fatal and nonfatal stroke between the return of the 1976 question naire and 1 June 1996 . Nurses who reported a nonfatal infa rct ion or stroke were asked for permission to review their medical records . Nonfatal myocardial infa rct ions were confirmed by hospital records if they met World Health Organization criteria ( 7 ) ( symptoms plus either elevated levels of cardiac enzymes or diagnostic electrocardiograms ) . Infa rct ions that required hospitalization and were corroborated by interview or letter but for which medical records were unobtainable were included as probable . Infa rct ions of indeterminate age discovered on routine examination were excluded . Nonfatal strokes were confirmed by review of medical records if they were characterized by a typical neurologic deficit , were rapid in onset , lasted at least 24 hours , and met the criteria of the National Survey of Stroke ( 8) . We classified strokes as ischemic ( thrombotic or embolic occlusion of a cerebral artery ) , subarachnoid hemorrhage , or intraparenchymal hemorrhage . We excluded subdural hematomas and strokes caused by infection or neoplasia . Strokes that required hospitalization and were corroborated by letter or interview but for which medical records were unavailable were included as probable . Most deaths were reported by the participants ' families . We search ed the National Death Index to identify deaths among nonrespondents to each 2-year question naire ; mortality follow-up was more than 98 % complete ( 9 ) . For all deaths possibly attributable to cardiovascular causes , we requested permission from relatives ( subject to state regulations ) to review the medical records . Deaths were considered to be due to coronary disease if medical records or autopsy findings confirmed a fatal myocardial infa rct ion . We also included coronary disease listed on the death certificate as the underlying cause without another , more plausible cause , if the nurse was known ( from hospital records , family , or other sources ) to have had coronary disease before death . In no case was the cause listed on the death certificate used as the sole criterion for coronary death . Sudden death within 1 hour of the onset of symptoms in participants with no other plausible cause of death besides coronary disease was also included . Fatal strokes were documented by autopsy or hospital records or if stroke was listed as the underlying cause on the death certificate . The category of major coronary heart disease combines nonfatal myocardial infa rct ion and coronary death ; similarly , total stroke includes nonfatal and fatal cases . The category of combined cardiovascular disease includes major coronary heart disease and stroke . Confirmed and probable cases in each category were analyzed together ( 80 % of major coronary events and 73 % of strokes were confirmed ) . In this and previous analyses ( 6 ) , results for probable cases were similar to those for confirmed cases . The investigators conducted all interviews and record review s without knowledge of participants ' hormone use status . Population for Analysis Women who reported stroke , myocardial infa rct ion , angina , coronary revascularization , or cancer ( except nonmelanoma skin cancer ) on the 1976 question naire were excluded because their disease may have caused them to alter their hormone use . Similarly , women who reported such diagnoses on a subsequent question naire were excluded from further analysis . Thus , at the start of each 2-year interval , the base population included no women reporting these diagnoses . Our own studies ( 6 , 10 ) and other studies ( 11 ) have suggested that hormone therapy may differentially affect incident and fatal strokes ; thus , we separately examined deaths due to stroke . In these analyses , we excluded women with cancer and cardiovascular disease at baseline but did not up date the exclusions because the women who develop cardiovascular disease during follow-up are those most likely to die of stroke . We classified women as postmenopausal from the time of natural menopause or hysterectomy with bilateral oophorectomy . Women who underwent hysterectomy without bilateral oophorectomy were considered postmenopausal when they reached the age at which natural menopause had occurred in 90 % of the cohort ( 54 years for smokers and 56 years for nonsmokers ) . In this cohort , the women 's reports of age at menopause ( 12 ) and type of menopause ( 13 ) were highly accurate . In 1976 , 21 947 postmenopausal women entered the analysis , and 48 586 women were added during follow-up as they became postmenopausal , for a total of 70 533 participants ; 808 825 person-years of follow-up were accrued from 1976 to 1996 . Statistical Analysis For each participant , person-months were allocated to hormone categories according to the 1976 data and were up date d every 2 years ( for estrogen dose , follow-up began in 1980 ) . For analyses of type of hormone therapy , we assigned the regimen reported on the 1978 question naire to women who reported hormone use in 1976 . Analyses of type of hormone therapy were limited to users of oral conjugated estrogen with or without oral medroxyprogesterone acetate , since these were the most common hormone regimens . If no data were available on hormones in a given time period , women were assigned to a missing category for that time period . To maintain the prospect i ve nature of the study , hormone use ( including duration ) during each 2-year period was established from women 's reports at the start of the period ; thus , we probably underestimate duration of use by an average of 1 year . Follow-up for a participant ended at the first diagnosis of cardiovascular disease , death , or 1 June 1996 , whichever came first . The primary analysis is based on incidence rates for which person-months of follow-up were used as the denominator . We used relative risk as the measure of association , defined as the incidence of cardiovascular events among women in various categories of hormone use divided by the incidence among women who never used hormones . We computed age-specific rates by using 5-year categories ( 14 ) and age-adjusted relative risks by using MantelHaenszel rate ratios ( 15 ) with 95 % CIs ( 16 ) . We used pooled logistic regression across the ten 2-year time periods to adjust simultaneously for potential confounding factors ( 17 ) . In this approach , independent blocks of person-time are pooled for regression analysis , and time-varying covariates are readily accommo date d by assigning successive blocks of person-time to the covariate values at the start of each follow-up cycle . The dependence of the incidence rates on time is modeled nonparametrically with indicator variables . Simulation studies have established the asymptotic equivalence of pooled logistic regression to Cox regression with time-dependent covariates ( 18 ) . The necessary conditions for this equivalence include relatively short time intervals and small probability of the outcome during each interval , both",
"AIMS R and omized trials have not demonstrated coronary heart disease benefit from hormone replacement therapy ( HRT ) . We hypothesized that low-dose HRT may avoid harm . METHODS AND RESULTS We studied the effects of HRT on lipids and coagulation in women with acute coronary syndromes . A total of 100 post-menopausal women > 55 years were enrolled between 2 and 28 days after an acute coronary syndrome and r and omized to oral oestradiol-17beta 1 mg plus norethisterone acetate 0.5 mg daily , or matching placebo , and followed for up to 12 months . Levels of lipids , lipoproteins , and haemostasis markers were measured at baseline , 3 , and 6 months . There were no significant differences in lipid levels between the two groups , probably due to concomitant statin use . Antithrombin and factor VII levels were significantly lower in the HRT group , whereas fibrinogen was significantly decreased in the placebo group . No evidence of increased coagulation activation was observed , nor of adverse cardiovascular outcomes [ odds ratio ( OR ) 0.63 ( 95 % confidence intervals 0.31 - 1.31 ) ] . CONCLUSION Low-dose HRT may give cardiovascular benefit . These findings require confirmation in a full clinical trial with evaluation of cardiovascular outcomes as the primary objective",
"OBJECTIVE To evaluate the influence of 2 continuous combined estrogen-progestin replacement products , compared with unopposed estrogen and placebo , on cardiovascular risk markers in postmenopausal women in a r and omized , double-blind , placebo-controlled trial . METHODS Two hundred seventy healthy postmenopausal women were r and omly assigned to 1 of 4 treatment groups : placebo , unopposed 17-beta estradiol ( 1 mg ) , 1 mg of 17-beta estradiol with 0.25 mg of norethindrone acetate , or 1 mg of 17-beta estradiol with 0.5 mg of norethindrone acetate . The primary outcome variable was change from baseline in low-density lipoprotein cholesterol concentration . Additional outcome variables included changes in other serum lipid levels , hemostatic variables , and indicators of carbohydrate metabolism . RESULTS The low-density lipoprotein cholesterol level was reduced to a similar degree in all groups receiving active treatment ( 10%-14 % from baseline ; P = .001 for 17-beta estradiol with 0.5 mg of norethindrone acetate , P = .004 for 17-beta estradiol with 0.25 mg of norethindrone acetate , and P = . 001 for 1 mg of 17-beta estradiol vs placebo ) . Compared with unopposed 17-beta estradiol , 17-beta estradiol with 0.5 mg of norethindrone acetate enhanced the reductions in total cholesterol and apolipoprotein B levels ( P levels of high-density lipoprotein cholesterol , apolipoprotein A-I , and triglycerides produced by 17-beta estradiol alone . Effects of 17-beta estradiol plus norethindrone on hemostatic variables were similar to those of 17-beta estradiol except for factor VII activity , which was significantly reduced with 17-beta estradiol combined with 0.25 mg ( P C-peptide and insulin levels produced by unopposed 17-beta estradiol but did not elevate these values compared with placebo . CONCLUSIONS 17-beta Estradiol plus norethindrone produced favorable changes in most cardiovascular risk markers evaluated and has a profile distinct from that of unopposed 17-beta estradiol . The impact of these differences on cardiovascular events warrants investigation . Arch Intern Med . 2000;160:3315 - 3325",
"A placebo-controlled trial has shown that 15 microgram of ethinyl oestradiol is as effective as 25 microgram daily in reducing both menopausal symptoms and the urinary excretion of calcium and hydroxyproline . Norethisterone 5 mg daily also showed a significant reduction in the climacteric symptoms but was less effective than either of the ethinyl oestradiol doses",
"Background At the time of feasibility work and final design of the trial there was no r and omised control trial evidence for the long-term risks and benefits of hormone replacement therapy . Observational studies had suggested that long term use of estrogen was likely to be associated , amongst other things , with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer . Concomitant use of progestogens had been shown to protect against endometrial cancer , but there were few data showing how progestogen might affect estrogen actions on other conditions . Disease specific risks from observational studies suggested that , overall , long-term HRT was likely to be beneficial . Several studies showed that mortality from all causes was lower in HRT users than in non-users . Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women . The WISDOM trial was design ed to compare combined estrogen and progestogen versus placebo , and estrogen alone versus combined estrogen and progestogen . During the development of WISDOM the Women 's Health Initiative trial was design ed , funded and started in the US . Design R and omised , placebo , controlled , trial . Methods The trial was set in general practice s in the UK ( 384 ) , Australia ( 94 ) , and New Zeal and ( 24 ) . In these practice s 284175 women aged 50–69 years were registered with 226282 potentially eligible . We sought to r and omise 22300 postmenopausal women aged 50 – 69 and treat for ten years . The interventions were : conjugated equine estrogens , 0.625 mg orally daily ; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily ; matched placebo . Primary outcome measures were : major cardiovascular disease , osteoporotic fractures , breast cancer and dementia . Secondary outcomes were : other cancers , all cause death , venous thromboembolism and cerebro-vascular disease . Results The trial was prematurely closed during recruitment following publication of early results from the Women 's Health Initiative . At the time of closure , 56583 had been screened , 8980 entered run-in , and 5694 ( 26 % of target of 22,300 ) r and omised . Those women r and omised had received a mean of one year of therapy , mean age was 62.8 years and total follow-up time was 6491 person years . Discussion The WISDOM experience leads to some simple messages . The larger a trial is the more simple it needs to be to ensure cost effective and timely delivery . When a trial is very costly and beyond the re sources of one country , funders and investigators should make every effort to develop international collaboration with joint funding",
"BACKGROUND Observational studies have suggested that estrogen-replacement therapy may reduce a woman 's risk of stroke and death . METHODS We conducted a r and omized , double-blind , placebo-controlled trial of estrogen therapy ( 1 mg of estradiol-17beta per day ) in 664 postmenopausal women ( mean age , 71 years ) who had recently had an ischemic stroke or transient ischemic attack . Women were recruited from 21 hospitals in the United States and were followed for the occurrence of stroke or death . RESULTS During a mean follow-up period of 2.8 years , there were 99 strokes or deaths among the women in the estradiol group , and 93 among those in the placebo group ( relative risk in the estradiol group , 1.1 ; 95 percent confidence interval , 0.8 to 1.4 ) . Estrogen therapy did not reduce the risk of death alone ( relative risk , 1.2 ; 95 percent confidence interval , 0.8 to 1.8 ) or the risk of nonfatal stroke ( relative risk , 1.0 ; 95 percent confidence interval , 0.7 to 1.4 ) . The women who were r and omly assigned to receive estrogen therapy had a higher risk of fatal stroke ( relative risk , 2.9 ; 95 percent confidence interval , 0.9 to 9.0 ) , and their nonfatal strokes were associated with slightly worse neurologic and functional deficits . CONCLUSIONS Estradiol does not reduce mortality orthe recurrence of stroke in postmenopausal women with cerebrovascular disease . This therapy should not be prescribed for the secondary prevention of cerebrovascular disease",
"The long-term effect of percutaneous and oral estrogen replacement therapy on blood pressure , plasma renin substrate , and serum estrogens was examined in a 2 year placebo-controlled study with 110 early postmenopausal women . The women were allocated to four treatment groups : ( 1 ) oral cyclical combination of 2 mg estradiol valerate and cyproterone acetate , ( 2 ) oral placebo , ( 3 ) percutaneous 17 beta-estradiol , supplemented by 200 mg oral progesterone during the second year , or ( 4 ) percutaneous placebo cream . Systolic and diastolic blood pressure remained unchanged in both hormone treatment groups , whereas the diastolic blood pressure tended to increase in both placebo groups . Plasma renin substrate increased during oral treatment with estradiol , but remained unchanged with percutaneous estradiol . No correlation was found between blood pressure and plasma renin substrate . During percutaneous administration of estradiol , the serum concentrations of estrone and estradiol continued to rise after 3 months and reached a plateau at 6 months of therapy . Serum estrone but not estradiol showed the same pattern during oral estradiol therapy . No further changes in any of the measured variables were observed in the women treated with percutaneous estradiol after addition of cyclical oral progesterone . We conclude that both oral and percutaneous treatment with estradiol may provide protection against the age-related increase in diastolic blood pressure observed in early postmenopausal women , and that the metabolic steady state is not attained until after 3 months of estradiol therapy",
"In a 5-yr r and omized prospect i ve study we examined the treatment effect of estrogen replacement therapy/hormone replacement therapy ( ERT/HRT ) , calcitriol , ERT/HRT and calcitriol , or placebo for 3 yr and the effect of discontinuation of therapy for 2 more yr on bone mineral density ( BMD ) , calciotropic hormones , markers of bone remodeling , and calcium absorption in 489 elderly women . The treatment phase of the study was double-blinded . After discontinuing therapy for 2 yr , there was rapid bone loss in all 3 treatment groups , and most of the decrease in BMD occurred in the first year . In the ERT/HRT group , spine BMD increased 5.5 % in yr 3 , decreased 3.2 % in yr 4 , and decreased 0.7 % in yr 5 ; femoral neck BMD increased 3.7 % in yr 3 , decreased 2.5 % in yr 4 , and decreased 0.4 % in yr 5 ; total body BMD increased 2.1 % in yr 3 , decreased 1.4 % in yr 4 , and decreased 0.6 % in yr 5 . In the combination group , spine BMD increased 7.1 % in yr 3 , decreased 4.3 % in yr 4 , and decreased 0.3 % in yr 5 ; femoral neck BMD increased 4.5 % in yr 3 , decreased 3.0 % in yr 4 , and decreased 0.01 % in yr 5 ; total body BMD increased 2.2 % in yr 3 , decreased 1.5 % in yr 4 , and decreased 0.6 % in yr 5 . In the calcitriol group , spine BMD increased 1.8 % in yr 3 , decreased 1.8 % in yr 4 , and showed no change in yr 5 ; femoral neck BMD increased 0.2 % in yr 3 , decreased 0.2 % in yr 4 , and decreased 0.6 % in yr 5 ; total body BMD decreased 0.4 % in yr 3 , decreased 0.6 % in yr 4 , and decreased 0.4 % in yr 5 . Compared with placebo , all treated groups at yr 5 had significantly higher total body BMD ; only the combination group had significantly higher spine BMD ( 3.4 % ; P total hip BMD ( 2.4 % ; P only spine BMD in the combination group was significantly higher ( 2.6 % ; P calcium absorption and the decrease in serum PTH levels in the calcitriol groups were reversed after discontinuation of treatment , and the decrease in bone markers was reversed in the hormone-treated groups . These results suggest that discontinuation of ERT/HRT and /or calcitriol therapy in elderly women leads to a decrease in much of the BMD gained on treatment ; however , in the combination group there was a statistically significant residual effect on spine BMD",
"BACKGROUND Postmenopausal hormone therapy has been reported to decrease levels of lipoprotein (Lp)(a ) in cross-sectional studies and small or short-term longitudinal studies . We report findings from a large , prospect i ve , placebo-controlled clinical trial that allows a broad characterization of these effects for four regimens of hormone therapy . METHODS AND RESULT The Postmenopausal Estrogen/Progestin Interventions study was a 3-year , placebo-controlled , r and omized clinical trial to assess the effect of hormone regimens on cardiovascular disease risk factors in postmenopausal women 45 to 65 years of age . The active regimens were conjugated equine estrogens therapy at 0.625 mg daily , alone or in combination with each of three regimens of progestational agents : medroxyprogesterone acetate ( MPA ) at 2.5 mg daily ( ie , continuous MPA ) , MPA at 10 mg days 1 to 12 ( ie , cyclical MPA ) , and micronized progesterone at 200 mg days 1 to 12 . Plasma levels of Lp(a ) were measured at baseline ( n = 366 ) , 12 months ( n = 354 ) , and 36 months ( n = 342 ) . Assignment to hormone therapy result ed in a 17 % to 23 % average drop in Lp(a ) concentrations relative to placebo ( P Lp(a ) associated with hormone therapy were positively correlated with changes in LDL cholesterol , total cholesterol , apolipoprotein B , and fibrinogen levels and were similar across subgroups defined by age , weight , ethnicity , and prior hormone use . CONCLUSIONS Postmenopausal estrogen therapy , with or without concomitant progestin regimens , produces consistent and sustained reductions in plasma Lp(a ) concentrations",
"Postmenopausal women are believed to have a higher risk of coronary artery disease than premenopausal women . In this study , we prospect ively determined changes in coronary risk factors that were attributable to natural menopause in 541 healthy , initially premenopausal women 42 to 50 years of age . After approximately 2 1/2 years , 69 women had spontaneously stopped menstruating for at least 12 months , and 32 women had stopped natural menstruation and received hormone-replacement therapy for a period of at least 12 months . An equal number of age-matched premenopausal women in the study group served as controls . In women who had a natural menopause and did not receive hormone-replacement therapy , serum levels of high-density lipoprotein ( HDL ) cholesterol declined as compared with those of premenopausal controls ( -0.09 vs. 0.00 mmol per liter ; P = 0.01 ) , and levels of low-density lipoprotein ( LDL ) cholesterol increased ( + 0.31 vs. + 0.14 mmol per liter ; P = 0.04 ) . In menopausal women who received hormone-replacement therapy , HDL and LDL cholesterol levels did not change , but the levels of triglycerides ( + 0.42 vs. -0.04 mmol per liter ; P less than 0.001 ) , apolipoprotein A-I ( + 0.18 vs. + 0.03 g per liter ; P less than 0.01 ) , and apolipoprotein A-II ( + 0.05 vs. -0.03 g per liter ; P less than 0.05 ) increased as compared with premenopausal controls . Natural menopause did not affect blood pressure , plasma glucose or insulin levels , body weight , the total number of kilojoules consumed in the diet , or the total number of kilojoules expended in physical activity . These results suggest that a natural menopause has an unfavorable effect on lipid metabolism , which may contribute to an increase in the risk of coronary disease . Hormone-replacement therapy may prevent some of these changes",
"Background The aim of the study was to determine the effect of postmenopausal hormone therapy on women 's symptom reporting and quality of life in a r and omized trial . Methods 1823 women participated in the Estonian Postmenopausal Hormone Therapy ( EPHT ) Trial between 1999 and 2004 . Women were r and omized to open-label continuous combined hormone therapy or no treatment , or to blind hormone therapy or placebo . The average follow-up period was 3.6 years . Prevalence of symptoms and quality of life according to EQ-5D were assessed by annually mailed question naires . Results In the hormone therapy arms , less women reported hot flushes ( OR 0.20 ; 95 % CI : 0.14–0.28 ) , sweating ( OR 0.56 ; 95 % CI : 0.44–0.72 ) , and sleeping problems ( OR 0.66 ; 95 % CI : 0.52–0.84 ) , but more women reported episodes of vaginal bleeding ( OR 19.65 ; 95 % CI : 12.15–31.79 ) . There was no difference between the trial arms in the prevalence of other symptoms over time . Quality of life did not depend on hormone therapy use . Conclusion Postmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems , but increased episodes of vaginal bleeding , and had no effect on quality of life . Trial registration numberIS RCT",
"OBJECTIVE Our purpose was to determine the efficacy of dietary calcium augmentation in the prevention of early postmenopausal bone density loss in comparison with hormonal replacement therapy and placebo . STUDY DESIGN A three-arm parallel r and omized trial comparing the influence of placebo , dietary calcium augmentation , and estrogen-progesterone-calcium in 118 women who were within 6 years of menopause was conducted . Dual photon absorptiometry was performed annually to measure lean and fat mass . In addition , the ratio of fat in the trunk/extremities was measured . RESULTS Body weight increased in each group . The increase was statistically significant in the hormone replacement group ( 0.8 kg/year ) . The percent of body fat increased in each group from baseline measurements , with the greatest increase in the hormonal replacement group . There was a decline in the extremity/trunk ratio in the hormonal replacement group as a result of a relatively greater increase in the trunk fat mass . There was a rapid rate of loss in lean body mass that was equal among groups . CONCLUSIONS Menopause is associated with a gain in fat mass and a loss of lean body mass , but these changes in body composition are not prevented by hormone replacement therapy",
"BACKGROUND Postmenopausal conjugated equine estrogens ( CEE ) therapies increase the risk of cognitive impairment in women aged 65 years or older and are associated with smaller regional brain volumes ; however , the link between these two phenomena has not been established . METHODS St and ardized magnetic resonance imaging was performed on 1,403 women , 1 - 4 years after they had participated in r and omized placebo-controlled clinical trials of CEE-based therapies . Women included in this report were aged 65 - 80 years and free of dementia and mild cognitive impairment ( MCI ) when originally enrolled in the trials , which lasted an average of 4 - 6 years and were conducted at 14 academic U.S. medical centers . The associations that regional brain volumes and ischemic lesion volumes had with the development of cognitive impairment ( i.e. , dementia or MCI ) were contrasted between treatment groups using analyses of covariance . RESULTS Fifty-three women developed MCI or probable dementia during follow-up . Among women who had been prescribed CEE-based therapies , cognitive impairment was associated with relatively smaller hippocampal ( p = .0002 ) and total brain volumes ( p = .03 ) . Qualitatively , these associations appeared to be independent of their level of pretreatment cognitive function . Among women who had been prescribed placebo , these relationships were not evident ; instead , cognitive impairment was associated with greater ischemic lesion volume in the frontal lobe ( p = .007 ) and overall ( p = .02 ) . CONCLUSION A mechanism by which CEE-based postmenopausal hormone therapy induces cognitive impairment appears to be through increased brain atrophy",
"Objective To assess the long term risks and benefits of hormone replacement therapy ( combined hormone therapy versus placebo , and oestrogen alone versus combined hormone therapy ) . Design Multicentre , r and omised , placebo controlled , double blind trial . Setting General practice s in UK ( 384 ) , Australia ( 91 ) , and New Zeal and ( 24 ) . Participants Postmenopausal women aged 50 - 69 years at r and omisation . At early closure of the trial , 56 583 had been screened , 8980 entered run-in , and 5692 ( 26 % of target of 22 300 ) started treatment . Interventions Oestrogen only therapy ( conjugated equine oestrogens 0.625 mg orally daily ) or combined hormone therapy ( conjugated equine oestrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily ) . Ten years of treatment planned . Main outcome measures Primary outcomes : major cardiovascular disease , osteoporotic fractures , and breast cancer . Secondary outcomes : other cancers , death from all causes , venous thromboembolism , cerebrovascular disease , dementia , and quality of life . Results The trial was prematurely closed during recruitment , after a median follow-up of 11.9 months ( interquartile range 7.1 - 19.6 , total 6498 women years ) in those enrolled , after the publication of early results from the women 's health initiative study . The mean age of r and omised women was 62.8 ( SD 4.8 ) years . When combined hormone therapy ( n=2196 ) was compared with placebo ( n=2189 ) , there was a significant increase in the number of major cardiovascular events ( 7 v 0 , P=0.016 ) and venous thromboembolisms ( 22 v 3 , hazard ratio 7.36 ( 95 % CI 2.20 to 24.60 ) ) . There were no statistically significant differences in numbers of breast or other cancers ( 22 v 25 , hazard ratio 0.88 ( 0.49 to 1.56 ) ) , cerebrovascular events ( 14 v 19 , 0.73 ( 0.37 to 1.46 ) ) , fractures ( 40 v 58 , 0.69 ( 0.46 to 1.03 ) ) , and overall deaths ( 8 v 5 , 1.60 ( 0.52 to 4.89 ) ) . Comparison of combined hormone therapy ( n=815 ) versus oestrogen therapy ( n=826 ) outcomes revealed no significant differences . Conclusions Hormone replacement therapy increases cardiovascular and thromboembolic risk when started many years after the menopause . The results are consistent with the findings of the women 's health initiative study and secondary prevention studies . Research is needed to assess the long term risks and benefits of starting hormone replacement therapy near the menopause , when the effect may be different . Trial registration Current Controlled Trials IS RCT N",
"BACKGROUND In recent r and omized trials , conjugated equine estrogens ( CEE ) with continuous medroxyprogesterone acetate provided no protection against coronary heart disease in postmenopausal women and may have increased cardiac risk . These trials did not address the role of unopposed estrogen for coronary protection . METHODS A total of 10 739 women aged 50 to 79 years at baseline ( mean age , 63.6 years ) who had previously undergone hysterectomy were r and omized to receive CEE , 0.625 mg/d , or placebo at 40 US clinical centers beginning in 1993 . The trial was terminated early after 6.8 years of follow-up ( planned duration , 8.5 years ) . This report includes final , central ly adjudicated results for the primary efficacy outcome ( myocardial infa rct ion or coronary death ) , secondary coronary outcomes , and subgroup analyses . RESULTS During the active intervention period , 201 coronary events were confirmed among women assigned to receive CEE compared with 217 events among women assigned to receive placebo ( hazard ratio , 0.95 ; nominal 95 % confidence interval , 0.79 - 1.16 ) . Among women aged 50 to 59 years at baseline , the hazard ratio for the primary outcome was 0.63 ( nominal 95 % confidence interval , 0.36 - 1.08 ) . In that age group , coronary revascularization was less frequent among women assigned to receive CEE ( hazard ratio , 0.55 ; nominal 95 % confidence interval , 0.35 - 0.86 ) , as were several composite outcomes , which included the primary outcome and coronary revascularization ( hazard ratio , 0.66 ; nominal 95 % confidence interval , 0.44 - 0.97 ) . CONCLUSIONS Conjugated equine estrogens provided no overall protection against myocardial infa rct ion or coronary death in generally healthy postmenopausal women during a 7-year period of use . There was a suggestion of lower coronary heart disease risk with CEE among women 50 to 59 years of age at baseline ",
"Background —Estrogen improves endothelial function in the coronary conduit vessels of animals ; however , its effects on the coronary microcirculation have not been studied completely in humans . Methods and Results —We measured myocardial blood flow ( MBF ) with a PET scan at rest , during cold pressor testing ( CPT ) , and during dipyridamole hyperemia in 54 postmenopausal women without coronary artery disease . Of these , 23 were not and 31 women were taking long-term hormone replacement therapy ( HRT ) using estrogen either alone or with a progestogen . Each group was subdivided by coronary risk factors ( RFs ) . Twelve young healthy women served as controls . In women not taking HRT , MBF measurements were repeated after 25 mg of conjugated equine estrogens IV . Neither short estrogen nor long-term HRT affected MBF at rest in women with and without RFs . Dipyridamole MBF was attenuated only in the women with RF who were not taking HRT . Short-term estrogen and long-term HRT did not reverse the abnormal response . MBF responses to CPT were abnormal in women not taking HRT , regardless of RFs ( 20±15 % versus 32±21 % ) and remained unchanged after short-term estrogen administration . Long-term HRT normalized the response to CPT only in women without RF ( 53±22 % versus 59±36 % in the young women ; NS ) . MBFs were similar for women on estrogen alone or estrogen plus a progestogen , regardless of presence or absence of RFs . Conclusion —Menopause is associated with abnormal CPT ( an indirect measure of endothelial function ) , which can be reversed by long-term HRT only when RFs are absent . Progestogens do not antagonize this effect . Long-term HRT may therefore be useful in the primary prevention of coronary artery disease in women without RFs",
"OBJECTIVE The positive short-term effects of postmenopausal hormone replacement therapy ( HRT ) on serum lipids are well known , but it has been suggested that they vanish with time . Cholecalciferol ( vitamin D3 ) is widely used to prevent postmenopausal osteoporosis but the influence of vitamin D3 on serum lipids is poorly known . The long-term effects of HRT and vitamin D3 on the concentrations of serum lipids were studied in a population -based prospect i ve 3-year study . DESIGN AND METHODS 464 women were r and omized into four treatment groups : ( i ) HRT ( sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate ) , ( ii ) Vit D3 ( vitamin D3 300 IU/day ) , ( iii ) HRT+Vit D3 ( both as above ) , ( iv ) placebo ( calcium lactate 500 mg/day ) . RESULTS 320 women completed the study . After three years of treatment , serum concentrations of low density lipoprotein ( LDL ) cholesterol decreased in the HRT group ( 10.1 % , P HRT+Vit D3 group ( 5.9 % , P=0.005 ) , increased in the Vit D3 group ( 4.1 % , P=0.035 ) but remained unchanged in the placebo group . The concentrations of total cholesterol decreased by 5.8 % in the HRT group ( P HRT+Vit D3 group ( P=0.023 ) , but did not change in the other two groups . Serum concentrations of high density lipoprotein ( HDL ) cholesterol decreased in the Vit D3 group ( 5.2 % , P=0.001 ) , HRT+Vit D3 group ( 3.7 % , P=0.046 ) , and the placebo group ( 4.5 % , P=0.006 ) but did not change significantly in the HRT group . The HDL/LDL ratio increased in the HRT group ( 10.5 % , P=0.006 ) and decreased in the Vit D3 group ( 10.5 % , P serum triglycerides increased similarly in all groups ( 14.0 - 18.8 % , P HRT with sequential estradiol valerate and cyproterone acetate on serum lipid concentrations . In addition , the results suggest that vitamin D3 supplementation may have unfavorable effects on lipids in postmenopausal women . Pure vitamin D3 treatment was associated with increased serum LDL cholesterol . Furthermore , the beneficial effects of HRT on serum LDL cholesterol content were reduced when estradiol valerate was combined with vitamin D3 . However , the relevance of these associations to cardiovascular morbidity remains to be established",
"BACKGROUND Results of observational studies suggest that hormone replacement therapy ( HRT ) could reduce the risk of coronary heart disease ( CHD ) , but those of r and omised trials do not indicate a lower risk in women who use oestrogen plus progestagen . The aim of this study was to ascertain whether or not unopposed oestrogen reduces the risk of further cardiac events in postmenopausal women who survive a first myocardial infa rct ion . METHODS The study was a r and omised , blinded , placebo controlled , secondary prevention trial of postmenopausal women , age 50 - 69 years ( n=1017 ) who had survived a first myocardial infa rct ion . Individuals were recruited from 35 hospitals in Engl and and Wales . Women received either one tablet of oestradiol valerate ( 2 mg ; n=513 ) or placebo ( n=504 ) , daily for 2 years . Primary outcomes were reinfa rct ion or cardiac death , and all-cause mortality . Analyses were by intention-to-treat . Secondary outcomes were uterine bleeding , endometrial cancer , stroke or other embolic events , and fractures . FINDINGS Frequency of reinfa rct ion or cardiac death did not differ between treatment groups at 24 months ( rate ratio 0.99 , 95 % CI 0.70 - 1.41 , p=0.97 ) . Similarly , the reduction in all-cause mortality between those who took oestrogen and those on placebo was not significant ( 0.79 , 0.50 - 1.27 , p=0.34 ) . The relative risk of any death ( 0.56 , 0.23 - 1.33 ) and cardiac death ( 0.33 , 0.11 - 1.01 ) was lowest at 3 months post-recruitment . INTERPRETATION Oestradiol valerate does not reduce the overall risk of further cardiac events in postmenopausal women who have survived a myocardial infa rct ion",
"CONTEXT The timing of initiation of hormone therapy may influence its effect on cardiovascular disease . OBJECTIVE To explore whether the effects of hormone therapy on risk of cardiovascular disease vary by age or years since menopause began . DESIGN , SETTING , AND PARTICIPANTS Secondary analysis of the Women 's Health Initiative ( WHI ) r and omized controlled trials of hormone therapy in which 10,739 postmenopausal women who had undergone a hysterectomy were r and omized to conjugated equine estrogens ( CEE ) or placebo and 16,608 postmenopausal women who had not had a hysterectomy were r and omized to CEE plus medroxyprogesterone acetate ( CEE + MPA ) or placebo . Women aged 50 to 79 years were recruited to the study from 40 US clinical centers between September 1993 and October 1998 . MAIN OUTCOME MEASURES Statistical test for trend of the effect of hormone therapy on coronary heart disease ( CHD ) and stroke across categories of age and years since menopause in the combined trials . RESULTS In the combined trials , there were 396 cases of CHD and 327 cases of stroke in the hormone therapy group vs 370 [ corrected ] cases of CHD and 239 cases of stroke in the placebo group . For women with less than 10 years since menopause began , the hazard ratio ( HR ) for CHD was 0.76 ( 95 % confidence interval [ CI ] , 0.50 - 1.16 ) ; 10 to 19 years , 1.10 ( 95 % CI , 0.84 - 1.45 ) ; and 20 or more years , 1.28 ( 95 % CI , 1.03 - 1.58 ) ( P for trend = .02 ) . The estimated absolute excess risk for CHD for women within 10 years of menopause was -6 per 10,000 person-years ; for women 10 to 19 years since menopause began , 4 per 10,000 person-years ; and for women 20 or more years from menopause onset , 17 per 10,000 person-years . For the age group of 50 to 59 years , the HR for CHD was 0.93 ( 95 % CI , 0.65 - 1.33 ) and the absolute excess risk was -2 per 10,000 person-years ; 60 to 69 years , 0.98 ( 95 % CI , 0.79 - 1.21 ) and -1 per 10,000 person-years ; and 70 to 79 years , 1.26 ( 95 % CI , 1.00 - 1.59 ) and 19 per 10,000 person-years ( P for trend = .16 ) . Hormone therapy increased the risk of stroke ( HR , 1.32 ; 95 % CI , 1.12 - 1.56 ) . Risk did not vary significantly by age or time since menopause . There was a nonsignificant tendency for the effects of hormone therapy on total mortality to be more favorable in younger than older women ( HR of 0.70 for 50 - 59 years ; 1.05 for 60 - 69 years , and 1.14 for 70 - 79 years ; P for trend = .06 ) . CONCLUSIONS Women who initiated hormone therapy closer to menopause tended to have reduced CHD risk compared with the increase in CHD risk among women more distant from menopause , but this trend test did not meet our criterion for statistical significance . A similar nonsignificant trend was observed for total mortality but the risk of stroke was elevated regardless of years since menopause . These data should be considered in regard to the short-term treatment of menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"Objective To investigate the long term effect of hormone replacement therapy on cardiovascular outcomes in recently postmenopausal women . Design Open label , r and omised controlled trial . Setting Denmark , 1990 - 93 . Participants 1006 healthy women aged 45 - 58 who were recently postmenopausal or had perimenopausal symptoms in combination with recorded postmenopausal serum follicle stimulating hormone values . 502 women were r and omly allocated to receive hormone replacement therapy and 504 to receive no treatment ( control ) . Women who had undergone hysterectomy were included if they were aged 45 - 52 and had recorded values for postmenopausal serum follicle stimulating hormone . Interventions In the treatment group , women with an intact uterus were treated with triphasic estradiol and norethisterone acetate and women who had undergone hysterectomy received 2 mg estradiol a day . Intervention was stopped after about 11 years owing to adverse reports from other trials , but participants were followed for death , cardiovascular disease , and cancer for up to 16 years . Sensitivity analyses were carried out on women who took more than 80 % of the prescribed treatment for five years . Main outcome measure The primary endpoint was a composite of death , admission to hospital for heart failure , and myocardial infa rct ion . Results At inclusion the women on average were aged 50 and had been postmenopausal for seven months . After 10 years of intervention , 16 women in the treatment group experienced the primary composite endpoint compared with 33 in the control group ( hazard ratio 0.48 , 95 % confidence interval 0.26 to 0.87 ; P=0.015 ) and 15 died compared with 26 ( 0.57 , 0.30 to 1.08 ; P=0.084 ) . The reduction in cardiovascular events was not associated with an increase in any cancer ( 36 in treated group v 39 in control group , 0.92 , 0.58 to 1.45 ; P=0.71 ) or in breast cancer ( 10 in treated group v 17 in control group , 0.58 , 0.27 to 1.27 ; P=0.17 ) . The hazard ratio for deep vein thrombosis ( 2 in treated group v 1 in control group ) was 2.01 ( 0.18 to 22.16 ) and for stroke ( 11 in treated group v 14 in control group ) was 0.77 ( 0.35 to 1.70 ) . After 16 years the reduction in the primary composite outcome was still present and not associated with an increase in any cancer . Conclusions After 10 years of r and omised treatment , women receiving hormone replacement therapy early after menopause had a significantly reduced risk of mortality , heart failure , or myocardial infa rct ion , without any apparent increase in risk of cancer , venous thromboembolism , or stroke . Trial registration Clinical Trials.gov NCT00252408",
"PURPOSE To determine the effect of progestin therapy on bone mineral density in postmenopausal women and to compare its effects to those of estrogen . SUBJECTS AND METHODS A prospect i ve , r and omized clinical trial was performed in 81 postmenopausal women aged 51.7 + /- 4.4 years ( mean + /- SD ) . They were assigned to one of four groups : Provera 20 mg , Premarin 0.6 mg , Premarin 0.3 mg plus Provera 10 mg , and a placebo . In addition , all women received calcium supplementation , if necessary , to a calcium intake of 1,000 mg/day . We used single- and dual-photon absorpiometry , metacarpal radiogrammetry , and computed axial tomography to measure bone mineral density in the total skeleton , spine , radius , and metacarpal . RESULTS Women receiving placebo lost bone at all sites ( p less than 0.01 ) . The Provera-treated group showed no change in total body calcium , but there were decreases in radial density ( p less than 0.01 ) , metacarpal cortex ( p less than 0.01 ) , and spine density ( p less than 0.01 ) . The Premarin-treated group had an increase in spine density and total body density ( p less than 0.05 ) , but a decrease in radial density ( p less than 0.05 ) . The Premarin-plus-Provera group showed no change in spine density , total body calcium , or radial density but had a decrease in metacarpal cortex ( p less than 0.01 ) . CONCLUSIONS Compared to placebo , Provera reduced the rate of loss in cortical areas of the skeleton , but not in the spine , which contains more trabecular bone . In contrast , Premarin reduced the rate of loss in both cortical and trabecular areas of the skeleton . The low-dose combination of Premarin plus Provera was similar in its effect on bone to that of Premarin alone , suggesting that there may be a synergistic effect of this hormone combination on bone . Serum cholesterol levels decreased with Provera , Premarin , and the combination of both , whereas levels of serum triglycerides increased with Premarin treatment , decreased with the Provera regimen , and were unchanged with the combination therapy . Provera does not adversely affect the lipid profile",
"The Women ’s Health Initiative ( WHI ) Clinical Trial ( CT ) includes three overlapping components , each a r and omized controlled comparison among women who were postmenopausal and 50 to 79 years of age at r and omization . The dietary modification ( DM ) component r and omly assigned 48,836 ( target 48,000 ) eligible women to either a sustained low-fat eating pattern ( 40 % ) or self-selected dietary behavior ( 60 % ) , with breast cancer and colorectal cancer as design ated primary outcomes and coronary heart disease as a secondary outcome . The nutrition goals for women assigned to the DM intervention group have been to reduce total dietary fat to 20 % , and saturated fat to less than 7 % of daily calories and , secondarily , to increase daily servings of vegetables and fruits to at least five and of grain products to at least six and to maintain these changes throughout trial follow-up . The r and omization of 40 % , rather than 50 % , of participating women to the DM intervention group was intended to reduce trial costs , while testing trial hypotheses with specified power . The postmenopausal hormone therapy ( PHT ) component comprises two r and omized , double-blind trials among 27,347 ( target 27,500 ) women , with coronary heart",
"CONTEXT Despite decades of accumulated observational evidence , the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain . OBJECTIVE To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States . DESIGN Estrogen plus progestin component of the Women 's Health Initiative , a r and omized controlled primary prevention trial ( planned duration , 8.5 years ) in which 16608 postmenopausal women aged 50 - 79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993 - 1998 . INTERVENTIONS Participants received conjugated equine estrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5 mg/d , in 1 tablet ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOMES MEASURES The primary outcome was coronary heart disease ( CHD ) ( nonfatal myocardial infa rct ion and CHD death ) , with invasive breast cancer as the primary adverse outcome . A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke , pulmonary embolism ( PE ) , endometrial cancer , colorectal cancer , hip fracture , and death due to other causes . RESULTS On May 31 , 2002 , after a mean of 5.2 years of follow-up , the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits . This report includes data on the major clinical outcomes through April 30 , 2002 . Estimated hazard ratios ( HRs ) ( nominal 95 % confidence intervals [ CIs ] ) were as follows : CHD , 1.29 ( 1.02 - 1.63 ) with 286 cases ; breast cancer , 1.26 ( 1.00 - 1.59 ) with 290 cases ; stroke , 1.41 ( 1.07 - 1.85 ) with 212 cases ; PE , 2.13 ( 1.39 - 3.25 ) with 101 cases ; colorectal cancer , 0.63 ( 0.43 - 0.92 ) with 112 cases ; endometrial cancer , 0.83 ( 0.47 - 1.47 ) with 47 cases ; hip fracture , 0.66 ( 0.45 - 0.98 ) with 106 cases ; and death due to other causes , 0.92 ( 0.74 - 1.14 ) with 331 cases . Corresponding HRs ( nominal 95 % CIs ) for composite outcomes were 1.22 ( 1.09 - 1.36 ) for total cardiovascular disease ( arterial and venous disease ) , 1.03 ( 0.90 - 1.17 ) for total cancer , 0.76 ( 0.69 - 0.85 ) for combined fractures , 0.98 ( 0.82 - 1.18 ) for total mortality , and 1.15 ( 1.03 - 1.28 ) for the global index . Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events , 8 more strokes , 8 more PEs , and 8 more invasive breast cancers , while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures . The absolute excess risk of events included in the global index was 19 per 10 000 person-years . CONCLUSIONS Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women . All-cause mortality was not affected during the trial . The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases , and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD",
"BACKGROUND While observational studies have suggested that unopposed estrogens reduce the incidence of coronary disease in postmenopausal women , there are few data on the effect of combined therapy with estrogens and progestins -- a regimen adopted in recent years to minimize the risk of endometrial hyperplasia and cancer . In clinical trials , the addition of progestins has an adverse effect on serum lipid levels , and these lipid effects have raised the question of whether combined estrogen-progestin therapy increases the risk of coronary disease compared with the use of estrogen alone . METHODS We conducted a population -based , case-control study among enrollees of Group Health Cooperative of Puget Sound . Cases were postmenopausal women who sustained an incident fatal or nonfatal myocardial infa rct ion in 1986 through 1990 . Controls were a stratified r and om sample of female Group Health Cooperative enrollees frequency matched to the cases by age and calendar year . We review ed the medical records of the 502 cases and 1193 controls and conducted brief telephone interviews with consenting survivors . The health maintenance organization 's computerized pharmacy data base was used to ascertain the use of postmenopausal hormones . For the primary analysis of current use , we classified women into one of three groups : ( 1 ) nonusers of hormones ; ( 2 ) users of estrogens alone ; or ( 3 ) users of combined therapy including both estrogens and progestins . Each group of hormone users was compared with nonusers . RESULTS After adjustment for potential confounding factors , the risk ratio of myocardial infa rct ion associated with current use of estrogens alone was 0.69 ( 95 % confidence interval , 0.47 to 1.02 ) ; and the risk ratio of myocardial infa rct ion associated with current use of combined therapy was 0.68 ( 95 % confidence interval , 0.38 to 1.22 ) . Duration of combined-therapy use was relatively short , averaging less than 2 years in cases and controls . CONCLUSIONS In this case-control study , the reduced risk of myocardial infa rct ion associated with the use of estrogens alone was consistent with previous observational studies . Although the 95 % confidence interval only excluded a risk above 1.22 , the current use of combined therapy was not associated with an adverse effect on the incidence of myocardial infa rct ion in postmenopausal women",
"BACKGROUND Apparently discrepant findings have been reported by the Women 's Health Initiative ( WHI ) trial compared with observational studies of postmenopausal hormone therapy ( HT ) and coronary heart disease ( CHD ) . METHODS We prospect ively examined the relation of HT to CHD , according to timing of hormone initiation relative to age and time since menopause . Participants were postmenopausal women in the Nurses ' Health Study , with follow-up from 1976 to 2000 . Information on hormone use was ascertained in biennial , mailed question naires . We used proportional hazards models to calculate multivariable adjusted relative risks ( RR ) and 95 % confidence intervals ( CI ) . We also conducted sensitivity analyses to determine the possible influence of incomplete capture of coronary events occurring shortly after initiation of HT . RESULTS Women beginning HT near menopause had a significantly reduced risk of CHD ( RR = 0.66 , 95 % CI 0.54 - 0.80 for estrogen alone ; RR = 0.72 , 95 % CI 0.56 - 0.92 for estrogen with progestin ) . In the subgroup of women demographically similar to those in the WHI , we found no significant relation between HT and CHD among women who initiated therapy at least 10 years after menopause ( RR = 0.87 , 95 % CI 0.69 - 1.10 for estrogen alone ; RR = 0.90 , 95 % CI 0.62 - 1.29 for estrogen with progestin ) . Among women who began taking hormones at older ages , we also found no relation between current use of estrogen alone and CHD ( for women aged 60 + years , RR = 1.07 , 95 % CI 0.65 - 1.78 ) , although there was a suggestion of possible reduced risk for combined HT ( RR = 0.65 , 95 % CI 0.31 - 1.38 ) . In sensitivity analyses , we found that the incomplete capture of coronary events occurring shortly after initiation of HT could not explain our observation of a reduced risk of coronary disease for current users of HT . CONCLUSIONS These data support the possibility that timing of HT initiation in relation to menopause onset or to age might influence coronary risk",
"Objective : The purpose of this study was to evaluate the isolated and associated effects of estrogen therapy ( estradiol valerate 1 mg/d orally ) and physical exercise ( moderate aerobic exercise , 3 h/wk ) on health-related quality of life ( HRQOL ) and menopausal symptoms among women who had undergone hysterectomy . Design : A 6-month , r and omized , double-blind , placebo-controlled clinical trial with 44 postmenopausal women who had undergone hysterectomy . The interventions were physical exercise and hormone therapy ( n = 9 ) , being sedentary and hormone therapy ( n = 14 ) , physical exercise and placebo ( n = 11 ) , and being sedentary and placebo ( n = 10 ) . HRQOL was assessed by a Brazilian st and ard version of the Medical Outcome Study Short-Form Health Survey and symptoms by Kupperman Index at baseline and after 6 months . Results : There was a decrease in symptoms in all groups , but only groups who performed physical exercise showed an increase in quality of life . Analysis of variance showed that changes in physical functioning ( P = 0.001 ) and bodily pain ( P = 0.012 ) scores over the 6-month period differed significantly between women who exercised and women who were sedentary , regardless of hormone therapy . Hormone therapy had no effect , and there was also no significant association between physical exercise and hormone therapy in HRQOL . Conclusions : Physical exercises can reduce menopausal symptoms and enhance HRQOL , independent of whether hormone therapy is taken",
"The Women 's Angiographic Vitamin and Estrogen trial was a r and omized , double-blind , placebo-controlled study design ed to test the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease . Postmenopausal women with one or more angiographically documented coronary stenoses of 15 - 75 % at baseline were assigned in a 2 x 2 factorial r and omization to active hormone replacement therapy ( conjugated estrogens for women who had had a hysterectomy or conjugated estrogens with medroxyprogesterone for women with intact uteri ) or placebo and to active vitamins E and C or their placebos . Seven clinical centers , five in the United States and two in Canada , r and omized 423 women between July 1997 and July 1999 . Quantitative coronary angiography was performed at baseline and repeated after projected mean follow-up of 3 years",
"BACKGROUND Recent r and omized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease ( CHD ) . In this report , we provide the final results with regard to estrogen plus progestin and CHD from the Women 's Health Initiative ( WHI ) . METHODS The WHI included a r and omized primary -prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line . Participants were r and omly assigned to receive conjugated equine estrogens ( 0.625 mg per day ) plus medroxyprogesterone acetate ( 2.5 mg per day ) or placebo . The primary efficacy outcome of the trial was CHD ( nonfatal myocardial infa rct ion or death due to CHD ) . RESULTS After a mean follow-up of 5.2 years ( planned duration , 8.5 years ) , the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits . Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 ( nominal 95 percent confidence interval , 1.00 to 1.54 ; 95 percent confidence interval after adjustment for sequential monitoring , 0.97 to 1.60 ) . The elevation in risk was most apparent at one year ( hazard ratio , 1.81 [ 95 percent confidence interval , 1.09 to 3.01 ] ) . Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy , higher base-line levels of C-reactive protein , other biomarkers , and other clinical characteristics did not significantly modify the treatment-related risk of CHD . CONCLUSIONS Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women , especially during the first year after the initiation of hormone use . This treatment should not be prescribed for the prevention of cardiovascular disease",
"Serum lipids and lipoproteins were studied in 86 healthy post-menopausal women at 3-monthly intervals throughout 2 yr of treatment with cyclic oestradiol valerate plus cyproterone acetate ( E2V + CPA ) , continuous 17 beta-oestradiol plus norethisterone acetate ( E2 + NETA ) , or placebo . Withdrawal effects were also investigated . Serum oestrogen levels were similar following the 2 hormone regimens . Serum total and low-density-lipoprotein ( LDL ) cholesterol were significantly reduced by 5 - 8 % during cyclic E2V + CPA therapy and by 15 - 20 % during continuous E2 + NETA treatment . The concentrations remained significantly reduced throughout the 2 yr of treatment . Virtually no changes were observed in the placebo group . High-density-lipoprotein ( HDL ) cholesterol concentrations were significantly reduced in relation to pretreatment values during the first year of continuous E2 + NETA therapy , but were not significantly different from the levels in the cyclic E2V + CPA or the placebo groups . Serum triglyceride levels remained almost constant in all the groups . Withdrawal of hormone therapy result ed in steep increases in total and LDL-cholesterol , the levels returning to pretreatment values . A similar increase in HDL-cholesterol was observed in the E2 + NETA group , following withdrawal . Vaginal bleeding episodes were experienced by all the women receiving the E2V + CPA regimen and they occurred regularly in 63 % of the women . Fifty-two ( 52 ) percent of the women receiving E2 + NETA did not bleed at all . The results of the present study suggest that the continuous addition of NETA may enhance the oestrogen-induced changes in total and LDL-cholesterol , whereas only minor changes in the oestrogen-induced effects on these variables are produced by the cyclic addition of CPA . However , in the case of HDL-cholesterol , the antagonistic effect of CPA seems to be moderate in comparison with that of NETA",
"Venous thromboembolism , including thrombosis of the deep veins of the legs and embolism to the pulmonary arteries , is a serious and potentially fatal event . Venous thromboembolism is uncommon in the general population , occurring in about 1 to 4 per 1000 adults annually ( 1 , 2 ) . However , the risk is increased in persons with previous venous thromboembolism ( 3 ) , recent surgical procedures ( 4 , 5 ) , immobilization , fracture of a lower extremity ( 4 , 6 , 7 ) , cancer ( 4 , 6 , 7 ) , and inherited coagulation disorders ( 8 , 9 ) . Use of oral contraceptive pills increases risk for venous thromboembolism ( 1 , 2 ) . This increased risk is thought to be due to estrogen and to be dose related ( 3 , 4 ) . The biological potency of the estrogens generally used in postmenopausal hormone therapy is about one-fourth to one-fifth that of the estrogens in modern oral contraceptives . Until recently , there has been little evidence that low-dose estrogen therapy is associated with increased risk for venous thromboembolism ( 5 - 8 ) . Recent observational studies have suggested that postmenopausal hormone therapy causes a twofold to fourfold increase in risk for idiopathic deep venous thrombosis and pulmonary embolism ( 9 - 13 ) . However , these findings may be biased if women taking estrogen are more likely to be evaluated for nonspecific symptoms suggestive of venous thromboembolism . The Heart and Estrogen/progestin Replacement Study ( HERS ) was a r and omized , blinded , placebo-controlled trial of the effect of daily conjugated equine estrogen , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg , on the rate of new coronary events in 2763 postmenopausal women with established coronary heart disease ( 14 ) . One of the specified secondary outcomes of this trial was venous thromboembolism . An increased risk for venous thromboembolism among women assigned to hormone therapy was noted by the HERS Data and Safety Monitoring Board . The Board instructed the HERS investigators to inform participants and the scientific community of this risk and to institute measures to reduce risk . At a mean follow-up of 3.3 years , the HERS investigators notified participants to discontinue study medication in situations associated with increased risk for venous thromboembolism , such as surgery , hospitalization , fracture , and cancer , and published a letter noting the increased risk ( 15 ) . This report presents the full analysis of the findings . Methods Participants in HERS were postmenopausal women younger than 80 years of age who had coronary disease ( myocardial infa rct ion , coronary artery bypass surgery , percutaneous coronary revascularization , or angiographic evidence of at least 50 % narrowing of one or more major coronary arteries ) and had not had a hysterectomy . Women were excluded if their coronary event occurred within 6 months of r and omization ; they had used hormone therapy within 3 months of r and omization ; they had a history or baseline findings suggestive of venous thromboembolism , breast cancer , or endometrial cancer ; or they had uncontrolled hypertension , diabetes , or other life-threatening diseases ( 16 ) . The protocol was approved by the institutional review board at each of the 20 HERS clinical centers , and all participants provided written informed consent . Participants were r and omly assigned to take one tablet daily of conjugated equine estrogen , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg , or placebo that was identical in appearance . R and omization was stratified by clinical center and performed in blocks of 4 . To prevent unblinding of clinical center staff , HERS participants reported breast discomfort and vaginal bleeding directly to gynecology staff , who were located separately from the clinical center staff , did not communicate with clinical center personnel about breast or gynecologic problems , and did not participate in ascertainment of outcomes . Follow-up visits to the clinical centers occurred at 4-month intervals . Coronary events ( nonfatal myocardial infa rct ion and coronary death ) were the primary outcome of the trial ( 14 ) . At each visit , clinic staff asked participants if they had been told by a physician that they had a blood clot in the legs or lungs . Women were also asked whether they had been hospitalized , and records were review ed to determine whether venous thromboembolism had occurred . Women were not routinely asked about symptoms of venous thrombosis , such as lower-extremity edema . Diagnosis of deep venous thrombosis required documentation of thrombosis of the popliteal or more proximal veins of the legs by venography , impedance plethysmography , or sonography . Pulmonary embolism required documentation by a nuclear lung scan that suggested a high probability of pulmonary embolism ( segmental or larger perfusion defect with ventilation mismatch ) or by pulmonary angiography that revealed a constant intraluminal filling defect on multiple films . Suspected venous thromboembolism was adjudicated independently and without knowledge of treatment assignment by two physicians at the HERS Coordinating Center , located at the University of California , San Francisco ; disagreements were resolved by consensus . Persons who analyzed data were also blinded to participants ' treatment status . Data were collected on events that occurred during the trial that might be predictors of venous thromboembolism , including fractures , nonfatal myocardial infa rct ion , congestive heart failure , stroke , and transient ischemic attack ( 16 ) . Venous thromboembolism was classified as idiopathic in women who did not have concomitant cancer , nonfatal myocardial infa rct ion , congestive heart failure , or stroke and did not have a fracture , inpatient surgery , or hospitalization in the 3 months before the venous thromboembolic event . In the primary analysis , an unadjusted Cox proportional-hazards model for time to first event was used to compare the rate of venous thromboembolism among women assigned to hormone therapy with the rate among women assigned to placebo . The primary analysis was intention-to-treat ; participants were categorized according to treatment assignment regardless of compliance . Participants who were lost to follow-up ( 33 women in the hormone therapy group and 36 in the placebo group ) were censored at the last date at which they were known to be alive without venous thromboembolism ; vital status was known for all women at the end of the trial . We also performed an as-treated analysis , in which inclusion in the risk sets was limited to women in both treatment groups whose average compliance with therapy during the trial ( measured by pill count ) was at least 80 % . Relative hazards were also estimated by year since r and omization ( women with events in earlier years were censored ) , and continuous trend in the log relative hazard was examined in a companion model . We repeated the main analyses separately for idiopathic and nonidiopathic venous thromboembolism . Potential risk factors for venous thromboembolism were first examined by using univariate proportional hazards models adjusted for treatment assignment . In these models , postr and omization events and medication use were represented by time-dependent indicators , which reverted to zero 90 days after fracture , surgery , or hospitalization or when therapy was discontinued . Variables associated with venous thromboembolism for which the associated P value was less than 0.2 in univariate analyses were considered for inclusion in multivariate models and retained in the model if the P value remained less than 0.2 . Statistical analyses were performed by using SAS software , version 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) . Results The 20 HERS centers enrolled 2763 women between February 1993 and September 1994 ; of these , 1380 were assigned to the hormone therapy group and 1383 to the placebo group . Participants ranged in age from 44 to 79 years ( mean age [ SD ] , 67 7 years ) . At baseline , the treatment groups did not differ significantly ( Table 1 ) . Table 1 . Baseline Characteristics of HERS Participants At the end of the first year , 82 % of women in the hormone therapy group and 91 % in the placebo group reported taking study medication ; by the end of the third year , these proportions had decreased to 75 % and 81 % , respectively . Cumulative incidence curves for all venous thromboembolic events ( deep venous thrombosis and pulmonary embolism ) are shown in the Figure . During 10 985 woman-years of follow-up , 47 women experienced a venous thromboembolic event : 34 in the hormone-treated group ( 6.2 per 1000 woman-years ) and 13 in the placebo group ( 2.3 per 1000 woman-years ) ( relative hazard , 2.7 [ 95 % CI , 1.4 to 5.0 ] [ P = 0.003 ] ; excess risk , 3.9 per 1000 woman-years [ CI , 1.4 to 6.4 per 1000 woman-years ] ; number needed to treat for harm , 256 [ CI , 157 to 692 ] ) . The relative hazard of venous thromboembolism did not differ significantly among the 20 clinical centers . Figure . Kaplan-Meier estimates of the cumulative incidence of venous thromboembolic events ( top ) , deep venous thrombosis ( middle ) , and pulmonary embolism ( bottom ) . More women in the hormone therapy group than in the placebo group experienced deep venous thrombosis ( 25 compared with 9 ; relative hazard , 2.8 [ CI , 1.3 to 6.0 ] ; P = 0.008 ) and pulmonary embolism ( 11 compared with 4 ; relative hazard , 2.8 [ CI , 0.9 to 8.7 ] ; P = 0.08 ) ( Table 2 ) . Two women , both in the hormone therapy group , died of pulmonary embolism . The relative hazard was increased for idiopathic ( relative hazard , 3.1 [ CI , 0.8 to 11.3 ] ) and nonidiopathic venous thromboembolic events ( relative hazard , 2.5 [ CI , 1.2 to 5.3 ] ) . The overall results were unchanged in an as-treated analysis that was limited to women who reported taking more than 80 % of their assigned study medication ( relative hazard , 3.2 [ CI , 1.5 to 6.9 ] ; P = 0.003 ) . Table 2 . Venous Thrombolic Events by Treatment Group and Year of R and omization Table 2 shows relative hazards for venous thromboembolism by year since r and omization . The number of episodes of pulmonary",
"Objectives The aim of this study was to assess the effects of 1 and 2 mg 17β-estradiol on serum lipid profile . Beneficial effects have been clearly established in previous studies with a 2 mg dose ; further evidence was required to confirm the beneficial effects of a 1 mg dose . Methods This double-blind , placebo-controlled study involved 579 postmenopausal women r and omized to oral treatment with placebo , 1 mg/day 17β-estradiol sequentially combined with 5 or 10 mg/day dydrogesterone for the last 14 days of each 28-day cycle , or 2 mg/day 17β-estradiol sequentially combined with 10 or 20 mg/day dydrogesterone for the last 14 days of each 28-day cycle . Treatment was continued for 26 cycles . Results High density lipoprotein ( HDL ) cholesterol levels were significantly ( p addition , low density lipoprotein ( LDL ) cholesterol and lipoprotein(a ) levels were significantly reduced , and apolipoprotein A1 and triglyceride levels were significantly increased , in all active treatment groups after 13 and 26 cycles . Conclusions The results of this study clearly indicate that sequential combinations of either 1 or 2 mg 17β-estradiol with dydrogesterone are associated with long-term , favorable changes in the serum lipid profile . There was no evidence that dydrogesterone compromised the 17β-estradiol-induced improvements in lipid profile",
"OBJECTIVE To evaluate the efficacy of lower doses of conjugated equine estrogens ( CEE ) plus medroxyprogesterone acetate ( MPA ) for relieving vasomotor symptoms and vaginal atrophy . DESIGN A r and omized , double-blind , placebo-controlled trial ( the Women 's Health , Osteoporosis , Progestin , Estrogen study ) . SETTING Study centers across the United States . PATIENT(S ) Two thous and , six hundred , seventy-three healthy , postmenopausal women with an intact uterus , including an efficacy-evaluable population ( n = 241 at baseline ) . INTERVENTION(S ) Patients received for 1 year ( 13 cycles ; in milligrams per day ) CEE , 0.625 ; CEE , 0.625 and MPA , 2.5 ; CEE , 0.45 ; CEE , 0.45 and MPA , 2.5 ; CEE , 0.45 and MPA , 1.5 ; CEE , 0.3 ; CEE , 0.3 and MPA , 1.5 ; or placebo . MAIN OUTCOME MEASURE(S ) Number and severity of hot flushes and Papanicolaou smear with vaginal maturation index ( VMI ) to assess vaginal atrophy . RESULT ( S ) In the efficacy-evaluable population , reduction in vasomotor symptoms was similar with CEE of 0.625 mg/d and MPA of 2.5 mg/d ( the most commonly prescribed doses ) and all lower combination doses . CEE of 0.625 mg/d alleviated hot flushes more effectively than the lower doses of CEE alone . VMI improved in all active treatment groups . CONCLUSION ( S ) Lower doses of CEE plus MPA relieve vasomotor symptoms and vaginal atrophy as effectively as commonly prescribed doses",
"BACKGROUND In postmenopausal women with coronary artery disease , conjugated equine estrogen with or without continuous administration of medroxyprogesterone acetate has failed to slow the progression of atherosclerosis . Whether 17beta-estradiol ( the endogenous estrogen molecule ) alone or administered sequentially with medroxyprogesterone acetate can slow the progression of atherosclerosis is unknown . METHODS We conducted a double-blind , placebo-controlled trial in 226 postmenopausal women ( mean age , 63.5 years ) who had at least one coronary-artery lesion . Participants were r and omly assigned to usual care ( control group ) , estrogen therapy with micronized 17beta-estradiol alone ( estrogen group ) , or 17beta-estradiol plus sequentially administered medroxyprogesterone acetate ( estrogen-progestin group ) . In all patients the low-density lipoprotein ( LDL ) cholesterol level was reduced to a target of less than 130 mg per deciliter . The primary outcome was the average per-participant change between base-line and follow-up coronary angiograms in the percent stenosis measured by quantitative coronary angiography . RESULTS After a median of 3.3 years of follow-up , the mean ( + /-SE ) change in the percent stenosis in the 169 participants who had a pair of matched angiograms was 1.89+/-0.78 percentage points in the control group , 2.18+/-0.76 in the estrogen group , and 1.24+/-0.80 in the estrogen-progestin group ( P=0.66 for the comparison among the three groups ) . The mean difference in the percent stenosis between the estrogen group and the control group was 0.29 percentage point ( 95 percent confidence interval , -1.88 to 2.46 ) , and the mean difference between the estrogen-progestin group and the control group was -0.65 ( 95 percent confidence interval , -2.87 to 1.57 ) . CONCLUSIONS In older postmenopausal women with established coronary-artery atherosclerosis , 17beta-estradiol either alone or with sequentially administered medroxyprogesterone acetate had no significant effect on the progression of atherosclerosis",
"Fifty-five depressed menopausal patients took part in a r and omized double-blind cross-over trial using ; Harmogen ' ( piperazine oestrone sulphate ) and placebo . The Beck depression inventory , hot flush counts , and patients ' subjective assessment of well-being were used to assess clinical status . Hormonal , biochemical and coagulation profiles were carried out . Hot flushes improved significantly on oestrogen compared with placebo . Depression scores and well-being showed significant and equal improvement on oestrogen and placebo . Significant improvement in flushes in patients on placebo was observed in the first half of the trial but did not occur in the second half , in patients who had previously taken oestrogen . No significant changes occurred in biochemistry . Coagulation tests showed acceleration of the prothrombin time in patients taking ; Harmogen ' compared with those on placebo . Piperazine oestrone sulphate is a relatively weak but safe oestrogen preparation , effective in treatment of vasomotor symptoms but no more effective than placebo in the treatment of depression",
"OBJECTIVES On the basis of epidemiological and experimental data , it has been supposed that hormone replacement therapy ( HRT ) inhibits atherosclerosis in postmenopausal women . This r and omized controlled trial examined whether 1 mg 17beta-estradiol daily , combined cyclically with 0.025 mg gestodene in every month ( HRT 1 ) , or in every third month ( HRT 2 ) slows the increase of intima-media thickness in femoral arteries compared with no HRT . METHODS Healthy postmenopausal women ( n=321 ) with an increased risk for future vascular disease as indicated by > 1 mm of intima-media thickness in the carotid arteries were equally r and omized to one of the three groups for 48 weeks . Ultrasound scans of femoral arteries were recorded at study start and study end , together with a thorough clinical examination and laboratory work-up . RESULTS Complete scans were obtained in 260 of the 264 subjects who participated until study end . Mean maximum intima-media thickness of four femoral artery segments ( common and superficial , both sides ) was 0.93+/-0.37 mm ( mean+/-S.D. ) at study start . It increased by 0.02+/-0.05 , 0.02+/-0.05 , and 0.03+/-0.05 mm in the HRT 1 , HRT 2 and no HRT groups , respectively ( HRT 1 versus no HRT , HRT 2 versus no HRT ; both P>0.2 ) . Compared with no HRT , HRT significantly lowered follicle stimulating hormone , low-density lipoprotein cholesterol , and fibrinogen . CONCLUSIONS In this 1-year trial , irrespective of the progestogen dose used , HRT with 1 mg 17 beta-estradiol did not inhibit progression of femoral artery atheroslerosis in postmenopausal women with sub clinical vascular disease",
"AIMS At the time of the design of the Osteoporosis Prevention and Arterial effects of tiboLone ( OPAL ) study in 1996 , oral hormone therapy ( HT ) was assumed to reduce cardiovascular risk . The evidence mainly came from the effects of combined conjugated equine oestrogens plus medroxyprogesterone acetate ( CEE/MPA ) therapy . Other HT regimes had not been studied widely . Tibolone , a selective tissue oestrogenic activity regulator , has several effects on cardiovascular risk factors , one of which is HDL lowering . Because the overall effect of tibolone on cardiovascular risk was unknown , the OPAL study was design ed . METHODS AND RESULTS The OPAL study was a three-arm , r and omized , placebo-controlled , double-blind study to determine the effect of tibolone ( 2.5 mg daily ) and of CEE/MPA ( 0.625/2.5 mg daily ) over 3 years on progression of carotid intima-media thickness ( CIMT ) in 866 healthy post-menopausal women . The women were recruited from six US and five European centres . The primary outcome was change in mean common CIMT . Annual common CIMT progression rates in the tibolone and CEE/MPA groups were higher than in the placebo group : 0.0077 mm [ 95 % confidence interval ( CI ) 0.0051 - 0.0103 ] in the tibolone group , 0.0074 mm ( 0.0048 - 0.0099 ) in the CEE/MPA group , and 0.0035 mm ( 0.009 - 0.0061 ) in the placebo group . The differences with placebo ( 0.0042 mm/year for tibolone and 0.0039 mm/year for CEE/MPA ) were statistically significant . HDL cholesterol increased in CEE/MPA group and was lowered in the tibolone group . CONCLUSION Both tibolone and CEE/MPA showed increased progression of common CIMT . Translation of the increased common CIMT progression of the CEE/MPA group into cardiovascular disease risk could not fully explain the observed increased cardiovascular risk as observed in the Women 's Health Initiative study . This suggests that the net effect of tibolone and CEE/MPA on cardiovascular events may depend on the combined effects on the arterial wall , clotting factors , and possibly inflammation",
"Objective : The aim of this study was to examine the effect of conjugated equine estrogens alone ( ET ) , conjugated equine estrogens + medroxyprogesterone ( EPT ) , calcitriol alone , calcitriol + EPT/ET , or placebo on serum lipid profile and analyze the interaction with estrogen receptor-&agr ; gene single nucleotide polymorphisms ( ESR-&agr ; SNPs ) on the response to therapy . Methods : A total of 489 postmenopausal women older than 65 years were enrolled into a 3-year double-blind , placebo-controlled clinical trial . Results : In both intent-to-treat and complier ( > 80 % adherent ) analysis , there was a significant increase in serum high-density lipoproteins and a significant decrease in serum low-density lipoproteins ( LDLs ) and the LDL/high-density lipoprotein ratio in all hormone treatment groups compared with placebo ( P serum triglycerides and very low-density lipoproteins increased in the EPT and ET + calcitriol groups versus placebo ( P treatment . Genotypes containing the p allele showed a significantly greater decrease in serum cholesterol and very low-density lipoprotein than those having the P allele in the ET + calcitriol group ( P serum cholesterol in the hormone therapy + calcitriol group at the end of 3 years versus the X allele , and a greater decrease in serum LDL in alleles x versus the X in the ET + calcitriol group ( P ET with or without progesterone had a favorable effect on lipid profile in postmenopausal older women , and this was dependent on estrogen receptor SNPs-PvuII and XbaI. However , this interaction with ESR-&agr ; SNPs needs to be confirmed in larger studies",
"OBJECTIVES At present the Women 's Health Initiative trial is the only reported r and omised controlled trial study ing the effects of hormone therapy among healthy postmenopausal women . The Women 's Health Initiative reports have been criticized for lacking in generalisability , due to the characteristics of the trial population . We aim ed to compare the health effects of oral continuous combined hormone therapy with a placebo and non-treatment among healthy Estonian women . METHODS Eligible women were r and omised into a blind group of hormone therapy versus placebo and into a non-blind group of open label hormone therapy versus non-treatment . One thous and seven hundred and seventy-eight postmenopausal women aged 50 - 64 at the time of sampling were recruited in 1999 - 2001 at three clinical centers in Estonia . Participants received conjugated equine oestrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5mg/d , or conjugated equine oestrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 5mg/d , if less than 3 years had passed since menopause at recruitment , or matched placebo or non-treatment . Trial treatment was stopped gradually from 1 January 2004 to 31 May 2004 . RESULTS After a follow-up period from 2.0 to 5.0 years the combined hazard ratio , stratified by blinding and adjusted for age at recruitment and former oral contraceptive use was 1.12 ( 95 % confidence interval [ CI ] : 0.90 - 1.40 ) for coronary heart disease , 1.24 ( 95 % CI : 0.85 - 1.82 ) for cerebrovascular disease , 1.36 ( 95 % CI : 0.73 - 2.52 ) for total cancer , and 0.61 ( 95 % CI : 0.42 to 0.89 ) for bone fractures . CONCLUSIONS The results from the Estonian Postmenopausal Hormone Therapy r and omised trial are consistent with the Women 's Health Initiative findings",
"The Heart and Estrogen/progestin Replacement Study ( HERS ) is a r and omized , double-blind , placebo-controlled trial design ed to test the efficacy and safety of estrogen plus progestin therapy for prevention of recurrent coronary heart disease ( CHD ) events in women . The participants are postmenopausal women with a uterus and with CHD as evidence d by prior myocardial infa rct ion , coronary artery bypass graft surgery , percutaneous transluminal coronary angioplasty , or other mechanical revascularization or at least 50 % occlusion of a major coronary artery . Between February 1993 and September 1994 , 20 HERS centers recruited and r and omized 2763 women . Participants ranged in age from 44 to 79 years , with a mean age of 66.7 ( SD 6.7 ) years . Most participants were white ( 89 % ) , married ( 57 % ) , and had completed high school or some college ( 80 % ) . As expected , the prevalence of coronary risk factors was high : 62 % were past or current smokers , 59 % had hypertension , 90 % had serum LDL-cholesterol of 100 mg/dL or higher , and 23 % had diabetes . Each woman was r and omly assigned to receive one tablet containing 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily or an identical placebo . Participants will be evaluated every 4 months for an average of 4.2 years for the occurrence of CHD events ( CHD death and nonfatal myocardial infa rct ion ) . We will also assess other major CHD endpoints , including revascularization and hospitalization for unstable angina . The primary analysis will compare the rate of CHD events in women assigned to active treatment with the rate in those assigned to placebo . The trial was design ed to have power greater than 90 % to detect a 35 % reduction in the incidence of CHD events , assuming a 50 % lag in effect for 2 years and a 5 % annual event rate in the placebo group . The design , analysis , and conduct of the study are controlled by the Steering Committee of Principal Investigators and coordinated at the University of California , San Francisco . HERS is the largest trial of any intervention to reduce the risk of recurrent CHD events in women with heart disease and is the first controlled trial to seek evidence of the efficacy and safety of postmenopausal hormone therapy to prevent recurrent CHD events",
"PURPOSE Our aim was to determine the effect of hormone replacement on physical performance measures , functional ability , physical activity , falls , and cognitive function in elderly women . SUBJECTS AND METHODS Following a 3-month , open-label , run-in phase , we r and omized 373 community-dwelling women aged 65 years and older to receive conjugated equine estrogen 0.625 mg/day plus or minus medroxyprogesterone 2.5 mg/day vs placebo for 3 years in a double-blind fashion . We assessed time to rise from a chair , timed walking , balance , Instrumental Activities of Daily Living , Physical Activity Scale of the Elderly , Folstein Mini-Mental State Examination , and falls . RESULTS Over 3 years , except for balance scores , performance measures declined significantly ( all P rising time ( 0.1 , -0.5 to 0.7 seconds [ mean , 95 % confidence interval ] ) , walking normal ( 0.0 , -0.4 to 0.4 seconds ) , and walking fast ( 0.2 , -0.1 to 0.6 seconds ) . There were no significant mean differences between the two groups for the Instrumental Activities of Daily Living ( 0.1 , -0.1 to 0.3 points ) , Physical Activity Scale of the Elderly ( -3 , -15 to 8 points ) , Folstein Mini-Mental State Examination ( -0.1 , -0.3 to 0.3 points ) , or the proportion of participants reporting falls ( -1 , -11 to 9 % ) . CONCLUSION In elderly women , hormone replacement had no statistically significant effect on cognition or balance , nor did it prevent the age-related decline in physical measures of mobility , ability to rise from a chair , self-reported activities of daily living , physical activity scores , or falls",
"BACKGROUND The Women 's Health Initiative ( WHI ) clinical trial of conjugated equine estrogens ( CEEs ) , involving 10,739 postmenopausal women with hysterectomy , aged 50 to 79 years , was stopped early owing to lack of overall health benefit and increased risk of stroke . Because CEE is still prescribed for treatment of menopausal symptoms and prevention of osteoporosis , it is important to underst and the overall impact of this therapy on health-related quality of life ( HRQOL ) . METHODS All participants completed 6 specific measures of quality of life at baseline and 1 year , and a sub sample ( n = 1189 ) also completed the questions 3 years after r and omization . Changes in scores were analyzed for treatment effect . RESULTS R and omization to CEE was associated with a statistically significant but small reduction in sleep disturbance at year 1 compared with baseline ( mean benefit , 0.4 points on a 20-point scale ) and a statistically significant but small negative effect on social functioning ( mean effect , -1.3 points on a 100-point scale ) . There were no significant improvements due to CEE in the areas of general health , physical functioning , pain , vitality , role functioning , mental health , depressive symptoms , cognitive function , or sexual satisfaction at year 1 . A subgroup examined 3 years after baseline had no significant benefits for any HRQOL outcomes . Among women aged 50 to 54 years with moderate to severe vasomotor symptoms at baseline , CEE did not improve any of the HRQOL variables at year 1 . CONCLUSION In this trial of postmenopausal women with prior hysterectomy , oral CEE did not have a clinical ly meaningful effect on HRQOL",
"OBJECTIVE This study was undertaken to assess whether estrogen therapy ( ET ) reduces the risk of cognitive decline in women with cerebrovascular disease . STUDY DESIGN We conducted a r and omized , double-blind trial of estradiol 17beta versus placebo for secondary stroke prevention in 664 postmenopausal women with a recent stroke or transient ischemic attack . The Mini-Mental State Examination ( MMSE ) and 5 domain measures were obtained at baseline and exit . RESULTS Among 461 women withdrawn alive without stroke , ET did not have a significant effect on cognitive measures after an average of 3 years ( relative risk of MMSE decline : 0.74 , 95 % CI , 0.49 - 1.13 ) . In women with normal MMSE at entry , estrogen was associated with less decline ( relative risk , 0.46 , 95 % CI , 0.24 - 0.87 ) . CONCLUSION In this study , estradiol did not have significant effects on cognitive measures . However , in women with normal function at baseline , there may be a benefit for ET in reducing the risk for cognitive decline",
"Postmenopausal hormone therapy is widely used to prevent diseases . This is not , however , based on the kind of evidence that is normally required of a preventive drug therapy : it is based on intermediary outcomes of trials and non-experimental studies . Many reasons can be postulated for the fact that we know little of this old and widely used therapy . To remedy the current situation , we should encourage r and omised controlled trials , reveal the insufficiency of the current evidence , and challenge the drug industry 's biased influence",
"Observational epidemiologic studies suggest that the incidence of cardiovascular disease is reduced by about 50 % in users of unopposed estrogens , but the reduction may have been overestimated because of a greater tendency for women at lower risk to use estrogens . To minimize bias due to such behavior , the authors conducted a case-control study of first myocardial infa rct ion among Massachusetts women aged 45 - 69 years during 1986 - 1990 , in which each of 858 cases was age-matched with a control from the same geographic area , and important correlates of estrogen use and myocardial infa rct ion were controlled by conditional logistic regression . The estimated relative risk was 0.9 for ever use of unopposed estrogen ( 95 % confidence interval 0.7 - 1.2 ) ; the estimate decreased with increasing duration of use to 0.6 for 5 or more years of use ( p for trend = 0.08 ) . The association with long-term use was stronger for recent use ( p for trend estrogens taken together with progestins . The results suggest that unopposed estrogen use may reduce the risk of first myocardial infa rct ion , that the reduction is related to the duration and recency of use , and that it may be smaller than previously believed . Despite efforts to control confounding , observational studies can not rule out the possibility that a tendency for women at lower risk for myocardial infa rct ion to use estrogens has contributed to the reduced risk in estrogen users , and r and omized trials are needed",
"The spontaneous calcanean bone loss occurring in healthy early post-menopausal women and the effect of two hormone replacement therapies ( HRT 's ) were investigated in a longitudinal study . There was no difference between the right and left calcanean BMC or BMD ( p > 0.15 ) . The spontaneous bone loss was similar at all the skeletal sites measured , with a mean spontaneous loss in calcanean BMD of 1.6 % over one year . Both HRT 's significantly ( p bone loss from all skeletal sites irrespective of the weight-bearing or content of trabecular bone , and ( for the weight-bearing bones ) there was even a gain in calcanean BMC and BMD and spinal BMD ( p < 0.01 ) . Bone mineral of the calcaneus and the spine correlated equally to body weight ( r approximately 0.4 , p < 0.001 ) , whereas bone mineral in the forearm was not correlated to body weight . The correlations between the changes in bone mineral at the sites measured were all significant ( r approximately 0.2 - 0.4 )",
"Fasting serum calcitonin levels were measured in 54 postmenopausal women who had for 10 years been taking part in a double blind trial to assess the effect of the synthetic oestrogen , mestranol , on postmenopausal bone loss . There were no differences in calcitonin levels between mestranol treated and placebo groups , Fifteen of the women were challenged with a calcium infusion to measure the secretory reserve of calcitonin . Oestrogen treatment did not increase the calcitonin response to calcium infusion . The three patients who exhibited the greatest responses were placebo treated . Bone density was measured by γ‐ray absorptiometry over the ten year period and the annual rate of change of bone density calculated . No correlation could be found between basal calcitonin level or calcitonin reserve and change in bone density . Our results indicate that postmenopausal osteoporosis is not caused by a deficiency of calcitonin and that the action of oestrogen therapy to prevent bone loss does not involve calcitonin",
"Background —Observational studies have reported less frequent carotid atherosclerosis in healthy women taking postmenopausal hormone therapy . Estrogen with progestin did not reduce peripheral arterial events among women with preexisting coronary heart disease . This analysis evaluates clinical peripheral arterial disease among generally healthy women in the Women ’s Health Initiative r and omized trial of estrogen plus progestin . Methods and Results —The Estrogen Plus Progestin trial assigned 16 608 postmenopausal women , mean age 63.3±7.1 years , to daily conjugated estrogens ( 0.625 mg ) with medroxyprogesterone acetate ( 2.5 mg ) or placebo and documented health outcomes over an average of 5.6 years of follow-up . Hospitalization for peripheral arterial disease was infrequent , with annualized rates of 0.08 % , 0.06 % , and 0.02 % for carotid disease , lower extremity arterial disease , and abdominal aortic aneurysm , respectively . The incidence of peripheral arterial events did not differ between treatment groups ( hazard ratio [ HR ] 0.89 , 95 % confidence interval 0.63 , 1.25 ) . The risk was slightly greater among women assigned to active estrogen with progestin in years 1 ( HR 1.33 ) and 2 ( HR 1.27 ) , and was slightly lower in later years ( HR 0.85 and 0.87 in years 5 and ≥6 ) . Among adherent participants , the hazard ratio for peripheral arterial events was 1.23 ( 95 % confidence interval 0.79 , 1.91 ) over the 5.6 years of follow up . Subgroup analysis identified no significant interactions between estrogen with progestin and baseline characteristics with regard to peripheral arterial disease risk . Conclusions —Among generally healthy postmenopausal women , conjugated estrogens with progestin did not confer protection against peripheral arterial disease ",
"The long term effects of hormone replacement therapy ( HRT ) and vitamin D3 ( Vit D ) on bone mineral density ( BMD ) were studied . A total of 464 nonosteoporotic early postmenopausal women from the Kuopio Osteoporosis Study ( n = 13100 ) were r and omized to four groups : 1 ) HRT ( sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate , 2 ) Vit D3 ( 300 and 100 IU/day during the fifth year ) , 3 ) HRT and Vit D combined , and 4 ) placebo . Lumbar ( L2-L4 ) and femoral neck BMD were determined by dual x-ray absorptiometry ( DXA ) at baseline and after 2.5 and 5 yr of treatment . Intention to treat analysis ( n = 464 ) showed that after 5 yr , lumbar BMD remained unchanged in the HRT and HRT plus Vit D groups [ + 0.2 % ( P = 0.658 ) and + 0.9 % ( P = 0.117 ) , respectively ] , whereas lumbar BMD decreased by 4.6 % in the Vit D group and by 4.5 % in the placebo group ( P loss of femoral neck BMD was less in the HRT ( -1.4 % ; P = 0.005 ) and HRT plus Vit D ( -1.3 % ; P = 0.003 ) groups than in the Vit D and placebo groups ( -4.3 % ; P 370 women who complied with the 5-yr treatment , the effect was more pronounced : lumbar BMD had increased by 1.5 % in the HRT ( P = 0.009 ) and by 1.8 % in the HRT plus Vit D group ( P = 0.005 ) , with a plateau after 2.5 yr , whereas lumbar BMD had decreased in both the Vit D and placebo groups ( 4.6 % and 4.7 % ; P Femoral neck BMD decreased again less in the HRT ( -0.4 % ) and HRT plus Vit D ( -0.6 % ) groups than in the Vit D and placebo groups ( -4.4 % in both ) . This study confirms the positive long term effect of HRT on BMD also seen in intention to treat analysis . The data suggest that low dose vitamin D3 supplementation does not prevent bone loss in healthy , nonosteoporotic , early postmenopausal women , and it confers no benefit additional to that of HRT alone ",
"The Estrogen Replacement and Atherosclerosis ( ERA ) trial is a three-arm , r and omized , placebo-controlled , double-blind trial to evaluate the effects of estrogen replacement therapy ( 0.625 mg/day oral conjugated estrogen ) with or without continuous low-dose progestin ( 2.5 mg oral medroxyprogesterone acetate/day ) versus placebo on progression of atherosclerosis . A total of 309 postmenopausal women at five sites underwent baseline coronary angiography and were r and omized . Participants will have repeat coronary angiography after an average of 3.25 years of treatment . The primary outcome of interest will be change in minimum diameter of the major epicardial segments , as assessed by quantitative coronary angiography . The primary aim is to test the hypothesis that either form of hormone therapy will slow the progression or induce regression of coronary atherosclerosis compared to placebo . The secondary aims are to assess the effects of the two treatments versus placebo on endothelial function ( measured using flow-mediated vasodilator responses ) , on several presumed mediators of estrogen 's effect on atherosclerosis ( i.e. , plasma lipids and lipoproteins , blood pressure , glucose metabolism , hemostatic factors , and antioxidant activity ) , on other factors that influence the development of coronary heart disease ( i.e. , diet , smoking status , exercise , weight , and health-related quality of life issues ) , and on clinical cardiovascular events . The ERA trial is the first angiographic endpoint clinical trial to examine the effects of postmenopausal hormone replacement on coronary atherosclerosis in women . It will provide an unparalleled opportunity to determine if either regimen of hormone therapy is effective in slowing the progress of angiographically defined coronary atherosclerosis . This study will complement other estrogen replacement trials , such as the PEPI , HERS , and Women 's Health Initiative studies , to provide a more comprehensive examination of the effects of estrogen replacement on cardiovascular risk factors , anatomic and functional manifestations of atherosclerosis , and risk for coronary heart disease in postmenopausal women . Control Clin Trials 2000;21:257 -",
"OBJECTIVE To compare the effect of continuous norethindrone acetate (NA)-ethinyl estradiol ( EE2 ) combinations with matching unopposed EE2 or placebo . DESIGN A 2-year , double-blind , placebo-controlled , parallel-group clinical trial . SETTING Out patients at 65 centers . PATIENTS Asymptomatic or mildly symptomatic women aged 40 years or older who had undergone the onset of spontaneous menopause within the last 5 years and who had an intact uterus . INTERVENTIONS Patients were equally r and omized to placebo or 1 of 8 treatment groups : 0.2 mg of NA and 1 microg of EE2 ; 0.5 mg of NA and 2.5 microg of EE2 ; 1 mg of NA and 5 microg of EE2 ; 1 mg of NA and 10 microg of EE2 ; 1 microg of EE2 ; 2.5 microg of EE2 ; 5 microg of EE2 ; or 10 microg of EE2 . PRIMARY OUTCOME MEASURES Bone mineral density ( BMD ) measured by quantitative computed tomography , serum lipids , and endometrial effects as assessed by rate of hyperplasia and proliferative status . RESULTS Twelve hundred sixty-five patients entered the study . Bone mineral density increased significantly from baseline ( P EE2 and the 1 mg NA-10 microg EE2 treatment groups at each annual assessment . Among the unopposed EE2 groups , only the 10-microg group had increased BMD above baseline , but also was accompanied by an unacceptably high rate of endometrial hyperplasia . The NA-EE2 treatment groups had a significant linear dose-response trend for increasing BMD . Increased endometrial proliferation and hyperplasia occurred with increasing unopposed estrogen doses . The combination of NA and EE2 effectively protected the endometrium against hyperplasia . The percentage of change in the ratio of high-density lipoprotein cholesterol to low-density lipoprotein cholesterol was positive for all treatment groups . The increase in triglyceride levels associated with EE2 was attenuated with NA-EE2 treatment . CONCLUSIONS Daily treatment with NA-EE2 was well tolerated and protected the endometrium from EE2-induced proliferation and hyperplasia . The NA-EE2 treatments produced a dose-related significant increase in BMD that was not present with unopposed EE2 treatment . The overall effect of NA-EE2 treatments on lipid measures was favorable",
"Historically , estrogen replacement therapy has been advocated in postmenopausal women with anticipated benefits of alleviating perimenopausal symptoms , slowing osteoporosis and preventing heart disease . While the first two effects are known , estrogen ’s role in the prevention of heart disease is unclear . Recommendations for postmenopausal estrogen replacement therapy for heart disease prevention are largely based on clinical , animal model , and tissue-culture studies demonstrating improvements in cardiovascular risk factors and experimental atherosclerosis and numerous observational studies showing fewer cardiovascular events among estrogen users than among non-users1 - 4 . However , definite conclusions regarding estrogen use for the prevention of heart disease can not be ascertained based on these data , due to study limitations and biases . Thus , r and omized clinical trials were needed to further clarify the role of postmenopausal estrogen replacement in the prevention of heart disease . The Heart and Estrogen/progestin Replacement Study ( HERS ) sought to establish the role of hormone replacement therapy for secondary prevention of coronary heart disease5 . But , contrary to expectations , 4.1 years of oral conjugated estrogen plus medroxyprogesterone acetate demonstrated no favorable effects over placebo in either primary ( non-fatal myocardial infa rct ion and coronary heart disease death ) or secondary outcomes . In fact , there was a statistically significant increase in coronary heart disease events in the treatment group compared to the placebo group during the first year . Various theories emerged as research ers attempted to underst and the HERS findings . Some wondered if medroxyprogesterone acetate decreased estrogen ’s favorable effects6 , while others suggested that other unrecognized effects , such as proinflammatory or prothrombotic effects , could be negating estrogen ’s favorable effects on the endothelium and lipids7",
"Objective : The contribution of progestogen therapy or progestogen type to risks and benefits of estrogen treatment is inadequately characterized . We examined the effect of conjugated equine estrogens ( CEE ) with and without concomitant progestogen treatments on changes in hemostasis measures among Postmenopausal Estrogen/Progestin Intervention participants . Design : Postmenopausal Estrogen/Progestin Intervention was a clinical trial that r and omized 875 postmenopausal women to one of five arms : placebo , CEE alone , CEE with cyclic micronized progesterone ( MP ) , CEE with cyclic medroxyprogesterone acetate ( MPA ) , and CEE with continuous MPA . Twelve hemostasis assays were measured in a sub study at baseline and 12 and 36 months . Using 12- and 36-month changes in hemostasis measures , we calculated change ratios for two comparisons of active treatments : CEE+MPA versus CEE and CEE+MPA versus CEE+MP . Results : Hemostasis measures were available for 288 women . Compared with women assigned to CEE alone , 12-month increases in factor VIIc and protein C among women assigned to CEE+MPA were relatively smaller ( ratios : 0.94 [ 95 % CI : 0.89 - 0.98 ] and 0.96 [ 95 % CI : 0.92 - 1.00 ] ) , respectively . Compared with women assigned to CEE+MP , women assigned to CEE+MPA had smaller increases in factor VIIc and larger decreases in plasminogen activator inhibitor-1 antigen at 12 months ( ratios : 0.94 [ 95 % CI : 0.90 - 0.98 ] and 0.70 [ 95 % CI : 0.53 - 0.93 ] , respectively ) . Thirty-six month ratios were similar to these . Women assigned to CEE+MPA had smaller increases in protein C than those assigned CEE+MP at 36 months only ( ratio : 0.95 [ 95 % CI : 0.91 - 0.99 ] ) . No other associations were significant . Conclusions : We found modest yet significant differences in hemostasis measure changes when comparing progestogen use and progestogen type in postmenopausal women using CEE",
"Estrogen replacement therapy confers many beneficial effects to postmenopausal women , such as slowing the rate of bone loss and decreasing the risk of coronary artery disease . This multicenter , placebo-controlled study evaluated the lowest effective daily dose of estrone sulfate ( 0.3 , 0.625 , or 1.25 mg ) combined with 1000 mg elemental calcium supplementation for preventing bone loss in the immediate postmenopausal period . Spinal bone mineral density was measured using quantitative computed tomography . Compared with baseline , bone mineral density increased significantly ( P Estrone sulfate administration ( 0.625 and 1.25 mg ) produced significant changes in various lipid measurements at both the 6- and 12-month observation points . The prevalence rates for adverse events were comparable among the estrone sulfate groups and the placebo group . Estrone sulfate 0.625 mg daily , combined with 1000 mg elemental calcium supplementation , was the minimum effective dosage to prevent loss of spinal bone mineral density in postmenopausal women over a 12-month period",
"Background : Atherosclerosis has long been thought to develop over time in a linear manner from gradual wall thickening to advanced thick lesions . However , evidence has emerged indicating a phasic rather than linear progression with time . A major reason for this non-linear pattern appears to be the occurrence of hemorrhages in the arterial wall , although data on this issue are still scarce . We studied the occurrence of temporarily impressive thickenings of the carotid arterial wall in a cohort of healthy postmenopausal women who were followed up for 3 years with regular carotid ultrasound examinations . Methods : The women were the European participants of a r and omized placebo-controlled trial into the effect of hormone replacement therapy on progression of carotid intima-media thickness ( CIMT ) . For a period of 3 years , the women underwent a st and ardized carotid ultrasound protocol every 6 months . Common , bifurcation and internal carotid segments were scanned on both sides , stored on videotape , and the near and far wall CIMT was measured on defined angles and segments , also in areas of plaque . Adverse events were routinely recorded . At the completion of the study , all segment-specific measurements were evaluated for outliers . Images were retrieved from videotape and evaluated whether the outlier result ed from a real morphological change or ‘ measurement error ’ . Results : The 509 healthy postmenopausal women , free from previous symptomatic cardiovascular disease , underwent 3,812 carotid ultrasound scans during the study , and 44,924 carotid segments were evaluated . In 203 segments of 188 participants outliers were observed . True morphological changes were found in 12 participants , equivalent to a 3-year risk of 2.4 % . These changes did not give rise to clinical symptoms . In the 6 women of whom we had follow-up measurements , the changes were reversed within 6–12 months . Conclusion : We observed acute increases in CIMT among 2.4 % of healthy postmenopausal European women followed for 3 years . When assuming these were the result of vessel wall hemorrhages , our findings add to the body of evidence suggesting that vessel wall hemorrhages contribute to atherosclerosis development and also appear to occur clinical ly silent",
"This manuscript describes the study design and rationalle for the Kronos Early Estrogen Prevention Study ( KEEPS ) and the KEEPS Cognitive and Affective ancillary study ( KEEPS Cog ) . KEEPS is a multicenter , r and omized , double-blinded , placebo-controlled trial , design ed to test the hypothesis that low-dose hormone therapy ( HT ) initiated in recently postmenopausal women will reduce the progression of sub clinical atherosclerosis as measured by carotid artery intima-media thickness ( CIMT ) and coronary artery calcification ( CAC ) over four years . The KEEPS Cog ancillary study was design ed to assess potential estrogenic treatment effects on cognition and mood . We present the KEEPS trial in the context of issues raised by the Women 's Health Initiative ( WHI ) and the Women 's Health Initiative Memory Study ( WHIMS ) . Here we also describe the most recent results and ongoing HT-related research studies design ed to address similar issues . This article is part of a Special Issue entitled Hormone Therapy",
"BACKGROUND Postmenopausal hormone therapy has been associated with a 2- to 3-fold increased risk of venous thromboembolism ( VT ) ( including deep vein thrombosis and pulmonary embolism ) in observational studies and secondary prevention clinical trials . Clinical trial data on the effects of estrogen alone on VT are limited . METHODS The Women 's Health Initiative estrogen trial enrolled 10 739 women aged 50 to 79 years without a uterus . Participants were r and omly assigned to receive conjugated equine estrogen ( 0.625 mg/d ) or placebo . RESULTS During a mean of 7.1 years , VT occurred in 111 women r and omly assigned to receive estrogen ( 3.0 per 1000 person-years ) and 86 r and omly assigned to receive placebo ( 2.2 per 1000 person-years ; hazard ratio , 1.32 ; 95 % confidence interval , 0.99 - 1.75 ) . Deep venous thrombosis was reported in 85 women r and omly assigned to receive estrogen ( 2.3 per 1000 person-years ) and 59 r and omly assigned to receive placebo ( 1.5 per 1000 person-years ; hazard ratio , 1.47 ; 95 % confidence interval , 1.06 - 2.06 ) . The VT risk was highest in the first 2 years . There were no significant interactions between estrogen use and age , body mass index , or most other VT risk factors . Comparison of Women 's Health Initiative VT findings for estrogen and previous Women 's Health Initiative findings for estrogen plus progestin showed that the hazard ratios for estrogen plus progestin were significantly higher than those for estrogen alone ( P = .03 ) , even after adjusting for VT risk factors . CONCLUSION An early increased VT risk is associated with use of estrogen , especially within the first 2 years , but this risk increase is less than that for estrogen plus progestin",
"As part of the Women 's Health Initiative Study , the 5-item Women 's Health Initiative Insomnia Rating Scale ( WHIIRS ) was developed . This article summarizes the development of the scale through the use of responses from 66,269 postmenopausal women ( mean age = 62.07 years , SD = 7.41 years ) . All women completed a 10-item question naire concerning sleep . A novel resampling technique was introduced as part of the data analysis . Principal-axes factor analysis without iteration and rotation to a varimax solution was conducted for 120,000 r and om sample s of 1,000 women each . Use of this strategy led to the development of a scale with a highly stable factor structure . Structural equation modeling revealed no major differences in factor structure across age and race-ethnic groups . WHIIRS norms for race-ethnicity and age subgroups are detailed",
"Coronary artery disease is the leading cause of death among women in the United States , accounting for 23 % of all deaths [ 1 , 2 ] . The incidence of coronary artery disease in women aged 35 to 44 years is 1 per 1000 , increasing to 4 per 1000 in women aged 45 to 54 years [ 3 , 4 ] . Among women in their fifth decade , the incidence of coronary artery disease is one half that of men . By the sixth decade , however , women and men have the same incidence of coronary disease [ 2 , 5 , 6 ] . This disparity between premenopausal women and men of similar age suggests that endogenous sex hormones such as estrogen may have a significant cardioprotective influence . In postmenopausal women , estrogen replacement therapy independently decreases the risk for cardiovascular events and mortality [ 6 , 7 ] . Estrogen therapy limited the uptake of cholesterol ester into the arterial wall and attenuated the development of dietary-induced atherosclerosis in monkeys and baboons that had ovariectomy [ 8 - 10 ] . Angiographic studies have consistently found less coronary artery disease in women who receive estrogen replacement therapy [ 7 , 11 , 12 ] . Beneficial effects of estrogen replacement therapy include its ability to reduce low-density lipoprotein ( LDL ) cholesterol levels and increase high-density lipoprotein ( HDL ) cholesterol levels [ 13 ] . Nonetheless , multiple regression analyses suggest that only 25 % to 50 % of the reduction in cardiovascular events is attributable to the lipid-lowering effects of estrogen replacement therapy [ 14 ] , suggesting that other mechanisms contribute to its cardioprotective potential . One such mechanism may involve the effect of estrogen on vascular function . Specifically , estrogen may directly enhance the activity of the endothelium-derived relaxing factor nitric oxide [ 10 , 15 - 17 ] and thereby lessen the potential for coronary vasoconstriction and thrombosis [ 18 - 21 ] . When administered to rabbits that had ovariectomy , long-term estrogen replacement improved endothelium-dependent relaxation in vitro [ 15 , 16 ] . In addition , both short-term and long-term estrogen administration improves in vivo the endothelium-dependent vasodilation in coronary arteries of atherosclerotic cynomolgus monkeys that had ovariectomy [ 10 , 17 ] . Several recent studies have suggested that short-term estrogen administration improves endothelium-dependent vasodilation of the coronary arteries of postmenopausal women [ 22 , 23 ] . We hypothesized that long-term estrogen administration would improve vasomotor function in postmenopausal women . Accordingly , we conducted a double-blind , r and omized , crossover , placebo-controlled trial to assess the effect of estrogen replacement therapy on endothelium-dependent vasodilation in postmenopausal women . We used high-resolution ultrasonography to serially assess vasomotor function in a peripheral conduit vessel , the brachial artery . Methods Patients The patients enrolled in this study were recruited from a larger cohort that was participating in a clinical research trial investigating the effect of estrogen replacement therapy on lipoprotein metabolism . Thirteen postmenopausal women aged 44 to 69 years ( average age , 55 7 years ) participated in this study . Women were eligible if menopause had occurred at least 1 year previously . Menopause was confirmed by measuring serum follicle-stimulating hormone levels . No patient had received hormone replacement therapy for at least 2 months before the study began . A history and physical examination were done to exclude persons with clinical evidence of coronary or peripheral atherosclerosis . Initial evaluation included a Papanicolaou smear ( if not done in past year ) , complete blood count , routine chemistry panel , and lipid profile . Inclusion criteria included mild hypercholesterolemia , defined as a serum cholesterol level of 5.17 mmol/L to 6.20 mmol/L and an LDL cholesterol level of 3.36 mmol/L to 4.13 mmol/L. Exclusion criteria included hypertension , diabetes mellitus , tobacco use , obesity ( body weight > 135 % of ideal weight ) , history of breast or uterine cancer , thromboembolism , and liver or renal disease . Eligible patients were placed on a low-cholesterol diet ( American Heart Association phase I ) for 6 weeks before r and omization . Patients were r and omly assigned to one of three treatment groups : placebo , oral 17 -estradiol ( Estrace , Mead Johnson , Evansville , Indiana . ) at a dose of 1 mg/d , or oral 17 -estradiol at a dose of 2 mg/d . At the conclusion of each 9-week treatment period , the patients were given progesterone ( Provera , Upjohn , Kalamazoo , Michigan ) at 10 mg/d for 10 days . Hormone replacement therapy was discontinued for 3 weeks before patients crossed over to the next treatment regimen . All patients received placebo and the two doses of estrogen in r and om order . Vascular function studies ( described below ) were done during the eighth or ninth week of each treatment period . Experimental Protocol Studies were done in a temperature-controlled vascular research laboratory . All patients were placed in the supine position . We studied vascular reactivity in a conduit vessel , the brachial artery , as previously described . An imaging study of the brachial artery was done using a high-resolution ultrasound machine ( Toshiba , Model SSA-270 , Otawara-shir , Tochigi-Ken , Japan ) that was equipped with a 7.5 MHz linear-array transducer . Baseline images of the brachial artery were obtained proximal to the antecubital fossa . Imaging of the artery was done longitudinally , allowing clear visualization of the posterior wall intima-lumen interface and the anterior wall media-adventitial interface . We assessed endothelium-dependent vasodilation by measuring the change in the caliber of the brachial artery during reactive hyperemia , a maneuver that increases flow through the conduit segment being studied ( flow-mediated vasodilation ) . To create this stimulus , a cuff placed on the upper arm was inflated to suprasystolic pressure for 5 minutes , thereby occluding flow to the forearm . This results in dilatation of downstream forearm resistance vessels . After cuff deflation , reactive hyperemia occurs , as brachial artery blood flow increases to accommo date the dilated resistance vessels . Imaging of the brachial artery was continually done for the 5-minute period after cuff deflation until basal conditions were re-established . Thereafter , sublingual nitroglycerin ( at a dose of 0.4 mg ) was administered to assess endothelium-independent vasodilation . The artery was studied for an additional 5 minutes . Blood pressure and heart rate were monitored continuously throughout the procedure . All images were recorded on Super VHS videotape for subsequent analysis . Image analysis was done on a personal computer that was equipped with a video frame grabber . Images recorded on videotape were analyzed by an investigator blinded to treatment assignment . Previous studies have shown that the peak diameter change during reactive hyperemia occurs approximately 1 minute after cuff deflation and 3 minutes after nitroglycerin administration [ 41 ] . We used these time points in our study . Images corresponding to the end of the T wave on a simultaneous electrocardiograph were selected and digitized . Image analysis was then done using a proprietary analysis software that search ed for the shortest distance between the points on the arterial wall , creating 10 to 20 paired measurements along a 10-mm length . We measured arterial diameter from the intima-lumen interface on the posterior wall to the media-adventitial interface on the anterior wall . We calculated brachial artery diameter by averaging these paired lumen measurements and reported them in millimeters using calibration factors derived from real-time ultrasonography . We used an average of three separate measurements for each condition . In our laboratory , this technique has a variability of only 0.0 0.1 mm [ 24 ] . To assure that the blood flow stimulus during reactive hyperemia was similar during each treatment phase , forearm blood flow was measured by venous occlusion strain gauge plethysmography using calibrated mercury-in-silastic strain gauges as previously described [ 25 ] . Statistical Analysis The variables compared during the placebo period and during therapy with each dose of estrogen included blood pressure , heart rate , forearm blood flow , basal brachial artery diameter , and the percentage increase in diameter during reactive hyperemia and after patients received sublingual nitroglycerin . Values are expressed as the mean SE . For statistical analysis , we used repeated-measure analysis of variance and the Scheffe-F post hoc test [ 26 ] . Significance was accepted at P 0.05 . Results Baseline Hemodynamic Measurements The effect of estrogen treatment on blood pressure , heart rate , forearm blood flow and forearm vascular resistance is presented in Table 1 . Estrogen therapy did not affect blood pressure or heart rate . Basal forearm blood flow tended to be higher during both estrogen treatment phases ( P = 0.08 ) . Basal forearm vascular resistance was similar during all three treatment phases . The peak forearm blood flow during reactive hyperemia was similar during placebo receipt and each estrogen treatment period . However , peak forearm blood flow was greater when patients received the 1-mg dose of estradiol than when they received the 2-mg dose ( P = 0.05 ) . Table 1 . Effect of Estrogen Replacement on Hemodynamic Measurements Flow-Mediated Endothelium-Dependent Vasodilation We obtained technically adequate ultrasound images during reactive hyperemia for 12 of the 13 patients . The brachial artery diameter , under basal conditions , measured 3.5 mm , 3.4 mm , and 3.3 mm while patients received placebo , estradiol at 1 mg/d , and estradiol at 2 mg/d , respectively ( P > 0.2 ) . The percentage increase in brachial artery diameter during reactive hyperemia for each treatment period is shown in Figure 1 . The change in brachial artery diameter was greater when patients received estradiol treatment ( 13.5 % and",
"1 . Auricchio A , Sommariva L , Salo RW , Scafuri A , Chiariello L. Improvement of cardiac function in patients with severe congestive heart failure and coronary artery disease by dual chamber pacing with shortened AV delay . Pacing Clin Electrophysiol 1993;16:2034–2043 . 2 . Hochleitner M , Hortnagl H , Hortnagl H , Fridrich L , Gschnitzer F. Long-term efficacy of physiologic dual-chamber pacing in the treatment of end-stage idiopathic dilated cardiomyopathy . Am J Cardiol 1992;70:1320–1325 . 3 . Innes D , Leitch JW , Fletcher PJ . VDD pacing at short atrioventricular intervals does not improve cardiac output in patients with dilated heart failure . Pacing Clin Electrophysiol 1994;17:959–965 . 4 . Gold MR , Feliciano Z , Gottlieb SS , Fisher ML . Dual-chamber pacing with a short atrioventricular delay in congestive heart failure : a r and omized study . J Am Coll Cardiol 1995;26:967–973 . 5 . Linde C , Gadler F , Edner M , Nordl and er R , Rosenqvist M , Ryden L. Results of atrioventricular synchronous pacing with optimized delay in patients with severe congestive heart failure . J Am Coll Cardiol 1995;75:919–923 . 6 . Hunt SA , Baker DW , Chin MH , Cinquegrani MP , Feldman AM , Francis GS , Ganiats TG , Goldstein S , Gregoratos G , Jessup ML , et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult : executive summary . A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines . J Am Coll Cardiol 2001;38 : 2101–2113 . 7 . Karpawich PP , Mital S. Comparative left ventricular function following atrial , septal , and apical single chamber heart pacing in the young . Pacing Clin Electrophysiol 1997;20:1983–1988 . 8 . Owen CH , Esposito DJ , Davis JW , Glower DD . The effects of ventricular pacing on left ventricular geometry , function , myocardial oxygen consumption , and efficiency of contraction in conscious dogs . Pacing Clin Electrophysiol 1998;21:1417–1429 . 9 . Zile MR , Blaustein AS , Shimizu G , Gaasch WH . Right ventricular pacing reduces the rate of left ventricular relaxation and filling . J Am Coll Cardiol 1987;10:702–709 . 10 . Blanc JJ , Etienne Y , Gilard M , Mansourati J , Munier S , Boschat J , Benditt DG , Lurie KG . Evaluation of different ventricular pacing sites in patients with severe heart failure : results of an acute hemodynamic study . Circulation 1997 ; 96:3273–3277 . 11 . Tantengco MV , Thomas RL , Karpawich PP . Left ventricular dysfunction after long-term right ventricular apical pacing in the young . J Am Coll Cardiol 2001;37:2093–2100 . 12 . Hamdan MH , Zagrodzky JD , Joglar JA , Sheehan CJ , Ramaswamy K , Erdner JF , Page RL , Smith M. Biventricular pacing decreases sympathetic activity compared with right ventricular pacing in patients with depressed ejection fraction . Circulation 2000;102:1027–1032",
"BACKGROUND Pulse pressure ( PP ) has been shown to predict risk for cardiovascular events in men ; however , this association has not been well established in women . Hormone replacement therapy may improve arterial compliance , but findings from cross-sectional and prospect i ve studies report inconsistent results . We sought to examine the relationship between PP and risk for cardiovascular events , and to determine the effect of hormone therapy on PP in postmenopausal women with coronary heart disease ( CHD ) . METHODS AND RESULTS A total of 2,763 postmenopausal women ( mean age , 66 + /- 7 years [ + /- SD ] ) with CHD in the Heart and Estrogen/Progestin Replacement Study , a r and omized , placebo-controlled , secondary CHD prevention trial of estrogen plus progestin , were followed up on average for 4.1 years . BP was measured at baseline and annually . Mean baseline PP was 62 + /- 16 mm Hg . There were 361 myocardial infa rct ions ( MIs ) or CHD deaths , 265 hospitalizations for congestive heart failure ( CHF ) , and 215 strokes or transient ischemic attacks ( TIAs ) . Women in the highest quartile of PP at baseline had a 47 % increase in risk for MI or CHD death and more than a twofold increase in risk for stroke and TIA events or hospitalization for CHF ( p incident stroke or TIA events ( odds ratio , 1.25 ; p = 0.02 ) and hospitalizations for CHF ( odds ratio , 1.31 ; p MI or CHD death . After adjustment for diastolic BP , systolic BP was similarly associated with stroke or TIA ( odds ratio , 1.30 ; p hospitalized CHF ( odds ratio , 1.30 ; p risk for MI and CHD death ( odds ratio , 1.18 ; p = 0.02 ) . Mean PP was 1- to 2-mm Hg higher in women r and omized to hormone replacement therapy vs those receiving placebo ( p PP had predictive value for CHF and stroke or TIA , but not MI or CHD death in this cohort of postmenopausal women with CHD . Use of hormone replacement therapy produced a small , statistically significant increase in PP . Further research is necessary to determine the clinical utility of PP as a potential therapeutic target",
"CONTEXT Observational studies have found lower rates of coronary heart disease ( CHD ) in postmenopausal women who take estrogen than in women who do not , but this potential benefit has not been confirmed in clinical trials . OBJECTIVE To determine if estrogen plus progestin therapy alters the risk for CHD events in postmenopausal women with established coronary disease . DESIGN R and omized , blinded , placebo-controlled secondary prevention trial . SETTING Outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 women with coronary disease , younger than 80 years , and postmenopausal with an intact uterus . Mean age was 66.7 years . INTERVENTION Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate in 1 tablet daily ( n = 1380 ) or a placebo of identical appearance ( n = 1383 ) . Follow-up averaged 4.1 years ; 82 % of those assigned to hormone treatment were taking it at the end of 1 year , and 75 % at the end of 3 years . MAIN OUTCOME MEASURES The primary outcome was the occurrence of nonfatal myocardial infa rct ion ( MI ) or CHD death . Secondary cardiovascular outcomes included coronary revascularization , unstable angina , congestive heart failure , resuscitated cardiac arrest , stroke or transient ischemic attack , and peripheral arterial disease . All-cause mortality was also considered . RESULTS Overall , there were no significant differences between groups in the primary outcome or in any of the secondary cardiovascular outcomes : 172 women in the hormone group and 176 women in the placebo group had MI or CHD death ( relative hazard [ RH ] , 0.99 ; 95 % confidence interval [ CI ] , 0.80 - 1.22 ) . The lack of an overall effect occurred despite a net 11 % lower low-density lipoprotein cholesterol level and 10 % higher high-density lipoprotein cholesterol level in the hormone group compared with the placebo group ( each P CHD events in the hormone group than in the placebo group in year 1 and fewer in years 4 and 5 . More women in the hormone group than in the placebo group experienced venous thromboembolic events ( 34 vs 12 ; RH , 2.89 ; 95 % CI , 1.50 - 5.58 ) and gallbladder disease ( 84 vs 62 ; RH , 1.38 ; 95 % CI , 1.00 - 1.92 ) . There were no significant differences in several other end points for which power was limited , including fracture , cancer , and total mortality ( 131 vs 123 deaths ; RH , 1.08 ; 95 % CI , 0.84 - 1.38 ) . CONCLUSIONS During an average follow-up of 4.1 years , treatment with oral conjugated equine estrogen plus medroxyprogesterone acetate did not reduce the overall rate of CHD events in postmenopausal women with established coronary disease . The treatment did increase the rate of thromboembolic events and gallbladder disease . Based on the finding of no overall cardiovascular benefit and a pattern of early increase in risk of CHD events , we do not recommend starting this treatment for the purpose of secondary prevention of CHD . However , given the favorable pattern of CHD events after several years of therapy , it could be appropriate for women already receiving this treatment to continue",
"BACKGROUND Postmenopausal hormone therapy has been examined extensively in relation to cardiovascular disease . However , research relating serum levels of sex hormones to cardiovascular disease is sparse , and the results are inconclusive . METHODS We measured sex hormones in longitudinally collected sample s of 180 postmenopausal women , 91 r and omized to 17beta-estradiol and 89 to placebo , in the Estrogen in the Prevention of Atherosclerosis Trial . Repeated measures of sex hormone levels were tested for an association with carotid artery intima-media thickness ( CIMT ) , which was also assessed longitudinally over 2 yr . RESULTS In all women , changes in serum estrone ( P = 0.02 ) , total estradiol ( P = 0.01 ) , free estradiol ( P = 0.02 ) , and SHBG ( P = 0.005 ) were significantly inversely associated with CIMT progression , controlling for age and body mass index . All the estrogen compounds and SHBG were significantly inversely related with low-density lipoprotein cholesterol and positively associated with high-density lipoprotein cholesterol ( all P low-density lipoprotein cholesterol and inversely associated with high-density lipoprotein cholesterol ( P serum-free estradiol with estradiol therapy , women with unchanged SHBG and free testosterone levels had an average ( se ) progression in CIMT of 8.53 ( 4.72 ) microm/yr , whereas women with increased free estradiol and SHBG and decreased free testosterone had the largest reduction in CIMT progression [ -5.45 ( 2.77 ) microm/yr ; trend P = 0.03 ] . CONCLUSION Estrogen and SHBG are associated with reduced sub clinical atherosclerosis progression in healthy postmenopausal women . These associations are partially mediated by their beneficial effects on lipids . Among women taking estradiol , the most beneficial hormone profile for CIMT progression was increased free estradiol and SHBG with concomitant decreased free testosterone",
"R and omized , controlled trial data from the Heart and Estrogen-progestin Replacement Study were used to evaluate the effect of estrogen plus progestin use on all-cause mortality in women with heart failure and coronary disease . Over the 4.1-year follow-up , estrogen plus progestin use had no effect on all-cause mortality ( hazard ratio 1.0 , 95 % confidence interval 0.7 to 1.4 , p = 0.8 ) in women with heart failure and coronary disease",
"BACKGROUND Heart disease is a major cause of illness and death in women . To underst and better the role of estrogen in the treatment and prevention of heart disease , more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects . METHODS We r and omly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day , 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day , or placebo . The women were followed for a mean ( + /-SD ) of 3.2+/-0.6 years . Base-line and follow-up coronary angiograms were analyzed by quantitative coronary angiography . RESULTS Estrogen and estrogen plus medroxyprogesterone acetate produced significant reductions in low-density lipoprotein cholesterol levels ( 9.4 percent and 16.5 percent , respectively ) and significant increases in high-density lipoprotein cholesterol levels ( 18.8 percent and 14.2 percent , respectively ) ; however , neither treatment altered the progression of coronary atherosclerosis . After adjustment for measurements at base line , the mean ( + /-SE ) minimal coronary-artery diameters at follow-up were 1.87+/-0.02 mm , 1.84+/-0.02 mm , and 1.87+/-0.02 mm in women assigned to estrogen , estrogen plus medroxyprogesterone acetate , and placebo , respectively . The differences between the values for the two active-treatment groups and the value for the placebo group were not significant . Analyses of several secondary angiographic outcomes and subgroups of women produced similar results . The rates of clinical cardiovascular events were also similar among the treatment groups . CONCLUSIONS Neither estrogen alone nor estrogen plus medroxyprogesterone acetate affected the progression of coronary atherosclerosis in women with established disease . These results suggest that such women should not use estrogen replacement with an expectation of cardiovascular benefit",
"OBJECTIVE This study examined the effect of hormone therapy ( HT ) on the plasma concentration of remnant lipoprotein cholesterol ( RLP-C ) and high-density lipoprotein ( HDL ) sub population s and the contribution of HT-related changes in these lipoproteins to the progression of coronary heart disease ( CHD ) in postmenopausal women . METHODS Study participants were 256 women who completed the Estrogen Replacement and Atherosclerosis ( ERA ) trial , a placebo-controlled , r and omized trial that examined the effects of 3.2 years of conjugated equine estrogen ( CEE , 0.625 mg/day ) or CEE ( 0.625 mg/day ) plus medroxyprogesterone acetate ( MPA , 2.5mg/day ) on postmenopausal women with established coronary atherosclerosis . Quantitative coronary angiography and plasma RLP-C and HDL sub population s were assessed at baseline and at follow-up . RESULTS Relative to placebo , both CEE and CEE+MPA caused a significant reduction in plasma RLP-C concentrations and a significant increase in alpha1 and alpha2 HDL sub population s. However , in the HT-treated subjects , faster progression of coronary atherosclerosis was observed in women who experienced the greatest reductions in RLP-C and in prebeta1 HDL sub population s. CONCLUSIONS Our data suggest that individual variability in RLP-C and HDL sub population response to HT is a predictor of CHD progression . Lipoprotein response to HT may be an indirect marker of susceptibility to other harmful effect of HT in postmenopausal women with established CHD or an indication of formation of dysfunctional lipoproteins",
"52 e held a very successful meeting in Manchester for practice nurses , which was attended by more than 100 . These appear to be very popular events , so it is our hope to stage two nurse meetings a year , one in London and the other in Manchester . We are also considering a series of one-day roadshows to be taken around the country which may be attractive to those unable to attend the annual meeting . Watch this space for further details . We still need more members for the Society , for the more members we have , the less likely it is for membership fees to rise . Please try to recruit one new member each , as this would make such a difference to the Society . The journal is certainly a good shop window for the BMS , and we now receive compliments from all over the world . Executive Secretary ’s report",
" Serum lipoproteins were measured in 72 post-menopausal women , 40 of whom had been taking the synthetic oestrogen , mestranol , for a period of 10 yr and 32 of whom had been taking identical placebo tablets . Mestranol therapy was found to increase serum triglycerides , decrease low density lipoprotein ( LDL ) cholesterol and increase high density lipoprotein ( HDL ) cholesterol . The increase in HDL cholesterol was due principally to a marked increase in the cardioprotective HDL2 fraction . It is concluded that long-term mestranol therapy has a beneficial effect on serum lipoproteins which may help to protect post-menopausal women against fatal ischaemic heart disease",
"CONTEXT Lower-than-commonly-prescribed doses of conjugated equine estrogens ( CEEs ) with medroxyprogesterone acetate ( MPA ) improve vasomotor symptoms and vaginal atrophy , provide acceptable bleeding and lipid profiles , and afford endometrial protection . This lower-dose therapy 's protection against loss of bone mineral density ( BMD ) associated with menopause has not been thoroughly investigated . OBJECTIVE To determine the effects of lower doses of CEEs only or CEEs-MPA on spine and hip BMD , total body bone mineral content ( BMC ) , and biochemical markers of bone turnover in postmenopausal women . DESIGN AND SETTING Two-year r and omized , double-blind , placebo-controlled sub study of the Women 's Health , Osteoporosis , Progestin , Estrogen trial , conducted at 19 US centers between August 1995 and October 2000 . PARTICIPANTS Eight hundred twenty-two healthy postmenopausal women aged 40 to 65 years who were within 4 years of their last menstrual period . INTERVENTIONS Patients were r and omly assigned to receive CEEs , 0.625 ; CEEs , 0.625 and MPA , 2.5 ; CEEs , 0.45 ; CEEs , 0.45 and MPA , 2.5 ; CEEs , 0.45 and MPA , 1.5 ; CEEs , 0.3 ; CEEs 0.3 and MPA , 1.5 ( all doses in mg/d ) ; or placebo for 2 years . All participants also received elemental calcium at 600 mg/d . MAIN OUTCOME MEASURES Changes from baseline in spine and total hip BMD , total body BMC , and biochemical markers of bone turnover ( serum osteocalcin and urinary cross-linked N-telopeptides of type I collagen ) , assessed at 6-month intervals and compared among treatment groups with a modified intention-to-treat approach . RESULTS At 24 months , women assigned to all of the active treatment groups had significant gains from baseline ( P spine and hip BMD and total body BMC ( except total body BMC in the group receiving CEEs , 0.3 mg/d ) . These changes were significantly different from those in the placebo group , in which losses of bone mass in spine and total body were evident over the course of the study ( P loss in hip BMD from baseline in the placebo group was significant at 18 ( P = .02 ) but not at 24 months ( P = .06 ) . Osteocalcin and N-telopeptides of type I collagen were significantly reduced from baseline ( P placebo group . For women treated with CEEs alone , the gains in spine BMD for the group taking CEEs , 0.625 mg/d , were significantly higher than those of the group taking CEEs , 0.3 mg/d ( P = .02 ) , but not the group treated with CEEs , 0.45 mg/d ( P = .48 ) . CONCLUSIONS Doses of CEEs or CEEs-MPA lower than 0.625 mg/d effectively increase BMD and BMC in early postmenopausal women",
"Forty women aged 64.7 + /- 5.1 yr with established postmenopausal osteoporosis were blindly allocated to 1 yr 's treatment with either continuous combined estrogen/progestogen therapy ( 2 mg estradiol + 1 mg norethisterone acetate + 500 mg calcium daily ) or placebo + 500 mg calcium daily . In the group treated with hormones bone mineral density in the spine ( dual photon absorptiometry ) and bone mineral content in the ultradistal forearm ( single photon absorptiometry ) increased highly significantly by 8 - 10 % during the 1 yr of treatment . Bone mineral content in the mid-shaft of the forearm ( single photon absorptiometry ) and the total body bone mineral ( dual photon absorptiometry ) increased by 3 - 5 % when compared to that in the placebo group , which showed virtually unchanged values at all measurement sites . Seven of the women treated with hormones were examined after a further year of treatment . BMC increased by another 3 - 6 % , reaching a 12 % increase in bone mineral density in the spine after 2 yr of treatment . Biochemical estimates of bone resorption ( fasting urinary calcium and hydroxyproline ) and bone formation ( serum alkaline phosphatase and plasma osteocalcin ) , decreased significantly ( P less than 0.001 ) in the group treated with hormones , but remained unchanged in the placebo group . The reduction in indices of bone resorption was more pronounced than that in bone formation after one year , indicating a positive bone balance . No further changes were seen in these bone turnover parameters during the second year of treatment . In the group treated with hormones , serum levels of triglycerides , total cholesterol , and low density lipoprotein cholesterol decreased by about 12 % ( P less than 0.05-P less than 0.01 ) , whereas high density lipoprotein cholesterol decreased by about 8 % ( P less than 0.001 ) . The high density lipoprotein cholesterol/low density lipoprotein cholesterol ratio was unchanged . The hormone treatment did not produce any major side effects , and only minor bleedings were experienced by a few women . The present study demonstrates that treatment with female sex hormones in this particular combination is a realistic approach to the treatment of women with established postmenopausal osteoporosis",
"We assessed the rates of vertebral fracture in patients with postmenopausal osteoporosis . Forty-five patients were not treated ( 91 person-years of observation ) ; 59 were treated conventionally , with calcium ( alone or combined with estrogen ) or vitamin D or both ( 218 years ) ; and 61 were treated with sodium fluoride combined with conventional therapy ( 251 years ) . The fracture rate ( per thous and person-years ) was 834 in untreated patients , 419 in those given calcium with or without vitamin D , 304 in those given fluoride and calcium with or without vitamin D , 181 in those given estrogen and calcium with or without vitamin D , and 53 in those given fluoride , estrogen , and calcium with or without vitamin D. It was reduced in all treatment groups ( P less than 0.001 for calcium and P less than 1 x 10(-6 ) for other combinations ) ; fluoride ( one years of treatment ) and estrogen ( but not vitamin D ) independently reduced the rate from that observed with calcium alone ( P less than 0.001 ) . The combination of calcium fluoride , and estrogen was more effective than any other combination ( P less than 0.001 ) . These results provide grounds for optimism about the efficacy of combinations of available agents with sodium fluoride for fracture in postmenopausal osteoporosis",
"Objective To assess the possible benefit of hormone replacement therapy ( HRT ) in the secondary prevention of ischaemic heart disease ",
"Despite several observational studies , 1–3 no clinical trial has evaluated the effect of hormone therapy on percutaneous transluminal coronary angioplasty ( PTCA ) outcomes in matched population s r and omized to hormones or placebo . We compared the incidence of coronary heart disease ( CHD ) events after PTCA among women who previously had been r and omly assigned to hormone therapy and placebo in the Heart and Estrogen/progestin Replacement Study ( HERS ) . The design , methods , and primary results of HERS have been previously published . 4,5 Briefl y , HERS participants were postmenopausal women aged 80 years with established CHD who had not had a hysterectomy . Inclusion criteria were prior myocardial infa rct ion , coronary artery bypass graft surgery ( CABG ) , PTCA , or angiographic evidence of a 50 % diameter narrowing of 1 major coronary artery . Exclusion criteria were a recent CHD event , New York Heart Association class IV or severe class III congestive heart failure , serum triglyceride levels 300 mg/ dl , recent use of any hormone therapy , uncontrolled hypertension or diabetes , a disease ( other than CHD ) judged likely to be fatal within 4 years , or prior intolerance to hormone therapy . At the initiation of the HERS , participants were r and omly assigned to receive a single identical tablet containing either conjugated equine estrogen 0.625 mg and medroxyprogesterone acetate 2.5 mg or placebo . During the HERS , 357 patients underwent PCTA and constituted the study population . These patients were followed subsequently to ascertain their rate for subsequent CHD events . Demographic characteristics , health history , CHD risk factors , medication use , educational level , and quality of life were assessed at baseline . Baseline levels of fasting total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , and lipoprotein ( a ) were determined by the Lipoprotein Analytical Laboratory at Johns Hopkins Hospital ( Baltimore , Maryl and ) . Follow-up time for this analysis began at the time of the initial PTCA and concluded at the closeout of the HERS . All suspected outcome events were classifi ed independently by 2 physician review ers who were unaware of treatment assignment . Discordant classifi cations were resolved in discussion s between the review ers",
"CONTEXT The Women 's Health Initiative ( WHI ) trial of estrogen plus progestin vs placebo was stopped early , after a mean 5.6 years of follow-up , because the overall health risks of hormone therapy exceeded its benefits . OBJECTIVE To report health outcomes at 3 years ( mean 2.4 years of follow-up ) after the intervention was stopped . DESIGN , SETTING , AND PARTICIPANTS The intervention phase was a double-blind , placebo-controlled , r and omized trial of conjugated equine estrogens ( CEE ) 0.625 mg daily plus medroxyprogesterone acetate ( MPA ) 2.5 mg daily , in 16,608 women aged 50 through 79 years , recruited by 40 centers from 1993 to 1998 . The postintervention phase commenced July 8 , 2002 , and included 15 730 women . MAIN OUTCOME MEASURES Semi-annual monitoring and outcomes ascertainment continued per trial protocol . The primary end points were coronary heart disease and invasive breast cancer . A global index summarizing the balance of risks and benefits included the 2 primary end points plus stroke , pulmonary embolism , endometrial cancer , colorectal cancer , hip fracture , and death due to other causes . RESULTS The risk of cardiovascular events after the intervention was comparable by initial r and omized assignments , 1.97 % ( annualized rate ) in the CEE plus MPA ( 343 events ) and 1.91 % in the placebo group ( 323 events ) . A greater risk of malignancies occurred in the CEE plus MPA than in the placebo group ( 1.56 % [ n = 281 ] vs 1.26 % [ n = 218 ] ; hazard ratio [ HR ] , 1.24 ; 95 % confidence interval [ CI ] , 1.04 - 1.48 ) . More breast cancers were diagnosed in women who had been r and omly assigned to receive CEE plus MPA vs placebo ( 0.42 % [ n = 79 ] vs 0.33 % [ n = 60 ] ; HR , 1.27 ; 95 % CI , 0.91 - 1.78 ) with a modest trend toward a lower HR during the follow-up after the intervention . All-cause mortality was somewhat higher in the CEE plus MPA than in the placebo group ( 1.20 % [ n = 233 ] vs 1.06 % [ n = 196 ] ; HR , 1.15 ; 95 % CI , 0.95 - 1.39 ) . The global index of risks and benefits was unchanged from r and omization through March 31 , 2005 ( HR , 1.12 ; 95 % CI , 1.03 - 1.21 ) , indicating that the risks of CEE plus MPA exceed the benefits for chronic disease prevention . CONCLUSIONS The increased cardiovascular risks in the women assigned to CEE plus MPA during the intervention period were not observed after the intervention . A greater risk of fatal and nonfatal malignancies occurred after the intervention in the CEE plus MPA group and the global risk index was 12 % higher in women r and omly assigned to receive CEE plus MPA compared with placebo . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"BACKGROUND The mechanisms by which postmenopausal hormone replacement therapy ( HRT ) may influence risk of cardiovascular disease are still unclear . Impaired fibrinolytic function is associated with an enhanced risk of cardiovascular disease and therefore the effect of HRT on fibrinolysis may be of importance . OBJECTIVES To investigate the prolonged effect of HRT on the fibrinolytic system and to determine whether two common polymorphisms in the plasminogen activator inhibitor-1 ( PAI-1 ) and tissue-type plasminogen activator ( t-PA ) genes modulate this effect . METHODS Healthy postmenopausal women ( n = 248 ) were r and omized to HRT ( n = 122 ) or no substitution ( n = 126 ) 5 years prior to investigation . RESULTS Significantly higher values of t-PA activity and lower values of PAI-1 activity and PAI-1 antigen were found in the HRT group compared with the control group . This effect was independent of smoking and without influence from the two common polymorphisms PAI-1 -675(4G/5 G ) and t-PA intron8ins311 . Furthermore , no difference between opposed estrogen ( with norethisterone acetate as the gestagen component ) and unopposed estrogen therapy was found . Both an intention-to-treat and a per- protocol analysis were performed and similar results were obtained . CONCLUSIONS Long-term treatment with HRT in healthy postmenopausal women was found to be associated with a beneficial fibrinolytic profile . This effect was found independent of smoking status , opposed and unopposed estrogen therapy had equal effect , and no influence of the two common polymorphisms PAI-1 - 675(4G/5 G ) and t-PA intron8ins311 was found . This effect of HRT on fibrinolytic capacity may be one of the beneficial effects of HRT in relation to cardiovascular diseases",
"CONTEXT Despite decades of use and considerable research , the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain . OBJECTIVE To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled disease prevention trial ( the estrogen-alone component of the Women 's Health Initiative [ WHI ] ) conducted in 40 US clinical centers beginning in 1993 . Enrolled were 10 739 postmenopausal women , aged 50 - 79 years , with prior hysterectomy , including 23 % of minority race/ethnicity . INTERVENTION Women were r and omly assigned to receive either 0.625 mg/d of conjugated equine estrogen ( CEE ) or placebo . MAIN OUTCOME MEASURES The primary outcome was coronary heart disease ( CHD ) incidence ( nonfatal myocardial infa rct ion or CHD death ) . Invasive breast cancer incidence was the primary safety outcome . A global index of risks and benefits , including these primary outcomes plus stroke , pulmonary embolism ( PE ) , colorectal cancer , hip fracture , and deaths from other causes , was used for summarizing overall effects . RESULTS In February 2004 , after review ing data through November 30 , 2003 , the National Institutes of Health ( NIH ) decided to end the intervention phase of the trial early . Estimated hazard ratios ( HRs ) ( 95 % confidence intervals [ CIs ] ) for CEE vs placebo for the major clinical outcomes available through February 29 , 2004 ( average follow-up 6.8 years ) , were : CHD , 0.91 ( 0.75 - 1.12 ) with 376 cases ; breast cancer , 0.77 ( 0.59 - 1.01 ) with 218 cases ; stroke , 1.39 ( 1.10 - 1.77 ) with 276 cases ; PE , 1.34 ( 0.87 - 2.06 ) with 85 cases ; colorectal cancer , 1.08 ( 0.75 - 1.55 ) with 119 cases ; and hip fracture , 0.61 ( 0.41 - 0.91 ) with 102 cases . Corresponding results for composite outcomes were : total cardiovascular disease , 1.12 ( 1.01 - 1.24 ) ; total cancer , 0.93 ( 0.81 - 1.07 ) ; total fractures , 0.70 ( 0.63 - 0.79 ) ; total mortality , 1.04 ( 0.88 - 1.22 ) , and the global index , 1.01 ( 0.91 - 1.12 ) . For the outcomes significantly affected by CEE , there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years . The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years . CONCLUSIONS The use of CEE increases the risk of stroke , decreases the risk of hip fracture , and does not affect CHD incidence in postmenopausal women with prior hysterectomy over an average of 6.8 years . A possible reduction in breast cancer risk requires further investigation . The burden of incident disease events was equivalent in the CEE and placebo groups , indicating no overall benefit . Thus , CEE should not be recommended for chronic disease prevention in postmenopausal women",
"The effects of four different treatment schedules on serum lipid concentrations were studied for 1 year in 402 postmenopausal women in the Kuopio Osteoporosis Study . The women were r and omized to four treatment groups : A , Sequential combination of estradiol valerate and cyproterone acetate ( Climen ) ; B , Vitamin D3 , 300 IU/day ; C , Climen+Vitamin D3 , D , placebo . In group A , serum concentrations of total cholesterol ( Chol ) decreased by 4.8 % in 6 months and by 6.2 % in 12 months ( P total-Chol in group A was accounted for by the 6.8 % to 7.5 % decrease in LDL-Chol levels ( P LDL-Chol in group C was statistically non-significant . Use of vitamin D3 ( group B ) , increased serum Chol by 2.7 % ( 6 months ) , P LDL-Chol levels in 6 and 12 months , respectively ( P Serum concentrations of HDL-Chol and TG remained relatively stable in all groups . No correlations were found between LDL-Chol , 25-OH-D3 and 1,25(OH)2-D3 levels in group B. Our results confirm the beneficial effect of estradiol valerate and cyproterone acetate on the lipid profile . In contrast , vitamin D3 had a negative influence on this profile by increasing serum concentrations of LDL-Chol . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The significance of an interrelation between nongenetic factors and genotype effects in the regulation of bone mass is not clear . In this prospect i ve study of 429 healthy early postmenopausal Danish women , we investigated the association between bone mineral density ( BMD ) and the FokI and BsmI polymorphisms in the vitamin D receptor ( VDR ) gene . Participants were allocated to either hormone-replacement therapy ( HRT ) or no treatment by r and omization or personal choice . After 5 years , 332 women with unchanged treatment status were available for analyses , 98 of these women were still on HRT . No association with initial BMD or 5-year change in BMD was found for either polymorphism . In women with body mass index ( BMI ) lower BMD of the hip ( p forearm ( p = 0.001 ) , and the b allele was associated with lower spine BMD ( p = 0.02 ) . Comparing thin/normal weight women with overweight/ obese women of the same genotype , FF women had similar BMD at all measured sites in contrast to Ff and ff women in whom BMD , as expected , was higher in the overweight/obese women . Similar results were found for the BsmI polymorphism with no difference in BMD between BMI groups in BB women . Segregation into groups according to dietary calcium intake did not reveal any genotype association with BMD . These results provide some evidence of a modifying effect of nongenetic factors , specifically BMI , on the association between VDR genotype and BMD . High BMI may protect against lower BMD seen in association with thef or b alleles . In some genotypes ( FF and BB ) , BMI had relatively little effect on BMD",
"OBJECTIVE To assess the efficacy of unopposed estrogen , and three estrogen/progestin regimens on selected heart disease risk factors among adherent women and to contrast those results with efficacy among all women in the PEPI study . DESIGN A 3-year , multicenter , r and omized , double-blinded , placebo-controlled clinical trial . PARTICIPANTS A total of 847 healthy postmenopausal women aged 45 to 64 years of age with no known contraindication to hormone therapy , who attended their 36 month clinical visit . INTERVENTION Participants were r and omized in equal numbers to one of the following treatments : ( 1 ) placebo ; ( 2 ) conjugated equine estrogen ( CEE ) 0.625 mg daily ; ( 3 ) CEE 0.625 daily plus medroxyprogesterone acetate ( MPA ) 10 mg , days 1 - 12 ; ( 4 ) CEE 0.625 daily plus MPA 2.5 mg daily ; or ( 5 ) CEE 0.625 daily plus micronized progesterone ( MP ) 200 mg , days 1 - 12 . ANALYSIS Analyses are based on adherent women , where adherence is defined as taking at least 80 % of pills at each 6-month visit . RESULTS Adherence rates were high in all groups except women with a uterus assigned to unopposed CEE . The difference in HDL-C levels result ing from the CEE vs. CEE+MP was approximately three times larger than in the intent-to-treat analyses , reaching statistical significance ( P LDL-C decreased 10 - 15 % . Triglycerides increased 15 - 20 % in each opposed CEE arm and over 25 % in the CEE only arm ; this difference was not statistically significant . Fibrinogen increased by 7 % among placebo adherers , but decreased or remained fairly stable among the active arm adherers . Systolic blood pressure increased 3 - 5 % in all treatment arms . Women adherent to the CEE+MPA arms had twice the increase of 2 h glucose levels as women adherent to CEE only , or CEE+MP ( 8 - 9 % vs. 3 - 4 % ) . Two-hour insulin levels decreased 3 - 12 % for all arms . The patterns of change for fibrinogen , SBP , 2 h glucose and insulin were similar to those from the intent-to-treat analyses . CONCLUSIONS In analyses limited to adherent women , all active treatments , compared to placebo , continued to have similar and favorable effects on LDL-cholesterol and fibrinogen and no significant effects on blood pressure or insulin levels . Given the overall high adherence rates in PEPI , the results are similar to the intent-to-treat analyses , as expected . Only the trend of HDL-C to have a larger increase in the CEE only arm ( in the intent-to-treat analyses ) gained statistical significance in analyses restricted to adherers",
"CONTEXT Postmenopausal hormone therapy is commonly used by women for disease prevention , but its effects on quality of life have not been well documented . OBJECTIVE To determine the effect on quality of life of estrogen plus progestin therapy used as secondary prevention in women with coronary artery disease . DESIGN , SETTING , AND PARTICIPANTS A total of 2763 postmenopausal women with documented coronary artery disease ( mean age , 67 years ) in the Heart and Estrogen/Progestin Replacement Study , a r and omized , placebo-controlled , double-blind trial conducted from January 1993 to July 1998 at outpatient and community setting s at 20 US clinical centers . INTERVENTION Participants were r and omly assigned to receive either 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate ( n = 1380 ) or placebo ( n = 1383 ) for 36 months . MAIN OUTCOME MEASURES Physical activity , measured by the Duke Activity Status Index ; energy/fatigue and mental health , measured by R AND scales ; and depressive symptoms , measured on the Burnam screening scale , at 3 years of follow-up . RESULTS In all patients , scores declined significantly over 3 years for physical function ( -3.8 ; P mental health ( -0.6 ; P = .05 ) , and energy/fatigue ( -3.8 ; P depressive symptoms were not significantly changed ( P = .20 ) . The effect of hormone therapy on these measures depended on the presence ( n = 434 ) or absence ( n = 2325 ) of flushing at study entry . Women with flushing who were assigned to hormone therapy had improved mental health ( + 2.6 vs - 0.5 ; P = .04 ) and fewer depressive symptoms ( -0.5 vs + 0.007 ; P = .01 ) over follow-up compared with those assigned to placebo . Women without flushing who were assigned to hormone therapy had greater declines in physical function ( -4.2 vs -3.3 ; P = .04 ) and energy/fatigue ( -4.6 vs -3.1 ; P = .03 ) over follow-up . Quality -of-life scores were significantly lower among patients with older age , diabetes , hypertension , chest pain , or heart failure . These differences in quality of life among women classified by clinical characteristics were much greater than the effects of hormone therapy . CONCLUSION Hormone therapy has mixed effects on quality of life among older women . The effects of hormone therapy depend on the presence of menopausal symptoms ; women without flushing had greater declines in physical measures , while women with flushing had improvements in emotional measures of quality of life",
"BACKGROUND AND PURPOSE Observational studies have found that women who take estrogen after menopause are less likely to have a stroke than women who do not take estrogen . Although these findings indicate that estrogen may prevent stroke , an alternative explanation for the improved outcome of estrogen users is that they are healthier before starting therapy than nonusers . To test the therapeutic effect of estrogen with research methods that avoid this selection bias , we design ed a r and omized controlled trial . TRIAL DESIGN The Women 's Estrogen For Stroke Trial ( WEST ) is a double-blind , r and omized trial with a primary goal of determining whether 1 mg 17beta-estradiol daily , when compared with placebo , reduces the risk of recurrent stroke or death among postmenopausal women who have experienced a transient ischemic attack or nondisabling ischemic stroke . Exclusion criteria include use of estrogen at the time of stroke , breast or uterine cancer , inability to speak English , and estimated survival less than 5 years . Once r and omized , women remain under the care of their personal physicians for management of stroke risk factors . For early detection of endometrial hyperplasia and cancer , asymptomatic women receive medroxyprogesterone yearly ( 5 mg for 12 days ) and vaginal ultrasonography or biopsy at the end of the trial . Unscheduled uterine bleeding is evaluated with biopsy . A total of 652 women are sought at 20 hospitals in Connecticut and one in Massachusetts . CONCLUSIONS The WEST promises to provide critical guidance to women and their physicians regarding the effectiveness of estrogen in secondary stroke prevention",
"Clinical trials indicate that hormone therapy ( HT ) does not decrease cardiovascular disease events or angiographic coronary disease progression . The effects of HT on SVG vessels are unknown . To determine whether postmenopausal hormone therapy started after coronary bypass surgery ( CABG ) decreases saphenous vein graft ( SVG ) disease , we conducted a multicenter r and omized placebo-controlled angiographic study of estradiol+/-medroxyprogesterone started within 6 months of CABG in 83 postmenopausal women . Angiographic and intravascular ultrasound ( IVUS ) assessment at 6 and 42 months was planned to assess SVG disease progression . The study was stopped early following publication of the Women 's Health Initiative Estrogen/Progestin study . Eighty-three subjects underwent a 6-month angiogram with 63 undergoing IVUS . Forty-five subjects completed the 42-month angiogram ( 20 underwent 42-month IVUS ) . In analysis of paired 6- and 42-month angiogram and IVUS studies , HT slowed angiographic progression of SVG disease assessed by mean percent stenosis ( p minimal lumen diameter ( p=0.029 ) , and total plaque volume ( p=0.006 ) . In contrast , HT accelerated disease progression in non-bypassed native coronary arteries ( minimum lumen diameter , p=0.01 ) . SVG disease and closure occurred in 38 % subjects within 1-year post-CABG . The groups had similar frequency of cardiovascular events expect for angioplasty that occurred in eight HT compared to one placebo subject ( p placebo subject angioplasty was indicated for SVG stenosis . This study suggests that hormone treatment may slow SVG disease progression while accelerating atherosclerosis in non-bypassed native coronary arteries",
"It was recently reported from the Women 's Health Initiative that healthy women using combined hormone replacement therapy ( HRT ) for 5 years have an increased cardiovascular risk . We hypothesize that the increased risk is confined to subgroups of atherosclerotic women . Such women may have higher arterial tissue factor expression and higher thrombin formation , and changes in tissue factor pathway coagulation inhibitor ( TFPI ) and thrombin activatable fibrinolysis inhibitor ( TAFI ) may be deleterious . Healthy postmenopausal women ( n = 719 ) were r and omized to hormone therapy [ n = 357 ; opposed ( n = 290 ) and unopposed ( n = 67 ) ] or no treatment ( n = 362 ) . Plasma TFPI and TAFI and the TFPI -287T/C and TAFI -438G/A polymorphisms were measured 5 - 6 years after r and omization . Concentrations of TFPI were significantly lower in the hormone group than in the control group ( P concentrations of TAFI did not differ between the two groups but were reduced by hormone therapy in homozygotes for the rare TAFI -438 A allele ( P hormone effects on TFPI and TAFI were similar in smokers and non-smokers and in women using unopposed and opposed therapy . The observed decrease in TFPI may contribute to the increased cardiovascular risk associated with HRT",
"BACKGROUND Although observational studies suggest that estrogen replacement therapy ( ERT ) reduces cardiovascular morbidity and mortality in postmenopausal women , use of unopposed ERT for prevention of coronary heart disease in healthy postmenopausal women remains untested . OBJECTIVE To determine the effects of unopposed ERT on the progression of sub clinical atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING University-based clinic . PATIENTS 222 postmenopausal women 45 years of age or older without preexisting cardiovascular disease and with low-density lipoprotein cholesterol levels of 3.37 mmol/L or greater ( > /=130 mg/dL ) . INTERVENTION Unopposed micronized 17beta-estradiol ( 1 mg/d ) or placebo . All women received dietary counseling . Women received lipid-lowering medication if their low-density lipoprotein cholesterol level exceeded 4.15 mmol/L ( 160 mg/dL ) . MEASUREMENTS The rate of change in intima-media thickness of the right distal common carotid artery far wall in computer image processed B-mode ultrasonograms obtained at baseline and every 6 months during the 2-year trial . RESULTS In a multivariable mixed-effects model , among women who had at least one follow-up measurement of carotid intima-media thickness ( n = 199 ) , the average rate of progression of sub clinical atherosclerosis was lower in those taking unopposed estradiol than in those taking placebo ( -0.0017 mm/y vs. 0.0036 mm/y ) ; the placebo-estradiol difference between average progression rates was 0.0053 mm/y ( 95 % CI , 0.0001 to 0.0105 mm/y ) ( P = 0.046 ) . Among women who did not receive lipid-lowering medication ( n = 77 ) , the placebo-estradiol difference between average rates of progression was 0.0147 mm/y ( CI , 0.0055 to 0.0240 ) ( P = 0.002 ) . Average rates of progression did not differ between estradiol and placebo recipients who took lipid-lowering medication ( n = 122 ) ( P > 0.2 ) . CONCLUSIONS Overall , the average rate of progression of sub clinical atherosclerosis was slower in healthy postmenopausal women taking unopposed ERT with 17beta-estradiol than in women taking placebo . Reduction in the progression of sub clinical atherosclerosis was seen in women who did not take lipid-lowering medication but not in those who took these medications",
"PURPOSE To compare the effect of blind design ( active drug and placebo ) and nonblind design ( active drug and no treatment ) on recruitment . SETTING A primary prevention trial with postmenopausal hormone therapy in Estonia . METHODS Women who were eligible and willing to participate on the basis of the question naire survey were r and omized into blind and nonblind groups . Recruitment rates are based on record keeping , and reasons for participating were requested in the first-year follow-up . RESULTS The recruitment was 30 % higher in the nonblind group : of the 4,295 women invited , 37 % ( 95 % confidence interval CI=35 - 39 % ) in the blind group and 48 % ( 95 % CI=46 - 49 % ) in the nonblind group were recruited . In both groups , once r and omized , most of the losses were women who did not attend the first clinical examination : 49 % ( blind ; 95 % CI=47 - 51 % ) and 40 % ( nonblind ; 95 % CI=38 - 42 % ) . The rest were found ineligible or lost their interest during clinical examinations . The reasons for joining the trial were relatively similar in the two groups . CONCLUSIONS Blinding decreased women 's interest in joining a long-term preventive trial . Women 's reasons for joining the trial were not influenced by blinding",
"BACKGROUND Estrogen plus progestin therapy increases the risk for coronary heart disease ( CHD ) in postmenopausal women . However , this increased risk might be limited to the first years of use and to women who start therapy late in menopause . OBJECTIVE To estimate the effect of continuous estrogen plus progestin therapy on CHD risk over time and stratified by years since menopause . DESIGN Women 's Health Initiative r and omized , double-blinded , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00000611 ) SETTING 40 U.S. clinical centers . PATIENTS 16 608 postmenopausal women with an intact uterus at baseline from 1993 to 1998 . INTERVENTION Conjugated equine estrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5 mg/d , or placebo . MEASUREMENTS Adherence-adjusted hazard ratios and CHD-free survival curves estimated through inverse probability weighting . RESULTS Compared with no use of hormone therapy , the hazard ratio for continuous use of estrogen plus progestin therapy was 2.36 ( 95 % CI , 1.55 to 3.62 ) for the first 2 years and 1.69 ( CI , 0.98 to 2.89 ) for the first 8 years . For women within 10 years after menopause , the hazard ratios were 1.29 ( CI , 0.52 to 3.18 ) for the first 2 years and 0.64 ( CI , 0.21 to 1.99 ) for the first 8 years , and the CHD-free survival curves for continuous use and no use of estrogen plus progestin crossed at about 6 years ( CI , 2 years to 10 years ) . LIMITATION The analysis may not have fully adjusted for joint determinants of adherence and CHD risk . Sample sizes for some subgroup analyses were small . CONCLUSION No suggestion of a decreased risk for CHD was found within the first 2 years of estrogen plus progestin use , including in women who initiated therapy within 10 years after menopause . A possible cardioprotective effect in these women who initiated therapy closer to menopause became apparent only after 6 years of use . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute",
"In a controlled single blind study to determine the minimal effective dose of estrogen for protection against bone loss , conjugated equine estrogens in doses of 0.625 and 1.25 mg per day were equally effective in reducing bone loss in postmenopausal and oophorectomized women when bone mass was estimated by single-photon absorptiometry or radiogrammetry . Daily dose levels of less than 0.625 mg were essentially ineffective . Fifty percent response level was calculated to be 0.45 mg per day . Concomitant biochemical effects , reduction in urine calcium and hydroxyproline , were compatible with the observed effects on bone mineral",
"Abstract . Eighty‐four normal women , 2.5‐5 years after their natural menopause , participated in a controlled double‐blind trial . The effect of various therapeutic regimens on postmenopausal bone mineral loss was measured by photonabsorptiometric determination of the bone mineral content of both forearms . The women were r and omized into four treatment groups : 1,25‐dihydroxycholecalciferol ( 1,25(OH)2D3 ) alone in a daily dose of 0.25 μg , oestrogens/gestagen alone or combined with 1,25(OH)2D3 , and placebo . The groups treated with oestrogens/gestagen ( without and with 1,25(OH)2D3 ) showed a similar increase in bone mineral content of about 1 % during one year of treatment . In contrast , both the placebo group and the 1,25(OH)2D3 group demonstrated a decrease of 1.9 % and 2.1 % , respectively , within the same period of time . While 1,25(OH)2D3 did not alter the rate of bone loss , it caused the characteristic and pronounced increase in urinary calcium excretion ( 15 % )",
"OBJECTIVE To characterize the long-term impact of four hormone therapy regimens on insulin and glucose concentrations measured during a st and ard oral glucose tolerance test . RESEARCH DESIGN AND METHODS The Postmenopausal Estrogen/Progestin Intervention Study was a 3-year placebo-controlled r and omized trial to assess effects of four hormone regimens on cardiovascular risk factors . This efficacy analysis describes glucose and insulin concentrations from 788 adherent women at baseline and at 1 and 3 years ' postr and omization RESULTS When compared with women taking placebo , those taking conjugated equine estrogen ( CEE ) at 0.625 mg/day with or without a progestational agent had mean fasting insulin levels that were 16.1 % lower , mean fasting glucose levels 2.2 mg/dl lower , and mean 2-h glucose levels 6.4 mg/dl higher ( each nominal P CEE only versus the three progestin regimens : medroxyprogesterone acetate ( MPA ) at 2.5 mg daily ( continuous MPA ) , MPA at 10 mg on days 1–12 ( cyclical MPA ) , and micronized progesterone ( MP ) ( cyclical ) at 200 mg on days 1–12 . The impact of hormone therapy on insulin and glucose depended on baseline levels of fasting insulin and 1-h glucose ( P carbohydrate metabolism appeared to be consistent across participant subgroups formed by lifestyle , clinical , and demographic characteristics . CONCLUSIONS Oral hormone therapy involving 0.625 mg/day of CEE may modestly decrease fasting levels of insulin and glucose . Postchallenge glucose concentrations are increased , however , which may indicate delayed glucose clearance",
"OBJECTIVE : To estimate the rates of endometrial hyperplasia , bleeding episodes , and interventions among menopausal women receiving unopposed oral estradiol or placebo therapy with ultrasound monitoring over 3 years . METHODS : Two-hundred eighteen healthy women with intact uteri enrolled in the Estrogen in the Prevention of Atherosclerosis Trial ( EPAT ) or the Women ’s Estrogen-Progestin Lipid-Lowering Hormone Atherosclerosis Regression Trial ( WELL-HART ) were r and omly assigned to either 1 mg of micronized 17&bgr;-estradiol ( n=96 ) or placebo ( n=122 ) daily for up to 3 years in a double-blind fashion . Patients were followed with annual measurement of endometrial thickness using transvaginal ultrasonography . Logistic regression was used to identify predictors of uterine bleeding and endometrial biopsy . RESULTS : Over the study periods , nine women ( 9.4 % of patients , 95 % confidence interval [ CI ] 3.6–15.2 % ) in the estradiol group developed hyperplasia . Eight of the nine cases ( 88.9 % ) of hyperplasia were simple without atypia . Women receiving estradiol were more likely than those receiving placebo to have at least one episode of uterine bleeding ( 67 % versus 11 % at 3 years , respectively , P estradiol group were also more likely to have an endometrial biopsy ( 48 % versus 4 % at 3 years , P estradiol , obesity ( body mass index [ BMI ] greater than 30 kg/m2 ) significantly increased the odds of uterine bleeding compared with normal-weight patients ( BMI 25 or less ) ( OR 3.7 , 95 % CI 1.2–11.8 ) . CONCLUSION : Short-term , unopposed estradiol therapy with gynecologic monitoring may be an option for the treatment of menopausal symptoms . Menopausal women choosing estradiol therapy , especially if obese , should anticipate uterine bleeding and the possibility of an endometrial biopsy . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT 00000559 and NCT 00115024 LEVEL OF EVIDENCE :",
"Objective : Although observational studies showed an apparent lower ischemic coronary disease risk in postmenopausal women receiving hormone therapy ( HT ) , r and omized clinical trials in postmenopausal women showed an increase in ischemic cardiovascular events . Soluble cell adhesion molecules have been associated with cardiovascular risk factors and events . HT reduces circulating levels of soluble cell adhesion molecules in healthy postmenopausal women , but its effects in postmenopausal women with coronary artery disease are less clear . We assessed the effect of HT on soluble cell adhesion molecules in the Estrogen Replacement and Atherosclerosis trial . Design : The Estrogen Replacement and Atherosclerosis trial was a double-blind , placebo-controlled study that r and omized 309 postmenopausal women ( mean age , 65.8 y ) to daily unopposed estrogen ( conjugated estrogens 0.625 mg ) , estrogen plus 2.5 mg of medroxyprogesterone acetate , or placebo , with a mean follow-up period of 3.2 years . Soluble intercellular adhesion molecule-1 , vascular cell adhesion molecule-1 , and E-selectin were measured in serum obtained from participants at baseline and after 12 months of follow-up . Results : Of the 265 women with complete data , 87 women were assigned to unopposed estrogen , 88 women to estrogen plus medroxyprogesterone acetate , and 90 women to placebo . Compared with placebo , 12 months of HT ( n = 175 ) was associated with reductions in soluble intercellular adhesion molecule-1 ( 25.6 ± 4.7 vs 10.6 ± 6.4ng/mL , P = 0.06 ) , soluble vascular cell adhesion molecule-1 ( 80.2± 10.6 vs 28.8 ± 14.7 ng/mL , P = 0.005 ) , and E-selectin ( 8.8 ± 0.9 vs −1.1 ± 1.2 ng/mL , P of HT in postmenopausal women with established coronary artery disease was associated with reductions in serum markers of endothelial cell activation/injury such as soluble intercellular adhesion molecule-1 , vascular cell adhesion molecule-1 , and E-selectin",
"Objective : The aim of this study was to assess the safety and efficacy of bazedoxifene (BZA)/conjugated estrogens ( CE ) treating moderate to severe vasomotor symptoms in the Selective Estrogen Menopause and Response to Therapy 2 trial . Methods : This was an outpatient , multicenter , double-blind , r and omized , placebo-controlled , phase 3 study conducted in the United States . Healthy postmenopausal women ( N = 332 ; aged 40 - 65 y ) with moderate to severe hot flushes ( ≥7/d or 50/wk ) were r and omized to BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , or placebo once daily for 12 weeks . Changes from baseline in the average daily number of moderate and severe hot flushes and daily severity score were assessed at weeks 4 and 12 ; adverse events were recorded . Results : BZA/CE significantly reduced the number and severity of hot flushes at weeks 4 and 12 ( P reduced hot flushes from baseline by 74 % ( 10.3 hot flushes [ baseline ] vs 2.8 [ week 12 ] ) and 80 % ( 10.4 vs 2.4 ) , respectively , compared with 51 % ( 10.5 vs 5.4 ) for placebo . More participants at week 12 had at least a 75 % decrease in hot flushes with BZA 20 mg/CE 0.45 mg ( 61 % ) and BZA 20 mg/CE 0.625 mg ( 73 % ) versus placebo ( 27 % ; P The safety profile was similar between BZA/CE and placebo , and no unexpected safety findings were reported . Conclusions : BZA 20 mg paired with CE 0.45 or 0.625 mg is effective , with short-term safety , for treating vasomotor symptoms in postmenopausal women",
"Objective The aim of this study was to examine the effect of hormone therapy and calcitriol on depression in older postmenopausal women and to determine whether the response was associated with polymorphisms of estrogen receptor & agr ; and vitamin D receptor . Methods In a double-blind placebo-controlled prospect i ve trial involving 489 postmenopausal older women , a secondary analysis of depression was done . The Geriatric Depression Scale was used to screen for depression . We used binary logistic regression to examine the effect of treatment on depression and one-way analysis of variance to find a relationship between gene polymorphisms and depression . Results There was no effect of hormone therapy ( odds ratio [ OR ] , 1.65 ; 95 % CI , 0.66 - 4.12 ; P = 0.277 ) , calcitriol ( OR , 1.15 ; 95 % CI , 0.43 - 3.11 ; P = 0.772 ) , or hormone therapy with calcitriol ( OR , 1.01 ; 95 % CI , 0.36 - 2.80 ; P = 0.979 ) on depression . Neither the polymorphisms of estrogen receptor & agr ; ( XbaI-&bgr ; = 0.093 ; CI , −0.337 to 1.350 ; P = 0.239 and PvuII-&bgr ; = −0.064 ; CI , −1.171 to 0.491 , P = 0.421 ) nor those of vitamin D receptor ( BsmI-&bgr ; = 0.044 , CI −2.546 to 3.030 , P = 0.865 and TaqI-&bgr ; = −0.015 , CI −2.900 to 2.738 , P = 0.955 ) were associated with depression . Conclusion In older postmenopausal women , there was no effect of hormone therapy and calcitriol either individually or in combination with depression . Estrogen receptor & agr ; and vitamin D receptor polymorphisms are not associated with depression or the response to intervention in older postmenopausal women . Additional trials are required to confirm these findings"
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411648a4-06ff-11f0-808a-c43d1ab1c353
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This systematic review examines the economic and human costs of depression and the potential savings associated with improvement in patient adherence to treatment with antidepressants through the use of enhanced-care programs . A MEDLINE search was conducted for papers published on the health economics and costs of depression and compliance , adherence , and persistence . Compliance data collected through the online antidepressant compliance support website iCAN ( www.ican.co.uk ) were compared with data for patients with depression from the IMS Disease Analyzer UK data base . Depression frequently causes unemployment , absenteeism , and presenteeism , which results in significantly reduced productivity . Indirect costs of depression accounted for more than $ 50 billion , whereas direct costs result ed in expenditure of $ 26 billion , in the US in 2000 . Improving patients ' compliance with their antidepressant medication results in improved outcomes and prolongs remission from depression , increasing work productivity , and thus reducing overall costs . The implementation of remote enhanced-care programs may improve compliance and reduce overall costs . Novel methods for delivering enhanced-care programs to assist in maintaining compliance have the potential to further reduce costs and should be a focus of future research . In conclusion , depression is a common disorder with a high economic impact . Enhanced-care programs may lower costs associated with depression and improve patients ' lives
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"BACKGROUND Depression is one of the most disabling diseases , and causes a significant burden both to the individual and to society . WHO data suggests that depression causes 6 % of the burden of all diseases in Europe in terms of disability adjusted life years ( DALYs ) . Yet , the knowledge of the economic impact of depression has been relatively little research ed in Europe . AIMS OF THE STUDY The present study aims at estimating the total cost of depression in Europe based on published epidemiologic and economic evidence . METHODS A model was developed to combine epidemiological and economic data on depression in Europe to estimate the cost . The model was populated with data collected from extensive literature review s of the epidemiology and economic burden of depression in Europe . The cost data was calculated as annual cost per patient , and epidemiologic data was reported as 12-month prevalence estimates . National and international statistics for the model were retrieved from the OECD and Eurostat data bases . The aggregated annual cost estimates were presented in Euro for 2004 . RESULTS In 28 countries with a population of 466 million , at least 21 million were affected by depression . The total annual cost of depression in Europe was estimated at Euro 118 billion in 2004 , which corresponds to a cost of Euro 253 per inhabitant . Direct costs alone totalled dollar 42 billion , comprised of outpatient care ( Euro 22 billion ) , drug cost ( Euro 9 billion ) and hospitalization ( Euro 10 billion ) . Indirect costs due to morbidity and mortality were estimated at Euro 76 billion . This makes depression the most costly brain disorder in Europe , accounting for 33 % of the total cost . The cost of depression corresponds to 1 % of the total economy of Europe ( GDP ) . DISCUSSION Our cost results are in good agreement with previous research findings . The cost estimates in the present study are based on model simulations for countries where no data was available . The predictability of our model is limited to the accuracy of the input data employed . As there is no earlier cost-of-illness study conducted on depression in Europe , it is , however , difficult to evaluate the validity of our results for individual countries and thus further research is needed . CONCLUSION The cost of depression poses a significant economic burden to European society . The simulation model employed shows good predictability of the cost of depression in Europe and is a novel approach to estimate the cost-of-illness in Europe . IMPLICATION S FOR HEALTH CARE PROVISION AND POLICIES : Health and social care policy and commissioning must be evidence -based . The empirical results from this study confirm previous findings , that depression is a major concern to the economic welfare in Europe which has consequences to both healthcare providers and policy makers . One important way to stop this explosion in cost is through increased research efforts in the field . Moreover , better detection , prevention , treatment and patient management are imperatives to reduce the burden of depression and its costs . Mental healthcare policies and better access to healthcare for mentally ill are other challenges to improve for Europe . IMPLICATION S FOR FURTHER RESEARCH This study has identified several research gaps which are of interest for future research . In order to better underst and the impact of depression to European society long-term prospect i ve epidemiology and cost-of-illness studies are needed . In particular data is lacking for Central European countries . On the basis of our findings , further economic evaluations of treatments for depression are necessary in order to ensure a cost-effective use of European healthcare budgets",
"Two dimensions of compliance ( drop-outs and adherence ) were investigated in patients treated with antidepressant drugs . Efficacy , compliance and its determinants were investigated in 66 patients suffering from major depressive disorder and treated in a double-blind manner with fluoxetine 20 mg/day or amitriptyline 150 mg/day for 9 weeks . Overall effectiveness [ 50 % decrease in the initial Hamilton Rating Scale for Depression ( HAM-D ) ] was similar in both groups ( 62.8 % for fluoxetine , 58.1 % for amitriptyline ) . The dropout rate due to side effects was 35.5 % for amitriptyline and 5.7 % for fluoxetine . A logistic regression analysis revealed that the initial HAM-D score was not predictive for dropping out , but this outcome was instead determined by sex ( increased risk for males ) , age ( increased risk for being younger ) and occurrence of severe side effects . Adherence was estimated using electronic Medication Event Monitoring System and defined as the percentage of days when the correct dose was taken out of the medication container . Of the patients studied 37 % had an adherence of less than 70 % . There was no relationship between adherence and efficacy and adherence was similar in patients on fluoxetine or amitriptyline . Side effects were not predictive of being adherent or not , but a higher initial HAM-D score predicted a higher adherence to the medication regimen . The demographic variables bad no significant effect . The present study suggests that the link between efficacy , side effects and compliance or adherence is more complex than is generally believed and that early termination and non-adherence seem to be determined by different factors",
"BACKGROUND This study augments a r and omized controlled trial to analyze the cost-effectiveness of 2 st and ardized treatments for major depression relative to each other and to the \" usual care \" provided by primary care physicians . METHODS A r and omized controlled trial was conducted in which primary care patients meeting DSM-III-R criteria for current major depression were assigned to pharmacotherapy ( where nortriptyline hydrochloride was given ) or interpersonal psychotherapy provided in a st and ardized framework or a primary physician 's usual care . Two outcome measures , depression-free days and quality -adjusted days , were developed using information on depressive symptoms over time . The costs of care were calculated . Cost-effectiveness ratios comparing the incremental outcomes with the incremental costs for the different treatments were estimated . Sensitivity analyses were performed . RESULTS In terms of both economic costs and quality -of-life outcomes , patients assigned to the pharmacotherapy group did slightly better than those assigned to interpersonal psychotherapy . Both st and ardized therapies provided better outcomes than primary physician 's usual care , but each consumed more re sources . No meaningful cost-offsets were found . The incremental direct cost per additional depression-free day for pharmacotherapy relative to usual care ranges from $ 12.66 to $ 16.87 which translates to direct cost per quality -adjusted year gained from $ 11270 to $ 19510 . CONCLUSIONS St and ardized treatments for depression lead to better outcomes than usual care but also lead to higher costs . However , the estimates of the cost per quality -of-life year gained for st and ardized pharmacotherapy are comparable with those found for other treatments provided in routine practice",
"BACKGROUND Exp and ing access to high- quality depression treatment will depend on the balance of incremental benefits and costs . We examine the incremental cost-effectiveness of an organized depression management program for high utilizers of medical care . METHODS Computerized records at 3 health maintenance organizations were used to identify adult patients with outpatient medical visit rates above the 85th percentile for 2 consecutive years . A 2-step screening process identified patients with current depressive disorders , who were not in active treatment . Eligible patients were r and omly assigned to continued usual care ( n = 189 ) or to an organized depression management program ( n = 218 ) . The program included patient education , antidepressant pharmacotherapy initiated in primary care ( when appropriate ) , systematic telephone monitoring of adherence and outcomes , and psychiatric consultation as needed . Clinical outcomes ( assessed using the Hamilton Depression Rating Scale on 4 occasions throughout 12 months ) were converted to measures of \" depression-free days . \" Health services utilization and costs were estimated using health plan-st and ardized cl aims . RESULTS The intervention program led to an adjusted increase of 47.7 depression-free days throughout 12 months ( 95 % confidence interval [ CI ] , 28.2 - 67.8 days ) . Estimated cost increases were $ 1008 per year ( 95 % CI , $ 534-$1383 ) for outpatient health services , $ 1974 per year for total health services costs ( 95 % CI , $ 848-$3171 ) , and $ 2475 for health services plus time-in-treatment costs ( 95 % CI , $ 880-$4138 ) . Including total health services and time-in-treatment costs , estimated incremental cost per depression-free day was $ 51.84 ( 95 % CI , $ 17.37-$108.47 ) . CONCLUSIONS Among high utilizers of medical care , systematic identification and treatment of depression produce significant and sustained improvements in clinical outcomes as well as significant increases in health services costs",
"Non-adherence to antidepressant drug treatment is common . In a recent study in depressed primary care patients , we reported a strong relationship between adherence and response after 6 months . With the use of a naturalistic design , the patients in that study were prospect ively followed for 2 years . The purpose of the present study was to investigate the patients ' long-term outcome and , in particular , to examine the impact of patients ' treatment adherence on response , remission and relapse . Of the 1031 patients in the intent-to-treat ( ITT ) sample , 835 completed the study . After 2 years , the overall remission rate defined as a Montgomery – Åsberg Depression Rating Scale score of nine or less was 68 % in the ITT sample analysed with the last observation carried forward ( LOCF ) technique , and 75 % in observed cases . In total , 34 % of the responders experienced at least one relapse . Response rates ( LOCF ) were significantly higher in adherent compared to non-adherent patients at week 24 [ 95 % confidence interval (CI)=21.4–32.1 ] , year 1 ( 95 % CI=12.3–22.2 ) and year 2 ( 95 % CI=9.2–19.0 ) . Remission rates ( LOCF ) were also significantly higher in the group of adherent patients at week 24 ( 95 % CI=9.6–21.5 ) , year 1 ( 95 % CI=10.0–21.5 ) and year 2 ( 95 % CI=11.0–22.0 ) . No relationship between adherence and relapse rate was observed , although the mean time from response to first sign of relapse was significantly longer in the adherent patients ( 95 % CI=9–97 days ) . In conclusion , this 2-year follow-up study showed superior long-term recovery in patients who were adherent to antidepressant medication compared to non-adherent patients",
"OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are widely used to treat depression , but the rates , timing , and baseline predictors of remission in \" real world \" patients are not established . The authors ' primary objectives in this study were to evaluate the effectiveness of citalopram , an SSRI , using measurement-based care in actual practice , and to identify predictors of symptom remission in out patients with major depressive disorder . METHOD This clinical study included out patients with major depressive disorder who were treated in 23 psychiatric and 18 primary care \" real world \" setting s. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks . The clinicians were assisted by a clinical research coordinator in the application of measurement-based care , which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures . Remission was defined as an exit score of 17-item Hamilton Depression Rating Scale ( HAM-D ) ( primary outcome ) or a score of 16-item Quick Inventory of Depressive Symptomatology , Self-Report ( QIDS-SR ) ( secondary outcome ) . Response was defined as a reduction of > or=50 % in baseline QIDS-SR score . RESULTS Nearly 80 % of the 2,876 out patients in the analyzed sample had chronic or recurrent major depression ; most also had a number of comorbid general medical and psychiatric conditions . The mean exit citalopram dose was 41.8 mg/day . Remission rates were 28 % ( HAM-D ) and 33 % ( QIDS-SR ) . The response rate was 47 % ( QIDS-SR ) . Patients in primary and psychiatric care setting s did not differ in remission or response rates . A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment . Participants who were Caucasian , female , employed , or had higher levels of education or income had higher HAM-D remission rates ; longer index episodes , more concurrent psychiatric disorders ( especially anxiety disorders or drug abuse ) , more general medical disorders , and lower baseline function and quality of life were associated with lower HAM-D remission rates . CONCLUSIONS The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials . The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results",
"CONTEXT Depression is a leading cause of disability worldwide , but treatment rates in primary care are low . OBJECTIVE To determine the cost-effectiveness from a societal perspective of 2 quality improvement ( QI ) interventions to improve treatment of depression in primary care and their effects on patient employment . DESIGN Group-level r and omized controlled trial conducted June 1996 to July 1999 . SETTING Forty-six primary care clinics in 6 community-based managed care organizations . PARTICIPANTS One hundred eighty-one primary care clinicians and 1356 patients with positive screening results for current depression . INTERVENTIONS Matched practice s were r and omly assigned to provide usual care ( n = 443 patients ) or to 1 of 2 QI interventions offering training to practice leaders and nurses , enhanced educational and assessment re sources , and either nurses for medication follow-up ( QI-meds ; n = 424 patients ) or trained local psychotherapists ( QI-therapy ; n = 489 ) . Practice s could flexibly implement the interventions , which did not assign type of treatment . MAIN OUTCOME MEASURES Total health care costs , costs per quality -adjusted life-year ( QALY ) , days with depression burden , and employment over 24 months , compared between usual care and the 2 interventions . RESULTS Relative to usual care , average health care costs increased $ 419 ( 11 % ) in QI-meds ( P = .35 ) and $ 485 ( 13 % ) in QI-therapy ( P = .28 ) ; estimated costs per QALY gained were between $ 15 331 and $ 36 467 for QI-meds and $ 9478 and $ 21 478 for QI-therapy ; and patients had 25 ( P = .19 ) and 47 ( P = .01 ) fewer days with depression burden and were employed 17.9 ( P = .07 ) and 20.9 ( P = .03 ) more days during the study period . CONCLUSIONS Societal cost-effectiveness of practice -initiated QI efforts for depression is comparable with that of accepted medical interventions . The intervention effects on employment may be of particular interest to employers and other stakeholders",
"CONTEXT Although guideline -concordant depression treatment is clearly effective , treatment often falls short of evidence -based recommendations . Organized depression care programs significantly improve treatment quality , but employer purchasers have been slow to adopt these programs based on lack of evidence for cost-effectiveness from their perspective . OBJECTIVE To evaluate the effects of a depression outreach-treatment program on workplace outcomes , a concern to employers . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial involving 604 employees covered by a managed behavioral health plan were identified in a 2-stage screening process as having significant depression . Patient treatment allocation was concealed and assessment of depression severity and work performance at months 6 and 12 was blinded . Employees with lifetime bipolar disorder , substance disorder , recent mental health specialty care , or suicidality were excluded . INTERVENTION A telephonic outreach and care management program encouraged workers to enter outpatient treatment ( psychotherapy and /or antidepressant medication ) , monitored treatment quality continuity , and attempted to improve treatment by giving recommendations to providers . Participants reluctant to enter treatment were offered a structured telephone cognitive behavioral psychotherapy . MAIN OUTCOME MEASURES Depression severity ( Quick Inventory of Depressive Symptomatology , QIDS ) and work performance ( World Health Organization Health and Productivity Question naire [ HPQ ] , a vali date d self-report instrument assessing job retention , time missed from work , work performance , and critical workplace incidents ) . RESULTS Combining data across 6- and 12-month assessment s , the intervention group had significantly lower QIDS self-report scores ( relative odds of recovery , 1.4 ; 95 % confidence interval , 1.1 - 2.0 ; P = .009 ) , significantly higher job retention ( relative odds , 1.7 ; 95 % confidence interval , 1.1 - 3.3 ; P = .02 ) , and significantly more hours worked among the intervention ( beta=2.0 ; P=.02 ; equivalent to an annualized effect of 2 weeks of work ) than the usual care groups that were employed . CONCLUSIONS A systematic program to identify depression and promote effective treatment significantly improves not only clinical outcomes but also workplace outcomes . The financial value of the latter to employers in terms of recovered hiring , training , and salary costs suggests that many employers would experience a positive return on investment from outreach and enhanced treatment of depressed workers . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00057590",
"We describe a secondary analysis of data from a r and omized trial conducted at seven primary care clinics of a Seattle area HMO . Adults with major depression ( n=290 ) beginning antidepressant treatment completed structured interviews at baseline , 1 , 3 , 6 , 9 , 12 , 18 , and 24 months . Interviews examined clinical outcomes ( Hamilton Depression Rating Scale and depression module of the Structured Clinical Interview for DSM-IIIR ) , employment status , and work days missed due to illness . Medical comorbidity was assessed using computerized pharmacy data , and medical costs were assessed using the HMO 's computerized accounting data . Using data from the 12-month assessment , patients were classified as remitted ( 41 % ) , improved but not remitted ( 47 % ) , and persistently depressed ( 12 % ) . After adjustment for depression severity and medical comorbidity at baseline , patients with greater clinical improvement were more likely to maintain paid employment ( P=.007 ) and reported fewer days missed from work due to illness ( P lower health care costs during the second year of follow-up ( P=.06 ) . We conclude that recovery from depression is associated with significant reductions in work disability and possible reductions in health care costs . Although observational data can not definitively prove any causal relationships , these longitudinal results strengthen previous findings regarding the economic burden of depression on employers and health insurers",
"BACKGROUND We evaluated depression severity , health-related quality of life ( HRQL ) , and medical cost outcomes of primary care patients receiving recommended and less-than-recommended levels of antidepressant treatment . METHODS We performed a secondary analysis of clinical trial data from primary care clinics in a staff-model managed care organization . The trial included patients with Diagnostic and Statistical Manual of Mental Disorders , Third Edition , Revised ( DSM-III-R ) criteria for major depression who were starting antidepressant treatment . The primary outcomes measures used were the 17-item Hamilton Depression Rating Scale ( HDRS ) , Hopkins Symptom Checklist depression scores , the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) mental and physical component summary scores , and the total outpatient and inpatient medical costs . RESULTS Of 358 patients starting antidepressant treatment , 195 ( 54.5 % ) received doses recommended by the Agency for Health Care Policy and Research for 90 days or more . Mean HDRS score decreased from 14.1 to 8.8 in patients receiving less-than-recommended treatment and decreased from 13.8 to 8.9 in patients with minimum recommended treatment ( P = .761 ) . No significant differences in improvement of HRQL outcomes during 6 months were observed between patients receiving recommended or less-than-recommended antidepressant therapy . Mean total medical costs over 6 months for patients taking the recommended levels of antidepressant treatment were $ 1872 + /- 140 compared with $ 2622 + /- 413 for patients taking less-than-recommended treatment ( P = .032 ) . The differences in total medical costs were attributable to significantly lower nonmental health-related inpatient costs in the recommended antidepressant treatment group ( $ 104 vs $ 785 , P = .004 ) . CONCLUSIONS Patients receiving minimum recommended levels of antidepressant therapy for 3 months showed improvement in depression severity and HRQL comparable with patients receiving less-than-recommended treatment . Patients receiving minimum recommended treatment had lower total costs and nonmental health-related inpatient costs . Antidepressant treatment in primary care patients may have the greatest impact on the frequency of health care visits and on costs for medical conditions and impairments",
"OBJECTIVE To evaluate the impact of mail-based physician and member educational interventions on patient adherence to antidepressant medications . STUDY DESIGN The r and omized controlled prospect i ve design included patients followed for 6 months after filling a new prescription for an antidepressant . A pharmacy cl aims data base was used to identify patients and track medication adherence . PATIENTS AND METHODS Patients receiving a new prescription for an antidepressant and their prescribers were included . Prescribers were r and omly assigned to the intervention and control groups . Patient assignment was linked to their physician 's assignment . The control group received no intervention . The educational intervention consisted of monthly letters to patients and prescribers regarding the Health Plan Employer Data and Information Set ( HEDIS ) st and ards or educational information regarding the importance of medication adherence . The primary outcome was adherence as measured by the medication possession ratio and measurement as specified by HEDIS . The Student 's ttest , the chi2 test , and a logistic regression model were used to compare groups and the variables that affect adherence . Other secondary measurements of adherence were performed . RESULTS A total of 9564 patients were included . Patients in the intervention group demonstrated greater adherence compared with the control group at 90 and 180 days ( P adherence ( P Adherence in the total population was significantly higher for selective serotonin reuptake inhibitors than for other agents ( P mail-based educational intervention program regarding antidepressant medications can positively influence patient adherence to therapy",
"Objective : Patients with major depression discontinue taking their antidepressants for many reasons . Although side effects are often cited as the reason for discontinuation , few prospect i ve studies have addressed this question , and none has specifically examined discontinuation in patients with severe depression . Method : In patients and out patients treated with a selective serotonin reuptake inhibitor for major depressive disorder were identified after admission . Three months later , patients were contacted and interviewed to determine antidepressant usage and the side effects experienced , including when these were experienced and their severity . Results : Between October 2001 and April 2003 , 406 English- or Spanish-speaking patients aged 18 to 75 years were followed up . One in 4 patients discontinued the index antidepressant . Among specific side effects noted , only \" change in weight \" and \" anxiety \" were significant predictors of discontinuation after controlling for confounders . Experiencing 1 or more \" extremely \" bothersome side effects was associated with more than a doubling of the risk of discontinuation , but the presence of side effects and side effects less severe than \" extremely \" bothersome were not significant predictors . There were no differences among selective serotonin reuptake inhibitor antidepressants in either the presence/absence of side effects or in the discontinuation rates . Conclusion : The results suggest that the contribution of side effects to antidepressant discontinuation is more complex than previously suggested . Disparate findings from earlier studies may reflect aspects of study design , such as examining population s whose severity of depression varied widely or not controlling for important confounding factors . Future research should separately examine high-risk groups ( or control for severity of depression ) and carefully rule out other potential contributors to discontinuation",
"OBJECTIVE Although major depression is thought to have substantial negative effects on work performance , the possibility of recall bias limits self-report studies of these effects . The authors used the experience sampling method to address this problem by collecting comparative data on moment-in-time work performance among service workers who were depressed and those who were not depressed . METHOD The group studied included 105 airline reservation agents and 181 telephone customer service representatives selected from a larger baseline sample ; depressed workers were deliberately over sample d. Respondents were given pagers and experience sampling method diaries for each day of the study . A computerized autodialer paged respondents at r and om time points . When paged , respondents reported on their work performance in the diary . Moment-in-time work performance was assessed at five r and om times each day over a 7-day data collection period ( 35 data points for each respondent ) . RESULTS Seven conditions ( allergies , arthritis , back pain , headaches , high blood pressure , asthma , and major depression ) occurred often enough in this group of respondents to be studied . Major depression was the only condition significantly related to decrements in both of the dimensions of work performance assessed in the diaries : task focus and productivity . These effects were equivalent to approximately 2.3 days absent because of sickness per depressed worker per month of being depressed . CONCLUSIONS Previous studies based on days missed from work significantly underestimate the adverse economic effects associated with depression . Productivity losses related to depression appear to exceed the costs of effective treatment",
"OBJECTIVE The authors evaluated the incremental cost-effectiveness of stepped collaborative care for patients with persistent depressive symptoms after usual primary care management . METHOD Primary care patients initiating antidepressant treatment completed a st and ardized telephone assessment 6 - 8 weeks after the initial prescription . Those with persistent major depression or significant subthreshold depressive symptoms were r and omly assigned to continued usual care or collaborative care . The collaborative care included systematic patient education , an initial visit with a consulting psychiatrist , 2 - 4 months of shared care by the psychiatrist and primary care physician , and monitoring of follow-up visits and adherence to medication regimen . Clinical outcomes were assessed through blinded telephone assessment s at 1 , 3 , and 6 months . Health services utilization and costs were assessed through health plan cl aims and accounting data . RESULTS Patients receiving collaborative care experienced a mean of 16.7 additional depression-free days over 6 months . The mean incremental cost of depression treatment in this program was $ 357 . The additional cost was attributable to greater expenditures for antidepressant prescriptions and outpatient visits . No off setting decrease in use of other health services was observed . The incremental cost-effectiveness was $ 21.44 per depression-free day . CONCLUSIONS A stepped collaborative care program for depressed primary care patients led to substantial increases in treatment effectiveness and moderate increases in costs . These findings are consistent with those of other r and omized trials . Improving outcomes of depression treatment in primary care requires investment of additional re sources , but the return on this investment is comparable to that of many other widely accepted medical interventions"
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411648ea-06ff-11f0-808a-c43d1ab1c353
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Abstract This paper determines the perceptions of people diagnosed with osteoarthritis towards their conservative management strategies . A systematic review of the published ( AMED , CINAHL , EMBASE , PsychINFO , SportsDisc , MEDLINE , Cochrane Clinical Trials Registry , PubMed ) and unpublished/trial registry data bases ( WHO International Clinical Trials Registry Platform , Current Controlled Trials , the United States National Institute of Health Trials Registry , NIHR Clinical Research Portfolio Data base ) search ed from their inception to July 2013 . Eligible studies included those which presented the attitudes or perceptions of people with osteoarthritis towards non-operative management strategies . Study quality was appraised using the CASP and the Gough ’s weight of evidence appraisal tools . Data were analysed through a meta-ethnography approach . Thirty-three studies including 1,314 people with osteoarthritis were sample d ; the majority diagnosed with knee osteoarthritis . The overarching themes indicated people with osteoarthritis delay their diagnosis , opting for self-management and informal information gathering . This informal rather than health professional-led guidance is sought and maintained as an important re source throughout the care of this population and is valued . Diagnosis is sought at a ‘ critical point ’ . Healthcare interventions largely provided are poorly perceived . The period of subsequent self-management is an expectation before the inevitable requirement for joint replacement . There remains uncertainty regarding when this is required , but the expected failure of conservative treatment to manage pain and symptoms is common . In conclusion , patients should be enthused towards the principles of self-management and clinicians should not trivialise osteoarthritis . This may provide a more valuable perception of non-operative management to promote its adoption and adherence in managing osteoarthritis
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"STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention",
"Osteoarthritis ( OA ) is a common and often disabling condition that predominately affects older adults . It is the commonest cause of locomotor disability and forms a major element of the workload in primary care . Previous studies suggest that there are both deficits in the knowledge patients have about their disease and extensive ' unmet ' information needs . This paper explores the patients ' perspective on the meaning and significance of living with arthritis , identified through quantitative and qualitative approaches undertaken during a trial that evaluated the effectiveness of a primary care-based patient education programme . This paper draws on qualitative and quantitative data from : the baseline interview ( knowledge of arthritis , satisfaction with services and support received in primary care ) ; patient diaries ( individual goals and reflections on treatment ) ; and group teaching sessions ( themes describing the patient 's experience ) . The different data sources were interrogated for common and divergent themes . One hundred and ninety-four participants were identified and 170 completed baseline interviews . Participants were predominantly female ( 73 % ) , with a mean age of 63 and arthritis of long-st and ing ; 55 % reported that they had had it for 5 years or more . Use of primary care services was high , with 41 % consulting their GP in the 2 weeks before interview . Levels of information were low , with less than 25 % receiving support/advice about the disease , pain management or its impact upon daily life . Set against negative perceptions of the quality of services , patients ' personal priorities were for improved pain management and enhanced mobility/functional ability . The combined quantitative and qualitative data provide insight into the patients ' perspective on the causes and impact of knee OA , individual goals desired from treatment and the quality of care . There is consistent evidence of unmet needs for information and support and the priority placed by patients on finding strategies to cope with OA and maintaining independence . Even within a tightly defined study sample participating in the intervention , a diversity of experience and goals were revealed , which highlights the importance of taking account of context ual factors and individual differences when evaluating complex interventions",
"This study identified factors associated with exercise participation and adherence in a sample of 102 sedentary , functionally limited , community-dwelling adults aged 60 to 94 years who participated in a home-based resistance training program . Stepwise regression analyses revealed that baseline physical factors ( i.e. , higher levels of mobility , weaker muscle strength , and fewer numbers of new medical conditions ) were associated with higher rates of participation in the home program . Positive attitudes and a sense of control toward exercise , lower levels of confusion and depressive moods , and the development of fewer new medical problems during the program were related to higher levels of adherence to the program . Findings revealed that although physical health variables were the primary indicators of an older person 's overall participation in the program , it was the psychological factors that were most important to adherence to this home-based program",
"OBJECTIVE Beliefs about the causes of osteoarthritis ( OA ) have been examined infrequently . The purpose of this study was to provide insight into patients ' beliefs about the causes of OA in a primary care population . METHODS This study involved 31 individuals with OA who were purposively sample d to reflect age , sex , and self-efficacy scores from the intervention arm of a r and omized controlled trial examining the effectiveness of an arthritis self-management program in primary care . Participants took part in face-to-face interviews . Data were analyzed using interpretative phenomenologic analysis . RESULTS A total of 31 patients with OA ( 17 [ 55 % ] men ) with a median age of 68 years ( range 56 - 84 years ) were recruited . OA and painful joints were considered to be an inevitable aspect of aging rather than an indication of disease . Participants attributed the cause of OA to multiple factors , the most commonly reported being wear and tear . CONCLUSION Insight into beliefs about the causes of OA among older people may help explain attitudes towards the uptake of health care among this group of patients",
"This study investigated the physical and psychosocial consequences of living with osteoarthritis ( OA ) in daily life and peoples ’ views of total knee arthroplasty ( TKA ) and the role of physiotherapy . In-depth interview data were used from a prospect i ve qualitative study conducted by the senior author ( KY ) . Participants were 15 volunteers with knee OA who were awaiting TKA at a specialized orthopaedic tertiary care facility in Toronto . A modified grounded theory method approach was used to analyze the interview data . The findings showed that experiences for the participants with OA were conceptualized as a “ breakpoint . ” The breakpoint was centred on the experiences/processes of living with unremitting pain , the limitations of mobility , leisure and social activities , and the result ing consequences to the participant 's physical and psychological well-being . In addition to the above experiences , participants also discussed their perceptions of TKA surgery . The findings showed that expectations of TKA were linked to participants ’ knowledge of the procedure and its outcomes . The participants listed acquaintances , friends , family members , and doctors as the main sources of knowledge for TKA . On the basis of the above analysis , recommendations are made for developing a preoperative physiotherapy program that would focus on minimizing preoperative disability and maximizing postoperative recovery",
"We examined the personal models of osteoarthritis ( OA ) of 61 patients over 60 years of age . Models were elicited using a structured interview . Shared beliefs included perceiving OA as a serious , painful , chronic , and incurable condition that can be managed by recommended medical treatment . Considerable individual differences were found on six personal-model constructs : Symptoms , Seriousness , Cause , Control , Helpfulness of Treatment , and Negative Feelings about Treatment . The constructs of Symptoms and Seriousness were consistently related to a variety of important outcomes . For example , participants with higher scores on Symptoms and Seriousness reported higher levels of self-management ( both concurrently and prospect ively ) , reported more utilization of medical services , and experienced a poorer quality of life . The implication s for the design of health-education material s and for patient-provider interactions are discussed"
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Background The body of evidence related to the effect of physical activity monitor-based interventions has grown over the recent years . However , the effect of physical activity monitor-based interventions in older adults remains unclear and should be systematic ally review ed . Objective The objective of this systematic review was to estimate the effect of physical activity monitor-based interventions on physical activity behavior in participants aged 65 and above . Subsequently we explored the effect on body mass index , physical capacity , and health-related quality of life and finally the impact of patient- and intervention characteristics . Methods Search es in MEDLINE , EMBASE , SPORTD iscus , CINAHL , and CENTRAL were performed on April 26 , 2018 . No publication date filters were applied . References of eligible studies were scrutinized and relevant journals were h and - search ed . R and omized controlled trials and r and omized cross-over trials investigating the effect of a physical activity monitor-based intervention on physical activity were included . Studies were included if the mean age of the participants was above 65 years , and participants could walk independently with or without walking aids . The Cochrane h and book was used as a template for extracting data and the RoB 2.0 tool was used to assess risk of bias . R and om-effects meta- analysis using Hedges g , were used to pool the study results . The main outcome of this study was physical activity . Results Twenty-one studies with 2783 participants were included . The median participant age in the studies was 70.5 years , the median percentage of male participants was 42 % , and the median baseline daily step count was 5268 . Physical activity monitor-based interventions had a moderate effect ( SMD = 0.54 , 95 % CI : 0.34 to 0.73 ) compared to control interventions , corresponding to an average increase of 1297 steps per day in the intervention groups . No impact of patient and intervention characteristics on the effect estimates were found . Short conclusion Low quality of evidence was found for a moderate effect of physical activity monitor-based interventions on physical activity compared with control interventions . More studies with higher research methodology st and ards are required . PROSPERO registration CRD42018083648
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"Background The majority of older adults do not reach the physical activity guidelines . One possible explanation for this may be that older adults overestimate their physical activity levels , because they are unable to identify exercise intensity . Methods Forty-four older adults were recruited and r and omly assigned into two walking groups lasting 6 weeks . The intervention group was asked to walk a minimum of 150 min per week at moderate intensity using walking cadence indicated with a pedometer . The control group did not get any feedback on walking intensity . Results The ability to identify moderate intensity while walking did not significantly improve in neither groups ( p = 0.530 ) . However , participants in the intervention group increased significantly the time spent at moderate intensity , in 10 min bouts ( p pedometer providing walking cadence to reach moderate intensity is a good tool for increasing time walked at the recommended intensity , but not because participants know more what is considered moderate intensity",
"Rationale : Increasing physical activity is a key therapeutic aim in chronic obstructive pulmonary disease ( COPD ) . Pulmonary rehabilitation ( PR ) improves exercise capacity , but there is conflicting evidence regarding its ability to improve physical activity levels . Objectives : To determine whether using pedometers as an adjunct to PR can enhance time spent in at least moderate‐intensity physical activity ( time expending ≥3 metabolic equivalents [ METs ] ) by people with COPD . Methods : In this single‐blind r and omized controlled trial , participants were assigned 1:1 to receive a control intervention ( PR comprising 8 wk , two supervised sessions per week ) or the trial intervention ( PR plus pedometer‐directed step targets , review ed weekly for 8 wk ) . In the r and omization process , we used minimization to balance groups for age , sex , FEV1 percent predicted , and baseline exercise capacity and physical activity levels . Outcome assessors and PR therapists were blinded to group allocation . The primary analysis was based on the intention‐to‐treat principle . Measurements and Main Results : The primary outcome was change from baseline to 8 weeks in accelerometer‐measured daily time expending at least 3 METs . A total of 152 participants ( 72 % male ; mean [ SD ] FEV1 percent predicted , 50.5 % [ 21.2 ] ; median [ first quartile , third quartile ] time expending ≥3 METs , 46 [ 21 , 92 ] min ) were enrolled and assigned to the intervention ( n = 76 ) or control ( n = 76 ) arm . There was no significant difference in change in time expending at least 3 METs between the intervention and control groups at 8 weeks ( median [ first quartile , third quartile ] difference , 0.5 [ −1.0 , 31.0 ] min ; P = 0.87 ) or at the 6‐month follow‐up ( 7.0 [ −9 , 27 ] min ; P = 0.16 ) . Conclusions : Pedometer‐directed step‐count targets during an outpatient PR program did not enhance moderate‐intensity physical activity levels in people with COPD . Clinical trial registered with www . clinical trials.gov ( NCT01719822 )",
"Background A physically active lifestyle has the potential to prevent cognitive decline and dementia , yet the optimal type of physical activity/exercise remains unclear . Dance is of special interest as it complex sensorimotor rhythmic activity with additional cognitive , social , and affective dimensions . Objectives To determine whether dance benefits executive function more than walking , an activity that is simple and functional . Methods Two-arm r and omized controlled trial among community-dwelling older adults . The intervention group received 1 h of ballroom dancing twice weekly over 8 months ( ~69 sessions ) in local community dance studios . The control group received a combination of a home walking program with a pedometer and optional biweekly group-based walking in local community park to facilitate socialization . Main outcomes Executive function tests : processing speed and task shift by the Trail Making Tests , response inhibition by the Stroop Color-Word Test , working memory by the Digit Span Backwards test , immediate and delayed verbal recall by the Rey Auditory Verbal Learning Test , and visuospatial recall by the Brief Visuospatial Memory Test ( BVST ) . Results One hundred and fifteen adults ( mean 69.5 years , SD 6.4 ) completed baseline and delayed baseline ( 3 weeks apart ) before being r and omized to either dance ( n = 60 ) or walking ( n = 55 ) . Of those r and omized , 79 ( 68 % ) completed the follow-up measurements ( 32 weeks from baseline ) . In the dance group only , “ non-completers ” had significantly lower baseline scores on all executive function tests than those who completed the full program . Intention-to-treat analyses showed no group effect . In a r and om effects model including participants who completed all measurements , adjusted for baseline score and covariates ( age , education , estimated verbal intelligence , and community ) , a between-group effect in favor of dance was noted only for BVST total learning ( Cohen ’s D Effect size 0.29 , p = 0.07 ) and delayed recall ( Cohen ’s D Effect size = 0.34 , p = 0.06 ) . Conclusion The superior potential of dance over walking on executive functions of cognitively healthy and active older adults was not supported . Dance improved one of the cognitive domains ( spatial memory ) important for learning dance . Controlled trials targeting inactive older adults and of a higher dose may produce stronger effects , particularly for novice dancers . Trial registration Australian and New Zeal and Clinical Trials Register ( ACTRN12613000782730 )",
"Background Physical activity contributes to older adults ’ autonomy , mobility , and quality of life as they age , yet fewer than 1 in 5 engage in activities as recommended . Many older adults track their exercise using pencil and paper , or their memory . Commercially available physical activity monitors ( PAM ) have the potential to facilitate these tracking practice s and , in turn , physical activity . An assessment of older adults ’ long-term experiences with PAM is needed to underst and this potential . Objective To assess short and long-term experiences of adults > 70 years old using a PAM ( Fitbit One ) in terms of acceptance , ease-of-use , and usefulness : domains in the technology acceptance model . Methods This prospect i ve study included 95 community-dwelling older adults , all of whom received a PAM as part of r and omized controlled trial piloting a fall-reducing physical activity promotion intervention . Ten-item surveys were administered 10 weeks and 8 months after the study started . Survey ratings are described and analyzed over time , and compared by sex , education , and age . Results Participants were mostly women ( 71/95 , 75 % ) , 70 to 96 years old , and had some college education ( 68/95 , 72 % ) . Most participants ( 86/95 , 91 % ) agreed or strongly agreed that the PAM was easy to use , useful , and acceptable both 10 weeks and 8 months after enrolling in the study . Ratings dropped between these time points in all survey domains : ease-of-use ( median difference 0.66 points , P=.001 ) ; usefulness ( median difference 0.16 points , P=.193 ) ; and acceptance ( median difference 0.17 points , P=.032 ) . Differences in ratings by sex or educational attainment were not statistically significant at either time point . Most participants 80 + years of age ( 28/37 , 76 % ) agreed or strongly agreed with survey items at long-term follow-up , however their ratings were significantly lower than participants in younger age groups at both time points . Conclusions Study results indicate it is feasible for older adults ( 70 - 90 + years of age ) to use PAMs when self-tracking their physical activity , and provide a basis for developing recommendations to integrate PAMs into promotional efforts . Trial Registration Clinical trials.gov NCT02433249 ; https:// clinical trials.gov/ct2/show/NCT02433249 ( Archived by WebCite at http://www.webcitation.org/6gED6eh0I",
"Background Brisk walking in older people can increase step-counts and moderate to vigorous intensity physical activity ( MVPA ) in ≥10-minute bouts , as advised in World Health Organization guidelines . Previous interventions have reported step-count increases , but not change in objective ly measured MVPA in older people . We assessed whether a primary care nurse-delivered complex intervention increased objective ly measured step-counts and MVPA . Methods and Findings A total of 988 60–75 year olds , able to increase walking and r and omly selected from three UK family practice s , were invited to participate in a parallel two-arm cluster r and omised trial ; r and omisation was by household . Two-hundred-ninety-eight people from 250 households were r and omised between 2011 and 2012 ; 150 individuals to the intervention group , 148 to the usual care control group . Intervention participants received four primary care nurse physical activity ( PA ) consultations over 3 months , incorporating behaviour change techniques , pedometer step-count and accelerometer PA intensity feedback , and an individual PA diary and plan . Assessors were not blinded to group status , but statistical analyses were conducted blind . The primary outcome was change in accelerometry assessed average daily step-counts between baseline and 3 months , with change at 12 months a secondary outcome . Other secondary outcomes were change from baseline in time in MVPA weekly in ≥10-minute bouts , accelerometer counts , and counts/minute at 3 months and 12 months . Other outcomes were adverse events , anthropometric measures , mood , and pain . Qualitative evaluations of intervention participants and practice nurses assessed the intervention ’s acceptability . At 3 months , eight participants had withdrawn or were lost to follow-up , 280 ( 94 % ) individuals provided primary outcome data . At 3 months changes in both average daily step-counts and weekly MVPA in ≥10-minute bouts were significantly higher in the intervention than control group : by 1,037 ( 95 % CI 513–1,560 ) steps/day and 63 ( 95 % CI 40–87 ) minutes/week , respectively . At 12 months corresponding differences were 609 ( 95 % CI 104–1,115 ) steps/day and 40 ( 95 % CI 17–63 ) minutes/week . Counts and counts/minute showed similar effects to steps and MVPA . Adverse events , anthropometry , mood , and pain were similar in the two groups . Participants and practice nurses found the intervention acceptable and enjoyable . Conclusions The PACE-Lift trial increased both step-counts and objective ly measured MVPA in ≥10-minute bouts in 60–75 year olds at 3 and 12 months , with no effect on adverse events . To our knowledge , this is the first trial in this age group to demonstrate objective MVPA increases and highlights the value of individualised support incorporating objective PA assessment in a primary care setting . Trial Registration Controlled-Trials.com IS RCT",
"Background People over the age of 70 carry the greatest burden of chronic disease , disability and health care use . Participation in physical activity is crucial for health , and walking accounts for much of the physical activity undertaken by sedentary individuals . Pedometers are a useful motivational tool to encourage increased walking and they are cheap and easy to use . The aim of this pilot study was to evaluate the feasibility of the use of pedometers plus a theory-based intervention to assist sedentary older women to accumulate increasing amounts of physical activity , mainly through walking . Methods Female participants over the age of 70 were recruited from primary care and r and omised to receive either pedometer plus a theory-based intervention or a theory-based intervention alone . The theory-based intervention consisted of motivational techniques , goal - setting , barrier identification and self-monitoring with pedometers and daily diaries . The pedometer group were further r and omised to one of three target groups : a 10 % , 15 % or 20 % monthly increase in step count to assess the achievability and acceptability of a range of targets . The primary outcome was change in daily activity levels measured by accelerometry . Secondary outcome measures were lower limb function , health related quality of life , anxiety and depression . Results 54 participants were recruited into the study , with an average age of 76 . There were 9 drop outs , 45 completing the study . All participants in the pedometer group found the pedometers easy to use and there was good compliance with diary keeping ( 96 % in the pedometer group and 83 % in the theory-based intervention alone group ) . There was a strong correlation ( 0.78 ) between accelerometry and pedometer step counts i.e. indicating that walking was the main physical activity amongst participants . There was a greater increase in activity ( accelerometry ) amongst those in the 20 % target pedometer group compared to the other groups , although not reaching statistical significance ( p = 0.192 ) . Conclusion We have demonstrated that it is feasible to use pedometers and provide theory-based advice to community dwelling sedentary older women to increase physical activity levels and a larger study is planned to investigate this further",
"BACKGROUND Although many Japanese older adults spend more than an hour each day walking for exercise , the intensity is often lower than the minimum level associated with various health benefits . The purpose of this study was to evaluate the efficacy of a lifestyle physical activity intervention on improving quantity and quality of daily physical activity ( DPA ) as well as cardiorespiratory endurance in community-dwelling older women . METHODS 68 women ( 60 - 78 yr of age ) were r and omly assigned to either a lifestyle physical activity intervention group ( LIFE ) or control group . During the 12-wk intervention , feedback based on accelerometer DPA data ( number of daily steps ( STEPS ) and time spent performing daily moderate intensity physical activity ( MPA ) was provided to each participant in LIFE every two weeks . Cardiorespiratory endurance was evaluated using the 12-Minute Walk Test ( 12-MW ) . RESULTS Following the 12-wk intervention , significant group interactions were observed for STEPS , MPA , and cardiorespiratory endurance . LIFE increased STEPS by 16 % , MPA by 53 % , and the distance walked during the 12-MW by 10 % . CONCLUSIONS Promotion of DPA using accelerometers can significantly improve quantity and quality of daily physical activity as well as cardiorespiratory endurance in older women",
"Background Low activity levels in inpatient rehabilitation are associated with adverse outcomes . The study aim ed to test whether activity levels can be increased by the provision of monitored activity data to patients and clinicians in the context of explicit goal setting . Methods A r and omized controlled trial in three sites in Australia included 255 in patients aged 60 and older who had a rehabilitation goal to become ambulant . The primary outcome was patients ’ walking time measured by accelerometers during the rehabilitation admission . Walking times from accelerometry were made available daily to treating therapists and intervention participants to motivate patients to improve incidental activity levels and reach set goals . For the control group , ‘ usual care ’ was followed , including the setting of mobility goals ; however , for this group , neither staff nor patients received data on walking times to aid the setting of daily walking time targets . Results The median daily walking time in the intervention group increased from 10.3 minutes at baseline to 32.1 minutes at day 28 , compared with an increase from 9.5 to 26.5 minutes per day in the control group . Subjects in the intervention group had significantly higher non-therapy walking time by about 7 minutes [ mean ( 95 % CI ) : 24.6 ( 21.7 , 27.4 ) ] compared to those in the control group [ mean(95 % CI ) : 17.3 ( 14.4 , 20.3 ) ] ( p = 0.001 ) . Conclusions Daily feedback to patients and therapists using an accelerometer increased walking times during rehabilitation admissions . The results of this study suggest objective monitoring of activity levels could provide clinicians with information on clinical ly important , mobility-related activities to assist goal setting . Trial Registration Australian New Zeal and Clinical Trials Registry ACTRN12611000034932",
"PURPOSE We compared the effectiveness of 2 physical activity prescriptions delivered in primary care — the st and ard time-based Green Prescription and a pedometer step-based Green Prescription — on physical activity , body mass index ( BMI ) , blood pressure , and quality of life in low-active older adults . METHODS We undertook a r and omized controlled trial involving 330 low-active older adults ( aged = 65 years ) recruited through their primary care physicians ’ patient data bases . Participants were r and omized to either the pedometer step-based Green Prescription group ( n = 165 ) or the st and ard Green Prescription group ( n = 165 ) . Both groups had a visit with the primary care practitioner and 3 telephone counseling sessions over 12 weeks aim ed at increasing physical activity . Outcomes were the changes in physical activity ( assessed with the Auckl and Heart Study Physical Activity Question naire ) , blood pressure , BMI , quality of life ( assessed with the 36-Item Short Form Health Survey ) , physical function status ( assessed with the Short Physical Performance Battery ) , and falls over a 12-month period . RESULTS Of the patients invited to participate , 57 % responded . At 12 months , leisure walking increased by 49.6 min/wk for the pedometer Green Prescription compared with 28.1 min/wk for the st and ard Green Prescription ( P=.03 ) . For both groups , there were significant increases across all physical activity domains at 3 months ( end of intervention ) that were largely maintained after 12 months of follow-up . BMI did not change in either group . Significant improvements in blood pressure were observed for both groups without any differences between them . CONCLUSIONS Pedometer use result ed in a greater increase in leisure walking without any impact on overall activity level . All participants increased physical activity , and on average , their blood pressure decreased over 12 months , although the clinical relevance is unknown",
"Background . Physical activity can positively influence health for older adults . Primary care is a good setting for physical activity promotion . Objective . To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations . Methods . Design : Two-arm ( intervention/control ) 12-week r and omized controlled trial with a 12-week follow-up for the intervention group . Setting : One general practice in Glasgow , UK . Participants : Participants were aged ≥65 years . The intervention group received two 30-minute physical activity consultations from a trained practice nurse , a pedometer and a walking programme . The control group continued as normal for 12 weeks and then received the intervention . Both groups were followed up at 12 and 24 weeks . Outcome measures : Step counts were measured by sealed pedometers and an activPALTM monitor . Psychosocial variables were assessed and focus groups conducted . Results . The response rate was 66 % ( 187/284 ) , and 90 % of those r and omized ( 37/41 ) completed the study . Qualitative data suggested that the pedometer and nurse were helpful to the intervention . Step counts ( activPAL ) showed a significant increase from baseline to week 12 for the intervention group , while the control group showed no change . Between weeks 12 and 24 , step counts were maintained in the intervention group , and increased for the control group after receiving the intervention . The intervention was associated with improved quality of life and reduced sedentary time . Conclusions . It is feasible to recruit and retain older adults from primary care and help them increase walking . A larger trial is necessary to confirm findings and consider cost-effectiveness",
"OBJECTIVE To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance ( IGT ) . RESEARCH DESIGN AND METHODS Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester , U.K. Participants were r and omly assigned to one of three groups . Group 1 received a 3-h group-based structured education program design ed to promote walking activity using personalized steps-per-day goals and pedometers . Group 2 received a 3-h group-based structured education program design ed to promote walking activity using generic time-based goals . Group 3 received a brief information leaflet ( control condition ) . Outcomes included an oral glucose tolerance test , st and ard anthropometric measures , ambulatory activity , and psychological variables . Follow-up was conducted at 3 , 6 , and 12 months . RESULTS A total of 87 individuals ( 66 % male , mean age 65 years ) were included in this study . At 12 months , significant decreases in 2-h postchallenge glucose and fasting glucose of −1.31 mmol/l ( 95 % CI −2.20 to −0.43 ) and −0.32 mmol/l ( −0.59 to −0.03 ) , respectively , were seen in the pedometer group compared with the control group . No significant improvements in glucose control were seen in those given the st and ard education program . CONCLUSIONS This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT . This result is likely to have important implication s for future primary care – based diabetes prevention initiatives",
"OBJECTIVES To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults . DESIGN R and omized controlled trial . SETTING Kyoto , Japan . PARTICIPANTS Community-dwelling older adults ( N = 48 ) were r and omized into an exercise group ( n = 24 ) and a control group ( n = 24 ) . INTERVENTION Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase . Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase . MEASUREMENTS The outcome measures were global cognitive function , memory function , executive function , and brain activation ( measured using functional magnetic resonance imaging ) associated with visual short-term memory . RESULTS Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group ( P activation was found in several brain regions associated with visual short-term memory , including the prefrontal cortex , in the exercise group ( P physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults , which is associated with improvements in memory and executive function",
"PURPOSE We evaluated the effects of low-intensity and home-based pulmonary rehabilitation ( PR ) on physical activity ( PA ) and the feedback provided by a pedometer in stable elderly patients with chronic obstructive pulmonary disease ( COPD ) . METHODS We assessed PA using a newly developed triaxial accelerometer ( A-MES ™ , Kumamoto , Japan ) , which measures the time spent walking , st and ing , sitting and lying down . Twenty-seven elderly patients with COPD ( age 74 ± 8 yrs ; % FEV1 56.6 ± 18.7 % ) participated . They were r and omly selected to undergo PR ( pulmonary rehabilitation only ) or PR + P ( PR plus the feedback from using a pedometer ) . Their PA and pulmonary function , exercise capacity ( 6-min walking distance ; 6MWD ) , quadriceps femoris muscle force ( QF ) were evaluated before the PR began ( baseline ) and at 1 year later . We compared the patients ' changes in PA and other factors between the baseline values and those obtained 1 year later and analyzed the relationships between the changes in PA and other factors in the both groups . RESULTS The increase in the time spent walking in the PR + P group ( 51.3 ± 63.7 min/day ) was significantly greater than that of PR group ( 12.3 ± 25.5 min/day ) after the PR . The improvement rate of daily walking time after PR was significantly correlated with that of the 6MWD and QF in all subjects . CONCLUSIONS These data suggest that low-intensity and home-based PR with the feedback from using pedometer was effective in improving PA , and the improvements of physiological factors were correlated with increased walking time in stable elderly patients with COPD",
"This study investigated the effect of a 12-week pedometer-based intervention on daily step counts of 147 older adults r and omly assigned to an intervention or wait-list control group ( M age = 72.9 years , SD = 8.8 ) . The intervention group significantly increased their daily step counts after 12 weeks ( M = 639 , SD = 2,239 ) and continued to significantly increase during a 12-week maintenance period ( M = 680 , SD = 1,721 ) . The control group exhibited no change during the control period ( M = -393 , SD = 2,050 ) but had a significant increase in daily step counts ( M = 1,580 , SD = 2,305 ) when enrolled in the intervention . The pedometer-based intervention was effective in increasing participants ' daily step counts",
"OBJECTIVES To determine whether a home-based pedometer-driven walking program with arthritis self-management education ( Walk + ) would increase physical activity , muscle strength , and functional performance in older adults with osteoarthritis ( OA ) of the knee as opposed to arthritis self-management education alone ( EDU ) . DESIGN A r and omized two-by-three ( group-by-time ) design with participants assigned to Walk + ( n = 17 , mean age + /- st and ard deviation = 69.6 + /- 6.7 ) or EDU ( n = 17 , age = 70.8 + /- 4.7 ) . SETTING Community located in the Baltimore-Washington area . PARTICIPANTS Thirty-four community-dwelling adults , aged 60 and older with symptomatic knee OA and self-reported functional impairment . INTERVENTIONS Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks . In addition , the Walk + group received individualized instruction in the use of a pedometer , with the goal of increasing their step count by 30 % of their baseline step count . MEASUREMENTS The outcome measures were physical activity ( daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer ) , quadriceps femoris strength ( isometric peak torque ) , and functional performance tasks ( 100-foot walk-turn-walk , timed stair climb , timed chair rise , and pain status ) . RESULTS Daily steps walked showed a significant group-by-time interaction ( P = .04 ) after controlling for age . From baseline to completion of training , a 23 % increase in daily steps occurred in the Walk + group and a 15 % decrease in the EDU group . Although steps increased in the Walk + group , total activity vector magnitude was maintained , suggesting a more efficient gait . The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk ( P = .04 ) . An isometric strength gain of 21 % postintervention was seen in the Walk + group , compared with a loss of 3.5 % in the EDU group . CONCLUSION In older adults with symptomatic knee OA , Walk + appears to increase walking , with improvements in muscle strength and walking performance . The use of a home-based pedometer-driven program to increase physical activity , strength , and function in this population warrants further research",
"OBJECTIVES To determine the effectiveness of a behavior change intervention ( BCI ) with or without a pedometer in increasing physical activity in sedentary older women . DESIGN Prospect i ve r and omized controlled trial . SETTING Primary care , City of Dundee , Scotl and . PARTICIPANTS Two hundred four sedentary women aged 70 and older . INTERVENTIONS Six months of BCI , BCI plus pedometer ( pedometer plus ) , or usual care . MEASUREMENTS PRIMARY OUTCOME change in daily activity counts measured by accelerometry . SECONDARY OUTCOMES Short Physical Performance Battery , health-related quality of life , depression and anxiety , falls , and National Health Service re source use . RESULTS One hundred seventy-nine of 204 ( 88 % ) women completed the 6-month trial . Withdrawals were highest from the BCI group ( 15/68 ) followed by the pedometer plus group ( 8/68 ) and then the control group ( 2/64 ) . After adjustment for baseline differences , accelerometry counts increased significantly more in the BCI group at 3 months than in the control group ( P = .002 ) and the pedometer plus group ( P = .04 ) . By 6 months , accelerometry counts in both intervention groups had fallen to levels that were no longer statistically significantly different from baseline . There were no significant changes in the secondary outcomes . CONCLUSION The BCI was effective in objective ly increasing physical activity in sedentary older women . Provision of a pedometer yielded no additional benefit in physical activity , but may have motivated participants to remain in the trial",
"OBJECTIVE To determine the effectiveness of a pedometer-based telephone intervention on the physical activity levels of cardiac patients who did not attend a CRP . METHODS A r and omised controlled trial was conducted with 215 patients referred to a CRP but who could not or chose not to attend . The 6-week intervention included self-monitoring of physical activity using a pedometer and step calendar ; and behavioural counselling and goal setting sessions . Data were collected at baseline , 6 weeks and 6 months . RESULTS Study groups did not differ significantly at baseline . After 6 weeks , improvements in total physical activity time ( p=0.027 ) , total physical activity sessions ( p=0.003 ) , walking time ( p=0.013 ) and walking sessions ( p=0.002 ) in the intervention group were significantly greater than the control group after adjusting for baseline differences , and remained significant at 6 months . CONCLUSION The findings that the pedometer-based telephone intervention was successful in increasing physical activity levels in cardiac patients who did not attend a CRP could result in major health benefits for this group of people . PRACTICAL IMPLICATION S The pedometer-based telephone intervention could be offered as an effective and accessible option for patients not attending a CRP to increase and maintain their physical activity levels after hospitalisation",
"Objective : This study determined the effectiveness of an individually tailored , Internet-mediated physical activity ( PA ) intervention for increasing walking behavior in inactive older adults . Method : This 12-week r and omly controlled intervention divided participants ( N = 170 ) into three groups : control ( CON , n = 51 ) , pedometer only ( PED , n = 62 ) , and an individually tailored , Internet-mediated pedometer ( TI-PED , n = 57 ) group . The PED group was instructed to increase weekly step count by 10 % until 10,000 steps per day was achieved . The TI-PED group was given the same goal and received tailored feedback via an online platform . Changes in average step count pre-to-post were assessed . Results : Total retention rate at postintervention was 75.3 % . PED ( p TI-PED ( p increased step count pre-to-post , which was higher than the CON group at 12 weeks ( PED , p TI-PED group had a higher step count at 12 weeks than the PED group ( p Internet-mediated PA interventions are an effective way to significantly increase PA in older adults ",
"Objective : First , to investigate the effects of a telerehabilitation intervention on health status and activity level of patients with Chronic Obstructive Pulmonary Disease ( COPD ) , compared to usual care . Second , to investigate how patients comply with the intervention and whether compliance is related to treatment outcomes . Design : a r and omized controlled pilot trial Subjects : Thirty-four patients diagnosed with COPD . Intervention : The telerehabilitation application consists of an activity coach ( 3D-accelerometer with smartphone ) for ambulant activity registration and real-time feedback , complemented by a web portal with a symptom diary for self-treatment of exacerbations . The intervention group used the application for 4 weeks . The control group received usual care . Main measures : Activity level measured by a pedometer ( in steps/day ) , health status by the Clinical COPD Question naire at baseline and after intervention . Compliance was expressed as the time the activity coach was worn . Results : Fourteen intervention and 16 control patients completed the study . Activity level ( steps/day ) was not significantly affected by the intervention over time . There was a non-significant difference in improvement in health status between the intervention ( −0.34±0.55 ) and control group ( 0.02±0.57 , p=0.10 ) . Health status significantly improved within the intervention group ( p=0.05 ) . The activity coach was used more than prescribed ( 108 % ) and compliance was related to the increase in activity level for the first two feedback weeks ( r=0.62 , p=0.03 ) . Conclusions : This pilot study shows the potential of the telerehabilitation intervention : compliance with the activity coach was high , which directly related to an improvement in activity levels "
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41164962-06ff-11f0-808a-c43d1ab1c353
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The development of urethral stricture ( US ) or bladder neck contracture is a relatively uncommon but well described condition observed primarily in men . Despite familiarity with US disease , management remains challenging for urologists . Risk factors for the development of USs or bladder neck contracture include primary treatment modality , tobacco smoking , coronary artery disease and poorly controlled diabetes mellitus . Numerous treatment options exist for this condition that vary in procedural complexity , including intermittent self catheterization ( CIC ) , serial urethral dilation , endoscopic techniques and open reconstructive repairs . Repetitive procedures for this condition may carry increased failure rates and morbidities . For the treatment of refractory or recalcitrant bladder neck contracture , newer intralesional anti-proliferative , anti-scar agents have been used in combination with transurethral bladder neck incisions to augment outcome and long-term effect . The primary focus of this systematic review of the published literature is to streamline and summarize various and newer therapeutic modalities available to manage patients with US or bladder neck contracture
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[
"PURPOSE We evaluate the efficacy of repeated dilation or urethrotomy as treatment of male urethral strictures . MATERIAL S AND METHODS Between January 1991 and January 1994 , 210 men with proved urethral strictures were prospect ively r and omized to undergo filiform dilation ( 106 ) or internal urethrotomy ( 104 ) . Followup was scheduled at 3 , 6 , 9 , 12 , 24 , 36 and 48 months . Dilation or internal urethrotomy was repeated at the first and second stricture recurrence . The Kaplan-Meier method was used to estimate survivor function for the treatment methods ( survival time being the time to first stricture recurrence ) and the log rank test was used to compare the efficacy of different treatments . RESULTS Followup ( mean 24 months , range 2 to 63 ) was available in 163 patients ( 78 % ) . After a single dilation or urethrotomy not followed by re-stricturing at 3 months , the estimated stricture-free rate was 55 to 60 % at 24 months and 50 to 60 % at 48 months . After a second dilation or urethrotomy for stricture recurrence at 3 months the stricture-free rate was 30 to 50 % at 24 months and 0 to 40 % at 48 months . After a third dilation or urethrotomy for stricture recurrence at 3 and 6 months the stricture-free rate at 24 months was 0 ( p Dilation and internal urethrotomy are useful in a select group ( approximately 70 % of all patients ) who are stricture-free at 3 months , and of whom 50 to 60 % will remain stricture-free up to 48 months . A second dilation or urethrotomy for early stricture recurrence ( at 3 months ) is of limited value in the short term ( 24 months ) but of no value in the long term ( 48 months ) , whereas a third repeated dilation or urethrotomy is of no value",
"BACKGROUND To evaluate the effects of hyaluronic acid ( HA ) and carboxymethylcellulose ( CMC ) on the recurrence of urethral stricture after treatment with endoscopic internal urethrotomy ( EIU ) . METHODS A total of 120 patients underwent EIU for urethral stricture . Recruited patients were r and omly divided into two groups : group A and B. Patients in group A ( 60 patients , experimental group ) received HA/CMC instillation and patients in group B ( 60 patients , control group ) received lubricant instillation after internal urethrotomy . Each patient was evaluated at 4 weeks ( V1 ) , 12 weeks ( V2 ) , and 24 weeks ( V3 ) after the surgery . The effectiveness of HA/CMC instillation was evaluated based on the International Prostate Symptom Score/ Quality of Life , peak urine flow rate , voided volume and postvoiding residual urine volume . The visual analogue scale ( VAS ) pain score and degree of satisfaction were also determined for each participant . RESULTS Among 120 initial participants , 53 patients in group A and 48 patients in group B had completed the experiment . VAS pain scores were 0.67±0.76 and 3.60±1.52 ( p and degrees of satisfaction were 0.28±0.50 and 0.80±0.81 in group A and group B at 1 month after surgery ( p=0.001 ) . The recurrence of urethral stricture was observed in five cases ( 9.4 % ) in group A and 11 ( 22.9 % ) in group B ( p=0.029 ) . CONCLUSIONS HA/CMC instillation during EIU may decrease the incidence of urethral stricture recurrence . In addition , the use of HA/CMC was effective in reducing pain during the early postoperative period without an adverse effect",
"OBJECTIVES Urethral stricture is one of the oldest known urologic diseases and remains a common problem with high morbidity . Internal urethrotomy refers to any procedure that opens the stricture by incising or ablating it transurethrally . The most common complication of internal urethrotomy is stricture recurrence . The curative success rate of internal urethrotomy is approximately 20 % . Mitomycin C has antifibroblast and anticollagen properties and in sporadic reports of animal and clinical studies it has increased the success rate of trabeculectomy and myringotomy . This study evaluated the efficacy of mitomycin C in the prevention of anterior urethral stricture recurrence after internal urethrotomy . PATIENTS AND METHODS Forty male patients with anterior urethral strictures were r and omized to undergo internal urethrotomy with or without urethral submucosal mitomycin C injection . Using general anaesthesia , the urethrotomy was performed under direct vision . Mitomycin C ( 0.1 mg ) was injected submucosally at the urethrotomy site in 20 patients . The patients were re-evaluated after 6 mo and the stricture recurrence rate was compared between the two groups ( chi(2 ) analysis ) . RESULTS Urethral stricture recurred in 2 patients ( 10 % ) in the mitomycin C-treated group and in 10 patients ( 50 % ) in the other group . This difference in stricture recurrence between the two groups was statistically significant ( p=0.006 ) . CONCLUSIONS To our knowledge , this is the first prospect i ve , r and omized , clinical trial to evaluate the efficacy of mitomycin C application in internal urethrotomy . Submucosal injection of mitomycin C significantly reduced stricture recurrence after internal urethrotomy . Further investigations are warranted to confirm its efficacy and safety",
"PURPOSE We compared the efficacy of dilation versus internal urethrotomy as initial outpatient treatment for male urethral stricture disease . MATERIAL S AND METHODS A total of 210 men with proved urethral strictures was r and omized to undergo filiform dilation ( 106 ) or optical internal urethrotomy ( 104 ) with local anesthesia on an outpatient basis . RESULTS Life table survival analysis showed no significant difference between the 2 treatments with regard to stricture recurrence . Hazard function analysis showed that the risk of stricture recurrence was greatest at 6 months , whereas the risk of failure after 12 months was slight . The recurrence rate at 12 months was approximately 40 % for strictures shorter than 2 cm . and 80 % for those longer than 4 cm . , whereas the recurrence rate for strictures 2 to 4 cm . long increased from approximately 50 % at 12 months to approximately 75 % at 48 months . Cox regression analysis showed that for each 1 cm . increase in length of the stricture the risk of recurrence was increased by 1.22 ( 95 % confidence interval 1.05 to 1.43 ) . CONCLUSIONS There is no significant difference in efficacy between dilation and internal urethrotomy as initial treatment for strictures . Both methods become less effective with increasing stricture length . We recommend dilation or internal urethrotomy for strictures shorter than 2 cm . , primary urethroplasty for those longer than 4 cm . and a trial of dilation or urethrotomy for those 2 to 4 cm . long",
"INTRODUCTION Peyronie 's disease afflicts at least 3 % of sexually active men over the age of 30 . Many pharmacologic therapies have been tried , but to date , no systemic or local therapy has been proven to provide predictable and lasting results . AIM This study was design ed to assess the efficacy and safety of intralesional clostridial collagenase injection therapy in a series of patients with Peyronie 's disease . METHODS Twenty-five patients aged 21 - 75 years who were referred to a single institution with a well-defined Peyronie 's disease plaque were treated with three intralesional injections of clostridial collagenase 10,000 units in a small volume ( 0.25 cm(3 ) per injection ) administered over 7 - 10 days , with a repeat treatment ( i.e. , three injections of collagenase 10,000 units/25 cm(3 ) injection over 7 - 10 days ) at 3 months . Primary efficacy measures were changes from baseline in the deviation angle and plaque size . Secondary efficacy end points were patient responses to a Peyronie 's disease question naire and improvement according to the investigators ' global evaluation of change . MAIN OUTCOME MEASURE The primary efficacy measures were change in deviation angle and change in plaque size . Secondary end points were patient question naire responses and improvement according to the investigators ' global evaluation of change . RESULTS Significant decreases from baseline were achieved in the mean deviation angle at months 3 ( P = 0.0001 ) and 6 ( P = 0.0012 ) , plaque width at months 3 ( P = 0.0052 ) , 6 ( P = 0.0239 ) , and 9 ( P = 0.0484 ) , and plaque length at months 3 ( P = 0.0018 ) and 6 ( P = 0.0483 ) . More than 50 % of patients in this series considered themselves \" very much improved \" or \" much improved \" at all time points in the study , and the drug was generally well tolerated . CONCLUSION The benefits of intralesional clostridial collagenase injections in this trial lend support to prior studies supporting its use in the management of Peyronie 's disease . A double-blind , placebo-controlled study is currently under development",
"PURPOSE The efficacy of the bipolar endoscopic resection for anastomotic stricture was assessed and compared with holmium laser treatment . PATIENTS AND METHODS We studied a cohort of 39 patients with anastomotic strictures in years 1999 to 2007 . Twenty-two patients had undergone bipolar resection , and 17 patients had undergone holmium laser treatment . The mean age of the bipolar cohort was 63.8 years ; initial prostate-specific antigen ( PSA ) level was 10.7 ng/mL. The mean age of the laser cohort was 64 years ; initial PSA level was 7.8 ng/mL. The results were evaluated by measurement of the maximum urinary flow ( Qmax ) and the postvoid residual volume of urine ( PVR ) before surgery , and at 6 weeks and 6 months after surgery . The Wilcoxon rank-sum test was used for statistical analysis , and a P value Qmax and PVR were recorded in the two cohorts . In the bipolar cohort , the mean values of Qmax were 3.9 mL/s , 14 mL/s , and 13 ml/s , while PVR values were 46 mL , 10 mL , and 11 mL. The mean values of Qmax in the laser cohort were 3.7 mL/s , 11 mL/s and 6.1 mL/s ; PVR were 25 mL , 16 mL , and 19 mL. Statistically significantly better results of Qmax over 6 months were in the bipolar cohort ( P perioperative complications and no deterioration of urinary continence were recorded . CONCLUSION The bipolar resection of an anastomotic stricture is a highly effective method that produces better long-term results than the holmium laser treatment",
"OBJECTIVES To quantify complications to surgery in patients treated with robot-assisted radical prostatectomy ( RARP ) and open retropubic radical prostatectomy ( RRP ) at our institution . Radical prostatectomy is associated with specific complications that can affect outcome results in patients . METHODS Between January 2002 and August 2007 , a series of 1738 consecutive patients underwent RARP ( n = 1253 ) or RRP ( n = 485 ) for clinical ly localized prostate cancer . Surgery-related complications were assessed using a prospect i ve hospital-based complication registry . The baseline characteristics of all patients were documented preoperatively . RESULTS Overall , 170 patients required blood transfusions ( 9.7 % ) , 112 patients ( 23 % ) in the RRP group compared with 58 patients ( 4.8 % ) in the RARP group . Infectious complications occurred in 44 RRP patients ( 9 % ) compared with 18 ( 1 % ) in the RARP group . Bladder neck contracture was treated in 22 ( 4.5 % ) patients who had undergone RRP compared with 3 ( 0.2 % ) in the RARP group . Clavien grade IIIb-V complications were more common in RRP patients ( n = 63 ; 12.9 % ) than in RARP patients ( n = 46 ; 3.7 % ) . CONCLUSIONS The introduction of RARP at our institution has result ed in decreased number of patients with Clavien grade IIIb-V complications , such as bladder neck contractures , a decrease in the number of patients who require blood transfusions , and decreased numbers of patients with postoperative wound infections",
"OBJECTIVES To analyze whether the addition of a cyclooxygenase (COX)-2 inhibitor after transurethral resection of the prostate ( TURP ) offers an advantage compared with TURP alone in reducing postoperative urethral strictures . At urethroscopy , stenosis of the urethra with a circumference of less than 19 mm was defined as stricture . METHODS This was a prospect i ve , unblinded , r and omized , single-center study . Between December 2001 and December 2003 , 96 consecutive men with benign prostatic hyperplasia underwent TURP . After TURP , patients were r and omly assigned to receive or not receive a COX-2 inhibitor ( rofecoxib 25 mg/day ) . In the group given the COX-2 inhibitor , the therapy was started at catheter removal and continued for 20 days . Follow-up was performed on an outpatient basis after 1 month . A diagnosis of postoperative urethral stricture was assessed during a follow-up of 12 months . RESULTS At the 1-month visit , the mean and median improvement in the peak urinary flow rate from preoperative values was + 6.25 + /- 3.76 mL/s ( median 7.30 ) in the no COX-2 inhibitor group and + 9.42 + /- 3.06 mL/s ( median 8.75 ) in the COX-2 inhibitor group . The improvement was significantly ( P urethral stricture had been diagnosed in 8.3 % of all cases ; in particular , in 17 % and 0 % of cases in the no COX inhibitor group and COX-2 inhibitor group , respectively . Post-TURP COX-2 inhibitor therapy was significantly ( P = 0.0039 ) and inversely ( r = -0.2876 ) associated with urethral stricture development . CONCLUSIONS We suggest that limited postoperative treatment with a COX-2 inhibitor can effectively prevent post-TURP urethral stricture development by specifically interfering with the inflammatory processes that can precede scar formation",
"PURPOSE We developed a reproducible animal model for the induction of urethral stricture in the rabbit and evaluated the role of halofuginone in limiting stricture formation . MATERIAL S AND METHODS A total of 20 New Zeal and male rabbits were used in the first phase of the experiment . Bulbar urethral stricture was induced by electrocoagulation . The animals were then r and omly assigned to 2 groups of 10 each , which received a diet containing halofuginone or a normal diet . In the second phase electrocoagulation induced stricture was treated with visual internal urethrotomy in 45 rabbits . These rabbits were r and omly assigned to 2 groups , namely a halofuginone and a control group . RESULTS In the first phase stricture developed in 2 study rabbits ( 20 % ) vs 10 controls ( 100 % ) . In the second phase 37 rabbits were evaluable ( 8 died ) . Recurrent stricture was observed in 5 of the 18 study rabbits ( 27 % ) vs 14 of the 19 controls ( 73 % ) . CONCLUSIONS Halofuginone is effective in limiting the occurrence of de novo urethral stricture and recurrent stricture after visual internal urethrotomy . This antifibrotic molecule may become an important therapy to treat urethral stricture and /or recurrence following endoscopic manipulation of stricture in humans",
"OBJECTIVES To evaluate the incidence and characteristics of anastomotic strictures ( AS ) after radical retropubic prostatectomy ( RRP ) with bladder-neck preservation ( BNP ) , the efficacy of management with cold-knife incision ( CKI ) , and its impact on urinary continence . METHODS Seven hundred five consecutive patients who underwent RRP with BNP were prospect ively followed with uroflowmetry at postoperative months 1 , 3 , 6 , 9 , 12 , and investigated for urinary incontinence with the 1-h pad test at AS diagnosis obtained with urethroscopy . If the instrument could not dilate the stricture , CKI was subsequently performed . Follow-up after treatment was performed with uroflowmetry and 1-h pad test at months 1 , 3 , 6 , 9 , 12 . Recurrent AS was always treated with repeated CKI . RESULTS Six hundred forty-eight patients were assessable . After a median time of 3.8 mo from RRP , 46 ( 7.1 % ) patients developed AS . Urinary incontinence was present in 21 ( 46 % ) men at AS diagnosis . Three ( 7 % ) patients were successfully managed by urethroscopic dilation only , whereas 43 ( 93 % ) required CKI . Eleven ( 26 % ) of the latter had recurrent AS . After a median follow-up of 48 mo from the last AS treatment , all patients are stricture-free , de novo urinary incontinence was never documented , and of the 21 originally incontinent men , 11 became continent , 8 improved and 2 remained unchanged . CONCLUSIONS In our experience , BNP does not decrease the incidence of AS after RRP ; however , AS can be effectively managed with repeated CKI with a final 100 % success rate . CKI has a possible positive impact on urinary continence in 90 % of patients , without causing de novo incontinence",
"OBJECTIVE To prospect ively analyse the morbidity of radical prostatectomy . METHODS Morbidity data from 188 consecutive radical prostatectomy patients were collected prospect ively . Mortality , intraoperative , early postoperative and late postoperative complications were analysed . RESULTS 1.5 % mortality . 3.7 % suffered an intraoperative complication . Early postoperative problems were common ( 43 % ) . Of those with greater than 1 year follow-up , 5.9 % remained with some incontinence , and a further 11 patients had artificial sphincters implanted ; 32 % had narrowing of the anastomosis , requiring at least 1 dilation ; 43 % of patients retained their potency . CONCLUSIONS It is concluded that radical prostatectomy can be performed with minimal mortality and acceptable morbidity",
"PURPOSE The long-term success rate of dilation and /or internal urethrotomy is low in cases of recurrent urethral stricture . We investigated the ability of the Memokath ™ 044TW stent to maintain urethral patency after dilation or internal urethrotomy for recurrent urethral stricture . MATERIAL S AND METHODS A total of 92 patients with recurrent bulbar urethral strictures ( mean length 2.7 cm ) were treated with dilation or internal urethrotomy and r and omized to short-term urethral catheter diversion ( 29 ) or insertion of a Memokath 044TW stent ( 63 ) . The primary end point was urethral patency , as assessed by passage of a calibrated endoscope . Secondary end points included urinary symptoms and uroflowmetry parameters . Stents were scheduled to remain in situ for 12 months . RESULTS The rate of successful stent insertion was 93.6 % ( 59 of 63 patients ) . In stented patients patency was maintained significantly longer than controls ( median 292 vs 84 days , p improved uroflowmetry and symptom scores . The stent was removed in 100 % of patients . The most frequently noted side effects in stented patients were bacteriuria , hematuria and penile pain , which were usually mild and transient . There was no difference in sexual function between stented and control patients . Stent dislocation and occlusion were observed in 8 and 3 patients , respectively . CONCLUSIONS Patients with recurrent bulbar urethral strictures treated with dilation or urethrotomy and a Memokath 044TW stent maintained urethral patency significantly longer than those treated with dilation or urethrotomy alone . The stent side effect profile was favorable . The stent was straightforward to insert and it was removed without difficulty even after long-term placement",
"PURPOSE We evaluated urethrotomy combined with intralesional injection of the antiproliferative agent mitomycin C for the treatment of severe , recurrent bladder neck contractures after traditional endoscopic management failed . We report our experience with radial urethrotomy and intralesional mitomycin C in patients with recurrent bladder neck contractures . MATERIAL S AND METHODS A retrospective review was performed of patients evaluated for severe , recurrent bladder neck contractures between January 2007 and April 2010 . All patients had at least 1 prior failed incision of a bladder neck contracture . Tri or quadrant cold knife incisions of the bladder neck were performed followed by injection of 0.3 to 0.4 mg/ml mitomycin C at each incision site . RESULTS A total of 18 patients were treated with bladder neck incision and mitomycin C injection . Preoperatively 4 ( 22 % ) patients presented with indwelling Foley catheters while 7 ( 39 % ) required a dilation schedule . At a median followup of 12 months ( range 4 to 26 ) 13 patients ( 72 % ) had a patent bladder neck after 1 procedure , as did 3 ( 17 % ) after 2 procedures and 1 after 4 procedures . All of the patients presenting with a prior indwelling urethral catheter or requiring a dilation schedule had a stable , patent bladder neck . CONCLUSIONS Management of recurrent bladder neck contractures with radial urethrotomy combined with intralesional mitomycin C result ed in bladder neck patency in 72 % of the patients after 1 procedure and in 89 % after 2 procedures . Although early results are promising , longer followup and r and omized , prospect i ve studies are required to vali date these findings",
"OBJECTIVE The purpose of this study is to evaluate the effect of intraurethral captopril gel as an antifibrotic agent on patients with urethral stricture . MATERIAL S AND METHODS In the first phase of clinical trial , 13 rabbits were included and local side-effects of captopril gel were evaluated . In the second phase , 56 patients were enrolled from April 2004 to January 2006 . After internal urethrotomy the patients were classified into three patient groups : ( i ) received placebo gel ( group I ) ; ( ii ) received 0.1 % captopril gel ( group II ) ; and ( iii ) instilled 0.5 % captopril gel intraurethrally ( group III ) . RESULTS In phase I , no significant local side-effects were seen in the urethra of rabbits . In phase II , the mean age of the patients was 39.5 and the mean follow-up duration was 16 months . The most common etiology of the urethral stricture in the patients was iatrogenic ( 35.7 % ) , most of their strictures had a depth of 0.5 cm or less ( 67.8 % ) , and the length of most strictures was between 1 and 2 cm ( 41.1 % ) . The patients ' maximum urine flow increased more in groups II and III , than in group I ( P recurrence rate was less in groups II and III than in group I ( P maximal urine flow and recurrence rate , no significant difference was seen between group II and group III ( P = 0.13 , P = 0.21 , respectively ) . CONCLUSION Captopril gel is a safe , effective and non-toxic agent for decreasing the recurrence rate of the urethral stricture after internal urethrotomy . However , more studies , including more cases and a longer follow up , are needed to prove the effect of captopril gel on patients ' urethra",
"OBJECTIVES /HYPOTHESIS The objective was to determine treatment dose and time-dependent effects of injected mitomycin C on extracellular matrix fibroblasts , collagen , and fibronectin , important mediators in the wound healing response , in a rat cutaneous wound model . STUDY DESIGN A prospect i ve , controlled animal study . METHODS Forty rats were injected with three different doses ( 0.4 , 2.3 , and 5.0 mg/mL ) of mitomycin C at three different wound sites with a fourth wound site receiving saline as a control . The rats were grouped to have their tissue harvested at five different date s ranging from 1 week to 8 weeks . After death , sample s from the wound site underwent Western blot analysis for collagen and fibronectin and histological analysis measuring fibroblast apoptosis . RESULTS Over an 8-week period , collagen and fibronectin significantly decreased and fibroblast apoptosis significantly increased . No correlation was found between the injected dose of mitomycin C and either the extracellular matrix protein concentration or the rate of fibroblast apoptosis . CONCLUSION Mitomycin C demonstrated a long-term effect in a wound , inhibiting collagen and fibronectin production and inducing apoptosis . Use of mitomycin C in excess of 0.4 mg/mL did not alter protein concentrations or rate of apoptosis",
"PURPOSE We evaluated an endoscopic technique to treat the challenging problem of an obliterated anastomosis following radical prostatectomy . MATERIAL S AND METHODS Four men with a mean 2.25 cm . obliterative defect underwent visual internal urethrotomy along a sternal guide wire passed under direct ante grade and retro grade vision . Men then performed self-dilation according to an increasing interval protocol . RESULTS All 4 men maintained anastomotic patency for a mean followup of 12.5 months and 1 no longer requires self-calibration . There were no complications of this procedure . CONCLUSIONS Endoscopic management coupled with self-dilation offers a safe , minimally invasive option for difficult , long obliterative anastomotic defects following radical prostatectomy",
"We investigated 49 men with Peyronie 's disease in a prospect ively r and omized placebo controlled double-blind study , comparing the effects on plaque size and penile deformity of intralesional purified clostridial collagenase and saline placebo . For the group as a whole , treatment out-performed placebo ( p absolute angular change in patients responding to treatment was small . No significant side effects were noted within a 3-month followup"
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4116499e-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Amitriptyline is a tricyclic antidepressant that was synthesis ed in 1960 and introduced as early as 1961 in the USA , but is still regularly used . It has also been frequently used as an active comparator in trials on newer antidepressants and can therefore be called a ' benchmark ' antidepressant . However , its efficacy and safety compared to placebo in the treatment of major depression has not been assessed in a systematic review and meta- analysis . OBJECTIVES To assess the effects of amitriptyline compared to placebo or no treatment for major depressive disorder in adults . SEARCH METHODS We search ed the Cochrane Depression , Anxiety and Neurosis Group 's Specialised Register ( CCDANCTR- Studies and CCDANCTR-References ) to August 2012 . This register contains relevant r and omised controlled trials from : The Cochrane Library ( all years ) , EMBASE ( 1974 to date ) , MEDLINE ( 1950 to date ) and PsycINFO ( 1967 to date ) . The reference lists of reports of all included studies were screened and manufacturers of amitriptyline contacted for details of additional studies . SELECTION CRITERIA All r and omised controlled trials ( RCTs ) comparing amitriptyline with placebo or no treatment in patients with major depressive disorder as diagnosed by operationalised criteria . DATA COLLECTION AND ANALYSIS Two review authors independently extracted data . For dichotomous data , we calculated the odds ratio ( OR ) with 95 % confidence intervals ( CI ) . We analysed continuous data using st and ardised mean differences ( with 95 % CI ) . We used a r and om-effects model throughout . MAIN RESULTS The review includes 39 trials with a total of 3509 participants . Study duration ranged between three and 12 weeks . Amitriptyline was significantly more effective than placebo in achieving acute response ( 18 RCTs , n = 1987 , OR 2.67 , 95 % CI 2.21 to 3.23 ) . Significantly fewer participants allocated to amitriptyline than to placebo withdrew from trials due to inefficacy of treatment ( 19 RCTs , n = 2017 , OR 0.20 , 95 % CI 0.14 to 0.28 ) , but more amitriptyline-treated participants withdrew due to side effects ( 19 RCTs , n = 2174 , OR 4.15 , 95 % CI 2.71 to 6.35 ) . Amitriptyline also caused more anticholinergic side effects , tachycardia , dizziness , nervousness , sedation , tremor , dyspepsia , sedation , sexual dysfunction and weight gain . In subgroup and meta-regression analyses the results of the primary outcome were robust towards publication year ( 1971 to 1997 ) , mean participant age at baseline , mean amitriptyline dose , study duration in weeks , pharmaceutical sponsor , inpatient versus outpatient setting and two-arm versus three-arm design . However , higher severity at baseline was associated with higher superiority of amitriptyline ( P = 0.02 ) , while higher responder rates in the placebo groups were associated with lower superiority of amitriptyline ( P = 0.05 ) . The results of the primary outcome were rather homogeneous , reflecting comparability of the trials . However , methods of r and omisation , allocation concealment and blinding were usually poorly reported . Not all studies used intention-to-treat analyses and in many of them st and ard deviations were not reported and often had to be imputed . Funnel plots suggested a possible publication bias , but the trim and fill method did not change the overall effect size much ( seven adjusted studies , OR 2.64 , 95 % CI 2.24 to 3.10 ) . AUTHORS ' CONCLUSIONS Amitriptyline is an efficacious antidepressant drug . It is , however , also associated with a number of side effects . Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences
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"Prevention of relapse following depression is a pressing research problem . The authors tested the efficacy of the tricyclic antidepressant amitriptyline and psychotherapy , alone and in combination , in preventing the relapse of 150 neurotic depressed female patients . They found that patients receiving amitriptyline and little psychotherapy had a 12-percent relapse rate , compared to a 16-percent rate for those receiving more psychotherapy and no medication . There was no significant difference between drug therapy alone or drug therapy in combination with psychotherapy . However , psychotherapy was beneficial to patients with problems of social adjustment and interpersonal relations . The need for further research and implication s for treatment are discussed",
"Adinazolam , a triazolobenzodiazepine , was compared with amitriptyline and placebo in a double-blind protocol involving melancholic depressives . Forty-eight patients entered the study , and 35 completed 6 weeks of evaluation . Patients were well matched in each of the groups . Initially , the adinazolam group showed more improvement than the placebo group , but this trend did not persist beyond day 7 . The amitriptyline group tended to show more improvement than either the placebo or adinazolam groups , and final scores were significantly better for amitriptyline . Depressive symptoms in the amitriptyline dropout group appeared improved , whereas in the adinazolam and placebo dropout groups they were unchanged or worse . Both amitriptyline and adinazolam were more frequently associated with complaints of side effects than placebo . Thus , amitriptyline was observed to be superior to adinazolam and placebo in improvement in depressive symptoms while adinazolam had only a brief early advantage over placebo",
"The present report examines the predictors and modifiers of response to amitriptyline in an effort to : identify variables whose effects on drug response are general enough to apply to a range of patient types and treatment setting s , isolate predictors , and evaluate the extent to which contrasting conditions across treatment setting s may lead to contrasting predictors of treatment effects . The sample comprised moderately depressed neurotic out patients from three treatment setting s : 84 clinic patients from an outpatient clinic in a city hospital , 95 patients from the private practice of general practitioners , and 78 patients from the private practice of a group of psychiatrists . Potential predictors from which regressors in a step search multiple regression procedure could be selected were : patient demographic and attitudinal characteristics , assessment s of presenting illness and its history , and evaluations of aspects of the patient-therapist interaction",
"Summary : To establish the differential indication of trazodone and to find the predictors of its efficacy , we conducted a study in which 45 patients with major depressive disorder and 75 patients with acute schizophrenia were r and omly assigned under double‐blind conditions to either 400 mg trazodone daily , 150 mg amitriptyline daily , 20 mg haloperidol daily , or placebo daily . At the beginning of the investigations , numerous variables ( basic data , MMPI , AMDP , HAM‐A , HAM‐D ) were documented and evaluated on days 3 , 7 , 14 , and 21 . In our study , trazodone proved to be as effective an antidepressant drug as amitriptyline . In group comparison , no antipsychotic action of trazodone in schizophrenic patients could be proved . Yet the trazodone treatment was clearly of less risk than the amitriptyline treatment . Under trazodone , provocation of schizophrenic symptoms , which occurred numerously under amitriptyline , was found only in one patient out of 17 schizophrenics . Related to anamnesis and characteristics of the schizophrenic patient , a predictor‐variable concerning the antipsychotic effect was not found . It can be assured , however , that patients with depressive symptoms ( regarding the entity classification ) respond to trazodone . After only 7 days of trazodone treatment , a relatively reliable decision can be established as to whether a therapeutical success can be expected if treatment is continued",
"This report examines the hypothesis that for phenelzine to be more effective than placebo it is necessary to achieve at least 80 % inhibition of platelet MAO activity . This hypothesis was examined in the context of a double-blind comparison of phenelzine , amitriptyline and placebo in depressed patients . When phenelzine became significantly more effective than placebo at 4 weeks , the average MAO inhibition was 85 % . By the 5th week , with MAO inhibition greater than 90 % , phenelzine was significantly more effective than amitriptyline . A highly significant correlation was noted between improvement and MAO inhibition within the phenelzine group",
"The cardiovascular effects of trazodone ( TZD ) , amitriptyline ( AMT ) and placebo were studied in out- patients with major depression . AMT was shown to have the expected effects on the electrocardiograph and on systolic time intervals consistent with its proven anticholinergic and quinidine-like properties . TZD , in contrast , had no quinidine-like effects and minor effects on systolic time intervals . However , it was not without any cardiovascular effects . Although TZD was shown to be a safer preparation than the reference drug AMT , long-term monitoring is needed to explain the minor effect on heart rate and T wave changes",
"A controlled double-blind trial of amitriptyline at two dosage levels ( 75 and 150 mg/day ) , amylobarbitone ( 150 mg/day ) , and an inert substance for a period of four weeks was conducted on four matched groups of women attending their general practitioners and suffering from a depressive illness . Improvement at 7 and 28 days was noted on several measures of depression and anxiety in all treatment groups . Of these treatments amitriptyline 150 mg/day was the most consistent in relieving depression and anxiety . Troublesome side effects were equally distributed among the four treatments",
"Following a 1-week , single-blind placebo washout , 150 patients were r and omized to double-blind treatment with daily doses of either mianserin , 30 mg to 150 mg ; amitriptyline , 60 mg to 300 mg ; or placebo , 1 to 5 capsules taken at bedtime ( qhs ) . Mianserin and amitriptyline were found to be comparable in efficacy , and both significantly more effective than placebo in the treatment of major depressive illness . Rating instruments , all of which showed significant improvement in the active drug groups over the placebo , included the 17- and 21-item Hamilton Rating Scale for Depression ( HAM-D ) , Montgomery and Asberg Depression Rating Scale ( MADRS ) , Self-rating Depression Scale ( SDS ) index , and the Clinical Global Impressions ( CGI ) Severity of Illness and Improvement rating scales . Furthermore , for most efficacy parameters in the efficacy-evaluable group , the earliest statistically significant difference vs. placebo could be observed at Visit 1 for the mianserin patients and at Visit 3 for the amitriptyline patients . The safety profile for mianserin was comparable with placebo with respect to laboratory values , electrocardiogram changes , vital signs , ophthalmologic evaluations , and most adverse clinical experiences . Complaints of somnolence and weight gain were comparable in the amitriptyline and mianserin groups . Mianserin was superior to amitriptyline in terms of vital signs ; anticholinergic effects ; and complaints of dizziness , dyspepsia , and tremor",
"MIA is an effective antidepressant , comparable in therapeutic efficacy to the TCAs . Further , because of its weak antimuscarinic effects . Further , because of its weak antimuscarinic effects , MIA produces no significant cognitive impairment , alteration of cardiovascular function of anticholinergic side effects compared to the TCA 's . While drowsiness is the most frequently reported adverse reaction with MIA , an h.s . dosing schedule can provide relief of insomnia and improve the quality of sleep ( 47,61 ) . Therefore , because of MIA 's advantageous pharmacodynamic profile , it offers an improvement in therapeutic index over the TCAs in the treatment of depression in the elderly",
"SIR,-We wish to record a further instance of fatal paraquat poisoning . So far as we can ascertain , this is the tenth reported fatality caused by this widely used herbicidal preparation.\"q In December 1965 a 42-year-old male accidentally drank a small quantity of \" weed-killer \" from an unlabelled stout bottle . It was later estimated that the quantity of fluid consumed was about threequarters of a teaspoonful . The nature of the substance could not be immediately ascertained , but it was subsequently identified as Gramaxone 19 % ' w/w paraquat ion ) by the laboratories of I.C.I. Ltd. On admission to hospital a few hours after taking the poison , the patient complained of a burning sensation in the throat and repeated -vomiting . Despite immediate gastric lavage , prophylactic penicillin , and abundant oral and intravenous fluids , there was progressive clinical deterioration . At three days the tongue was severely ulcerated and two days later haemoptysis occurred . On the eighth day jaundice , pyrexia , tachycardia , and a blood urea of 375 mg./100 ml . were recorded . The patient died some hours later . The outst and ing necropsy findings included focal myocardial necrosis , -severe pulmonnary haemorrhage and oedema , dense eosinophilic alveolar membrane , and proliferation of fibroblast-like cells in the alveolar septa . It is apparent from this and other reports that the lethal dose of paraquat may be very small . Further fatalities will -nly be avoided by proper , care in the storage and use of this valuable -but potentially dangerous compound . A detailed and illustrated clinico-pathological report is being prepared for publication.-We are , etc .",
"Eighty-five female depressed patients were treated for 4 weeks with amitriptyline in a flexible dose ( median , 150 mg daily ) . Predictive analyses of outcome were carried out , using both typological and regressional models based on the same 29 predictor variables . The typological prediction utilized a previously described four-group typology derived by multivariate cluster analysis and comprising psychotic depressives , anxious depressives , hostile depressives , and young depressives with personality disorder . Patients were assigned to groups by discriminant functions on the basis of scores on the predictor variables . The four groups were found to predict outcome significantly . Psychotic depressives , initially the most severely depressed , improved the most ; anxious depressives , a little less severely ill initially , showed the least improvement and the most residual illness at 4 weeks ; hostile depressives and young depressives with personality disorders , initially the least severely ill , showed intermediate improvement and were least ill , by a small margin , at 4 weeks . The 29 predictor variables also predicted outcome significantly in linear multiple regression analyses . Five variables showed regression weights significantly different from zero : high initial severity predicted high improvement but more residual illness ; initial insomnia , more previous depressions , longer illness , and hypochondriasis all predicted low improvement and more residual illness . Predictions by using typological and regression models were compared , and their interrelationships were examined . The regression prediction accounted for more variance in outcome measures than did the typology , but the statistical significance s of the regression and typological predictions were of the same order . Two variables appeared particularly important — high initial severity of illness which characterized the psychotic depresives and increased number of previous depressions which characterized the anxious depressives . Typological prediction was not solely due to these two variables in linear regression model sicne it remained significant when the outcome measure was adjusted for both by analysis of covariance . Both typological and regressional models provide useful approaches to prediction , with only limited overlap . The typological approach , which has been relatively neglected in recent years , warents more frequent application as an alternative to multiple regression",
"Summary Forty-five patients suffering from a major depression were administered zimeldine , amitriptyline or placebo ( 15 patients in each group ) in a double-blind controlled study . In the zimeldine group , seven of the 14 patients treated for more than one week presented a toxic syndrome consisting in a severe prostration , fever , myalgias and arthralgias . In all patients presenting this syndrome , laboratory analyses revealed an elevation of alkaline phosphatase and of aspartate and alanine aminotransferases and a decrease in white blood cell and platelet counts . Three patients presented a mild proteinuria and hematuria . Although an immunological mechanism can not be ruled out , several characteristics of this reaction suggest the formation of a metabolite of zimeldine with direct cellular toxicity . The relatively high starting dose of 200 mg/day of zimeldine administered in the present study and the increment to 300 mg/day after only seven days might have contributed to the high incidence of toxic reactions observed",
" One hundred and fifteen patients from 5 general practice s participated in a 12-week , double-blind study comparing L-tryptophan , amitriptyline , L-tryptophan-amitriptyline combination and placebo in the treatment of depression . Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo . Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups . Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active treatment groups , but this difference was not significant . Plasma amitriptyline and nortriptyline levels were similar in the amitriptyline and combined treatment groups . St and ard haematological and biochemical profiles did not alter significantly in any group , but mean heart rate was significantly increased in patients receiving amitriptyline . There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms",
"In a multicenter series of trials , viloxazine was compared with imipramine , amitriptyline , doxepin and placebo in 123 neurotic and endogenous depressive in patients and out patients . While significant period effects reflecting improvement were obtained on the majority of efficacy variables , no significant differences were obtained among the treatment groups or depressive types . Imipramine and amitriptyline exhibited more anticholinergic adverse reactions ; while , viloxazine exhibited greater CNS effects . Dizziness and nausea were much more frequent in neurotic depressives which may be related to their psychopathology",
"In a multicenter , placebo-controlled , clinical trial , the efficacy of Limbitrol was compared with that of its components , amitriptyline and chlordiazepoxide . All patients had a diagnosis of primary depression . Data from 279 patients were evaluated using the Hamilton depression scale , the Beck depression inventory , and physician and patient global change measures .Statistically significant differences favoring Limbitrol occurred after 1 week of treatment , and a trend in favor of Limbitrol continued throughout the remaining 3 weeks . In most efficacy comparisons , the combination was as good as , or better than , amitriptyline alone . It was superior to chlordiazepoxide alone after 2 and 4 weeks of treatment . Each component produced an independent contribution to the total therapeutic effect : the chlordiazepoxide effect was more prominent in the first 2 weeks and the amitriptyline effect in the latter 2 weeks . A trend favoring amitriptyline over chlordiazepoxide was evident by week 4.The overall incidence of side effects was comparable in both Limbitrol- and amitriptyline-treated groups . Limbitrol-treated patients exhibited more sedation , but significantly fewer Limbitrol patients discontinued treatment prematurely because of side effects",
" Of 580 patients r and omly assigned to short-term , double-blind treatment with either mirtazapine , amitriptyline or placebo , a total of 217 patients clinical ly judged to be responders subsequently continued on the same medication for up to 2 years in the long-term treatment study ( mirtazapine , n = 74 ; amitriptyline , n = 86 and placebo , n = 57 ) . The efficacy of mirtazapine in relapse prevention was seen in an analysis of the first 20 weeks data . Significantly fewer patients relapsed during treatment with mirtazapine compared with placebo ( p relapse was shown on the survival analysis . There was a significant advantage for amitriptyline compared with placebo in the first 20 weeks , with fewer patients relapsing . There was a significant advantage for mirtazapine compared with amitriptyline at 20 weeks seen on the survival analysis ( p mirtazapine compared with placebo was also seen in the prophylactic phase of treatment after 20 weeks . At the endpoint there were significantly more patients in the placebo group with a return of symptoms and significantly fewer showing sustained response , Amitriptyline was better than placebo with fewer patients suffering a recurrence of symptoms , but there was no difference from placebo in the proportion of patients with sustained response . Mirtazapine was well tolerated with a side-effect profile similar to that of placebo . The only adverse event reported significantly more frequently on mirtazapine than on placebo was weight gain . Objective ly measured weight gain was more frequent with amitriptyline ( 22 % of patients ) compared with mirtazapine ( 13 % of patients ) . Amitriptyline was associated with significantly more adverse events than either mirtazapine or placebo , in particular sedative and anticholinergic side effects . The efficacy of mirtazapine in reducing the risk of relapse and the recurrence of depression , which on some measures showed an advantage compared with amitriptyline , coupled with its improved side-effect profile , commends this antidepressant for the long-term treatment of depression",
"ABSTRACT — Zimeldine tolerability was compared to amitriptyline and placebo in a large multicentre study performed at three clinical research units in the U.S.A. Prior to a placebo washout period of 3–7 days , patients were r and omly assigned to zimeldine , a potent and selective 5‐HT reuptake blocker , amitriptyline or placebo . Dosage range was 75–300 mg/day for active medications , and the scheduled treatment period was 4 weeks",
"A double blind comparison is reported of a new tetracyclic antidepressant , maprotiline , with amitriptyline and placebo in psychiatric out patients . Amitriptyline was significantly more effective than placebo in its global effect on depression . Maprotiline emerged as neither inferior to amitriptyline nor superior to placebo . Method ological difficulties prevented an adequate assessment of the anxiolytic activity of maprotiline",
"The relationship between treating physician 's prognosis and treatment response to active drug or placebo in sample s of 517 anxious and 569 depressed out patients who had participated in 4-week double-blind drug trials was examined . Log-linear analyses employing diagnosis , prognosis , treatment ( active drug or placebo ) , and treatment response were conducted . Anxious patients had been treated with either chlordiazepoxide or placebo , and depressed patients had received either amitriptyline or placebo . Significant differences were found , suggesting that physician prognosis is related to pharmacologically induced symptom relief in anxious but not in depressed patients . In the depressed patient sample , prognosis and improvement were found to be significantly related in placebo but not drug-treated patients",
"Speed of onset of antidepressant effect was studied in 20 depressed out patients assigned double-blind to equipotent doses of amoxapine or amitriptyline . In counterbalanced order , each patient had 2 periods of 3 weeks on active agent interspersed with 2 similar periods of placebo control . On daily and weekly self-ratings , amoxapine was found to reduce symptoms significantly more rapidly than amitriptyline . Psychiatrist-ratings were consonant with selfreports",
"As reported by Prien ( see p 847 ) , two United States committees concluded in 1975 that lithium is prophylactically efficacious , ie , significantly better than placebo , in recurrent bipolar affective illness . The committees felt , however , that they could not recommend the prophylactic use of lithium in recurrent unipolar affective illness ( 1 ) because there is uncertainty as to what a unipolar disorder represents and ( 2 ) because the evidence for the efficacy of lithium in this disease type is based on a relatively small number of patients . With the first reason given , the committees more or less acknowledge that lack of trust in the psychiatrists ' ability to diagnose recurrent unipolar affective illness played a role in their decision . I have no comment to offer on this . As regards the second reason : It might be worth comparing the evidence now available for prophylactic efficacy of lithium and of cyclic antidepressants in unipolar affective illness .",
"We performed a r and omized , double-blind clinical trial comparing the efficacy and safety of zimelidine with amitriptyline and placebo in out patients with major depression , in particular patients with mixed anxiety/depressive symptomatology . Overall , amitriptyline was more effective than zimelidine and placebo after 4 weeks of treatment . However , when those patients with more severe depression were specifically examined , both antidepressants were equal in efficacy and superior to placebo . We also found no evidence for a greater likelihood of a zimelidine-induced peripheral neuropathy in this study . The present results suggest that zimelidine may be more effective in the treatment of severely depressed patients , rather than those with more mild mixed anxiety/depressive syndromes",
"In a four-week study of 08 volunteer subjects with mixed symptoms of anxiety and depression , amitriptyline produced significantly more improvement than placebo . Significant differences were noted between the amitriptyline and placebo treatment groups at two weeks in relief of somatic and anxiety symptoms and at four weeks in relief of depressive symptoms . The marked sensitivity of the volunteers to certain amitriptyline-induced side effects appeared to be related to their relatively high level of education , employment , and anxiety . Comparison data indicated that the results obtained with volunteers are relevant to out patients treated in general practice",
"A double-blind multicenter evaluation compared the antidepressant efficacy of bupropion ( Wellbutrin ) to both placebo and amitriptyline ( Elavil , Endep ) in adult patients who met DSM-III criteria for major depressive disorder . Steady-state plasma sample s were obtained 11 - 12 hours and 4 hours after the last dose in 50 and 44 patients , respectively , who were treated for 6 weeks with bupropion . There was a curvilinear relationship between antidepressant efficacy and trough plasma bupropion concentrations , with maximum response observed at 5 - 100 ng/ml and virtually none below 25 ng/ml . The increase in plasma bupropion concentration from the trough level to the 4 hour postdose peak level was also positively related to antidepressant response",
"A step- search multiple regression procedure was applied to data obtained from 120 amitriptyline-treated and 138 placebo-treated depressed nonpsychotic out patients in order to : 1 ) assess the magnitude of the drug 's effect in an outpatient sample after the possibly contaminating effects of relevant sources of patient heterogeneity have been statistically removed and 2 ) identify predictors of response to amitriptyline , placebo , or both . Patient , illness , and treatment attributes deemed of possible relevance were employed as potential predictors . Patients were drawn from two city hospital clinics and the private practice s of both general practitioners and private psychiatrists . The double blind drug trial employed was of 4 weeks ' duration , and improvement was assessed through both a patient global rating of change and a pretreatment-post-treatment difference in physicianevaluated depressive psychopathology ( PDS improvement ) . The drug effect was highly significant . Its magnitude was left unchanged for global improvement and slightly enhanced for PDS improvement when possibly contaminating influences of other predictors were statistically controlled through the regression procedure . For both improvement measures , drug-placebo differences were greater in more severely than in less severely ill patients . For all patients , irrespective of treatment agent , acute illness 6 months ) responded better to treatment than did long term illness . For the global measure there were indications that the more adequate personal and social re sources , as well as the more favorable and realistic attitudes , of the higher socioeconomic class patient were instrumental in effecting greater drug-placebo differences than occurred for patients of lower socioeconomic class affiliation . Finally , in replication of previous results , placebo patients were found to show greater global improvement when their physicians reported liking them less",
"Paroxetine is a new compound in the group of the selective serotonin-reuptake inhibitors . The results of several open and double-blind control-group studies demonstrate clear antidepressive efficacy of paroxetine . However , most data were collected in sample s of out patients . To overcome this restriction , a six-week double-blind control-group study , comparing 30 mg paroxetine with 150 mg amitriptyline per day , was performed in a sample of in patients suffering from major depression . Generally speaking , the efficacy analysis of 160 patients was not able to demonstrate statistically significant differences in the antidepressive activity of paroxetine or amitriptyline , either with respect to the total score on the Hamilton Depression Scale ( HAMD ) and the Clinical Global Impressions or with respect to the subscores of the HAMD . One exception was the retardation subscore , in which amitriptyline showed a greater degree of reduction . Both drugs had a characteristic side-effect profile . Paroxetine was characterized by a lack of anticholinergic side-effects and a higher rate of nausea",
" Improvements of individual depressive symptoms in patients with depression was compared between those treated with tricyclic antidepressants ( TAD ) and those treated with other psychoactive drugs or placebo . In the majority of comparisons , patients did not improve significantly more with TAD than with other drugs or placebo . These findings indicated that tricyclic antidepressants are not useful in the treatment of most patients with depression . Despite our findings , it is realized that a minority of patients with depression may benefit by treatment with tricyclic antidepressants",
"The authors report clinical study of 34 asthmatic children between the ages of ten and 15 , followed at a specialized outpatient clinic of a large pediatric hospital in Montreal . Evaluation of the children and their families involved the use of clinical scores with inter-rater agreement . The study found strong associations between certain personality traits and an excessive use of medication , and between personality traits and family structure . Regardless of the severity of their asthma , children with high levels of anxiety and dependence were more likely to live with highly cohesive families and to use greater quantities of cortisone than children with better adapted personality structures . Pathological family setting s are known to cause more emotional and behaviour problems in children . We suggest there is a reciprocal influence , and we consider the effects on the family of an early childhood disease that is persistent , worrisome , unpredictable , and necessitates repeated hospitalization . Prospect i ve studies of the high-risk subgroups identified in this study could facilitate early intervention for asthmatic children and their families",
"We are performing a double-blind trial with inward psychiatric patients . The indication for our psychotropic or psychotherapeutic intervention is mainly severe depression ( = major depressive disorders DSM III ) . For a 3-week trial course trazodone ( 400 mg daily ) , amitriptyline ( 150 mg/die ) or placebo capsules were given at r and om . All patients received the same type of cognitive behaviour therapy . The test battery consists of CGI , BPRS , HAMD , HAMA and AMDP ; adverse drug reactions are documented as “ free reports ” ( = freier Nebenwirkungsbericht ) . The interim results ( until March 1987 ) will be presented . Our investigation indicates that it is probable that the trazodone treatment we used is equivalent to corresponding amitriptyline treatment",
"The noradrenaline ( NA ) hypothesis of depression is founded primarily on pre clinical and clinical ly indirect evidence . In two three-compartment r and omized parallel clinical trials conducted serially , we examined the significance of NA uptake for antidepressant activity . The racemic compound oxaprotiline ( hydroxymaprotiline ) is a highly specific inhibitor of NA uptake , whereas its R-(- ) enantiomer levoprotiline is totally devoid of this property . Oxaprotiline significantly resembled amitriptyline in its antidepressant potential . Conversely , levoprotiline significantly resembled placebo in antidepressant potential . Therefore , NA uptake was necessary for the observed therapeutic effect of this experimental antidepressant",
"Cognitive effects of brief antidepressant treatments were studied in depressed out patients assigned double-blind to equipotent doses of amoxapine or amitriptyline in a 12-week double-crossover of 3-week periods of active agent and placebo . The two drugs had different profiles of effects : amitriptyline was associated with faster reaction time on tests of attention and immediate memory , reduced accuracy on an attention task , and impaired long-term memory ( after 1 but not 3 weeks ) ; amoxapine slowed performance and increased intraperson variability on a psychomotor coordination task . Amitriptyline facilitated performance in the more depressed patients , and amoxapine in the older patients . Both agents also increased pulse rate and reduced palmar sweating",
"Abstract Objective : To determine whether , in the treatment of major depression in primary care , a brief psychological treatment ( problem solving ) was ( a ) as effective as antidepressant drugs and more effective than placebo ; ( b ) feasible in practice ; and ( c ) acceptable to patients . Design : R and omised controlled trial of problem solving treatment , amitriptyline plus st and ard clinical management , and drug placebo plus st and ard clinical management . Each treatment was delivered in six sessions over 12 weeks . Setting : Primary care in Oxfordshire . Subjects : 91 patients in primary care who had major depression . Main outcome measures : Observer and self reported measures of severity of depression , self reported measure of social outcome , and observer measure of psychological symptoms at six and 12 weeks ; self reported measure of patient satisfaction at 12 weeks . Numbers of patients recovered at six and 12 weeks . Results : At six and 12 weeks the difference in score on the Hamilton rating scale for depression between problem solving and placebo treatments was significant ( 5.3 ( 95 % confidence interval 1.6 to 9.0 ) and 4.7 ( 0.4 to 9.0 ) respectively ) , but the difference between problem solving and amitriptyline was not significant ( 1.8 ( −1.8 to 5.5 ) and 0.9 ( −3.3 to 5.2 ) respectively ) . At 12 weeks 60 % ( 18/30 ) of patients given problem solving treatment had recovered on the Hamilton scale compared with 52 % ( 16/31 ) given amitriptyline and 27 % ( 8/30 ) given placebo . Patients were satisfied with problem solving treatment ; all patients who completed treatment ( 28/30 ) rated the treatment as helpful or very helpful . The six sessions of problem solving treatment totalled a mean therapy time of 3 1/2 hours . Conclusions : As a treatment for major depression in primary care , problem solving treatment is effective , feasible , and acceptable to patients . Key messages Key messages Patient compliance with antidepressant treatment is often poor , so there is a need for a psychological treatment This study found that problem solving is an effective psychological treatment for major depression in primary care — as effective as amitriptyline and more effective than placebo Problem solving is a feasible treatment in primary care , being effective when given over six sessions by a general practitioner Problem solving treatment is acceptable to",
"This r and omized double-blind study in 342 mildly to moderately depressive out patients investigated the antidepressant effectiveness and speed of action of lorazepam , alprazolam and amitriptyline versus placebo . Six weeks of drug treatment were followed by a drug taper period , a control period with placebo and a control period without placebo , of 2 weeks duration each . Clinical improvement was assessed by rating scales ( Clinical Global Impressions , Hamilton Rating Scales for Depression and Anxiety ) and patient 's self-ratings ( Patient 's Global Impressions , Self-rating Depression Scale and Visual Analogue Scale ) . At the end of week 6 all active drugs showed similar efficacy which was significantly superior to placebo . Compared to placebo , onset of efficacy was earlier on benzodiazepines than on amitriptyline . While tapering by decreasing the dosage , replacing drug with placebo and finally discontinuing placebo , clear withdrawal phenomena were not seen , but 20 % of patients , equally distributed to all treatment groups , did not want to stop taking tablets after replacing drug with placebo . Drop-out rate during the treatment period was very low ( 9 % ) . Significantly interfering adverse effects were seen in 27 patients , without predominance in one of the active drug groups",
"The National Institute of Mental Health ( NIMH ) Treatment of Depression Collaborative Research Program ( Elkin et al. , Archives of General Psychiatry , 46 , 971 - 982 ; 1989 ) reported treatment-by-severity interactions favouring pharmacotherapy for more depressed out patients , on a minority of relevant comparisons . The present study reports secondary analyses from a similar , preexisting data set in which treatment-by-severity interactions are systematic ally investigated with depressed out patients treated either with nondirective psychotherapy , behaviour therapy , pharmacotherapy , or relaxation/placebo . Despite multiple severity measures and variable severity cut scores , no treatment was differentially effective in improving more severely depressed patients . Also , there was little difference across symptom severity levels in the proportions of recovered patients between treatment groups . Finally , dynamic cluster analysis demonstrated that the proportion of pharmacotherapy nonresponders ( 20 % ) did not differ from the proportion of nonresponders in behaviour therapy or placebo groups . It is concluded that this failure to replicate the NIMH trial findings can not be attributed to treatment differences , population s or statistical power . The suggestion that pharmacotherapy be the treatment of choice for more severely depressed out patients appears to be unjustified on the basis of available evidence",
"In a double-blind , placebo-controlled study , the therapeutic efficacy of two antidepressants with different neurochemical mechanisms of action , amitriptyline and amineptine , was investigated in patients affected by anxious depression . Sixty-six patients with the primary diagnosis of major depression or bipolar affective disorder ( DSM-III-R ) and meeting additional operational clinical criteria such as anxiety , trepidation , restlessness , early and /or late insomnia , impulsivity , hostility , dysphoria , compulsivity , hyperperspiration , palpitation , pollakiuria and phobias were included . They were r and omly assigned to three groups ( n = 22 ) and treated either with placebo , amitriptyline ( up to 100 mg/day ) or amineptine ( up to 200 mg/day ) for 6 weeks . Patients showed better response to amitriptyline , a preferential inhibitor of serotonin reuptake , than to amineptine , a selective inhibitor of dopamine reuptake . The present results suggest that alterations in serotonergic rather than dopaminergic transmission contribute to the pathophysiology of anxious depression",
"We report on the results of a study comparing mianserin with amitriptyline and placebo , in out patients with major depression ( DSM-III 296.2 or 296.3 ) . One hundred and forty-nine patients were r and omized to mianserin ( n = 50 ) , amitriptyline ( n = 50 ) or placebo ( n = 49 ) . Medication was taken in a nightly ( qhs ) dose . During Week 1 , the maximum dose was 60 mg mianserin , 120 mg amitriptyline or two placebo capsules . Beginning at Day 7 ( through Day 42 ) maximum dosages were 150 mg mianserin , 300 mg amitriptyline or five placebo capsules . At multiple weeks and endpoint , statistically significant reductions in the Hamilton Depression Scale ( HAM-D ) 17− and 21-item scores were recorded for both active drugs compared with placebo . Positive results with the HAM-D were corroborated by other measures of efficacy . There were no statistically significant differences between mianserin and amitriptyline in terms of efficacy ; however , the results do suggest a more rapid therapeutic response for mianserin compared with amitriptyline , in terms of percentage of patients showing ≥ 50 % improvement at Weeks 2 ( 30 % vs 23 % ) and 4 ( 61 % vs 44 % ) . The most common adverse experiences were somnolence ( amitriptyline and mianserin 60 % , placebo 31 % ) and dry mouth ( amitriptyline 76 % , mianserin 30 % and placebo 20 % ) . Our results indicate that mianserin is clearly superior to placebo , compares favorably with amitriptyline , and is a safe , well-tolerated , effective medication in the treatment of depressed out patients",
"Depressions in general practice tend to be mild and non-endogenous . The value of antidepressants and indications for their use in such depressions are not well documented . One hundred and forty one general practice depressives were treated from four to six weeks with amitriptyline in median dose 125 mgs daily or placebo in a r and omised controlled trial . Significant drug placebo differences were apparent by two weeks and were strong by six weeks . Detailed examination of symptom ratings showed that the effect was a true antidepressant one , on core symptoms of depression . Interactions were examined between drug-placebo differences and a range of predictor characteristics . There were no significant interactions for demographic characteristics , history of illness or endogenous depression in terms of symptom pattern , absence of life stress or non-neurotic personality . Drug was superior to placebo in all subgroups . Only for initial severity of illness were significant interactions found . Amitriptyline was superior to placebo in probable and definite major depressions on the Research Diagnostic Criteria but not in minor depressions . It was also superior to placebo in patients with initial Hamilton Scale scores of more than 12 , but not 6 - 12 . Overall these findings indicate that tricyclic antidepressant is of clear therapeutic benefit in a spectrum of milder depressions except for the most mild of these",
"Treatment efficacy is typically evaluated by examining group means and pre-post change scores . Although informative , such analyses may obscure individual or subgroup differences in response ( outcome profiles ) . The present study used two different methods to define treatment outcome profiles -- rationally-derived criteria ( Frank et al. , Archives of General Psychiatry 48 , 851 - 855 , 1991 ) and dynamic clustering -- to evaluate four treatments of unipolar depression : behaviour therapy , amitriptyline , psychodynamic psychotherapy and relaxation training ( attention placebo ) . The profiling methods yielded similar results . Regardless of treatment , the majority of patients displayed either a recovery or nonremission outcome profile , with relatively few instances of remission followed by a recurrence of depression . These findings challenge the view that any of the treatments are associated with a strong tendency to relapse , at least over the 3-month follow-up period . To further characterize the major outcome profiles , discriminant analysis was performed . Results indicated that recovery and nonremission profiles differed in that the latter was associated with a longer and more severe index episode and greater neuroticism . A number of variables , including family history of depression and therapists ' prediction of outcome , failed to distinguish recovered from unremitted patients",
"BACKGROUND A r and omized controlled clinical trial compared three treatments for major depression in primary care . Ninety-one patients were r and omized to receive either problem-solving , or amitriptyline with st and ard clinical management , or drug placebo with st and ard clinical management . This paper examines the possible predictive value of a range of demographic clinical and personality variables in determining outcome . METHODS To examine the interaction between treatment group and predictor variables , analyses of co-variants were carried out for two outcome measures : the Hamilton Rating Scale for Depression and the Beck Depression Inventory . Predictor variables were also entered into a stepwise forward logistic regression in which patients were categorized as recovered or not recovered . RESULTS None of the predictor variables examined interacted with treatment to predict outcome . Patients with a longer duration of illness , chronic social difficulties , or definite , as opposed to probable , major depression had a poorer outcome at the end of treatment , irrespective of treatment group . CONCLUSIONS The findings in this study do not enable clear guidelines to be given as to which patients with major depression in primary care might benefit from either a psychological or pharmacological treatment",
"Demographic and auxological data were analysed from 818 girls with Turner 's syndrome treated with recombinant human growth hormone ( GH ) and entered into the Kabi Pharmacia International Growth Study . Size at birth was low and correlated with the heights of both parents . The median age at start of GH treatment was 11.4 years and the parents had a median height SDS of ‐2.9 . Height SDS at the start of treatment correlated with parental heights . Height velocities conformed to Turner‐specific st and ards . The weight‐for‐height index increased sharply above 9 years of age . The frequency of spontaneous appearance of Tanner breast stage 2 was high ( 34.1 % of girls > 10 years of age ) . Bone age ( Greulich and Pyle ) data were described by the equation : bone age = 1.61 ( chronological age ) ‐0.04(chronological age)2 ‐ 3.61 . This equation was used to correct adult height predictions . The median initial dose of GH was 0.8 IUkglweek and was maintained during the first 3 years of treatment . The median frequency of injections was six/week . Height velocity increased from 4.1 to 6.8 cm/year in the first year , and height velocity SDS for chronological age remained positive for 4 years . The height prediction corrected for bone age increased over the first 2 years only . Differences in demography and auxology were described according to karyotype and country of origin . A greater height velocity SDS was observed at higher GH doses and when ox and rolone was used concomitantly",
"The authors conducted a double-blind , placebo-controlled clinical trial of the selective 5-HT reuptake inhibitor zimelidine in the treatment of major depressive illness . Zimelidine had the same antidepressant efficacy as amitriptyline but significantly fewer side effects , especially anticholinergic effects",
"Weight data taken from a 6-week r and omized double-blind study comparing amitriptyline , trazodone and placebo were analyzed to determine differential weight changes between the two drugs . In 272 depressed out patients doses were increased over a period of 4 days to reach a maximum level of 200 mg amitriptyline or 400 mg trazodone . After grouping the subjects according to initial weights ( ideal , overweight , 20 % above , and underweight , 20 % below ) mean changes were determined for each treatment . The results indicate that amitriptyline , which differed from placebo and trazodone , produced significantly higher weight gains in the ideal and overweight groups . Trazodone on the other h and produced a slight weight loss in the overweight group . Due to a low number of patients in the underweight group , the results were not significantly statistically . The antidepressant effects of both trazodone and amitriptyline were the same and no correlations between Hamilton scores and weight change were found",
"No longer prescribed only for vegetative signs of depression , tricyclic antidepressants also lessen depressive cognitive distortions . Less clear is whether they ameliorate depressed patients ' other cognitive deficits in memory , information processing speed , and psychomotor performance . We tested the alternative hypothesis that amitriptyline , because of its anticholinergic and sedative properties , would exacerbate depressed patients ' cognitive disturbances . Depressed out patients received double-blind placebo ( n=15 ) , amitriptyline ( n=10 ) , or clovoxamine fumarate ( n=10 ) , a serotonin reuptake inhibitor relatively lacking in anticholinergic properties . Depression , memory , and psychomotor performance were assessed at baseline and after 7 and 28 days of drug treatment . Depression was alleviated after all treatments , including placebo . Only amitriptyline impaired performance on tests of memory , producing a significant decrement , relative to placebo , after 4 weeks of treatment . None of the treatments adversely affected performance on psychomotor tasks . These findings add to the evidence that antidepressant drugs with high anticholinergic activity can impair memory , despite alleviation of depression",
"BACKGROUND This study was design ed to compare the efficacy , safety , tolerability profiles , and effects on quality of life of the serotonin selective reuptake inhibitor antidepressant sertraline versus the nonselective tricyclic antidepressant amitriptyline and placebo in patients with major depression . METHOD Out patients with DSM-III-R major depression were r and omly assigned to double-blind treatment for 8 weeks with sertraline ( 50 - 200 mg daily ) , amitriptyline ( 50 - 150 mg daily ) , or matching placebo . Assessment s included the Hamilton Rating Scale for Depression , Montgomery-Asberg Depression Rating Scale , Clinical Global Impressions-Severity of Illness scale , Clinical Global Impressions-Improvement scale , Global Assessment Scale , Profile of Mood States , Beck Depression Inventory , Quality of Life Enjoyment and Satisfaction Question naire , and Health-Related Quality of Life battery . RESULTS All treatment groups demonstrated statistically significant improvement from baseline in depression ratings by Week 1 and thereafter . The antidepressant effects of amitriptyline and sertraline were significantly ( p placebo and did not differ significantly from each other . Sertraline was associated with significantly ( p subjective ( i.e. , patient-rated ) improvement in mood than amitriptyline or placebo . Both active drugs were associated with greater improvements than placebo on most quality of life measurements . On several items , sertraline , but not amitriptyline , was superior to placebo . There was a discernible effect of sertraline earlier than amitriptyline on most quality of life scales . Amitriptyline therapy was associated with significantly more treatment-related adverse events , and discontinuations due to treatment-related adverse events , in comparison to both sertraline and placebo therapy . CONCLUSION Sertraline and amitriptyline each were effective treatments for major depression as assessed by both physician- and patient-rated scales . These results show that sertraline therapy is better tolerated than amitriptyline therapy . Quality of life was also improved by effective antidepressant treatment , with sertraline showing a tendency to produce greater improvements on quality of life measures",
"In a double-blind , r and om-assignment , parallel-group trial , out patients with major depression received either the new antidepressant clovoxamine , the tricyclic amitriptyline , or placebo for 6 weeks . By an \" improvement \" criterion of 50 % or greater improvement in the Hamilton Depression Scale ( HAM-D ) total score , 88 % of clovoxamine completers improved versus 75 % with amitriptyline and 43 % with placebo ; however , due to small numbers , the differences failed to reach statistical significance . Diminished salivary flow was significantly greater with amitriptyline , as were complaints of dry mouth , somnolence , dizziness , and headache . Nausea and vomiting were more common in the clovoxamine-treated group . With amitriptyline , but not with clovoxamine , memory performance declined over a month . However , psychomotor performance was not affected",
"The authors contrasted four treatments for unipolar ( nonpsychotic ) depression : 1 ) amitriptyline , 2 ) social skills training plus amitriptyline , 3 ) social skills training plus placebo , and 4 ) psychotherapy plus placebo . They studied 72 female out patients , 52 of whom completed the 12 weeks of treatment . The four treatments , conducted by experienced clinicians , were not substantially different from one another . Each treatment produced significant and clinical ly meaningful changes in symptomatology and social functioning . However , the authors identified several notable differences across groups : a significant difference in dropout rates ( from a high of 55.6 % for the amitriptyline group to a low of 15 % for the social skills plus placebo group ) and a significant difference in the proportion of patients who were substantially improved . The social skills plus placebo treatment was the most effective treatment on this dimension",
"A study of 203 depressed out patients who were r and omly assigned to one of seven active drug treatment groups or to a placebo group demonstrated that the inclusion of a placebo group is essential for valid assessment of the efficacy of antidepressant drugs . Although all groups improved on depression ratings in relation to their own baselines , only one group achieved a level of improvement that was significantly better than that of the placebo group",
"Abstract 3-Cyano-imipramine ( cianopramine ) is a potent and selective inhibitor of serotonin uptake into synaptosomes . In a double-blind trial , 60 patients with various types of depression fulfilling the DSM-III criteria of depressive episodes were treated with either cianopramine ( n=20 , mean daily dose 3.3±0.6 mg ) amitriptyline ( n=20 , mean daily dose 86.4±21 mg ) or placebo ( n=20 ) orally . According to the ratings of the Hamilton Scale of Dpression and clinical global evaluations , both active drugs showed statistical superiority over placebo ( P . The frequencies of anticholinergic side effects in the cianopramine group were comparable to those of the placebo group and were less than in the amitriptyline group . The findings suggest that cianopramine is a promising new antidepressant",
" Electrocardiograms of 65 patients treated with dothiepin , a sulphur substituted tricyclic antidepressant , were compared to those of 57 patients receiving amitriptyline and 62 patients given placebo . Amitriptyline produced an average heart rate increase of 10 beats/minute as compared to 5 beats/minute for dothiepin ( p less than .02 ) . Amitriptyline also produced a significant prolongation of the corrected QT interval as compared to both dothiepin and placebo ( p less than .01 and p less than .001 , respectively ) . Dothiepin had no significant effect on any index of myocardial conduction ( PR interval , corrected QT interval , and QRS duration ) as compared to placebo",
"Fifty out- patients took part in a double-blind controlled comparison of two antidepressants dothiepin and amitriptyline . The subjects ' psychiatric state was assessed by both self-rating and clinician-rated scales . Patients were followed up for a period of about three months . The results of the trial showed that dothiepin was superior to amitriptyline at the 5 % significance level in terms of its antidepressant activity . Dothiepin was better tolerated in relation to its side effects than amitriptyline . For relief of anxiety symptoms both drugs appeared equally effective",
"In a prospect i ve , controlled , double-blind study , 37 patients with major depressive disorder were subclassified into primary depression ( N = 25 ) and secondary ( N = 12 ) depression and treated with either amitriptyline ( primary depressives N = 13 , secondary depressives N = 6 ) or bupropion ( primary depressives N = 12 , secondary depressives N = 6 ) . A differential response to the novel antidepressant bupropion was observed between the two diagnostic subgroups , but no differential response to amitriptyline was observed ; patients with primary depression and secondary depression responded equally well to amitriptyline but not to bupropion . Our results provide pharmacological evidence supporting the usefulness of this subclassification of depression",
"The purpose of this study was to compare the effects of amitriptyline and ECT in the treatment of depression . Thirty patients were assigned r and omly to 4 treatment groups : amitriptyline , ECT , placebo and simulated ECT . Global improvement ratings , the Depression Rating Scale , the Ward Observation Inventory , the M.M.P.I. , the Wechsler-Bellevue Intelligence Scale and the Bender-Gestalt test were used in evaluating the response to treatment . Amitriptyline and ECT were both more effective than control procedures . There was no appreciable difference after one month of treatment between the therapeutic effects of amitriptyline and ECT",
" Five hundred four out patients suffering from a major depressive episode were r and omly assigned to receive either amitriptyline , doxepin , alprazolam , or placebo . The study was conducted in three treatment centers during a six-week period . All three active medications produced significantly more clinical improvement than did placebo , irrespective of the patient 's initial anxiety , depression , and psychomotor retardation and irrespective of the patient 's assignment to various subtypes of depression , including the DSM-III melancholia subtype . Compared with placebo , sedation was reported more frequently with all three medications , whereas anticholinergic effects were reported more frequently only for the two tricyclic antidepressants , but not for alprazolam",
"Discriminant function analyses were applied to data obtained from anxious psychiatric out patients treated with either chlordiazepoxide ( n = 353 ) or placebo ( n = 259 ) and depressed out patients treated with either amitriptyline ( n = 310 ) or placebo ( n = 328 ) , who had participated in controlled drug trials of 4 weeks ’ duration , in an attempt to identify factors associated with complaints of drowsiness made by these patients . Although the magnitude of the relationships between individual predictors and drowsiness was small , several factors emerged which had consistent impact across treatment groups . Predictors of complaints of drowsiness attributed to active drugs arose primarily from demographic attributes probably reflective of life style , and from illness and treatment history . In contrast , predictors of drowsiness attributed to placebo were almost exclusively confined to indices of the severity of several aspects of presenting symptomatology . In particular , more frequent complaints of drug‐induced drowsiness were found among better educated individuals with an illness of long duration . Complaints of placebeinduced drowsiness were more common among patients with more severe emotional ( phobic‐obsessive ) symptomatology and more frequent headaches and among those individuals in whom hypochondriasis was less severe",
"Out patients with depression and mixed anxiety-depression were treated for six weeks with phenelzine sulfate , amitriptyline hydrochloride , or placebo in a controlled trial . Both active drugs were superior to placebo and were closely comparable in efficacy . Interactions were examined between drug response and classifications based on three different usages of the term atypical depression : additional anxiety or phobic symptoms , atypical functional shift , and nonendogenous depression . Some additional related classifications were also included . There was a tendency for phenelzine to have stronger effects in patients with additional anxiety and without evidence of chronic characterological depression . However , interactions were relatively few . These findings suggest that the two classes of antidepressant affect similar clinical subgroups within the outpatient depressive spectrum , with only relatively weak differences",
"Data regarding open-label treatment with fluoxetine following failure to respond to tricyclic antidepressants ( TCAs ) or intolerance of TCA side effects , suggest a response rate between 51.4 % and 62.1 % , depending on the definition of TCA refractoriness employed . Double-blind study of this issue would extend these findings . Fluoxetine is well tolerated in patients unable to tolerate TCAs . Within this population , more than 80 % of patients unable to tolerate TCAs found fluoxetine acceptable . Fluoxetine , as an alternative to polypharmaceutical augmentation , may represent a logical choice as the next step in therapy for a patient who has initially been treated with a TCA and has proven refractory or intolerant",
"A double-blind , placebo- and amitriptyline-controlled comparison study was performed to evaluate the antidepressant efficacy of sertraline , a specific serotonin uptake inhibitor . Patients with DSM-III-defined major depression r and omly received either sertraline ( N = 149 ) , amitriptyline ( N = 149 ) , or placebo ( N = 150 ) once daily for the 8-week study period . The mean final daily medication dose for the all- patients group was 145 mg and 104 mg for the sertraline- and amitriptyline-treatment groups , respectively . As measured by the Hamilton Rating Scale for Depression and the Clinical Global Impressions Scale , both the sertraline and amitriptyline treatment groups showed a significantly greater improvement from baseline ( p less than or equal to .001 ) than the placebo group . The sertraline group had a higher proportion of gastrointestinal complaints and male sexual dysfunction than either the amitriptyline or the placebo group . The amitriptyline group showed a higher proportion of anticholinergic and sedative side effects and dizziness compared with patients who received either sertraline or placebo",
"Thirty-nine unipolar depressed patients were treated , after a washout period of seven days in a double blind study with either moclobemide , placebo or amitriptyline , for 42 days . The psychopathological assessment and HRSD were done on seven day intervals and thyroid analysis was done on 14 day intervals . At the end of therapy , the levels of T4 and fT4 decreased significantly in the responders if amitriptyline was used , and non-significantly if placebo or moclobemide were used . The T4 and fT4 values of the non-responders increased non-significantly . The weight change was minimal and non-significant",
"& NA ; Changes in appetite and weight were examined in a group of 47 carefully diagnosed primary depressives who were treated in a r and om design with either placebo ( N = 17 ) or amitryptyline ( N = 30 ) over a 35‐day protocol . While the amitriptyline treated group as a whole showed a greater gain in weight than did the placebo group ( 4.5 vs. 0.5 lb , p the self‐report of decreased appetite and final weight change was noted in the placebo group , no simple relationship between final weight change and self‐reported changes in appetite were apparent in the drug‐treated patients . There was , however , a relationship between the report of decreased appetite and clinical severity of depression in the drug nonresponder subgroup despite significant weight gain during the protocol . Thus , weight change during this study period did not appear to show a simple relationship to corresponding clinical change . The clinical lore that has supported the notion that increased appetite and weight gain in patients being treated with tricyclic antidepressants are “ good ” signs can not be confirmed by our findings",
"Eighty-six depressed in patients were divided into four groups : patients in each of three groups were treated , respectively , with identical capsules of verapamil , amitriptyline , or placebo , whereas the fourth group was treated eclectically by the ward physician with so-called state-adjusted treatment ( SAT ) . Each treatment period lasted 5 weeks . Psychopathology was assessed with the Hamilton Rating Scale for Depression , by the Zung self-rating scale , by the 100-mm analog scale , and by general clinical impression . Results indicated that amitriptyline and SAT were superior to verapamil or placebo . There was no significant difference between verapamil and placebo or between SAT and amitriptyline . This finding was more definitive in the homogeneous subgroup of 55 women with DSM-III diagnosis of Major depression . In addition , 12 manic in patients ( DSM-III ) were treated orally with verapamil , 24 with neuroleptics , and 11 with both neuroleptics and lithium carbonate . The decline of their psychopathology , assessed by the Brief Psychiatric Rating Scale ( BPRS ) and general impression , was fully comparable . Using Analysis of Variance ( ANOVA ) , the statistical difference among courses of psychopathology expressed as total BPRS scores reaches borderline significance in favor of verapamil . In contrast to neuroleptics , verapamil did not induce any sedative , hypnotic , or cataleptic effects , and was well tolerated ",
"Comparative effects of the antidepressant drug , amitriptyline hydrochloride , marital therapy , and the drug-psychotherapy interaction effects were studied in a 12-week course of treatment of outpatient depressives . Patients were assigned r and omly to four treatment groups , in a 2 times 2 factorial design : ( 1 ) drug-marital therapy ; ( 2 ) drug-minimal contact ; ( 3 ) placebo-marital therapy ; and ( 4 ) placebo-minimal contact . Both drug and marital therapy showed substantial beneficial advantages over their control conditions , but drug therapy was faster and generally superior in symptom relief and clinical improvement . Marital therapy was superior in family role task performance and perception of the marital relationship . For reducing hostility and enhancing the perception of the marital relationship , drug therapy had a better early effect , but marital therapy had superior effects by the end of treatment",
"General practice depressives were treated for 6 weeks with amitriptyline or placebo in a controlled trial . Overall , drug was found strongly superior to placebo . Interactions were examined between drug effects and a number of variables , principally reflecting demographic characteristics , history of illness , severity of illness , and endogenous depression separately in symptoms and stress . Only in the area of severity were significant interactions found . Amitriptyline was superior to placebo in probable or definite major depression on the Research Diagnostic Criteria , but not in minor depression . It was also superior to placebo in subjects with initial scores on the Hamilton Depression Scale of 13 - 15 , and 16 or more , but not with lower scores . Findings indicate that tricyclic antidepressants are of considerable benefit in relatively mild depressions , except in the mildest range",
"Patients ( n = 150 ) were r and omized to a 6-week , double-blind study to evaluate the relative efficacy and safety of mirtazapine , amitriptyline , and placebo in the treatment of major depressive disorder symptoms . Average daily modal doses were mirtazapine , 18 mg ; amitriptyline , 111 mg ; and placebo , 4.6 capsules . Mirtazapine- and amitriptyline-treated patients had statistically significantly greater mean Hamilton Rating Scale for Depression ( HAM-D ) score reductions ( weekly visits 1 , 2 , 4 , and endpoint ) compared to placebo . These findings were supported by the Montgomery-Asberg Depression Rating Scale ( MADRS ) ; the Zung Self-rating Depression Scale ( SDS ) ; and the Clinical Global Impressions ( CGI ) scales . Somnolence and weight gain were the only adverse clinical experiences ( ACEs ) reported substantially more often by mirtazapine-treated patients than by those in the placebo group . However , more amitriptyline-treated patients reported decreased visual accommodation , dry mouth , dyspepsia , constipation , tachycardia , hypertension , hypotension , discoordination , dizziness , and tremor than mirtazapine- or placebo-treated patients . Results of this study indicate that mirtazapine is more effective than placebo in the treatment of these patients , and superior to amitriptyline in respect to anticholinergic and cardiovascular effects",
"Changes in alpha-2 adrenoreceptor density and affinity during antidepressant treatment were studied using 3H-yohimbine binding to human platelet membranes . Baseline measurements were conducted in 21 patients diagnosed as having major depressive disorder with melancholia , and an equal number of age and sex matched normal controls . No differences were observed in receptor density or binding between pre-treatment subject groups and normal matched controls . Subjects participated for 6 weeks in a trial of placebo , adinazolam , or amitriptyline . Alpha-2 adrenoreceptor binding was not significantly changed from baseline following antidepressant treatment ",
"Summary The study compares the therapeutic effects of a sustained release form of amitriptyline ( ‘ Lentizol ’ ) with st and ard amitriptyline in depressed patients using a higher dosage than previously reported . Clinical results were correlated on the Hamilton scale and the Wakefield self- assessment inventory . Similar therapeutic effect was found from the sustained release formulation at two-thirds the dosage of the st and ard amitriptyline . Side-effects were not significantly different in the two groups ; except the sustained release version produced less dryness of the mouth but increased incidence of mild difficulties in micturition",
"To investigate the effectiveness of a new benzodiazepine , alprazolam , and to compare this with amitriptyline ( AMT ) and with placebo , a trial was undertaken in 65 patients in whom depression was considered to be the dominating feature but not considered to be the primary cause of their condition ; it was design ed to exclude endogenous depressions . A consistent pattern was found favouring alprazolam over AMT both in rate of response and in total response , as well as significant differences in favour of both alprazolam and AMT over placebo . A comparison of side effects showed a definite trend in favour of alprazolam and placebo over AMT",
"Depressed patients in general practice were included in a double-blind placebo-controlled six-week trial of amitriptyline ( median dose 125 mg ) . The patients were relatively mildly ill and satisfied diagnostic criteria for depression and treatment with antidepressants in routine practice . Amitriptyline was found to be considerably superior to placebo after six weeks and significantly so as early as two weeks after the start of treatment . The effects of the antidepressant were on the core symptoms of depression , and were apparent in all but the most mildly ill patients . The findings suggest that tricyclic antidepressants are of considerable therapeutic benefit to depressed patients in general practice",
"The authors reanalyzed data from two earlier studies that used double-blind placebo-controlled formats to study the efficacy of amitriptyline . Using a 14-day drug-free ' wash-out ' period , they found that the placebo response rates were 0 % for psychotic depressives and 13.3 % for nonpsychotic depressives . Amitriptyline was significantly superior to placebo for both psychotic ( P less than or equal to 0.05 ) and nonpsychotic ( P less than or equal to 0.05 ) depressed patients",
"The perceived intensity of a stimulus may be magnified during depression . Stimulus intensity control can be studied by means of cortical evoked potentials . In a study of 33 depressives , cortical evoked potentials were greater during depression than on recovery . The effect of doxepin on the amplitudes of evoked potentials of depressives was compared with that of amitriptyline . Doxepin reduced amplitudes . Amitriptyline had a similar , but non-significant effect ",
"In a 7-week prospect i ve multicentre study , the efficacy , tolerability and safety of moclobemide were compared to those of amitriptyline and placebo in parallel groups of out- patients ( n=173 ) fulfilling the DSM III-R criteria for a major depressive episode . Participants were required to have a minimum baseline total score of 18 on the 17-item Hamilton Depression Rating Scale ( HAMD ) . After a 1-week placebo washout , patients were r and omly allocated to the three treatment groups . Assessment of efficacy , as judged by the number of responders achieving a 50 % reduction in HAMD score by the end of treatment , showed that both moclobemide and amitriptyline were significantly superior to placebo , but that they were not significantly different from each other . Both treatments differed significantly from placebo with respect to the Physician 's Global Assessment of Efficacy ( ‘ very good ’ or ‘ good ’ response : moclobemide 57 % , amitriptyline 60 % and placebo 35 % ) . Assessment of tolerance as judged by the spontaneous reporting of adverse events showed a significant superiority of moclobemide over amitriptyline , but there was no significant difference between moclobemide and placebo . At termination of the study , amitriptyline patients showed a significant elevation of heart rate both supine ( 10.8 beats/min ) and st and ing ( 15.5 beats/min ) , as well as significant weight gain ( 1.7 kg ) , but no changes were seen in the moclobemide or placebo groups . In conclusion , both moclobemide and amitriptyline were found to be more effective than placebo in the treatment of depression , while moclobemide had fewer side effects"
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Flaxseed consumption may be inversely associated with obesity ; however , findings of available r and omized controlled trials ( RCTs ) are conflicting . The present study aim ed to systematic ally review and analyse RCTs assessing the effects of flaxseed consumption on body weight and body composition . PubMed , Medline via Ovid , SCOPUS , EMBASE and ISI Web of Sciences data bases were search ed up to November 2016 . Mean changes in body composition indices including body weight , body mass index ( BMI ) and waist circumference were extracted . Effect sizes were expressed as weighted mean difference ( WMD ) and 95 % confidence intervals ( CI ) . Heterogeneity between studies was assessed with the I2 test . Publication bias and subgroup analyses were also performed . The quality of articles was assessed via the Jadad scale . A total of 45 RCTs were included . Meta-analyses suggested a significant reduction in body weight ( WMD : -0.99 kg , 95 % CI : -1.67 , -0.31 , p = 0.004 ) , BMI ( WMD : -0.30 kg m-2 , 95 % CI : -0.53 , -0.08 , p = 0.008 ) and waist circumference ( WMD : -0.80 cm , 95 % CI : -1.40 , -0.20 , p = 0.008 ) following flaxseed supplementation . Subgroup analyses showed that using whole flaxseed in doses ≥30 g d-1 , longer-term interventions ( ≥12 weeks ) and studies including participants with higher BMI ( ≥ 27 kg m-2 ) had positive effects on body composition . Whole flaxseed is a good choice for weight management particularly for weight reduction in overweight and obese participants
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"The effect of partial dietary replacement of linoleic acid ( 18:2n-6 ; linoleic acid-rich diet ) with alpha-linolenic acid ( 18:3n-3 ; alpha-linolenic acid-rich diet ) on plasma lipids was investigated in twenty-nine healthy young men . After a 2-week stabilization period subjects were r and omly assigned to either the alpha-linolenic acid-rich diet group ( n 15 ) , receiving a mean of 10.1 g of alpha-linolenic acid and 12.1 g of linoleic acid/d , or the linoleic acid-rich diet group ( n 14 ) , receiving a mean of 1.0 g of alpha-linolenic acid and 21.0 g of linoleic acid/d , for a 6-week test period . Blood sample s were taken at the commencement of the stabilization period and at the start ( week 0 ) , midpoint ( week 3 ) and endpoint ( week 6 ) of the test period and plasma lipids analysed . The changes occurring on the linoleic acid-rich diet and alpha-linolenic acid-rich diet were compared but no significant differences in the changes in plasma total cholesterol , LDL-cholesterol , HDL-cholesterol , the subfractions HDL2 and HDL3 or triacylglycerols were found . These results indicate that dietary replacement of linoleic acid with alpha-linolenic acid in the diet of healthy male subjects offers similar cardioprotective benefits with respect to lipid metabolism",
"The study hypothesis was that fasting glucose , insulin , fructosamine , C-reactive protein , and interleukin-6 decrease and adiponectin increases with daily flaxseed consumption in overweight or obese individuals with pre-diabetes . In this r and omized , cross-over study overweight or obese men and postmenopausal women ( n = 25 ) with pre-diabetes consumed 0 , 13 , or 26 g ground flaxseed for 12 weeks . Glucose , insulin , homeostatic model assessment ( HOMA-IR ) , and normalized percent of α-linolenic fatty acid ( ALA ) were significantly different by treatment ( multiple analysis of variance , P = .036 , P = .013 , P = .008 , P = .024 respectively ) . Paired t tests showed glucose decreased on the 13 g intervention compared to the 0 g period [ 13 g = -2.10 ± 1.66 mg/L ( mean ± SEM ) , 0 g = 9.22 ± 4.44 mg/L , P = .036 ] . Insulin decreased on the 13 g intervention but not the 26 g ( P = .021 ) and 0 g ( P = .013 ) periods ( 13 g = -2.12 ± 1.00 mU/L , 26 g = 0.67 ± 0.84 mU/L , 0 g = 1.20 ± 1.16 mU/L ) . HOMA-IR decreased on the 13 g period but not on the 26 g ( P = .012 ) and 0 g ( P = .008 ) periods ( 13 g = -0.71 ± 0.31 , 26 g = 0.27 ± 0.24 , 0 g = 0.51 ± 0.35 ) . The α-linolenic fatty acid decrease for the 0 g period was different than the 13 g ( P = .024 ) and 26 g ( P = .000 ) periods ( 13 g = 0.20 ± 0.04 , 26 g = 0.35 ± 0.07 , 0 g = -0.01 ± 0.07 ) . Fructosamine , high sensitivity C-reactive protein , adiponectin , and high-sensitivity interleukin-6 had no significant differences . Flaxseed intake decreased glucose and insulin and improved insulin sensitivity as part of a habitual diet in overweight or obese individuals with pre-diabetes",
"Background Flaxseed has received attention for its anti-inflammatory and antioxidant role . The present study hypothesizes if flaxseed added to a weight loss diet could improve the lipid and metabolic profiles and decrease risk factors related to cardiovascular disease . Methods In a prospect i ve , single blinded 42 days protocol , subjects were allocated into two groups with low carbohydrates intake : GriceLC ( 35 % of carbohydrate and 60 g of raw rice powder per day ) and GflaxLC ( 32 % of carbohydrate and 60 g of flaxseed powder per day ) . Blood pressure , anthropometric measures and serum levels of isoprostane , C-reactive protein , Tumor Necrosis Factor-alpha , glucose , lipidic profile , uric acid , adiponectin , leptin and insulin were measured at baseline and at the end of interventions . Serum and urinary enterodiol and enterolactione were also measured . Results A total of 27 men with cardiovascular risk factors were evaluated , with mean age of 33 ± 10 years to GriceLC and 40 ± 9 years to GflaxLC . Both groups experienced weight loss and systolic blood pressure reduction . A decrease in inflammatory markers ( CRP and TNF-α ) was observed after flaxseed intake ( mean decrease of 25 % and 46 % for GflaxLC respectively ) . All groups also showed improvement in levels of total cholesterol , LDL-c , uric acid and adiponectin . Only GflaxLC group showed a decrease in triglyceride levels . Conclusion This study suggests that flaxseed added to a weight loss diet could be an important nutritional strategy to reduce inflammation markers such as CRP and TNF-α . Trial registration Clinical Trials.gov NCT02132728",
"Abstract Purpose The aim of the study was to investigate the influence of foods enriched with vegetable oils varying in their n-3 polyunsaturated fatty acids profile on cardiovascular risk factors for hypertriglyceridemic subjects . Methods Fifty-nine hypertriglyceridemic subjects ( triglycerides ≥ 1.5 mmol/L ) were included in the r and omized , double-blind , placebo-controlled , crossover study . The placebo group received sunflower oil [ linoleic acid ( LA ) group ; 10 g LA/day ] . The intervention groups received linseed oil [ α-linolenic acid ( ALA ) group ; 7 g ALA/day ] , echium oil [ stearidonic acid ( SDA ) group ; 2 g SDA/day ] or microalgae oil [ docosahexaenoic acid ( DHA ) group ; 2 g DHA/day ] over 10 weeks . Blood sample s were collected at baseline and at the end of each period . Results Total cholesterol ( TC ) and low-density-lipoprotein cholesterol decreased significantly in the LA and ALA groups ( LA : P ≤ 0.01 , ALA : P ≤ 0.05 ) . No changes in blood lipids were observed in the SDA group . Significant increases in TC and high-density-lipoprotein cholesterol occurred in the DHA group ( P ≤ 0.05 ) . In the ALA and SDA groups , the content of eicosapentaenoic acid in erythrocyte lipids increased significantly ( P ≤ 0.05 ) after 10 weeks ( ALA group : 38 ± 37 % , SDA group : 73 ± 59 % ) . Conclusion Foods enriched with different vegetable oils rich in ALA or SDA are able to increase the n-3 long-chain polyunsaturated fatty acids content in erythrocyte lipids ; echium oil is more potent in comparison with linseed oil . Blood lipids were beneficially modified through the consumption of food products enriched with sunflower , linseed and microalgae oils , whereas echium oil did not affect blood lipids . Clinical Trials.gov : NCT01437930",
"Background Dietary fibers have been proposed to play a role in cardiovascular risk as well as body weight management . Flaxseeds are a good source of dietary fibers , and a large proportion of these are water-soluble viscous fibers . Method Here , we examine the effect of flaxseed dietary fibers in different food matrices on blood lipids and fecal excretion of fat and energy in a double-blind r and omized crossover study with 17 subjects . Three different 7-d diets were tested : a low-fiber control diet ( Control ) , a diet with flaxseed fiber drink ( 3/day ) ( Flax drink ) , and a diet with flaxseed fiber bread ( 3/day ) ( Flax bread ) . Total fat and energy excretion was measured in feces , blood sample s were collected before and after each period , and appetite sensation registered 3 times daily before main meals . Results Compared to control , Flax drink lowered fasting total-cholesterol and LDL-cholesterol by 12 and 15 % , respectively , ( p Fecal fat and energy excretion increased by 50 and 23 % with Flax drink consumption compared to control ( p fecal fat excretion was increased with Flax bread compared to control ( p Flax drink and Flax bread result ed in decreased plasma total and LDL-cholesterol and increased fat excretion , but the food matrix and /or processing may be of importance . Viscous flaxseed dietary fibers may be a useful tool for lowering blood cholesterol and potentially play a role in energy balance . Trial Registration Clinical Trials.gov :",
"Background Linseed oil has been investigated as a rich source of n-3 series polyunsaturated fatty acids , which mainly produce a non-atherogenic lipid profile . The objective of this study was to investigate the effect of linseed oil supplementation associated with nutritional guidelines on the lipid profiles of older adults , according to the intake of saturated fatty acids ( SFA ) . Methods We conducted a double-blind , placebo-controlled clinical trial with 110 older adults r and omized in two groups : placebo and linseed oil . The linseed oil group received supplementation with 3 g of linseed oil . Both groups received nutritional guidance and were supplemented for 90 days with monthly blood collection for biochemical analysis . The dietary intake of saturated fat was subdivided into low ( 7 % SFA/day of the total energy value ) . Results Low SFA ( total cholesterol concentrations . However , we observed that the linseed oil group , including older adults who consumed > 7 % SFA/day , had a greater reduction in total cholesterol than the placebo group ( P=0.020 ) . The same was observed for low-density lipoprotein ( LDL ) cholesterol ( P High-density lipoprotein ( HDL ) cholesterol concentrations were increased significantly in only the linseed group , suggesting that the nutritional intervention alone did not improve HDL cholesterol . Conclusion The results suggest that the nutritional intervention was effective , but linseed oil showed notable effects by increasing the HDL cholesterol concentration . In addition , consumption of linseed oil , demonstrating the importance of reducing the consumption of saturated fat",
"The n-6/n-3 fatty acid ( FA ) ratio has increased in the Western-style diet to ~10–15:1 during the last century , which may have contributed to the rise in cardiovascular disease ( CVD ) . Prior studies have evaluated the effects on CVD risk factors of manipulating the levels of n-6 and n-3 FA using food and supplements or investigated the metabolic fate of linoleic acid ( LNA ) and α-linolenic acid ( ALA ) by varying the n-6/n-3 ratios . However , no previous studies have investigated the potential interaction between diet ratios and supplementation with eicosapentaenoic acid ( EPA , 20:5n-3 ) and docosahexaenoic acid ( DHA , 22:6n-3 ) . We used a factorial design approach with adults ( n = 24 ) in a controlled feeding trial to compare the accretion of EPA and DHA into red blood cell membranes ( RBC ) by adding a direct source ( algal oil supplement ) of EPA and DHA in a diet with a 10:1 versus 2:1 ratio of n-6/n-3 FA . Subjects were r and omized into 8-week crossover diet sequences and each subject consumed three of four diets [ 10:1 , 10:1 plus supplement ( 10:1 + S ) , 2:1 and 2:1 + S ] . LNA and ALA intakes were 9.4 and 7.7 % , and 1.0 and 3.0 % during the low and high ALA diets , respectively . Compared to the Western-style 10:1 diet , the 2:1 diet increased EPA by 60 % ( P however , DHA levels increased in both diet ratios only with a direct DHA source . Shifting towards a 2:1 diet is a valid alternative to taking EPA-containing supplements",
"BACKGROUND An increase in plasma n-3 fatty acid content , particularly eicosapentaenoic acid ( 20:5n-3 ; EPA ) and docosahexaenoic acid ( 22:6n-3 ; DHA ) , is observed after consumption of fish oil-enriched supplements . Because alpha-linolenic acid ( 18:3n-3 ; ALA ) is the direct precursor of EPA and DHA , ALA-enriched supplements such as flax may have a similar effect , although this hypothesis has been challenged because of reported low conversion of ALA into DHA . OBJECTIVE To address this question , we design ed a clinical trial in which flax oil , fish-oil , and sunflower oil ( placebo group ) capsules were given to firefighters ( n = 62 ) , a group traditionally exposed to cardiovascular disease risk factors . DESIGN Firefighters were r and omly divided into 6 experimental groups receiving 1.2 , 2.4 , or 3.6 g flax oil/d ; 0.6 or 1.2 g fish oil/d ; or 1 g sunflower oil/d for 12 wk . Blood was drawn every 2 wk , and the total phospholipid fatty acid composition of red blood cells was determined . RESULTS As expected , fish oil produced a rapid increase in erythrocyte DHA and total n-3 fatty acids . The consumption of either 2.4 or 3.6 g flax oil/d ( in capsules ) was sufficient to significantly increase erythrocyte total phospholipid ALA , EPA , and docosapentaenoic acid ( 22:5n-3 ) fatty acid content . There were no differences among groups in plasma inflammatory markers or lipid profile . CONCLUSIONS The consumption of ALA-enriched supplements for 12 wk was sufficient to elevate erythrocyte EPA and docosapentaenoic acid content , which shows the effectiveness of ALA conversion and accretion into erythrocytes . The amounts of ALA required to obtain these effects are amounts that are easily achieved in the general population by dietary modification",
"BACKGROUND Currently there is considerable interest in the potential health benefits of oil seeds , such as soy and flaxseed , especially in relation to cardiovascular disease and cancer . OBJECTIVE We therefore evaluated health aspects of partially defatted flaxseed in relation to serum lipids , indicators of oxidative stress , and ex vivo sex hormone activities . DESIGN Twenty-nine hyperlipidemic subjects ( 22 men and 7 postmenopausal women ) completed two 3-wk treatment periods in a r and omized , crossover trial . Subjects were given muffins that contributed approximately 20 g fiber/d from either flaxseed ( approximately 50 g partially defatted flaxseed/d ) or wheat bran ( control ) while they consumed self-selected National Cholesterol Education Program Step II diets . Both muffins had similar macronutrient profiles . Treatment phases were separated by > or = 2 wk . RESULTS Partially defatted flaxseed reduced total cholesterol ( 4.6+/-1.2 % ; P = 0.001 ) , LDL cholesterol ( 7.6+/-1.8 % ; P serum lipoprotein ratios at week 3 compared with the control . There were no significant effects on serum HDL cholesterol , serum protein carbonyl content , or ex vivo and rogen or progestin activity after either treatment . Unexpectedly , serum protein thiol groups were significantly lower ( 10.8+/-3.6 % ; P = 0.007 ) at week 3 after the flaxseed treatment than after the control , suggesting increased oxidation . CONCLUSIONS These data indicate that partially defatted flaxseed is effective in lowering LDL cholesterol . No effects on lipoprotein ratios , ex vivo serum and rogen or progestin activity , or protein carbonyl content were observed . The significance of increased oxidation of protein thiol groups with flaxseed consumption requires further investigation",
"A lignan complex rich in the plant lignan secoisolariciresinol diglucoside ( SDG ) was isolated from flaxseed . SDG is metabolized by the colonic microflora to the mammalian lignans enterodiol ( END ) and enterolactone ( ENL ) , and was hypothesized to reduce plasma lipid concentrations and improve antioxidant capacity . The aim of this study was to investigate the effects of a lignan complex , providing 500 mg/d of SDG , on serum concentration and urinary excretion of ENL , plasma lipids , serum lipoprotein oxidation resistance , and markers of antioxidant capacity . Healthy postmenopausal women ( n = 22 ) completed a r and omized , double-blind , placebo-controlled , crossover study . Women consumed daily a low-fat muffin , with or without a lignan complex , for 6 wk , separated by a 6-wk washout period . Serum ENL concentration , urinary ENL excretion , plasma concentrations of total cholesterol ( TC ) , LDL cholesterol ( LDL-C ) , HDL cholesterol ( HDL-C ) , triacylglycerol ( TAG ) , serum lipoprotein oxidation lag time , plasma Trolox-equivalent antioxidant capacity ( TEAC ) , and ferric reducing ability of plasma ( FRAP ) were measured at the beginning and end of each intervention period . ENL concentrations in serum ( P ENL urinary excretion ( P Plasma concentrations of TC , LDL-C , HDL-C , TAG , lipoprotein oxidation lag time , TEAC and FRAP were not affected . Daily consumption for 6 wk of a low-fat muffin enriched with a lignan complex significantly increased serum ENL concentrations and urinary ENL excretion in healthy postmenopausal women , but had no effect on plasma lipid concentrations , serum lipoprotein oxidation resistance , or plasma antioxidant capacity",
"Thirty healthy male volunteers were r and omly allocated into two dietary treatment groups . The flaxseed group ( n = 15 ) maintained a diet high in alpha-linolenic acid ( alpha-LA ; 18:3n-3 ) and low in linoleic acid ( LA ; 18:2n-6 ) by using a flaxseed oil and spread that are high in alpha-LA . The control group ( n = 15 ) maintained a diet high in LA and low in alpha-LA , typifying a Western diet . Both groups maintained their diets for 4 wk , followed by another 4-wk period in which they supplemented the diets with fish oil [ 1.62 g eicosapentaenoic acid ( EPA , 20:5n-3 ) daily and 1.08 g docosahexaenoic acid ( DHA , 22:6n-3 ) daily ] in a triglyceride form . The flaxseed oil-containing diet result ed in significant increases in alpha-LA concentrations in the plasma phospholipid , cholesteryl ester , and triglyceride fractions ( eightfold increase ) and neutrophil phospholipids ( 50 % increase ) . EPA concentrations increased by 2.5-fold in the plasma lipid fractions and neutrophil phospholipids . After fish-oil supplementation EPA concentrations increased in parallel in both dietary groups , remaining higher in the flaxseed group for both the plasma lipid fractions and neutrophil phospholipids . The results indicate that alpha-LA-rich vegetable oils can be used in a domestic setting ( in conjunction with a background diet low in LA ) to elevate EPA in tissues to concentrations comparable with those associated with fish-oil supplementation",
"OBJECTIVE The fatty acid profile of dietary fats may contribute to its channelling toward oxidation versus storage , influencing energy and weight balance . Our objective was to compare the effects of diets enriched with high-oleic canola oil ( HOCO ) , alone or blended with flaxseed oil ( FXCO ) , on energy expenditure , substrate utilization , and body composition versus a typical Western diet ( WD ) . MATERIAL S/ METHODS Using a r and omized crossover design , 34 hypercholesterolemic subjects ( n=22 females ) consumed 3 controlled diets for 28 days containing ~49 % energy from carbohydrate , 14 % energy from protein , and 37 % energy from fat , of which 70 % of fat was provided by HOCO rich in oleic acid , FXCO rich in alpha-linolenic acid , or WD rich in saturated fat . Indirect calorimetry measured energy expenditure and substrate oxidation . Body composition was analyzed by dual-energy x-ray absorptiometry . RESULT After 28 days , resting and postpr and ial energy expenditure and substrate oxidation were not different after consumption of the HOCO or FXCO diets compared with a typical Western diet . No significant changes in body composition measures were observed between diets . However , the and roid-to-gynoid ratio tended to increase ( P=.055 ) after the FXCO diet compared with the HOCO diet . CONCLUSIONS The data suggest that substituting a typical Western dietary fatty acid profile with HOCO or FXCO does not significantly modulate energy expenditure , substrate oxidation or body composition in hypercholesterolemic males and females",
"Purpose The aim of this study was to investigate the effects of flaxseed oil consumption on serum systemic and vascular inflammation markers , and oxidative stress in hemodialysis ( HD ) patients . Methods In this r and omized , double-blind , clinical trial , 34 HD patients were r and omly assigned to either the flaxseed oil or the control group . The patients in the flaxseed oil group received 6 g/day flaxseed oil for 8 week , whereas the control group received 6 g/day medium-chain triglycerides ( MCT ) oil . At baseline and the end of week 8 , serum concentrations of high-sensitive C-reactive protein ( hs-CRP ) , soluble intercellular adhesion molecule type 1 ( sICAM-1 ) , soluble vascular cell adhesion molecule type 1 ( sVCAM-1 ) , sE-selectin , and malondialdehyde ( MDA ) were measured after a 12- to 14-h fast . Results Serum hs-CRP , a systemic inflammation marker , and sVCAM-1 , a vascular inflammation marker , reduced significantly in the flaxseed oil group at the end of week 8 compared to baseline ( P MCT oil group ( P changes in serum sICAM-1 , sE-selectin , and MDA . Conclusion This study indicates that daily consumption of 6 g flaxseed oil reduces serum hs-CRP and sVCAM-1 , which are two risk factors for CVD . Therefore , the inclusion of flaxseed oil in the usual diet of HD patients can be considered as a strategy for reducing CVD risk factors",
"Background : Prostate cancer affects one of six men during their lifetime . Dietary factors are postulated to influence the development and progression of prostate cancer . Low-fat diets and flaxseed supplementation may offer potentially protective strategies . Methods : We undertook a multisite , r and omized controlled trial to test the effects of low-fat and /or flaxseed-supplemented diets on the biology of the prostate and other biomarkers . Prostate cancer patients ( n = 161 ) scheduled at least 21 days before prostatectomy were r and omly assigned to one of the following arms : ( a ) control ( usual diet ) , ( b ) flaxseed-supplemented diet ( 30 g/d ) , ( c ) low-fat diet ( Blood was drawn at baseline and before surgery and analyzed for prostate-specific antigen , sex hormone-binding globulin , testosterone , insulin-like growth factor-I and binding protein-3 , C-reactive protein , and total and low-density lipoprotein cholesterol . Tumors were assessed for proliferation ( Ki-67 , the primary endpoint ) and apoptosis . Results : Men were on protocol an average of 30 days . Proliferation rates were significantly lower ( P the flaxseed arms . Median Ki-67-positive cells/total nuclei ratios ( ×100 ) were 1.66 ( flaxseed-supplemented diet ) and 1.50 ( flaxseed-supplemented , low-fat diet ) versus 3.23 ( control ) and 2.56 ( low-fat diet ) . No differences were observed between arms with regard to side effects , apoptosis , and most serologic endpoints ; however , men on low-fat diets experienced significant decreases in serum cholesterol ( P = 0.048 ) . Conclusions : Findings suggest that flaxseed is safe and associated with biological alterations that may be protective for prostate cancer . Data also further support low-fat diets to manage serum cholesterol . ( Cancer Epidemiol Biomarkers Prev 2008;17(12):3577–87",
"Phytoestrogens are increasingly incorporated into the diet of menopausal women . However , there are limited data on the efficacy of flaxseed on the consequences of estrogen deficiency in menopausal women . The purpose of the study was to assess the effects of flaxseed incorporation into the diet of healthy menopausal women . One hundred and ninety-nine menopausal women were r and omly assigned to consume 40 g flaxseed/d ( n = 101 ) or wheat germ placebo ( n = 98 ) for 12 months . At baseline and at month 12 , serum levels of lipids , bone mineral density ( BMD ) , and menopausal symptoms were evaluated . Statistical analysis was performed under the intention to treat principle . Flaxseed reduced serum total ( -0.20 + /- 0.51 mmol/liter ; P = 0.012 ) and high-density lipoprotein ( -0.08 + /- 0.24 mmol/liter ; P = 0.031 ) cholesterol concentrations compared with wheat germ placebo . BMD did not differ significantly between the two arms . Both flaxseed and wheat germ reduced ( P severity scores of menopausal symptoms , but no statistical difference was found between the two arms . Our findings suggest that 1-yr incorporation of flaxseed into the diet produced a favorable , but not clinical ly significant , effect on blood cholesterol and caused no significant change in BMD or symptoms in healthy menopausal women",
"Background Obesity leads to an increase in inflammation and insulin resistance . This study determined antioxidant activity of flaxseed and its role in inflammation and insulin resistance in obese glucose intolerant people . Methods Using a r and omized crossover design , nine obese glucose intolerant people consumed 40 g ground flaxseed or 40 g wheat bran daily for 12 weeks with a 4-week washout period . Plasma inflammation biomarkers ( CRP , TNF-α , and IL-6 ) , glucose , insulin , and thiobaribituric acid reactive substance ( TBARS ) were measured before and after of each supplementation . Results Flaxseed supplementation decreased TBARS ( p = 0.0215 ) and HOMA-IR ( p = 0.0382 ) . Flaxseed or wheat bran supplementation did not change plasma inflammatory biomarkers . A positive relationship was found between TBARS and HOMA-IR ( r = 0.62 , p = 0.0003 ) . Conclusions The results of the study weakly support that decreased insulin resistance might have been secondary to antioxidant activity of flaxseed . However , the mechanism(s ) of decreased insulin resistance by flaxseed should be further determined using flaxseed lignan",
"Objective : The omega-3 polyunsaturated fatty acid ( n-3 PUFA ) as well as lignan components of flaxseed ( FLX ) can have beneficial effects . In this 6-week-long , r and omized , double-blinded , placebo-controlled study , we investigated the effects of FLX lignans on cardiovascular risk factors . Methods : Thirty-seven subjects ( 13 men and 24 women , age : 54 ± 7 years , body mass index [ BMI ] : 29.7 ± 1 kg/m2 ) consumed nutrition bars with similar macronutrient contents . The fatty acid composition and the lignan contents of the bars differed significantly . Two FLX bars both contained 3.0 g of alpha linolenic acid ( ALA : 18:3 n-3 ) but different amount of lignans ( 0.15 g vs. 0.41 g ) . Results : High-lignan FLX decreased total cholesterol ( C ) by 12 % ( p = 0.044 ) , LDL-C by 15 % ( p = 0.022 ) , and oxidized (Ox)-LDL by 25 % ( p = 0.035 ) . Regular FLX tended to increase Ox-LDL by 13 % ( p = 0.051 ) . The difference between the effects of high-lignan vs. regular lignan FLX on Ox-LDL was highly significant ( p = 0.004 ) . Conclusion : High-lignan FLX has the unique property of decreasing Ox-LDL , which is an independent risk factor for cardiovascular disease",
"OBJECTIVE Supplementation of type II diabetic diets with n-3 fatty acids ( FAs ) from fish oil ( FO ) has been associated with lowered triglyceride and VLDL levels , although reports of impaired glycemic control have limited their use . Effects of n-3FAs from nonmarine sources are less well documented . Therefore , an investigation comparing the effects of linseed oil ( LO ) with FO supplementation was undertaken in subjects with type II diabetes . RESEARCH DESIGN AND METHODS Eleven subjects with type II diabetes were given supplements with LO and FO for 3 months each in a r and omized double-blind crossover fashion after 3 months of olive oil placebo . Oils were given as 35 mg FA · kg body wt−1 · day−1 . After each 3-month period , fasting glucose and insulin levels , HbA1c , lipid profiles , insulin sensitivity ( SI ) , glucose effectiveness ( SG ) , and acute insulin response to glucose ( AIRG ) were evaluated . RESULTS HbA1c and lipid values were within the normal range at r and omization . Repeated measures analysis of variance testing found no significant differences in weight ; fasting glucose and insulin levels ; HbA1c ; total , LDL , and HDL cholesterol levels ; SI ; SG ; or AIRG with either active oil . FO was associated with significant reductions in triglycerides and a trend toward decreased SI . CONCLUSIONS In a population with well-controlled type II diabetes , 3 months of FO but not LO result ed in lowered triglyceride levels . Neither LO nor FO significantly affected glycemic control , cholesterol values , SG , or insulin secretion , while a nonsignificant trend toward decreased insulin sensitivity was found with FO",
"BACKGROUND AND AIMS Elevated levels of circulating omega-3 polyunsaturated fatty acids like alpha linolenic acid ( ALA ) may be beneficial for cardiovascular health . Circulating ALA concentrations are elevated dramatically by a cholesterol supplemented diet which increases ALA bioavailability through enhanced micelle formation in the intestines . Conversely , it is possible that drugs which inhibit cholesterol metabolism in the intestine may also inhibit fatty acid absorption . The purpose of this study is to determine if a cholesterol absorption inhibitor , ezetimibe , will decrease circulating levels of ALA . METHODS AND RESULTS Cardiac patients ( n = 34 ) between 44 and 80 years old , requiring statin therapy to regulate blood cholesterol levels , were r and omly assigned to one of four groups for a 6 week trial : 1 ) placebo ; 2 ) ezetimibe therapy ; 3 ) a supplement of flaxseed oil ( containing 1.0 g ALA in 2.0 g of flaxseed oil ) ; or 4 ) ezetimibe and flaxseed oil supplementation . Ingestion of flaxseed oil result ed in a significant increase in circulating ALA levels ( 6 ug/dl ) in patients who were not given ezetimibe . However , in the presence of ezetimibe , circulating ALA levels did not increase significantly even in the presence of flax oil supplementation ( a decrease of 4 ug/dl ) . There were no significant differences amongst the groups in terms of circulating total cholesterol , LDL , HDL , triglyceride levels in the blood . CONCLUSION Ezetimibe therapy inhibited the absorption of omega-3 fatty acids . Patients receiving ezetimibe therapy may not receive the expected cardiovascular benefits from dietary supplementation with omega-3 fatty acids . CLINICAL TRIAL REGISTRATION NCT00955227",
"Flaxseed contains & ohgr;-3 fatty acids , lignans , and fiber that together may provide benefits to patients with cardiovascular disease . Animal work identified that patients with peripheral artery disease may particularly benefit from dietary supplementation with flaxseed . Hypertension is commonly associated with peripheral artery disease . The purpose of the study was to examine the effects of daily ingestion of flaxseed on systolic ( SBP ) and diastolic blood pressure ( DBP ) in peripheral artery disease patients . In this prospect i ve , double-blinded , placebo-controlled , r and omized trial , patients ( 110 in total ) ingested a variety of foods that contained 30 g of milled flaxseed or placebo each day over 6 months . Plasma levels of the & ohgr;-3 fatty acid & agr;-linolenic acid and enterolignans increased 2- to 50-fold in the flaxseed-fed group but did not increase significantly in the placebo group . Patient body weights were not significantly different between the 2 groups at any time . SBP was ≈10 mm Hg lower , and DBP was ≈7 mm Hg lower in the flaxseed group compared with placebo after 6 months . Patients who entered the trial with a SBP ≥140 mm Hg at baseline obtained a significant reduction of 15 mm Hg in SBP and 7 mm Hg in DBP from flaxseed ingestion . The antihypertensive effect was achieved selectively in hypertensive patients . Circulating & agr;-linolenic acid levels correlated with SBP and DBP , and lignan levels correlated with changes in DBP . In summary , flaxseed induced one of the most potent antihypertensive effects achieved by a dietary intervention",
"Aim . Animal and human study evidence supports the hypothesis that flaxseed lignan complex ( FLC ) at a dose of 600 mg secoisolariciresinol diglucoside (SDG)/day for three months would combat hyperglycaemia , dyslipidemia , blood pressure , central obesity , prothrombotic state , inflammation , and low density lipoprotein ( LDL ) oxidation . Methods . Sixteen type 2 diabetic patients completed this double-blind , r and omised crossover placebo-controlled study . A univariate repeated measures analysis of covariance ( significance P for multiple comparisons ( MCC ) . Results . Prior to MCC , FLC caused decreased fasting plasma glucose , A1c , inflammation ( c-reactive protein ( CRP ) and interleukin-6 ( IL-6 ) ) , and increased bleeding time . After correction for multiple comparisons , FLC induced a statistically significant increase in bleeding time and smaller waist circumference gain . No treatment effect occurred in the other variables before or after adjustment . Conclusions . It is concluded that FLC significantly increased bleeding time thus reducing the prothrombotic state , reduced central obesity gain as measured by waist circumference , and did not affect significantly the other dependent variables measured after adjustment for multiple comparisons . These findings , not yet published in human type 2 diabetes , suggest that this FLC dose over at least three months , may , subject to further investigation , reduce polypharmacy",
"Background The effects of alpha-linolenic acid ( ALA ) on cardiovascular risk factors considerably vary between published reports . Therefore , we investigated the effects of 12-week supplementation with flaxseed oil ( FO ) , which is a rich source of ALA , on cardiovascular risk factors such as serum small dense low-density lipoprotein ( sd-LDL ) concentrations . Methods In a r and omized , double blind , crossover study , 15 subjects ingested 10 g of FO or corn oil ( CO ) , containing 5.49 g and 0.09 g of ALA , respectively , once daily with dinner . Blood sample s were collected at 0 , 4 and 12 weeks , and were used for analysis of serum lipid , lipid-related proteins , serum fatty acids and serum sd-LDL cholesterol . Differences during the test period were identified using a repeated- measures analysis of variance ( ANOVA ) for within-group effects . Group differences were identified using paired t-test at each blood sampling time point . Results ALA and eicosapentaenoic acid concentrations were significantly higher in the FO period at 4 and 12 weeks than in the CO period . No significant differences in docosahexaenoic acid concentrations were observed between two periods , and cholesteryl ester transfer protein and apolipoprotein B concentrations were significantly lower in the FO period than in the CO period at 12 weeks . FO supplementation was associated with a significant decrease in sd-LDL concentrations at 4 and 12 weeks , and CO supplementation had no effect . Moreover , sd-LDL concentrations were significantly lower in the FO period than in the CO period at 4 weeks . Among subjects with triglyceride ( TG ) concentrations of > 100 mg/dl , FO supplementation markedly reduced sd-LDL concentrations at 4 and 12 weeks compared with baseline . Sd-LDL concentrations significantly differed between the periods at both 4 and 12 weeks . Conclusion This study indicates that the FO , which is a rich source of ALA , leads to lower sd-LDL cholesterol concentrations",
"Background Flaxseed consumption has been shown to improve blood lipids in humans and flaxseed-derived lignan has been shown to enhance glycemic control in animals . The study aim ed to investigate the effect of a flaxseed-derived lignan supplement on glycemic control , lipid profiles and insulin sensitivity in type 2 diabetic patients . Methodology /Principal Findings This was a r and omized , double-blind , placebo-controlled , cross-over trial and it was conducted between April and December 2006 in Shanghai , China . Seventy-three type 2 diabetic patients with mild hypercholesterolemia were enrolled into the study . Patients were r and omized to supplementation with flaxseed-derived lignan capsules ( 360 mg lignan per day ) or placebo for 12 weeks , separated by an 8-week wash-out period . HbA1c , lipid profiles , insulin resistance index and inflammatory factors were measured . Sixty-eight completed the study and were included in the analyses . The lignan supplement significantly improved glycemic control as measured by HbA1c ( -0.10±0.65 % vs. 0.09±0.52 % , P = 0.001 ) compared to placebo ; however , no significant changes were observed in fasting glucose and insulin concentrations , insulin resistance and blood lipid profiles . Urinary excretion of lignan metabolites ( enterodiol and enterolactone ) was significantly higher after the lignan supplement intervention compared to baseline ( 14.2±18.1 vs. 1.2±2.4 µg/mL , P improvements in glycemic control in type 2 diabetic patients without apparently affecting fasting glucose , lipid profiles and insulin sensitivity . Further studies are needed to vali date these findings and explore the efficacy of lignans on type 2 diabetes . Trial Registration Clinical Trials.gov",
"Background Dietary alpha-linolenic acid ( ALA ) has been associated with reduced risk of development of atherosclerosis . Adiponectin is a hormone specifically secreted by adipocytes and considered to have anti-atherogenic properties . Aim of the study We examined the effect of increased dietary intake of ALA on plasma concentration of adiponectin . Methods Thirty-five non-diabetic , dyslipidemic men , 38–71 years old , were r and omly allocated to take either 15 ml of flaxseed oil rich in ALA ( 8.1 g/day ; n = 18 ) , or 15 ml of safflower oil per day , containing the equivalent n-6 fatty acid ( 11.2 g/day linoleic acid , LA ; n = 17 ) ( control group ) . The intervention period lasted for 12 weeks . Results Plasma levels of adiponectin did not change after the increase in dietary intake of ALA in the flaxseed oil supplementation group , compared to the control group . No changes in body mass index , serum lipid concentrations , LDL density , or plasma TNF-α were found in the flaxseed oil versus the control group . Conclusions Dietary ALA has no effect on plasma adiponectin concentration in dyslipidemic men",
"BACKGROUND Inflammation plays an important role in the pathogenesis of coronary artery disease . We examined whether dietary supplementation with alpha-linolenic acid ( ALA , 18:3n-3 ) affects the levels of inflammatory markers in dyslipidaemic patients . METHODS We recruited 76 male dyslipidaemic patients ( mean age=51+/-8 years ) following a typical Greek diet . They were r and omly assigned either to 15 ml of linseed oil ( rich in ALA ) per day ( n=50 ) or to 15 ml of safflower oil ( rich in linoleic acid ( LA , 18:2n-6 ) ) per day ( n=26 ) . The ratio of n-6:n-3 in linseed oil supplemented group was 1.3:1 and in safflower oil supplemented group 13.2:1 . Dietary intervention lasted for 3 months . Blood lipids and C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , and interleukin-6 ( IL-6 ) levels were determined prior and after intervention . CRP and SAA were measured by nephelometry and IL-6 by immunoassay . RESULTS Dietary supplementation with ALA decreased significantly CRP , SAA and IL-6 levels . The median decrease of CRP was 38 % ( 1.24 vs. 0.93 mg/l , P=0.0008 ) , of SAA 23.1 % ( 3.24 vs. 2.39 mg/l , P=0.0001 ) and of IL-6 10.5 % ( 2.18 vs. 1.7 pg/ml , P=0.01 ) . The decrease of inflammatory markers was independent of lipid changes . Dietary supplementation with LA did not affect significantly CRP , SAA and IL-6 concentrations but decreased cholesterol levels . CONCLUSIONS Dietary supplementation with ALA for 3 months decreases significantly CRP , SAA and IL-6 levels in dyslipidaemic patients . This anti-inflammatory effect may provide a possible additional mechanism for the beneficial effect of plant n-3 polyunsaturated fatty acids in primary and secondary prevention of coronary artery disease",
"Objective : To determine the effects of dietary consumption of milled flaxseed or flaxseed oil on glycemic control , n-3 fatty acid status , anthropometrics , and adipokines in individuals with type 2 diabetes . Design : Thirty-four participants were r and omized into a parallel , controlled trial . Subjects : The participants were adults with type 2 diabetes ( age 52.4 ± 1.5 years , body mass index 32.4 ± 1.0 kg/m2 , n = 17 men and 17 women ) . Interventions : Participants consumed a selection of bakery products containing no flax ( control group [ CTL ] , n = 9 ) , milled flaxseed ( FXS , n = 13 ; 32 g/d ) , or flaxseed oil ( FXO , n = 12 ; 13 g/d ) daily for 12 weeks . The FXS and FXO groups received equivalent amounts of alpha-linolenic acid ( ALA ; 7.4 g/day ) . Measures of Outcome : The primary outcome measures were fasting plasma hemoglobin A1c , glucose , insulin , and phospholipid fatty acid composition . The secondary outcome measures were fasting circulating leptin and adiponectin , as well as body weight , body mass index , and waist circumference . Dietary intake assessment and calculations for homeostasis model assessment for insulin resistance and quantified insulin sensitivity check were also completed . Results : The FXS and FXO groups had increases in plasma phospholipid n-3 fatty acids ( ALA , eicosapentaenoic acid [ EPA ] , or decosapentaenoic acid [ DPA ] , but not docosahexaenoic acid ) , and the FXO group had more EPA and DPA in plasma phospholipids compared to the FXS group . All groups had similar caloric intakes ; however , the CTL group experienced a 4 % weight gain compared to baseline ( p including glycemic control , were unchanged by dietary treatment . Conclusions : Milled FXS and FXO intake does not affect glycemic control in adults with well-controlled type 2 diabetes . Possible prevention of weight gain by flax consumption warrants further investigation",
"Background : Cardiovascular diseases ( CVDs ) are an increasing health problem all over the world . The search for natural hypolipidemic agents that can be used besides the synthetic drugs is still in its experimental stage . Plant seeds , particularly flaxseed ( Linum usitatissimum ) , which is a rich source of n-3 fatty acids , lignans and phenolic compounds , have also received increasing attention for their potential role in preventing lipid disorders . The present study was undertaken to evaluate the therapeutic potential of flaxseeds in dyslipidemia . Methods : The study included 50 dyslipidemic subjects selected by purposive r and om sampling and were divided into two groups , a control and an experimental group . Both the groups were prescribed similar dietary guidelines . Subjects in the experimental group received 30 g of roasted flaxseed powder for 3 months . Anthropometric parameters , blood pressure , and blood lipid profile were estimated before the study and after completion of the study . Results : Flaxseed supplementation result ed in a remarkable improvement in anthropometric measurements , blood pressure , and lipid profile in the experimental group . Body weight and body mass index ( BMI ) of the experimental group were significantly reduced ( p systolic and diastolic blood pressure ( p dyslipidemic subjects . Concomitantly , a highly significant reduction ( p total cholesterol , triglycerides , low density lipoprotein-cholesterol ( LDL-C ) , and very low density lipoprotein-cholesterol ( VLDL-C ) levels , with simultaneous elevation ( p high density lipoprotein-cholesterol ( HDL-C ) levels was observed . Improvement in lipid levels result ed in reduction of atherogenic indices . Conclusions : The supplementation of roasted flaxseed powder for 3 months improved the BMI , blood pressure , and lipid profile of dyslipidemic subjects , thus exhibiting cardio protective effect",
"Inflammation and lipid abnormalities are two important risk factors for cardiovascular disease in hemodialysis ( HD ) patients . The present study was design ed to investigate the effects of flaxseed consumption on systemic inflammation and serum lipid profile in HD patients with lipid abnormalities . This was an unblinded , r and omized clinical trial . Thirty HD patients with dyslipidemia ( triglyceride > 200 mg/dL and /or high‐density lipoprotein‐cholesterol ( HDL‐C ) were r and omly assigned to either a flaxseed or control group . Patients in the flaxseed group received 40 g/day ground flaxseed for 8 weeks , whereas patients in the control group received their usual diet , without any flaxseed . At baseline and at the end of week 8 , 7 mL of blood was collected after a 12‐ to 14‐hour fast and serum concentrations of triglyceride , total cholesterol , low‐density lipoprotein‐cholesterol ( LDL‐C ) , HDL‐C , and C‐reactive protein ( CRP ) were measured . Serum concentrations of triglyceride ( P ( P 0.01 ) , LDL‐C ( P 0.01 ) , and CRP ( P the flaxseed group at the end of week 8 compared with baseline , whereas serum HDL‐C showed a significant increase ( P in the flaxseed group were significant in comparison with the control group . The study indicates that flaxseed consumption improves lipid abnormalities and reduces systemic inflammation in HD patients with lipid abnormalities",
"Purpose Lipoprotein associated phospholipase A2 ( Lp-PLA2 ) is a novel inflammatory factor that has been independently associated with stroke and cardiovascular disease ( CVD ) . Omega-3 fats have been implicated in reducing inflammation associated with CVD . The aim of this study was to determine if an 8-week isocaloric diet supplemented with eicosapentaenoic acid ( EPA ) and docosahexaenoic ( DHA ) in the form of fish oil or α-linolenic acid ( ALA ) in the form of flaxseed oil would alter Lp-PLA2 among healthy adults ages 50 years and older . Methods Fifty-nine healthy adults ( ~75 % female , average age 61 years ) were r and omized to one of three groups with equal amounts of total fat intake . All capsules contained ~1 g of fat . The control group ( n = 19 ) consumed olive oil capsules ( ~11 g/day ) ; the ALA group ( n = 20 ) consumed flaxseed oil capsules ( ~11 g/day ) and the EPA/DHA group ( n = 20 ) consumed fish oil capsules ( ~2 g/day + 9 g/day of olive oil ) . Fasting blood sample s were obtained before and after the 8-week intervention for determination of Lp-PLA2 mass and activity as well as lipid values . Results We did not find any significant changes in Lp-PLA2 mass or activity after the intervention in any of the groups ; however , change in oxidized LDL was associated with change in Lp-PLA2 mass ( r = 0.37 , p with omega-3 fatty acids for 8-weeks did not influence Lp-PLA2 activity or mass among older adults ; altering oxidized LDL may be necessary to see changes in Lp-PLA2 levels",
"INTRODUCTION Hyperlipidemia is one of the most important risk factors of ischemic heart disease . Previous studies showed that flaxseed has the potential to improve lipid profiles . In this study we investigated the effects of flaxseed powder intake on lipid profiles of patients with hyperlipidemia . MATERIAL S AND METHODS This study was a r and omized controlled clinical trial . Seventy patients with hyperlipidemia participated in the research . After detailed diet and lifestyle education , blood sample s were collected from the participants . Patients with hyperlipidemia were r and omly divided in to two intervention and control groups . The intervention group received 30 g of raw flaxseed powder every day for 40 days . Serum lipids were measured again in two groups after that time . Activity and food intakes of two groups were recorded . RESULTS In the intervention group , weight and body mass index were considerably reduced . Total cholesterol was reduced in the intervention group and increased in the control group , both of which were significant . Low density lipoprotein significantly increased in the control group and reduced in intervention group ; also , triglyceride was increased in the control group and reduced in the intervention group , which were significant Table 1 . CONCLUSION Based on the findings obtained in this research , flaxseed powder intake desirably reduced serum lipids . The differences between two groups on the basis of analysis of covariance test were significant . In all cases except for the HDL-c , this is an effective intervention . Therefore , flaxseed may be regarded as a useful therapeutic food for reducing hyperlipidemia",
"Supplementation with eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) has been reported to reduce lipid peroxidation products formed from arachidonic acid ( F(2)-isoprostanes ) in healthy humans , as well as in those under oxidative stress . alpha-Linolenic acid ( ALA ) is a precursor to EPA and DHA ; however , its conversion in humans is thought to be inefficient . ALA can also undergo free radical oxidation , forming compounds known as F(1)-phytoprostanes , which are found in all plants and are in high concentrations in plant pollens . In this study , we examined the effect of ALA supplementation on plasma and urine F(1)-phytoprostane and F(2)-isoprostane concentrations in men . Thirty-six nonsmoking men , aged 20 - 65 y , were recruited from the general population and r and omly allocated to consume 9 g/d of either flaxseed oil ( 62 % ALA , 5.4 g/d ) or olive oil ( placebo ) for 4 wk in a parallel design . At baseline and after 4 wk of supplementation , blood sample s and a 24-h urine sample were collected for measurement of plasma and urinary F(1)-phytoprostanes and F(2)-isoprostanes and plasma fatty acids . Compared with the olive oil group , plasma phospholipid ALA was greater ( P F(1)-phytoprostanes in plasma ( P = 0.049 ) and urine ( P = 0.06 ) in the flaxseed oil group after 4 wk supplementation . Flaxseed oil did not affect plasma or urinary F(2)-isoprostanes . The greater plasma F(1)-phytoprostane concentration in the flaxseed oil group most likely result ed from the increased plasma concentration of the ALA substrate and /or the F(1)-phytoprostane content of the flaxseed oil . Future studies are needed to determine the physiological importance of increased plasma and urine F(1)-phytoprostanes and their relevance to heart disease prevention",
"OBJECTIVE Olive oil ( OO ) is a rich source of monounsaturated fat and bioactive components that exert strong anti-oxidant and anti-inflammatory properties . Flaxseed oil ( FO ) is rich in α-linolenic n-3 fatty acid ( ALA ) , which also exhibits anti-inflammatory effects . This r and omized , cross-over study aim ed at exploring whether diet 's enrichment with FO could beneficially alter inflammatory markers and lipid profile , compared to OO , in a sample of normal weight , apparently healthy young adults . MATERIAL S AND METHODS Participants were supplied with 15 mL/day of either FO or OO . Each intervention and the wash-out period lasted 6 weeks . Dietary , anthropometric and physical activity variables were recorded at the beginning and the end of each intervention . Serum biochemical and inflammatory markers were measured . Compliance to the intervention was evaluated by fatty acid analysis in erythrocytes . Repeated Measures ANOVA was used to assess the effect of the treatment . RESULTS Thirty seven participants completed the study . No difference between the two interventions was observed in adiponectin , TNF-α , high sensitivity-CRP or glucose levels and lipid profile . At the end of the FO period , participants exhibited significant reductions in total ( -5.0 % ) and LDL-cholesterol ( -6.7 % ) levels ( all P period serum adiponectin changes were significantly correlated with changes in erythrocyte % ALA ( rs=0.34 , P=0.007 ) and in erythrocyte % EPA ( r(s)=0.47 , P=0.01 ) , respectively . CONCLUSIONS Daily consumption of FO did not confer any benefit in inflammatory or biochemical markers in normal weight young adults , who traditionally use olive oil as the main edible oil",
" Abstract A two-arm r and omized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease ( NAFLD ) . Participants were assigned to take either a lifestyle modification ( LM ) , or LM + 30 g/day brown milled flaxseed for 12 weeks . At the end of the study , body weight , liver enzymes , insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups ( p took flaxseed supplementation ( p in hepatic markers between flaxseed and control group , respectively : ALT [ −11.12 compared with −3.7 U/L ; P AST [ −8.29 compared with −4 U/L ; p GGT [ −15.7 compared with −2.62 U/L ; p 0.001 ] , fibrosis score [ −1.26 compared with −0.77 kPa ; p = 0.013 ] and steatosis score [ −47 compared with −15.45 dB/m ; p = 0.022 ] . In conclusion , flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management",
"BACKGROUND Botanical omega-3 fatty acid ( alphalinolenic acid/ALA ) has been shown to alleviate the prothrombotic and proinflammatory profile of metabolic syndrome , however clinical protocol s are still scarce . Aim ing to focus an obese population , a pilot study was design ed . METHODS Morbidly obese c and i date s for bariatric surgery ( n = 29 , age 46.3 ± 5.2 years ) , 82.8 % females ( 24/29 ) , BMI 44.9 ± 5.2 kg/m² , with C-reactive protein/CRP > 5 mg/L were recruited . Twenty were r and omized and after exclusions , 16 were available for analysis . Flaxseed powder ( 60 g/day , 10 g ALA ) and isocaloric roasted cassava powder ( 60 g/day , fat-free ) were administered in a double-blind routine for 12 weeks . RESULTS During flaxseed consumption neutrophil count decreased and fibrinogen , complement C4 , prothrombin time and carotid diameter remained stable , whereas placebo ( cassava powder ) was associated with further elevation of those measurements . CONCLUSIONS Inflammatory and coagulatory markers tended to exhibit a better outlook in the flaxseed group . Also large-artery diameter stabilized whereas further increase was noticed in controls . These findings raise the hypothesis of a less deleterious cardiovascular course in seriously obese subjects receiving a flaxseed supplement ",
"Background Morbidly obese patients frequently display asymptomatic chronic activation of acute phase response , with potentially adverse metabolic and cardiovascular consequences . Nutritional preparations to improve this phenomenon have rarely been administered . Aim ing to investigate the supplementation of flaxseed flour , a source of omega-3 fatty acids , a prospect i ve r and omized double-blind cross-over study was design ed . Methods Outpatient obese subjects ( n = 41 ) were clinical ly and biochemically screened , and results for 24 r and omized subjects are shown . Age was 40.8 ± 11.6 years ( 83.3 % females ) and body mass index ( BMI ) was 47.1 ± 7.2 kg/m2 . Flaxseed flour ( Farinha de Linhaca Dourada LinoLive , Cisbra , Brazil ) in the amount of 30 g/day ( 5 g of alpha-linolenic acid – omega-3 ) and an equal mass of placebo ( manioc flour ) were administered for 2 weeks each . Variables included general biochemical investigation , white blood cell count ( WBC ) , C-reactive protein ( CRP ) , serum amyloid A ( SAA ) and fibronectin . Results No intolerance was registered . Body weight and general biochemical indices remained stable . Initial CRP and SAA were elevated ( 13.7 ± 9.9 and 17.4 ± 8.0 ) . WBC ( 8100 ± 2100/mm3 ) and fibronectin ( 463.2 ± 61.3 mg/dL ) were acceptable but in the upper normal range . Corresponding findings after supplementation of flaxseed were 10.6 ± 6.2 mg/L , 14.3 ± 9.2 mg/L , 7300 ± 1800/mm3 and 412.8 ± 38.6 respectively ( P when placebo was r and omized to be given first ; however , when it followed omega-3 supplementation , CRP and SAA recovered , whereas WBC and fibronection remained depressed during those 2 weeks ( 7500 ± 2100/mm3 and 393.2 ± 75.8 mg/dL , P Various inflammatory markers were elevated in the studied population , although not necessarily exceeding the normal range ; 2 ) Significant reduction could be demonstrated ; 3 ) Some persistent effects of flaxseed supplement 2 weeks after discontinuation were observed",
"The objective of this study was to evaluate the efficacy of flaxseed meal and flaxseed extract in reducing climacteric symptoms of menopausal women . Ninety menopausal women were r and omly distributed into three study groups : group I received 1 g per day of flaxseed extract containing at least 100 mg of secoisolariciresinol diglucoside ( SDG ) , group II received 90 g per day of flaxseed meal containing at least 270 mg of SDG , and group III received 1 g per day of collagen ( placebo group ) . Subjects were assessed for menopausal symptoms by the Kupperman index at the beginning and at the end of the 6 months of treatment . Subjects were also assessed for endometrial thickness and vaginal cytology . The Kupperman index values at the beginning and end of the treatments were analyzed using the paired t-test . Both the flaxseed extract ( P=.007 ) and the flaxseed meal ( P=.005 ) were effective in reducing the menopausal symptoms when compared with the placebo control ( P=.082 ) . Alternatively , the changes in Kupperman index were also computed and su bmi tted to analysis of variance . In this case , no significant differences were found ( P=.084 ) although the data indicate a decreasing tendency for the Kupperman index by both the flaxseed extract and the flaxseed meal groups . Neither the flaxseed extract nor the flaxseed meal exerted clinical ly important estrogenic effects on the vaginal epithelium or endometrium as revealed by the absence of changes in the blood levels of follicle stimulating hormone and estradiol , as well as in the endometrial thickness , and vaginal epithelial maturation value . No serious adverse events related to the treatments were reported . Although the results of the present study do not allow an unequivocal conclusion about the action of flaxseed on the menopausal symptoms , they suggest that it could be premature to conclude that no such action exists . Clearly the matter still deserves further experimental attention",
"SCOPE To investigate the effects of n-3 fatty acid supplements , both marine and plant-based , on glycemic traits in Chinese type 2 diabetes patients . METHOD AND RESULTS In a double-blind r and omized controlled trial , 185 recruited Chinese type 2 diabetes patients were r and omized to either fish oil ( FO , n = 63 ) , flaxseed oil ( FSO , n = 61 ) , or corn oil group ( served as control group , n = 61 ) for 180 days . The patients were asked to take corresponding oil capsules ( four capsules/day ) , which totally provided 2 g/day of eicosapentaenoic acid + docosahexaenoic acid in FO group and 2.5 g/day of alpha-linolenic acid in FSO group . No group × time interaction was observed for homeostatic model assessment of insulin resistance , fasting insulin , or glucose . Significant group × time interaction ( P = 0.035 ) was observed for glycated hemoglobin A1c ( HbA1c ) , with HbA1c decreased in FO group compared with corn oil group ( P = 0.037 ) . We also found significant group × time interactions for lipid traits , including LDL cholesterol ( P = 0.043 ) , total cholesterol ( P = 0.021 ) , total cholesterol/HDL cholesterol ( P = 0.009 ) , and triacylglycerol ( P = 0.003 ) , with the lipid profiles improved in FO group . No significant effects of FSO on glycemic traits or blood lipids were observed . CONCLUSIONS Marine n-3 PUFA supplements may improve glycemic control and lipid profiles among Chinese type 2 diabetic patients"
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Background sarcopenia in ageing is a progressive decrease in muscle mass , strength and /or physical function . This review aims to summarise the definitions of sarcopenia in community-dwelling older adults and explore similarities and differences in prevalence estimates by definition . Methods a systematic review was conducted to identify articles which estimated sarcopenia prevalence in older population s using search terms for sarcopenia and muscle mass . Overall prevalence for each sarcopenia definition was estimated stratified by sex and ethnicity . Secondary analyses explored differences between studies and within definitions , including participant age , muscle mass measurement techniques and thresholds for muscle mass and gait speed . Results in 109 included articles , eight definitions of sarcopenia were identified . The lowest pooled prevalence estimates came from the European Working Group on Sarcopenia/Asian Working Group on Sarcopenia ( 12.9 % , 95 % confidence interval : 9.9 - 15.9 % ) , International Working Group on Sarcopenia ( 9.9 % , 3.2 - 16.6 % ) and Foundation for the National Institutes of Health ( 18.6 % , 11.8 - 25.5 % ) definitions . The highest prevalence estimates were for the appendicular lean mass (ALM)/weight ( 40.4 % , 19.5 - 61.2 % ) , ALM/height ( 30.4 % , 20.4 - 40.3 % ) , ALM regressed on height and weight ( 30.4 % , 20.4 - 40.3 % ) and ALM / body mass index ( 24.2 % , 18.3 - 30.1 % ) definitions . Within definitions , the age of study participants and the muscle mass cut points used were substantive sources of between- study differences . Conclusion estimates of sarcopenia prevalence vary from 9.9 to 40.4 % , depending on the definition used . Significant differences in prevalence exist within definitions across population s. This lack of agreement between definitions needs to be better understood before sarcopenia can be appropriately used in a clinical context
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"Muscle mass decreases with age , leading to \" sarcopenia , \" or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia",
"Background Sarcopenia , defined as low muscle mass ( LMM ) , and dynapenia have been associated with adverse outcomes in elderly . Objective Contrast the association of sarcopenia versus dynapenia with incidence of disability . Design A four-year prospect i ve study ( 2006–2010 ) . Setting São Paulo , Brazil . Participants 478 individuals aged 60 and older from the Saúde , Bem-Estar e Envelhecimento ( SABE ) study who were non-disabled at baseline . Measurements Sarcopenia , measured according to the European Working Group on Sarcopenia in Older People ( EWGSOP ) , includes : LMM assessed by skeletal muscle mass index ≤8.90kg/m2 ( men ) and ≤6.37kg/m2 ( women ) ; low muscle strength ( LMS ) assessed by h and grip strength low physical performance ( LPP ) assessed by gait speed ≤0.8 m/s . Diagnosis of sarcopenia required LMM plus LMS or LPP . Dynapenia was defined as h and grip strength variables , medical conditions , hospitalization , depressive symptoms , cognition , perception of vision , hearing and body mass index . Outcomes Disability in mobility or instrumental activities of daily living ( IADL ) or disability in activities of daily living ( ADL ) and IADL . Results The incidence density of mobility or IADL disability was 43.4/1000 person/year and 22.6/1000 person/year for IADL and ADL disability . There was no significant difference in incidence density according sarcopenia or dynapenia status . After controlling for all covariates , sarcopenia was associated with mobility or IADL disability ( relative risk ratio = 2.23 , 95%Confidence Interval : 1.03–4.85 ) . Dynapenia was not associated with disability . Conclusions Sarcopenia according to the EWGSOP definition can be used in clinical practice as a screening tool for early functional decline ( mobility or IADL disability )",
"Background Age-related losses in bone mineral density ( BMD ) , muscle strength , balance , and gait have been linked to an increased risk of falls , fractures and disability , but few prospect i ve studies have compared the timing , rate and pattern of changes in each of these measures in middle-aged and older men and women . This is important so that targeted strategies can be developed to optimise specific musculoskeletal and functional performance measures in older adults . Thus , the aim of this 10-year prospect i ve study was to : 1 ) characterize and compare age- and gender-specific changes in BMD , grip strength , balance and gait in adults aged 50 years and over , and 2 ) compare the relative rates of changes between each of these musculoskeletal and functional parameters with ageing . Methods Men ( n = 152 ) and women ( n = 206 ) aged 50 , 60 , 70 and 80 years recruited for a population -based study had forearm BMD , grip strength , balance and gait velocity re-assessed after 10-years . Results The annual loss in BMD was 0.5 - 0.7 % greater in women compared to men aged 60 years and older ( p loss in grip strength , balance or gait . From the age of 50 years there was a consistent pattern of loss in grip strength , while the greatest deterioration in balance and gait occurred from 60 and 70 years onwards , respectively . Comparison of the changes between the different measures revealed that the annual loss in grip strength in men and women aged BMD , balance and gait velocity . Conclusion There were no gender differences in the timing ( age ) and rate ( magnitude ) of decline in grip strength , balance or gait in Swedish adults aged 50 years and older , but forearm BMD decreased at a greater rate in women than in men . Furthermore , there was heterogeneity in the rate of loss between the different musculoskeletal and function parameters , especially prior to the age of 70 years , with grip strength deteriorating at a greater rate than BMD , balance and gait",
"Summary Sarcopenia may be diagnosed in the clinic using operational definitions based on low muscle mass or function . This prospect i ve , population -based study revealed that sex-specific associations may exist between operational definitions of sarcopenia and falls in community-dwelling middle-aged and older adults . Introduction The objective of this study is to verify associations between sarcopenia and falls risk and to determine changes in sarcopenia prevalence over 5 years in middle-aged and older men and women according to different anthropometric and performance-based operational definitions . Methods N = 681 volunteers ( 48 % female ; mean ± SD age 61.4 ± 7.0 years ) participated in baseline and follow-up assessment s ( mean 5.1 ± 0.5 years later ) . Appendicular lean mass ( ALM ) was assessed by dual-energy X-ray absorptiometry , h and grip ( HGS ) and lower-limb ( LLS ) strength were assessed by dynamometry , and falls risk was determined using the physiological profile assessment . Anthropometric definitions ( ALM/height squared [ ALM – H ] , ALM/weight × 100 and a residuals method [ ALM – R ] ) and performance-based definitions ( HGS , LLS and upper- and lower-limb muscle quality [ LMQ ] ) of sarcopenia were examined . The lowest 20 % of the sex-specific distribution for each definition at baseline was classified as sarcopenia . Results Sarcopenia prevalence increased after 5 years for all operational definitions except ALM – H ( men : −4.0 % ; women : −5.5 % ) . Men classified with sarcopenia according to anthropometric definitions , and women classified with sarcopenia according to performance-based definitions , had significant increases in falls risk over 5 years ( all P ALM-R , LLS and LMQ ( all P Sarcopenia prevalence generally increases at a higher rate when assessed using performance-based definitions . Sarcopenia is associated with increases in falls risk over 5 years in community-dwelling middle-aged and older adults , but sex-specific differences may exist according to different anthropometric or performance-based definitions",
"Sarcopenia , the age-related decline in muscle mass , affects the muscle strength and muscle quality , and these changes decrease functional capacity . The prevalence of thyroid dysfunction increases with age , and changes in thyroid hormone level lead to neuromuscular deficits . We investigated the effects of sub clinical hypothyroidism on the muscle mass , strength or quality in elderly people . One thous and one hundred eighteen subjects aged ≥65 yr were r and omly selected from a local population and classified into a euthyroid ( 280 men and 358 women ) , sub clinical ly hypothyroid ( 61 men and 75 women ) , or overtly hypothyroid ( 7 men and 16 women ) group . Although women with sub clinical hypothyroidism had a higher prevalence of sarcopenia , defined according to the ratio of appendicular skeletal muscle mass to the square of height , muscle mass , strength or quality did not differ in relation to thyroid status in men or in women . Multivariate analysis including age , diabetes , hypertension , acute coronary event , alcohol , smoking , presence of pain , physical activity score , and lipid profile , showed that thyroid-stimulating hormone level was not associated with muscle mass , strength or quality . In conclusion , sub clinical hypothyroidism has little influences on muscle mass , strength or quality , and may not be associated with sarcopenia",
"BACKGROUND Sarcopenia is prevalent in older population s with many causes and varying outcomes however information for use in clinical practice is still lacking . AIMS The aim of this report is to identify the clinical determinants and prognostic significance of sarcopenia in a cohort of hospitalized acutely ill older patients . METHODS Four hundred and thirty two r and omly selected patients had their baseline clinical characteristic data assessed within 72 h of admission , at 6 weeks and at 6 months . Nutritional status was assessed from anthropometric and biochemical data . Sarcopenia was diagnosed from low muscle mass and low muscle strength-h and grip using anthropometric measures based on the European Working Group criteria . RESULTS Compared with patients without sarcopenia , those diagnosed with sarcopenia 44 ( 10 % ) were more likely to be older , have more depression symptoms and lower serum albumin concentration . The length of hospital stay ( LOS ) was significantly longer in patients diagnosed with sarcopenia compared with patients without sarcopenia [ mean ( SD ) LOS 13.4 ( 8.8 ) versus 9.4 ( 7 ) days respectively , p = 0.003 ] . The risk of non-elective readmission in the 6 months follow up period was significantly lower in patients without sarcopenia compared with those diagnosed with sarcopenia ( adjusted hazard ratio .53 ( 95 % CI : .32 to .87 , p = 0.013 ) . The death rate was also lower in patients without sarcopenia 38/388 ( 10 % ) , compared with those with sarcopenia 12/44 ( 27 % ) , p-value = .001 . CONCLUSION Older people with sarcopenia have poor clinical outcome following acute illness compared with those without sarcopenia",
"BACKGROUND AND AIMS sarcopenia has been indicated as a reliable marker of frailty and poor prognosis among the oldest individuals . We evaluated the impact of sarcopenia on the risk of all-cause death in a population of frail older persons living in community . METHODS we analysed data from the Aging and Longevity Study , a prospect i ve cohort study that collected data on all subjects aged 80 years and older residing in the Sirente geographic area ( n = 364 ) . The present analysis was conducted among those subjects who were between 80 and 85 years of age at the time of the baseline assessment ( n = 197 ) . The main outcome measure was all-cause mortality over 7-year follow-up . According to the European Working Group on Sarcopenia in Older People ( EWGSOP ) criteria , the diagnosis of sarcopenia required the documentation of low muscle mass and the documentation of either low muscle strength or low physical performance . Cox proportional regression models were used to estimate crude and adjusted hazard ratios and 95 % confidence intervals of death by the presence of sarcopenia . RESULTS using the EWGSOP-suggested criteria , 43 subjects with sarcopenia ( 21.8 % ) were identified . During the 7-year follow-up , 29 ( 67.4 % ) participants died among subjects with sarcopenia compared with 63 subjects ( 41.2 % ) without sarcopenia ( P activities of daily living ( ADL ) impairment , body mass index , hypertension , congestive heart failure , chronic obstructive pulmonary disease , number of diseases , TNF-α , participants with sarcopenia had a higher risk of death for all causes compared with non-sarcopenic subjects ( HR : 2.32 , 95 % CI : 1.01 - 5.43 ) . CONCLUSIONS our results obtained from a representative sample of very old and frail subjects show that sarcopenia is associated with mortality , independently of age and other clinical and functional variables"
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Objective To compare these managements focusing on the efficacy and safety to treat overactive bladder ( OAB ) in children through network meta- analysis ( NMA ) . Methods We search ed PubMed , Embase , the Cochrane Library Central Register of Controlled Trials ( CENTRAL ) and the reference lists up to May 1st , 2017 . Data from eligible r and omized controlled trails ( RCT ) studies including three different treatment options were extracted . The primary outcome was maximal voiding volume ( MVV ) . We performed pairwise meta-analyses by r and om effects model and NMA by Bayesian model . We used the Grading of Recommendations , Assessment , Development and Evaluations ( GRADE ) framework to assess the quality of evidence contributing to each network estimate . Results Six RCTs ( 462 patients ) comparing three different interventions fulfilled the inclusion criteria . A low risk of bias was shown for the majority of the study items . The results of NMA showed that compared with antimuscarinic drugs , Parasacral transcutaneous electrical nerve stimulation was associated with significant improvement in the MVV ( mean difference [ MD ] = 58.50 , 95 % confidential interval [ CI ] : 45.95–69.52 ) , followed by urotherapy group ( MD = 21.03 , 95 % CI : 11.85–29.97 ) . When it comes to the constipation , antimuscarinic drugs exerted significant benefit than PTENS ( odds ratio [ OR ] : 0.22 , 95 % CI : 0.01–0.46 ) . No significant difference was found between other treatments . Conclusion Compared with antimuscarinic drugs , PTENS was associated with significant better efficacy considering MVV , but more constipation events in de novo OAB children . Antimuscarinic drugs showed remarkably better efficacy considering MVV and comparable safety profile compared with urotherapy . Clinicians should take all known safety and compliance of patients into account when choosing an optimal strategy
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"Purpose Transcutaneous electrical stimulation ( TES ) speeds up colonic transit in children with slow-transit constipation ( STC ) . This study examined if concurrent upper gastrointestinal dysmotility ( UGD ) affected response to TES . Methods Radio-nuclear transit studies ( NTS ) were performed before and after TES treatment of STC as part of a larger r and omised controlled trial . UGD was defined as delayed gastric emptying and /or slow small bowel transit . Improvement was defined as increase of ≥1 Geometric Centre ( median radiotracer position at each time [ small bowel = 1 , toilet = 6 ] ) . Results Forty-six subjects completed the trial , 34 had NTS after stimulation ( 21 M , 8–17 years , mean 11.3 years ; symptoms > 9 years ) . Active stimulation increased transit in > 50 % versus only 25 % with sham ( p = 0.04 ) . Seventeen children also had UGD . In children with STC and either normal upper GI motility ( NUGM ) and UGD , NTS improved slightly after 1 month ( 57 vs. 60 % ; p = 0.9 ) and more after 2 months ( 88 vs. 40 % ; p = 0.07 ) . However , mean transit rate significantly increased with NUGM , but not UGD ( 5.0 ± 0.2 : 3.6 ± 0.6 , p greater increased transit compared to those with UGD . Higher numbers are needed to determine if the difference is important",
"PURPOSE We evaluated the effectiveness of parasacral transcutaneous electrical nerve stimulation to treat overactive bladder in children . We design ed a prospect i ve r and omized trial with sham control for this evaluation . MATERIAL S AND METHODS We prospect ively r and omized 25 girls and 12 boys with an average age of 7.6 years ( range 4 to 12 ) into the test ( active treatment ) or sham ( superficial scapular electrical stimulation ) group . A total of 20 sessions , 20 minutes each ( 10 Hz ) were performed 3 times weekly . The criteria used to evaluate the rate of success were 1 ) self-reported cure , or significant , mild or no improvement ; 2 ) visual analogue scale ( level of success 0 to 10 ) ; 3 ) percent improvement ; 4 ) modified Toronto score ; and 5 ) maximum voided volume , average voided volume and number of voids daily based on bladder diary entries . After completion of the 20 sessions controls who were not cured underwent active treatment . RESULTS A total of 21 patients in the test group and 16 in the sham group underwent treatment . Among the active treatment group 61.9 % of parents reported cure . In the sham group no parent reported cure ( p visual analogue scale a score of 10 was indicated by 13 parents in the test group , while 1 parent in the sham group indicated a score of 9 ( p = 0.002 ) . Additionally 100 % improvement was reported by 12 parents in the test group and no parent in the sham group . Toronto score improved significantly in the test group ( p significantly in the test group compared to the sham group ( p = 0.011 ) . In the test group average and maximum voided volumes showed a statistically significant increase and the number of voids daily decreased . After superficial scapular electrical stimulation 13 of the 16 patients who underwent parasacral transcutaneous electrical nerve stimulation were cured . CONCLUSIONS This is the first known r and omized clinical trial to demonstrate that parasacral transcutaneous electrical nerve stimulation is effective in the treatment of children with overactive bladder",
"BACKGROUND The aim of the present study was to investigate whether addition of transcutaneous electrical nerve stimulation ( TENS ) treatment improves the results of st and ard urotherapy in children with overactive bladder ( OAB ) symptoms . MATERIAL AND METHODS Sixty-two children with symptoms of OAB and incontinence were included . The children were r and omized either to st and ard urotherapy treatment alone or a combination of st and ard urotherapy and TENS . The effect variables were taken from a voiding-drinking diary : number of voiding , number of incontinence episodes , and maximum voided volume . RESULTS Both treatment groups had good treatment results , with no significant difference between the groups . In the st and ard treatment group 13/28 ( 46 % ) were completely dry and 11/28 ( 40 % ) had a decrease in incontinence episodes , compared to 16/24 ( 67 % ) and 3/24 ( 13 % ) , respectively , in the st and ard+TENS group ( p=0.303 ) . The number of voiding decreased in two-thirds of the patients in both groups . However , maximal voided volume only increased in the st and ard treatment group . Subjectively 72 % and 80 % considered themselves significantly improved or free of symptoms . Previous treatment was registered in 15/55 ( 27 % ) . All efficacy variables decreased in those with previous treatment , but with no difference between the st and ard and st and ard+TENS treatment groups . The only difference noted was when comparing the children without previous treatment in the groups : a significantly higher proportion were completely dry in the TENS group ( 12/18 [ 71 % ] versus 10/22 [ 48 % ] , p=0.05 ) . CONCLUSION Our results showed no significant difference overall in treatment response to OAB symptoms between urotherapy only and urotherapy+TENS , whereas a tendency to difference was found in children without previous treatment . Thus with good urotherapy support , TENS only seems to have marginal additional effects on OAB symptoms",
"INTRODUCTION Overactive bladder ( OAB ) is the most prevalent voiding disorder in childhood , and its main manifestation is urinary urgency . In general , urotherapy and anticholinergics are the first choices of treatment . Parasacral Transcutaneous Electrical Neural Stimulation ( PTENS ) was introduced as an alternative for the treatment of detrusor overactivity in children , but treatment protocol s described to date require several sessions per week or long-lasting sessions , making it difficult for the child to adhere to the treatment . Thus , this study aims to evaluate the effectiveness of PTENS in single weekly sessions in the treatment of OAB in children . STUDY DESIGN This prospect i ve , r and omized controlled trial included 16 children with OAB . Children were divided into two groups : CG ( urotherapy and electrical stimulation placebo ) and EG ( urotherapy and PTENS ) . For both groups , therapy was delivered in 20 weekly sessions , of duration 20 min each . Placebo electrical stimulation was done in the scapular area . The children were evaluated prior to treatment ( T1 ) , at the end of the 20 sessions ( T2 ) , and 60 days after the completion of treatment ( T3 ) , with a 3-day voiding diary , visual analogue scale ( VAS ) , Rome III diagnostic criteria , and the Bristol Scale . RESULTS The groups were similar in age , gender , and ethnicity . In the initial assessment , all children , in both groups , had urgency and incontinence , 50 % in each group had constipation , and enuresis was present in seven children ( 87.5 % ) in the EG and six ( 75 % ) in the CG . No differences were found between the groups regarding the volumetric measurements made in the voiding diary , urinary frequency and constipation evaluated by the Rome III criteria and the Bristol Scale . Sixty days after treatment , a significant improvement was found in the EG group ( p = 0.03 ) regarding urgency ( Table ) , as well as an increase in dry nights in those presenting with enuresis ( p = 0.03 ) . No difference was noted regarding urinary incontinence ( Table ) . At the end of 20 sessions and after 60 days of treatment , those responsible for the children in the EG perceived greater improvement in symptoms measured by the VAS ( p = 0.05 and 0.04 , respectively ) . CONCLUSIONS Our preliminary results demonstrate that PTENS performed in single weekly sessions is effective in treating the bladder for symptoms of urinary urgency and enuresis , and in the perception of those responsible for the children . Further studies with larger population s are needed to corroborate these results",
"BACKGROUND Until now no confirmatory clinical trial in children suffering from nonneurogenic overactive bladder ( OAB ) and urinary incontinence could demonstrate superiority for antimuscarinics over placebo . OBJECTIVES The following study was conducted to prove efficacy and tolerability of propiverine compared to placebo . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled phase 3 trial with parallel-group design in children aged 5 - 10 yr was performed . Prior to the 8-wk medical therapy urologic baseline diagnostics , a 3-wk lifestyle advice ( urotherapy ) was established . INTERVENTION After re-evaluation of in- and exclusion criteria and uroflowmetry , only children fulfilling the requested criteria were allocated to a body-weight-adjusted therapy ( 10 or 15 mg propiverine twice daily or corresponding placebo ) . MEASUREMENTS Efficacy parameters derived from bladder diary and a micturition volume protocol . Decrease in voiding frequency per day was chosen as primary efficacy parameter ; secondary endpoints included voided volume and incontinence episodes . A safety assessment was conducted . RESULTS AND LIMITATIONS Of 171 r and omized children , 87 were treated with propiverine and 84 with placebo . The primary efficacy parameter showed a decrease in voiding frequency ( -2.0 episodes for propiverine versus -1.2 for placebo ; p=0.0007 ) . Superiority could also be demonstrated for voided volume ( 31.4 vs. 5.1 ml ; p incontinence episodes ( -0.5 vs. -0.2 episodes per d ; p=0.0005 ) . The trial design did not allow for separate evaluation of the effect of urotherapy prior to medical treatment . Propiverine was well-tolerated in children . Altogether 23 % of side-effects were reported for propiverine and 20 % for placebo . CONCLUSIONS This clinical trial showed superior efficacy of propiverine over placebo and good tolerability for the treatment of children suffering from OAB and urinary incontinence . An important additional factor for the success of the trial was a modified trial design with previous urotherapy . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00603343",
"PURPOSE Transcutaneous electrical stimulation ( TES ) ( 3 sessions/wk ) over the abdomen stimulated bowel functions in a r and omized controlled trial . This pilot study assessed whether daily TES at home with a safe , portable machine would be possible and more efficacious than trial results . METHODS Eleven patients ( 6 male/5 female ; mean age , 14 years ; range , 12 - 18 years ) with slow-transit constipation who relapsed or responded poorly in the trial were recruited ( 11 + /- 5 months later ) . An EPM-IF-4160 ( Fuji Dynamics , Hong Kong ) portable machine ( sine waveform , 4 kHz carrier frequency , 80 - 160 Hz beat frequency , intensity delivering interferential current ( 2 electrodes over epigastrium + 2 over kidneys ) was applied 1 hour daily at home . Continence diaries were kept for 1 month before and 2 months during treatment . RESULTS All children completed more than 1 month of treatment after baseline recording . Defecation increased in 9 of 11 children , and soiling decreased in 4 of 11 children . There was a significant increase in total episodes of defecation per week ( mean + /- SD , 2.5 + /- 2.1 vs 6.7 + /- 4.4 ; P = .008 ) and a nonsignificant decrease in soiling ( 3.8 + /- 1.6 vs 1.1 + /- 0.5 episodes/wk , P = .1 ) . Daily stimulation does not affect abdominal pain . No adverse events occurred . CONCLUSIONS Daily TES at home is safe and significantly improved bowel function in children who did not respond to 3 times per week of TES . Home TES may be a novel treatment of intractable slow transit constipation , avoiding hospital visits",
"PURPOSE We evaluated the effect of percutaneous electrical nerve stimulation on voiding dysfunction in a group of children with therapy resistant , nonneuropathic bladder sphincter dysfunction . MATERIAL S AND METHODS In a prospect i ve study 17 boys and 15 girls with mean age of 11.7 years underwent percutaneous electrical nerve stimulation after the failure of more than 2 years of urological and /or pharmacotherapy . The device for percutaneous electrical nerve stimulation consists of an interface cable , a surface electrode , a percutaneous needle and a portable stimulator . The needle is inserted at the tibial nerve level and a portable stimulator provided pulsations at a frequency of 20 Hz . for 30 minutes once weekly . Every 6 weeks the children were evaluated . Evaluation parameters were urgency , daytime incontinence , voiding frequency , the uroflowmetry curve and bladder capacity . When favorable results were observed after 6 sessions , therapy was continued for another 12 sessions . In 24 children anticholinergics started before stimulation that had only a partial effect were continued during stimulation . RESULTS In 7 of the 28 children with urgency before therapy it disappeared after therapy and in 10 it improved . Of the 23 children with daytime incontinence before treatment 4 became dry after stimulation and in 12 incontinence decreased . Of the 19 patients who reported disturbed voiding frequency of less than 4 or more than 8 voids daily 16 achieved a normal frequency of 4 to 6 voids daily . In 21 children an abnormal uroflowmetry curve was observed before stimulation , while in 9 the flow curve was normal after therapy . Mean bladder capacity increased significantly from 185.16 to 279.19 ml . CONCLUSIONS Percutaneous electrical nerve stimulation has a significant effect on voiding frequency , the uroflowmetry curve and bladder capacity in children with nonneurogenic bladder sphincter",
"OBJECTIVE To study the epidemiology of micturition disturbances in teenagers . SUBJECTS AND METHODS A sub sample of 1034 teenagers previously evaluated at age 7 years was reinvestigated 10 years later . A postal question naire was used and a response rate of 71 % ( 736 ) obtained . Those who reported bladder symptoms were contacted by telephone for a detailed history concerning imperative urge , daytime incontinence , emptying difficulties and bedwetting . RESULTS There was a general decrease in the frequency and intensity of symptoms from 7 to 17 years of age . At age 17 at least one symptom was reported by 5.9 % of the girls and 0.9 % of the boys . Overall the symptoms were regarded as mild or moderate . CONCLUSION At age 17 years , micturition disturbances were reported infrequently and few subjects wanted medical help",
"BACKGROUND Solifenacin , an effective , well-tolerated treatment for adult overactive bladder ( OAB ) symptoms , has not been evaluated in placebo-controlled paediatric clinical trials . OBJECTIVES To evaluate the efficacy and safety of once-daily oral solifenacin suspension in OAB patients aged 5- DESIGN , SETTING , AND PARTICIPANTS The study involved a 4-wk urotherapy run-in followed by 1:1 r and omisation to 12-wk double-blind solifenacin or placebo treatment alongside urotherapy . INTERVENTION Solifenacin paediatric equivalent doses ( PEDs ) of adult doses : 2.5 mg , 5 mg , 7.5 mg , and 10 mg . The starting dose was PED 5 mg ; all patients were titrated to an optimum dose at 3-wk intervals over 9 wk , result ing in ≥3 wk at the optimum dose before end of treatment ( EoT ) . OUTCOME MEASUREMENTS AND STATISTICS Superiority of solifenacin versus placebo in change from baseline to EoT for mean volume voided/micturition ( MVV , primary endpoint ) ; daytime maximum volume voided/micturition ( DMaxVV ) ; incontinence episodes ( mean/24h ) ; mean number of incontinence-free days or nights/7 d ; micturition frequency ; and Micturition frequency adjusted for baseline total voided volume ( VTB ) as an exploratory parameter ) . Efficacy parameters were analysed using analysis of covariance . Safety parameters ( treatment-emergent adverse events , serious adverse events , laboratory variables , vital signs , electrocardiogram , postvoid residual volume ) are summarised using descriptive statistics . RESULTS AND LIMITATIONS In children , solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV ( solifenacin-placebo difference 12.1ml , 95 % confidence interval [ CI ] 0.2 - 24.0 ; p=0.046 ) , DMaxVV ( difference in adjusted mean change from baseline for solifenacin-placebo 31.9ml , 95 % CI 4.3 - 59.5 ; p=0.024 ) , VTB-adjusted micturition frequency ( p=0.028 ) . Other endpoints were not significantly different . Solifenacin was well tolerated . For adolescents , it was not possible to draw firm efficacy conclusions because of the low numbers recruited . CONCLUSIONS Once-daily solifenacin oral suspension in children with OAB was superior to placebo for MVV ( primary efficacy endpoint ) and was well tolerated . PATIENT SUMMARY In this 12-wk study , a once-daily oral suspension of solifenacin in children aged 5- was superior to placebo in increasing mean volume voided/micturition , the primary efficacy variable in the study . Solifenacin was well tolerated , with a low incidence of dry mouth and constipation . This study is registered at Clinical Trials.gov as NCT01565707",
"OBJECTIVE To determine the prevalence and natural history of urinary symptoms and incontinence among healthy adolescent schoolchildren . SUBJECTS AND METHODS A prospect i ve longitudinal study using a confidential question naire administered to an original cohort of 1176 local schoolchildren at 11 - 12 years and again at 15 - 16 years old . RESULTS There was a decrease in the prevalence of urinary symptoms with age . Daywetting was reported by 12.5 % of children aged 11 - 12 years and 3.0 % of children aged 15 - 16 years . Nocturnal enuresis was reported by 4.7 % of children at 11 - 12 years and 1.1 % at 15 - 16 years . Some of the children reporting daywetting and nocturnal enuresis at 15 - 16 years old had not reported these symptoms at 11 - 12 years old . CONCLUSION Urinary symptoms become less prevalent with age , but are reported by a significant number of healthy schoolchildren",
"PURPOSE We evaluated the efficacy of transcutaneous neuromodulation to treat urinary urgency and urge incontinence in children with nonneurological bladder dysfunction . MATERIAL S AND METHODS Surface neuromodulation was delivered via skin electrodes away from the genital region for a short duration daily on a home treatment basis . Clinical outcome was measured by 3 tools previously tested for reliability including the frequency volume chart , urgency visual analog scale and accident diary ( \" Dry Pie \" ) . RESULTS After at least 1 month of application dryness had improved in 73.3 % of children , mean urgency score had improved to equate action at urge as being ' easy to hold on ' and there was a significant increase in mean voided volume . CONCLUSIONS Initial evaluation of the home application of surface neuromodulation in children with urgency and /or urge incontinence revealed positive results and warrants a r and omized controlled investigation . The finding that children were not completely dry with this treatment in isolation suggests that further study is needed to identify optimal treatment duration and stimulus intensity",
"PURPOSE We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a r and omized clinical trial . MATERIAL S AND METHODS Nine boys and 19 girls with a mean ± SD age of 6.4 ± 2.18 years were r and omly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy . Success was assessed by 1 ) the rate of complete symptom resolution , 2 ) a visual analog scale of 0 to 10 , 3 ) the dysfunctional voiding score system , 4 ) voiding diary records , 5 ) Rome III criteria and 6 ) side effect frequency in each group . RESULTS A total of 13 and 15 patients were r and omized to groups 1 and 2 , respectively . Symptoms completely resolved in 6 patients in group 1 ( 46 % ) and 3 in group 2 ( 20 % ) ( p = 0.204 ) . A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records . However , no statistically significant difference was found between the groups in the visual analog scale score , voiding frequency , and maximum and mean voided volume ( p = 0.295 , 0.098 , 0.538 and 0.650 , respectively ) . Constipation improved in 100 % of group 1 patients but in only 55 % in group 2 ( p = 0.031 vs 0.073 ) . Group 1 showed no side effects while dry mouth , hyperthermia and hyperemia developed in 58 % , 25 % and 50 % of group 2 patients ( p = 0.002 , 0.096 and 0.005 , respectively ) . Treatment was discontinued by 13.3 % of patients in group 2 . CONCLUSIONS Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children . However , transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects . Oxybutynin was more effective for decreasing voiding frequency "
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QUESTION What is the effect of exercise on increasing participation and activity levels and reducing impairment in the rehabilitation of people with upper limb fractures ? DESIGN Systematic review of controlled trials . PARTICIPANTS Adults following an upper limb fracture . INTERVENTION Any exercise therapy program , including trials where exercise was delivered to both groups provided that the groups received different amounts of exercise . OUTCOME MEASURES Impairments of body structure and function , activity limitations and participation restrictions . RESULTS Twenty-two trials were identified that evaluated 1299 participants with an upper limb fracture . There was insufficient evidence from 13 trials to support or refute the effectiveness of home exercise therapy compared with therapist-supervised exercise or therapy that included exercise following distal radius or proximal humeral fractures . There was insufficient evidence from three trials to support or refute the effectiveness of exercise therapy compared with advice/no exercise intervention following distal radius fracture . There was moderate evidence from five trials ( one examining distal radius fracture , one radial head fracture , and three proximal humeral fracture ) to support commencing exercise early and reducing immobilisation in improving activity during upper limb rehabilitation compared with delayed exercise and mobilisation . There was preliminary evidence from one trial that exercise to the non-injured arm during immobilisation might lead to short-term benefits on increasing grip strength and range of movement following distal radius fracture . Less than 40 % of included trials reported adequate exercise program descriptions to allow replication according to the TIDieR checklist . CONCLUSION There is emerging evidence that current prescribed exercise regimens may not be effective in reducing impairments and improving activity following an upper limb fracture . Starting exercise early combined with a shorter immobilisation period is more effective than starting exercise after a longer immobilisation period . REGISTRATION CRD42016041818 . [ Bruder AM , Shields N , Dodd KJ , Taylor NF ( 2017 ) Prescribed exercise programs may not be effective in reducing impairments and improving activity during upper limb fracture rehabilitation : a systematic review . Journal of Physiotherapy 63 : 205 - 220 ]
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"BACKGROUND There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocol s for distal radial fractures treated with open reduction and internal fixation ( ORIF ) . The purpose of this study was to compare the early postoperative outcomes ( at zero to twelve weeks postoperatively ) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a st and ard rehabilitation protocol following ORIF for a distal radial fracture . We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a st and ard protocol . METHODS From November 2007 to November 2010 , eighty-one patients with an unstable distal radial fracture were prospect ively r and omized to follow either an accelerated or a st and ard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture . Both groups began with gentle active range of motion at three to five days postoperatively . At two weeks , the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises , whereas the st and ard group initiated passive range of motion and strengthening at six weeks postoperatively . Patients were assessed at three to five days , two weeks , three weeks , four weeks , six weeks , eight weeks , twelve weeks , and six months postoperatively . Outcomes included Disabilities of the Arm , Shoulder and H and ( DASH ) scores ( primary outcome ) and measurements of wrist flexion/extension , supination , pronation , grip strength , and palmar pinch . RESULTS The patients in the accelerated group had better mobility , strength , and DASH scores at the early postoperative time points ( zero to eight weeks postoperatively ) compared with the patients in the st and ard rehabilitation group . The difference between the groups was both clinical ly relevant and statistically significant . CONCLUSIONS Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more st and ard rehabilitation protocol . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence",
"Unilateral Colles ' fractures in 187 patients over the age of 55 years were studied in a r and omised prospect i ve trial : 97 fractures were minimally displaced and were treated either conventionally or in a crêpe b and age ; 90 displaced Colles ' fractures were reduced and of these 47 were treated conventionally while 43 were encouraged to mobilise the wrist in a cast which restricted extension . Early wrist movement hastened functional recovery and led to earlier resolution of wrist swelling . Discomfort was no greater than in patients who were treated conventionally . The bony deformity , which recurred irrespective of the method of treatment , was not adversely affected by early mobilisation",
"PURPOSE To investigate whether there was a difference in Patient-Rated Wrist H and Evaluation ( PRWHE ) scores between patients with and without comorbidities who receive regular supervised therapy provided by a certified h and therapist ( CHT ) compared with patients who were provided with a home exercise program and were regularly monitored . METHODS Fifty patients with a diagnosis of distal radius fractures and volar plate fixation were enrolled in a prospect i ve , r and omized clinical trial comparing those who received therapy under the supervision of a CHT with those enrolled in a home exercise program that was instructed and monitored by a CHT . The primary outcome measure ( PRWHE ) and secondary outcome measures , total arc of motion for wrist flexion and extension , supination and pronation , and grip strength , were assessed at 12 weeks . The primary outcome measure for both groups was also gathered at 6 months . RESULTS There were no statistically significant differences between the final scores of the PRWHE , wrist or forearm motion , pain , or grip strength between groups . Effect size calculations revealed that both groups experienced a large effect size for all outcomes . CONCLUSIONS Supervised clinic-based therapy is equally beneficial for patients without complications . Clinic-based therapy may be preferable for patients with noteworthy complications after a distal radius fracture with volar plate fixation . Patients with decreased finger motion and various comorbidities may benefit from therapy provided in a clinic under the supervision of a certified h and therapist . TYPE OF STUDY /LEVEL OF EVIDENCE Therapeutic II",
"Background Distal radius fractures are among the most common fractures and account for approximately one-sixth of all fractures diagnosed . Therapy results after distal radius fracture , especially of elderly patients , are often suboptimal . The inevitable immobilization for several weeks leads to reduction in range of motion , deterioration of muscle strength , malfunction of fine motor skills as well as changes of motor and sensory representations in the brain . Currently , there are no strategies to counteract these immobilization problems . The overall aim of the study is to investigate the therapeutic potential of motor-cognitive approaches ( mental practice or mirror therapy ) on h and function after wrist fracture . Methods / Design This study is a controlled , r and omized , longitudinal intervention study with three intervention groups . One experimental group imagines movements of the fractured upper extremity without executing them ( mental practice ) . The second experimental group receives a mirror therapy program consisting of the performance of functional movement synergies using the unaffected forearm , wrist , and h and . The control group completes a relaxation training regime . Additionally , all patients receive usual care by the general practitioner . We include women aged 60 years and older having a distal radius fracture and sufficient cognitive function . All groups are visited at home for therapy sessions 5 times per week for the first 3 weeks and 3 times per week for weeks 4 to 6 . Measurements are taken at therapy onset , and after 3 , 6 and 12 weeks . The primary outcome measure will assess upper extremity functioning ( Patient-Rated Wrist Evaluation [ PRWE ] ) , while secondary outcome measures cover subjective wrist function ( Disabilities of the Arm and Shoulder ; [ DASH ] , objective impairment ( range of motion , grip force ) and quality of life ( EuroQol-5D , [ EQ5D ] ) . Discussion Results from this trial will contribute to the evidence on motor-cognitive approaches in the early therapy of distal radius fractures . Trial registration The trial is registered at Clinical Trials.gov with registration number NCT01394809 and was granted permission by the Medical Ethical Review Committee of the University of Tübingen in June 2011",
"The results of a prospect i ve controlled trial of early mobilisation of Colles ' fractures in the elderly are presented . Early mobilisation produced less pain and a stronger grip . It did not lead to any greater loss of reduction of the fracture . However , there was no significant improvement in the final range of movement of the wrist . Immobilisation of the wrist for six weeks in plaster is extremely inconvenient for the elderly living alone and the patients greatly appreciated the reduction of this period of time to a minimum",
"Abstract Colles ’ fracture patients who received physiotherapy immediately following cast removal were compared with patients who received no active therapy following cast removal in a prospect i ve r and omised study . Patients who attended physiotherapy achieved significantly greater increases in wrist extension and grip strength after 6 weeks compared to patients who received no active therapy",
"42 patients with undisplaced , proximal humeral fractures were r and omly assigned into two groups in order to compare the results of instruction to the patient for independent exercises and conventional physiotherapy . No differences appeared between the groups subjectively or as regards functional parameters at 1 as well as at 3 months after the fracture and at a follow up more than 1 year later . As no disadvantage could be found instructions to the patients should in these cases be regarded as a satisfactory after-treatment",
"Introduction This study was conducted according to GCP criteria as a prospect i ve r and omized cross-over study . The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment . 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period . Each patient r and omly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis applied postoperatively in the operating theatre to achieve postoperative immobilization . After one week all patients were crossed over to the complementary device maintaining the immobilization until end of week 2 . After week 2 both groups were allowed to exercise wrist mobility with a physiotherapist , in the orthosis group the device was deblocked , thus allowing limited wrist mobility . After week 4 the devices were removed in both groups . Follow-up exams were performed after postoperative weeks 1 , 2 , 4 and 12 . Results and Discussion Results were determined after week 1 and 2 using SF 36 and a personally compiled question naire ; after weeks 4 and 12 with a clinical check-up , calculation of ROM and the DASH Score . Comparison of the two groups showed a significant difference in ROM for volar flexion after 4 weeks , but no significant differences in DASH Score , duration of disability or x-ray findings . With regard to satisfaction with comfort and hygiene , patients were significantly more satisfied with the dynamic orthosis , and 23 of the 29 patients would prefer the flexible vacuum orthosis in future . Trial Registration German Clinical Trials Register ( DRKS )",
"OBJECTIVE To determine the effect of 2 different postoperative therapy approaches after operative stabilization of the wrist fractures : treatment by a physical therapist with 12 sessions and an unassisted home exercise program . DESIGN R and omized controlled cohort study . SETTING Hospital-based care , primary center of orthopedic surgery . PARTICIPANTS Volunteers ( N=48 ) with fractures of the distal radius after internal fixation with locking plates . There were 46 patients available for follow-up after exclusion of 2 participants due to physiotherapy sessions in excess of the study protocol . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Evaluation of grip strength using a Jamar dynamometer , range of motion ( ROM ) , and Patient Related Wrist Evaluation ( PRWE ) . RESULTS After a 6-week period of postoperative treatment , the patients ( n=23 ) performing an independent home exercise program using a training diary showed a significantly greater improvement of the functionality of the wrist . Grip strength reached 54 % ( P=.003 ) , and ROM in extension and flexion 79 % ( P Ulnar and radial abduction was also higher in this group . In contrast , patients who were treated by a physical therapist achieved grip strength equal to 32 % , and ROM in extension and flexion of 52 % of the uninjured side . Patients who were performing the home training after operation recorded an improved wrist function with a nearly 50 % lower value ( P PRWE score . CONCLUSIONS In the postoperative rehabilitation of wrist fractures , instructions in a home exercise program are an effective alternative to prescribed physical therapy treatment",
"QUESTION Are 6 weeks of synergistic wrist and finger exercises with the metacarpophalangeal joint constrained in an orthosis ( constrained exercises ) more effective than traditional finger exercises with the metacarpophalangeal joint unconstrained ( unconstrained exercises ) after open reduction and internal fixation of a proximal phalangeal fracture in terms of impairment , activity limitation and participation restriction at 6 and 12 weeks ? DESIGN R and omised , parallel-group trial with concealed allocation , intention-to-treat analysis and blinded outcome assessors . PARTICIPANTS Sixty-six participants within 1 week of open reduction and internal fixation of proximal phalangeal fractures . INTERVENTION The experimental group carried out 6 weeks of synergistic wrist and finger exercises with the metacarpophalangeal joint constrained , whilst the control group carried out finger exercises with the metacarpophalangeal joint unconstrained , as part of a comprehensive rehabilitation program . OUTCOME MEASURES The primary outcomes were : active proximal interphalangeal joint extension of the injured finger , total active range of motion , and strength . Secondary outcomes were : pain , difficulty with specific h and activity and difficulty with usual h and activity . A blinded assessor measured outcomes at Weeks 1 , 6 and 12 . RESULTS By Week 6 , there were no significant between-group differences in improvement for : active proximal interphalangeal joint extension ( MD 2 deg , 95 % CI -3 to 7 ) ; total active finger range of motion ( MD 0 deg , 95 % CI -21 to 22 ) ; strength ( MD -2 kg , 95 % CI -8 to 4 ) ; pain ( MD 1/50 , 95 % CI -3 to 5 ) ; difficulty with specific h and activity ( MD 2/60 , 95 % CI -3 to 8) ; or difficulty with usual h and activity ( MD 0/40 , 95 % CI -4 to 3 ) . By Week 12 , there were also no significant between-group differences in any outcome . CONCLUSIONS Constrained and unconstrained exercises has similar effects after open reduction and internal fixation of proximal phalangeal fracture . REGISTRATION Australian New Zeal and Clinical Trials Registry ( ACTRN12610000294055 )",
"Two methods of physiotherapy after fracture of the proximal end of the humerus were compared . The study was design ed as a r and omized , controlled and single-blind trial . Twenty patients were assigned to two groups 10 - 12 days after the injury . One group was treated conventionally , the other received instructions in self-training with follow-up control of results . Objective examination and subjective assessment were made at five intervals , up to one year after the injury . The greatest improvement in function was shown in both groups between 3 and 8 weeks . The patients deemed their daily life functions to be normal 8 weeks after the injury . The objective assessment was normal at later stages . No significant differences were found between the two groups in any of the tests . Instruction in self-training with control of results including objective assessment s are therefore an adequate method in the rehabilitation of these patients",
"Ninety consecutive women with unilateral Colles ' fractures were r and omized into two different treatment groups . The control group was treated for 5 weeks in conventional short-arm , below the elbow plaster of Paris casts . The other group ( N = 45 ) was treated similarly in plaster casts for 3 weeks and then had flexible casting applied for the remaining 2 weeks which allowed for early joint mobilization . Functional recovery was assessed by measuring grip strength and joint mobility at intervals over the 3 years . Radiographic and overall assessment s were also made during 3 year course of study . Virtually all patients reported greater comfort after switching to the flexible casting . Mean grip scores and joint mobilities were higher at all time points with early mobilization , reaching levels of statistical significance at 6 months for grip score and at 3 months for joint mobility . By 3 years most differences between treatment groups had resolved . We found no evidence that early mobilization was detrimental to recovery . We conclude that early mobilization is a satisfactory treatment option for Colles ' fracture , and may , in fact , hasten functional recovery",
"Forty patients participated in a study of the importance of early occupational therapy for the prognosis in stable Colles ' fractures . Seventeen patients were treated by an occupational therapist 1 - 3 days after the injury , and the need for appliances and home-care was estimated . Twenty-three patients completed the usual treatment . Five weeks after the injury , we found significantly ( p less than 0.05 ) better function of the h and in the 17 patients with early occupational therapy . This difference in function could not be found after 13 weeks . The rate of complications was the same in the two groups . The results indicate that contact with the occupational therapist shortly after the injury is valuable in patients with stable Colles ' fractures",
"Background Exercise programmes have shown to be important for the prevention of fractures in patients with established osteoporosis . However , few studies have evaluated the effect of such programmes for women with low bone mineral density ( BMD ) ( osteoporosis or osteopenia ) who have already suffered a fracture . Studies have indicated that exercise programmes concentrating on muscular strength and dynamic balance have a positive effect on significant risk factors for falls such as quadriceps strength and balance . The aim of the present study was to assess the effect of a 6-month exercise programme and a patient education component ( OsteoACTIVE ) on quadriceps strength , BMD , dynamic balance , walking capacity , physical activity level and quality of life in postmenopausal women with osteopenia and a previous wrist fracture . Methods Eighty postmenopausal women with low BMD and a healed wrist fracture were r and omized to OsteoACTIVE ( n = 42 ) ( age 65.5 , range 51.2–79.2 years ) or patient education only ( control group ) ( n = 38 ) ( age 63.9 , range 52.7–86.8 years ) . Follow-up was conducted after 6 months ( end of intervention ) and 1 year . Outcome measures included quadriceps strength , BMD , dynamic balance , walking capacity , physical activity level and quality of life . Results Thirty-five participants ( 83 % ) completed the OsteoACTIVE programme . Mean adherence to OsteoACTIVE was 87 % ( range 48–100 % ) . Twenty-five participants ( 72 % ) met the a priori goal of 80 % adherence to the program . No adverse events were reported . There were no significant differences between the two groups over the 1-year follow-up for any of the outcome measures . Conclusion The OsteoACTIVE rehabilitation programme revealed no significant effect on quadriceps strength , BMD , dynamic balance , walking capacity or self-reported functional outcomes over the 1-year follow-up . Trial registration NCT01357278 at Clinical Trials.gov ( date of registration 2010 - 04 - 21 )",
"Summary Aim To evaluate the efficacy of combined physical and occupational therapy in comparison with physical therapy alone in patients with conservatively treated distal radius fracture . Methods Sixty-one participants , conservatively treated after a distal radius fracture , were included in a r and omized and single-blind trial . Group A had physical therapy only ( n = 31 ) and group B had physical and occupational therapy ( n = 30 ) . The assessment was performed three times : upon inclusion in the study in the first week after removal of the cast ( T1 ) , immediately after the end of the rehabilitation ( T2 ) , and 1 month after completing the rehabilitation ( T3 ) . The passive wrist range-of-motion , grip strength , and Disabilities of Arm , Shoulder and H and ( DASH ) score were used as rehabilitation outcomes . Results Rehabilitation outcomes were analyzed using two-way mixed analysis of variance . The effect of time was statistically significant ( p grip strength only ( p = 0.038 ) . The interaction effect was statistically significant for rotation ( p = 0.034 ) and grip strength ( p = 0.021 ) . A comparison between time points T3:T1 showed statistically significant difference in grip strength in favor of group B 67 % ( 95 % CI 60–74 % ) versus group A 53 % ( 95 % CI 45–61 % ) , p = 0.024 . Conclusion The combined therapy result ed in a statistically significant increase of grip strength in comparison with isolated physical therapy in the period of 12–16 weeks after the fracture . This effectiveness was not confirmed with DASH score results",
"BACKGROUND There have been few r and omized controlled trials evaluating nonoperative treatment of proximal humeral fractures . To investigate shortening the period of dependence , we assessed the feasibility and efficacy of early mobilization of the shoulder ( within three days after the fracture ) in comparison with those of conventional three-week immobilization followed by physiotherapy . METHODS We r and omly assigned seventy-four patients with an impacted proximal humeral fracture to receive early passive mobilization or conventional treatment . The primary outcome was the overall shoulder functional status ( as measured with the Constant score ) at three months . The secondary outcomes were the Constant score at six weeks and at six months , the change in pain ( on a visual analog scale ) , and the active and passive range of motion . RESULTS At three months and at six weeks , the early mobilization group had a significantly better Constant score than did the conventional-treatment group ( between-group difference , 9.9 [ 95 % confidence interval , 1.9 to 17.8 ] [ p = 0.02 ] and 10.1 [ 95 % confidence interval , 2.0 to 18.1 ] [ p = 0.02 ] , respectively ) and better active mobility in forward elevation ( between-group difference , 12.0 [ 95 % confidence interval , 1.7 to 22.4 ] [ p = 0.02 ] and 28.1 [ 95 % confidence interval , 7.1 to 49.1 ] [ p = 0.01 ] , respectively ) . At three months , the early mobilization group had significantly reduced pain compared with the conventional-treatment group ( between-group difference , 15.7 [ 95 % confidence interval , 0.52 to 30.8 ] [ p = 0.04 ] ) . No complications in displacement or nonhealing were noted . CONCLUSIONS Early mobilization for impacted nonoperatively treated proximal humeral fractures is safe and is more effective for quickly restoring the physical capability and performance of the injured arm than is conventional immobilization followed by physiotherapy",
"OBJECTIVE To evaluate the effects of cross-education ( contralateral effect of unilateral strength training ) during recovery from unilateral distal radius fractures on muscle strength , range of motion ( ROM ) , and function . DESIGN R and omized controlled trial ( 26-wk follow-up ) . SETTING Hospital , orthopedic fracture clinic . PARTICIPANTS Women older than 50 years with a unilateral distal radius fracture . Fifty-one participants were r and omized and 39 participants were included in the final data analysis . INTERVENTIONS Participants were r and omized to st and ard rehabilitation ( Control ) or st and ard rehabilitation plus strength training ( Train ) . St and ard rehabilitation included forearm casting for 40.4±6.2 days and h and exercises for the fractured extremity . Nonfractured h and strength training for the training group began immediately postfracture and was conducted at home 3 times/week for 26 weeks . MAIN OUTCOME MEASURES The primary outcome measure was peak force ( h and grip dynamometer ) . Secondary outcomes were ROM ( flexion/extension ; supination/pronation ) via goniometer and the Patient Rated Wrist Evaluation question naire score for the fractured arm . RESULTS For the fractured h and , the training group ( 17.3±7.4 kg ) was significantly stronger than the control group ( 11.8±5.8 kg ) at 12 weeks postfracture ( P no significant strength differences between the training and control groups at 9 ( 12.5±8.2 kg ; 11.3±6.9 kg ) or 26 weeks ( 23.0±7.6 kg ; 19.6±5.5 kg ) postfracture , respectively . Fractured h and ROM showed that the training group had significantly improved wrist flexion/extension ( 100.5 ° ±19.2 ° ) than the control group ( 80.2 ° ±18.7 ° ) at 12 weeks postfracture ( P for flexion/extension ROM at 9 ( 78.0 ° ±20.7 ° ; 81.7 ° ±25.7 ° ) or 26 weeks ( 104.4 ° ±15.5 ° ; 106.0 ° ±26.5 ° ) or supination/pronation ROM at 9 ( 153.9 ° ±23.9 ° ; 151.8 ° ±33.0 ° ) , 12 ( 170.9 ° ±9.3 ° ; 156.7 ° ±20.8 ° ) or 26 weeks ( 169.4 ° ±11.9 ° ; 162.8 ° ±18.1 ° ) , respectively . There were no significant differences in Patient Rated Wrist Evaluation question naire scores between the training and control groups at 9 ( 54.2±39.0 ; 65.2±28.9 ) , 12 ( 36.4±37.2 ; 46.2±35.3 ) , or 26 weeks ( 23.6±25.6 ; 19.4±16.5 ) , respectively . CONCLUSIONS Strength training for the nonfractured limb after a distal radius fracture was associated with improved strength and ROM in the fractured limb at 12 weeks postfracture . These results have important implication s for rehabilitation strategies after unilateral injuries ",
"Abstract . In this r and omized trial , we enrolled 30 patients treated for a distal radius Colles ' type fracture . The fractures were reduced if necessary and fixed in a below-elbow plaster cast for 5 weeks . One group consisting of 14 patients received instructions for shoulder ; elbow and finger exercise and the other group consisting of 16 patients had occupational therapy . At 5 weeks , 3 and 9 months we measured the functional scores . There were no statistically significant differences between the groups at any time . It seems that for non-surgically treated patients with a distal radius fracture only instructions are necessary . Résumé . Etude r and omisée de 30 patients traités d'une fracture distale du radius de type Pouteaux-Colles . Les fractures furent réduites si nécessaire et fixées dans une manchette plâtrée durant 5 semaines . L'un des groupes était constitué de 14 patients qui avaient reçu des instructions d'exercices pour l'épaule , le coude et les doigts . L'autre groupe était constitué de 16 patients qui ont bénéficié d'une ergothérapie . Une évaluation a été faite après 5 semaines , 3 et 9 mois . Il n'avait aucune différence significative entre les 2 groupes en aucune période . Il semble ainsi suffisant , dans les fractures distales du radius traitées orthopédiquement , d'instruire les patients en vue d'une autoréeducation",
"QUESTION Does a program of exercise and structured advice implemented during the rehabilitation phase following a distal radial fracture achieve better recovery of upper limb activity than structured advice alone ? DESIGN A phase I/II , multi-centre , r and omised , controlled trial with concealed allocation , assessor blinding and intention-to-treat analysis . PARTICIPANTS Thirty-three adults ( 25 female , mean age 54 years ) following distal radial fracture managed in a cast . INTERVENTION The experimental intervention was a 6-week program of progressive exercise and structured advice implemented over three consultations by a physiotherapist . The control intervention was a program of structured advice only , delivered by a physiotherapist over three consultations . OUTCOME MEASURES The primary outcome was upper limb activity limitations , assessed by the Patient-Rated Wrist Evaluation and the shortened version of the Disabilities of the Arm , Shoulder and H and outcome measure ( QuickDASH ) . The secondary outcomes were wrist range of movement , grip strength and pain . All measures were completed at baseline ( week 0 ) , after the intervention ( week 7 ) and at 6 months ( week 24 ) . RESULTS There were no significant between-group differences in upper limb activity as measured by the Patient-Rated Wrist Evaluation at week 7 and week 24 assessment s ( mean difference -4 units , 95 % CI -10 to 2 ; mean difference 0 units , 95 % CI -3 to 3 , respectively ) , or QuickDASH at week 7 and week 24 assessment s ( mean difference -5 units , 95 % CI -16 to 6 ; mean difference 0.3 units , 95 % CI -6 to 7 , respectively ) . The secondary outcomes did not demonstrate any significant between-group effects . CONCLUSION The prescription of exercise in addition to a structured advice program over three physiotherapy consultations may convey no extra benefit following distal radial fracture managed in a cast . TRIAL REGISTRATION ACTRN12612000118808 . [ Bruder AM , Shields N , Dodd KJ , Hau R , Taylor NF ( 2016 ) A progressive exercise and structured advice program does not improve activity more than structured advice alone following a distal radial fracture : a multi-centre , r and omised trial . Journal of Physiotherapy62 : 145 - 152 ]",
"Objectives : We compared 2 different protocol s of early mobilization with a protocol of delayed mobilization in patients with simple radial head fractures ( B2.1 type of Orthopaedic Trauma Association Classification ) . An attempt to correlate certain characteristics of the radial head fractures with outcome was made . Design : Prospect i ve r and omized comparative study . Setting : Level 1 trauma center . Patients / Participants : One hundred eighty consecutive patients were r and omly allocated into 3 different protocol s. Intervention : In the first group , immediate mobilization of the elbow joint was applied . In the second , a sling was used for 2 days and then active mobilization was introduced . The third protocol represented the control group where immobilization in a cast for 7 days before the mobilization was applied . Main Outcome Measurements : Broberg and Morrey score , The American Shoulder and Elbow Surgeons-Elbow score , visual analogue scale , and grip and pinch strength were evaluated . Results : The 2 protocol s introducing early mobilization result ed in better outcome compared with immobilization . The first protocol result ed in worse pain in the first 3 days . Range of motion , strength , and functional outcome was better in patients allocated to the second protocol . These differences were more evident in displaced fractures . A fragment displacement of more than 4 mm and an angulation of more than 30 degrees proved to impair outcome . Conclusions : Early mobilization of simple radial head fractures seemed to be a safe and an effective treatment option . It seems that a delay of 48 hours before early mobilization could be advantageous . Individualization of treatment in accordance to the characteristics of fracture could be a decisive factor for outcome . Level of Evidence : Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence",
"The capacity for physiotherapy to improve the outcome after fracture of the distal radius is unproven . We carried out a r and omised controlled trial on 96 patients , comparing conventional physiotherapy with a regime of home exercises . The function of the upper limb was assessed at the time of removal of the plaster cast and at three and six months after injury . Factors which may predict poor outcome in these patients were sought . Grip strength and h and function did not significantly differ between the two groups . Flexion and extension of the wrist were the only movements to improve with physiotherapy at six months ( p = 0.001 ) . Predictors of poor functional outcome were malunion and impaired function before the fracture . These patients presented with pain , decreased rotation of the forearm and low functional scores at six weeks . Our study has shown that home exercises are adequate rehabilitation after uncomplicated fracture of the distal radius , and routine referral for a course of physiotherapy should be discouraged . The role of physiotherapy in patients at high risk of a poor outcome requires further investigation",
"The 2-year results of a r and omized , prospect i ve , controlled trial of minimally displaced proximal humeral fractures treated either by immediate physiotherapy ( group A ) or after 3 weeks of immobilization ( group B ) are reported . At 1 year shoulder disability , as measured with the Croft shoulder disability question naire , was found in 42.8 % of patients in group A and 72.5 % in group B ( P shoulder disability in group A remained unchanged ( 43.2 % ) but had reduced in group B ( 59.5 % ) . This difference was not statistically significant . Immediate physiotherapy after a minimally displaced proximal humeral fracture results in faster recovery , with maximal functional benefit being achieved at 1 year . Delayed rehabilitation by 3 weeks of shoulder immobilization produces a slower recovery , which continues for at least 2 years after the time of injury",
"Objective : To investigate whether progressive early digit mobilization result ed in better outcomes for h and stiffness and related functional results , as well as the effects on the bone healing process . Design : Prospect i ve , pilot r and omized controlled trial . Setting : A university hospital in southern Taiwan . Participants : Twenty-two patients with distal radius fracture r and omized into two groups : early digit mobilization or control . Interventions : The intervention group received 45 minutes per treatment session and three sessions per week until the external fixator was removed 6 weeks after fracture . The control group received usual home programmes . After removing fixators , both groups received regular rehabilitation programmes until 12 weeks after surgery . Main measures : H and strength , dexterity and functional outcomes were obtained using a dynamometer , Purdue pegboard and self-report assessment , respectively , and X-rays of the distal radius were taken to reveal bone healing 1 , 3 , 6 and 12 weeks after surgery . A motion tracking system measured various kinematic parameters . Results : The recovery rates between the groups showed statistically significant differences in both thumb workspace ( 81.55 % vs. 69.54 % , P = 0.04 ) and finger workspace ( 89.22 % vs. 59.97 % , P = 0.03 ) 12 weeks after injury . However , no statistical differences were found in finger dexterity , strength and self-reported outcomes . The radiographic assessment showed no significant differences between the groups for radial inclination , radial height and volar tilt throughout the examinations . Conclusions : The findings suggest that early rehabilitative intervention for digits is applicable for distal radius fracture treatment , and does not produce additional bone deformities",
"QUESTION Does an advice and exercise program improve outcome for adults following distal radius fracture ? DESIGN R and omised trial with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS Fifty-six patients whose fracture had been managed with pins and /or cast . INTERVENTION The experimental group received a physiotherapist-directed program of advice and exercises . The control group did not receive any physiotherapy intervention . OUTCOME MEASURES The primary outcome was wrist extension ( measured with a goniometer ) . Secondary outcomes were the other wrist ranges of motion ( measured with a goniometer ) , grip strength ( measured with a dynamometer ) , pain , and activity limitations ( measured with question naires ) . These outcomes were measured initially , then three and six weeks later . Participants also rated their satisfaction with physiotherapy intervention at Week 6 . RESULTS No difference was found between groups for the primary outcome of wrist extension ( mean difference 6 deg , 95 % CI -3 to 14 ) , nor for the secondary outcomes of other range of motion data and grip strength . The difference between groups for pain was -16 points out of 100 ( 95 % CI -27 to -5 ) at Week 3 , and -14 points ( 95 % CI -25 to -3 ) points at Week 6 , and for activity was -13 points out of 100 ( 95 % CI -24 to -2 ) at Week 3 ; in favour of the experimental group . The experimental group was also more satisfied with the amount of physiotherapy intervention . CONCLUSION An advice and exercise program provided some additional benefits over no intervention for adults following distal radius fracture",
"We compared two protocol s of early mobilisation for minimally displaced radial head fractures through a single-blinded , prospect i ve r and omised trial . Sixty patients were r and omly allocated to either immediate active mobilisation or 5-day delay before active mobilisation was commenced . Patients were review ed at 7 days , 4 weeks and 3 months after injuries . A blinded observer assessed each patient . All fractures united by the third month . At the end of 7 days , the mobilisation group had less pain ( visual analogue scale ( VAS ) 6 versus 7.6 , P=0.002 ) ; greater flexion ( mean 112 versus 98 degrees , P=0.0004 ) ; greater strength in supination ( P better elbow function ( Morrey Score : 54 versus 43 , P=0.005 ) . By the fourth week , both groups were comparable in all parameters and improvement continued into the third month . Mean limit of extension at the third month were 2.3 degrees in the immediate mobilisation group and 1.8 degrees in the delayed group ( NS ) . All had excellent function on the basis of the Morrey Score . Immediate mobilisation did not adversely affect the outcome ; the patients had less pain and better elbow function at 1-week post-injury . Pain , ranges of movement and function were similar by the fourth week post-injury",
"Introduction : Physiotherapy is considered by some authorities to be an important aspect of management in patients following distal radius fractures . There is evidence of improvement in impairment with physiotherapy ; however , there is no evidence to support early return of functional activity . Traditional physiotherapy management has focussed on improving impairment ; however , there are no trials with emphasis on skill acquisition via motor re-learning principles . Material s and methods : Forty-one participants with conservatively managed distal radius fractures were studied in a r and omised , single-blinded , prospect i ve trial . Two treatment options were compared : exercise and advice versus activity-focussed physiotherapy with measurement periods of 6 weeks after removal of cast and follow-up at 24 weeks . Results : Participants allocated to the exercise and advice group consulted a physiotherapist an average of 0.9 ( SD 0.4 ) times , while the participants allocated to the more intensive activity-focussed group consulted with physiotherapy a mean of 4.4 ( SD 2.3 ) times . At both 6 and 24 weeks there were no significant differences between the groups for change in impairment ( as measured by grip strength , range of motion of wrist flexion and extension and pain intensity ) , activity limitation and participation restriction , as measured by the Patient-Rated Wrist Evaluation ( PRWE ) . Exercise and advice given by a physiotherapist were equally as effective as activity-focussed physiotherapy in recovery both at 6 and 24 weeks . Conclusion : The results suggest that after removal of cast from fracture of distal radius , patients may routinely require no more than a single session of advice and exercise provided by a physiotherapist",
"This is a prospect i ve follow up of 190 consecutive cases of volar plate avulsion fractures . A st and ard management regimen of immediate , active movement was followed in all cases and physiotherapy was rarely required . Of the 190 patients , 162 were followed up for at least one year . An excellent or good outcome was achieved in 98 per cent . Patients presenting more than three weeks from injury had a worse outcome . The size and displacement of the avulsed fragment did not affect the outcome . For the stable joint , early active mobilisation with minimal or no splintage provides a good result",
"STUDY DESIGN R and omized controlled clinical trial . INTRODUCTION Manual edema mobilization ( MEM ) is a method of edema reduction based on the lymphatic system 's ability to drain and resolve subacute edema . PURPOSE OF THE STUDY To investigate the effect of a modified MEM approach and compare it with a traditional edema technique in patients with subacute h and /arm edema after a distal radius fracture . METHOD The patients were r and omized into one of two treatment groups : a group that received traditional edema treatment and a group that received a modified MEM treatment . All patients were examined for edema , active range of motion ( AROM ) , pain , and activities of daily living ( ADL ) . The number of edema sessions and the number of all sessions were counted . RESULT No statistically significant changes were observed in edema reduction , AROM , pain , and ADL at six and nine weeks between the treatment groups . A statistically significant improvement was observed in ADL after three weeks after inclusion ( p=0.03 ) in the modified MEM group compared with the control group . Furthermore , fewer edema treatment sessions were needed ( p=0.03 ) in the modified MEM group . At six weeks , we observed a difference between the two groups ' needs for further edema treatment ( p=0.04 ) . CONCLUSION Neither the traditional nor the modified MEM treatment program was superior in terms of edema reduction , although the modified MEM result ed in fewer sessions to decrease subacute h and /arm edema compared with using traditional edema reduction techniques in patients after distal radius fracture . LEVEL OF EVIDENCE 1",
"QUESTION Do dynamic splints reduce contracture following distal radial fracture ? DESIGN Assessor-blinded , r and omised controlled trial . PARTICIPANTS Forty out patients with contracture following distal radial fracture . INTERVENTION The control group received routine care consisting of exercises and advice for 8 weeks . In addition to routine care , during the day the experimental group received a dynamic splint , which stretched the wrist into extension but allowed intermittent movement . OUTCOME MEASURES The primary outcomes were passive wrist extension and the Patient Rated H and Wrist Evaluation ( PRHWE ) . The secondary outcomes were active wrist extension , flexion , radial deviation , and ulnar deviation , and the performance and satisfaction items of the Canadian Occupational Performance Measure ( COPM ) . All outcomes were measured at commencement , at the end of 8 weeks of treatment , and at 12 weeks ( ie , 1 month follow-up ) . RESULTS The mean between-group difference for passive wrist extension and PRHWE at 8 weeks were 4 deg ( 95 % CI -4 to 12 ) and -2 points ( 95 % CI -8 to 4 ) , respectively . The corresponding values at 12 week follow-up were 6 deg ( 95 % CI 1 to 12 ) and 2 points ( 95 % CI -5 to 9 ) . There were no sufficiently important between-group differences for any of the secondary outcome measures at 8 or 12 weeks . CONCLUSION It is unclear whether dynamic splints following distal radial fracture have therapeutic effects on passive wrist extension or PRHWE , but they clearly do not have any therapeutic effects on active wrist extension , flexion , radial or ulnar deviation , or on the performance or satisfaction items of the COPM . The ongoing use of dynamic splints following distal radial fracture is difficult to justify . TRIAL REGISTRATION ACTRN12608000309381",
"This r and omized controlled trial compares 2 mobilization regimens after shoulder hemiarthroplasty for acute 3- and 4-part fractures . The aim was to establish whether the length of immobilization plays a role in the functional outcome , tuberosity healing , and subsequent range of motion . The same prosthesis and surgical technique were used . We recruited 59 patients into the study ; 31 were r and omized to early ( 2 weeks ) mobilization and 28 to late ( 6 weeks ) mobilization . Greater tuberosity migration was assessed with a series of radiographs , and the functional outcome was assessed with the Constant Shoulder Assessment and Oxford shoulder scores . Of the patients , 49 ( mean age , 70 years ) met the inclusion criteria and were followed up for 12 months . Greater tuberosity migration occurred in 3 cases in the early mobilization group and once in the late mobilization group ( P > .10 ) . There was no significant difference in the Constant Shoulder Assessment and Oxford scores between the 2 groups . Although there was a decreased incidence of tuberosity migration in the group undergoing late mobilization , this was not statistically significant",
"PURPOSE Patient-rated instruments are increasingly used to measure orthopedic outcomes . However , the clinical relevance of modest score changes on such instruments is often unclear . This study was design ed to define the minimal clinical ly important differences ( MCIDs ) of the Disabilities of the Arm , Shoulder , and H and ( DASH ) , QuickDASH ( subset of DASH ) , and Patient-Rated Wrist Evaluation ( PRWE ) question naires for atraumatic conditions of the h and , wrist , and forearm . METHODS We prospect ively analyzed 102 patients undergoing nonoperative treatment for isolated tendinitis , arthritis , or nerve compression syndromes from the forearm to the h and . By phone , patients completed the DASH , QuickDASH , and PRWE at enrollment and at 2 weeks ( n = 78 used in the analysis ) and 4 weeks ( n = 24 used in the analysis ) after initiating treatment . Patients reporting clinical improvement each contributed a single data point categorized as no change ( n = 41 ) , minimal improvement ( n = 30 ) , or marked improvement ( n = 31 ) via a vali date d anchor-based approach . We calculated the MCID as the mean change score for each outcome measure in the minimal improvement group . RESULTS The MCID ( 95 % confidence interval ) for the DASH was 10 ( 5 - 15 ) . The MCID for the QuickDASH was 14 ( 9 - 20 ) . The MCID was 14 ( 8 - 20 ) for the PRWE . The MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement . The MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores . CONCLUSIONS Longitudinal changes on the DASH of 10 points , on the QuickDASH of 14 points , and on the PRWE of 14 points represent minimal clinical ly important changes . We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients . These MCID values may provide a basis for sample size calculations for future investigation using these common patient-rated outcome measures . TYPE OF STUDY /LEVEL OF EVIDENCE Diagnostic III",
"We undertook a prospect i ve , controlled trial which compared two rehabilitation programmes for 86 patients who sustained two-part fractures of the proximal humerus . Patients were r and omised either to receive immediate physiotherapy within one week ( group A ) or delayed physiotherapy after three weeks of immobilisation in a collar and cuff sling ( group B ) . At 16 weeks after the fracture , patients in group A had less pain ( p greater shoulder function ( p shoulder function and less pain , there was no statistical difference when compared with group B. By analysis of the area under the curve , an overall measure up to the 52-week period , group A experienced less pain as measured by the SF36 general health question naire and had improved shoulder function . Our results show that patients with two-part fractures of the proximal humerus who begin immediate physiotherapy , experience less pain . The gains in shoulder function persist at 52 weeks which suggests that patients do not benefit from immobilisation before beginning physiotherapy",
"IMPORTANCE The benefits of rehabilitation after immobilization for ankle fracture are unclear . OBJECTIVES To determine the effectiveness of a supervised exercise program and advice ( rehabilitation ) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex . DESIGN , SETTING , AND PARTICIPANTS The EXACT trial was a pragmatic , r and omized clinical trial conducted from December 2010 to June 2014 . Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were r and omized on the day of removal of immobilization . Of 571 eligible patients , 357 chose not to participate and 214 were allocated to rehabilitation ( n = 106 ) or advice alone ( n = 108 ) , with 194 ( 91 % ) followed up at 1 month , 173 ( 81 % ) at 3 months , and 170 ( 79 % ) at 6 months . There were no withdrawals attributed to adverse effects . Recruitment terminated early on December 31 , 2013 ( planned enrollment , 342 ; actual , 214 ) , because funding was exhausted . INTERVENTIONS Supervised exercise program and advice about self-management ( rehabilitation ) ( individually tailored , prescribed , monitored , and progressed ) or advice alone , both delivered by a physical therapist . MAIN OUTCOMES AND MEASURES Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale ( score range , 0 - 80 ; higher scores indicate better activity ) , and quality of life assessed using the Assessment of Quality of Life ( score range , 0 - 1 ; higher scores indicate better quality of life ) , measured at baseline and at 1 , 3 ( primary time point ) , and 6 months . RESULTS Mean activity limitation and quality of life at baseline were 30.1 ( SD , 12.5 ) and 0.51 ( SD , 0.24 ) , respectively , for advice and 30.2 ( SD , 13.2 ) and 0.54 ( SD , 0.24 ) for rehabilitation , increasing to 64.3 ( SD , 13.5 ) and 0.85 ( SD , 0.17 ) for advice vs 64.3 ( SD , 15.1 ) and 0.85 ( SD , 0.20 ) for rehabilitation at 3 months . Rehabilitation was not more effective than advice for activity limitation ( mean effect at 3 months , 0.4 [ 95 % CI , -3.3 to 4.1 ] ) or quality of life ( -0.01 [ 95 % CI , -0.06 to 0.04 ] ) . Treatment effects were not moderated by fracture severity or age and sex . CONCLUSIONS AND RELEVANCE A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture . These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12610000979055",
"OBJECTIVE To evaluate the immediate effect of repetitive wrist extension on grip strength in patients with distal radial fracture . DESIGN Interventional study . SETTING Patients who were admitted to a hospital department of occupational therapy . PARTICIPANTS Consecutive patients with a unilateral distal radial fracture ( N=28 ) . INTERVENTION Each patient was r and omly allocated to either the experimental group ( n=14 ) or the control group ( n=14 ) . The experimental group performed 30 repetitive wrist extensions with maximal isometric contraction of the extensors of their affected h and s during a 6-minute intervention period , whereas the control group did not perform the exercise . MAIN OUTCOME MEASURES Grip strength was measured just before and after the intervention period . Pain during grip strength measurements was also quantified using the visual analog scale . Wrist extension strength was measured 10 minutes after the grip strength measurement . RESULTS Grip strength increased immediately after repetitive wrist extension in the experimental group , but it remained the same in the control group . Visual analog scale scores indicated that pain was relieved only in the experimental group . However , pain was unrelated to strength production . CONCLUSIONS The intervention used in this study might be useful during physical examination to reveal the potential grip strength of patients . The intervention may also be an effective warm-up training procedure in preparation for conventional grip-strengthening exercises",
"BACKGROUND The effect of formal occupational therapy on recovery after open reduction and volar plate fixation of a fracture of the distal part of the radius is uncertain . We hypothesized that there would be no difference in wrist function and arm-specific disability six months after open reduction and volar plate fixation of a distal radial fracture between patients who receive formal occupational therapy and those with instructions for independent exercises . METHODS Ninety-four patients with an unstable distal radial fracture treated with open reduction and volar locking plate fixation were enrolled in a prospect i ve r and omized controlled trial comparing exercises done under the supervision of an occupational therapist with surgeon-directed independent exercises . The primary study question addressed combined wrist flexion and extension six months after surgery Secondary study questions addressed wrist motion , grip strength , Gartl and and Werley scores , Mayo wrist scores , and DASH ( Disabilities of the Arm , Shoulder and H and ) scores at three months and six months after surgery . RESULTS There was a significant difference in the mean arc of wrist flexion and extension six months after surgery ( 118 ° versus 129 ° ) , favoring patients prescribed independent exercises . Three months after surgery , there was a significant difference in mean pinch strength ( 80 % versus 90 % ) , mean grip strength ( 66 % versus 81 % ) , and mean Gartl and and Werley scores , favoring patients prescribed independent exercises . At six months , there was a significant difference in mean wrist extension ( 55 ° versus 62 ° ) , ulnar deviation ( 82 % versus 93 % ) , mean supination ( 84 ° versus 90 ° ) , mean grip strength ( 81 % versus 92 % ) , and mean Mayo score , favoring patients prescribed independent exercises . There were no differences in arm-specific disability ( DASH score ) at any time point . CONCLUSIONS Prescription of formal occupational therapy does not improve the average motion or disability score after volar locking plate fixation of a fracture of the distal part of the radius"
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INTRODUCTION Apical constriction has been proposed as the most appropriate apical limit for the endodontic working length . Despite being the most used , some limitations are attributed to the radiographic method of working length determination . It lacks precision because it is based on the average position of the apical constriction . The electronic apex locators have been presented as an alternative to the odontometry performed by radiography . These devices detect the transition of the pulp to the periodontal tissue , which is anatomically very close to the apical constriction and may perform with improved accuracy . METHODS A systematic review was performed to compare the radiographic and electronic methods . Clinical studies that compared both methods were search ed for on 7 electronic data bases , a manual search was performed on the bibliography of articles collected on the electronic data bases , and the authors were contacted to ask for references of more research not detected on the electronic and manual search . RESULTS Twenty-one articles were selected . The majority were comparative or evaluation studies , and very few clinical studies comparing both methods are available . Several method ological limitations are present on the collected articles and debated in this review . CONCLUSIONS Although the available scientific evidence base is short and at considerable risk of bias , it is still possible to conclude that the apical locator reduces the patient radiation exposure and also that the electronic method may perform better on the working length determination . At least one radiographic control should be performed to detect possible errors of the electronic devices
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"Background Obtaining a correct working length is critical to the success of endodontic therapy . Different methods have been used to identify this crucial measurement . The Aim of this clinical study was to compare the effect of working length determination using apex locator alone or in combination with working length radiograph on the apical extent of root canal filling . Methods A total number of 66 patients , 151 canals were r and omized into two groups , In group ( I ) working length was determined by apex locator alone , while in group ( II ) working length was determined by apex locator confirmed by working length radiograph , length of obturation was assessed , and the total number of radiographs was recorded . The data were analyzed using SAS system and T. tests were carried out . Statistical significance was considered to be P ≤ 0.05 . Results Sixty seven canals in group I were treated with a mean distance from the tip of root canal filling to radiographic apex -0.5 mm ± 0.5 and a mean of a total number of radiographs of 2.0 , while in group II eighty four canals were treated with a mean distance from the tip of root canal filling to radiographic apex -0.4 mm ± 0.5 and a mean of a total number of radiographs of 3.2 . There was no statistically significant difference in the mean distance from the tip of root filling to radiographic apex between group I and group II ( P > 0.05 ) . Conclusion The practice of using electronic apex locator in the determination of working length is useful and reliable with no statistical difference of the radiographic extent of root canal filling when using apex locator alone or in combination with working length radiograph . Under the clinical conditions of this study , it is suggested that the correct use of an apex locator alone could prevent the need for further diagnostic radiographs for determination of working length . This method can be useful in patients who need not to be exposed to repeated radiation because of mental , medical or oral conditions",
"The objective of this study was to investigate whether the use of an electronic apex locator results in a reduction in X-ray exposure during endodontic therapy . Fifty , sound , extracted , single-rooted canine and incisor teeth were selected and r and omly divided into two groups ( A and B ) of 25 teeth . The working length was determined radiographically with ( group B ) and without ( group A ) adjunctive use of an apex locator by one operator . After working length determination , the teeth were sectioned and the actual working length measured for comparison . For group A , 14 retake radiographs were required to determine the working length , whereas group B required no retake radiographs ; this difference was highly significant ( p electronic apex locator was extremely accurate in locating the apical foramen with all teeth tested within 0.5 mm of the anatomical apex and 11 ( 44 % ) teeth at the apical foramen . In contrast , 15 ( 60 % ) teeth tested using radiographs alone were within 0.5 mm of the anatomical apex and only 4 ( 16 % ) teeth were actually at the anatomical apex . It was concluded that using an electronic apex locator as an aid to endodontic therapy could potentially reduce the number of diagnostic radiographs required for working length determination . Location of the apical foramen using a combination of an electronic apex locator and radiographs to determine working length is more accurate than using radiographs alone",
"The purpose of this study was to determine the effect of using electronic apex locators on the number of radiographs taken and the adequacy in length of the final obturation . Patients in an undergraduate student endodontics clinic participated in the study . The working length ( WL ) was estimated by the authors for all cases ( 36 teeth ; 58 canals ) , using both a preoperative st and ardized radiograph and an electronic measurement . The students were then asked to place WL files to one of the estimates ( electronic or radiographic ; chosen by r and om assignment ) and take a WL radiograph . Neither the students nor their instructors knew which method was chosen for the estimates . Once treatment was completed , the total number of working radiographs was counted . The number of cases with acceptable ( 0 to 2 mm short of the apex ) or unacceptable obturation was also blindly registered . An electronic estimate of the WL improved length quality of the final obturation , compared with a radiographic estimate . The number of working radiographs taken was less in the electronic apex locator group in anterior and premolar teeth , but not in molars",
"AIM The aim of this study was to assess the clinical perfomance of a cordless h and piece with a built-in apex locator - the Tri Auto ZX - design ed for root canal preparation with nickel-titanium rotary files . METHODOLOGY Twenty-five human maxillary incisor and canine teeth scheduled for extraction with mature apices were selected for the study . Informed written consent was obtained from each patient before treatment . After administration of local anaesthesia , the teeth were isolated and the pulp cavities accessed . The Tri Auto ZX along with a size 15 K-file was used in its electronic apex locating function based on the manufacturer 's recommendations . A periapical radiograph with the file at the electronically determined constriction was taken , the file removed and the measurement registered as the electronic length ( EL ) . To test the auto reverse function , a size 20 ProFile.04 taper NiTi rotary instrument was mounted in the h and piece . The point for the auto apical reverse function was preset on the panel at the 0.5 mm level . After the file was introduced into the canal and reached the predetermined level , the file automatically stopped and rotated in the opposite direction . A reference point was marked and this measurement was registered as the auto reverse length ( ARL ) . All measurements were made twice by two different investigators . Teeth were then extracted and immersed in a 20 % formalin solution for 48 h. After fixation , a size 15 file was inserted into the canal to measure the actual root canal length from the same reference point obtained with the Tri Auto ZX to the apical foramen , as seen in the stereo microscope . When the file tip was visible at the anatomical end of the canal it was withdrawn 0.5 mm and this measurement was registered as the actual length ( AL ) . All measurements were expressed in mm and the measuring accuracy was set to 0.5 mm . The significance of the mean differences between EL and ARL and between EL and AL measurements at the 5 % confidence level was evaluated . RESULTS EL measurements were coincident to ARL in all instances . EL and ARL were coincident to AL in 10 ( 40 % ) canals , in the remaining 15 canals ( 60 % ) the AL measurements were longer than EL and ARL ( + 0.5 mm ) in 14 instances and shorter ( -0.5 mm ) in one case . Overall , the AL was longer than the EL or ARL , the mean difference being -0.23 mm + /- 0.32 ( P < 0.05 ) . CONCLUSIONS It was concluded that the Tri Auto ZX was useful and reliable . The Tri Auto ZX measurements protected against overpreparation",
"The accuracy of many apex locators is affected by electrolytes including sodium hypochlorite . According to the manufacturer a new device , the ENDEX , overcomes this problem . The purpose of this study was to assess the accuracy of the ENDEX in comparison with a traditional device , the RCM Mark II . The lengths of 61 canals with various contents ( vital pulp , necrotic pulp , pus/exu date , sodium hypochlorite , and water ) were determined in vivo . Files were cemented within the canals at lengths determined by the ENDEX . The teeth were then radiographed and extracted , and the distance between the file tip and apical foramen was recorded . Derived readings for the RCM Mark II were compared with the actual ENDEX reading and corresponding radiograph . The results indicated that most of the file tips that were at the radiographic apex actually extended through the apical foramen , and canal content had a varying effect on each device . The overall accuracy of the ENDEX ( 71.7 % ) was higher than that of the RCM Mark II ( 43.5 % ) within 0.5 mm of the apical foramen . The ENDEX , unlike the RCM Mark II , proved accurate in the presence of sodium hypochlorite",
"Identifying the point of apical termination in endodontic therapy is of indisputable importance . In this study , the accuracy of an electronic apex locator was clinical ly evaluated in 26 maxillary molar teeth , and comparisons were made to the radiographic and direct anatomical measurements of tooth length . The results indicated that a higher percentage of acceptable measurements were obtained by the radiographic method as compared with the electronic method ( 88.5 % to 73.1 % ) . Additionally , inaccurate electronic estimates were long in every instance . The results of this study do not support the replacement of radiographs with electronic devices in endodontic therapy",
"INTRODUCTION Obtaining a correct working length is critical to the success of endodontic therapy . The aim of this clinical study was to compare the effect of working length determination using electronic apex locator or working length radiograph on the length adequacy of final working length as well as the final obturation . METHODS A total of 84 patients with 188 canals were r and omized into two groups ; in group 1 , the working length was determined by working length radiograph , whereas in group 2 , it was determined by the Raypex5 electronic apex locator ( VDW , Munich , Germany ) . Length adequacy was assessed in each group for master cone and final obturation radiography and categorized into short , acceptable , and over cases . RESULTS There was no statistically significant difference between the rates of acceptable ( master cone radiography : group 1 = 82.1 % and group 2 = 90.4 % ; final radiography : group 1 = 85.7 % and group 2 = 90.4 % ) and short cases ( master cone radiography : group 1 = 7.1 % and group 2 = 8.7 % ; final radiography : group 1 = 1.2 % and group 2 = 1 % ) between the two groups . Over cases in master cone radiography were significantly more in group 1 ( 10.7 % ) than group 2 ( 1 % ) ( χ² , p = 0.00 ) . However , this category did not show a significant difference for final obturation between group 1 ( 13.1 % ) and group 2 ( 8.7 % ) . CONCLUSION The results of endodontic treatment using the Raypex5 electronic apex locator are quite comparable , if not superior , to radiographic length measurement regarding the rates of acceptable and short cases . Furthermore , in addition to reducing the radiographic exposure , electronic apex locators are superior in reducing overestimation of the root canal length "
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Sport is a promising setting for obesity prevention among youth , but little is known about whether it prevents obesity . We review ed research comparing sport participants with non participants on weight status , physical activity , and diet . Among 19 studies , we found no clear pattern of association between body weight and sport participation . Among 17 studies , we found that sport participants are more physically active than those who do not participate . We found seven studies that compared the diet of sport participants with non- participants . These studies reported that youth involved in sport were more likely to consume fruits , vegetables , and milk , and also more likely to eat fast food and drink sugar-sweetened beverages and consume more calories overall . It is unclear from these results whether sports programs , as currently offered , protect youth from becoming overweight or obese . Additional research may foster underst and ing about how sport , and youth sport setting s , can help promote energy balance and healthy body weight
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"OBJECTIVE To evaluate the feasibility , acceptability , and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children . DESIGN Six-month , 2-arm , parallel-group , pilot r and omized controlled trial . SETTING Low-income , racial/ethnic minority community . PARTICIPANTS Twenty-one children in grade s 4 and 5 with a body mass index at or above the 85th percentile . INTERVENTIONS The treatment intervention consisted of an after-school soccer program . The \" active placebo \" control intervention consisted of an after-school health education program . MAIN OUTCOME MEASURES Implementation , acceptability , body mass index , physical activity measured using accelerometers , reported television and other screen time , self-esteem , depressive symptoms , and weight concerns . RESULTS All 21 children completed the study . Compared with children receiving health education , children in the soccer group had significant decreases in body mass index z scores at 3 and 6 months and significant increases in total daily , moderate , and vigorous physical activity at 3 months . CONCLUSION An after-school team soccer program for overweight children can be a feasible , acceptable , and efficacious intervention for weight control",
"BACKGROUND Underst and ing the factors that influence physical activity behavior is important in the design of intervention programs targeted at youth . METHODS A prospect i ve study design was used to identify the predictors of vigorous physical activity ( VPA ) ( > or = 6 METs ) and moderate and vigorous physical activity ( MVPA ) ( > or = 3 METs ) among 202 rural , predominantly African-American children . Selected social-cognitive determinants of physical activity were assessed via question naire in the fifth grade . Participation in VPA and MVPA was assessed via the previous day physical activity recall 1 year later in the sixth grade . RESULTS For girls , participation in community sports , self-efficacy in overcoming barriers , enjoyment of school physical education , race ( white > black ) , and perception of mother 's activity level ( active vs inactive ) were significant predictors of VPA . For MVPA , participation in community sports and self-efficacy in overcoming barriers were significant predictors . For boys , self-efficacy in overcoming barriers was the only significant predictor of VPA , while beliefs regarding activity outcomes and participation in community sports were significant predictors of MVPA . CONCLUSION Social-cognitive constructs such as physical activity self-efficacy , access to community physical activity outlets , and positive beliefs regarding physical activity outcomes are important predictors of future physical activity behavior among rural , predominantly African-American children",
"Objective : To estimate total energy intake and the energy gap — the daily imbalance between energy intake and expenditure — associated with discretionary behaviors of adolescents , namely their leisure active behaviors ( playing or participating in sports and heavy chores ) , leisure sedentary behaviors ( television ( TV ) viewing and playing video and computer games ) , productive sedentary behaviors ( reading or doing homework ) . Design : Prospect i ve observational study . Participants : A total of 538 students ( mean age at baseline=11.7 years ) from public schools in the Boston area studied prospect ively from the fall of 1995 to the spring of 1997 . Measurements : Anthropometric assessment including height and weight , dietary assessment using a youth food frequency question naire and measures of TV , video , reading/doing homework and youth physical activity . Results : We estimate the change in total energy intake for each hour change in discretionary activity using regression methods . A 1-h increase in watching TV is associated with a 106 kcal h−1 increase in total energy intake ( 95 % confidence interval ( CI ) : 61–150 kcal day−1 ) . A similar change of 92 kcal h−1 ( 95 % CI : 37–147 kcal day−1 ) is seen with playing video and computer games . The change in energy intake associated with an hour change in physical activity is 292 kcal h−1 ( 95 % CI : 262–321 kcal day−1 ) . No significant change is associated with reading/doing homework . Assuming that typical energy expenditures are associated with these behaviors , reading/doing homework appears to be an ‘ energy neutral ’ activity , whereas watching TV and playing video and computer games is associated with an energy surplus . If we assume that physical activity levels are moderate ( 3.5 METs ) , then this is also an energy surplus activity . If physical activity is assumed to be vigorous for the entire time allotted ( > 6.0 METs ) , an energy deficit could be achieved . We vali date d these estimates by calculating regressions predicting change in weight . Results indicate that each hour increase in TV viewing is associated with a weight increase of 0.38 kg ( 95 % CI : 0.17–0.59 kg ) , with no significant associations for the other behaviors . A model with change in BMI as the dependent variable produced similar results . Conclusion : Watching TV is an activity associated with a daily energy surplus . Although physical activity is thought of as an energy deficit activity , our estimates do not support this hypothesis . Reading/doing homework is the only discretionary activity examined which appears to be clearly energy neutral . The differential impacts of these discretionary behaviors on energy intake and the energy gap are discussed in relation to food-related advertisements aim ed at children and adolescents",
"OBJECTIVE This study compared correlates of physical activity ( PA ) among African-American and white girls of different weight groups to guide future interventions . RESEARCH METHODS AND PROCEDURES Participants were 1015 girls ( mean age , 14.6 years ; 45 % African-American ) from 12 high schools in South Carolina who served as control subjects for a school-based intervention . Post-intervention measures obtained at the end of ninth grade were used . PA was measured using the Three-Day PA Recall , and a question naire measured social-cognitive and environmental variables thought to mediate PA . Height and weight were measured , and BMI was calculated . Girls were stratified by race and categorized into three groups , based on BMI percentiles for girls from CDC growth charts : normal ( BMI or = 95th percentile ) . Girls were further divided into active and low-active groups , based on a vigorous PA st and ard ( average of one or more 30-minute blocks per day per 3-day period ) . Mixed-model ANOVA was used to compare factors among groups , treating school as a r and om effect RESULTS None of the social-cognitive or environmental variables differed by weight status for African-American or white girls . Perceived behavioral control and sports team participation were significantly higher in girls who were more active , regardless of weight or race group . In general , social-cognitive variables seem to be more related to activity in white girls , whereas environmental factors seem more related to activity in African-American girls . DISCUSSION PA interventions should be tailored to the unique needs of girls based on PA levels and race , rather than on weight status alone",
"OBJECTIVE To assess different aspects of physical fitness and physical activity in obese and nonobese Flemish youth . RESEARCH METHODS AND PROCEDURES A r and om sample of 3214 Flemish schoolchildren was selected and divided into an \" obese \" and \" nonobese \" group based on body mass index and sum of skinfolds . Physical fitness was assessed by the European physical fitness test battery . Physical activity was estimated by a modified version of the Baecke Question naire . RESULTS Obese subjects had inferior performances on all tests requiring propulsion or lifting of the body mass ( st and ing-broad jump , sit-ups , bent-arm hang , speed shuttle run , and endurance shuttle run ) compared with their nonobese counterparts ( p strength on h and grip ( p leisure-time physical activity ; however , nonobese boys had a higher sport index than their obese counterparts ( p performances on weight-bearing tasks , but did not have lower scores on all fitness components . To encourage adherence to physical activity in obese youth , it is important that activities are tailored to their capabilities . Results suggest that weight-bearing activities should be limited at the start of an intervention with obese participants and alternative activities that rely more on static strength used",
"UNLABELLED Decreased fitness and increased fatness are relevant factors for decreased cardiovascular and bone health in children . One way to increase physical activity and hence fitness and to reduce the risk for overweight might be sports club participation ( SCP ) . PURPOSE To investigate the association of SCP with fatness and fitness in children in general and in those with increased risk for overweight and /or low fitness . METHODS A cross-sectional study was conducted in a r and om sample of 502 first- and fifth- grade primary school children . Fitness components were determined by 10 motor tests and body fatness by the sum of four skinfolds . SCP was defined as participation of at least once a week . RESULTS Two thirds of all children were participating in a sports club . Girls ' and boys ' participation rate as well as those of overweight children and of children with overweight parents were comparable to their respective normal weight peers . In contrast , children from migrant families ( odds ratio = 0.31 ; 95 % confidence interval = 0.20 - 0.48 ) and from inactive parents ( odds ratio = 0.16 ; 95 % confidence interval = 0.05 - 0.45 ) participated significantly less ( all P endurance ( 0.53 > beta > 0.37 , all P speed , strength , and coordination ( 0.41 > beta > 0.18 , all P overweight children and in children from overweight parents and migrant families , this association was not found . There was no association between SCP and fatness in any of the groups . CONCLUSIONS SCP rates were high and were associated with higher levels of most fitness components in children . Participation rates were lower for children of migrant families and children from inactive parents . In addition , the association between SCP and fitness components was not found in overweight children and in children from overweight parents and migrant families",
"BACKGROUND To investigate the prevalence of overweight and obesity in an adolescent group representative of a rural Mediterranean area and to determine possible associations with energy and nutrient intakes and levels of physical exercise . METHODS A representative sample of adolescents was drawn from the secondary school of Torre Pacheco ( Murcia ) , a rural Mediterranean area located in the southeast of Spain . The population selected ( 331 adolescents aged 14 - 18 years ) , was divided into two groups : normal-weight subjects with a body mass index less than 23 kg/m2 and overweight or obese subjects with a body mass index of 23 kg/m2 or more . Weight , height , abdominal and hip perimeters , triceps skinfold , and upper arm circumference were measured . A prospect i ve 7-consecutive-days food record and physical activity question naire were completed . RESULTS Overweight boys and girls had an apparently lower energy intake ( P = 0.001 and P = 0.042 , respectively ) , and carbohydrate intake ( P = 0.000 , P = 0.032 ) than their normal-weight counterparts , but they tended to underreport more often . Overweight boys derived a greater percentage of their energy from fat ( P = 0.049 ) and less from carbohydrate ( P = 0.016 ) than their normal-weight counterparts . Among girls , the percentage of energy derived from fat increased with body mass index ( r = 0.210 , P = 0.008 ) , whereas fiber intake decreased ( r = -0.145 ; P = 0.041 ) . Overweight and obesity were negatively related to physical activity level only among boys ( P = 0.033 ) . CONCLUSION There is a high prevalence of overweight and obesity in the adolescent population studied ( 48.2 % in boys and 30.7 % in girls ) . The study shows an association between overweight and obesity and nutrient intake and activity level",
"Aims : Although childhood obesity is becoming increasingly prevalent , treatment options are limited and the continued development of effective treatment strategies is necessary . It is equally important to explore involvement of other re sources in society , such as sports associations . This study was design ed to investigate the possibility of reducing the degree of obesity in obese children by focusing on physical activity as an intervention . Methods : Seventy-six children ( 40 boys ) aged 8—12 years ( mean age 10.5 years , mean body mass index ( BMI ) 28.9 , st and ard deviation ( SD ) 3.0 ; mean BMI z-score 3.24 , SD 0.49 ) were invited to participate in a one-week sports camp and six-month support system . After the camp a sports coach from a local sports club supported the child during participation in a chosen sport for six months . Weight , height , body composition ( using dual energy x-ray absorptiometry and magnetic resonance imaging ) , and lifestyle ( using a question naire ) were measured at baseline and after 12 months . Data were pooled from two camps , one with a self-selected control group and one r and omized controlled trial . Results : Twelve months after the camp the intervention group had a significant decrease in BMI z-score ( baseline BMI z-score 3.22 ; follow up 3.10 , p = 0.023 ) . The control group also reduced their BMI z-score ( baseline BMI z-score 3.27 ; follow up 3.18 , p = 0.022 ) . No differences were found in baseline values , follow-up values , or changes in BMI z-score between groups , nor between boys and girls . Conclusions : The focus on physical activity as an intervention had no effect on degree of obesity when compared with a waiting list control group"
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BACKGROUND Traditional methods of heart failure ( HF ) management are based on reactive strategies to treat late indicators of decompensated HF . Advances in monitoring methods have become available with the evolution of implantable cardioverter-defibrillators and cardiac-resynchronization therapy devices . These devices provide new diagnostic data and remote monitoring capabilities that allow clinicians to proactively monitor patients for earlier signs of worsening HF . The integration of data obtained from implantable cardioverter-defibrillator and cardiac-resynchronization therapy technology could improve outpatient HF care , potentially leading to decreased readmission rates and improved patient outcomes . OBJECTIVE This review will synthesize the literature regarding the efficacy of device diagnostic data and the usability of the data in the clinical setting . METHODS Articles for review were obtained using Cumulative Index to Nursing and Allied Health Literature , MEDLINE , PubMed , and Clinical Trials.gov . RESULTS Device diagnostics showed strong correlation with established HF biomarkers and hemodynamic measures . The findings from this review indicate that device diagnostic parameters predict impending HF much earlier than traditional methods of monitoring do . Device diagnostics are also more accurate in the early prediction of HF when compared with noninvasive objective measures , particularly when multiple parameters are combined and monitored for trends . Device diagnostics possess a distinct advantage over traditional methods of monitoring for HF because they allow clinicians to remotely monitor the status of their HF patients without relying on patient compliance for data entry and reporting . CONCLUSIONS Studies regarding the efficacy of device diagnostic parameters suggest that their integration into clinical practice will provide a more accurate and reliable mechanism for assisting clinicians in risk stratifying and predicting potential episodes of decompensated HF
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"BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups",
"Background — Heart failure is associated with frequent hospitalizations , often result ing from volume overload . Measurement of intrathoracic impedance with an implanted device with an audible patient alert may detect increases in pulmonary fluid retention early . We hypothesized that early intervention could prevent hospitalizations and affect outcome . Methods and Results — We studied 335 patients with chronic heart failure who had undergone implantation of an implantable cardioverter-defibrillator alone ( 18 % ) or with cardiac resynchronization therapy ( 82 % ) . All devices featured a monitoring tool to track changes in intrathoracic impedance ( OptiVol ) and other diagnostic parameters . Patients were r and omized to have information available to physicians and patients as an audible alert in case of preset threshold crossings ( access arm ) or not ( control arm ) . The primary end point was a composite of all-cause mortality and heart failure hospitalizations . During 14.9±5.4 months , this occurred in 48 patients ( 29 % ) in the access arm and in 33 patients ( 20 % ) in the control arm ( P=0.063 ; hazard ratio , 1.52 ; 95 % confidence interval , 0.97–2.37 ) . This was due mainly to more heart failure hospitalizations ( hazard ratio , 1.79 ; 95 % confidence interval , 1.08–2.95 ; P=0.022 ) , whereas the number of deaths was comparable ( 19 versus 15 ; P=0.54 ) . The number of outpatient visits was higher in the access arm ( 250 versus 84 ; P increased heart failure hospitalizations and outpatient visits in heart failure patients . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT 00480077",
"AIMS To evaluate the utility of intrathoracic impedance monitoring for detecting heart failure ( HF ) deterioration in patients with an implanted cardiac resynchronization/defibrillation device . METHODS AND RESULTS Patients enrolled in the European InSync Sentry Observational Study were audibly alerted by a device algorithm if a decrease in intrathoracic impedance suggested fluid accumulation . Clinical HF status and device data were assessed at enrolment , during regular follow-up , and if patients presented with an alert or HF deterioration . Data from 373 subjects were analysed . Fifty-three alert events and a total of 53 clinical events ( HF deterioration defined by worsening of HF signs and symptoms ) were reported during a median of 4.2 months . Adjusted for multiple events per patient , the alert detected clinical HF deterioration with 60 % sensitivity ( 95 % CI 46 - 73 ) and with a positive predictive value of 60 % ( 95 % CI 46 - 73 ) . Higher NYHA class at baseline was predictive for adequate alert events during follow-up ( P HF deteriorations without preceding alert , an upstroke of the fluid index occurred without reaching the programmed alert threshold . CONCLUSION A device-based algorithm that alerts patients in case of decreasing intrathoracic impedance facilitates the detection of HF deterioration . Future r and omized , controlled trials are needed to test whether the tailored use of intrathoracic impedance monitoring can improve the ambulatory management of patients with chronic HF and an implanted device",
"Acute heart failure syndromes ( AHFS ) represent the most common discharge diagnoses in adults over age 65 and translate into dramatically increased heart failure – associated morbidity and mortality . Conventional approaches to the early detection of pulmonary and systemic congestion have been shown to be of limited sensitivity . Despite their proven efficacy , disease management and structured telephone support programs have failed to achieve widespread use in part due to their re source intensiveness and reliance upon motivated patients . While once thought to hold great promise , results from recent prospect i ve studies on telemonitoring strategies have proven disappointing . Implantable devices with their capacity to monitor electrophysiologic and hemodynamic parameters over long periods of time and with minimal reliance on patient participation may provide solutions to some of these problems . Conventional electrophysiologic parameters and intrathoracic impedance data are currently available in the growing population of heart failure patients with equipped devices . A variety of implantable hemodynamic monitors are currently under investigation . How best to integrate these devices into a systematic approach to the management of patients before , during , and after AHFS is yet to be established",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"BACKGROUND We performed a prospect i ve , r and omized investigation assessing the incremental effect of automated health monitoring ( AHM ) technology over and above that of a previously described nurse directed heart failure ( HF ) disease management program . The AHM system measured and transmitted body weight , blood pressure , and heart rate data as well as subjective patient self- assessment s via a st and ard telephone line to a central server . METHODS AND RESULTS A total of 188 consented and eligible patients were r and omized between intervention and control groups in 1:1 ratio . Subjects r and omized to the control arm received the Specialized Primary and Networked Care in Heart Failure ( SPAN-CHF ) heart failure disease management program . Subjects r and omized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system . The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days . The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 ( 95%CI [ 0.25 - 0.99 ] , P = .05 ) . CONCLUSIONS Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment . Long-term benefits in this model remain to be studied",
"BACKGROUND Heart failure is a common and important cause of morbidity and mortality . Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients , but experimental data on the efficacy of such programs are limited . METHODS AND RESULTS A total of 151 patients hospitalized with heart failure were r and omized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline -based therapy as prescribed by primary physicians . Nurses also screened patients for heart failure exacerbations , which they managed with supplemental diuretics or by contacting the primary physician for instructions . Outcomes included time to hospital encounter , mortality , number and cost of hospitalizations , functional status , and satisfaction with care . Intervention patients had a longer time to encounter ( hazard ratio [ HR ] = 0.67 ; 95 % confidence interval [ CI ] 0.47 - 0.96 ; P = .029 ) , hospital readmission ( HR = 0.67 ; CI 0.46 - 0.99 ; P = .045 ) , and heart failure-specific readmission ( HR = 0.62 ; CI 0.38 - 1.03 ; P = .063 ) . The number of admissions , hospital days , and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year . The intervention had little effect on functional status , mortality , and satisfaction with care . CONCLUSION A nurse-administered , telephone-based disease management program delayed subsequent health care encounters , but had minimal impact on other outcomes",
"BACKGROUND This trial was design ed to determine whether cardiac-resynchronization therapy ( CRT ) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms , a reduced ejection fraction , and a wide QRS complex . METHODS During a 4.5-year period , we enrolled and followed 1820 patients with ischemic or nonischemic cardiomyopathy , an ejection fraction of 30 % or less , a QRS duration of 130 msec or more , and New York Heart Association class I or II symptoms . Patients were r and omly assigned in a 3:2 ratio to receive CRT plus an implantable cardioverter-defibrillator ( ICD ) ( 1089 patients ) or an ICD alone ( 731 patients ) . The primary end point was death from any cause or a nonfatal heart-failure event ( whichever came first ) . Heart-failure events were diagnosed by physicians who were aware of the treatment assignments , but they were adjudicated by a committee that was unaware of assignments . RESULTS During an average follow-up of 2.4 years , the primary end point occurred in 187 of 1089 patients in the CRT-ICD group ( 17.2 % ) and 185 of 731 patients in the ICD-only group ( 25.3 % ) ( hazard ratio in the CRT-ICD group , 0.66 ; 95 % confidence interval [ CI ] , 0.52 to 0.84 ; P=0.001 ) . The benefit did not differ significantly between patients with ischemic cardiomyopathy and those with nonischemic cardiomyopathy . The superiority of CRT was driven by a 41 % reduction in the risk of heart-failure events , a finding that was evident primarily in a prespecified subgroup of patients with a QRS duration of 150 msec or more . CRT was associated with a significant reduction in left ventricular volumes and improvement in the ejection fraction . There was no significant difference between the two groups in the overall risk of death , with a 3 % annual mortality rate in each treatment group . Serious adverse events were infrequent in the two groups . CONCLUSIONS CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complex . ( Clinical Trials.gov number , NCT00180271 .",
"Purpose The aim of the present study is to evaluate if remote monitoring with the CareLink Network may improve clinical management of tachyarrhythmias and heart failure episodes in patients treated with biventricular defibrillators ( CRT-D ) . Methods Patients implanted with CRT-D for more than 6 months received the CareLink monitor and were trained to perform device interrogation . At-home transmissions were scheduled at 2 weeks , 1 and 2 months after training , with a final in-office visit after 3 months . Results Sixty-seven patients performed 264 data transmissions . Twenty-three unscheduled data transmissions were requested by the centers after patient contact . Ventricular tachyarrhythmias were reported in nine patients during 16 data review s. Thirteen data review s ( 81 % ) were performed remotely via CareLink transmissions ( nine scheduled and four unscheduled ) , in seven patients . Of these events , in two cases ( 15 % ) in-hospital visits were requested , while in 11 ( 85 % ) no action was needed and no additional in-clinic visits were scheduled . During the study period , in 20/28 ( 71 % ) intra-thoracic impedance alerts , the patients remotely transmitted their device data . After remote data review , in ten cases drug therapy was adjusted by phone and in four cases no action was needed and the patient reassured . In six episodes an in-hospital extra visit was scheduled . On the whole , in 14 cases ( 70 % ) , the patient could be managed remotely avoiding a visit to the hospital . Conclusions Our study showed that remote follow-up is an efficient method to manage tachyarrhythmias and heart failure episodes in CRT-D patients . Early reaction to clinical events may improve overall patient care",
"Changes in intrathoracic impedance ( Z ) leading to crossing of a derived fluid index ( FI ) threshold has been associated with heart failure ( HF ) hospitalization . The authors developed a remote monitoring program as part of HF disease management and prospect ively examined the feasibility and re source utilization of monitoring individuals with an implanted device capable of measuring Z. An HF nurse analyzed all transmitted data daily , as they were routinely uploaded as part of quarterly remote device monitoring , and called the patient if the FI crossed the threshold ( arbitrarily defined at 60 Omega ) to identify clinical ly relevant events ( CREs ) that occurred during this period ( eg , worsening dyspnea or increase in edema or weight ) . A total of 400 uploads were completed during the 4-month study period . During this period , 34 patients ( 18 % ) had an FI threshold crossing , averaging 0.52 FI threshold crossings per patient-year . Thirty-two of 34 patients contacted by telephone ( 94 % ) with FI threshold crossing had evidence of CREs during this period . However , only 6 ( 18 % ) had HF hospitalizations , 19 ( 56 % ) had reported changes in HF therapy , and 13 ( 38 % ) reported drug and /or dietary plan nonadherence . The average data analysis time required was 30 min daily when focusing on those with FI threshold crossing , averaging 8 uploads for review per working day and 5 telephone follow-ups per week . Our pilot observations suggested that Internet-based remote monitoring of Z trends from existing device interrogation uploads is feasible as part of a daily routine of HF disease management",
"BACKGROUND Previous studies have demonstrated that intrathoracic impedance monitoring ( IIM ) is associated with fluid overload . However , it remains unclear whether this new technology can predict heart failure ( HF ) before deterioration . Whether fluid status based on IIM predicts HF in patients with left ventricular ( LV ) systolic dysfunction was investigated . METHODS AND RESULTS A prospect i ve clinical observational study of 123 patients implanted with IIM-capable cardiac devices was carried out . The primary endpoint was the positive predictive value ( PPV ) at 12 months . Secondary endpoints were a correlation between onset of HF and IIM , optimal threshold of fluid index and duration between the alert and HF . Complete follow-up clinical data were obtained from 111 patients . During the observational period , 168 alerts were confirmed from 68 patients . In patient-based analysis ( alert-based analysis ) , PPV was 33.8 % ( 33.9 % ) . Sensitivity , specificity and false positive was 67.6 % ( 83.8 % ) , 49.4 % ( 28.4 % ) and 50.6 % ( 71.6 % ) , respectively . Mean duration between the alert and HF event was 21.4 ± 6.1 days . On multivariate logistic analysis , maximum fluid index , LV ejection fraction and atrial fibrillation were independent predictors of HF events . The optimal cut-off value determined by receiver operating characteristic curve was 114-ohm·day with sensitivity and specificity of 89.5 % and 73.0 % , respectively . CONCLUSIONS IIM-based fluid index in patients with HF due to LV systolic dysfunction was effective in predicting worsening HF ",
"Purpose To determine the association between device-determined diagnostic indices , including intrathoracic impedance , and heart failure ( HF ) hospitalization . Methods Clinical and device diagnostic data of 558 HF patients indicated for CRT-D therapy ( In Sync Sentry , Medtronic Inc. ) were prospect ively collected from 34 centers . Device-recorded intrathoracic impedance fluid index threshold crossing event ( TCE ) , mean activity counts , tachyarrhythmia events , night heart rate ( NHR ) and heart rate variability ( HRV ) were compared within patients with vs. without documented HF hospitalization . Results Mean follow-up was 326 ± 216 days . Patients hospitalized for HF had significantly higher rates of TCE , a higher percentage of days with the thoracic impedance fluid index above the programmed threshold , a higher percentage of days with low activity , with low HRV or with high NHR.Multivariate analysis showed that TCE result ed in a 36 % increased probability of HF hospitalization . Both TCE duration and patient activity were also significantly associated with hospitalization . Kaplan Meier analysis indicated that patients with more TCE events were significantly more likely to be hospitalized ( log rank test , p = 0.005 ) . Conclusions Decreased intrathoracic impedance , low patient activity and low HRV were all independently associated with increased risk for HF hospitalization in HF patients treated with resynchronization therapy . Device-derived diagnostic data may provide valuable and reliable indices for the prognostic stratification of HF patients",
"OBJECTIVES The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias , cardiovascular ( CV ) disease progression , and device issues compared to patients receiving st and ard in-office care . A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms . BACKGROUND In addition to providing life-saving therapy , implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient 's heart disease . Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits . METHODS The CONNECT ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision ) study was a multicenter , prospect i ve , r and omized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator ( including cardiac resynchronization therapy devices ) and were followed up for 15 months . Health care utilization data included all CV-related hospitalizations , emergency department visits , and clinic office visits . RESULTS The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm ( p mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm ( p = 0.002 ) . CONCLUSIONS Wireless remote monitoring with automatic clinician alerts as compared with st and ard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay . ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [ CONNECT ] ; NCT00402246 )",
"BACKGROUND Hospitalizations due to decompensation are a frequent problem in treating patients with congestive heart failure ( CHF ) . Continuous impedance measurement via implantable devices may detect pulmonary fluid accumulation due to worsening CHF . An acoustic alert might allow an earlier treatment of impending decompensation . An algorithm that implemented impedance measurement into clinical decision making in treating CHF patients was evaluated . METHODS Forty-two CHF patients ( ejection fraction : 27 + /- 6 % ; New York Heart Association 2.9 + /- 0.6 ) with cardiac resynchronization therapy and automatic impedance measurements were included . Upon an alert , a stepped therapy was initiated : category ( 1 ) overt decompensation , hospitalization ; category ( 2 ) worsened CHF , increase of diuretics ; category ( 3 ) no CHF worsening , brain natriuretic peptide ( BNP ) measurement , elevated BNP : increase of diuretics , normal BNP : no specific treatment . RESULTS During 18 + /- 4 months , 45 alerts were treated according to the algorithm . Eleven category 1 alerts led to hospitalization ; 21 category 2 and 11 category 3 patients ( elevated BNP ) were treated conservatively . Two category 3 alerts ( normal BNP ) received no treatment . CONCLUSIONS Automatic impedance measurement can be integrated into CHF management . BNP measurement restricted to patients with alert but without clinical signs of worsened CHF may prevent premature therapy escalation",
"The purpose of this r and omized field study was to determine the effects of telehomecare on hospitalization , emergency department ( ED ) use , mortality , and symptoms related to sodium and fluid intake , medication use , and physical activity . The sample consists of 284 patients with heart failure . The authors used logistic regression to study the effects of telehomecare on health services utilization and mortality and a general linear model to analyze changes in self-reported symptoms . On average , patients in the telehomecare groups had a lower probability of hospitalizations and ED visits than did patients in the control group . Differences were statistically significant at 60 days but not 120 days . Results show a greater reduction in symptoms for patients using telehomecare compared to control patients . The technology enables frequent monitoring of clinical indices and permits the home health care nurse to detect changes in cardiac status and intervene when necessary",
"PURPOSE Some implantable cardioverter-defibrillators ( ICDs ) are now able to monitor intrathoracic impedance . The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs . METHODS AND RESULTS Five hundred thirty-two heart failure ( HF ) patients implanted with these ICDs were followed up for 11 + /- 7 months . A clinical event ( CE ) was deemed to have occurred if it result ed in hospitalization or milder manifestations of HF deterioration . Three hundred sixty-two acute decreases in intrathoracic impedance ( Z events ) occurred in 230 patients . Of these episodes , 171 ( 47 % ) were associated with a CE within 2 weeks of the Z event . In another 71 ( 20 % ) Z events , drug therapy was adjusted despite the absence of overt signs of clinical deterioration . The rate of unexplained Z events was 0.25 per patient-year and 25 hospitalizations were not associated with Z events . The audible alert was disabled in a group of 102 patients ( OFF group ) . HF hospitalizations occurred in 29 ( 7 % ) patients in the ON group and 20 ( 20 % , P rate of combined cardiac death and HF hospitalization was lower in patients with Alert ON ( log-rank test , P = 0.007 ) . CONCLUSIONS The ICD reliably detected CE and yielded low rates of unexplained and undetected events . The alert capability seemed to reduce the number of HF hospitalizations by allowing timely detection and therapeutic intervention",
"AIMS Early recognition of impending decompensation and timely intervention may prevent heart failure ( HF ) hospitalization . We investigated the performance of OptiVol ® intrathoracic fluid monitoring for the prediction of HF events in chronic HF patients newly implanted with a device ( implantable cardioverter-defibrillator with or without cardiac resynchronization therapy ) . METHODS AND RESULTS SENSE-HF was a prospect i ve , multi-centre study that enrolled 501 patients . Phase I ( double blinded , 6 months ) determined the sensitivity and positive predictive value ( PPV ) of the OptiVol data in predicting HF hospitalizations . Of 58 adjudicated HF hospitalizations that occurred during the first 6 months in Phase I , 12 were predicted by OptiVol ( sensitivity = 20.7 % ) . Sensitivity appeared to be dynamic in nature and at the end of Phase I , had increased to 42.1 % . With 253 OptiVol detections , PPV for Phase I was 4.7 % . Phase II/III ( unblinded , 18 months ) determined the PPV of the first OptiVol Patient Alert for detection of worsening HF status with signs and /or symptoms of pulmonary congestion . A total of 233 patients noted such an OptiVol alert and for 210 , HF status was evaluated within 30 days . Heart failure status had worsened for 80 patients ( PPV = 38.1 % ) . CONCLUSIONS An intrathoracic impedance-derived fluid index had low sensitivity and PPV in the early period after implantation of a device in chronic HF patients . Sensitivity improved within the first 6 months after implant . Further studies are needed to assess the place of this monitoring technology in the clinical management of patients with HF",
"OBJECTIVES We sought to determine the utility of combined heart failure ( HF ) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction . BACKGROUND Some implantable devices continuously monitor HF device diagnostic information , but data are limited on the ability of combined HF device diagnostics to predict HF events . METHODS The PARTNERS HF ( Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure ) was a prospect i ve , multicenter observational study in patients receiving cardiac resynchronization therapy ( CRT ) implantable cardioverter-defibrillators . HF events were independently adjudicated . A combined HF device diagnostic algorithm was developed on an independent data set . The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period : long atrial fibrillation duration , rapid ventricular rate during atrial fibrillation , high ( > or = 60 ) fluid index , low patient activity , abnormal autonomics ( high night heart rate or low heart rate variability ) , or notable device therapy ( low CRT pacing or implantable cardioverter-defibrillator shocks ) , or if they only had a very high ( > or = 100 ) fluid index . We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month . RESULTS We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 + /- 2 months . Ninety patients had 141 adjudicated HF hospitalizations with pulmonary congestion at least 60 days after implantation . Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month ( hazard ratio : 5.5 , 95 % confidence interval : 3.4 to 8.8 , p HF hospitalizations within the subsequent month . ( PARTNERS HF : Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure ; NCT00279955 )",
"The relative sensitivity and unexplained detection rate of changes in intrathoracic impedance has not been compared with st and ard heart failure ( HF ) monitoring using daily weight changes . The Fluid Accumulation Status Trial ( FAST ) prospect ively followed 156 HF patients with implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator devices modified to record daily changes in intrathoracic impedance in a blinded fashion for 537±312 days . Daily impedance changes were used to calculate a fluid index that could be compared with a prespecified threshold . True positives were defined as adjudicated episodes of worsening HF occurring within 30 days of a fluid index above threshold or an acute weight gain . Unexplained detections were defined as threshold crossings or acute weight gains not associated with worsening HF . Impedance measurements were performed on > 99 % of follow-up days , compared with only 76 % of days for weight measurements . Sixty-five HF events occurred during follow-up ( 0.32/patient-year ) . Forty HF events were detected by impedance but not weight , whereas 5 were detected by weight but not impedance . Sensitivity was greater ( 76 % vs 23 % ; P unexplained detection rate was lower ( 1.9 vs 4.3/patient-year ; P for intrathoracic impedance monitoring at the threshold of 60Ω days compared with acute weight increases of 3 lbs in 1 day or 5 lbs in 3 days and also over a wide range of fluid index and weight thresholds . The sensitivity and unexplained detection rate of intrathoracic impedance monitoring was superior to that seen for acute weight changes . Intrathoracic impedance monitoring represents a useful adjunctive clinical tool for managing HF in patients with implanted devices"
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41164b88-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To discuss healthy diet from a psychological perspective by considering definitions of healthy diet in terms of consumer underst and ing ; the health effects of specific dietary elements in terms of overweight and ( chronic ) illness ; the prevalence of healthy diet ; the psychological and environmental determinants of healthy diet ; and the psychological interventions that have been design ed to promote healthy diet . DESIGN A systematic review of the psychological literature on healthy diet . RESULTS Our findings suggest that consumers have a relatively poor underst and ing of a healthy diet . The literature also demonstrates that there is poor evidence on the health protective effects of single foods or nutrients . We further show that low SES is the single consistent risk factor for not adhering to a healthy diet . Our review of the literature on determinants demonstrates that intentions , habits , self-regulatory skills , and the social and physical environment are the most important determinants of a healthy diet , which are in turn amenable to change by intervention strategies with varying levels of effectiveness . Educational interventions generally show a limited effect on practising a healthy diet whereas interventions targeting habitual behaviour and /or the physical environment seem more promising . CONCLUSIONS In view of the large number of people who are concerned about their diets and make attempts to change their dietary patterns , we conclude that it is crucial to gain a better underst and ing of both the automatic and environmental influences that are responsible for people not acting upon their good intentions for diet change
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"OBJECTIVE Using self-refilling soup bowls , this study examined whether visual cues related to portion size can influence intake volume without altering either estimated intake or satiation . RESEARCH METHODS AND PROCEDURES Fifty-four participants ( BMI , 17.3 to 36.0 kg/m2 ; 18 to 46 years of age ) were recruited to participate in a study involving soup . The experiment was a between-subject design with two visibility levels : 1 ) an accurate visual cue of a food portion ( normal bowl ) vs. 2 ) a biased visual cue ( self-refilling bowl ) . The soup apparatus was housed in a modified restaurant-style table in which two of four bowls slowly and imperceptibly refilled as their contents were consumed . Outcomes included intake volume , intake estimation , consumption monitoring , and satiety . RESULTS Participants who were unknowingly eating from self-refilling bowls ate more soup [ 14.7+/-8.4 vs. 8.5+/-6.1 oz ; F(1,52)=8.99 ; p normal soup bowls . However , despite consuming 73 % more , they did not believe they had consumed more , nor did they perceive themselves as more sated than those eating from normal bowls . This was unaffected by BMI . DISCUSSION These findings are consistent with the notion that the amount of food on a plate or bowl increases intake because it influences consumption norms and expectations and it lessens one 's reliance on self-monitoring . It seems that people use their eyes to count calories and not their stomachs . The importance of having salient , accurate visual cues can play an important role in the prevention of unintentional overeating",
"BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk ratios ranging from 1.64 to 2.86 with count > 9x10(9)/L ) , female sex ( adjusted risk ratios , 0.27 to 0 . 46 ) , and aspirin use ( adjusted risk ratios , 0.59 to 0.82 ) were each significantly and independently associated with recurrence . CONCLUSIONS The protective effect of the Mediterranean dietary pattern was maintained up to 4 years after the first infa rct ion , confirming previous intermediate analyses . Major traditional risk factors , such as high blood cholesterol and blood pressure , were shown to be independent and joint predictors of recurrence , indicating that the Mediterranean dietary pattern did not alter , at least qualitatively , the usual relationships between major risk factors and recurrence . Thus , a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet . It should be associated with other ( pharmacological ? ) means aim ed at reducing modifiable risk factors . Further trials combining the 2 approaches are warranted",
"OBJECTIVE Although increasing evidence shows the importance of habits in explaining health behaviour , many studies still rely solely on predictors that emphasize the role of conscious intentions . The present study was design ed to test the importance of habit strength in explaining unhealthy snacking behaviour in a large representative community sample ( N= 1,103 ) . To test our hypothesis that habits are crucial when explaining unhealthy snacking behaviour , their role was compared to the ' Power of Food ' , a related construct that addresses sensitivity to food cues in the environment . Moreover , the relation between Power of Food and unhealthy snacking habits was assessed . DESIGN AND METHODS A prospect i ve design was used to determine the impact of habits in relation to intention , Power of Food and a number of demographic variables . One month after filling out the question naire , including measures of habit strength and Power of Food , participants reported their unhealthy snacking behaviour by means of a 7-day snack diary . RESULTS Results showed that habit strength was the most important predictor , outperforming all other variables in explaining unhealthy snack intake . CONCLUSIONS The findings demonstrate that snacking habits provide a unique contribution in explaining unhealthy snacking behaviour , stressing the importance of addressing habit strength in further research and interventions concerning unhealthy snacking behaviour",
"Definitive solutions wo n’t come from another million observational papers or small r and omized trials",
"The present study investigates the effectiveness of different strategies to improve Willingness to Taste disliked vegetables and the moderating role of Reward Sensitivity . Preschool children ( N = 204 ; age : M = 4.48 , SD = 1.01 ) were r and omly allocated to one of four different Willingness to Taste strategies . The findings indicate that first , Willingness to Taste is higher in the modelling and reward strategies compared to neutral instructions . Second , there is a differential effect of Willingness to Taste strategies dependent upon individual differences : children high in Reward Sensitivity were more likely to taste immediately when rewarded , while children low in Reward Sensitivity were more willing to taste when verbally encouraged , but with hesitation . This article thus highlights the roles of both individual differences and behavioral techniques for promoting a healthy diet in children",
"OBJECTIVE This study tested whether an intervention that combined information with self-regulation strategies had a better effect on eating fruits and vegetables than an information-only intervention . DESIGN Women between age 30 and 50 ( N = 255 ) participated in a 24-month r and omized controlled trial comparing two brief interventions : All participants received the same information intervention ; participants in the information plus self-regulation group additionally learned a self-regulation technique that integrates mental contrasting with implementation intentions . MAIN OUTCOME MEASURES Participants reported in daily diaries how many servings of fruits and vegetables they ate per day during 1 week at baseline , and in the first week , 1 , 2 , 4 , and 24 months after intervention . RESULTS Participants in both groups ate more fruits and vegetables ( 0.47 to 1.00 daily servings ) than at baseline during the first 4 months after intervention . Two years later , participants in the information plus self-regulation group maintained the higher intake , whereas participants in the information group returned to baseline levels . CONCLUSION Adding self-regulation training to an information intervention increased its effectiveness for long-term behavior change",
"OBJECTIVE To determine whether responsivity of reward circuitry to food predicts future increases in body mass and whether polymorphisms in DRD2 and DRD4 moderate these relations . DESIGN The functional magnetic resonance imaging ( fMRI ) paradigm investigated blood oxygen level dependent activation in response to imagined intake of palatable foods , unpalatable foods , and glasses of water shown in pictures . DNA was extracted from saliva sample s using st and ard salting-out and solvent precipitation methods . PARTICIPANTS Forty-four adolescent female high school students ranging from lean to obese . MAIN OUTCOME Future increases in body mass index ( BMI ) . RESULTS Weaker activation of the frontal operculum , lateral orbitofrontal cortex , and striatum in response to imagined intake of palatable foods , versus imagined intake of unpalatable foods or water , predicted future increases in body mass for those with the DRD2 TaqIA A1 allele or the DRD4 - 7R allele . Data also suggest that for those lacking these alleles , greater responsivity of these food reward regions predicted future increases in body mass . DISCUSSION This novel prospect i ve fMRI study indicates that responsivity of reward circuitry to food increases risk for future weight gain , but that genes that impact dopamine signaling capacity moderate the predictive effects , suggesting two qualitatively distinct pathways to unhealthy weight gain based on genetic risk",
"Prospect i ve studies indicate that elevated scores on dietary restraint scales predict bulimic symptom onset , but experiments indicate that assignment to dietary restriction interventions reduces bulimic symptoms . One possible explanation for the inconsistent findings is that the dietary restraint scales used in the former studies are not valid measures of dietary restriction . The authors previously found that dietary restraint scales were not inversely correlated with objective measures of short-term caloric intake ( E. Stice , M. Fisher , & M. R. Lowe , 2004 ) . In this follow-up report , 3 studies indicated that the Three-Factor Eating Question naire dietary restraint scale was not correlated with doubly labeled water estimated energy intake over 2-week periods or with observationally measured caloric intake over 3 months . Results from this study and others suggest that dietary restraint scales may not be valid measures of moderate- to long-term dietary restriction and imply the need to reinterpret findings from studies that have used dietary restraint scales",
"BACKGROUND The U.S. food and beverage industry recently released a new front-of-package nutrition labeling system called Facts Up Front that will be used on thous and s of food products . PURPOSE To test consumer underst and ing of the Facts Up Front system ( Facts Up Front ) compared to the Multiple Traffic Light system ( Traffic Light ) . Facts Up Front displays grams/milligrams and percentage daily value information for various nutrients ; Traffic Light uses an interpretive color-coded scheme to alert consumers to low , medium , and high levels of certain nutrients . DESIGN Participants in an Internet-based study were r and omized to one of five front-of-package label conditions : ( 1 ) no label ; ( 2 ) Traffic Light ; ( 3 ) Traffic Light plus information about protein and fiber ( Traffic Light+ ) ; ( 4 ) Facts Up Front ; or ( 5 ) Facts Up Front plus information about \" nutrients to encourage \" ( Facts Up Front+ ) . SETTING / PARTICIPANTS A total of 703 adults recruited through an online data base in May 2011 participated in this study , and data were analyzed in June 2011 . MAIN OUTCOME MEASURES Total percentage correct quiz scores were generated reflecting participants ' ability to compare two foods on nutrient levels , based on their labels , and to estimate amounts of saturated fat , sugar , sodium , fiber and protein in the foods . RESULTS The front-of-package label groups outperformed the control group on nearly all of the nutrient quizzes ( p Up Front+ group on the sugars quiz . Those in the Traffic Light+ group had the best overall performance ( > 80 % on all quizzes ) . CONCLUSIONS Overall , those in the Traffic Light+ condition performed better than those in the Facts Up Front conditions on measures of nutrition knowledge and label perceptions . TRIAL REGISTRATION This study is registered at clinical trials.gov NCT01626729",
"Background Accumulating evidence suggests that fruit and vegetable intake ( FVI ) plays a protective role against major diseases . Despite this protective role and the obesity p and emic context , population s in Western countries usually eat far less than five servings of fruits and vegetables per day . In order to increase the efficiency of interventions , they should be tailored to the most important determinants or mediators of FVI . The objective was to systematic ally review social cognitive theory-based studies of FVI and to identify its main psychosocial determinants . Methods Published papers were systematic ally sought using Current Contents ( 2007 - 2009 ) and Medline , Embase , PsycINFO , Proquest and Thesis , as well as Cinhal ( 1980 - 2009 ) . Additional studies were identified by a manual search in the bibliographies . Search terms included fruit , vegetable , behaviour , intention , as well as names of specific theories . Only studies predicting FVI or intention to eat fruits and vegetables in the general population and using a social cognitive theory were included . Independent extraction of information was carried out by two persons using predefined data fields , including study quality criteria . Results A total of 23 studies were identified and included , 15 study ing only the determinants of FVI , seven study ing the determinants of FVI and intention and one study ing only the determinants of intention . All pooled analyses were based on r and om-effects models . The r and om-effect R2 observed for the prediction of FVI was 0.23 and it was 0.34 for the prediction of intention . Multicomponent theoretical frameworks and the theory of planned behaviour ( TPB ) were most often used . A number of method ological moderators influenced the efficacy of prediction of FVI . The most consistent variables predicting behaviour were habit , motivation and goals , beliefs about capabilities , knowledge and taste ; those explaining intention were beliefs about capabilities , beliefs about consequences and perceived social influences . Conclusions Our results suggest that the TPB and social cognitive theory ( SCT ) are the preferable social cognitive theories to predict behaviour and TPB to explain intention . Efficacy of prediction was nonetheless negatively affected by method ological factors such as the study design and the quality of psychosocial and behavioural measures",
"OBJECTIVE To examine the effect of communicating images of energy-dense snack foods paired with aversive images of the potential health consequences of unhealthy eating , on implicit and explicit attitudes and food choice behavior . DESIGN Participants were r and omly allocated to either an evaluative conditioning ( EC ) procedure that paired images of snack foods with images of potential adverse health consequences or a control condition that featured images of snack foods alone . MAIN OUTCOME MEASURES Implicit attitudes were assessed pre- and post-intervention . Explicit attitudes and food choice behavior were assessed post-intervention . RESULTS The conditioning intervention made implicit attitudes toward energy-dense snacks more negative , with this effect greatest in those with relatively more favorable implicit attitudes toward these snacks at baseline . Participants in the conditioning intervention were more likely to choose fruit rather than snacks in a behavioral choice task , a relationship mediated by changes in implicit attitudes . CONCLUSION Presenting aversive images of potential health consequences with those of specific foodstuffs can change implicit attitudes , which impacts on subsequent food choice behavior",
"The sum of evidence -based nutrition has to be more than a Cochrane-type meta- analysis of r and omised controlled trials ( RCTs ) . Most of the evidence base in nutrition is observational , especially cohort studies . RCTs of diet change through to disease outcome are uncommon and the change has usually been addition or removal of only a single food component . Trials with whole diets through to disease outcome are rare and dietary changes made by individuals are unlikely to be an exact copy of the prescription . It is hard to even imagine a trial in which half ( r and omised ) of a large group of middle-aged people agree to avoid vegetables for 5 y and be followed up to see who will develop cancer . Most of the USA 's health cl aims , permitted by the Food and Drug Administration , are not supported by RCTs . But where controlled trials of nutritional change and disease outcome have been achieved , they must be review ed very carefully . Two Cochrane review s on diet and cardiovascular disease ( CVD ) , published in the widely read British Medical Journal ( BMJ ) , were criticised after their publication and the conclusions have not been subsequently adopted by expert committees . The first of these review s was ‘ Dietary fat and prevention of CVD : a systematic review ’ . The second was ‘ Systematic review of long term effects of advice to reduce dietary salt in adults ’ . A critique of these two Cochrane review s is presented here as a contribution to our discussion of the potential of Cochrane methodology to the reliability of knowledge about diet and disease",
"OBJECTIVE Anecdotal evidence exists that the public is becoming skeptical about nutrition messages . This article examines whether there is a backlash against dietary recommendations and whether it is associated with less healthful diets . DESIGN / PARTICIPANTS Data are from a 1997 - 1998 Washington State r and om-digit-dial survey of 1,751 adults design ed to monitor attitudes and behavior related to cancer risk and prevention . STATISTICAL ANALYSES Responses to the nutrition backlash survey were weighted to reflect the Washington State population . Linear regression was used to examine associations of nutrition backlash with fat and fruit and vegetable intake . RESULTS This survey did not find strong evidence that nutrition backlash was widespread . However , 70 % of respondents thought that Americans are obsessed with the fat in their diet and that the government should not tell people what to eat . More than a quarter agreed with the statement that eating low-fat foods takes the pleasure out of eating . Nutrition backlash was associated with less healthful diets : individuals showing high backlash had a fat-related diet habits score of 2.11 compared with a score of 1.73 among those showing low backlash ( P for trend = .001 ) , which corresponds to a difference of roughly 4 percentage points in percentage energy from fat . Individuals showing high backlash reported eating only 2.72 servings of fruits and vegetables per day , compared with 3.35 servings among those showing low backlash ( P for trend = .001 ) . APPLICATIONS/ CONCLUSIONS Nutrition professionals need to ensure that dietary recommendations are clear and positive to avoid the possibility that consumers may disregard nutrition messages entirely",
"Objective : This longitudinal experimental study compared effects of self-efficacy , planning and education-based conditions , encouraging adolescents to eat fruit and vegetable in place of energy-dense foods . Design : Data were collected among 506 adolescents ( 13–18 years old ) who were r and omly assigned to control ( n = 181 ) , planning ( n = 153 ) or self-efficacy ( n = 172 ) conditions . Measurements were taken at baseline ( T1 ) , at a 2-month follow-up ( T2 ) , and at a 14-month follow-up ( T3 ) . Interventions /control group procedures were delivered at T1 and T2 . Outcome measures : Self-reports of fruit and vegetable intake ( FVI ) and energy-dense foods intake were collected at three times . Cognitive mediators ( self-efficacy and planning ) were assessed at T1 and T2 . Body weight and height were objective ly measured at T1 and T3 . Results and conclusions : Similar significant increases of FVI were found for planning and self-efficacy interventions ( T3 ) . The planning intervention did not influence energy-dense food intake ( T3 ) , but the self-efficacy intervention tended to result in stabilising intake ( compared to an increase found in the control group ) . There were no effects on body weight . Similar patterns were found for the total sample and for a sub sample of adolescents with overweight/obesity . The effects of interventions on FVI were mediated by respective cognitions",
"Research indicates that dysfunctional food reward processing may contribute to pathological eating behaviour . It is widely recognized that both the amygdala and the orbitofrontal cortex ( OFC ) are essential parts of the brain 's reward circuitry . The aims of this fMRI study were ( 1 ) to examine the effects of food deprivation and calorie content on reward processing in the amygdala and the OFC , and ( 2 ) to examine whether an explicit evaluation of foods is necessary for OFC , but not amygdalar activity . Addressing the first aim , healthy females were presented with high and low calorie food pictures while being either hungry or satiated . For the second aim , attention focus was manipulated by directing participants ' attention either to the food or to a neutral aspect . This study shows that hunger interacts with the energy content of foods , modulating activity in the posterior cingulate cortex , medial OFC , insula , cau date putamen and fusiform gyrus . Results show that satiated healthy females show an increased reward processing in response to low calorie foods . Confirming our hypothesis , food deprivation increased activity following the presentation of high calorie foods , which may explain why treatments of obesity energy restricting diets often are unsuccessful . Interestingly , activity in both the amygdala and mOFC was only evident when participants explicitly evaluated foods . However , attention independent activity was found in the mPFC following the high calorie foods cues when participants where hungry . Current findings indicate that research on how attention modulates food reward processing might prove especially insightful in the study of the neural substrates of healthy and pathological eating behaviour"
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41164bc4-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND AND AIMS Increasing prescription stimulant abuse among youth without diagnoses of attention deficit hyperactivity disorder ( ADHD ) is of concern . The most frequently cited motive for abuse is improved academic achievement via neurocognitive enhancement . Our aim in review ing the literature was to identify neurocognitive effects of prescription stimulants in non-ADHD youth . METHODS A systematic review was conducted for youth aged 12–25 years using Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines . Fourteen papers were included . RESULTS Modafinil appears to improve reaction time ( P ≤ 0.04 ) , logical reasoning ( P ≤ 0.05 ) and problem-solving . Methylpheni date appears to improve performance in novel tasks and attention-based tasks ( P ≤ 0.05 ) , and reduces planning latency in more complex tasks ( P ≤ 0.05 ) . Amphetamine has been shown to improve consolidation of information ( 0.02 ≥ P ≤ 0.05 ) , leading to improved recall . Across all three types of prescription stimulants , research shows improved attention with lack of consensus on whether these improvements are limited to simple versus complex tasks in varying youth population s. CONCLUSIONS The heterogeneity of the non-attention deficit hyperactivity disorder youth population , the variation in cognitive task characteristics and lack of replication of studies makes assessing the potential global neurocognitive benefits of stimulants among non-attention deficit hyperactivity disorder youth difficult ; however , some youth may derive benefit in specific cognitive domains
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"OBJECTIVES Stimulant medications appear effective at restoring simple alertness and psychomotor vigilance in sleep deprived individuals , but it is not clear whether these medications are effective at restoring higher order complex cognitive capacities such as planning , sequencing , and decision making . DESIGN After 44 hours awake , participants received a double-blind dose of one of 3 stimulant medications or placebo . After 45 - 50 hours awake , participants were tested on computerized versions of the 5-Ring Tower of Hanoi ( TOH ) , the Tower of London ( TOL ) , and the Wisconsin Card Sorting Test ( WCST ) . SETTING In-residence sleep-laboratory facility at the Walter Reed Army Institute of Research . PARTICIPANTS Fifty-four healthy adults ( 29 men , 25 women ) , ranging in age from 18 to 36 years . INTERVENTIONS Participants were r and omly assigned to 1 of 3 stimulant medication groups , including caffeine , 600 mg ( n=12 ) , modafinil , 400 mg ( n=12 ) , dextroamphetamine , 20 mg ( n=16 ) , or placebo ( n=14 ) . MEASUREMENTS AND RESULTS At the doses tested , modafinil and dextroamphetamine groups completed the TOL task in significantly fewer moves than the placebo group , and the modafinil group demonstrated greater deliberation before making moves . In contrast , subjects receiving caffeine completed the TOH in fewer moves than all 3 of the other groups , although speed of completion was not influenced by the stimulants . Finally , the modafinil group outperformed all other groups on indices of perseverative responding and perseverative errors from the WCST . CONCLUSIONS Although comparisons across tasks can not be made due to the different times of administration , within-task comparisons suggest that , at the doses tested here , each stimulant may produce differential advantages depending on the cognitive dem and s of the task",
"Abstract Rationale . Modafinil , a novel wake-promoting agent , has been shown to have a similar clinical profile to that of conventional stimulants such as methylpheni date . We were therefore interested in assessing whether modafinil , with its unique pharmacological mode of action , might offer similar potential as a cognitive enhancer , without the side effects commonly experienced with amphetamine-like drugs . Objectives . The main aim of this study was to evaluate the cognitive enhancing potential of this novel agent using a comprehensive battery of neuropsychological tests . Methods . Sixty healthy young adult male volunteers received either a single oral dose of placebo , or 100 mg or 200 mg modafinil prior to performing a variety of tasks design ed to test memory and attention . A r and omised double-blind , between-subjects design was used . Results . Modafinil significantly enhanced performance on tests of digit span , visual pattern recognition memory , spatial planning and stop-signal reaction time . These performance improvements were complemented by a slowing in latency on three tests : delayed matching to sample , a decision-making task and the spatial planning task . Subjects reported feeling more alert , attentive and energetic on drug . The effects were not clearly dose dependent , except for those seen with the stop-signal paradigm . In contrast to previous findings with methylpheni date , there were no significant effects of drug on spatial memory span , spatial working memory , rapid visual information processing or attentional set-shifting . Additionally , no effects on paired associates learning were identified . Conclusions . These data indicate that modafinil selectively improves neuropsychological task performance . This improvement may be attributable to an enhanced ability to inhibit pre-potent responses . This effect appears to reduce impulsive responding , suggesting that modafinil may be of benefit in the treatment of attention deficit hyperactivity disorder",
"The authors present a unified account of 2 neural systems concerned with the development and expression of adaptive behaviors : a mesencephalic dopamine system for reinforcement learning and a \" generic \" error-processing system associated with the anterior cingulate cortex . The existence of the error-processing system has been inferred from the error-related negativity ( ERN ) , a component of the event-related brain potential elicited when human participants commit errors in reaction-time tasks . The authors propose that the ERN is generated when a negative reinforcement learning signal is conveyed to the anterior cingulate cortex via the mesencephalic dopamine system and that this signal is used by the anterior cingulate cortex to modify performance on the task at h and . They provide support for this proposal using both computational modeling and psychophysiological experimentation",
"Abstract . Rationale : In 1998 , the FDA approved modafinil for treating excessive daytime sleepiness in narcoleptics , and this has raised questions about the appropriateness of this compound for enhancing alertness in sleep-deprived controls . This study explored the efficacy of modafinil for maintaining the performance of volunteers required to accomplish highly dem and ing tasks despite sleep loss . Objective : The principal objective was to determine whether prophylactic doses of modafinil would attenuate decrements in aviator performance and arousal throughout 2 days and 1 night without sleep . Methods : Six pilots were exposed to two 40-h periods of continuous wakefulness . In one , three 200-mg doses of modafinil were given and in the other , matching placebos were administered . Helicopter simulator flights , resting EEGs , and Profile of Mood States ( POMS ) question naires were evaluated . Results : Modafinil attenuated sleep deprivation effects on four of six flight maneuvers , reduced slow-wave EEG activity , and lessened self-reported problems with mood and alertness in comparison to placebo . The most noticeable benefits occurred between 0330 and 1130 hours , when the combined impact of sleep loss and the circadian trough was most severe . The most frequently observed drug side effects were vertigo , nausea , and dizziness . These could have been related to : 1 ) the motion-based testing , 2 ) the use of a simulator rather than an actual aircraft ( i.e. , \" simulator sickness \" ) , and /or 3 ) the administration of more than 400 mg modafinil . Conclusions : Modafinil is a promising countermeasure for sleep loss in normals ; however , additional studies aim ed at reducing side effects are needed before it should be used in aviators",
"BACKGROUND Response inhibition is an executive function that requires voluntary control over responses when there is a change of context . The right inferior frontal cortex is necessary for response inhibition , and a deficit in right frontostriatal circuitry might underlie attention-deficit/hyperactivity disorder ( ADHD ) . Many studies of childhood ADHD have demonstrated impaired response inhibition and its amelioration by methylpheni date ( MPH ) . The current study tested response inhibition and the effect of MPH in adult ADHD . METHODS Response inhibition was assessed with the \" tracking \" stop-signal test in 13 adults with a diagnosis of ADHD , both while taking and while not taking medication , and 13 healthy , unmedicated , age- and intelligence quotient-matched control subjects . RESULTS Stop-signal reaction time was significantly slower in unmedicated adults with ADHD relative to healthy control subjects , and this deficit was significantly ameliorated by medication . CONCLUSIONS Adult ADHD patients had a response inhibition profile similar to that produced by lesions to the right inferior frontal cortex , which was remedied by stimulant medication",
"Nonmedical use of prescription-stimulant medication such as methylpheni date ( MPH ) has increased among college students over the past several years . Common motivations for use include enhancements in cognition and subjective arousal . As it is unclear whether stimulant medication exerts the same effect on healthy individuals as for those with attention-deficit/hyperactivity disorder , it is possible that many reported effects of prescription stimulants by healthy individuals may stem from placebo effects , which may be an important mechanism underlying initiation and maintenance of nonmedical use . This study examined whether placebo effects influence reports of subjective mood and cognitive performance among college students who endorsed several risk factors for prescription-stimulant misuse ( i.e. , low grade point average , fraternity/sorority involvement , binge drinking , cannabis use ) . Ninety-six subjects ( 60 % male ) completed cognitive tests and question naires assessing present mood state on two occasions . Forty-seven participants were r and omized to an experimental condition and orally ingested what they believed to be MPH , though actually placebo , on one visit and received no medication on the other visit . The control group received no medication on either visit . During the administration visit , experimental participants reported feeling significantly more high and stimulated compared with the nonadministration visit and to the control subjects . However , cognitive enhancement differences were not generally seen between visits or groups . This research demonstrates that placebo effects for prescription stimulants do influence subjective mood and may be implicated in nonmedical stimulant use . This knowledge may be useful in challenging prescription-stimulant-related expectancies to decrease the prevalence of use among college students",
"How the brain monitors ongoing behavior for performance errors is a central question of cognitive neuroscience . Diminished awareness of performance errors limits the extent to which humans engage in corrective behavior and has been linked to loss of insight in a number of psychiatric syndromes ( e.g. , attention deficit hyperactivity disorder , drug addiction ) . These conditions share alterations in monoamine signaling that may influence the neural mechanisms underlying error processing , but our underst and ing of the neurochemical drivers of these processes is limited . We conducted a r and omized , double-blind , placebo-controlled , cross-over design of the influence of methylpheni date , atomoxetine , and citalopram on error awareness in 27 healthy participants . The error awareness task , a go/no-go response inhibition paradigm , was administered to assess the influence of monoaminergic agents on performance errors during fMRI data acquisition . A single dose of methylpheni date , but not atomoxetine or citalopram , significantly improved the ability of healthy volunteers to consciously detect performance errors . Furthermore , this behavioral effect was associated with a strengthening of activation differences in the dorsal anterior cingulate cortex and inferior parietal lobe during the methylpheni date condition for errors made with versus without awareness . Our results have implication s for the underst and ing of the neurochemical underpinnings of performance monitoring and for the pharmacological treatment of a range of disparate clinical conditions that are marked by poor awareness of errors",
"Psychostimulants such as mixed amphetamine salts ( MAS , br and name Adderall ) are widely used for cognitive enhancement by healthy young people , yet laboratory research on effectiveness has yielded variable results . The present study assessed the effects of MAS in healthy young adults with an adequately powered double-blind cross-over placebo-controlled trial . We examined effects in 13 measures of cognitive ability including episodic memory , working memory , inhibitory control , convergent creativity , intelligence and scholastic achievement , with the goals of determining ( 1 ) whether the drug is at least moderately enhancing ( Cohen 's d > = .5 ) to some or all cognitive abilities tested , ( 2 ) whether its effects on cognition are moderated by baseline ability or COMT genotype , and ( 3 ) whether it induces an illusory perception of cognitive enhancement . The results did not reveal enhancement of any cognitive abilities by MAS for participants in general . There was a suggestion of moderation of enhancement by baseline ability and COMT genotype in a minority of tasks , with MAS enhancing lower ability participants on word recall , embedded figures and Raven 's Progressive Matrices . Despite the lack of enhancement observed for most measures and most participants , participants nevertheless believed their performance was more enhanced by the active capsule than by placebo . We conclude that MAS has no more than small effects on cognition in healthy young adults , although users may perceive the drug as enhancing their cognition . This article is part of a Special Issue entitled ' Cognitive Enhancers ' ",
"OBJECTIVES To explore the illicit use of specific prescription stimulants among college students and add to our underst and ing of reasons ( motives ) and routes of administration associated with illicit use of these drugs . METHODS A r and om sample of 4580 college students self-administered a Web-based survey . The survey contained a variety of items pertaining to the illicit use of prescription stimulants . An extensive list of prescription stimulants was provided , and students were asked to select all the specific prescription stimulants that they had used illicitly . Items were also included to assess the motives and routes of administration associated with illicit use of prescription stimulants . RESULTS Lifetime and past-year prevalence rates for illicit use of prescription stimulants were 8.3 % ( 382 students ) and 5.9 % ( 269 students ) , respectively . Approximately three fourths ( 75.8 % ) of the 269 past-year illicit users of prescription stimulants reported using an amphetamine-dextroamphetamine combination agent ( e.g. , Adderall ) in the past year , and approximately one fourth ( 24.5 % ) reported using methylpheni date ( e.g. , Ritalin , Concerta , Meta date , Methylin ) . Past-year illicit use of prescription stimulants was more than 3 times more likely among Caucasians ( odds ratio [ OR ] 3.1 , 95 % confidence interval [ CI ] 1.5 - 6.6 ) and Hispanics ( OR 3.8 , 95 % CI 1.6 - 9.3 ) compared with African-Americans , and more than twice as likely among Caucasians ( OR 2.1 , 95 % CI 1.3 - 3.4 ) and Hispanics ( OR 2.6 , 95 % CI 1.4 - 5.1 ) compared with Asians . The most commonly reported motives for illicit use were to help with concentration ( 65.2 % ) , help study ( 59.8 % ) , and increase alertness ( 47.5 % ) . Other motives included getting high ( 31.0 % ) and experimentation ( 29.9 % ) . Nearly every illicit user ( 95.3 % ) reported oral administration , and 38.1 % reported snorting prescription stimulants . CONCLUSION Illicit use of amphetamine-dextroamphetamine is more prevalent than illicit use of methylpheni date formulations among college students",
"Rationale The majority of studies investigating the cognitive effects of modafinil , a wake-promoting compound , demonstrate some improvements in attention . The potential of the drug to selectively benefit distinct components of attention has yet to be fully explored in healthy adults . Objective The present study was conducted to investigate modafinil ’s effect on specific cognitive tasks that tax components of attention switching . One required the rapid switching of attention between stimuli , and another contained an embedded working memory component on top of the attentional shift requirements . Additionally , prospect i ve memory was examined , which requires the interruption of an ongoing activity to retrieve and act upon a previously formed intention . Material s and methods Healthy non-smoking volunteers , matched on age , intelligence , and baseline cognitive ability , received either a capsule that contained 200 mg modafinil or placebo . Subjective measures of mood and physiological response were taken throughout the experimental session , and the tasks were completed between 2 and 3 h post-dosing . Results Two hundred milligrams modafinil improved accuracy without a reaction time trade-off , in both conditions of the attention-shifting task , but only when re sources were most challenged . In contrast , the drug afforded no improvement in prospect i ve remembering or in the ongoing task that was interrupted . Conclusion Modafinil appears to promote rapid switching of attention in conditions that are most dem and ing , whilst it offers no benefits in a task that requires unpredictable and infrequent disengagement of attention from an ongoing task in order to act upon an alternative task",
"Healthy human volunteers 16–82 years of age with at least 10 years of schooling were exposed to two different memory tasks . The first task involved incidental memory . The subjects were asked , as casually as possible : “ Did you watch any movie on TV 2 days ago ? And 7 days ago ? If so , do you remember the title of the movie(s ) and the name of the first two actors ( actresses ) ? ” Retention scores ( maximum = 3 : title , actor 1 , and actor 2 ) were equally high ( overall mean = 2.6 , n = 61 ) in all age groups ( 16–20 , 21–30 , 31–40 , 41–60 , and 61–82 years ) for the day 2 scores . Scores for the movie seen 7 days before decreased significantly and progressively in the three older groups in relation to age , which indicates reduced persistence of this type of memory beginning at the age of 41–50 years and becoming more extensive over the years . The other task was a formal memory procedure . Subjects were asked to study a brief text with factual information on the 1954 World Soccer Cup for 10 min . They were then exposed to 10 questions on the text 2 days and , again , 7 days later . Retention scores declined between the two tests , but in this task , the decline of persistence occurred to a similar extent in all age groups , and thus was not dependent on age . Methylpheni date ( 10 mg p.o . ) given 12 hours after acquisition markedly enhanced persistence of the two memory types . This suggests an involvement of dopaminergic processes in persistence in the late posttraining period",
"Abstract Rationale : Altered serotonergic and dopaminergic function have been widely implicated in behavioural disorders associated with impulsivity and risk-taking . However , little research has addressed the specific cognitive consequences of changed monoaminergic function that might contribute to the production of impulsive behaviour . Objectives and methods : We compared the effects of rapid plasma tryptophan depletion , acute doses of the mixed indirect catecholamine agonist , methylpheni date ( 40 mg ) , and acute doses of the α1/α2 agonist , clonidine ( 1.5 µg/kg ) , on aspects of visual discrimination learning involving either acquisition of altered stimulus-reward associations ( i.e. updating the affective valence of exteroceptive stimuli ) or the control of attention towards relevant as opposed to irrelevant stimulus dimensions . Results : Relative to subjects who received placebo , subjects with reduced tryptophan exhibited a deficit in the ability to learn changed stimulus-reward associations , but were still able to shift an acquired attentional set away from a now-irrelevant stimulus dimension towards a newly relevant dimension . By contrast , subjects who received methylpheni date were able to learn effectively about changing stimulus-reward associations , but showed an enhanced ability to shift an attentional bias , in combination with slowed response times . Subjects who received clonidine showed neither of these changes . Conclusions : These results suggest that reduction in central serotonin leads to altered neuromodulation of the cortical and subcortical regions ( e.g. orbitofrontal cortex , striatum and anterior temporal structures ) that mediate important aspects of associative learning whereby exteroceptive stimuli acquire altered incentive motivational value . On the other h and , facilitation of catecholamine neurotransmitters may disrupt the allocation of attention between relevant and irrelevant features of the environment , perhaps through altered modulation of the dorsolateral prefrontal cortex . The implication s of these results for underst and ing the differential neuromodulation of cognitive functions are discussed",
"Abstract Previous studies of the effects of the psychomotor stimulant , methylpheni date , have concentrated on vigilance and reaction time tasks . In this study , the effects of methylpheni date on more complex aspects of cognition were studied using tasks from the CANTAB battery and related tests which have been shown to be sensitive to frontal lobe dysfunction . Twenty-eight young healthy men participated in a counterbalanced , double-blind , placebo-controlled study of the effects of methylpheni date . Cognitive assessment included tests of spatial working memory , planning , verbal fluency , attentional set-shifting and sustained attention . Methylpheni date had significant effects on performance of the tests of spatial working memory and planning but not on the attentional and fluency tests . When the drug was taken on the first test session , performance on the spatial tests was enhanced by the drug compared to placebo . However , when the drug was taken second , performance accuracy was impaired whereas response latencies were decreased . These results are consistent with a hypothesis that methylpheni date influences performance in two conflicting ways ; enhancing executive aspects of spatial function on novel tasks but impairing previously established performance . This pattern of effects is discussed within the framework of dual , interacting arousal mechanisms",
"Models of information processing currently popular in cognitive psychology divide the reaction process into a series of discrete separable stages . The distinction between one stage and another is verified by the additive factors method ( AFM ) as defined by Sternberg ( 1969 ) . Task factors that do not interact with each other are inferred to affect different stages . The distinction between stimulus evaluation stages and response selection stages has been supported by brain event related potential ( ERP ) studies . The latency of the P300 component of the ERP is sensitive to changes in stimulus complexity but not to to changes in response complexity . The focus of this research is to determine the effects of stimulant drugs on stages of information processing using both reaction time ( RT ) and P300 latency within an AFM framework . four doses of methylpheni date ( MP ) were used in a within-subjects design to examine the effects of MP on stimulus and response processing . We found that MP speeds RT , and that this effect does not interact with the effect of stimulus complexity on RT . MP dose interacts with response complexity , the dose for optimal speeding varying with the level of complexity . The latency of P300 is increased by stimulus complexity , and not by response complexity , nor is it affected by MP . These results show that the stimulant drug acts on processes involved in response selection , rather than in stimulus evaluation . Individual differences in drug response are dose dependent , but also point to an effect on response processing",
"Self-monitoring refers to the ability to assess accurately one 's own performance in a specific environment . The present study investigated the effects of the stimulating drugs modafinil ( 300 mg ) and d-amphetamine ( 20 mg ) on the ability to self-monitor cognitive performance during 64 h of sleep deprivation ( SD ) and sustained mental work . Two cognitive tasks were investigated : a visual ( perceptual ) judgement task and a complex mental addition task . Subjects in the placebo condition displayed marked circadian and SD effects on cognitive task performance but their self-monitoring was substantively undisturbed by SD . Subjects performing under the influence of d-amphetamine likewise displayed highly proficient self-monitoring throughout the SD period . In contrast , modafinil had a disruptive effect on self-monitoring , inducing a reliable ' overconfidence ' effect ( i.e. an overestimation of actual cognitive performance ) , which was particularly marked 2 - 4 h post-dose . Although modafinil has proven to be a safe and effective countermeasure to the effects of extensive SD on cognitive task performance , we encourage a more comprehensive underst and ing of the relation between its subjective and performance enhancing effects before the drug is recommended as a viable fatigue countermeasure",
"A series of five experiments was conducted to investigate the temporal aspects of human memory consolidation of symbolic material through the administration of amphetamine . Subjects had to recall or recognise unrelated words from a previously presented list . The first experiments support the conjecture , based on animal studies , that amphetamine enhances long-term memory performance . Subsequently , enhancement is demonstrated with oral administration before learning , as well as with intramuscular injection after learning . It is shown that improved recall can not be explained solely by general arousal or attentional processes , but must be due to consolidation . By introducing different test delays we show that consolidation of symbolic material can be modulated by amphetamine during the 1st hour after learning . In a final experiment we demonstrate that the memory enhancement applies to recall as well as to recognition . The implication s of the present results are discussed in the context of recent research on LTP processes",
"The behavioral , cognitive , and electrophysiological effect of a single dose of dextroamphetamine ( 0.5 milligram per kilogram of body weight ) or placebo was examined in 14 normal prepubertal boys ( mean age , 10 years 11 months ) in a double-blind study . When amphetamine was given , the group showed a marked decrease in motor activity and reaction time and improved performance on cognitive tests . The similarity of the response observed in normal children to that reported in children with \" hyperactivity \" or minimal brain dysfunction casts doubt on pathophysiological models of minimal brain dysfunction which assume that children with this syndrome have a clinical ly specific or \" paradoxical \" response to stimulants",
"The study examined the effects of expectation on the subjective effects and oral self-administration of 15 mgd-amphetamine ( AMP ) and placebo in 40 volunteers who reported no prior use of stimulants other than caffeine . A balanced placebo design was used to create four groups : told Placebo/got Placebo ( P/P ) , told Placebo/got Stimulant ( P/S ) , told Stimulant/got Placebo ( S/P ) , told Stimulant/got Stimulant ( S/S ) . There were three sessions . On one session ( INFO ) , participants received a capsule containing AMP or placebo and were given information about the contents of the capsule according to the balanced placebo design . On another session ( NO INFO ) , participants received no information about the capsule 's contents and were given placebo . On the final session , participants were allowed to choose either the INFO or NO INFO capsule . Participants came to the laboratory to ingest their capsules , and then returned to their normal environments where they completed subjective effects question naires every 2 h for 8 h. Expectancies influenced the subjective effects reported during the INFO session , regardless of whether subjects actually received AMP or placebo : subjects who expected a stimulant had higher ratings of “ feel drug ” and “ like drug ” . The pharmacological effects of AMP were also evident on the INFO sessions : AMP produced its prototypic subjective effects regardless of subjects ' expectancies . Significant interactions between drug and expectancy were obtained on self-report measures of anxiety and arousal : anxiety was higher for groups who received substances that did not match their expectations ( P/S and S/P ) and arousal increased most in volunteers who expected placebo but received stimulant . Choice of drug was determined primarily by pharmacology : participants who received AMP on the INFO session usually chose that capsule , regardless of information about its identity ( P/S : 8/10 ; S/S : 9/10 ) . In contrast , participants who received placebo on the INFO session chose this capsule at chance levels , regardless of information about its identity ( S/P : 3/10 ; P/P : 6/10 ) . Thus , expectancy influenced some of the subjective effects of AMP and placebo , but the pharmacological effects of the AMP were instrumental in determining whether volunteers would self-administer the drug",
"To assess the prevalence and motives for illicit use of prescription stimulants and alcohol and other drugs ( AODs ) , associated with these motives , the authors distributed a self-administered Web survey TO a r and om sample of 9,161 undergraduate college students . Of the study participants , 8.1 % reported iifetime and 5.4 % reported past-year illicit use of prescription stimulants . The most prevalent motives given for illicit use of prescription stimulants were to ( 1 ) help with concentration , ( 2 ) increase alertness , and ( 3 ) provide a high . Although men were more likely than women were to report illicit use of prescription stimulants , the authors found no gender differences in motives . Regardless of motive , illicit use of prescription stimulants was associated with elevated rates of AOD use , and number of motives endorsed and AOD use were positively related . Students appear to be using these prescription drugs non-medically , mainly to enhance performance or get high",
"The effects of a single oral dose of dextroamphetamine sulfate on motor activity , vigilance , learning , and mood were compared for normal and hyperactive prepubertal boys and normal college-aged men using a double-blind crossover design . Both groups of boys and men showed decreased motor activity increased vigilance , and improvement on a learning task after taking the stimulant drug . The men reported euphoria , while the boys reported only feeling \" tired # or \" different # after taking the stimulant . It is not clear whether this difference in effect on mood between adults and children is due to differing experience with drugs , ability to report affect , or a true pharmacologic age-related effect . While there were some quantitative differences in drug effects on motor activity and vigilance between these different groups , stimulants appear to act similarly on normal and hyperactive children and adults"
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Several studies have investigated the effect of bleaching on dental tissues . The evaluation of the effect of home bleaching with 10 % carbamide peroxide is important for assessing alterations in enamel microhardness that may affect dental health in terms of resistance to masticatory forces . This meta- analysis was performed in order to determine scientific evidence regarding the effects of home vital bleaching with 10 % carbamide peroxide gel on the microhardness of human dental enamel . A systematic electronic literature search was conducted in the PubMed and Web of Science data bases using search terms . Two independent research ers evaluated the information and method ological quality of the studies . Inclusion and exclusion criteria were established for article selection ; further , only studies published in English were selected . Thirteen studies that met all of the inclusion and exclusion criteria were selected and underwent statistical analysis . The results of this meta- analysis showed no significant changes in enamel microhardness when using the 10 % carbamide peroxide bleaching gel over periods of 7 , 14 and 21 days
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"The aim of this study was to evaluate the surface roughness , microhardness and morphology of human enamel exposed to six bleaching agents ( at baseline and post-treatment ) . Human dental enamel sample s were obtained from human third molars and r and omly divided into seven groups ( n = 11 ) : control , Whiteness Perfect--10 % carbamide peroxide ( 10 % CP ) , Colgate Platinum--10 % CP , Day White 2Z--7.5 % hydrogen peroxide ( 7.5 % HP ) , Whiteness Super--3 % CP , Opalescence Quick--35 % CP and Whiteness HP--35 % HP . Bleaching agents were applied according to manufacturers ' instructions . The control group remained not treated and stored in artificial saliva . Microhardness testing was performed with a Knoop indentor and surface roughness was analyzed with a profilometer . Morphologic observations were carried out with scanning electron microscopy ( SEM ) . Results were statistically analyzed by two-way analysis of variance and Tukey 's test ( 5 % ) , and revealed a significant decrease in microhardness values and a significant increase in surface roughness post-bleaching . Changes in enamel morphology after bleaching were observed under SEM . It was concluded that bleaching agents can alter the microhardness , roughness and morphology of dental enamel surface",
"Objectives : This study investigated the effects of post bleaching treatments to prevent restaining and the change of enamel surface microhardness after dental bleaching in vitro . Methods : Sixty intact human incisor teeth were stained in tea solution and r and omly assigned into four groups ( n=15 ) . Then sample s were bleached for two weeks ( 8 hours daily ) by 15 % carbamide peroxide . Tooth color was determined both with a spectrophotometer and visually before bleaching ( T1 ) and immediately after bleaching ( T2 ) . Next , it was applied in group 1 fluoride ( Naf 2 % ) gel for 2 minutes , and in group 2 a fractional CO2 laser ( 10 mJ , 200 Hz , 10 s ) , and in group 3 , nanohydroxyapatite gel for 2 minutes . The bleached teeth in group 4 remained untreated ( control group ) . Then teeth placed in tea solution again . Color examinations were repeated after various post bleaching treatments ( T3 ) and restaining with tea ( T4 ) and color change values recorded . The microhardness was measured at the enamel surface of sample s. Data was analyzed using ANOVA , Tukey HSD test and Dunnett T3 ( α = 0.05 ) . Results : Directly after bleaching ( ΔE T3-T2 ) , the treatment with nanohydroxyapatite showed significantly the least color lapse in colorimetric evaluation . In experimental groups , the color change between T3 and T4 stages ( ΔE T4-T3 ) was significantly lower than control group ( P significant increase in surface microhardness compared to control group ( P Application of fluoride , fractional CO2 laser and nanohydroxyapatite as post bleaching treatments are suggested for prevention of stain absorption and increasing the hardening of bleached enamel",
"OBJECTIVES The aim of this study was to evaluate the efficacy , color stability , risk , and intensity of tooth sensitivity ( TS ) of combined bleaching techniques performed with 20 % or 35 % hydrogen peroxide for an in-office protocol . METHODS Thirty patients were r and omly divided into two groups and su bmi tted to a single 45-minute in-office bleaching session with 35 % hydrogen peroxide or 20 % hydrogen peroxide . At-home bleaching was performed with 10 % carbamide peroxide for two hours daily over the course of two weeks . The color was evaluated with the value-oriented shade guide Vita Classical at different periods up to 12 months after bleaching . Patients recorded the intensity of TS using a five-point verbal scale . Color change data were su bmi tted to a two-way repeated- measures analysis of variance and Tukey test ( α=0.05 ) . The absolute risk and intensity of TS were compared with the Fisher exact test and Mann-Whitney test , respectively ( α=0.05 ) . RESULTS On average , an effective and similar whitening of three units in shade guide was observed for both groups , which remained stable for 12 months . When both protocol s were compared , the one with hydrogen peroxide 35 % showed a higher risk ( p=0.02 ) and intensity of TS ( p=0.04 ) . In regard to the TS intensity , no significant difference was observed up to 48 hours after in-office bleaching ( p=0.09 ) and during the at-home bleaching phase of the study ( p=0.71 ) . CONCLUSION The combined bleaching technique using at-home bleaching associated with in-office bleaching was effective and stable over the course of 12 months , regardless of the concentration of the hydrogen peroxide used for in-office bleaching . However , the protocol with 20 % hydrogen peroxide produced lower risk and intensity of TS",
"This in vitro study evaluated the surface microhardness of human enamel su bmi tted to bleaching with 10 % carbamide peroxide ( CP ) containing calcium or fluoride . Ninety-eight dental blocks ( 5 x 5 mm2 ) with polished enamel surfaces were r and omly assigned to 7 treatment groups ( n=14 ) , as follows : without bleaching and storage in artificial saliva ( control ) ; 10 % CP ; 10 % CP + 0.05 % calcium ; 10 % CP + 0.1 % calcium ; 10 % CP + 0.2 % calcium ; 10 % CP + 0.2 % fluoride ; and 10 % CP + 0.5 % fluoride . During 14 days , enamel surfaces were daily exposed to a 6-h bleaching regimen followed by storage in artificial saliva . Surface microhardness was measured before ( baseline ) , during ( 7th day ) , immediately after bleaching ( 14th day ) and 1 week post bleaching . Data were analyzed by two-way ANOVA and Tukey 's test ( p reduced SM significantly during the bleaching cycle ( 7th day ) , immediately after bleaching ( 14th day ) and 1 week post bleaching , compared to baseline and to the unbleached control group . In conclusion , in spite of the addition of calcium and fluoride , all bleaching treatments affected the enamel surface microhardness",
"Background There is little data regarding the effect of tooth whitening on microhardness of white spot lesions . This study was conducted to investigate the effect of home-bleaching and laser-assisted in-office bleaching on microhardness of demineralized enamel . Material and Methods Forty bovine incisors were selected and immersed in a demineralizing solution for 12 weeks to induce white spot lesions . Enamel blocks were prepared and r and omly assigned to two groups of 20 each . The first group underwent home bleaching with 15 % carbamide peroxide which was applied for 8 hours a day over a period of 15 days . In the second group , in-office bleaching was performed by 40 % hydrogen peroxide and powered by irradiation from an 810 nm gallium-aluminum-arsenide ( GaAlAs ) diode laser ( CW , 2W ) . This process was performed for 3 sessions every seven days , in 15 days . The specimens were stored in Fusayama Meyer artificial saliva during the experiment . Surface microhardness was assessed before and after the bleaching therapies in both groups . Results Microhardness decreased significantly following both home bleaching and laser-assisted in-office bleaching ( p hardness values among the two groups either before ( p=0.131 ) or after ( p=0.182 ) the bleaching procedures . Conclusions Tooth whitening through home bleaching or laser-assisted in-office bleaching can result in a significant reduction in microhardness of white spot lesions . Therefore , it is suggested to take protective measures on bleached demineralized enamel . Key words : White spot lesion , bleaching , laser , microhardness , demineralized enamel , home bleaching , in-office bleaching",
"This in vitro study evaluated the new formulas of bleaching products and the effect of subsequent applications of fluoride on the hardness of enamel during and after tooth bleaching . The crowns of 60 extracted intact human molars were sectioned longitudinally ; the buccal part was embedded in acrylic resin , the occlusal part was ground flat , exposing enamel and dentin , and then polished . Baseline Knoop microhardness ( KHN ) of enamel was determined . The specimens were then r and omly divided into six groups of 10 specimens , and each group was assigned to a specific 10 % carbamide peroxide ( CP ) bleaching agent . A : Opalescence , B : Opalescence PF ( 3 % potassium nitrate and 0.11 % fluoride ) , C : Nite White Excel 3 ( ACP ) , D : Opalescence + F ( acidulated phosphate fluoride 1.23 % ) , E : Opalescence PF + F , F : Nite White Excel 3 + F. The teeth were bleached for eight hours ; after each procedure , the specimens were stored in artificial saliva at 37 degrees C. Immediately after day 21 of bleaching , the specimens in groups D , E and F received fluoride 1.23 % for five minutes . KHN tests w ere performedbefore ( baseline = control ) , during ( 14 , 21 ) and two weeks ( 35 days ) after the bleaching procedure and were statistically compared using ANOVA/Tukey 's t-test ( alpha no significant difference among the bleaching material s ( p = 0.123 ) . A significant enamel KHN reduction ( p fluoride showed a significant increase in microhardness . For the new bleaching formulas , the enamel was restored to a value similar to baseline",
"BACKGROUND Various agents are used these days for increasing the esthetics . One such procedure is bleaching that offers various advantages , as it is minimal invasive and cheap option to color the teeth and remove stain . The altered enamel after the bleaching process shows surface demineralization and porosities . The present study aim ed to evaluate the effect of different bleaching agents on the microhardness of enamel . MATERIAL S AND METHODS A total of 100 freshly human extracted maxillary premolar teeth were selected for the study . Teeth with sound tooth structure were included for the study . All the specimens were r and omly divided into four groups with 25 specimens in each group depending upon the type of bleaching agent used : Group A , artificial saliva ( Control group ) ; Group B , 35 % hydrogen peroxide ( HP ) ; Group C , 25 % HP ; Group D , 10 % carbamide peroxide ( CP ) . Knoop Hardness Number ( KHN ) was calculated at 24 , 48-hour , and 7-week interval . RESULTS Results showed no statistical significant differences between the microhardness of enamel of different groups ( p value of KHN was seen in all the groups , except for the control group , although the results were statistically nonsignificant ( p > 0.005 ) . CONCLUSION Although nonsignificantly , all the bleaching solutions produced some amount of alterations in the microstructure of enamel . More studies with higher study groups and more advanced estimation technologies are required to minimize microstructure alterations and promote for better outcome of bleaching procedures",
"Sodium ascorbate has recently been suggested to compensate decreased bond strength of composite resin to bleached tooth surfaces . The aim of present study was to evaluate the effect of 10 % sodium ascorbate on bleached bovine enamel morphology and microhardness considering the possibility of its effect on enamel surface characteristics . A total of 69 bovine enamel slabs were prepared and mounted in acrylic resin . Subsequent to polishing , they were r and omly divided into 3 groups of 23 specimens each ; 3 for Scanning Electron Microscopy ( SEM ) analysis and 20 for hardness test . In group 1 the specimens were immersed in distilled water as control group ; in group 2 the specimens were bleached with 35 % carbamide peroxide for 30 min a week for 3 consecutive weeks ; and in group 3 the specimens were exposed to 10 % sodium ascorbate for 30 min subsequent to bleaching similar to group 1 . After 3 weeks Vickers hardness of the specimens was measured at 3 points with equal distances from each other under a force of 50 g. The mean of the hardness values of each specimen was calculated and data was analyzed by one-way ANOVA ( P microhardness values were observed in group 1 and group 2 , respectively . However , there were no statistically significant differences in microhardness between the groups ( P = 0.12 ) . The use of 35 % carbamide peroxide alone or with 10 % sodium ascorbate does not affect bovine enamel hardness . SEM analysis showed a network of sodium ascorbate adsorbed to the bleached enamel surface",
"BACKGROUND Several studies have been published about the effect of carbamide peroxide on enamel surface morphology . However , only a few studies have been carried out under intraoral conditions . The purpose of this study was to investigate the effect of two commercially available 10 % carbamide peroxide bleaching products ( Colgate Platinum and Starbrite ) on the enamel surface morphology under intraoral conditions . MATERIAL S AND METHODS Twenty-four subjects were divided into two groups and assigned a product to use for 2 weeks . Epoxy resin replicas obtained from the maxillary right central incisors of the subjects before , immediately after , and 3 months after the bleaching procedure were examined under a scanning electron microscope . RESULTS Immediately after the bleaching procedure , the surface porosity of enamel had increased in the Colgate Platinum group , whereas erosive surface alterations were observed in the Starbrite group . At 3 months , the surface morphology of enamel in the Colgate Platinum group was similar to the untreated enamel surface . In the Starbrite group , erosive defects on the enamel surface had decreased within 3 months , and the appearance of the enamel surface was almost the same as the untreated enamel . CONCLUSION Even though both bleaching agents caused alterations in the surface morphology of enamel , these alterations were reversed within 3 months following treatment . CLINICAL SIGNIFICANCE The results of this study suggest that 10 % carbamide peroxide bleaching products cause alterations in enamel surface morphology immediately after bleaching , and the degree of these alterations depends on the br and of bleaching agent and duration of application time . However , these alterations revert to almost normal within 3 months",
"OBJECTIVE To evaluate the effect of home-use bleaching agent containing 16 % Carbamide Peroxide ( CP ) and in-office bleaching agent containing 38 % Hydrogen Peroxide ( HP ) on enamel micro-hardness . STUDY DESIGN An in vitroexperimental study . PLACE AND DURATION OF STUDY Department of Operative Dentistry and Science of Dental Material s at Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences , Dow University of Health Sciences and Material Engineering Department of NED University of Engineering and Technology , Karachi , from July to December 2014 . METHODOLOGY Atotal of 90 enamel slabs from 45 sound human 3rd molar were r and omly divided into 3 groups . Each group contained 30 specimens ( n=30 ) . Group 1 was kept in artificial saliva at 37 ° C in incubator during the whole experiment . However , Groups 2 and 3 were treated with power whitening gel and tooth whitening pen respectively . After bleaching session , specimens were thoroughly rinsed with deionized water again for 10 seconds and then stored in artificial saliva at 37 ° C in incubator . Artificial saliva was changed after every 2 days . The Vickers hardness tester ( Wolpert 402 MVD , Germany ) was adjusted to a load of 0.1 kg ( 100 gm ) and dwell time of 5 seconds . Three Vickers were performed on each specimen using a hardness tester according to the ISO 6507 - 3:1998 specification . Micro-hardness measurements were performed before and after bleaching at day 1 , 7 and 14 . RESULTS In the control group , the baseline micro-hardness was 181.1 ±9.3 which was reduced after the storage on day 1 , 7 and 14 ( p = 0.104 ) . In Group 2 , baseline micro-hardness was 180.4 ±10.1 which was reduced to 179.79 ±10.0 units after day 1 . Whereas , on day 7 and 14 , the values of micro-hardness were 179.8 ±10 and 179.7 ±10.29 , respectively ( p=0.091 ) . Furthermore , the baseline micro-hardness in Group 3 was 174.0 ±22.9 units which was reduced to 173 ±23 on day 1 , 170 ±30 on day 7 and 173 ±23 on day 14 ( p = 0.256 ) . The statistically insignificant difference was found among micro-hardness values of different bleaching agents ( p = 0.118 ) . CONCLUSION Bleaching with 38 % Hydrogen Peroxide ( HP ) and 16 % Carbamide Peroxide ( CP ) result ed in insignificant effect on surface micro-hardness of enamel",
"Aims and Objectives : The purpose of the study was to evaluate and compare the microhardness of enamel after the application of anticay on bleached enamel with fluoride containing and fluoride free bleaching agent . Material s and Methods : Twenty freshly extracted teeth decoronated and divided mesiodistally into two halves were r and omly divided into five groups with 10 sample s in each group . The enamel surface was treated as follows : Group 1 - no treatment , Group 2 - fluoride free bleaching agent , Group 3 - fluoride containing bleaching agent , and Group 4 - fluoride free bleaching agent followed by anticay application . The sample s were subjected to indentation to test the microhardness using Vicker 's hardness analyzer . Conclusion : Enamel microhardness significantly increased in sample s where anticay was used after the application of bleaching agent",
"This study sought to evaluate the microhardness of enamel su bmi tted to 10 % carbamide peroxide treatment and different methods of remineralization involving sodium fluoride ( NaF ) . Non-erupted third molars were used and 75 enamel blocks with st and ardized dimensions ( 4.0 x 4.0 x 2.0 mm ) were obtained . Enamel blocks were r and omly divided into five groups ( n = 15 ) : one control ( no bleaching and no fluoride treatment ) , one receiving a 10 % carbamide peroxide treatment , one receiving 10 % carbamide peroxide plus acidulated phosphate fluoride , one receiving 10 % carbamide peroxide with 0.2 % NaF , and one receiving 10 % carbamide peroxide and 0.05 % NaF. There were no differences among four of the groups ( p > 0.05 ) ; the group receiving 10 % carbamide peroxide only was different from all other groups ( p NaF therapies are recommended during carbamide peroxide bleaching treatments",
"PURPOSE This study evaluated the effect of two home bleaching regimens ( 1 h/day versus 7 h/day for a total of 21 days ) on the microhardness of superficial enamel treated with 10 % carbamide peroxide gel . MATERIAL S AND METHODS Rectangular enamel specimens ( 2.5 x 2.5 x 1 mm ) were obtained from human third molars and mounted on the palatal aspect of removable orthodontic retainers . Nine enamel specimens were mounted in each of 10 retainers , used by 10 volunteers during the active phase of the study . Modified 0.089 cm thick bleaching trays were fabricated for each participant . Each bleaching tray fit a participant 's arch and the retainer containing the enamel specimens . Enamel specimens were treated with a 10 % carbamide peroxide bleaching gel ( Nite White Excel 2Z , Discus Dental , Culver City , CA , USA ) for either 1 h/day ( n = 30 ) or 7 h/day ( n = 30 ) , both for 21 days . Three enamel specimens in each retainer were never treated and served as controls . The retainers were worn by the participants whether or not they underwent bleaching . This simulated the natural action of the saliva/oral fluids on the enamel specimens . Enamel specimens were subjected to pre- and post-treatment microhardness measurements . Post-treatment Knoop hardness numbers were compared with baseline values and analyzed statistically . RESULTS Bleaching treatment result ed in a nonsignificant reduction in microhardness values when compared with values of the control nontreated specimens ( 1.7 % and 2.5 % reduction in hardness for 1 h/day and 7 h/day , respectively ) . There was no difference in microhardness between the different treatment regimens . CONCLUSION Home bleaching with 10 % carbamide peroxide for up to 7 h/day for 21 days does not significantly affect enamel microhardness . CLINICAL SIGNIFICANCE Bleaching with 10 % carbamide peroxide for 1 h/day or 7 h/day for a total of 21 days is safe for human enamel",
"OBJECTIVE To evaluate the effect of home-use bleaching agent containing 16 % Carbamide Peroxide ( CP ) and in-office bleaching agent with 38 % Hydrogen Peroxide ( HP ) on surface micro-morphology of enamel . STUDY DESIGN An experimental study . PLACE AND DURATION OF STUDY The discs were prepared at Material Engineering Department of NED University of Engineering and Technology , Karachi , and surface morphology was analyzed at Central ized Science Laboratory of Karachi University , Pakistan . Duration of study was one year from January to December 2012 . METHODOLOGY Forty five sound human third molar crowns , extracted for periodontal reason , were included in the study . Longitudinal sections were made using diamond disks ( 0.2 mm ) under water lubrication to obtain enamel slabs measuring ( 3 mm x 3 mm ) . The slabs were embedded in polystyrene resin by using 2.0 cm diameter PVC molds , leaving the outer enamel surface uncovered by the resin . Ninety dental enamel slabs were prepared . The slabs were then r and omly divided into 3 groups . Each group contained thirty specimens ( n=30 ) . Group 1 was kept in artificial saliva at 37 ° C in incubator ( Memart , Germany ) during whole experiment . Group 2 was treated with power whitening gel ( White Smile 2011 , Germany ) . Group 3 was treated with tooth whitening pen ( White Smile 2011 , Germany ) . The most central region or the region that was most representative of the entire surface area was used . The SEM ( Jeol-Japan-JSM6380A , JAPAN ) micrographs were examined to determine the type of surface presented . The enamel changes were classified as no or mild alteration , moderate alteration and severe altered surface . RESULTS Regarding micro-morphology , the enamel surface of control groups showed smooth surface in general with some scattered clear scratches due to the polishing procedure . The specimens bleached in group 2 and group 3 , represented areas of mild erosion . CONCLUSION Bleaching with 38 % Hydrogen Peroxide ( HP ) and 16 % Carbamide Peroxide ( CP ) result ed in mild changes in surface micro-morphology of enamel",
"BACKGROUND There exists limited data in the literature regarding the efficacy and safety of consumer-available , paint-on bleaching solutions . PURPOSE The purpose of this in vitro study was to evaluate the effect of two consumer-available , paint-on bleaching products on enamel microhardness against a control and a dentist-prescribed , home-applied ( DPHA ) bleaching product . MATERIAL S AND METHODS Eighty enamel slabs were obtained from extracted human teeth and r and omly divided into four treatment groups : ( 1 ) control ; ( 2 ) Opalescence ( Ultradent Products , Inc. , South Jordan , UT , USA ) ; ( 3 ) Crest Night Effects ( Procter & Gamble , Cincinnati , OH , USA ) ; and ( 4 ) Colgate Simply White Night ( Colgate-Palmolive Co. , Piscataway , NJ , USA ) . Opalescence is a carbamide peroxide DPHA product , whereas Crest Night Effects and Colgate Simply White Night are consumer-available products . The specimens in groups 2 to 4 underwent 2 weeks of treatment for 8 h/d . Specimens were maintained in artificial saliva at 37 degrees C between treatments . Subsequently , one-half of the specimens in groups 2 to 4 ( n=10 ) underwent an additional seven treatments for 8 h/d , while the other half were stored in artificial saliva , receiving no further treatment . Microhardness was measured as Knoop hardness numbers ( KHNs ) at baseline and after 1 , 7 , 14 , and 21 treatment days . The results were analyzed for statistical significance both intra- and intergroups using analysis of variance ( p=.05 ) . RESULTS A statistically significant reduction in mean KHN was observed compared with baseline at 1 , 7 , 14 , and 21 treatment days for group 4 and at 7 treatment days for group 3 . When compared with the control or DPHA product , group 4 was the only treatment that result ed in significantly lower mean KHNs at 7 , 14 , and 21 treatment days . CONCLUSION When evaluating enamel microhardness , consumer available , paint-on bleaching solutions may adversely affect enamel microhardness compared to a control and 10 % carbamide peroxide DPHA bleaching solution . CLINICAL SIGNIFICANCE With numerous consumer-available bleaching products on the market , it is crucial to be judicious in their selection and use . The results of this in vitro study showed that the consumer-available , paint-on bleaching solutions adversely affected enamel microhardness at some time during the study . Consumers should be made aware of this effect on enamel",
"PURPOSE To evaluate the effect of tray-based and trayless tooth whitening systems on surface and subsurface microhardness of human enamel . METHODS Enamel slabs were obtained from recently extracted human third molars . Specimens were r and omly assigned to six groups according to tooth whitening treatment ( n = 10 ) : 6.0 % hydrogen peroxide ( HP ) ( Crest Whitestrips ) , 6.5 % HP ( Crest Professional Whitestrips ) , 7.5 % HP ( Day White Excel 3 ) , 9.5 % HP ( Day White Excel 3 ) , 10 % carbamide peroxide ( Opalescence ) , and a control group ( untreated ) . Specimens were treated for 14 days following manufacturers ' recommended protocol s , and were immersed in artificial saliva between treatments . Enamel surface Knoop microhardness ( KHN ) was measured immediately before treatment , and at days 1 , 7 , and 14 of treatment . After treatment , subsurface microhardness was measured at depths of 50 - 500 microm . Data were analyzed for statistical significance using analysis of variance . RESULTS Differences in microhardness for treated vs. untreated enamel surface were not statistically significant at any time interval . For 6.5 % and 9.5 % HP , there was a decrease in surface microhardness values during treatment , but at the end of treatment the microhardness values were not statistically different from the baseline values . For the enamel subsurface values , no differences were observed between treated vs. untreated specimens at each depth . Trayless and tray-based tooth whitening treatments do not significantly affect surface or subsurface enamel microhardness",
"This in situ study evaluated the microhardness of sound and demineralized enamel and dentin su bmi tted to treatment with 10 % carbamide peroxide for three weeks . A 10 % carbamide peroxide bleaching agent -- Opalescence/Ultradent (OPA)--was evaluated against a placebo agent ( PLA ) . Two hundred and forty dental fragments--60 sound enamel fragments ( SE ) , 60 demineralized enamel fragments ( DE ) , 60 sound dentin fragments ( SD ) and 60 demineralized dentin fragments (DD)--were r and omly fixed on the vestibular surface of the first superior molars and second superior premolars of 30 volunteers . The volunteers were divided into two groups that received bleaching or the placebo agent at different sequences and periods at a double blind 2 x 2 crossover study with a wash-out period of two weeks . Microhardness tests were performed on the enamel and dentin surface . The SE and DE su bmi tted to treatment with OPA showed lower microhardness values than the SE and DE su bmi tted to treatment with PLA . There were no statistical differences in microhardness values for SD and DD su bmi tted to the treatment with OPA and PLA . The results suggest that treatment with 10 % carbamide peroxide bleaching material for three weeks alters the enamel microhardness , although it does not seem to alter the dentin microhardness",
"OBJECTIVES The aim of this study was to evaluate the effects of low concentrations of carbamide peroxide bleaching agents ( CP ) on the ultimate tensile strength of enamel ( UTS ) . METHODS Resin composite structure was built-up on the bonded occlusal surface of 12 sound third molars to facilitate specimen preparation for microtensile testing . The bonded teeth were sectioned in a bucco-lingual direction in slices approximately 0.7 mm thick . Each slice was trimmed with a fine diamond bur to reduce the buccal , internal slope enamel of the cusps to a dumb-bell shape with a cross-sectional area at the ' neck ' of less than 1 mm2 . The sample was r and omly divided into six groups of 10 specimens each : Control ( C-untreated ) ; Opalescence 10 % ( O10 ) , Opalescence 15 % ( O15 ) , Opalescence 20 % ( O20 ) , Whiteness 10 % ( W10 ) and Whiteness 16 % ( W16 ) . Specimens in each group received the application of the CP for 6 h/day , at 37 degrees C , during 14 days and were stored in artificial saliva in between each application . After the bleaching regimen , specimens were tested with the microtensile method at 0.5 mm/min . Data were analyzed by ANOVA and Tukey test ( 5 % ) . RESULTS Mean tensile strengths were ( MPa ) : C = 47.5 + /- 6.2a ; O10 = 37.6 + /- 5.8b ; O15 = 33.2 + /- 6.0b ; O20 = 31.2 + /- 3.5b ; W10 = 32.5 + /- 6.1b ; W16 = 30.6 + /- 7.7b . Specimens subjected to the bleaching regimen presented significantly lower UTS than the control group . No differences were found among the type and concentration of the bleaching agents . SIGNIFICANCE Results suggested that bleaching enamel with CP could significantly reduce its UTS within a 14 days treatment"
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BACKGROUND The current meta- analysis evaluated the outcomes of various lifestyle interventions , including diet modifications ( DIET ) , physical activity ( PA ) , and patient education ( EDU ) in reducing the risk of cardiovascular disease in patients with type 2 diabetes . METHODS R and omized clinical trials comparing lifestyle intervention with " usual care " ( control ) in type 2 diabetes patients were h and - search ed from medical data bases by two independent review ers using the terms " diabetes , cardiovascular risk , lifestyle , health education , dietary , exercise/physical activities , and behavior intervention " . RESULTS Of the 235 studies identified , 17 were chosen for the meta- analysis . The average age of patients ranged from 50 - 67.3 years . Results reveal no significant difference between the groups , with respect to BMI , while PA and DIET yielded a greater reduction in HbA1c . Significant reduction in both systolic and diastolic pressures in the DIET group , and diastolic pressure in the PA group , was observed . HDL-c in the DIET group was significantly higher than the control group , while no change in LDL-c levels , was seen in all three intervention subtypes . There was no difference between the EDU vs. the control group in terms of HbA1c , blood pressure or HDL-c and LDL-c . CONCLUSION DIET intervention showed an improvement in HbA1c , systolic/diastolic blood pressure and HDL-c , with an exception of LDL-c and BMI , suggesting that nutritional intervention had a significant impact on the quality of life by reducing the cardiovascular risk in type 2 diabetes patients
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"AIMS To assess the effect of regular diabetic health education on cardiovascular risk factors in Chinese Type 2 diabetic patients . METHODS This was a 1-year prospect i ve r and omized study . One hundred and eighty Type 2 diabetic subjects were recruited from three regional diabetic centres in Hong Kong . Ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every 3 months ( intervention group ) . The others received the same medical care except no nursing reinforcement ( control group ) . Outcome measures included fasting plasma glucose , HbA(1c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after 1 year . RESULTS Two of the controls defaulted follow-up . The intervention group and controls had similar age and sex distribution . At the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , HbA(1c ) , total cholesterol and low-density lipoprotein cholesterol levels . The controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels . Other cardiovascular risk factors were not significantly changed in the controls . Addition of drugs and /or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups . CONCLUSIONS Regular structured reinforcement with diabetic health education is useful . It helps to control more successfully some of the cardiovascular risk factors in Chinese Type 2 diabetic patients",
"OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes",
"BACKGROUND Increased blood pressure ( BP ) in type 2 diabetes ( T2DM ) markedly increases cardiovascular disease morbidity and mortality risk compared to having increased BP alone . OBJECTIVE To investigate whether exercise reduces suboptimal levels of untreated suboptimal BP or treated hypertension . DESIGN Prospect i ve , r and omized controlled trial for 6 months . SETTING Single center in Baltimore , MD , USA . PATIENTS 140 participants with T2DM not requiring insulin and untreated SBP of 120–159 or DBP of 85–99 mmHg , or , if being treated for hypertension , any SBP INTERVENTIONS upervised exercise , 3 times per week for 6 months compared with general advice about physical activity . MEASUREMENTS Resting SBP and DBP ( primary outcome ) ; diabetes status , arterial stiffness assessed as carotid-femoral pulse-wave velocity ( PWV ) , body composition and fitness ( secondary outcomes ) . RESULTS Overall baseline BP was 126.8 ± 13.5 / 71.7 ± 9.0 mmHg , with no group differences . At 6 months , BP was unchanged from baseline in either group , BP 125.8 ± 13.2 / 70.7 ± 8.8 mmHg in controls ; and 126.0 ± 14.2 / 70.3 ± 9.0 mmHg in exercisers , despite attaining a training effects as evidence d by increased aerobic and strength fitness and lean mass and reduced fat mass ( all p Overall baseline PWV was 959.9 ± 333.1 cm/s , with no group difference . At 6-months , PWV did not change and was not different between group ; exercisers , 923.7 ± 319.8 cm/s , 905.5 ± 344.7 , controls . LIMITATIONS A completion rate of 81 % . CONCLUSIONS Though exercisers improve fitness and body composition , there were no reductions in BP . The lack of change in arterial stiffness suggests a resistance to exercise-induced BP reduction in persons with T2DM",
"Aims /hypothesisThe aim of this study was to investigate the effectiveness of physical activity counselling in promoting physical activity in people with Type 2 diabetes and to evaluate result ant physiological and biochemical effects . Methods A total of 70 inactive people with Type 2 diabetes were given st and ard exercise information and r and omised to receive physical activity counselling ( n=35 , experimental ) or not ( n=35 , control ) . Physical activity consultations were delivered at baseline and after 6 months , with follow-up phone calls after 1 , 3 , 6 and 9 months . Changes from baseline after 6 and 12 months were assessed for physical activity ( 7-day recall and accelerometer ) , for physiological characteristics ( body mass index and blood pressure ) and for biochemical variables ( HbA1c , lipid profile , fibrinogen , tissue plasminogen activator and microalbuminuria ) . Results Significant differences between groups were recorded for physical activity after 6 and 12 months ( p levels of physical activity from baseline to 6 months ( p0.05 ) . In the control group , accelerometer counts per week decreased from baseline to 12 months ( p=0.03 ) . Between-group differences ( p HbA1c ( experimental : 0.26 % decrease ; control : 0.15 % increase ) , for systolic blood pressure ( experimental : 7.7 mm Hg decrease ; control : 5.6 mm Hg increase ) and for fibrinogen ( experimental : 0.28 mmol/l decrease ; control : 1.43 mmol/l increase ) from baseline to 6 months , and for total cholesterol ( experimental : 0.33 mmol/l decrease ; control : 0.04 mmol/l increase ) from baseline to 12 months ( p activity counselling was effective in promoting physical activity in people with Type 2 diabetes . The counselling improved glycaemic control as well as the status of cardiovascular risk factors in these patients",
"BACKGROUND Behavioral research to improve lifestyle in broadly defined population s of patients with type 2 diabetes is limited . OBJECTIVE We evaluated a behavioral intervention featuring technology-based self-monitoring on biophysiologic outcomes of glycemic control and markers of cardiovascular risk . DESIGN In this single-site , r and omized clinical trial , participants were stratified by good and poor glycemic control ( glycated hemoglobin and r and omized within strata . Measurements were obtained at 0 , 3 , and 6 months . PARTICIPANTS / SETTING Self-referred , community-dwelling adults with type 2 diabetes mellitus . INTERVENTION The intervention group received Social Cognitive Theory-based counseling paired with technology-based self-monitoring , and results were compared with an attention control group . MAIN OUTCOME MEASURES Glycated hemoglobin , fasting serum glucose , lipid levels , blood pressure , weight , body mass index , and waist circumference were evaluated . STATISTICAL ANALYSES PERFORMED Mean differences within and between r and omization groups were compared over time . Intervention effects over time were estimated using r and om intercept models . RESULTS Two hundred ninety-six subjects were r and omized , 256 ( 86.5 % ) completed 3-month and 246 ( 83.1 % ) completed 6-month assessment s. Glycated hemoglobin was reduced in the intervention group by 0.5 % at 3 months and 0.6 % at 6 months ( P baseline glycated hemoglobin ≥8 % and estimated glomerular filtration rate ≥60 mL/min , glycated hemoglobin was reduced in the intervention group by 1.5 % at 3 months and 1.8 % at 6 months ( P reduction in glycated hemoglobin of 0.29 % was not significant . CONCLUSIONS Two behavioral approaches to improving general lifestyle management in individuals with type 2 diabetes mellitus were effective in improving glycemic control , but no significant between-group differences were observed",
"Aims /hypothesisThe aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes . Methods A total of 2,033 eligible Japanese men and women aged 40–70 years with type 2 diabetes from 59 institutes were r and omised to a conventional treatment group ( CON ) , which continued to receive the usual care , and a lifestyle intervention group ( INT ) , which received education on lifestyle modification regarding dietary habits , physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit , in addition to the usual care . R and omisation and open-label allocation were done by a central computer system . Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period . Results Although status of control of most classic cardiovascular risk factors , including body weight , glycaemia , serum lipids and BP , did not differ between groups during the study period , the incidence of stroke in the INT group ( 5.48/1,000 patient-years ) was significantly lower than in the CON group ( 9.52/1,000 patient-years ) by Kaplan – Meier analysis ( p = 0.02 by logrank test ) and by multivariate Cox analysis ( HR 0.62 , 95 % CI 0.39–0.98 , p = 0.04 ) . The incidence of CHD , retinopathy and nephropathy did not differ significantly between groups . Lipoprotein(a ) was another significant independent risk factor for stroke . Conclusions /interpretationThese findings suggest that lifestyle modification had limited effects on most typical control variables , but did have a significant effect on stroke incidence in patients with established type 2 diabetes . Clinical Trial Registration : UMIN-CTR C000000222 Funding : The Ministry of Health , Labour and Welfare ,",
"PURPOSE To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control , intermediate cardiovascular outcomes , satisfaction with care , and re source utilization . METHODS We conducted a r and omized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C ) ( HbA(1C ) ) levels > or=7.5 % . Two nurse practitioner case managers worked with patients and their primary care providers , monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts , collaborative goal setting , and treatment algorithms . Control patients received educational material s and usual care from their primary care providers . RESULTS At the conclusion of the study , both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C ) level ( 9.3 % vs. 9.2 % ; difference = 0.1 % ; 95 % confidence interval : -0.4 % to 0.7 % ; P = 0.65 ) . There was also no evidence that the intervention result ed in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy . However , intervention patients were substantially more satisfied with their diabetes care , with 82 % rating their providers as better than average compared with 64 % of patients in the control group ( P = 0.04 ) . CONCLUSION An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes . The type of patients targeted for intervention , organizational factors , and program structure are likely critical determinants of the effectiveness of case management . Health systems must underst and the potential limitations before expending substantial re sources on case management , as the expected improvements in outcomes and downstream cost savings may not always be realized",
"Objective : To investigate the effect of a pharmacist care program on cardiovascular risks in type 2 diabetic patients . Methods : A 9-month , prospect i ve , r and omized , controlled study was conducted in a public hospital in Hong Kong . Patients in the intervention group had regular drug-counseling sessions with pharmacists in addition to routine medical care , whereas patients in the control group received only routine medical care . The primary outcome was the change in coronary heart disease ( CHD ) risk . Results : A total of 105 patients completed the study . Patients in the intervention group had a statistically significant reduction in CHD risk compared to those in the control group ( −1.64 % ± 3.56 % ; n = 51 vs −0.01 % ± 3.08 % ; n = 54 , P = .013 ) . For stroke , a reduction in risk was noted in the intervention group , while an increased risk was noted in the control group ( −1.06 % ± 1.82 % vs 0.31 % ± 2.51 % , P = .002 ) . In addition , hemoglobin A1c levels were significantly reduced in the intervention group compared with the control group ( −1.57 % ± 1.50 % vs –0.40 % ± 1.19 % , P with low-density lipoprotein cholesterol ( −0.36 ± 0.76 vs −0.03 ± 0.74 , P = .026 ) . Furthermore , there were nonsignificant improvements in high-density lipoprotein cholesterol , triglyceride , and blood pressure in the intervention group . The increased level of underst and ing regarding medications in the intervention group was statistically significant ( P Conclusion : The pharmacist care program implemented in this study demonstrated a significant cardiovascular risk reduction in type 2 diabetic patients ; therefore such a program would be a valuable addition to a multidisciplinary care of diabetic patients",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk ",
"Background Individual health education is considered to be essential in the overall care of patients with type 2 diabetes ( DM2 ) , although there is some uncertainty regarding its metabolic control benefits . There have been very few r and omized studies on the effects of individual education on normal care in DM2 patients with a control group , and none of these have assessed the long-term results . Therefore , this study aims to use this design to assess the effectiveness of the PRECEDE ( Predisposing , Reinforcing , Enabling , Causes in Educational Diagnosis , and Evaluation ) education model in the metabolic control and the reduction of cardiovascular risk factors , in patients with type 2 diabetes . Methods An open community effectiveness study was carried out in 8 urban community health centers in the North-East Madrid Urban Area ( Spain ) . Six hundred patients with DM2 were r and omized in two groups : PRECEDE or conventional model for health promotion education . The main outcome measures were glycated hemoglobin A1c , body mass index ( BMI ) , blood pressure , lipids and control criteria during the 2-year follow-up period . Results Glycated hemoglobin A1c and systolic blood pressure ( SBP ) levels decreased significantly in the PRECEDE group ( multivariate analysis of covariance , with baseline glycated hemoglobin A1c , SBP , and variables showing statistically significant differences between groups at baseline visits ) . The decrease levels in diastolic blood pressure ( DBP ) , triglycerides and LDL cholesterol were nonsignificant . PRECEDE increased compliance in all control criteria , except for LDL cholesterol . BMI did not change during the study in either of the two models analyzed . Conclusions PRECEDE health education model is a useful method in the overall treatment in patients with type 2 diabetes , which contributes to decrease glycated hemoglobin A1c and SBP levels and increase the compliance in all the control criteria , except for LDL cholesterol . Trial registration number Clinical Trials.gov",
"BACKGROUND Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease ( CVD ) risk factors in individuals with type 2 diabetes mellitus , but no long-term data are available . We examined the effects of lifestyle intervention on changes in weight , fitness , and CVD risk factors during a 4-year study . METHODS The Look AHEAD ( Action for Health in Diabetes ) trial is a multicenter r and omized clinical trial comparing the effects of an intensive lifestyle intervention ( ILI ) and diabetes support and education ( DSE ; the control group ) on the incidence of major CVD events in 5145 overweight or obese individuals ( 59.5 % female ; mean age , 58.7 years ) with type 2 diabetes mellitus . More than 93 % of participants provided outcomes data at each annual assessment . RESULTS Averaged across 4 years , ILI participants had a greater percentage of weight loss than DSE participants ( -6.15 % vs -0.88 % ; P improvements in treadmill fitness ( 12.74 % vs 1.96 % ; P ( -0.36 % vs -0.09 % ; P ( -5.33 vs -2.97 mm Hg ; P .001 ) and diastolic ( -2.92 vs -2.48 mm Hg ; P = .01 ) blood pressure , and levels of high-density lipoprotein cholesterol ( 3.67 vs 1.97 mg/dL ; P ) and triglycerides ( -25.56 vs -19.75 mg/dL ; P .001 ) . Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants ( -11.27 vs -12.84 mg/dL ; P = .009 ) owing to greater use of medications to lower lipid levels in the DSE group . At 4 years , ILI participants maintained greater improvements than DSE participants in weight , fitness , hemoglobin A(1c ) levels , systolic blood pressure , and high-density lipoprotein cholesterol levels . CONCLUSIONS Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness , glycemic control , and CVD risk factors in individuals with type 2 diabetes . Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00017953",
"OBJECTIVE To assess the impact of personalized exercise prescription on habitual physical activity and glycemic control in sedentary , insulin treated type 2 diabetes patients during a 2-y intervention period . RESEARCH DESIGN AND METHODS 74 patients were r and omized to the intervention ( n=38 ) or control ( n=36 ) group . The intervention group was stimulated to increase daily physical activity through regular , structured , and personalized exercise prescription by a physical therapist over the 2-y intervention period . RESULTS Physical activity levels at work or in leisure time were not modulated by the exercise prescription intervention . In accordance , no changes in body composition , glycemic control , medication use or risk factors for cardiovascular disease were observed . CONCLUSIONS Long-term behavioral intervention programs , providing individualized exercise prescription , are not sufficient to change sedentary behavior and /or improve glycemic control in insulin treated , type 2 diabetes patients",
"AIMS To determine whether tighter cardiovascular risk factor control with structured education in individuals with type 2 diabetes ( T2DM ) and microalbuminuria benefits cardiovascular risk factors . METHODS Participants from a multiethnic population , recruited from primary care and specialist clinics were r and omised to intensive intervention with structured patient ( DESMOND model ) education ( n=94 ) or usual care by own health professional ( n=95 ) . PRIMARY OUTCOME change in HbA1c at 18months . SECONDARY OUTCOMES changes in blood pressure ( BP ) , cholesterol , albuminuria , proportion reaching risk factor targets , modelled cardiovascular risk scores . RESULTS Mean ( SD ) age and diabetes duration of participants were 61.5 ( 10.5 ) and 11.5 ( 9.3 ) years , respectively . At 18months , intensive intervention showed significant improvements in HbA1c ( 7.1(1.0 ) vs. 7.8(1.4)% , p ( 129(16 ) vs. 139(17 ) mmHg , p BP ( 70(11 ) vs. 76(12 ) mmHg , p cholesterol ( 3.7(0.8 ) vs. 4.1(0.9 ) mmol/l , p=0.001 ) . Moderate and severe hypoglycaemia was 11.2 vs. 29.0 % ; p=0.001 and 0 vs. 6.3 % ; p=0.07 , respectively . More intensive participants achieved ≥3 risk factor targets with greater reductions in cardiovascular risk scores . CONCLUSIONS Intensive intervention showed greater improvements in metabolic control and cardiovascular risk profile with lower rates of moderate and severe hypoglycaemia . Intensive glycaemic interventions should be underpinned by structured education promoting self-management in T2DM",
"Abstract Aims /hypothesis . Metabolic control worsens progressively in Type II ( non-insulin-dependent ) diabetes mellitus despite intensified pharmacological treatment and lifestyle intervention , when these are implemented on a one-to-one basis . We compared traditional individual diabetes care with a model in which routine follow-up is managed by interactive group visits while individual consultations are reserved for emerging medical problems and yearly checks for complications . Methods . A r and omized controlled clinical trial of 56 patients with non-insulin-treated Type II diabetes managed by systemic group education and 56 control patients managed by individual consultations and education . Results . Observation times were 51.2±2.1 months for group care and 51.2±1.8 for control subjects . Glycated haemoglobin increased in the control group but not in the group of patients ( p whom BMI decreased ( p and HDL-cholesterol increased ( p ) . Quality of life , knowledge of diabetes and health behaviours improved with group care ( p . Dosage of hypoglycaemic agents decreased ( p retinopathy progressed less ( p subjects . Diastolic blood pressure ( p and relative cardiovascular risk ( p the quality of life score . Conclusion /interpretation . Group care by systemic education is feasible in an ordinary diabetes clinic and cost-effective in preventing the deterioration of metabolic control and quality of life in Type II diabetes without increasing pharmacological treatment",
"Background Diabetes mellitus ( DM ) and chronic inflammation are strongly related to increased cardiovascular risk . The purpose of this study was to evaluate whether an aerobic training programme would ameliorate inflammatory and anti-inflammatory markers in patients with type 2 DM . Design Interventional study . Methods A total of 60 overweight individuals with type 2 DM , but without vascular complications , were r and omly assigned to either a 6-month aerobic exercise training programme ( four times/week , 45 - 60 min/session ) , design ated as exercise group , or to the control group . All participants were on an oral antidiabetic regimen and none was receiving lipid-lowering medications . Anthropometric parameters , cardiorespiratory fitness , glycaemic and lipid profiles , high sensitivity C-reactive protein ( hs CRP ) , adiponectin , interleukin (IL)-10 , IL-18 , tumour necrosis factor (TNF)-a , insulin , reciprocal index of homoeostasis model assessment ( HOMA-IR ) , body fat and blood pressure ( BP ) were measured at baseline and at the end of the study . Results In comparison with baseline and control group , exercise-treated patients improved glucose control , lipid profile , exercise capacity ( Vo2 peak ) and exhibited decreased insulin resistance and systolic BP considerably ( P changed slightly across treatment ( P > 0.05 ) , whereas diastolic BP and fat mass tended to decrease ( P = 0.071 and 0.061 , respectively ) . Exercise training reduced hs CRP ( from 0.48 ± 0.16 to 0.29 ± 0.2 mg/dl ; P = 0.04 ) and IL-18 ( from 315.19 ± 122.76 to 203.77 ± 96.02 pg/ml ; P = 0.02 ) . Moreover , exercise provided anti-inflammatory protection through IL-10 increment ( P = 0.039 ) and IL-18/IL-10 ratio downregulation ( P = 0.014 ) . In multiple regression analysis , alteration in IL-18 was independently correlated with hs CRP and Vo2 peak changes ( P ) . Conclusion Aerobic exercise training without significant weight loss improves metabolic profile and exerts anti-inflammatory effects in patients with type 2 DM . Eur J Cardiovasc Prev Rehabil 14 : 837 - 843 © 2007 The European Society of",
"BACKGROUND This study aim ed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity ( PA ) and improving hemoglobin A(1c)(HbA(1c ) ) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus ( T2DM ) . METHODS Of 691 eligible sedentary patients with T2DM and the metabolic syndrome , 606 were enrolled in 22 outpatient diabetes clinics across Italy and r and omized by center , age , and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling ( exercise group ) vs counseling alone ( control group ) for 12 months . End points included HbA(1c ) level ( primary ) and other cardiovascular risk factors and coronary heart disease risk scores ( secondary ) . RESULTS The mean ( SD ) volume of PA ( metabolic equivalent hours per week ) was significantly higher ( P exercise ( total PA [ nonsupervised conditioning PA + supervised PA ] , 20.0 [ 0.9 ] , and nonsupervised , 12.4 [ 7.4 ] ) vs control ( 10.0 [ 8.7 ] ) group . Compared with the control group , supervised exercise produced significant improvements ( mean difference [ 95 % confidence interval ] ) in physical fitness ; HbA(1c ) level ( -0.30 % [ -0.49 % to -0.10 % ] ; P .001 ) ; systolic ( -4.2 mm Hg [ -6.9 to -1.6 mm Hg ] ; P = .002 ) and diastolic ( -1.7 mm Hg [ -3.3 to -1.1 mm Hg ] ; P = .03 ) blood pressure ; high-density lipoprotein ( 3.7 mg/dL [ 2.2 to 5.3 mg/dL ] ; P ) and low-density lipoprotein ( -9.6 mg/dL [ -15.9 to -3.3 mg/dL ] ; P = .003 ) cholesterol level ; waist circumference ( -3.6 cm [ -4.4 to -2.9 cm ] ; P These parameters improved only marginally in controls . CONCLUSIONS This exercise intervention strategy was effective in promoting PA and improving HbA(1c ) and cardiovascular risk profile . Conversely , counseling alone , though successful in achieving the currently recommended amount of activity , was of limited efficacy on cardiovascular risk factors , suggesting the need for a larger volume of PA in these high-risk subjects . Trial Registration is rct n.org Identifier : IS RCT N04252749",
"Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment . Design R and omised controlled trial . Setting Dunedin , New Zeal and . Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin ( HbA1c ) of more than 7 % despite optimised drug treatments plus at least two of overweight or obesity , hypertension , and dyslipidaemia . Intervention Intensive individualised dietary advice ( according to the nutritional recommendations of the European Association for the Study of Diabetes ) for six months ; both the intervention and control participants continued with their usual medical surveillance . Main outcome measures HbA1c was the primary outcome . Secondary outcomes included measures of adiposity , blood pressure , and lipid profile . Results After adjustment for age , sex , and baseline measurements , the difference in HbA1c between the intervention and control groups at six months ( −0.4 % , 95 % confidence interval −0.7 % to −0.1 % ) was highly statistically significant ( P=0.007 ) , as were the decreases in weight ( −1.3 kg , −2.4 to −0.1 kg ; P=0.032 ) , body mass index ( −0.5 , −0.9 to −0.1 ; P=0.026 ) , and waist circumference ( −1.6 cm , −2.7 to −0.5 cm ; P=0.005 ) . A decrease in saturated fat ( −1.9 % total energy , −3.3 % to −0.6 % ; P=0.006 ) and an increase in protein ( 1.6 % total energy , 0.04 % to 3.1 % ; P=0.045 ) in the intervention group were the most striking differences in nutritional intake between the two groups . Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment . Trial registration Clinical trials NCT00124553",
"OBJECTIVE To assess the effectiveness of a culturally sensitive , structured education programme ( CSSEP ) on biomedical , knowledge , attitude and practice measures among Arabs with type two diabetes . RESEARCH DESIGN S AND METHODS A total of 430 patients with type II diabetes mellitus living in Doha , Qatar were enrolled in the study . They were r and omized to either intervention ( n = 215 ) or a control group ( n = 215 ) . A baseline and one-year interval levels of biomedical variables including HbA1C , lipid profile , urine for microalbuminuria ; in addition to knowledge , attitude and practice ( KAP ) scores were prospect ively measured . The intervention was based on theory of empowerment , health belief models and was culturally sensitive in relation to language ( Arabic ) , food habits and health beliefs . It consisted of four educational sessions for each group of patients ( 10 - 20 patients per session ) , lasting for 3 - 4 h. The first session discussed diabetes pathophysiology and complications ; while the second session discussed healthy life style incorporating the Idaho plate method ; and the third session dealt with exercise benefits and goal setting and the fourth session concentrated enhancing attitude and practice using counselling techniques . Outcomes were assessed at base line and 12 months after intervention . RESULTS After 12 months participation in the intervention was shown to have led to a statistically significant reduction in HbA1C in the ( CSSEP ) group ( -0.55 mmol/L , P = 0.012 ) , fasting blood sugar ( -0.92 mmol/L , P = 0.022 ) , body mass index ( 1.70 , P = 0.001 ) and albumin/creatinine ratio ( -3.09 , P Diabetes knowledge ( 5.9 % , P attitude ( 6.56 % , P practice ( 6.52 % , P = 0.0001 ) . CONCLUSION This study demonstrates the effectiveness of culturally sensitive , structured , group-based diabetes education in enhancing biomedical and behavioural outcomes in Diabetic patients"
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Background : Assessment of patient satisfaction with orthosis is a key point for clinical practice and research , requiring question naires with robust psychometric properties . Objectives : To identify which vali date d question naires are used to investigate patient satisfaction with orthosis in limb orthotics and to analyse ( 1 ) their main fields of clinical application , ( 2 ) the orthosis-related features analysed by the question naires and ( 3 ) the strength of their psychometric properties . Study design : Systematic review . Methods : A literature search using MEDLINE ( PubMed ) , Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) and Scopus data bases for original articles published within the last 20 years was performed . Results : A total of 106 papers pertaining to various clinical fields were selected . The main features of patient satisfaction with orthosis analysed were as follows : aesthetic , ease in donning and doffing the device , time of orthotic use and comfort . Conclusion : Of the question naires used to investigate patient satisfaction with orthosis , only four are adequately vali date d for this purpose : two for generic orthotic use ( Quebec User Evaluation of Satisfaction with assistive Technology 2.0 and Client Satisfaction with Device of Orthotics and Prosthetic Users ’ Survey ) and two for specific application with orthopaedic shoes ( Question naire for the Usability Evaluation of orthopaedic shoes and Monitor Orthopaedic Shoes ) . Further development , refinement and validation of outcome measures in this field are warranted . Clinical relevance Given the importance of analysing patient satisfaction with orthosis ( PSwO ) , appropriate instruments to assess outcome are needed . This article review s the currently available instruments and reflects on how future studies could be focused on the development , refinement and validation of outcome measures in this field
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"OBJECTIVES The structural and functional changes in the RA foot often affect the patient 's gait and mobility , impacting on the patient 's quality of life . Successful management of these foot pathologies and result ant problems can involve the provision of specialist therapeutic footwear . The aim of the study was to evaluate the value of a new footwear design based on patients ' opinions compared with a traditional footwear design . METHOD A total of 80 patients with RA of 5 yrs or more duration , foot deformity , difficulty in being able to obtain suitable retail footwear and self-reported foot pain were recruited . Patients were r and omly assigned to either an intervention group ( new design ) or the control group ( traditional design ) . Patients completed two specific health-related quality of life scales ( Foot Health Status Question naire and the Foot Function Index ) at baseline and after 12 weeks . RESULTS Only 36 patients completed the trial . Ten refused the footwear outright and 34 withdrew from the study after the footwear was supplied , due to either non-footwear related problems or reasons related to the footwear . Both the specific health-related quality of life scales demonstrated significant improvement from baseline to week 12 with the intervention group ( P health-related quality of life scales after week 12 with the traditional group ( P > 0.05 ) . CONCLUSIONS Improvement in pain and patient satisfaction with the new design of footwear for patients with RA over the traditional design indicates the importance of patient involvement in the design process and throughout the process of supplying and monitoring the footwear . The fact that the new- design shoe was based on patients ' involvement in the design process in a previous study may be the most important factor in its success . In order to meet the clinical goals of this footwear the patients need to wear them , and to achieve this the patients ' requirements need to be acknowledged",
"Background and Purpose — Drop foot after stroke may be addressed using an ankle foot orthosis ( AFO ) or a foot drop stimulator ( FDS ) . The Functional Ambulation : St and ard Treatment versus Electric Stimulation Therapy ( FASTEST ) trial was a multicenter , r and omized , single-blinded trial comparing FDS and AFO for drop foot among people ≥3 months after stroke with gait speed ⩽0.8 m/s . Methods — Participants ( n=197 ; 79 females and 118 males ; 61.14±11.61 years of age ; time after stroke 4.55±4.72 years ) were r and omized to 30 weeks of either FDS or a st and ard AFO . Eight dose-matched physical therapy sessions were provided to both groups during the first 6 weeks of the trial . Results — There was significant improvement within both groups from baseline to 30 weeks in comfortable gait speed ( 95 % confidence interval for mean change , 0.11–0.17 m/s for FDS and 0.12–0.18 m/s for AFO ) and fast gait speed . However , no significant differences in gait speed were found in the between-group comparisons . Secondary outcomes ( st and ard measures of body structure and function , activity , and participation ) improved significantly in both groups , whereas user satisfaction was significantly higher in the FDS group than in the control group . Conclusions — Using either an FDS or an AFO for 30 weeks yielded clinical ly and statistically significant improvements in gait speed and other functional outcomes . User satisfaction was higher in the FDS group . Although both groups did receive intervention , this large clinical trial provides evidence that FDS or AFO with initial physical therapy sessions can provide a significant and clinical ly meaningful benefit even years after stroke . Clinical Trial Registration Information— URL : http://www . clinical trials.gov . Unique Identifier : NCT01138995",
"CONTEXT Hallux valgus is a common foot deformation in adults , but evidence for effectiveness of surgical and conservative treatments for this condition is limited . OBJECTIVE To compare the effectiveness of surgical and orthotic treatment with no treatment in patients with hallux valgus . DESIGN AND SETTING R and omized controlled trial conducted in 4 general community hospitals in Finl and in 1997 - 1998 , with a follow-up period of 12 months . PARTICIPANTS Two hundred nine consecutive patients ( mean age , 48 years ; 93 % women ) with a painful bunion and a hallux valgus angle 35 degrees or less . INTERVENTIONS Patients were r and omly assigned to surgery ( distal chevron osteotomy ; n = 71 ) , orthosis ( n = 69 ) , or a 1-year waiting list ( control group , n = 69 ) . MAIN OUTCOME MEASURES Pain intensity during walking on a visual analog scale ( 0 - 100 ) , patient assessment of global improvement , number of painful days , cosmetic disturbance , footwear problems , functional status , and treatment satisfaction , compared among treatment groups . RESULTS Follow-up rates at 6 and 12 months were 99 % and 98 % , respectively . At 6 months , pain intensity decreased more in the surgical group than in the control group ( adjusted mean differences , -20 [ 95 % confidence interval ( CI ) , -28 to -12 ] ) and more in orthosis than in the control groups ( adjusted mean difference , -14 [ 95 % CI , -22 to -6 . At 1 year , pain intensity decreased more in the surgical than in the control groups ( adjusted mean difference , -19 [ 95 % CI , -28 to -10 ] ) and more than in the surgical and orthosis groups ( adjusted mean difference , -14 [ 95 % CI , -22 to -5 ] ) . At 1 year , 83 % , 46 % , and 24 % in the surgery , orthosis , and control groups , respectively , thought they had improved compared with baseline ( number needed to treat ) , 1.7 between surgical and control groups ) . Number of painful days , cosmetic disturbance , and footwear problems were least and functional status and satisfaction with treatment were best in the surgical group . CONCLUSIONS Surgical osteotomy is an effective treatment for painful hallux valgus . Orthoses provide short-term symptomatic relief",
"Background Recent studies have shown an important reduction of joint overload during locomotion in elderly women with knee osteoarthritis ( OA ) after short-term use of minimalist shoes . Our aim is to investigate the chronic effect of inexpensive and minimalist footwear on the clinical and functional aspects of OA and gait biomechanics of elderly women with knee OA . Methods / Design Fifty-six elderly women with knee OA grade 2 or 3 ( Kellgren and Lawrence ) are r and omized into blocks and allocated to either the intervention group , which will use flexible , non-heeled shoes— Moleca ® —for six months for at least six hours daily , or the control group , which could not use these shoes . Neither group is undergoing physical therapy treatment throughout the intervention period . Moleca ® is a women ’s double canvas , flexible , flat walking shoe without heels , with a 5-mm anti-slip rubber sole and a 3-mm internal wedge of ethylene vinyl acetate . Both groups will be followed for six months and will be assessed at baseline condition , after three months , and after six months ( end of intervention ) . All the assessment s will be performed by a physiotherapist that is blind to the group allocation . The primary outcome is the pain Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) score . The secondary outcomes are global WOMAC score ; joint stiffness and disability WOMAC scores ; knee pain with a visual analogue scale ; walking distance in the six-minute walk test ; Lequesne score ; amount and frequency ( number of days ) of paracetamol ( 500 mg ) intake over six months ; knee adduction moment during gait ; global medical assessment score ; and global patient auto- assessment score . At baseline , all patients receive a diary to record the hours of daily use of the footwear intervention ; every two weeks , the same physiotherapist makes phone calls to all patients in order to verify adherence to treatment . The statistical analysis will be based on intention-to-treat analysis , as well as general linear models of analysis of variance for repeated measure to detect treatment – time interactions ( α = 5 % ) . Discussion This is the first r and omized , clinical trial protocol to assess the chronic effect of minimalist footwear on the clinical and functional aspects and gait biomechanics of elderly women with knee osteoarthritis . We expect that the use of Moleca ® shoes for six months will provide pain relief , reduction of the knee adduction moment when walking , and improve joint function in elderly women with knee OA , and that the treatment , thus , can be considered another inexpensive and easy-to-use option for conservative OA treatment . Trial registration",
"Background Whilst laterally wedged insoles , worn inside the shoes , are advocated as a simple , inexpensive , non-toxic self-administered intervention for knee osteoarthritis ( OA ) , there is currently limited evidence to support their use . The aim of this r and omised , double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain , physical function and health-related quality of life , and slower structural disease progression as well as being more cost-effective , than control flat insoles in people with medial knee OA . Methods / Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and r and omly allocated to lateral wedge or control insole groups using concealed allocation . Participants will be blinded as to which insole is considered therapeutic . Blinded follow up assessment will be conducted at 12 months after r and omisation . The outcome measures are valid and reliable measures recommended for OA clinical trials . Question naires will assess changes in pain , physical function and health-related quality -of-life . Magnetic resonance imaging will measure changes in tibial cartilage volume . To evaluate cost-effectiveness , participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis . To test the effect of the intervention using an intention-to-treat analysis , linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics . Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA.Trial registration ACTR12605000503628 ; NCT00415259",
"Objective . The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration ( DFU ) in high-risk diabetic patients . Research Design and Methods . A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot . Out of 334 patients ( 17.8 % ) with a score ≥2 , 298 accepted to participate in this prospect i ve trial and were r and omized into 2 groups : group A , which received st and ard treatment , and group B , in which the patients received , as a part of a structured prevention program , custom-made orthesis and shoes . Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years , respectively . Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program ; costs were also compared . Results . Among the patients enrolled in this follow-up analysis , 46 % had neuropathy and deformities , 20 % had previous ulceration , 25 % had previous minor amputation , and 9 % had neuro-osteoarthropathy . During the first 12-month follow-up , 11.5 % of patients in group B developed a DFU compared with 38.6 % in group A ( P the cumulative incidence of ulcer in group B compared with group A was 17.6 % versus 61 % ( P use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs",
"BACKGROUND For several years , confectioned or customized interdigital silicone orthoses have been used to treat toe malformations ; however , long-term clinical and biomechanical studies are missing . The aim of this study was to evaluate the biomechanical effects of these orthoses and their clinical acceptance . METHODS In 2008 , 46 patients ( 30 women and 16 men ; average age , 56.8 years ) received interdigital silicone orthoses . All of the patients were included in the biomechanical and clinical study . Compliance and acceptance were measured by the Muenster shoe and foot question naire , which includes 13 items on pain , activities of daily living , satisfaction , and activity . Mean follow-up was 18 months . Ten feet ( eight patients ) were chosen by r and om and underwent pedobarography . One forefoot sensor and two single sensors were attached between the skin and the orthosis . Measurements were performed in-shoe three times with and without the orthosis without removal of the sensors . RESULTS Forty-four of the 46 patients ( 95.7 % ) were included . At the 18-month investigation , 19 patients no longer used their orthoses , most commonly because of pain and failure of the material . Twenty-two patients regularly used their orthoses ( 8 h/d on average ) . In-shoe peak pressure lowered significantly with orthosis use ( P Interdigital silicone orthoses reduce in-shoe peak pressure . Patient satisfaction was good . The durability of the material has to be optimized , and manufacturing remains difficult . The effect on ulcer reduction must be evaluated in a large prospect i ve study",
"OBJECTIVES . Isolated distal fibular ankle fractures in children are very common and at very low risk for future complications . Nevertheless , st and ard therapy for these fractures still consists of casting , a practice that carries risks , inconveniences , and use of subspecialty health care re sources . Therefore , the main objective of this study was to determine whether children who have these low-risk ankle fractures that are treated with a removable ankle brace have at least as effective a recovery of physical function as those that are treated with a cast . METHODS . This was a noninferiority , r and omized , single-blind trial in which children who were 5 to 18 years of age and treated in a pediatric emergency department for low-risk ankle fractures were r and omly assigned to a removable ankle brace or a below-knee walking cast . The primary outcome at 4 weeks was physical function , measured by using the modified Activities Scale for Kids . Additional outcomes included patient preferences and costs . RESULTS . The mean activity score at 4 weeks was 91.3 % in the brace group ( n = 54 ) , and this was significantly higher than the mean of 85.3 % in the cast group ( n = 50 ) . Significantly more children who were treated with a brace had returned to baseline activities by 4 weeks compared with those who were casted ( 80.8 % vs 59.5 % ) . Fifty-four percent of the casted children would have preferred the brace , but only 5.7 % of children who received the brace would have preferred the cast . The cost-effectiveness acceptability curve was always > 80 % ; therefore , the brace was cost-effective compared with the cast . CONCLUSIONS . The removable ankle brace is more effective than the cast with respect to recovery of physical function , is associated with a faster return to baseline activities , is superior with respect to patient preferences , and is also cost-effective",
"Foot orthoses and night splints have been used separately to treat patients with plantar fasciitis , but were not always successful . Combined use of both orthoses might give better outcomes . This study evaluated the effectiveness of a soft and self-adjustable dorsiflexion night splint in combination with an accommodative foot orthosis for patients with plantar fasciitis . Twenty-eight patients were assigned to group A ( foot orthosis only ) and group B ( combination of foot orthosis and dorsiflexion night splints ) . A foot function index ( FFI ) question naire was used to evaluate the pain and functions of feet just before , 2 weeks after , and 8 weeks after the treatments . Results showed that subjects in group B had significantly reduced pain scores at week 2 ( p pain ( p = 0.15 ) , disability ( p = 0.56 ) , activity limitation ( p = 0.75 ) , and total FFI ( p = 0.35 ) scores for the three time periods . The application of foot orthoses with adjustable dorsiflexion night splints was found to be more effective than the application of foot orthoses alone in relieving foot pain in patients with plantar fasciitis",
"Background Functional treatment is a widely used and generally accepted treatment for ankle sprain . A meta- analysis comparing the different functional treatment options could not make definitive conclusions regarding the effectiveness , and until now , little was known about patient satisfaction in relation to the outcome . Methods Patients with acute ankle sprain received rest , ice , compression and elevation with an compressive b and age at the emergency department . After 5 - 7 days , 100 patients with grade II and III sprains were r and omized into two groups : one group was treated with tape and the other with a semi-rigid ankle brace , both for 4 weeks . Post-injury physical and proprioceptive training was st and ardized . As primary outcome parameter patient satisfaction and skin complications were evaluated using a predefined question naire and numeric rating scale . As secondary outcome parameter the ankle joint function was assessed using the Karlsson scoring scale and range of motion . Results Patient-reported comfort and satisfaction during treatment with a semi-rigid brace was significantly increased . The rate of skin complication in this group was significantly lower compared to the tape group ( 14.6 % versus 59.1 % , P Functional outcome of the ankle joint was similar between the two treatment groups , as well as reported pain . Conclusion Treatment of acute ankle sprain with semi-rigid brace leads to significantly higher patient comfort and satisfaction , both with similar good outcome",
"OBJECTIVE To assess the perceived usability and use of custom- made footwear in diabetic patients who are at high-risk for foot ulceration , and to eluci date the determinants of usability and use . DESIGN Survey . SUBJECTS A total of 153 patients with diabetes , peripheral neuropathy , prior plantar foot ulceration and newly prescribed custom-made footwear , recruited from 10 Dutch multidisciplinary foot clinics . METHODS The Question naire of Usability Evaluation was used to assess the patients ' perception of weight , appearance , comfort , durability , donning/doffing , stability , benefit and overall appreciation of their prescription footwear ( all expressed as visual analogue scores ) . Data on priorities for usability and footwear use ( in h/day ) were obtained from patient reports . Multivariate logistic regression analysis was used to assess determinants of usability and use . RESULTS Median ( interquartile range ) score for overall appreciation was 8.3 ( 7.1 - 9.1 ) . Scores ranged from 6.5 ( 4.5 - 8.6 ) for weight to 9.6 ( 6.3 - 9.9 ) for donning/doffing . Footwear comfort was listed most often ( 33.3 % ) as the highest priority . Footwear use was footwear use was the perceived benefit of the footwear ( p = 0.045 ) . CONCLUSION Perceived usability of footwear was mostly positive , although individual scores and priorities varied considerably . Footwear use was low to moderate and dependent only on the perceived benefit of the footwear . Therefore , practitioners should focus on enhancing the patient 's ap-preciation of the therapeutic benefit of custom-made footwear ",
"Background Dupuytren 's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired h and function . St and ard treatment involves surgical release or excision followed by post-operative h and therapy and splinting , however the evidence supporting night splinting is of low quality and equivocal . Methods A multi-centre , pragmatic , open , r and omised controlled trial was conducted to evaluate the effect of night splinting on self-reported function , finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy . 154 patients from 5 regional hospitals were r and omised after surgery to receive h and therapy only ( n = 77 ) or h and therapy with night-splinting ( n = 77 ) . Primary outcome was self-reported function using the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire . Secondary outcomes were finger range of motion and patient satisfaction . Primary analysis was by intention to treat . Results 148 ( 96 % ) patients completed follow-up at 12 months . No statistically significant differences were observed on the DASH question naire ( 0 - 100 scale : adjusted mean diff . 0.66 , 95%CI - 2.79 to 4.11 , p = 0.703 ) , total extension deficit of operated digits ( degrees : adjusted mean diff 5.11 , 95%CI -2.33 to 12.55 , p = 0.172 ) or patient satisfaction ( 0 - 10 numerical rating scale : adjusted mean diff -0.35 , 95%CI -1.04 to 0.34 , p = 0.315 ) at 1 year post surgery . Similarly , in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes . Conclusions No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving h and therapy and only splinted if and when contractures occurred . Given the added expense of therapists ' time , thermoplastic material s and the potential inconvenience to patients having to wear a device , the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits reoccur . Trial registration The trial was registered as an International St and ard R and omised Controlled Trial IS RCT",
"Objective . To describe the usage of functional wrist orthoses and to identify factors contributing to usage in patients with rheumatoid arthritis ( RA ) . Methods . A multicentre , cross-sectional study , including a r and om selection of patients with RA visiting outpatient clinics . A total of 240/362 eligible patients ( 66 % ) completed question naires , a semi-structured interview and a clinical assessment . Usage was registered according to eight categories ranging from ‘ always ’ to ‘ never ’ . Factors potentially associated with usage included demographic variables , the presence of wrist and h and complaints , general disease characteristics , mental and physical functioning , coping strategies and satisfaction with functional wrist orthoses . Logistic regression analyses were used to determine which factors were associated with the usage of wrist splints . Results . One hundred twenty-eight patients ( 53 % ) possessed functional wrist orthoses , whereas 74/128 ( 58 % ) were actually using them . Patients used them mainly during house keeping and cycling/driving . Main reasons for using the orthoses were relief of pain and joint protection , and main reasons for not using them were no need and problems with ease of use . Factors significantly associated with usage included the presence of wrist and h and complaints , worse physical functioning and greater satisfaction with comfort of the wrist orthoses . Conclusion . About half of patients with RA possessed functional wrist orthoses , with 58 % of them actually being used . Apart from local complaints and general functional ability , satisfaction with comfort of the functional wrist orthoses appears to be an important factor for their usage . These results point at the need for additional research regarding modifiable factors associated with compliance , such as comfort and ease of use",
"Customized foot orthotics are widely prescribed for patients with chronic , non-specific low back pain and lower limb pain , but there are few trials demonstrating effectiveness , and none for fibromyalgia . A total of 67consecutive patients presenting with chronic , widespread pain , who met the 1990 American College of Rheumatology criteria for fibromyalgia , were included in the study . A total of 32 subjects were prescribed a spinal exercise therapy program along with analgesics . These subjects formed the Control group . A second group , comprised of 35 subjects , received the same therapy , along with customized foot orthotics ( Orthotics group ) . All subjects completed the Revised Fibromyalgia Impact Question naire ( FIQR ) at the initiation of the study and at 8 weeks follow-up . The number of subjects using any type of prescription analgesic or other medication for chronic pain at baseline and at 8 weeks was also recorded . A total of 30 subjects in the Control group and 33 in the Orthotics group completed the study . All subjects completed the baseline and 8-week FIQR . The two groups were well matched in terms of age ( 45.3 ± 11.5 years in the Orthotics group vs. 47.2 ± 8.7 years in the cohort Control ) , medication use , duration of pain ( 6.5 ± 4.3 years in the Orthotics group vs. 6.2 ± 3.4 years in the cohort Control group ) , as well as baseline FIQR scores ( 55.2 ± 11.0 in the Orthotics group vs. 56.3 ± 12.2 in the cohort Control group ) . At 8 weeks , the Orthotics group had a greater reduction in the FIQR score than the cohort Control group ( reduction of 9.9 ± 5.9 vs. 4.3 ± 4.4 , respectively ) , and this was mainly due to changes in the ‘ function ’ domain of the FIQR ( reduction of 19.6 ± 9.4 in the Orthotics group vs. 8.1 ± 4.3 in the cohort Control group ) . As part of a complex intervention , in a cohort-controlled trial of primary care patients with fibromyalgia , the addition of custom-made foot orthotics to usual care appears to improve functioning in the short term",
"BACKGROUND Plantar fasciitis is one of the most common foot complaints . It is often treated with foot orthoses ; however , studies of the effects of orthoses are generally of poor quality , and to our knowledge , no trials have investigated long-term effectiveness . The aim of this trial was to evaluate the short- and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis . METHODS A pragmatic , participant-blinded , r and omized trial was conducted from April 1999 to July 2001 . The duration of follow-up for each participant was 12 months . One hundred and thirty-five participants with plantar fasciitis from the local community were recruited to a university-based clinic and were r and omly allocated to receive a sham orthosis ( soft , thin foam ) , a prefabricated orthosis ( firm foam ) , or a customized orthosis ( semirigid plastic ) . RESULTS After 3 months of treatment , estimates of effects on pain and function favored the prefabricated and customized orthoses over the sham orthoses , although only the effects on function were statistically significant . Compared with sham orthoses , the mean pain score ( scale , 0 - 100 ) was 8.7 points better for the prefabricated orthoses ( 95 % confidence interval , -0.1 to 17.6 ; P = .05 ) and 7.4 points better for the customized orthoses ( 95 % confidence interval , -1.4 to 16.2 ; P = .10 ) . Compared with sham orthoses , the mean function score ( scale , 0 - 100 ) was 8.4 points better for the prefabricated orthoses ( 95 % confidence interval , 1.0 - 15.8 ; P = .03 ) and 7.5 points better for the customized orthoses ( 95 % confidence interval , 0.3 - 14.7 ; P = .04 ) . There were no significant effects on primary outcomes at the 12-month review . CONCLUSIONS Foot orthoses produce small short-term benefits in function and may also produce small reductions in pain for people with plantar fasciitis , but they do not have long-term beneficial effects compared with a sham device . The customized and prefabricated orthoses used in this trial have similar effectiveness in the treatment of plantar fasciitis",
"The purpose of this prospect i ve , r and omized , clinical trial was to evaluate the effect of knee bracing after anterior cruciate ligament reconstruction . Sixty patients were r and omized into one of two groups : Patients in the braced group wore rehabilitative braces for 2 weeks , followed by functional braces for 10 weeks , and patients in the nonbraced group did not wear braces . Data were recorded preoperatively , and postoperatively after 6 weeks , 3 and 6 months , and 1 and 2 years . The following outcome measures were used : KT-1000 arthrometry , the Cincinnati knee score , goniometry to record range of motion , computed tomography to determine thigh atrophy , Cybex 6000 isokinetic testing to evaluate muscle strength , three functional knee tests , and a visual analog scale to evaluate pain . At all follow-up times there were no significant differences between the two groups with regard to knee joint laxity , range of motion , muscle strength , functional knee tests , or pain . However , the Cincinnati knee score showed that patients in the braced group had significantly improved knee function compared with patients in the nonbraced group at the 3-month follow-up , even though the braced group showed significantly increased thigh atrophy compared with the nonbraced group at 3 months",
"Objective To study the additional effect of a pneumatic leg brace with st and ard rehabilitation for the treatment of medial tibial stress syndrome ( MTSS ) in recruits . Methods In a single blinded r and omized study , 15 recruits ( age 17 - 22 ) followed a rehabilitation programme consisting of leg exercises and a grade d running programme . Recruits performed daily exercises and ran three times a week . The running programme consisted of 6 consecutive phases . One group was , after r and omization , additionally provided with a pneumatic leg brace . Follow-up was provided every other week . Days to completing the running programme was the primary outcome measure , the Sports Activity Rating Scale ( SARS ) score and satisfaction with the treatment were secondary outcome measures . Results In total 14 recruits completed the rehabilitation programme . No differences were found in the number of days until phase six of the running schedule was finished between the brace and the control group ( Brace 58.8 ± 27.7 ( mean ± SD ) vs Non-Brace 57.9 ± 26.2 ( mean ± SD , p = 0.57 ) . Also no differences were found in the SARS scores between the groups . Overall satisfaction with the treatment was 6.4 ± 1.1 ( mean ± SD ) on a 1 - 10 scale for the brace group and 7.1 ± 0.7 ( mean ± SD ) for the control group ( p = 0.06 ) . Comfort of the brace was assessed as 4.8 ± 1.3 ( mean ± SD ) on a 1 - 10 scale . Conclusions No additional large effect of the pneumatic leg brace could be found in recruits and wearing of the brace was not feasible , since the wearing comfort was low",
"OBJECTIVES To study the actual use of orthopedic shoes by patients with degenerative foot disorders and to identify factors associated with use and nonuse , based on the parameters of the International Organization for St and ardization definition of usability : effectiveness , efficiency , satisfaction , and context of use . DESIGN Multicenter , prospect i ve cohort study . SETTING Outpatient clinics of 7 rehabilitation centers in the Netherl and s. PARTICIPANTS One hundred consecutive patients with degenerative foot disorders . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Usability was assessed by means of the Question naire for Usability Evaluation of orthopedic shoes . RESULTS Seventy of 93 patients with degenerative foot disorders wore their orthopedic shoes for more than 3 days a week after 3 months of follow-up . Factors significantly associated with the actual use of orthopedic shoes were ( 1 ) increase in stance duration ( effectiveness odds ratio [OR]=2.14 ; 95 % confidence interval [ CI ] , 1.19 - 3.85 ) , ( 2 ) decrease in skin abnormalities ( effectiveness OR=1.35 ; 95 % CI , 1.02 - 1.8 ] ) , ( 3 ) problems experienced with putting on and taking off orthopedic shoes ( efficiency OR=.46 ; 95 % CI , .26-.82 ) , and ( 4 ) cosmetic appearance of orthopedic shoes ( satisfaction OR=1.54 ; 95 % CI , 1.1 - 2.15 ) . The overall fit of the multiple logistic regression model ( R 2 ) was 56.3 % . CONCLUSIONS By adding efficiency and satisfaction factors and not focusing only on the effectiveness factors , the amount of explained variance increases , and it becomes possible to evaluate and design products for people with special needs more comprehensively",
"OBJECTIVE To assess the tolerability and efficacy of a commercially available footdrop neuroprosthesis for treatment of footdrop in children with hemiparetic cerebral palsy . DESIGN A prospect i ve , observational pilot study . SETTING Marshfield Clinic , Department of Physical Medicine . PARTICIPANTS Ten children , ages 7 - 12 years , with hemiparetic cerebral palsy , who use an ankle foot orthosis ( AFO ) for correction of footdrop . METHODS Children replaced their AFO with a transcutaneous peroneal ( fibular ) nerve stimulation neuroprosthesis for 3 months . MAIN OUTCOME MEASUREMENTS The ability to tolerate fitting and programming of the device , device-recorded wear time , a daily-use diary , satisfaction survey , and secondary measures , including passive range of motion and gait laboratory measurement of gait velocity and ankle kinematics . RESULTS All 10 participants ( 100 % ) tolerated fitting and programming of the neuroprosthesis and wore the device for 6 weeks . Seven of 10 ( 70 % ) wore the device for the entire 3-month study period ; 6 of 10 ( 60 % ) continued to use the device after study completion . Wear time varied from 2 to 11 hours per day . Tolerability and satisfaction were high ; although 6 participants complained of \" size \" and \" bulkiness \" of the device , and 2 reported skin irritation . Gait velocity increased in 5 subjects ( 50 % ) . Seven participants ( 70 % ) preferred the neuroprosthesis to their AFO . CONCLUSION Analysis of the preliminary evidence suggests that electrical stimulation by a footdrop neuroprosthesis is tolerated well by children and is effective for the treatment of footdrop in children with hemiparetic cerebral palsy . Commercially available neuroprostheses may offer a promising alternative treatment option for children with footdrop",
"Midfoot osteoarthritis ( OA ) is a degenerative condition of the foot that can be treated non-operatively by the use of orthotics . This prospect i ve study was conducted to determine the effects of custom-made semi-rigid foot orthoses ( FOs ) and rigid carbon fibre ( CF ) footplates for the treatment of midfoot OA evaluated using specifically design ed question naires . Fifty-seven subjects diagnosed with midfoot OA were recruited through a private clinic for inclusion in the study . Subjects were required to complete pre-treatment question naires prior to receiving orthotic treatment . All subjects received a pair of custom-made full-length semi-rigid FOs and 36 subjects also received CF footplates that were incorporated into the soles of the shoes worn on the symptomatic feet . Subjects completed post-treatment question naires at six weeks , three months and six months after receiving the orthotic treatment . The results demonstrated that there were no significant differences between the results of the subjects who received CF footplates and those who did not . The results of the question naires demonstrated that subjects experienced significant improvements in pain , activity levels , walking ability and footwear comfort at all intervals following the orthotic treatment ( p satisfaction with the appearance of their footwear did not decrease with the orthotic treatment despite needing shoes to fit the FOs and CF footplates . The question naires also demonstrated that subjects were generally satisfied with the orthotic treatment for the management of their midfoot OA",
"OBJECTIVES To characterise 12 months ' adult , foot and ankle orthotic out-patient consultations in a regional centre ; and to survey patients regarding their satisfaction with services received . METHODS Prospect i ve survey question naires completed by : ( 1 ) orthotists , during consecutive clinic consultations ( n=4402 representing 2494 patients ) ; ( 2 ) all patients receiving foot or ankle orthoses ( n=1469 ) , mailed 5 weeks later . Questions included a st and ard foot pain item , patients ' perceived usefulness of the orthosis , and satisfaction with services received . Logistic regression identified factors associated with patients finding their orthosis ' very ' or ' fairly helpful ' . RESULTS Consultations addressed myriad foot , ankle or other conditions . EVA ( soft ) foot orthoses were most commonly prescribed . The response rate from patients was 72 % . Most ( 73 % ) said their orthosis would be ' very ' or ' fairly helpful ' . Following adjustment , females were less likely than males to find orthoses helpful ( OR 0.71 , p=0.031 ) . All older age groups were at least twice as likely to find orthoses helpful as patients aged ( p very ' or ' fairly satisfied ' with the service received . CONCLUSIONS Women , younger patients and those with more severe pain were less likely to perceive benefit from foot and ankle orthoses than other groups and may therefore require adjuvant or alternative intervention",
"Objective : To examine whether the use of a shoulder joint functional orthosis over four weeks can mitigate the development or progression of the shoulder – h and syndrome in patients with shoulder joint subluxation after stroke . Design : Two-armed r and omized controlled trial . Setting : Rehabilitation unit of a neurological hospital , single centre . Subjects : Forty-one patients with caudal subluxation of the glenohumeral joint and hemiparesis of the upper extremity after ischaemic brain stroke . Interventions : Support by functional orthosis Neuro-Lux ( Sporlastic , Nürtingen , Germany ) on top of usual care according to current guidelines ( experimental , n = 20 ) versus usual care alone ( control , n = 21 ) . Main measures : Weekly shoulder – h and syndrome scores ( severity of clinical symptoms ranging from 0 to 14 ) , discomfort caused by the orthosis , and its usage rate . The primary outcome was the average shoulder – h and syndrome score on days 14 , 21 and 28 , adjusted for the baseline shoulder – h and syndrome score . Results : The adjusted mean shoulder – h and syndrome score was lower by 3.1 in the intervention compared to the control subjects ( 95 % confidence interval 1.9 to 4.3 , P Marginal or no discomfort from treatment with the orthosis was reported in 15 patients ( 75 % ) , and only a single patient ( 5 % ) felt severe discomfort during the entire treatment . Use of the orthosis during the prescribed time was 89 % . Conclusions : The orthosis examined in this trial has been successfully shown to reduce and prevent the development of clinical symptoms of shoulder – h and syndrome . Timing and duration of application of the orthosis as well as its combination with other therapeutic measures should be investigated in future clinical trials",
"OBJECTIVE To evaluate the effectiveness of a night-time h and positioning splint in patients with rheumatoid arthritis . DESIGN R and omized controlled trial . METHODS Fifty patients with rheumatoid arthritis were divided r and omly into 2 groups . The study group used a night-time splint starting at baseline , while the control group used the splint only during evaluations . All patients attended evaluations wearing their splints , so that the assessor remained blinded to patient allocation . The splints used in the control group were stored in a cabinet between assessment s. Participants were evaluated at baseline , 45 and 90 days , using the visual analogue scale for pain ; the Jamar dynamometer for grip strength ; a pinch gauge for pinch strength ; a Health Assessment Question naire for function ; the Disability of the Arm , Shoulder and H and ( DASH ) question naire for upper limb disability and symptoms ; and a Likert scale for patient satisfaction with treatment . RESULTS The groups were homogenous for all parameters at baseline . Pain , Health Assessment Question naire score , DASH score , grip strength and pinch strength were significantly different between groups over time and satisfaction with the splint was reported as \" better \" and \" much better \" by most participants . CONCLUSION The use of a night-time h and positioning splint reduces pain , improves grip and pinch strength , upper limb function and functional status in patients with rheumatoid arthritis",
"With lateral ankle sprains being the most frequent sports-related injury , there is an evident dem and for the preventive measures in active individuals with chronic ankle instability . Braces are commonly used for prevention and treatment of ankle injuries . Various investigations — mostly performed with healthy subjects — focused on this problem , yet they often compared only a few models or used only limited testing procedures . However , controversy exists whether braces affect sports performance . The purpose of the present study was to compare the effects of ten different ankle braces — one rigid , five semirigid , four soft models — in a comprehensive evaluation with multiple testing procedures in 34 subjects with self-reported chronic ankle instability . The multiple testing procedures evaluated objective performance-related parameters and subjective parameters related to comfort and stability . The subjects performed an agility course with maximal effort . The course included a vertical jump and a cutting maneuver , both on a force platform , a single leg hopping test on level and inclined plates , a combined straight and curve sprint and sidesteps . Three valid trials were measured and averaged for each brace and every subject . Subjective aspects were evaluated with a question naire about h and ling , perceived restrictions , support and comfort ; it was completed after each brace was worn and tried . With regard to the objective parameters , no significant differences were found between the braces except for the rigid brace which showed decreased values for the vertical jump and longer times for the other tests compared to all other braces . The subjective evaluation of the braces revealed significant differences with respect to comfort and h and ling and therefore , permitted a distinction between semirigid and soft braces . Although significant differences between braces were found in subjective performance restriction , no significant differences were revealed in the objective evaluation . From that point of view , patients could choose a brace model according to their individual needs . A comfortable brace might have a positive influence on the athlete ’s state of mind although other aspects like the brace ’s stabilizing effect play an additional role and should also be taken into account for recommendation of braces",
"OBJECTIVE To compare the effectiveness and acceptability of silver ring splints ( SRS ) and commercial prefabricated thermoplastic splints ( PTS ) in treating swan neck deformities in patients with rheumatoid arthritis ( RA ) . METHODS Consecutive patients with RA and a mobile swan neck deformity were included in a r and omized , crossover trial . In 2 different sequences , patients used both splints for 4 weeks , with a washout period of 2 weeks . Afterward , patients used the preferred splint for another 12 weeks . The primary outcome measure was dexterity measured with the Sequential Occupational Dexterity Assessment ( SODA ) . Secondary outcome measures included other measures of h and function , satisfaction with the splints , and splint preference . RESULTS Fifty patients were included , and 47 ( 94 % ) of those completed the study . Eighteen patients ( 36 % ) had 1 swan neck deformity , whereas the other patients had 2 or more . The improvement of the total SODA score with the SRS ( 11.2 ; 95 % confidence interval [ 95 % CI ] 8.1 , 14.3 ) and PTS ( 10.8 ; 95 % CI 7.5 , 14.1 ) was similar ( difference -0.5 ; 95 % CI -2.2 , 1.2 ) . In addition , there were no significant differences in change scores regarding the other clinical outcome measures , or satisfaction . Twenty-four patients preferred the SRS , 21 preferred the PTS , and 2 patients chose neither . A comparison in the 12-week followup period yielded similar clinical outcomes , with the exception of a significantly higher score in 3 items of satisfaction in the SRS group . CONCLUSION For patients with RA and a mobile swan neck deformity , SRS and PTS are equally effective and acceptable",
"BACKGROUND High-energy extremity trauma is common in combat . Orthotic options for patients whose lower extremities have been salvaged are limited . A custom energy-storing ankle-foot orthosis , the Intrepid Dynamic Exoskeletal Orthosis ( IDEO ) , was created and used with high-intensity rehabilitation as part of the Return to Run clinical pathway . We hypothesized that the IDEO would improve functional performance compared with a non-custom carbon fiber orthosis ( BlueRocker ) , a posterior leaf spring orthosis , and no brace . METHODS Eighteen subjects with unilateral dorsiflexion and /or plantar flexion weakness were evaluated with six functional tests while they were wearing the IDEO , BlueRocker , posterior leaf spring , or no brace . The brace order was r and omized , and five trials were completed for each of the functional measures , which included a four-square step test , a sit-to-st and five times test , tests of self-selected walking velocity over level and rocky terrain , and a timed stair ascent . They also completed one trial of a forty-yard ( 37-m ) dash , filled out a satisfaction question naire , and indicated whether they had ever considered an amputation and , if so , whether they still intended to proceed with it . RESULTS Performance was significantly better with the IDEO with respect to all functional measures compared with all other bracing conditions ( p forty-yard dash improved by approximately 35 % over the values for the posterior leaf spring and no-brace conditions , and by 28 % over the BlueRocker . The BlueRocker demonstrated a significant improvement in the forty-yard dash compared with no brace ( p = 0.033 ) , and a significant improvement in self-selected walking velocity on level terrain compared with no brace and the posterior leaf spring orthosis ( p significant difference was found among the posterior leaf spring , BlueRocker , and no-brace conditions with respect to any other functional measure . Thirteen patients initially considered amputation , but after completion of the clinical pathway , eight desired limb salvage , two were undecided , and three still desired amputation . CONCLUSIONS Use of the IDEO significantly improves performance on vali date d tests of agility , power , and speed . The majority of subjects initially considering amputation favored limb salvage after this noninvasive intervention",
"Background : Degenerative disorders of the foot often are painful during st and ing and walking . It is assumed that , because of bone deformity , callus , and deformity of the plantar pads , the plantar pressure distribution changes . Prescription of orthopaedic shoes for patients with degenerative disorders of the foot is based on the hypothesis that excessive pressure under the foot causes pain . The goal of this study was to evaluate the effectiveness of custom-made orthopaedic shoes , in terms of pressure and pain , in patients with degenerative disorders of the foot . Additionally , the relationship between plantar pressure parameters and foot pain was studied , with special emphasis on second and third metatarsal heads . Methods : Seventy-seven consecutive patients with degenerative disorders of the foot were recruited from the outpatient clinics of seven rehabilitation centers and rehabilitation departments of university hospitals in the Netherl and s. The study was prospect i ve . The Question naire for Usability Evaluation for Orthopaedic Shoes was used to measure perceived foot pain . To measure plantar pressures , the Pedar in-shoe pressure measurement system ( Novel GmbH , Munich ) was used . The effectiveness of custom-made orthopaedic shoes , in terms of pressure and pain in patients with degenerative disorders of the foot , was analyzed by means of a paired sample t-test . To select the pressure parameter ( Pmax , PTI , and Pav ) most closely associated with walking pain , within-subject correlation coefficients were calculated . Results : Custom-made orthopaedic shoes significantly decreased perceived foot pain by at least 23 % , and significantly reduced plantar pressure under all foot regions by at least 9 % . A significant correlation ( r = 0.521 ) was found between walking pain and the average pressure beneath the second and third metatarsal heads . Conclusions : Based on these results , it can be concluded that custom-made orthopaedic shoes are effective in reducing foot pain and foot pressure . The moderate ( significant ) relationship between average pressure and walking pain can be used as a tool for evaluating custom-made orthopaedic shoes prescribed for patients with degenerative disorders of the foot",
"This study evaluated the clinical effectiveness and cost-effectiveness of two different types of foot orthoses used to treat plantar heel pain . Forty-eight patients were r and omly assigned to receive either a functional or an accommodative orthosis . General ( EuroQol ) and specific ( Foot Health Status Question naire ) health-status measures were used . Data were also collected using economic question naires relating to National Health Service costs for podiatry , other health-service costs , and patient costs . Data were measured at baseline and at 4- and 8-week intervals . Thirty-five patients completed the study . The results demonstrated a significant decrease in foot pain and a significant increase in foot function with the functional foot orthoses over the 8-week trial . The accommodative foot orthoses demonstrated a significant reduction in foot pain only at 4 weeks . The cost-effectiveness analysis demonstrated that functional orthoses , although initially more expensive , result in a better quality of life . Use of functional orthoses result ed in an increased cost of pound 17.99 ( 32.74 dollars ) per patient , leading to an incremental cost per quality -adjusted life year of pound 1,650 ( 3,003 dollars ) for functional orthoses",
"Objective : To assess the effect of a hinged ankle foot orthosis ( AFO ) on functional mobility and gait impairments in people with a severe hemiplegia undergoing rehabilitation , and to investigate the patients ' views of the hinged AFO . Design : With/without group comparison , and face-to-face question naire . Subjects and setting : Twenty-five subjects over 18 years , with a hemiplegia following cerebrovascular accident ( CVA ) undergoing rehabilitation in a regional rehabilitation unit . Outcome measures : Functional Ambulation Categories as a measure of disability . Paper walkways to measure gait impairments – stride length , step length , symmetry , cadence and velocity . Face-to-face question naire to determine the users ' opinion of the hinged AFO . Results : Comparison of gait with and without the hinged AFO showed significant improvements in functional mobility ( p = 0.000 ) and in some gait impairments ; stride length of the weak ( p –1.6 ) and sound legs ( p ) , velocity ( p = 0.00 , 95 % CI –0.1 , –0.03 ) and cadence ( p for step length in the weak or sound leg or symmetry . The subjects ' response was positive , 24 ( 96 % ) felt they walked better with the AFO and found it comfortable . Twenty-three ( 92 % ) were unbothered by the appearance and 16 ( 64 % ) could doff and don it . Conclusion : The hinged AFO improved objective measures of gait impairments and disability and patients were positive about it",
"The purpose of this study was to determine if short form (SF)-12 physical component would increase with unloader brace use . Patient expectations and predictors of significant improvement were determined . Our hypothesis was that patients with unloader braces will have increases in general physical health ( SF-12 ) and function ( Western Ontario and McMaster Universities Arthritis Index [ WOMAC ] ) . Patients were enrolled in institutional review board-approved prospect i ve cohort study . They completed a self-administered question naire ( SF-12 ; WOMAC , Tegner activity scale , expectations ) at enrollment , 3 weeks , 6 weeks , and 6 months . In this study , 39 patients , 23 males and 16 females ( average age = 61 years [ range 44 to 87 ] ) , were prescribed an unloader brace . Patients had significant improvement in quality of life ( SF-12 ) ( p pain , stiffness , and function ( WOMAC ) ( p Tegner of 3 or greater at final follow-up had significantly higher SF-12 physical component ( 48 vs. 37 ; p = 0.023 ) . Return to recreational sports was very important in 83 % and somewhat important in 17 % . Improving ability to walk was very important in 89 % . Pain relief was very important in 69 % , somewhat important in 17 % . Of these , 39 % expected most pain to be relieved and 57 % expected all pain to be relieved . The most important expectations were to have confidence in knee ( 97 % very important ) , avoid future knee degeneration ( 90 % very important ) , and improve ability to maintain general health ( 93 % very important ) . Patients demonstrated a significant decrease in pain and disability . Patients saw improvement in SF-12 physical component . Braces specifically design ed to unload the degenerative compartment of the knee can be an effective treatment to decrease pain and maintain activity level to increase overall physical health",
"OBJECTIVE To investigate the clinical effectiveness of early foot orthosis intervention for painful correctable valgus deformity of the rearfoot in rheumatoid arthritis ( RA ) . METHODS Patients with RA were r and omized to receive custom manufactured rigid foot orthoses under podiatry supervision ( n = 50 ) or enter a control group ( n = 48 ) . The control group received foot orthoses only when prescribed under normal medical care . Foot pain and disability , using the Foot Function Index ( FFI ) , along with disease activity , tolerance , and adverse reactions , were serially measured over 30 mo continuous treatment . RESULTS The group assigned foot orthoses demonstrated an immediate clinical improvement , the effect peaking at 12 mo . At 30 mo the FFI total score was reduced by 23.1 % from baseline in the intervention group . Area under the curve analysis showed a statistically significant reduction in FFI scores for total score ( p = 0.026 ) , foot pain ( p = 0.014 ) , and foot disability ( p = 0.016 ) when intervention was compared to control scores . There were no confounding effects from differences between groups for disease activity or pharmacological or other management strategies . Most patients ( 96 % ) used their orthoses and most found them comfortable ( 97 % ) , although minor adverse reactions , such as tender spots , blisters , and callus , were reported in 30 % of patients in the early stages of treatment and persisted in 12 % for 30 mo . CONCLUSION Custom design ed foot orthoses used continuously over a 30 mo treatment period result ed in a reduction in foot pain by 19.1 % , foot disability by 30.8 % , and functional limitation by 13.5 % . Clinical effectiveness might be enhanced by their use in the early stages of rearfoot pain and deformity",
"Objective The ankle foot orthosis ( AFO ) has been used for control of ankle motion in stroke patients for a long time . However , studies on the material s used in construction of AFOs have been limited . In this study , the authors attempted to investigate the effect of a hybrid AFO made with polypropylene and fabric in comparison with a conventional plastic AFO in terms of convenience and effect in patients with chronic hemiparetic stroke . Design Seventeen patients with chronic hemiparetic stroke who have used plastic AFOs were recruited for this study . Two types of AFOs were used : plastic AFO made with polypropylene and hybrid AFO made with polypropylene covered with canvas fabric , which were individually molded and fitted . Convenience was evaluated using a self-developed question naire on patients ’ satisfaction and weights of AFO , and effect was evaluated using gait analysis . Results On the satisfaction question naire , satisfaction was greater for the hybrid AFO , and it was lighter in weight than the plastic AFO ( P faster walking speed , larger mean and peak ankle dorsiflexion angles , and ankle dorsiflexion angles at heel strike and toe off were observed for the hybrid and plastic AFOs compared with barefoot ( P ankle dorsiflexion angle at heel strike , in which the plastic AFO showed higher ankle dorsiflexion angle than did the hybrid AFO . Conclusions According to the results of this study , the hybrid AFO showed a similar effect in function , except for ankle dorsiflexion angle at heel strike , and was superior with regard to convenience compared with the conventional plastic AFO in chronic hemiparetic stroke patients . Therefore , it seems that , in general , the hybrid AFO can be recommended for hemiparetic stroke patients who require an AFO ",
"A prospect i ve study was carried out on the clinical application and features of a carbon fibre reinforced plastic leg orthosis ( carbon orthosis ) for polio survivors . The subjects comprised 9 polio survivors , and 11 carbon knee-ankle-foot orthoses ( KAFOs ) were prescribed , fabricated , and checked out at the authors ' post-polio clinic . Walking was classified based on the functional ambulatory category , and the features of walking with a carbon orthosis were self-evaluated by using a visual analogue scale . The period from modelling a cast to completion was 55 ± 25 days ; the weight of a carbon KAFO was 27.8 % lighter than that of the ordinary KAFO ; the st and ard carbon KAFO was 50 % more expensive than the ordinary KAFO . The carbon KAFO remained undamaged for at least 2 years . It improved the scores in the functional ambulation categories , but there was no difference between walking with an ordinary and with a carbon KAFO . The self-evaluation of walking with a carbon KAFO revealed that the subjects using a carbon KAFO were satisfied with their carbon KAFO . The carbon KAFO is lightweight , durable , slim and smart , and is positively indicated for polio survivors",
"Hyperpronation is a common foot problem in dancers . The aim of this study was to investigate the usage and effectiveness of orthotics in the management of symptomatic hyperpronation among dancers . A prospect i ve cohort study of all dancer- patients in the investigators ' practice who were prescribed orthotics for new symptoms related to hyperpronation between July 2008 and January 2009 was conducted . In this group , the longitudinal medial arch angle of the foot was measured by the foot build registration system ( FBRS ) , both barefoot and while wearing the orthotics . In addition , patients filled out question naires addressing perceived effectiveness of the orthotics for pain reduction and dance ability , among other items . A second retrospective study was conducted in order to obtain longitudinal data regarding dancers ' compliance with , and subjective evaluation of , wearing orthotics over the preceding 6 years . Among participating dancers who met criteria for the prospect i ve ( N = 24 ) or retrospective ( N = 81 ) aspects of the study ( total N = 105 ) , 67 % wore orthotics at the time of follow-up . The average compliance in usage was 6.0 ( ± 1.5 ) days per week and 7.5 ( ± 3 ) hours per day . The average rate of satisfaction was 67.9 ( ± 26.5 ) , average degree of relief in symptoms was 58.3 ( ± 28.3 ) , and self-reported degree of improvement in dance ability was 45.7 ( ± 27.9 ) on a 100 mm Visual Analogue Scale ( VAS ) . There was a significant decrease in pain from the day of orthotics prescription to follow-up ( 25.9 % , or 18.9 mm decrease on the VAS , CI 6.6 - 30.9 , p = 0.005 ) in the prospect i ve group ( N = 24 ) . Orthotics were found to decrease the medial longitudinal arch angle significantly during static stance with the orthotic in place ( CI 0.08 - 1.65 , p = 0.03 ) . It is concluded that the dancers in this study demonstrated a high rate of compliance in obtaining and wearing their orthotics and experienced a significant decrease in pain ",
"Background : Rheumatoid arthritis is a chronic inflammatory joint disease which affects the joints and soft tissues of the foot and ankle . Rocker shoes may be prescribed for the symptomatic foot in rheumatoid arthritis ; however , there is a limited evidence base to support the use of rocker shoes in these patients . Objectives : The aim of this study was to evaluate the effectiveness of heel-to-toe rocker shoes on pain , disability , and activity limitation in patients with rheumatoid arthritis . Study design : Clinical trial . Methods : Seventeen female patients with rheumatoid arthritis of 1 year or more duration , disease activity score of less than 2.6 , and foot and ankle pain were recruited . Heel-to-toe rocker shoe was made according to each patient ’s foot size . All the patients were evaluated immediately , 7 and 30 days after their first visit . Foot Function Index values were recorded at each appointment . Results : With the use of rocker shoes , Foot Function Index values decreased in all subscales . This reduction was noted in the first visit and was maintained throughout the trials . Conclusion : Rocker shoe can improve pain , disability , and activity limitation in patients with rheumatoid foot pain . All the subjects reported improved comfort levels . Clinical relevance The results of this study showed that high-top , heel-to-toe rocker shoe with wide toe box was effective at reducing foot and ankle pain . It was also regarded as comfortable and acceptable footwear by the patients with rheumatoid foot problems",
"STUDY DESIGN Nonr and omized mixed current and historical cohort follow-up study . The purpose of the study was to test the effectiveness of static splinting after arthroplasty in patients with osteoarthritis . Dynamic splinting is recommended after proximal interphalangeal joint pyrocarbon implant arthroplasty ; however , static splinting may be more feasible to deliver . Nine consecutive patients received static splinting in this study . These patients were compared with those of a historical control group ( n = 10 ) who received dynamic splinting . Function and performance variables were measured preoperatively and 3 months after surgery . All patients underwent surgery by the same h and surgeon , and most of the patients were treated by the same certified h and therapist . Both static and dynamic groups showed improvement on several function and performance measures . Compared with the dynamic group , the static group showed greater improvements in the Michigan . H and Outcomes Question naire subset of work performance ( 21.00 ± 14.75 vs 3.13 ± 14.13 , p ( -11.58 ± 5.44 vs -2.81 ± 3.23 , p received static splinting had similar outcomes to those who received the dynamic splinting . Static splinting requires less therapist training and offers greater patient convenience and is a promising protocol that should be evaluated in a larger study",
"Patients with a cavus or high-arched foot frequently experience foot pain , which can lead to significant limitation in function . Custom foot orthoses are widely prescribed to treat cavus foot pain . However , no clear guidelines for their construction exist , and there is limited evidence of their efficacy . In a r and omized , single-blind , sham-controlled trial , the effect of custom foot orthoses on foot pain , function , quality of life , and plantar pressure loading in people with a cavus foot type was investigated . One hundred fifty-four participants with chronic musculoskeletal foot pain and bilateral cavus feet were r and omly assigned to a treatment group receiving custom foot orthoses ( n = 75 ) or to a control group receiving simple sham insoles ( n = 79 ) . At 3 months , 99 % of the participants provided follow-up data using the Foot Health Status Question naire . Foot pain scores improved more with custom foot orthoses than with the control ( difference , 8.3 points ; 95 % confidence interval [ CI ] , 1.2 to 15.3 points ; P = .022 ) . Function scores also improved more with custom foot orthoses than with the control ( difference , 9.5 points ; 95 % CI , 2.9 to 16.1 points ; P = .005 ) . Quality -of-life data favored custom foot orthoses , although differences reached statistical significance only for physical functioning ( difference , 7.0 points ; 95 % CI , 1.9 to 12.1 points ; P = .008 ) . Plantar pressure improved considerably more with custom foot orthoses than with the control for all regions of the foot ( difference , -3.0 N . s/cm(2 ) ; 95 % CI , -3.7 to -2.4 N . s/cm(2 ) ; P custom foot orthoses are more effective than a control for the treatment of cavus foot pain and its associated limitation in function",
"OBJECTIVE To study the effect of Silver Ring Splints ( SRSs ) on h and function in patients with rheumatoid arthritis ( RA ) . METHODS RA patients with stable disease and finger deformities eligible for splinting received 1 or more SRSs . Primary outcome was dexterity , which was measured with the Sequential Occupational Dexterity Assessment ( SODA ) . Secondary outcome measures were self-reported h and function ( Dutch Arthritis Impact Measurement Scales 2 ) , h and pain , grip and pinch strength , Disease Activity Score in 28 joints ( DAS28 ) , and patient satisfaction . RESULTS Seventeen patients ( median age 65 years ; median disease duration 21 years ) received a total of 72 SRSs . After 1 year , 48 SRSs were regularly used . Two patients dropped out because of adverse events related to SRSs . In the remaining 15 patients , SODA dexterity scores increased significantly ( median 71 at baseline , 81 at 3 months , and 85 at 12 months ) , Wilcoxon signed ranks test P=0.005 and P=0.026 . DAS28 scores did not change at 3 months and improved slightly after 12 months ( -0.5 ; P=0.019 ) . Grip strength , self-reported h and function , and h and pain showed no significant changes . Eleven patients stated they would continue using their splints . CONCLUSION SRSs can improve dexterity in selected patients with rheumatoid h and deformities . For a satisfactory result , careful patient pre assessment and optimal adjustment of SRSs are essential",
"Aim : To assess whether the use of a night splint is of added benefit on functional outcome in treating chronic midportion Achilles tendinopathy . Methods : This was a single-blind , prospect i ve , single centre , r and omised controlled trial set in the Sports Medical Department , The Hague Medical Centre , The Netherl and s. Inclusion criteria were : age 18–70 years , active participation in sports , and tendon pain localised at 2–7 cm from distal insertion . Exclusion criteria were : insertional disorders , partial or complete ruptures , or systemic illness . 70 tendons were included and r and omised into one of two treatment groups : eccentric exercises with a night splint ( night splint group , n = 36 ) or eccentric exercises only ( eccentric group , n = 34 ) . Interventions : Both groups completed a 12-week heavy-load eccentric training programme . One group received a night splint in addition to eccentric exercises . At baseline and follow-up at 12 weeks , patient satisfaction , Victorian Institute of Sport Assessment –Achilles question naire ( VISA-A ) score and reported compliance were recorded by a single-blind trained research er who was blinded to the treatment . Results : After 12 weeks , patient satisfaction in the eccentric group was 63 % compared with 48 % in the night splint group . The VISA-A score significantly improved in both groups ; in the eccentric group from 50.1 to 68.8 ( p = 0.001 ) and in the night splint group from 49.4 to 67.0 ( p . There was no significant difference between the two groups in VISA-A score ( p = 0.815 ) and patient satisfaction ( p = 0.261 ) . Conclusion : A night splint is not beneficial in addition to eccentric exercises in the treatment of chronic midportion Achilles tendinopathy",
"A prospect i ve r and omized study of 116 patients with plantar fasciitis was performed to determine the effectiveness of adjuvant night splint therapy in relieving the acute symptoms of plantar fasciitis . Patients were r and omized into one of two groups . Patients in Group 1 were treated with 1 month of oral antiinflammatory medication , Achilles stretching exercises , and shoe recommendations . Patients in Group 2 received identical treatment but also used a dorsiflexion night splint for 3 months . Blinded clinical review of patients was performed at 4 , 6 , and 12 weeks . Health status data Short Form 36 also was collected at these times and again at an average 19 months of followup . Overall , 68 % of patients reported improvement with this nonoperative protocol for a 12-week period . No statistical difference was seen with the presence or absence of a night splint . In addition , no differences in improvement rates were observed with gender , duration of antecedent symptoms , the presence of bilateral symptoms , or the presence of a heel spur . Age older than 45 years did prove to be a statistically significant poor prognostic factor for improvement at the 12-week follow-up . Short Form 36 data obtained at baseline showed significantly lowered perception of health when compared with age matched controls . Patients in both treatment groups had significant improvement in Short Form 36 scores with 12 weeks of conservative care",
"OBJECTIVES To examine the effectiveness of shock-absorbing insoles in the immediate reduction of knee joint load , as well as reductions in knee joint load , pain , and dysfunction after 1 month of wear , in individuals with knee osteoarthritis ( OA ) . DESIGN Pre-post design with participants exposed to 2 conditions ( normal footwear , shock-absorbing insoles ) with a 1-month follow-up . SETTING University laboratory for testing and general community for intervention . PARTICIPANTS Community-dwelling individuals ( N=16 ; 6 men , 10 women ) with medial compartment knee OA . INTERVENTION Participants were provided with sulcus length shock-absorbing insoles to be inserted into their everyday shoes . MAIN OUTCOME MEASURES Primary outcome measures included the peak , early stance peak , and late stance peak external knee adduction moment ( KAM ) ; the KAM impulse ( positive area under the KAM curve ) ; and peak tibial vertical acceleration . Secondary outcomes included walking pain , the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale and total score , and a timed stair climb task . RESULTS There was a significant reduction in the late stance peak KAM with shock-absorbing insoles ( P=.03 ) during follow-up compared with the baseline test session . No other immediate or longitudinal significant changes ( P>.05 ) in the other KAM parameters or peak tibial acceleration after use of a shock-absorbing insole were observed . However , significant improvements in all measures of pain and function ( P Shock-absorbing insoles produced significant reductions in self-reported knee joint pain and physical dysfunction with 1 month of wear in patients with knee OA despite no consistent changes in knee joint load . Further research using r and omized controlled trials , with larger sample sizes and explorations into long-term use of shock-absorbing insoles and their effect on disease progression , is warranted",
"Background Despite a lack of evidence for their effectiveness , functional knee braces are commonly prescribed to patients after anterior cruciate ligament ( ACL ) reconstruction . Purpose This trial was conducted to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve . Hypothesis Patients using a brace will have superior outcomes than those using a sleeve . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods One hundred fifty patients were r and omized to receive a brace ( n = 76 ) or neoprene sleeve ( n = 74 ) at their 6-week postoperative visit after primary ACL reconstruction with hamstring autograft . Patients were assessed preoperatively , then 6 weeks and 6 , 12 , and 24 months postoperatively . Outcome measures included disease-specific quality of life ( Anterior Cruciate Ligament– Quality of Life [ ACL-QOL ] Question naire ) , anterior tibial translation ( KT-1000 arthrometer side-to-side difference ) , the single-limb forward hop test ( limb symmetry index ) , and Tegner Activity Scale . Outcomes at 1 and 2 years were compared after adjusting for baseline scores . Subjective ratings of how patients felt while using the brace/sleeve were also collected for descriptive purpose s using a question naire . Four a priori directional subgroup hypotheses were evaluated using tests for interactions . Results There were no significant differences between brace ( n = 62 ) and sleeve ( n = 65 ) groups for any of the outcomes at 1- and 2-year follow-ups . Adjusted mean differences at 2 years were as follows : −0.94 ( 95 % confidence interval [ CI ] , −7.52 to 5.64 ) for the ACL-QOL Question naire , −0.10 mm ( 95 % CI , −0.99 to 0.81 ) for KT-1000 arthrometer side-to-side difference , −0.87 % ( 95 % CI , −8.89 to 7.12 ) for hop limb symmetry index , and −0.05 ( 95 % CI , −0.72 to 0.62 ) for the Tegner Activity Scale . Subjective ratings of confidence in the knee provided by the brace/sleeve were higher for the brace group than the sleeve group . Subgroup findings were minimal . Adverse events were few and similar between groups . Conclusions A functional knee brace does not result in superior outcomes compared with a neoprene sleeve after ACL reconstruction . Current evidence does not support the recommendation of using an ACL functional knee brace after ACL reconstruction",
"OBJECTIVE To evaluate the effectiveness of static resting splints in early RA . METHODS A multicentre , r and omized , trial was conducted . Patients ( n = 120 ) received either static resting splints [ positioned with the wrist in neutral , MCP joint ( MCPJ ) and IP joint ( IPJ ) in a maximum of 60 degrees and 30 degrees of flexion , respectively ] plus st and ardized occupational therapy or st and ardized occupational therapy alone . Change in grip strength ( Ns ) , structural impairment ( MCPJ ulnar deviation ) , applied dexterity ( Button Board ) , self-report h and ability [ Michigan H and Outcomes Question naire ( MHQ ) ] , h and pain and morning h and stiffness were assessed at 0 and 12 months . RESULTS Data for 56 ( 97 % ) splinted and 60 ( 97 % ) control group patients were analysed . Splint wear adherence was moderate ; 24.5 % ' never wore ' the splints . The adjusted mean difference between groups for h and grip was -14.2 Ns ( P = 0.342 ; 95 % CI -43.7 , 5.4 ) ; MCPJ ulnar deviation -1.1 degrees ( P = 0.657 ; 95 % CI = -6.2 , 3.9 ) ; dexterity 0.1 s ( P = 0.975 ; 95 % CI = -6.6 , 6.8 ) and self-report ability -3.0 on the MHQ score ( P = 0.426 ; 95 % CI -10.5 , 4.5 ) . Pain scores were unchanged in either group ( P = 0.15 ) . The occurrence of morning h and stiffness was reduced in a small group of splinted patients ( P = 0.021 ) , but the duration shortened in control patients ( P = 0.010 ) . CONCLUSIONS There was no significant difference between the two interventions on grip strength , deformity , h and function and pain . The data favoured the control group and this study suggests that resting splints should not be used as a routine treatment of patients with early RA",
"OBJECTIVE To evaluate the efficacy and safety of a hip flexion assist orthosis ( HFAO ) in ambulatory patients with multiple sclerosis ( MS ) . DESIGN Fourteen week pre- and postintervention uncontrolled trial . SETTING Outpatient rehabilitation clinic within an MS center . PARTICIPANTS Ambulatory MS patients ( N=21 ) with unilateral ( or unilateral predominant ) hip flexor weakness . INTERVENTION Subjects were fitted with the HFAO on the weaker side , trained to use the device , and given a wear schedule . Subjects completed 2 baseline evaluations and follow-up testing at 8 and 12 weeks . MAIN OUTCOME MEASURES Lower-extremity manual muscle testing , pain , and gait performance ( Timed 25-Foot Walk , Timed Up & Go , 6-minute walk test , Mellen Center Gait Test ) . Subject satisfaction was evaluated by using a 9-item custom question naire . RESULTS There was a statistically significant improvement of strength in the affected lower extremity at 8 and 12 weeks ( effect size [ES]=0.63 ; ES=1.32 , respectively ) , of pain at 12 weeks only ( ES=-0.64 ) , and of all gait tests at 8 and 12 weeks ( ES range , 0.38 - 1.33 ) . The overall mean satisfaction score at 12 weeks was 39 ( maximum score , 45 ) . No serious adverse events were recorded during the study . The most frequent side effect of the HFAO was low back pain ( 19 % ) . No side effects led to discontinuation of the HFAO use during the study . CONCLUSIONS The HFAO was safe and well tolerated . HFAO use was associated with significant improvement of gait performance as well as improvement of strength in the lower extremity fitted with the HFAO . Subjective reports suggest that there was an increase in daily life activity level",
"OBJECTIVE To compare the effectiveness of an intensive lumbrical splint/stretch combination with 3 less intensive lumbrical splint/stretch combinations on carpal tunnel symptoms and function . DESIGN R and omized Clinical Trial . SETTING Outpatient h and therapy clinics . PARTICIPANTS Volunteers ( N=124 ) with mild to moderate carpal tunnel syndrome . INTERVENTIONS A 4-week home regimen of nocturnal splints ( lumbrical splints or cock-up splints ) combined with stretches ( lumbrical intensive or general ) performed 6 times daily . MAIN OUTCOME MEASURES The effect of the intervention on carpal tunnel symptoms and function was examined with the Carpal Tunnel Symptom Severity and Function Question naire ( CTQ ) and Disabilities of the Arm , Shoulder , and H and ( DASH ) . We also evaluated whether subjects obtained surgery at 24 weeks . RESULTS There were significant main effects over time for all outcome measures at 4 , 12 , and 24 weeks . There was a significant interaction effect for the CTQ-Function and DASH at 12 weeks . Post hoc analyses indicated significant differences between the lumbrical splint/general stretch and general splint/lumbrical stretch groups and the other 2 groups . At 24 weeks , a significantly greater percentage of subjects in the general splint/lumbrical stretch group achieved a clinical ly important improvement on the CTQ-Function . By 24 weeks , only 25.5 % of subjects had elected to undergo surgery . CONCLUSIONS A combination of a cock-up splint with lumbrical intensive stretches was the most effective combination for improvements in functional gains at 24 weeks postbaseline . Our findings support further evaluation of this combination as a method of conservative carpal tunnel syndrome treatment",
"Objective : To evaluate the effectiveness of a functional thumb orthosis on the dominant h and of patients with rheumatoid arthritis and boutonniere thumb . Methods : Forty patients with rheumatoid arthritis and boutonniere deformity of the thumb were r and omly distributed into two groups . The intervention group used the orthosis daily and the control group used the orthosis only during the evaluation . Participants were evaluated at baseline as well as after 45 and 90 days . Assessment s were preformed using the O'Connor Dexterity Test , Jamar dynamometer , pinch gauge , goniometry and the Health Assessment Question naire . A visual analogue scale was used to assess thumb pain in the metacarpophalangeal joint . Results : Patients in the intervention group experienced a statistically significant reduction in pain . The thumb orthosis did not disrupt grip and pinch strength , function , Health Assessment Question naire score or dexterity in either group . Conclusion : The use of thumb orthosis for type I and type II boutonniere deformities was effective in relieving pain",
"Objective : To investigate the association between patients ’ expectations and the actual use of custom-made orthopaedic shoes . Design : A prospect i ve cohort study with internal comparison . Setting : Twelve orthopaedic shoe companies . Patients : During six months , consecutive patients who were provided with their first ever pair of orthopaedic shoes and aged 16 years or older were recruited . A total of 339 patients with different pathologies were included ( response 67 % ) . Mean ( SD ) age of the patients was 63 ( 15 ) years , and 129 patients ( 38 % ) were male . Main measures : A practical and reproducible question naire , measuring : frequency of use of orthopaedic shoes , patients ’ expectations and experiences of aspects of the usability of orthopaedic shoes , and communication about patients ’ expectations . Results : Patients ’ expectations were not associated with the use of orthopaedic shoes ( P-values range : 0.106 to 0.607 ) , but the difference between expectations and experiences was ( P-values range : expectations of patients who frequently used their orthopaedic shoes were in concordance with their experiences , whereas the expectations of patients who did not use their orthopaedic shoes were much higher than their experiences . There was no communication of patients ’ expectations with the medical specialist or orthopaedic shoe technician in 34 % and 25 % of the patients respectively . Conclusions : In relation to the actual use of orthopaedic shoes , it is crucial that patients ’ expectations are not much higher than their experiences",
"Background and objectives Treatment of chronic running-related overuse injuries by orthopaedic shoe orthoses is very common but not evidence -based to date . Hypothesis Polyurethane foam orthoses adapted to a participant 's barefoot plantar pressure distribution are an effective treatment option for chronic overuse injuries in runners . Design Prospect i ve , r and omised , controlled clinical trial . Intervention 51 patients with running injuries were treated with custom-made , semirigid running shoe orthoses for 8 weeks . 48 served as a r and omised control group that continued regular training activity without any treatment . Main outcome measures Evaluation was made by the vali date d pain question naire Subjective Pain Experience Scale , the pain disability index and a comfort index in the orthoses group ( ICI ) . Results There were statistically significant differences between the orthoses and control groups at 8 weeks for the pain disability index ( mean difference 3.2 ; 95 % CI 0.9 to 5.5 ) and the Subjective Pain Experience Scale ( 6.6 ; 2.6 to 10.6 ) . The patients with orthoses reported a rising wearing comfort ( pre-treatment ICI 69/100 ; post-treatment ICI 83/100 ) that was most pronounced in the first 4 weeks ( ICI 80.4/100 ) . Conclusion Customised polyurethane running shoe orthoses are an effective conservative therapy strategy for chronic running injuries with high comfort and acceptance of injured runners"
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INTRODUCTION : Against a background of concern about the safety of new pharmaceutical products , there has been renewed interest in one of the oldest antiepileptic drugs ( AEDs ) , phenobarbital . Although still in widespread use in developing countries , its popularity has slipped in Western countries over the past century , partly because of controversy about its adverse effect profile . This critical review examines the evidence supporting its effectiveness and its associated behavioural adverse effects for febrile convulsions and childhood epilepsy . METHODS : Relevant r and omised controlled trials ( RCTs ) of phenobarbital vs other antiepileptic drugs or placebo between 1970 - 2005 were identified through a comprehensive manual and computer data base search of the world biomedical literature . Eleven RCTs of febrile convulsions and nine RCTs of childhood epilepsy were systematic ally review ed against a conventional set of quality criteria . RESULTS : With a few exceptions , the overall quality of clinical trial methodology , especially in the early studies conducted in the 1970s and 1980s , was poor . There is no evidence for a difference in antiepileptic efficacy between phenobarbital and any other compared AED , yet no evidence for absolute efficacy . No convincing evidence exists for an excess of behavioural adverse effects , over other AEDs , attributable to phenobarbital . Masked studies of phenobarbital in childhood epilepsy have shown no significant differences in behavioural or cognitive adverse effects compared to other AEDs . This is in contrast to the excess of such adverse effects reported in studies open to observer bias . However , the one finding of reduction in cognitive ability associated with phenobarbital treatment for febrile convulsions remains a concern . Future areas of clinical and genetic epidemiological research are outlined
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"BACKGROUND Infantile spasms , which comprise a severe infantile seizure disorder , have a high morbidity and are difficult to treat . Hormonal treatments ( adrenocorticotropic hormone and prednisolone ) have been the main therapy for decades , although little evidence supports their use . Vigabatrin has been recorded to have a beneficial effect in this disorder . We aim ed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms . METHODS The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre , r and omised controlled trial in 150 hospitals in the UK . The primary outcome was cessation of spasms on days 13 and 14 . Minimum doses were vigabatrin 100 mg/kg per day , oral prednisolone 40 mg per day , or intramuscular tetracosactide depot 0.5 mg ( 40 IU ) on alternate days . Analysis was by intention to treat . FINDINGS Of 208 infants screened and assessed , 107 were r and omly assigned to vigabatrin ( n=52 ) or hormonal treatments ( prednisolone n=30 , tetracosactide n=25 ) . None was lost to follow-up . Proportions with no spasms on days 13 and 14 were : 40 ( 73 % ) of 55 infants assigned hormonal treatments ( prednisolone 21/30 [ 70 % ] , tetracosactide 19/25 [ 76 % ] ) and 28 ( 54 % ) of 52 infants assigned vigabatrin ( difference 19 % , 95 % CI 1%-36 % , p=0.043 ) . Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone . Adverse events were reported in 30 ( 55 % ) of 55 infants on hormonal treatments and 28 ( 54 % ) of 52 infants on vigabatrin . No deaths were recorded . INTERPRETATION Cessation of spasms was more likely in infants given hormonal treatments than those given vigabatrin . Adverse events were common with both treatments",
"Using a r and omized parallel group study design , we compared the cognit i ve effects of carbamazepine ( CBZ ) , phenobarbital ( PB ) , and valproate ( VPA ) in children with epilepsy . Seventy-three children with newly diagnosed epilepsy were tested with the Wechsler Intelligence Scale for Children-Revised ( WISC-R ) , Bender-Gestalt test , and auditory event-related potentials ( P 300 ) before and 6 and 12 months after antiepileptic drug ( AED ) treatment . There were no significant differences in WISC-R IQs and Bender-Gestalt scores for children in any group at any of the three sessions . P 300 latencies were increased in the children receiving PB but not in children receiving CBZ and VPA . P 300 amplitudes were significantly reduced in treated children in all three groups , but amplitudes were not significantly different among the three groups . These findings suggest that PB may affect cognitive function of epileptic children and that the P 300 may be a sensitive additional procedure that can be used to assess the cognitive effect of AEDs",
"Cognitive and behavioral effects of phenobarbital in toddlers were assessed in a r and omized , placebo-controlled study of patients who had had a febrile seizure . There were no significant differences in IQ ( Binet or Bayley Scales ) between placebo and phenobarbital groups after eight to 12 months of therapy . However , detrimental effects of phenobarbital were found in memory , for which serum level influenced scores , and in comprehension , in that length of treatment time affected performance . Hyperactivity was not seen . Behavioral changes , reported by parents , were increased fussiness and a characteristic disturbance of sleep . These changes varied in severity and were classified as transient , dose related , or unacceptable . After 12 months in the study , most parents could not distinguish between phenobarbital and placebo . Our data suggest that although most toddlers do not have major side effects from phenobarbital therapy when treated for a year , serum levels and length of time on phenobarbital should be kept at a minimum to reduce negative cognitive and behavioral effects",
"BACKGROUND The use of phenobarbital for childhood epilepsy is controversial because of reported behavioural side-effects ; however , whether this research can validly be extrapolated to developing countries is not clear . We undertook a r and omised comparison of phenobarbital and phenytoin to assess the acceptability and efficacy of phenobarbital as monotherapy for childhood epilepsy in rural India . METHODS Between August , 1995 , and February , 1996 , 109 unselected children aged 2 - 18 years with partial and generalised tonic-clonic epilepsy were identified by population screening . 15 families declined to take part . 94 children were r and omly allocated treatment with phenobarbital ( 1.5 mg/kg daily for 2 weeks ; maintenance dose 3.0 mg/kg daily ; n = 47 ) or phenytoin ( 2.5 mg/kg daily then 5.0 mg/kg daily ; n = 47 ) . Children were followed up for 12 months . The primary outcome measure was the frequency of behavioural side-effects ; behaviour was assessed by the Conners parent rating scale for children aged 6 years and older , and by the preschool behaviour screening question naire ( BSQ ) for those aged 2 - 5 years , at 12 months or at withdrawal from treatment . Analysis was by intention to treat . FINDINGS The mean log-transformed scores on the behaviour rating scales did not differ significantly between the phenobarbital and phenytoin groups ( Conners 2.64 [ SD 0.71 ] vs 2.65 [ 0.89 ] , p = 0.97 ; n = 32 in each group : BSQ 2.12 [ 1.31 ] vs 2.18 [ 1.02 ] , p = 0.94 ; n = 4 vs 3 ) . The odds ratio for behavioural problems ( phenobarbital vs phenytoin ) was 0.51 ( 95 % CI 0.16 - 1.59 ) . There was no excess in parental reports of side-effects for phenobarbital . We found no difference in efficacy between the study drugs ( adjusted hazard ratio for time to first seizure from r and omisation 0.97 [ 0.28 - 3.30 ] ) . INTERPRETATION This evidence supports the acceptability of phenobarbital as a first-line drug for childhood epilepsy in rural setting s in developing countries",
"Some pediatric neurologists maintain that mephobarbital ( Mebaral ) causes fewer behavioral side effects than phenobarbital . Because this hypothesis has not been previously tested , we conducted a prospect i ve , double-blind , r and omized , crossover study of these two anticonvulsants . Both drugs were equally effective in reducing the frequency of seizure , although serum phenobarbital levels were significantly higher when the patients were taking phenobarbital compared to mephobarbital . As measured by the Abbott Parent Question naire , there was no significant deterioration of behavior with either phenobarbital or mephobarbital , regardless of which drug was administered first . J Child Neurol 1986;1:361 - 363",
"Phenytoin and carbamazepine are effective and inexpensive anti-epileptic drugs ( AEDs ) . As with many AEDs , a broad range of doses is used , with the final \" maintenance \" dose normally determined by trial and error . Although many genes could influence response to these medicines , there are obvious c and i date s. Both drugs target the alpha-subunit of the sodium channel , encoded by the SCN family of genes . Phenytoin is principally metabolized by CYP2C9 , and both are probable substrates of the drug transporter P-glycoprotein . We therefore assessed whether variation in these genes associates with the clinical use of carbamazepine and phenytoin in cohorts of 425 and 281 patients , respectively . We report that a known functional polymorphism in CYP2C9 is highly associated with the maximum dose of phenytoin ( P = 0.0066 ) . We also show that an intronic polymorphism in the SCN1A gene shows significant association with maximum doses in regular usage of both carbamazepine and phenytoin ( P = 0.0051 and P = 0.014 , respectively ) . This polymorphism disrupts the consensus sequence of the 5 ' splice donor site of a highly conserved alternative exon ( 5N ) , and it significantly affects the proportions of the alternative transcripts in individuals with a history of epilepsy . These results provide evidence of a drug target polymorphism associated with the clinical use of AEDs and set the stage for a prospect i ve evaluation of how pharmacogenetic diagnostics can be used to improve dosing decisions in the use of phenytoin and carbamazepine . Although the case made here is compelling , our results can not be considered definitive or ready for clinical application until they are confirmed by independent replication",
"The results of a prospect i ve assessment of antiepileptic drug treatment carried out over a 12-month period , in the context of existing community health care in a rural area of a developing country ( a highl and region of northern Ecuador ) , are reported . A house to house survey defined all patients in the area with a history of epileptic seizures , and 192 patients with active epilepsy were recruited into the programme . These patients were r and omised to treatment with carbamazepine or phenobarbital , and 139 completed the assessment . Treatment was carried out by health visitors and rural doctors , monitored by a team of neurologists , and st and ard treatment regimens were used . Treatment was effective in controlling seizures , 53 % of the patients were rendered entirely seizure free in the second 6 months of therapy , and a further 14 % had a 50 % or more reduction in seizures . These results were similar to those reported in hospital based studies in developed countries . No significant differences were found between the efficacy and safety of phenobarbital or carbamazepine . Antiepileptic drug levels were monitored during the study , and ranges similar to those found in developed countries were recorded . Compliance was good . In view of the successful treatment in this community control programme , we would recommend that community programmes for the control of epilepsy in rural setting s should be given a higher priority in the planning of health care provision than is commonly the case . Finally , the programme afforded the opportunity to study the efficacy of treatment in patients with chronic long-st and ing epilepsy , who had not been previously treated , and the results of this treatment were good",
"The effect of phenobarbital on total sleep time , night awakenings , and lengthy awakenings was examined as part of a r and omized trial of children with febrile seizures ; information about sleep patterns was gathered by parental observation . Children were between ages 8 - 36 months at enrollment and were examined subsequently for 2 1/2 years . Night awakenings were not more common in children assigned to phenobarbital except for those who were poor sleepers at the beginning of the study . Total sleep time was no different in children assigned to phenobarbital than in those assigned to placebo . It is concluded that sleep problems reported in most young children with febrile seizures treated with phenobarbital did not exceed those reported in children treated with placebo , but a subset of predisposed children did experience an increase in night awakenings",
"A r and omized double-blind study was carried out comparing single daily dose phenobarbital plus antipyretic instruction to a placebo plus antipyretic instruction to prevent a recurrent seizure following an initial simple febrile seizure . Parents of 138 consecutive children presenting to an emergency room with a first simple febrile convulsion received verbal and written instructions about fever control . Seventy-nine then agreed to participate in this study . Children were r and omized to receive either placebo with riboflavin tracer ( n = 40 ) or phenobarbital 5 mg/kg in a single daily dose with a riboflavin tracer ( n = 39 ) for 12 months or until another seizure occurred . Urine fluorescence for riboflavin was used to monitor compliance in all patients . Serum phenobarbital levels were obtained at each follow-up visit and averaged 1.4 mg/dl throughout the study . The significant difference ( P less than 0.02 ) in the incidence of recurrent seizures between patients receiving phenobarbital ( 2/39 ) and those receiving placebo ( 10/40 ) suggests that a single daily dose of phenobarbital is more effective than counseling parents about antipyretic therapy in preventing recurrent seizures following an initial febrile seizure",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
" Thirty-nine children were treated with either phenobarbital ( PB ) or carbamazepine ( CBZ ) for newly diagnosed partial onset seizures . Drug selection was r and omized in 33 subjects . Parents and the psychologist evaluating the child were blind to drug identity . Psychometric and behavioral evaluations were done at intake and at 6- and 12-month follow-ups . There were no significant differences between drugs in effect on behavior or cognitive function . CBZ caused more systemic problems . There was a trend toward better seizure control with CBZ , but this was not statistically significant . Although individual children in each group had changes in behavior or cognitive status , neither group changed significantly , in either acute or chronic follow-up",
"After their first episode of febrile convulsions , 195 previously healthy children , aged 6 - -30 months , were given either diazepam or phenobarbitone for a year . Each child was assigned at r and om to one of the two medications : children admitted on even days were given a suppository containing 5 mg diazepam every 8 hours when the rectal temperature was greater than or equal to 38.5 degree C. Children admitted on odd days were given treatment with phenobarbitone , 3.5 + /- 1 mg/kg per day . 156 children completed treatment and outpatient control for a year , 83 in the diazepam and 73 in the phenobarbitone group . The rate of recurrence was independent of the prophylactic and 15 - -16 % of the children in both groups had new febrile convulsions within a year . The recurrence rate after 6 months was also similar , 11 % in the diazepam group and 9 % in the phenobarbitone group . New convulsions were of similar duration and severity in both groups . In both groups 6 % of all febrile episodes led to new convulsions . Long-term treatment with phenobarbitone thus offered no advantage over intermittent diazepam",
"The purpose of this study was to compare three different modes of treatment in the prevention of relapses of febrile convulsions ( Phenobarbital = PH , Sodium Valproate = SV , Placebo = PO ) in a r and omized therapeutic trial . The patients included in the study had shown their first generalized convulsive seizure during a bout of fever ( greater than or equal to 38.5 degrees C ) and were aged between 6 months and 4 years . They were subsequently followed up as out patients , and Phenobarbital and sodium valproate levels were measured regularly to ascertain compliance with the treatment and to adjust the dosage accordingly . The patients ' families were question ed with respect to the occurrence of feverish bouts and convulsive seizures during the interval between visits , as well as possible adverse reactions . An EEG was carried out yearly . Results were as follows : - 69 patients - 35 boys and 34 girls - with an average age of 24 months were divided into 3 groups according to treatment : 21 cases on PH , 22 cases on SV , and 26 cases on PO . - they were followed up for an average duration of 21 months . - the average number of feverish bouts per child and per year was evaluated at 2.5 , no statistically significant difference being noticeable between the various modes of prophylaxis . - 15 relapses of febrile seizures were noted in 14 children , over an average duration of 23 months ; on average , relapses occurred after 9 months ; among the 14 children who had relapsed , one had been treated with SV , 4 with PH and 9 with PO , leading to estimated relapse rates of 4 % , 19 % , and 35 % respectively . There is a statistically significant difference in the relapse rates between the treated groups ( SV and PH ) and the Placebo group , and a particularly significant difference between Sodium Valproate and Placebo . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Seizures commonly complicate cerebral malaria and are associated with an increased risk of death and neurological sequelae . We undertook a r and omised study to assess the efficacy of intramuscular phenobarbital in preventing seizures in childhood cerebral malaria . METHODS Children with cerebral malaria admitted to one hospital in Kilifi , Kenya , were r and omly assigned a single intramuscular dose of phenobarbital ( 20 mg/kg ) or identical placebo . Clinical tolerance was assessed at the start of the trial , with particular reference to respiratory depression and hypotension . Seizures were timed and recorded , and treated in a st and ard way . Plasma phenobarbital concentrations were measured . Analyses were by intention to treat . FINDINGS 440 children with cerebral malaria were admitted to the hospital ; 100 were not recruited to the study . Of the remaining 340 , 170 received phenobarbital and 170 placebo . The drug was adequately absorbed and well tolerated . Seizure frequency was significantly lower in the phenobarbital group than in the placebo group ( 18 [ 11 % ] vs 46 [ 27 % ] children had three or more seizures of any duration ; odds ratio 0.32 [ 95 % CI 0.18 - 0.58 ] ) but mortality was doubled ( 30 [ 18 % ] vs 14 [ 8 % ] deaths ; 2.39 [ 1.28 - 4.64 ] ) . The frequency of respiratory arrest was higher in the phenobarbital group than in the placebo group , and mortality was greatly increased in children who received phenobarbital plus three or more doses of diazepam ( odds ratio 31.7 [ 1.2 - 814 ] ) . INTERPRETATION In children with cerebral malaria , phenobarbital 20 mg/kg provides highly effective seizure prophylaxis but is associated with an unacceptable increase in mortality . Use of this dose can not , therefore , be recommended",
"OBJECTIVE The aim of this study was to clarify the effect of genetic polymorphisms of CYP2C19 on the pharmacokinetics of phenobarbitone ( PB ) using a nonlinear mixed-effects model ( NONMEM ) analysis in Japanese adults with epilepsy . METHODS A total of 144 serum PB concentrations were obtained from 74 subjects treated with both PB and phenytoin but without valproic acid . All patients were classified into three groups by CYP2C19 genotyping : G1 , G2 and G3 were homozygous for the wild type of CYP2C19 ( * 1/*1 ) , heterozygous extensive metabolizers ( EMs ) , ( * 1/*2 or * 1/*3 ) , and poor metabolizers ( PMs ) , ( * 2/*2 , * 2/*3 ) , respectively . All data were analyzed using NONMEM to estimate pharmacokinetic parameters of PB with respect to the CYP2C19 genotype . RESULTS Thirty-three patients belonged to G1 ( 44.6 % ) , 35 to G2 ( 47.3 % ) , and 6 to G3 ( 8.1 % ) . The total clearance ( CL ) of PB significantly decreased by 18.8 % in PMs ( G3 ) relative to EMs ( G1 and G2 ) . The CL tended to be lower in G2 than in G1 . CONCLUSION In this study , we first demonstrated the effect of the CYP2C19 polymorphism on pharmacokinetics of PB by genotyping . The contribution of other metabolic enzymes in the metabolism of PB in humans remains to be eluci date d ; however , it appears that the disposition of PB is mediated in part by this enzyme . The estimated population clearance values in the three genotype groups can be used to predict the PB dose required to achieve an appropriate serum concentration in an individual patient",
" A group of 355 children who were seen after a first febrile convulsion at the Kaiser Foundation Foundation Hospitals in Southern California from 1970 to 1975 were r and omly assigned to three treatment groups-daily phenobarbital , \" intermittent \" phenobarbital given at the onset of fever , and no phenobarbital . We found that 42 % had a relative with a febrile seizure and 16 % a relative with an afebrile convulsion . 13 % had seizures which were either lateralized or longer than ten minutes . Parents were unaware of the fever prior to the seizure in about 30 % of the cases . In 81 % the preseizure duration of fever was less than 24 hours . The mean follow-up was 28 months , with a range of 6 to 70 months . There was no significant difference in the recurrence rate between children receiving \" intermitent \" as compared with no phenobarbital . The recurrence rate in children receiving daily phenobarbital was significantly decreased compared to either of the other two groups . Severe recurrent febrile seizures occurred in no children on daily phenobarbital and in 4.4 % of the children receiving either intermittent or no phenobarbital . Parental resistance , compliance , and reversible hyperactivity were the main problems encountered with the continuous phenobarbital regimen",
"Psychometric tests were performed on 50 children with a history of febrile convulsions . Twenty-five of these had received daily phenobarbital for a mean of 35 months ; 25 had received no phenobarbital . The two groups were matched for sex , age at the time of testing , race , and socioeconomic status . The tests used were the Wechsler Preschool and Primary Scale of Intelligence ( WPPSI ) , the Matching Familiar Figures Test , and the Children 's Embedded Figures Test . There were no significant differences in test results between the two groups",
"The primary analysis of a r and omized clinical trial should compare patients in their r and omly assigned treatment groups ( intention to treat analysis ) . When a substantial number of subjects fail to take a prescribed medication or are switched to a different study medication , it is tempting to consider treatment comparisons using only those subjects with treatment as actually received rather than as prescribed . There are several arguments against this approach : the prognostic balance brought about by r and omization is likely to be disturbed ; sample size will be reduced ; and the validity of the statistical test procedures will be undermined . Further , results of analysis by treatment actually received may suffer from a bias introduced by using compliance , a factor often related to outcome independently of the treatment received , to determine the groups for comparison . The extent and nature of this bias will be related to the definition of compliance in an as treated analysis , a definition which could be unintentionally self-serving . We have investigated the problem of the definition of actual treatment in the context of a recent clinical trial . We used several definitions to classify patients as having received or not received treatment as prescribed . These definitions , when used in as treated analyses , provided results that were at times inconsistent or counter-intuitive , and which neither helped to confirm nor further explain the intention to treat analysis",
"Phenobarbital is widely used in the treatment of children with febrile seizures , although there is concern about possible behavioral and cognitive side effects . In 217 children between 8 and 36 months of age who had had at least one febrile seizure and were at heightened risk of further seizures , we compared the intelligence quotients ( IQs ) of a group r and omly assigned to daily doses of phenobarbital ( 4 to 5 mg per kilogram of body weight per day ) with the IQs of a group r and omly assigned to placebo . After two years , the mean IQ was 7.03 [ corrected ] points lower in the group assigned to phenobarbital than in the placebo group ( 95 percent confidence interval , -11.52 to -2.5 , P = 0.0068 [ corrected ] ) . Six months later , after the medication had been tapered and discontinued , the mean IQ was 5.2 points lower in the group assigned to phenobarbital ( 95 percent confidence interval , -10.5 to 0.04 , P = 0.052 ) . The proportion of children remaining free of subsequent seizures did not differ significantly between the treatment groups . We conclude that phenobarbital depresses cognitive performance in children treated for febrile seizures and that this disadvantage , which may outlast the administration of the drug by several months , is not offset by the benefit of seizure prevention",
"Traditional clinical monitoring of children with epilepsy does not appear to be sufficiently sensitive to cognitive functioning and behavioral problems . Although subtle , these changes may alter a child 's ability to perform well in school and in society . Physicians must prevent seizures without producing intolerable side effects , and ways of more appropriately assessing these side effects must be developed . In this double-blind , counter-balanced , crossover study of 21 children , the effects of phenobarbital and valproic acid on cognitive functioning and behavior were measured . There was no difference in seizure control between the drugs , and each medication was maintained in the therapeutic range for 6 months ( mean phenobarbital level , 21.2 micrograms/mL ; mean valproic acid level , 94.1 micrograms/mL ) . Children were treated with each drug for 6 months . Differences between the drugs were seen on measurements of cognitive function and behavior . On four tests of neuropsychologic function , children performed significantly less well while receiving phenobarbital ( P less than .01 ) . There was no evidence that the patients were se date d or less able to perform continuous performance tasks while receiving phenobarbital . Parental assessment of behavior indicated significantly worse behavior with the phenobarbital regimen for three items ( P less than .01 ) and children were measurably more \" hyperactive \" ( P less than .05 ) . Routine clinical assessment of the patients did not reveal differences between the drugs with respect to routine laboratory measurements or side effects as assessed by history or physical examination . Although children may appear to tolerate a medication without clinical ly apparent problems , subtle but significant changes in intellectual function and behavior may be occurring . Additional , more sensitive , methods of monitoring patients while receiving these drugs is necessary",
" Of 138 children who had a first febrile convulsion before their second birthday , 48 were treated with phenobarbitone , 47 with phenytoin , and 43 with a placebo for 12 months . Drug levels were monitored and adverse effects of the drugs were noted . Compared with placebo , phenobarbitone significantly reduced recurrences among children under 14 months old at the time of their first convulsion , but nor among older children . Phenytoin was an ineffective prophylactic agent . Ideal drug levels were difficult to maintain , and many recurrences occurred when concentrations were suboptimal . Behavioural disturbance in children taking phenobarbitone was not a serious problem . The decision to give continuous prophylaxis for febrile convulsions is complex , and each case must be judged on its merits . For children who have a first seizure before 14 months of age prophylaxis may be advisable and phenobarbitone is effective",
" One-hundred-sixty-five children without known neurological disorder who presented with their first febrile convulsion between the ages of six months and three years were assigned to daily phenobarbitone treatment or to a control group and followed up at a special clinic for six months . One-hundred- and -sixty-one-one children completed the trial , and of the 88 children assigned to phenobarbitone treatment 10 had further convulsions during this period compared with 14 of the 73 control children . Only 49 of those assigned to phenobarbitone took the drug regularly throughout the trial , and four of these had further febrile convulsions , a proportion not significantly different from that in the controls . All four had mean plasma phenobarbitone concentrations over 69 mumol/l ( 16 mug/ml ) during the trial and in three the plasma concentration was at or over this figure within eight hours over 69 mumol/l ( 16 mug/ml ) during the trial and in three the plasma concentration was at or over this figure within eight hours of the repeat convulsion . Regular phenobarbitone does not seem to prevent febrile convulsions . Attention should instead be directed to organising emergency services to allow early termination of fevrile convulsions , whether first or subsequent , to prevent irreversible brain damage",
"BACKGROUND The medical treatment of childhood epilepsy is largely influenced by clinical trials in adult patients . We know of only one r and omised comparative trial ( of two drugs ) in newly diagnosed childhood epilepsy . We have undertaken a long-term , prospect i ve , r and omised , unmasked , pragmatic trial of the comparative efficacy and toxicity of four st and ard antiepileptic drugs used as monotherapy in children with newly diagnosed epilepsy . METHODS Between 1981 and 1987 , 167 children aged 3 - 16 years , who had had at least two previously untreated tonic-clonic or partial seizures , with or without secondary generalisation , were r and omly allocated treatment with phenobarbitone , phenytoin , carbamazepine , or sodium valproate . The protocol was design ed to conform to st and ard clinical practice . Efficacy was assessed by time to first seizure after the start of treatment and time to achieving 1-year remission . FINDINGS The overall outcome with all four drugs was good . 20 % of children remained free of seizures and 73 % had achieved 1-year remission by 3 years of follow-up . We found no significant differences between the drugs for either measure of efficacy at 1 , 2 , or 3 years of follow-up . The overall frequency of unacceptable side-effects necessitating withdrawal of the r and omised drug was 9 % . This total included six of the first ten children assigned phenobarbitone ; no further children were allocated this drug . Of the other three drugs , phenytoin ( 9 % ) was more likely to be withdrawn than carbamazepine ( 4 % ) or sodium valproate ( 4 % ) . INTERPRETATION Our data will inform choice of drug and outcome with four of the st and ard drugs available for newly diagnosed tonic-clonic or partial seizures with or without secondary generalisation in children",
"A programme of antiepileptic treatment in a rural and semi-urban region in Kenya was assessed . Patients with generalised tonic-clonic seizures were treated according to one of two simple drug protocol s. Health workers screened cases reported by key informants in the community . From the 529 patients identified by health workers as having active seizures 302 patients aged 6 - 65 years were recruited by a psychiatrist for therapy with carbamazepine or phenobarbitone . Treatment was supervised largely by primary health workers , and the programme was monitored by a research team , which assessed the effectiveness of treatment . Of the 249 patients who completed the study , 53 % became seizure-free in the second 6 months of therapy , and another 26 % had substantially ( 50 % or more reduction ) fewer seizures than in the 6 months before therapy . The similarity of these findings to those obtained in newly diagnosed patients in the developed world , the low drop-out rate , the low rate of withdrawal due to adverse effects , and the acceptable compliance with therapy indicate that health workers can monitor therapy adequately . Most patients had had several years of delay before starting therapy for their epilepsy , yet they responded well -- a finding that does not support the suggestion that the disorder becomes intractable if not treated early",
"In a double-blind trial , children who had recurrent and /or complex febrile convulsions were treated with either phenobarbital sodium or carbamazepine . Forty children were suitable for analysis ; 19 were receiving carbamazepine , and 21 were receiving phenobarbital . Of the carbamazepine-treated patients , nine ( 47 % ) had recurrent convulsions despite therapeutic levels of the drug , while only two ( 10 % ) of the phenobarbital-treated patients suffered further seizures . These results confirm previous findings suggesting that carbamazepine is not as effective in the prophylactic treatment of febrile convulsions as phenobarbital",
" One hundred and eighty‐six consecutive children aged between six and 72 months admitted to the Manchester Children 's Hospitals with a febrile convulsion in the first year of life , a complicated febrile convulsion , or more than one febrile convulsion within two years , were allocated r and omly to one of three groups who were offered rectal diazepam in the event of a subsequent prolonged febrile convulsion , or prophylactic treatment with sodium valproate or phenobarbitone . Over‐all risk of recurrence was 30 per cent and adequate prophylaxic treatment did not lessen this risk . Side‐effects in 24 per cent of the valproate group and 61 per cent of the phenobarbitone group did not justify the use of prophylactic treatment",
"An unselected and representative series of 208 children admitted following their first febrile convulsion has been offered a continuous prophylactic treatment with phenobarbital . The treatment was started in 174 of the patients and planned to be given for 2 years . For various reasons – the major one being sideeffects – the drug was discontinued at different times before the end of 2 years in 59 patients , 31 are still in treatment and 84 have completed the course"
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Several studies have demonstrated the neuromodulating function of oxytocin ( OT ) in response to anxiogenic stimuli as well as its potential role in the pathogenesis of depression . Consequently , intranasal OT ( IN-OT ) has been proposed as a potential treatment of anxiety and depressive disorders . The present systematic review aim ed to summarize the r and omized controlled trials ( RCTs ) evaluating the effect of IN-OT on anxiety and depressive symptoms . Overall , 15 studies were included , involving patients with social anxiety disorders ( 7 studies ) , arachnophobia ( 1 ) , major depression ( 3 ) or post-natal depression ( 4 ) , and mainly evaluating single-dose administrations of IN-OT . Results showed no significant effects on core symptomatology . Five crossover studies included functional magnetic resonance imaging investigation : one trial showed reduced amygdala hyper-reactivity after IN-OT in subjects with anxiety , while another one showed enhanced connectivity between amygdala and bilateral insula and middle cingulate gyrus after IN-OT in patients but not in healthy controls . More studies are needed to confirm these results . In conclusion , up to date , evidence regarding the potential utility of IN-OT in treating anxiety and depression is still inconclusive . Further RCTs with larger sample s and long-term administration of IN-OT are needed to better eluci date its potential efficacy alone or in association with st and ard care
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"Oxytocin is a neuropeptide that is active in the central nervous system and is generally considered to be involved in prosocial behaviors and feelings . In light of its documented positive effect on maternal behavior , we design ed a study to ascertain whether oxytocin exerts any therapeutic effects on depressive symptoms in women affected by maternal postnatal depression . A group of 16 mothers were recruited in a r and omized double-blind study : the women agreed to take part in a brief course of psychoanalytic psychotherapy ( 12 sessions , once a week ) while also being administered , during the 12-weeks period , a daily dose of intranasal oxytocin ( or a placebo ) . The pre-treatment evaluation also included a personality assessment of the major primary -process emotional comm and systems described by Panksepp ( ) and a semi-quantitative assessment by the therapist of the mother ’s depressive symptoms and of her personality . No significant effect on depressive symptomatology was found following the administration of oxytocin ( as compared to a placebo ) during the period of psychotherapy . Nevertheless , a personality trait evaluation of the mothers , conducted in our overall sample group , showed a decrease in the narcissistic trait only within the group who took oxytocin . The depressive ( dysphoric ) trait was in fact significantly affected by psychotherapy ( this effect was only present in the placebo group so it may reflect a positive placebo effect enhancing the favorable influence of psychotherapy on depressive symptoms ) but not in the presence of oxytocin . Therefore , the neuropeptide would appear to play some role in the modulation of cerebral functions involved in the self-centered ( narcissistic ) dimension of the suffering that can occur with postnatal depression . Based on these results , there was support for our hypothesis that what is generally defined as postnatal depression may include disturbances of narcissistic affective balance , and oxytocin supplementation can counteract that type of affective disturbance . The result ing improvements in well-being , reflected in better self-centering in post-partuent mothers , may in turn facilitate better interpersonal acceptance of ( and interactions with ) the child and thereby , improved recognition of the child ’s needs",
"Oxytocin has numerous prosocial and antipsychotic-like effects in animals . Prosocial effects of acute intranasal oxytocin administration have also been reported in human subjects . We conducted a r and omized , placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia . PANSS scores declined significantly and several social cognition measures improved significantly or nearly significantly in oxytocin ( N=11 ) but not placebo ( N=9 ) recipients . Our results suggest that , in addition to reducing classic psychotic symptoms , oxytocin may diminish certain social cognition deficits that are not improved by current antipsychotic medications",
"Individual psychotherapy is an important treatment for a number of psychiatric conditions and involves a unique form of human attachment . This raises the question of whether oxytocin ( OT ) , the paradigmatic \" attachment hormone \" , may have benefits in this context . In this r and omized , double-blind , crossover trial , we gave male psychiatric out patients with major depressive disorder 40 IU intranasal OT or placebo before a videotaped session with a therapist and measured a number of subjective , physiological , and behavioral parameters . We report three main findings . Surprisingly - in contrast to prior reports of OT 's anxiolytic properties - we found OT caused an increase in anxiety over the course of the therapy session . Secondly , though it had no main effect on cortisol , eye contact , or overall behavior , we did find that OT caused a decrease in nonverbal behaviors that cut off social contact , after controlling for level of depressive symptoms . Lastly , we replicated prior findings that OT improves social cognition ( performance on the reading the mind in the eyes test ( RMET ) ) , albeit in a depressed patient group . These results inform future studies of oxytocin and psychotherapy and suggest that in certain clinical population s and context s , OT has heterogeneous subjective effects which may include acute anxiogenesis . Moreover , the similarity of some of these acute effects to those of single-dose serotonergic antidepressants raises interesting questions about the potential antidepressant benefits of chronic OT administration",
"Postnatal depression ( PND ) is common and negatively affects the mother – infant relationship ; oxytocin ( OT ) has been found to have positive effects on parenting , although psychiatric disorders may reduce these effects . Thus , we explored the role of OT in mothers diagnosed with PND . A within-subject , r and omized controlled double-blind design was used to test the effects of nasal administration of OT or placebo on sensitive caregiving . The outcome measures were perceptual and caregiving responses to prerecorded cry sounds , as well as observed maternal sensitivity . We found that in the OT condition mothers with PND were more likely to rate an infant cry as more urgent and they were more likely to indicate they would chose a harsh caregiving strategy in response . There was no effect of OT on maternal sensitive interaction with their own baby . Further research is required prior to consideration of OT administration in depressed mothers of infants",
"Gossip is a pervasive social behavior . Its evolutionary survival seems related to its social functions , such as establishing group rules , punishing trespassers , exercising social influence through reputational systems , and developing and strengthening social bonds . We aim ed at evaluating the effect of gossip on hormones ( oxytocin and cortisol ) and at identifying potential mediators of hormonal response to gossip . Twenty-two female students were r and omly assigned to a gossip conversation or to an emotional non-gossip conversation . Additionally , all participants underwent a neutral conversation on the second day of the study . Salivary oxytocin and cortisol levels were measured . Oxytocin increased significantly in the gossip compared to the emotional non-gossip conversation . A decrease in cortisol levels was observed in all three conditions ( gossip , emotional non-gossip , neutral ) . Change in cortisol levels was similar across conditions . Psychological characteristics ( e.g. empathy , autistic traits , perceived stress , envy ) did not affect oxytocin rise in the gossip condition . Our findings suggest that oxytocin may represent a potential hormonal correlate of gossip behavior",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"The neuropeptide oxytocin ( OXT ) plays an important role in complex socio-affective behaviours such as affiliation , attachment , stress and anxiety . Previous studies have focused on the amygdala as an important target of OXT 's effects . However , the effects of OXT on connectivity of the amygdala with cortical regions such as medial frontal cortex , an important mediator of social cognition and emotion regulation , remain unexplored . In a r and omized , double-blind , cross-over design , 15 volunteers received intranasal OXT or placebo prior to resting-state functional magnetic resonance imaging . OXT significantly increased connectivity between both amygdalae and rostral medial frontal cortex ( rmFC ) , while having only negligible effects on coupling with other brain regions . These results demonstrate that OXT is a robust and highly selective enhancer of amygdala connectivity with rmFC , a region critical to social cognition and emotion regulation , and add to our underst and ing of the neural mechanisms by which OXT modulates complex social and cognitive behaviours ",
"BACKGROUND Successful parenting requires maternal behaviors that promote infant survival such as protection from predators . In animal studies , oxytocin ( OT ) has been linked to maternal aggression to protect offspring . No human study has explored this topic . Mothers with a diagnosis of postnatal depression ( PND ) are at higher risk of neglecting their infants . We hypothesized that intranasal OT administration would increase the protective behaviors of mothers with PND , toward their infants . METHODS Sixteen mothers with a diagnosis of PND participated in a double-blind , r and omized-controlled , within-subject pilot study . Participants received intranasal OT during one visit and placebo spray on the alternate visit . Maternal protective behavior toward their infant was measured , in the presence of a socially intrusive stranger . RESULTS The enthusiastic stranger paradigm stimulated participants ' protective responses in the presence of an intrusive stranger . Furthermore , this protective response of mothers with a diagnosis of PND was increased in the OT condition . CONCLUSIONS The study introduces a new paradigm , the enthusiastic stranger paradigm , which may be used to examine a neglected type of parental behavior , that is , protection of offspring . The protective response of mothers with PND increased , in line with the ' tend and defend ' effects of OT in animal models . In future work it should be tested whether this protection effect can also be found in non clinical sample s , or whether it is specific for clinical ly depressed mothers",
"The neuropeptide oxytocin ( OXT ) is thought to attenuate anxiety by dampening amygdala reactivity to threat in individuals with generalized social anxiety disorder ( GSAD ) . Because the brain is organized into networks of interconnected areas , it is likely that OXT impacts functional coupling between the amygdala and other socio-emotional areas of the brain . Therefore , the aim of the current study was to examine the effects of OXT on amygdala functional connectivity during the processing of fearful faces in GSAD subjects and healthy controls ( HCs ) . In a r and omized , double-blind , placebo (PBO)-controlled , within-subjects design , 18 HCs and 17 GSAD subjects performed a functional magnetic resonance imaging task design ed to probe amygdala response to fearful faces following acute intranasal administration of PBO or OXT . Functional connectivity between the amygdala and the rest of the brain was compared between OXT and PBO sessions using generalized psychophysiological interaction analyses . Results indicated that within individuals with GSAD , but not HCs , OXT enhanced functional connectivity between the amygdala and the bilateral insula and middle cingulate/dorsal anterior cingulate gyrus during the processing of fearful faces . These findings suggest that OXT may have broad pro-social implication s such as enhancing the integration and modulation of social responses",
"Oxytocin is known to regulate prosocial behavior and social cognition in animals ( Ross & Young , 2009 ) , and recent studies suggest that oxytocin may have similar functions in humans . For example , oxytocin increases trust ( Kosfeld , Heinrichs , Zak , Fischbacher , & Fehr , 2005 ) and accuracy in mental-state attribution ( Domes , Heinrichs , Michel , Berger , & Herpertz , 2007 ; Guastella et al. , 2009 ) . These findings have generated excitement about oxytocin ’s potential to ameliorate social deficits in such disorders as social phobia and autism ( Bartz & Holl and er , 2006 ; Guastella et al. , 2009 ; Kosfeld et al. , 2005 ) . This excitement has not been confined to the scientific community : Dubbed the “ hormone of love , ” oxytocin is a common topic in the popular press . Is oxytocin truly a universal social panacea ? Although some studies have shown that oxytocin improves social cognition and empathy ( Domes et al. , 2007 ; Guastella et al. , 2009 ) , others have not ( Singer et al. , 2008 ) . Even studies demonstrating positive effects have ambiguities : Domes et al. ( 2007 ) found that oxytocin improved performance for difficult — but not easy — test items . These observations imply that rather than working universally , oxytocin may selectively facilitate social cognition given certain constraints . For example , by altering specific motivational or cognitive states , oxytocin might increase the salience of social cues , which in turn could improve social-cognitive performance for some individuals , but not others . The effects of oxytocin , then , should be most pronounced in individuals who — at baseline — are less socially proficient ; this would be consistent with broader interactionist views emphasizing that individual differences in competencies interact with situational variables to determine behavior ( Mischel & Shoda , 1995 ) . To test whether normal variance in social proficiency moderates the effects of oxytocin on social-cognitive performance , we used a r and omized , double-blind , placebo-controlled , crossover challenge in which participants received either intranasal oxytocin or a placebo and performed an empathicaccuracy task that naturalistically measures social-cognitive abilities ( Zaki , Bolger , & Ochsner , 2008 ) . We measured variance in baseline social competencies with the Autism Spectrum Quotient ( AQ ; Baron-Cohen , Wheelwright , Skinner , Martin , & Clubley , 2001 ) , a self-report instrument that predicts social-cognitive performance ( Baron-Cohen , Wheelwright , Hill , Raste , & Plumb , 2001 ) . We hypothesized that drug condition and AQ score would interact to predict performance on the empathic-accuracy task , with oxytocin having the most pronounced effects for less socially proficient individuals ( i.e. , those with higher AQ scores )",
"Background Chronic depression is characterized by a high degree of early life trauma , psychosocial impairment , and deficits in social cognition . Undisturbed recognition and processing of facial emotions are basic prerequisites for smooth social interactions . Intranasal application of the neuropeptide oxytocin has been reported to enhance emotion recognition in neuropsychiatric disorders and healthy individuals . We therefore investigated whether oxytocin modulates attention to emotional faces in patients with chronic depression . Methods In this double-blind , r and omized , controlled study , 43 patients received a single dose of oxytocin or placebo nasal spray and were tested while fulfilling a facial dot probe task . We assessed reaction times to neutral probes presented at the location of one of two faces depicting happy , angry , or neutral expressions as a prime . Results When comparing reaction times to the congruent ( prime and probe at the same location ) with incongruent presentation of facial emotions , neither the placebo nor oxytocin group showed an attentional preference for emotional facial expressions in terms of a threat bias . However , oxytocin treatment did reveal two specific effects : it generally reduced the allocation of attention towards angry facial expressions , and it increased sustained attention towards happy faces , specifically under conditions of heightened awareness , i.e. trials with longer primes . Conclusions We investigated a heterogeneous group of medicated male and female patients . We conclude that oxytocin does modulate basic factors of facial emotion processing in chronic depression . Our findings encourage further investigations assessing the therapeutic potential of oxytocin in chronic depression . Trial registration EUDRA-CT 2010 - 020956 - 69 . Date registered : 23 February 2011",
"Abstract Animal studies have shown the role of oxytocin in affiliation and attachment , and recent evidence suggests that oxytocin is also involved in human models of approach behaviour , possibly by modulating the processing of emotionally valenced stimuli . Although oxytocin administration has been reported to decrease neural responses to facial emotional information , the effects on a wider range of behavioural measures of emotional processing shown to be sensitive to antidepressant manipulation have not been examined . The aim of this study was to investigate whether intranasally administered oxytocin affects the processing of positive and negative affective information in healthy male volunteers across tasks measuring attention , perception and memory . Twenty-nine male healthy volunteers were r and omly allocated to receive a single dose of oxytocin nasal spray ( 24 UI ) or placebo . 50 min later , participants completed a battery of psychological tests measuring emotional processing . A single dose of intranasally administered oxytocin slowed reaction time to correctly identify fearful facial expressions and reduced the misclassification of positive emotions as negative ones . These effects occurred in the absence of significant differences in subjective ratings of mood and anxiety . These results suggest that oxytocin modulates emotion processing in healthy male volunteers . This action may contribute to the emerging role of the neuropeptide in promoting affiliative and approach behaviours by reducing the salience of potentially ambiguous and threatening social stimuli",
"BACKGROUND Recent years have seen the emergence of a new paradigm for treatment of anxiety disorders focusing on development of drugs that facilitate psychotherapies via targeted effects on neuroplasticity . One compound that has generated interest in this regard is oxytocin ( OT ) , a mammalian neuropeptide that modulates activity of the neurocircuit mediating fear extinction and memory processes . Recent research in healthy humans has suggested that intranasal OT administered prior to fear extinction training enhances fear extinction performance , supporting its potential to augment exposure-based psychotherapy . Here , we tested the hypothesis that OT treatment would facilitate response to exposure therapy in patients with specific phobia . METHODS We conducted a small proof-of-concept trial investigating the effect of pretreatment intranasal OT administration on a brief , single-session exposure treatment for arachnophobia ( fear of spiders ) . The study was r and omized , double-blind , and placebo controlled ( n = 13 placebo , 11 females ; n = 10 OT , 8 females ) with 1-week and 1-month follow-up assessment s. Dependent measures attended to arachnophobia symptoms ( self-report ) , phobic behavior ( behavioral avoidance of spider task ) , and treatment credibility/therapeutic alliance . RESULTS Administration of OT prior to exposure therapy tended to impede treatment response as measured by self-report of symptoms at both follow-up periods . OT treatment did not significantly affect behavioral measures of fear . Immediately after OT administration but before therapy , the OT group trended toward less confidence in the treatment . The OT group also trended toward lower ratings of therapeutic alliance than placebo . CONCLUSIONS These results suggest that OT administration effects on extinction may vary depending on conditions and population",
"Generalized social anxiety disorder ( GSAD ) is characterized by aberrant patterns of amygdala-frontal connectivity to social signals of threat and at rest . The neuropeptide oxytocin ( OXT ) modulates anxiety , stress , and social behaviors . Recent functional neuroimaging studies suggest that these effects are mediated through OXT ’s effects on amygdala reactivity and /or amygdala-frontal connectivity . The aim of the current study was to examine OXT ’s effects on amygdala-frontal resting-state functional connectivity ( rsFC ) in GSAD patients and healthy controls ( HCs ) . In a r and omized , double-blind , cross-over design , 18 GSAD and 18 HC participants received intranasal OXT ( 24 IU or 40.32 μg ) or placebo ( PBO ) before resting-state functional magnetic resonance imaging . In individuals with GSAD , OXT enhanced rsFC of the left and right amygdala with rostral anterior cingulate cortex (ACC)/medial prefrontal cortex ( mPFC ) , and in doing so , reversed ( ie , ‘ normalized ’ ) the reduced amygdala-frontal connectivity observed relative to HCs evident on PBO . Higher social anxiety severity in GSAD subjects correlated with lower amygdala-ACC/mPFC connectivity on PBO and higher social anxiety also correlated with greater enhancement in amygdala-frontal connectivity induced by OXT . These findings show that OXT modulates a neural circuit known for social threat processing and emotion regulation , suggesting a neural mechanism by which OXT may have a role in the pathophysiology and treatment of social anxiety disorder",
"Ostracism is such a widely used and powerful tactic that the authors tested whether people would be affected by it even under remote and artificial circumstances . In Study 1 , 1,486 participants from 62 countries accessed the authors ' on-line experiment on the Internet . They were asked to use mental visualization while playing a virtual tossing game with two others ( who were actually computer generated and controlled ) . Despite the minimal nature of their experience , the more participants were ostracized , the more they reported feeling bad , having less control , and losing a sense of belonging . In Study 2 , ostracized participants were more likely to conform on a subsequent task . The results are discussed in terms of supporting K. D. Williams 's ( 1997 ) need threat theory of ostracism",
"The Fear of Spiders Question naire ( FSQ ) , an 18-item self-report question naire assessing spider phobia , was developed in an attempt to complement the information provided by the Spider Phobia Question naire ( SPQ ) . Data obtained from 338 undergraduates revealed that the FSQ was able to discriminate phobics from nonphobics , and indicated decrements in phobic responding from pretest to posttest following cognitive therapy . Test-retest data , obtained from non-treatment control groups , indicated that scores on the FSQ are stable over a one month period . The FSQ also demonstrated adequate convergent validity due to its significant correlations with the SPQ and a behavioral avoidance test . Finally , a factor analysis revealed two factors accounting for 55 % of the variance . It is argued that , compared to the SPQ , items on the FSQ are more explicit regarding the time period to be assessed , and may be more sensitive to differences between phobics and nonphobics and decrements in phobic responding following treatment",
"BACKGROUND A diagnostic hallmark of autism spectrum disorders is a qualitative impairment in social communication and interaction . Deficits in the ability to recognize the emotions of others are believed to contribute to this . There is currently no effective treatment for these problems . METHODS In a double-blind , r and omized , placebo-controlled , crossover design , we administered oxytocin nasal spray ( 18 or 24 IU ) or a placebo to 16 male youth aged 12 to 19 who were diagnosed with Autistic or Asperger 's Disorder . Participants then completed the Reading the Mind in the Eyes Task , a widely used and reliable test of emotion recognition . RESULTS In comparison with placebo , oxytocin administration improved performance on the Reading the Mind in the Eyes Task . This effect was also shown when analysis was restricted to the younger participants aged 12 to 15 who received the lower dose . CONCLUSIONS This study provides the first evidence that oxytocin nasal spray improves emotion recognition in young people diagnosed with autism spectrum disorders . Findings suggest the potential of earlier intervention and further evaluation of oxytocin nasal spray as a treatment to improve social communication and interaction in young people with autism spectrum disorders",
"In humans , oxytocin nasal administration reduces social-threat perception and improves processes involved in communication and the encoding of positive social cues . The aim of this study was to determine whether oxytocin given as an adjunct to exposure therapy improves treatment for social anxiety disorder ( SAD ) as indicated by a comprehensive set of symptom outcome measures . In a r and omized , double-blind , placebo-controlled trial , we administered 24 IU of oxytocin or a placebo in combination with exposure therapy to twenty-five participants who met primary diagnosis for SAD . Participants administered with oxytocin showed improved positive evaluations of appearance and speech performance as exposure treatment sessions progressed . These effects did not generalize to improve overall treatment outcome from exposure therapy . Participants who received oxytocin or placebo reported similar levels of symptom reduction following treatment across symptom severity , dysfunctional cognition , and life-impairment measures . This study shows that the administration of oxytocin improves mental representations of self , following exposure therapy . These effects may be either short term or situation specific . Future research is now needed to determine whether oxytocin can enhance treatment outcomes for SAD when used with greater frequency , with a wider variety of social learning experiences , and in conjunction with interventions that more specifically target change in broader dysfunctional cognitions",
"BACKGROUND Postnatal depression is common and negatively affects the mother-baby relationship ; oxytocin has been found to have positive effects on parenting behavior . We hypothesize that intranasal administration of oxytocin to mothers with depression will influence their parenting related expressed emotion , creating a better basis for sensitive parenting . METHODS Twenty-five postnatally depressed mothers with infants less than one year participated in a r and omized , double-blind , placebo controlled within-subject clinical study in 2011 . Mothers attended an out-patient perinatal psychiatry setting in NSW , Australia . They received 24 IU of oxytocin alternating with placebo approximately one week apart in r and om order , prior to completing outcome measures . The outcome measures were the Five Minute Speech Sample , the Self- Assessment Manikin and the Controlled Oral Word Association Test . RESULTS In the oxytocin condition mothers were sadder ( p=.01 ) , and they more often initially described their babies as difficult ( p=.038 ) , but they reported that the quality of their relationship with their infant was more positive ( p=.036 ) . LIMITATIONS Despite an adequate sample size to answer our central hypothesis , a larger sample may have eluci date d a moderating effect of childhood trauma . CONCLUSION Oxytocin did not make depressed mothers happier but their perception of the relationship with their baby improved . Treatment with intranasal oxytocin might show some unwanted side-effects in depressed individuals"
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41164d2c-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES The global burden of low back pain is the highest ranked condition contributing to years of living with disability . Exercise is moderately effective , and adherence to exercise may improve if participants are engaged . Identification of elements that enhance engagement would enable clinicians to prescribe appropriate interventions . The review objective was to identify and synthesize qualitative empirical studies that have explored beliefs about exercise therapy of people with nonspecific chronic low back pain . METHODS Two independent review ers conducted a structured review and meta synthesis informed by Cochrane and Campbell Collaboration guidelines and the PRISMA statement . Fifteen papers were included for data extraction , method quality assessment , and thematic analysis . RESULTS Four key themes emerged : ( 1 ) perceptions and classification of exercise ; ( 2 ) role and impact of the health professional ; ( 3 ) exercise and activity enablers/facilitators ; ( 4 ) exercise and activity barriers . Participants believed that there were distinctions between general activity , real/fitness exercise , and medical exercise . Levels of acquired skills and capability and participant experience with exercise culture require consideration in program design . People participating in exercise classes and group work may be more comfortable when matched for abilities and experience . When an intervention interferes with everyday life and appears to be ineffective or too difficult to implement , people make a reasoned decision to discontinue . DISCUSSION People are likely to prefer and participate in exercise or training programs and activities that are design ed with consideration of their preferences , circumstances , fitness levels , and exercise experiences
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"BACKGROUND Recent guidelines for those with acute low back pain have advocated early resumption of normal activity and increased physical activity . Little is known about the relationship between low back pain and physical activity , and on the impact of that relationship on the promotion of increased levels of physical activity within a general practice population . OBJECTIVES We aim ed to explore associations between factors that influence changes in physical activity and the way individuals perceive and behave with their low back pain , and the impact of those perceptions and behaviour on physical activity . METHODS Twenty-seven informants were chosen using a purposive sample from a larger group of individuals who , because of their low back trouble , had been referred by their GPs to a community-based , single-blind , r and omized controlled trial ( RCT ) at the University of York , which is evaluating the effectiveness and cost-effectiveness of a progressive exercise programme . Fifty-four interviews were conducted with this subgroup of the RCT ; four informants were interviewed once , 19 twice and four of them three times . Interviews were transcribed and analysed using manual and computer-aided approaches . RESULTS Physical activity was perceived as ( i ) activities of daily living , ( ii ) activities causing breathlessness that they went out of the way to do and ( iii ) more competitive-type activity . The avoidance of physical activity and fear of pain returning were the two main factors directly associated with informants ' backs and changes in physical activity . These two factors hindered increases in physical activity , even though the majority of informants believed strongly that being physically active helped ease their low back pain . CONCLUSIONS When advocating that individuals with acute low back pain return to or increase physical activity , it is important that clinicians identify avoidance of physical activity and /or fear of pain at the earliest stage in order to tailor advice and reassurance appropriately . If avoidance of activity and fear of pain is identified and clinicians want to encourage patients to take up and sustain increased physical activity , they should explore issues of fear of pain , and avoidance of and confidence to do physical activities , in addition to other factors influencing physical activity",
"OBJECTIVES To investigate the course of low back pain ( LBP ) in a general population over 5 years . DESIGN Prospect i ve population -based survey by postal question naires in 1991 , 1992 , and 1996 . SETTING The municipal of Ebeltoft , Denmark . SUBJECTS Two thous and people aged 30 to 50 years , representative of the Danish population . Main outcome measure Number of days with low back pain during the past year . RESULTS One thous and three hundred seventy were recruited of whom 813 ( 59 % ) were followed to 5 years . The responders could be divided into 3 groups with regard to LBP : no pain , short-term pain , and long-lasting/recurring pain . More than one third of people who experienced LBP in the previous year did so for > 30 days . Forty percent of people with LBP > 30 days at baseline remained in that group 1 and 5 years later , and 9 % with LBP > 30 days in year 0 were pain free in year 5 . People with LBP in year 0 were 4 times more likely to have LBP in year 1 , and 2 times more likely to be affected in year 5 . CONCLUSIONS Low back pain should not be considered transient and therefore neglected , since the condition rarely seems to be self-limiting but merely presents with periodic attacks and temporary remissions . On the other h and , chronicity as defined solely by the duration of symptoms should not be considered chronic",
"Background Non-specific chronic low back pain ( NSCLBP ) has become a significant problem due to high healthcare utilization , rising costs of care and perceived limitations of effectiveness of many current treatments . Systematic review s have repeatedly concluded that , on average across participants , exercise for NSCLBP appears effective in decreasing pain and improving function . Not all people with NSCLBP benefit from exercise programs and it would assist care-providers and care-seekers if factors that impact on program effectiveness and success were identified . Methods and design The study will be a r and omised controlled trial comparing an exercise rehabilitation program informed by a participant preferences question naire compared to a program without this guideline for patients with chronic low back pain . A sample of 150 patients will be recruited in Melbourne , Australia through community-based healthcare clinics that provide supervised exercise rehabilitation programs for people with non-specific chronic low back pain . Clinicians will be r and omly assigned to exercise preferences question naire or no question naire and participants will be allocated in a concealed manner . A qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design . Two qualitative focus group studies will also be conducted for participants in the intervention and the control groups to obtain feedback about participants ' experiences of the two types of exercise programs . The primary outcomes will be functional ability , pain , fear avoidance , exercise adherence . Discussion This trial will evaluate the effectiveness of individualised exercise prescription compared to usual exercise prescription for NSCLP and , using feedback following the trial , refine the exercise preferences question naire",
"OBJECTIVES To explore the views of participants in a r and omized controlled trial of physical treatments for low back pain about the treatment packages they received in the trial . METHODS Within a r and omized controlled trial that found small to moderate benefits from adding a manipulation package or an exercise programme to general practice care , we elicited participants ' views on the treatment using an open question in participant question naires . These data were analysed using an adapted framework approach . RESULTS We received a total of 1259 comments from 1334 participants . Participants r and omized to usual general practice care reported dissatisfaction with receiving only ' usual care ' , which consisted of providing analgesic medication without providing an explanation for their pain . Those r and omized to a manipulation package felt the intervention was appropriate to their needs and commonly reported striking benefits . Participants assigned to the exercise programme developed a sense of self-reliance in managing back pain , although some failed to be sufficiently motivated to continue their exercise regimen outside the classes . CONCLUSIONS This qualitative analysis has found much clearer differences between the groups than the main quantitative analysis . This suggests that some of the added value from being allocated to additional physical treatment for low back pain is not being captured by existing methods of measurement . Improved methods of assessment that consider a wider range of domains may be needed when interpreting the added value of such treatments to individual patients",
"Study Design . Population -based , prospect i ve cohort . Objectives . To estimate incidence and course of severity- grade d low back pain ( LBP ) episodes in adults . Summary of Background Data . Past studies report variable estimates that do not differentiate LBP severity . Methods . An incidence cohort of 318 subjects free of LBP and a course cohort of 792 prevalent cases was formed from respondents to a mailed survey . Incident , recurrent , persistent , aggravated , improved , and resolved episodes were defined by the Chronic Pain Question naire . The follow-up at 6 and 12 months was 74 % and 62 % , respectfully . Annual estimates were age and sex st and ardized . Results . The cumulative incidence was 18.6 % ( 95 % confidence interval [ CI ] , 14.2%–23.0 % ) . Most LBP episodes were mild . Only 1.0 % ( 95 % CI , 0.0%–2.2 % ) developed intense and 0.4 % ( 95 % CI , 0.0%–1.0 % ) developed disabling LBP . Resolution occurred in 26.8 % ( 95 % CI , 23.7%–30.0 % ) , and 40.2 % ( 95 % CI , 36.7%–43.8 % ) of episodes persisted . The severity of LBP increased for 14.2 % ( 95 % CI , 11.5%–16.8 % ) and improved for 36.1 % ( 95 % CI , 29.7%–42.2 % ) . Of those that recovered , 28.7 % ( 95 % CI , 21.2%–36.2%)had a recurrence within 6months , and 82.4 % of it was mild LBP . Younger subjects were less likely to have persistent LBP ( incidence rate ratio , 0.88 ; 95 % CI , 0.80–0.97 ) and more likely to have resolution ( incidence rate ratio , 1.26 ; 95 % CI , 1.02–1.56 ) . Conclusions . Most new and recurrent LBP episodes are mild . Less than one third of cases resolve annually , and more than 20 % recur within 6 months . LBP episodes are more recurrent and persistent in older adults",
"Spinal stabilisation exercises are commonly used in the management of low back pain ( LBP ) . There is limited evidence relating to patients ' experiences of their involvement in such programmes . The aim of this study was to explore the experiences of a sample of individuals with chronic LBP who participated in a r and omised controlled trial ( RCT ) investigating the most efficacious dosage and frequency of spinal stabilisation exercises . The qualitative study involved nine participants who took part in focus group discussion s. The data were analysed using thematic content analysis and provided insights into the experiences of the participants . Four themes emerged : Physical dimensions of the LBP experience , emotional and psychological dimensions of the LBP experience and perceived effects of the programme and lastly , the impact of the treatment programme on participants ' knowledge , underst and ing and adherence . In conclusion participants ' experiences were not limited to the positive effects of stabilisation exercises on pain , functional disability and quality of life , but also reflected increases in confidence , the formulation of self help strategies and the ability to exert better control over their LBP . The findings highlight the importance of well planned associated educational support packages in the treatment of LBP paving the way for future qualitative research",
"& NA ; Using latent class analysis ( LCA ) , a previous study on patients attending primary care identified four courses of low back pain ( LBP ) over the subsequent 6 months . To date , no studies have used longitudinal pain recordings to examine the “ natural ” course of recurrent and chronic LBP in a population ‐based sample of individuals . This study examines the course of LBP in the general population and elaborates on the stability and criterion‐related validity of the clusters derived . A r and om sample of 400 individuals reporting LBP in a population ‐based study was asked to complete a comprehensive question naire at the start and end of the year 's survey , and 52 weekly pain diaries in between . The latter were analyzed using LCA . 305 individuals returned more than 50 % of the diaries . Four clusters were identified ( severe persistent , moderate persistent , mild persistent , and fluctuating ) . The clusters differed significantly with regards to pain and disability . Assessment of cluster stability showed that a considerable proportion of patients in the “ fluctuating ” group changed their classification over time . Three of the four clusters describing the typical course of pain matched the clusters described previously for patients in primary care . Due to the population ‐based design , this study achieves , for the first time , a close insight into the “ natural ” course of chronic and recurrent low back pain , including individuals that did not necessarily visit the general practitioner . The findings will help to underst and better the nature of this pain in the general population"
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41164d68-06ff-11f0-808a-c43d1ab1c353
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The purpose of this systematic review was to determine whether smear layer removal reduces leakage of obturated human teeth in vitro . PubMed was search ed for articles published between 1975 and 2005 , and results were categorized based on the method of leakage test . Among 26 eligible papers with 65 comparisons , 53.8 % of the comparisons reported no significant difference , 41.5 % reported a difference in favor of removing the smear layer , and 4.7 % reported a difference in favor of keeping it ; differences were significant ( p dye leakage test for evaluation . The combined effect in this group showed smear layer removal decreases dye leakage ( z-score=0.37 , z=2.31 , p=0.021 ) . According to meta-regression , obturation type , test site and duration , sealer and dye , and publication year had no effect on the results . Under the conditions of these in vitro leakage studies , it is concluded that smear layer removal improves the fluid-tight seal of the root canal system whereas other factors such as the obturation technique or the sealer , did not produce significant effects
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"PURPOSE To evaluate whether the hybrid layer significantly contributes to the seal of adhesive Class V restorations placed in vivo and to the bond strength obtained in vitro . MATERIAL S AND METHODS 20 periodontally severely compromised anterior teeth were selected for the leakage study . In each tooth , one round 3 mm wide V-shaped cavity with a maximum depth of 2 mm was prepared on the labial surface crossing the cementum-enamel junction . The sample teeth were r and omly divided into two groups of ten sample s each : in Group 1 , Scotchbond Multi- Purpose Plus was applied in combination with Z-100 following the manufacturer 's instructions . In Group 2 the bonding procedure was the same as in Group 1 , except that after the phosphoric acid treatment , the cavities were treated with 5 % NaOCl for 2 min . Following a period of clinical service of 60 - 90 days , the teeth were extracted and processed for the leakage test . RESULTS At the enamel site , 30 % of the sample s of Group 1 and 70 % of the sample s of Group 2 showed dye penetration . At the dentin site , 50 % of the sample s of Group 1 showed leakage , while all the sample s of Group 2 were severely infiltrated . Statistically significant differences between the groups both for the enamel sites ( P dentin-cementum sites ( P Bond strength tests were performed on 2 mm thick dentin slides of tapered Class I cavities ( n = 10 in each group ) . The mean bond strength value obtained from cavities treated without NaOCl was 15.23 ( + /-1.40 ) MPa and with NaOCl treatment 20.52 ( + /-1.70 ) MPa . Statistical analysis showed significant differences ( P hybrid layer was detected on the NaOCl-treated sample s by scanning electron microscopy",
"It has been shown previously that the smear layer created during instrumentation of the root canal promotes apical microleakage . The purpose of the present study was to investigate the effect of removal of the smear layer on apical microleakage , using the fluid filtration method . Thirty-six single-rooted human premolar teeth were used . Six of the teeth were selected r and omly as controls , and the remaining 30 teeth were r and omly divided into two groups of 15 teeth each . For the first group ( group 1 ) teeth were irrigated with NaOCl only ( smear layer not removed ) . In the second group ( group 2 ) the teeth were irrigated with 15 % EDTA , followed by NaOCl to remove the smear layer . Both groups were filled with thermoplasticized gutta-percha ( Obtura II ) using glass-ionomer cement as sealer . All teeth were stored at 37 degrees C and 100 % humidity for 2 days . Apical microleakage of the filled root canal was measured by the fluid filtration technique . Hydraulic conductance was measured by the movement of an air bubble in a capillary tube after a pressure of 200 mm Hg was applied to the system . The mean microleakage rate of group 1 and group 2 were 13.0 ( SD + /- 5.1 ) and 16.9 ( SD + /- 15.3 ) nl/s , respectively . Removal of the smear layer caused significantly more apical microleakage ( p < 0.05 , Student 's t test ) than when the smear layer was left intact",
"AIM The purpose of this study was to evaluate the sealing ability of two contemporary endodontic obturation and restorative techniques and material s. METHODOLOGY Seventy-nine extracted human single-rooted teeth were distributed r and omly in two experimental groups of 36 and 37 specimens ( groups 1 and 2 , respectively ) , one group of three positive controls and one of three negative controls . The teeth were radiographed preoperatively , accessed , and instrumented . After smear layer removal , the teeth in group 1 were obturated using the System B and Obtura and were restored coronally with Core Paste using Tenure as a bonding agent . The teeth in group 2 were obturated using the Microseal technique and were restored coronally with amalgam using Panavia 21 as a bonding agent . All teeth in groups 1 and 2 were coated with three layers of nail varnish on all of their surfaces apart from the apical 4.0 mm and the coronal area above the cemento-enamel junction . The positive control teeth were obturated , restored coronally and completely coated with varnish , whereas the negative control teeth were not obturated , restored coronally , nor coated with varnish . The teeth were radiographed postoperatively and retained in saline solution for 10 days . For the next 10 days they were submerged in India ink . Subsequently all teeth were demineralized , dehydrated and rendered transparent . Dye penetration was measured using a stereomicroscope . RESULTS All material s and techniques provided minimal to zero dye penetration , apart from one specimen in the Core Paste group that showed 4.0 mm of dye penetration . The Wilcoxon rank sum test and t-test showed no statistically significant differences and all material s and techniques tested presented with a high degree of acceptability . CONCLUSIONS It was concluded that these contemporary techniques and material s provide equally good results , but long-term studies are needed for outright inferences to be drawn relative to their clinical performance",
"In light of the in vitro S. sanguis bacterial migration observed deep into root dentin , an in vitro system was developed to determine the viability of these bacteria at the end of migration . Also of interest is whether the smear layer formed during root canal instrumentation modifies migration into root dentinal tubules . Forty-eight bovine root dentin sample s were r and omly split into two groups . Group 1 dentin blocks were not instrumented and were treated with 17 % ethylenediamine tetraacetic acid and 2.5 % sodium hypochlorite for 4 minutes in an ultrasonic bath Group 2 root canals were conventionally instrumented . The smear layer formed was not removed . Dentin blocks were inoculated with a S. sanguis National Collection of Type Culture 7863 suspension . Each sample was immersed in a receiver broth , incubated at 37 degrees C , and checked daily for 14 days . After a 14-day incubation period , group 1 S. sanguis cells remained viable and capable of inoculating the receiver medium after migration through the tubules . Group 2 cells , where the smear layer was intact , revealed an absence of S. sanguis migration in 88 % of the cases . It is therefore plausible that smear layer on canal walls limits S. sanguis penetration of dentinal tubules in vitro",
"The presence of the smear layer prevents direct contact between dentine and a dentine adhesive . The use of agents to remove the smear layer theoretically should improve the bonding of composite resins to dentine . This study examined the effect of smear layer removal on the effectiveness of a dentine bonding agent in reducing marginal contraction gaps . The agent used for smear layer removal in this study was ethylenediamine tetra-acetic acid ( EDTA ) . Eighty cavities measuring 2 mm in diameter and 1.5 mm in depth were prepared in dentine and r and omly assigned to two equal groups . The control group was restored with Prisma Universal Bond 2 Adhesive and Prisma Fil Resin . The experimental group was similarly restored after pretreatment of dentine with 0.5 % EDTA for 60 s. All specimens were thermocycled and the marginal contraction gaps were assessed using a Nikon Measures cope . The mean contraction gap was expressed as a percentage of the cavity diameter . Results showed that the experimental group registered smaller contraction gaps ( mean : 0.021 % ) than the control group ( mean : 0.027 % ) . No penetration of material into dentine was observed . Pretreatment with EDTA did not significantly improve the effectiveness of the dentine bonding agent used in terms of reduction of marginal contraction gaps",
"Endosonic files are prone to constraint ; this reduces their efficiency , particularly in the apical third and in curved root canals . Precurving the file may reduce constraint , thereby improving the file 's ability to debride . This investigation was undertaken to compare both straight and precurved endosonic files as to debris and smear layer removal . Thirty-six curved root canals were r and omly allocated into six groups . Each group was prepared using a step-down technique , then instrumented with either a straight or precurved endosonic file of size 15 , 20 , or 25 . The tooth roots were split and examined under the scanning electron microscope . Blind examinations were made for debris and smear layer removal and evaluation scores were analyzed using a log linear approach . The root canals instrumented with the precurved files had a significantly lower debris score than those prepared with straight files . Precurving did not affect smear layer removal . In conclusion , precurving of files decreased the amount of debris but did not affect smear layer removal",
"AIM To compare in vitro the sealing properties of five different dentine adhesive material s ( Prime&Bond NT ( PBNT ) ; Prompt L-Pop ( PLP ) ; Clearfil SE Bond ( CSEB ) ; Scotchbond Multi Purpose Plus ( SMPP ) ; EBS-Multi ( EBSM ) ) inside the pulp chamber . METHODOLOGY Seventy-five recently extracted human molar teeth were used . The roof of the pulp chambers and roots were removed under water cooling . Pulp tissue was removed , and the canal orifices were sealed . The pulp chambers were then treated with 5 % sodium hypochlorite ( NaOCl ) for 1 min . The teeth were r and omly divided into five groups of 15 teeth each . Adhesive systems were applied to the pulp chamber walls according to the manufacturers ' instructions . The sample s were connected to Plexiglass plates , and a fluid filtration method was used for quantitative evaluation of leakage . Measurements of fluid movement were made at 2-min intervals for 8 min . The quality of seal of each specimen was measured immediately , after 24 h , 1 week and 1 month . The data were statistically analysed by repeated- measurements multivariate anova , Friedman test , Wilcoxon signed rank test , Kruskal-Wallis of one-way anova and Mann-Whitney U-tests . The pulp chamber wall with and without NaOCl and resin-dentine interfaces of specimens were observed under a scanning electron microscope ( SEM ) . RESULTS The leakage values of the material s were significantly different at different measurement periods . In all groups , leakage values decreased with time ( P PBNT and PLP had the least leakage during immediate measurements ( P leakage of all adhesive systems was not significantly different ( P irregular dentine surface without smear layer was present in the nontreated group . However , NaOCl application removed the collagen fibrils leaving the dentine surface smooth . At resin-dentine interfaces of specimens , no hybridization zone was observed . CONCLUSIONS None of the material s had created a perfect seal to the pulp chamber walls . PBNT and PLP had better sealing over the short term , but over the long term , there were no differences between the material",
"AIM To compare coronal bacterial and India ink leakage in three different obturation techniques with the smear layer having been removed . METHODOLOGY Seventy extracted single-rooted teeth were instrumented to an apical preparation size 7 Profile Series 29 ( Tulsa Dental Products , Tulsa , OK , USA ) . The smear layer was removed and 20 teeth were r and omly obturated with lateral compaction , 20 teeth with vertical compaction , and 20 teeth with Thermafil ( Tulsa Dental Products , Tulsa OK , USA ) . Ten teeth were used for positive ( five teeth ) and negative ( five teeth ) controls . Teeth were stored for 90 days in 100 % humidity , then subjected coronally to Proteus vulgaris for 21 days to assess bacterial leakage . Following bacterial challenge , India ink was placed coronally for a further 21 days , then scored according to depth of dye leakage . RESULTS Vertical compaction leaked significantly less than lateral compaction during bacterial challenge . However , when dye was used there were no significant differences . CONCLUSIONS Bacterial leakage and dye leakage demonstrated considerable variability . The use of a dye following bacterial testing may highlight the failure of experimental devices and vertical root fractures , thus avoiding false positive results found with bacterial testing alone",
"This study compared the sealing ability of Ketac Endo with and without smear layer and Tubli Seal . Thirty upper central incisors and canines with straight canals were instrumented and r and omly divided into three equal groups of 10 . All teeth were obturated with laterally condensed gutta-percha . An additional group of five teeth with unobturated++ root canals served as positive controls . The sealers were Tubli Seal ( group A ) , Ketac Endo ( group B ) , and Ketac Endo preceded by the removal of the smear layer ( group C ) . The teeth were immersed in India ink for 7 days , centrifuged for 5 min at 3000 rpm , cleared , and then examined under a light microscope at X 50 magnification . The mean value of ink penetration for group A was 0.14 mm , for group B 0.24 mm , and for group C 0.48 mm . No statistically significant differences were observed among groups ( p > 0.05 )",
"The effect on coronal leakage of the use of either a single gutta-percha cone or cold lateral condensation of gutta-percha , with a glass ionomer sealer cement was studied . In addition , the effect of the removal of the smear layer was also determined . Eighty-eight single-rooted teeth were prepared chemomechanically using h and files , with the balanced force technique . Lubrication was provided by either Hibiscrub ( maintaining the smear layer ) or an EDTA-containing paste ( to remove the smear layer ) . Copious irrigation was carried out with 2.2 % sodium hypochlorite . The teeth were allocated r and omly to four groups of 20 teeth each , the remaining eight teeth served as controls . Two groups of teeth , one with and one without smear layer , were obturated with either a single gutta-percha cone or cold laterally condensed gutta-percha , with Ketac Endo as the sealer . The teeth were stored for 6 weeks , thermocycled , and the extent of coronal leakage determined for each group after immersion in India ink for 90 h. The teeth were demineralized , dehydrated and immersed in methyl salicylate , which rendered them transparent . Linear measurement of maximum dye penetration was recorded . The mean depth ( + SD ) of leakage for the groups in which the smear layer was left intact was 1.68 mm ( + 0.38 ) for the single cone ( A1 ) and 2.29 mm ( + 1.58 ) for lateral condensation ( B1 ) . When the smear layer was removed the mean depth of leakage for the single cone group ( A2 ) was 2.04 mm ( + 0.73 ) and 2.37 mm ( + 1.70 ) for the laterally condensed group ( B2 ) . There was no significant difference in coronal leakage between the groups ( P > 0.05 )",
"The aim of this in vitro study was to assess the sealability of a recently introduced thermoplasticized gutta-percha technique ( Trifecta , Hygenic Corp. , OH , USA ) in the presence or absence of a smear layer . A total of 100 teeth with single straight root canals were included in the study . The teeth were decoronated and the canals prepared with a modified double-flared technique under constant irrigation with 2.5 % sodium hypochlorite solution . The apical matrix was prepared to size 40 and apical patency subsequently confirmed with a size 10 file . Four teeth were discarded for technical reasons and the remaining 96 allocated r and omly into two groups of 44 teeth and a group of eight teeth which acted as controls . Canals in group 1 were obturated r and omly with either cold lateral condensation of gutta-percha or with the Trifecta technique . Canals in Group 2 were rinsed with 17 % REDTA to remove the smear layer and then obturated with lateral condensation or the Trifecta technique . All teeth were suspended in India ink for 9 days , demineralized , and rendered transparent prior to the assessment of apical linear dye penetration . Apical extrusion of sealer and gutta-percha occurred commonly but there was no significant difference between the four obturation groups . However , overall , there was significantly more extrusion of sealer with the Trifecta technique compared with lateral condensation ( P < 0.05 ) . The majority of canals ( 79 out of 88 ) had no evidence of apical leakage and there was no significant difference between the groups . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The aim of this in vitro study was to determine the effect of removal of the smear layer on canal obturation as measured by penetration of bacteria from a coronal direction . One hundred and twenty extracted human teeth with straight , single root canals were decoronated . The canals were prepared using the modified double-flared technique with balanced force under copious irrigation . The apical matrix was prepared to size 40 and apical patency subsequently confirmed with a size 15 file . The teeth were divided r and omly into experimental groups ( 80 teeth ) and control groups ( 40 teeth ) . The root canals of 40 experimental and 20 control teeth were rinsed with 40 % citric acid and 2 % NaOCl to remove the smear layer before obturation . In experimental groups , 20 teeth with smear layer intact and 20 teeth with smear layer removed were obturated with lateral condensation of cold gutta-percha and Apexit sealer . A further 20 teeth with smear layer intact and 20 teeth with smear layer removed were obturated with the Trifecta technique with the same sealer . In control groups , 10 teeth with smear layer intact and 10 teeth with smear layer removed were obturated with lateral condensation of cold gutta-percha and Apexit sealer . These teeth were completely sealed both coronally and apically to serve as negative controls . The remaining 20 teeth with either smear layer intact or smear layer removed were not obturated and served as the positive controls . The root surface of each tooth was sealed with nail varnish . The cut end of a polypropylene tube was sealed around the coronal part of each root canal so that bacteria placed therein could move only through the obturated canal space . Each root was placed in a glass bottle containing sterile Todd-Hewitt Broth ( THB ) and aliquots of 0.5 ml of THB were injected into the polypropylene tube . The model system was centrifuged at 168 g. An innoculum of Streptococcus sanguis in THB was placed in each coronal chamber at 5-day intervals and daily observations were made for bacterial growth in the apical reservoir for 90 days . All positive control teeth showed bacterial penetration within 24 h , while the negative control teeth remained uncontaminated throughout the test period . Leakage through the experimental teeth was variable ranging from 7 to 86 days . There was no statistical significant difference ( P > 0.05 ) in leakage between the obturated canal when the smear layer was either removed or intact",
"This study compared the microleakage of light-cured and auto-set glass ionomer liners used in Class V composite laminated glass ionomer restorations by determining the amount of microleakage at the gingival cementum/dentin margins . St and ardized nonundercut V-shaped Class V cavities with gingival margins below the cementoenamel junction were prepared on the mesial and distal surfaces of 40 molars , establishing a total of 80 cavities , which were r and omly divided into four groups . Each was lined with glass ionomers : group 1 , Ketac-Bond ( ESPE-Premier ) , which served as the control ; group 2 , XR-Ionomer ( Kerr ) ; group 3 , XR-Ionomer with polyacrylic acid ( PAA ) pretreatment ( Kerr ) ; and group 4 , Vitrabond ( 3 M ) . Specimens were thermocycled for 300 cycles in 0.5 % aqueous solution of basic fuchsin between 4 and 55 C with a 1-minute dwell time , and individually embedded in an epoxy resin . Statistical analysis indicated no differences among groups using the light-cured glass ionomer ( groups 2 to 4 ) , and they showed significantly less leakage than the control ( group 1 ) at P less than 0.00001 ) . Removal of the smear layer using 10 % polyacrylic acid solution did not influence microleakage in restorations with light-cured glass ionomer liners ",
"The purpose of this study was to evaluate marginal leakage of composite resin restoration from cavities prepared by Er : YAG laser . The observation of the dentin surface after the application of laser irradiation was performed by LSM , the cutting surface showed a rough surface similar to scales , and exposed dentinal tubules were observed without striations or a smeared layer formation that were observed when using a rotary cutting device . Leakage tests revealed no significant differences in the marginal seal for both enamel and dentin between cavities prepared by Er : YAG laser irradiation and when using an air-turbine . In this study , the usefulness of cavity preparation by Er : YAG laser irradiation in composite resin restoration was suggested",
"AIM The aim of this study was to evaluate the adaptation and short- and long-term sealability of two different thermoplastic techniques -- a core carrier technique , Thermafil ; and a warm vertical continuous wave of compaction technique , System B. METHODOLOGY Fifty-one mesial roots of m and ibular molars with separate canals , patent canal orifices and curvature greater than 15 degrees were cleaned and shaped with Orifice Shapers and ProFile.04/.06 taper Ni-Ti rotary files using 5.25 % NaOCl and 17 % REDTA to a size 30.04 taper Profile at the apex to create a continuous tapered preparation . Canals were r and omly obturated with Sealapex root canal sealer and either alpha-phase gutta-percha on a plastic Thermafil carrier , or nonst and ardized beta-phase gutta-percha using the System B heat source . Proximal radiographs of roots were evaluated by three examiners based on established criteria for overall material adaptation , apical adaptation and filling material extrusion . Teeth were r and omly separated into three groups of 17 each and placed in black India ink for 10 days , 24 h , or after 67 days storage in Hank 's Balanced Salt Solution . All roots were demineralized and rendered transparent . Three examiners evaluated the apical leakage by the linear measurement of dye penetration under the stereo-microscope . The movement of filling material into canal irregularities was also evaluated . RESULTS Both obturation techniques were not significantly different in the overall canal obturation and in the apical third adaptation ( P > 0.05 ) . Significantly more filling material extrusion beyond the apex was noted with the Thermafil technique ( P 0.05 ) . The 67-day Thermafil group showed significantly more leakage than the 10-day and 24 h Thermafil groups . There was a significant difference in the degree of leakage between the 67-day Thermafil group and the 67-day System B group ( P 0.05 ) . Both obturation techniques produced substantial filling material movement into canal irregularities . CONCLUSIONS It was concluded that Thermafil demonstrated more filling material extrusion beyond the apex and significantly more long-term apical leakage",
"This study was design ed to compare different techniques for coronal dye leakage testing . One hundred and fifty extracted human anterior teeth were fully instrumented and r and omly divided into two experimental groups of 60 teeth each , plus two groups of 15 teeth each for positive and negative controls . One group was rinsed with 5.25 % NaOCl ( smear layer intact ) , whereas the other group was flushed with 17 % EDTA and 5.25 % NaOCl ( smear layer removed ) . Roots were obturated with gutta-percha using lateral condensation and AH Plus as root canal sealer . Each experimental group was divided into three subgroups of 20 teeth each for three methods of testing coronal dye leakage : passive dye penetration , penetration with vacuum applied , and fluid filtration methods . The teeth were left in 100 % humidity at 37 degrees C for 5 days before being immersed in Indian ink for 2 days and cleared . The linear extent of dye penetration was measured . Mean depth of leakage for the groups with the smear layer intact was 2.5 + /- 1.0 mm for passive dye penetration , 6.7 + /- 2.8 mm for vacuum dye penetration , and 3.0 + /- 1.1 mm for fluid filtration dye penetration . In the group in which the smear layer was removed , the mean depths of leakage were : 3.2 + /- 2.1 mm for passive dye penetration , 5.8 + /- 2.8 mm for vacuum dye penetration , and 3.4 + /- 2.1 mm for fluid filtration . The vacuum method result ed in significantly ( p dye penetration than fluid filtration and passive dye penetration . The presence or absence of smear layer had no statistically significant effect ( p > 0.05 ) on any of the leakage testing techniques",
"When dentin is planed by endodontic instruments , a smear layer forms . Whether this layer should be removed is unknown and controversial . This study was conducted to assess the effect of the smear layer on retention of bacteria using an in vitro root canal bacterial colonization model . Canals of 26 extracted human canines were step-back prepared using 2.5 % NaOCl . Teeth were then r and omly divided into two groups based on the type of high volume final flush : 1 - 20 ml of sterile saline ( 0.85 % wt/vol ) or ( 2 - 10 ml of 17 % EDTA followed by 10 ml of 2.5 % NaOCl which removes smear layer . Streptococcus anginosus ( milleri ) was cultured in trypticase soy broth supplemented with 0.5 % yeast extract at 37 degrees C in 5 % CO2 . Cells were harvested by centrifugation and resuspended in fresh media . Serial dilutions were performed to achieve inocula of 10(6 ) colony-forming units in a 30-microliters volume . Teeth were inoculated and incubated for 2 h in 5 % CO2 at 37 degrees C. Following incubation , teeth were split and processed for microbiological analysis . Numbers of colonizing bacteria were determined by a spiral-plating system . Enumeration of the numbers of bacteria revealed a reproducible , order of magnitude difference ( p = 0.0002 ) between teeth with smear layer ( 10(4 ) colony-forming units ) versus teeth without smear layer ( 10(5 ) colony-forming units ) . This suggests that smear layer produced during root canal therapy may inhibit bacterial colonization of root canals . One suggested mechanism is that smear layer may block bacterial entry into dentinal tubules",
"The purpose of this in vitro study was to observe the morphological changes and apical dye penetration at apical dentin surfaces induced by Nd : YAG laser irradiation at different power setting s with and without a laser initiator . Seventy five single rooted human maxillary anterior teeth were used . Following the establishment of the working lengths , the root canals were enlarged with step-back technique . The apex of each root was resected 3 mm perpendicular to its long axis . St and ard Class I cavities of 2 mm depth and 2 mm width were prepared . The teeth were r and omly divided into five groups with fifteen teeth in each . In Group 1 , the retro grade cavity preparations were lased with Nd : YAG laser at 2 W and those in Group 2 preparations were lased with Nd : YAG laser at 3.2 W. In Group 3 , the retro grade cavity surfaces were lased with Nd : YAG laser at 2 W following the application of India ink . Group 4 was lased with the same setting s of Group 2 after an absorbent cotton point soaked with India ink was inserted into the cut dentinal surfaces and the inner walls of the apical preparations . Group 5 served as control . Five teeth from each group were examined using scanning electron microscopy ( SEM ) . The amounts of smear layer , debris , and recrystalized dentin present were assessed and scored . Retro grade cavities of ten teeth from each group were filled with amalgam to examine apical dye penetration . The teeth were immersed in 2 % basic fuscin and kept for 48 hours . Dye penetration was evaluated by stereomicroscope at a magnification of X10 . The results showed the usage of India ink with Nd : YAG laser enhanced the amount of melting and recrystalization of dentin and the radiation and initiator increased the leakage",
"The purpose of this investigation was to study the effects of a Nd : YAG laser on the cut surface of teeth using scanning electron microscopy ( SEM ) . Eighteen single-rooted teeth were cleaned , shaped , and obturated with gutta-percha and root canal sealer . The apical 3 mm of each tooth were resected with a diamond fissure bur , and the teeth were r and omly divided into two groups of nine teeth each . The resected surface of each root in one group was lased twice . The duration of lasing and the number of pulses were recorded for each tooth . The teeth were air dried , mounted on stubs , sputter-coated with gold-palladium and examined under SEM . Application of the Nd : YAG laser caused melting of apical dentine surfaces . The melted material resembled the appearance of glazed interconnected droplets . Resolidification and recrystalization of the melted areas appeared to be incomplete and discontinuous . Some areas between the glazed regions appeared similar to those of non-lased apical dentine resected root surfaces",
"OBJECTIVES The goal of this study is to determine if the smear layer affects the passage of bacteria through or around obturating material as evidence d by penetration of bacteria through and out the canal . Specifically , this study focused on determining the effect of the smear layer on the magnitude of bacterial penetration through the apical foramen . METHODS Thirty extracted , maxillary central or lateral incisors were collected . Teeth were r and omly assigned ( 10 teeth per group ) to three groups : ( 1 ) smear layer removed , ( 2 ) smear layer present , and ( 3 ) negative control . Canal preparation and obturation using lateral condensation , gutta percha , and AH 26 sealer was performed on all of the teeth . Removal of the smear layer was accomplished by rinsing with 17 % EDTA . The model systems consisted of an upper chamber attached to the cemento-enamel junction and a lower chamber at the apices of the teeth . St and ardized bacterial suspensions containing Fusobacterium nucleatum , Campylobacter rectus , and Peptostreptococcus micros were inoculated into the upper chambers . Models were incubated anaerobically at 37 degrees C. At various times over a 60-day period , sample s were taken from the lower chamber and spiral-plated on selective-differential media to determine numbers and types of bacteria . RESULTS Leakage results were as follows : ( 1 ) smear layer present-6/10 leaked ; ( 2 ) smear layer removed-0/10 leaked ; ( 3 ) negative control-0/10 leaked . Profiles of bacterial leakage were similar among the groups . F. nucleatum was the predominant microorganism . CONCLUSIONS This study indicated that removal of the smear layer reduced the leakage of bacteria through the root canal system",
"This study compared the effectiveness of dentin adhesives in extracted molars from younger ( 16 - 26 ) and older ( 58 - 87 ) human subjects . Extracted molars were selected to be restored with one of two dentin bonding agents ( n = 22 per group ) . Opposite sides of each molar were ground flat and a 3 mm x 3 mm cylindrical preparation was milled into each surface . The opposing surfaces of each molar were then r and omly restored with either a dentin bonding system that adhered to the dentin smear layer or one which bonded to the dentin after the smear layer was removed . All sample s were examined at x150 to determine both the maximum gap in micrometers and extent of the gap in degrees . There were significantly shorter ( P microgaps in older dentin with a bonding system that removed smear layer . This bonding system also produced shorter gaps in older dentin than in younger dentin . However , there was no statistically significant difference in the percentage of gap-free margins between age groups",
"Because of inconsistency often found between in vitro testing and in vivo performance , a new restorative bonding system was evaluated by the placement of restorations in vivo in teeth to be extracted . The microleakage was determined following extraction after 3 months of clinical service . In each of the sample teeth , two restorations were placed on the labial surface , one in the middle of the enamel portion and the other extending over the cementoenamel portion . The results of this pilot study indicated that bonding to conditioned enamel with the new adhesive material is effective , and bonding to conditioned dentin appears to be clinical ly adequate",
"OBJECTIVES The incidence of bacterial microleakage , pulp inflammation and necrosis associated with dentine etching treatments prior to restoration are not known . Consequently , to resolve some of the controversy surrounding the effects and importance of vital dentine etching , the authors investigated these factors . METHODS 110 st and ardised class V cavities were cut into buccal dentine , without exposing the pulp of teeth scheduled for extraction for orthodontic reasons . Cavities were either left unetched , or etched with the non-equivalent treatments of phosphoric acid gel for 60s or Ethylenediaminetetraacetic acid ( EDTA ) for 30s , prior to placement of composite resin . Teeth were collected and pulp responses were evaluated according to ISO guidelines , using pathohistomorphometric analysis and ANOVA statistics . RESULTS Etching was found to be correlated to bacterial microleakage ( p=0.0001 ) and tertiary dentine formation ( p=0.0023 ) . Bacterial microleakage was correlated to inflammatory activity ( p=0.0001 ) . The frequency of bacterial microleakage was : no etching ( 65 % ) , EDTA ( 51 % ) and phosphoric acid ( PA ) ( 20 % ) . SIGNIFICANCE Vital dentine etching treatment is of extreme importance for the placement of RC to minimise bacterial microleakage . PA etching proved to be more effective at preventing bacterial microleakage than non-etching , and etching with EDTA"
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41164dae-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND There is no vali date d assessment of an older person 's risk of falling that is easily applied in primary care . We aim ed to develop a two-part tool for use in primary care or the community . Part 1 includes a rapid assessment of the individual 's risk of falling for administration by clinical or non- clinical staff . Part 2 ( for clinical staff ) includes guidance on further assessment , referral and interventions . We assessed the predictive validity of part 1 . METHODS The tool was developed by an expert panel following the updating of an existing systematic review of community-based prospect i ve studies identifying risk factors for falling and modified in accordance with the feedback from extensive piloting . We assessed predictive validity by a question naire survey sent at baseline and 6 months to a r and om sample of 1000 people aged over 65 in one Primary Care Group area . RESULTS Five items were included in part 1 : history of any fall in the previous year , four or more prescribed medications , diagnosis of stroke or Parkinson 's disease , reported problems with balance , inability to rise from a chair without using arms . The presence of three or more risk factors had a positive predictive value for a fall in the next 6 months of 0.57 ( 95 per cent confidence interval 0.43 - 0.69 ) . Less than three risk factors had a negative predictive value of 0.86 ( 0.82 - 0.89 ) , and a specificity of 0.92 ( 0.88 - 0.94 ) . CONCLUSION The tool may be useful for identifying people who would benefit from further assessment of their risk of falling and appropriate intervention
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"BACKGROUND Falls in elderly people are a common presenting complaint to accident and emergency departments . Current practice commonly focuses on the injury , with little systematic assessment of the underlying cause , functional consequences , and possibilities for future prevention . We undertook a r and omised controlled study to assess the benefit of a structured inderdisciplinary assessment of people who have fallen in terms of further falls . METHODS Eligible patients were aged 65 years and older , lived in the community , and presented to an accident and emergency department with a fall . Patients assigned to the intervention group ( n=184 ) underwent a detailed medical and occupational-therapy assessment with referral to relevant services if indicated ; those assigned to the control group ( n=213 ) received usual care only . The analyses were by intention to treat . Follow-up data were collected every 4 months for 1 year . FINDINGS At 12-month follow-up , 77 % of both groups remained in the study . The total reported number of falls during this period was 183 in the intervention group compared with 510 in the control group ( p=0.0002 ) . The risk of falling was significantly reduced in the intervention group ( odds ratio 0.39 [ 95 % CI 0.23 - 0.66 ] ) as was the risk of recurrent falls ( 0.33 [ 0.16 - 0.68 ] ) . In addition , the odds of admission to hospital were lower in the intervention group ( 0.61 [ 0.35 - 1.05 ] ) whereas the decline in Barthel score with time was greater in the control group ( p high-risk population can significantly decrease the risk of further falls and limit functional impairment",
"We investigated factors associated with falls in a community-based prospect i ve study of 761 subjects 70 years and older . The group experienced 507 falls during the year of monitoring . On entry to the study a number of variables had been assessed in each subject . Variables associated with an increased risk of falling differed in men and women . In men , decreased levels of physical activity , stroke , arthritis of the knees , impairment of gait , and increased body sway were associated with an increased risk of falls . In women , the total number of drugs , psychotropic drugs and drugs liable to cause postural hypotension , st and ing systolic blood pressure of less than 110 mmHg , and evidence of muscle weakness were also associated with an increased risk of falling . Most falls in elderly people are associated with multiple risk factors , many of which are potentially remediable . The possible implication s of this in diagnosis and prevention are discussed",
"Methods of prevention of falls in the home may differ for healthy and frail individuals . We therefore sought to determine whether measures of health and functioning in older persons are more useful in predicting falls at home not involving home hazards ( non-environmental falls ) than falls at home related to home hazards ( environmental falls ) , and whether these relationships differ among those who fell once and those who fell multiple times during follow-up . Data for this analysis are from a 1-year prospect i ve cohort study of 325 community-dwelling volunteers aged 60–93 years who had fallen during the year before baseline . In general , associations were stronger between poor functional ability and non-environmental falls than between poor functional ability and environmental falls . Independent predictors of non-environmental first falls during follow-up included Parkinson 's disease ( adjusted odds ratio ( AOR ) 7.66 , 95 % confidence interval ( 95 % CI ) 1.15–51.1 ) and being home alone 10 or more hours per day ( AOR 2.36 , 95 % CI 1.20–4.61 ) ; independent predictors of environmental first falls during follow-up included arthritis ( AOR 2.60 , 95 % CI 1.32–5.09 ) and poor depth perception ( AOR 0.73 , 95 % CI 0.59–0.89 , for each unit increase in depth perception score ) . Also , associations between poor function and falls were generally stronger among participants who fell repeatedly than among individuals who fell only once during the follow-up year . In conclusion , poor function predisposes to non-environmental falls at home in older persons and , to a lesser extent , environmental falls in those who fall repeatedly . Certain functional characteristics such as poor depth perception may predispose to environmental falls to a greater extent than do other disabilities",
"In this prospect i ve study , the authors determined intrinsic risk factors for falls and recurrent falls and constructed a risk profile that indicated the relative contribution of each risk factor and also estimated the probabilities of falls and recurrent falls . In 1992 , over a 28-week period , falls were recorded among 354 elderly subjects aged 70 years or over who were living in homes or apartments for the elderly in Amsterdam and the vicinity . During the study period , 251 falls were reported by 126 subjects ( 36 % ) , and recurrent falls ( > or = 2 falls ) were reported by 57 subjects ( 16 % ) . Associations of falls and recurrent falls with potential risk factors were identified in logistic regression models . Mobility impairment regarding one or more of the tested items ( i.e. , impairment of balance , leg-extension strength , and gait ) was associated with falls ( adjusted odds ratio ( OR ) = 2.6 ) and was strongly associated with recurrent falls ( OR = 5.0 ) . Dizziness upon st and ing was associated with falls ( OR = 2.1 ) and recurrent falls ( OR = 2.1 ) . However , several risk factors were associated with recurrent falls only : history of stroke ( OR = 3.4 ) , poor mental state ( OR = 2.4 ) , and postural hypotension ( OR = 2.0 ) . The authors constructed a risk profile for recurrent falls that included the five risk factors mentioned above . Inclusion of all risk factors in the profile implied an 84 % probability of recurrent falls over a period of 28 weeks , compared with 3 % when no risk factor was present . The probability of recurrent falls ranged only from 11 % to 29 % when predicted by number of falls occurring in the previous year . Physical activity , use of high-risk medication , and the use of vitamin D3 , which was r and omly allocated to the participants , were not strongly related to either falls or recurrent falls . In conclusion , a large range of probabilities of falls , especially of recurrent falls , was estimated by the risk profiles , in which mobility impairment was the major risk factor . Recurrent fallers may therefore be especially amenable to prevention based on mobility improvement",
"Background : In order to identify the risk factors essential for preventing major injurious falls , the associations between injurious falls and certain factors were assessed among disabled and independent elderly , respectively , who had fallen during a 2-year period . Methods : A prospect i ve population -based study was conducted in five rural northern Finnish municipalities . The series consisted of all inhabitants aged 70 years or over , initially 979 persons . During a 2-year follow-up period , all injurious falls were recorded on the basis of telephone contacts , diary reporting and a review of the medical records of the participants . Results : Thirty percent of the subjects having fallen sustained a major injury . The multivariate model applied to the disabled elderly showed the following variables to be related to a high risk for major injurious falls : divorced , widowed or unmarried marital status ( odds ratio = 2.2 ) , a low body mass index ( odds ratio = 3.1 ) , incomplete step continuity ( odds ratio = 2.2 ) , poor distant visual acuity ( odds ratio = 2.3 ) and the use of long-acting benzodiazepines ( odds ratio = 2.4 ) . Among the independent elderly , the risk of a fall result ing in major injury was high among the subjects who had peripheral neuropathy ( odds ratio = 2.5 ) or were suffering from insomnia ( odds ratio = 4.1 ) . Conclusions : The risk factors for major injuries in fall occurrences differ between the disabled and independent elderly . Preventive measures should be targeted according to the disabilities of the population",
"To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling",
"To determine how accurately elderly subjects recall recent falls , we studied 304 ambulatory men and women over the age of 60 years who completed a 12-month prospect i ve study of risk factors for falling . We developed a system of weekly follow-up and home visits to record and confirm all falls . During the study , 179 participants suffered at least one fall that was confirmed by home visit . At the end of the study , all subjects were interviewed by telephone about whether they had suffered a fall during the preceding 3 , 6 , or 12 months . Depending on the time period of recall , 13 % to 32 % of those with confirmed falls did not recall falling during the specific period of time . Recall was better for the preceding 12 months than for 3 or 6 months . There were only weak correlations ( r = 0.28 to 0.59 ) between the number of falls that were documented and the number that the subjects recalled during each of these periods . Those with lower scores on the Mini-Mental State Examination were more likely to forget falls . We conclude that elderly subjects often do not recall falls that occurred during specific periods of time over the preceding 3 to 12 months . Research ers and clinicians should consider using methods besides long-term recall for ascertaining and counting falls over specific periods of time",
"General practice p 994 Older people frequently fall . This is a serious public health problem , with a substantial impact on health and healthcare costs.1 These guidelines translate trial evidence about prevention of falls into recommendations that can be implemented in different setting s , with the aim of reducing the rate of falls and injurious falls in people over 65 ( see boxes 2 3 ) . # # # # Summary points Multifaceted interventions reduce falls in older people ( those over 65 ) Home assessment of older people at risk of falls without referral or direct intervention is not recommended Assessment of high risk residents in nursing homes with relevant referral is effective Evidence from well design ed single trials shows that assessment and modification of risk factors of older people who have presented to an accident and emergency department after a fall and the provision of hip protectors in residents of nursing homes are effective We up date d two previous systematic review s to include any new evidence up to March 1998 . 4 5 We electronically search ed Medline for all r and omised controlled trials and systematic review s by using the terms fall(s ) , accidental falls , fracture , elderly , aged , older , and senior . We followed up relevant references in papers , and we contacted research ers in prevention of falls for information about other trial evidence and about studies from journals not catalogued by the National Library of Medicine . For inclusion , studies had to be r and omised controlled trials of interventions design ed to minimise or prevent exposure to the risk factors for falling ( or fracture ) in people aged 65 years or over living in either community or residential care . Outcomes had to include the number of people who had fallen or the number of falls or fractures . We excluded drug or dietary treatments for the prevention of fractures . Trials that fulfilled the inclusion criteria were review ed and summarised",
"BACKGROUND Since falling is associated with serious morbidity among elderly people , we investigated whether the risk of falling could be reduced by modifying known risk factors . METHODS We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling : postural hypotension ; use of sedatives ; use of at least four prescription medications ; and impairment in arm or leg strength or range of motion , balance , ability to move safely from bed to chair or to the bathtub or toilet ( transfer skills ) , or gait . These subjects were given either a combination of adjustment in their medications , behavioral instructions , and exercise programs aim ed at modifying their risk factors ( intervention group , 153 subjects ) or usual health care plus social visits ( control group , 148 subjects ) . RESULTS During one year of follow-up , 35 percent of the intervention group fell , as compared with 47 percent of the control group ( P = 0.04 ) . The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 ( 95 percent confidence interval , 0.52 to 0.90 ) . Among the subjects who had a particular risk factor at base line , a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of re assessment , as follows : at least four prescription medications , 63 percent versus 86 percent , P = 0.009 ; balance impairment , 21 percent versus 46 percent , P = 0.001 ; impairment in toilet-transfer skills , 49 percent versus 65 percent , P = 0.05 ; and gait impairment , 45 percent versus 62 percent , P = 0.07 . CONCLUSIONS The multiple-risk-factor intervention strategy result ed in a significant reduction in the risk of falling among elderly persons in the community . In addition , the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group , as compared with the control group . Thus , risk-factor modification may partially explain the reduction in the risk of falling",
"OBJECTIVE Scant attention has been paid to the risk factors for recurrent falls among the home-dwelling elderly , although there are remarkable age and sex differences according to whether or not the falls recur . In this report we describe and analyse the risk factors for recurrent falls by selected clinical variables and the history of falling during the previous year . DESIGN A community-based prospect i ve study covering two years . SETTING All home-dwelling persons ( N = 1016 ) aged 70 years or older living in five municipalities in northern Finl and . OUTCOME MEASURES The risk factors of recurrent falling by selected clinical variables using cross-tabulations and multivariate analyses . RESULTS Previous falls , peripheral neuropathy , use of psychotropic medication and slow walking speed were independent risk factors for recurrent falling . The risk of recurrent falling increased with an increasing number of previous falls . CONCLUSIONS Early preventive measures should be taken among the elderly persons who are prone to falling . In order to reduce the risk of recurrent falls among the elderly , the attending physician should take a critical view of the use of psychotropic medications , and attempts should be made to treat conditions underlying peripheral neuropathies and abnormal gait",
"In a recent study of fall prevention in 301 community-living older persons ( the Yale FICSIT Trial , 1990 - 1993 ) , participants in the multifactorial targeted intervention ( TI ) group experienced significantly fewer falls than participants in the social visit ( SV ) control group . In the present paper , the authors explore the relation between changes in the studied risk factors and the occurrence of falling . In comparison with SV participants , TI participants showed significantly greater improvements in postural blood pressure change ( p = 0.01 ) , step length ( p = 0.004 ) , use of > or = 4 medications ( p = 0.003 ) , and unsafe tub and toilet transfers ( p = 0.05 ) , while change in balance was of borderline significance ( p = 0.08 ) . Reduction in the occurrence of falling , in turn , was at least marginally associated with improvements in balance , postural blood pressure change , step length , lower extremity strength/range of motion , and transfers . When participants were divided into tertiles based on a composite risk factor change score , a significantly higher percentage of TI participants ( 42 % ) than SV participants ( 22 % ) were in the greatest risk factor reduction tertile . Among TI participants , there was a progressively lower fall rate per person per year in the tertiles with the least , intermediate , and greatest risk reduction ( 0.832 , 0.624 , and 0.260 ) , respectively . A similar but weaker relation between risk factor reduction and fall rate was seen in the SV group . When compared within tertiles , essentially adjusting for the amount of risk factor reduction , the fall rates among TI and SV participants in the greatest risk factor reduction tertile were identical ( 0.260 falls per person per year ) , and the rates in the least reduction tertile were similar ( 0.832 vs. 1.040 falls per person per year ) ; this suggests that risk factor reduction at least partially mediated the treatment effect . These results support the feasibility of implementing and analyzing the effectiveness of a multiple risk factor reduction strategy in the aged"
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BACKGROUND People with no previous cardiovascular events or cardiovascular disease represent a primary prevention population . The benefits and harms of treating mild hypertension in primary prevention patients are not known at present . This review examines the existing r and omised controlled trial ( RCT ) evidence . OBJECTIVES PRIMARY OBJECTIVE To quantify the effects of antihypertensive drug therapy on mortality and morbidity in adults with mild hypertension ( systolic blood pressure ( BP ) 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) and without cardiovascular disease . SEARCH METHODS We search ed CENTRAL ( 2011 , Issue 1 ) , MEDLINE ( 1948 to May 2011 ) , EMBASE ( 1980 to May 2011 ) and reference lists of articles . The Cochrane Data base of Systematic Review s and the Data base of Abstract s of Review s of Effectiveness ( DARE ) were search ed for previous review s and meta-analyses of anti-hypertensive drug treatment compared to placebo or no treatment trials up until the end of 2011 . SELECTION CRITERIA RCTs of at least 1 year duration . DATA COLLECTION AND ANALYSIS The outcomes assessed were mortality , stroke , coronary heart disease ( CHD ) , total cardiovascular events ( CVS ) , and withdrawals due to adverse effects . MAIN RESULTS Of 11 RCTs identified 4 were included in this review , with 8,912 participants . Treatment for 4 to 5 years with antihypertensive drugs as compared to placebo did not reduce total mortality ( RR 0.85 , 95 % CI 0.63 , 1.15 ) . In 7,080 participants treatment with antihypertensive drugs as compared to placebo did not reduce coronary heart disease ( RR 1.12 , 95 % CI 0.80 , 1.57 ) , stroke ( RR 0.51 , 95 % CI 0.24 , 1.08 ) , or total cardiovascular events ( RR 0.97 , 95 % CI 0.72 , 1.32 ) . Withdrawals due to adverse effects were increased by drug therapy ( RR 4.80 , 95%CI 4.14 , 5.57 ) , ARR 9 % . AUTHORS ' CONCLUSIONS Antihypertensive drugs used in the treatment of adults ( primary prevention ) with mild hypertension ( systolic BP 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) have not been shown to reduce mortality or morbidity in RCTs . Treatment caused 9 % of patients to discontinue treatment due to adverse effects . More RCTs are needed in this prevalent population to know whether the benefits of treatment exceed the harms
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"CONTEXT The Systolic Hypertension in the Elderly Program ( SHEP ) demonstrated that treating isolated systolic hypertension in older patients decreased incidence of total stroke , but whether all types of stroke were reduced was not evaluated . OBJECTIVE To investigate antihypertensive drug treatment effects on incidence of stroke by type and subtype , timing of strokes , case-fatality rates , stroke residual effects , and relationship of attained systolic blood pressure to stroke incidence . DESIGN The SHEP study , a r and omized , double-blind , placebo-controlled trial began March 1 , 1985 , and had an average follow-up of 4.5 years . SETTING AND PARTICIPANTS A total of 4736 men and women aged 60 years or older with isolated systolic hypertension at 16 clinical centers in the United States . INTERVENTIONS Patients were r and omly assigned to receive treatment with 12.5 mg/d of chlorthalidone ( step 1 ) ; either 25 mg/d of atenolol or 0.05 mg/d of reserpine ( step 2 ) could be added ( n = 2365 ) ; or placebo ( n = 2371 ) . MAIN OUTCOME MEASURES Occurrence , type and subtype , and timing of first strokes and stroke fatalities ; and change in stroke incidence for participants ( whether in active treatment or placebo groups ) reaching study -specific systolic blood pressure goal ( decrease of at least 20 mm Hg from baseline to below 160 mm Hg ) compared with participants not reaching goal . RESULTS A total of 85 and 132 participants in the active treatment and placebo groups , respectively , had ischemic strokes ( adjusted relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.48 - 0.82 ) ; 9 and 19 had hemorrhagic strokes ( adjusted RR , 0.46 ; 95 % CI , 0.21 - 1.02 ) ; and 9 and 8 had strokes of unknown type ( adjusted RR , 1.05 ; 95 % CI , 0.40 - 2 . 73 ) , respectively . Four subtypes of ischemic stroke were observed in active treatment and placebo group participants , respectively , as follows : for lacunar , n = 23 and n = 43 ( adjusted RR , 0.53 ; 95 % CI , 0.32 - 0.88 ) ; for embolic , n = 9 and n = 16 ( adjusted RR , 0.56 ; 95 % CI , 0.25 - 1.27 ) ; for atherosclerotic , n = 13 and n = 13 ( adjusted RR , 0 . 99 ; 95 % CI , 0.46 - 2.15 ) ; and for unknown subtype , n = 40 and n = 60 ( adjusted RR , 0.64 ; 95 % CI , 0.43 - 0.96 ) . Treatment effect was observed within 1 year for hemorrhagic strokes but was not seen until the second year for ischemic strokes . Stroke incidence significantly decreased in participants attaining study -specific systolic blood pressure goals . CONCLUSIONS In this study , antihypertensive drug treatment reduced the incidence of both hemorrhagic and ischemic ( including lacunar ) strokes . Reduction in stroke incidence occurred when specific systolic blood pressure goals were attained . JAMA . 2000;284:465 -",
"The Systolic Hypertension in the Elderly Program ( SHEP ) , a r and omized , double-masked , placebo-controlled trial of 4736 persons , was design ed to assess the efficacy of antihypertensive drug treatment to reduce the risk of fatal and nonfatal strokes among people age 60 and over with isolated systolic hypertension . The statistical method used in interim monitoring of results was conditional power ( or stochastic curtailment ) . The findings did not become conclusive until near the completion of the trial , and therefore SHEP was continued to its scheduled closing date . The trial demonstrated a 36 % reduction in the incidence of stroke in the active treatment group ( P = .0003 ) . In addition to evaluating overall efficacy of treatment , the monitoring process considered such other issues as nonstroke outcomes , lag time between first report of stroke and final confirmation of stroke diagnosis , consistency of results across subgroups , and completeness of follow-up . The purpose of this article is to review these factors with primary emphasis on the statistical aspects",
"BACKGROUND There are scant data on the effect of body mass index ( BMI ) ( calculated as weight in kilograms divided by the square of height in meters ) on cardiovascular events and death in older patients with hypertension . OBJECTIVE To determine if low body mass in older patients with hypertension confers an increased risk of death or stroke . PATIENTS Participants were 3975 men and women ( mean age , 71 years ) enrolled in 17 US centers in the Systolic Hypertension in the Elderly Program trial , a r and omized , double-blind , placebo-controlled clinical trial of lowdose antihypertensive therapy , with follow-up for 5 years . MAIN OUTCOME MEASURES Five-year adjusted mortality and stroke rates from Cox proportional hazards analyses . RESULTS There was no statistically significant relation of death or stroke with BMI in the placebo group ( P = .47 ) , and there was a U- or J-shaped relation in the treatment group . The J-shaped relation of death with BMI in the treated group ( P = .03 ) showed that the lowest probability of death for men was associated with a BMI of 26.0 and for women with a BMI of 29.6 ; the curve was quite flat for women across a wide range of BMI s. For stroke , men and women did not differ , and the BMI nadir for both sexes combined was 29 , with risk increasing steeply at BMI s below 24 . Those in active treatment , however , had lower death and stroke rates compared with those taking placebo . CONCLUSIONS Among older patients with hypertension , a wide range of BMI s was associated with a similar risk of death and stroke ; a low BMI was associated with increased risk . Lean , older patients with hypertension in treatment should be monitored carefully for additional risk factors",
"OBJECTIVE To assess variability in the use of coronary artery bypass grafting ( CABG ) and percutaneous transluminal angioplasty ( PTCA ) in the Systolic Hypertension in the Elderly Program ( SHEP ) cohort with incident coronary heart disease ( CHD ) by age , sex , and race . DESIGN Retrospective analysis of a multicenter prospect i ve cohort study . SETTING Community-based ambulatory population in academic centers . PATIENTS Among 4736 subjects initially enrolled in SHEP , there were 432 incident cases of CHD , excluding those patients who experienced rapid or sudden cardiac death . MAIN OUTCOME MEASURE Incident cases of CHD who underwent CABG or PTCA . RESULTS Of those participants > or = 60 and age , 7.3 % underwent PTCA , compared with 3.9 % of those > or = 75 years ( P = 0.14 ) . 15.4 % of those CABG surgery , compared with 7.8 % of those 75 and older ( P = 0.018 ) . When both of these endpoints , CABG and PTCA , were combined , 22.4 % of those CABG or PTCA ( P use of procedures in participants Race , activity limitations , number of comorbid conditions , education level , marital status , employment status , and social support were not significantly associated with CABG or PTCA use . When the variables studied were entered into a logistic regression model , increased age and female sex remained independently associated with decreased CABG and PTCA use . CONCLUSION In the SHEP trial older patients and women , regardless of comorbid conditions , socioeconomic status , and social support , underwent less intensive cardiovascular interventions than did younger patients and men when they developed CHD",
"BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) and 29.1/16.8 mm Hg ( 19.2/10.1 ) in the losartan and atenolol groups , respectively . The primary composite endpoint occurred in 508 losartan ( 23.8 per 1000 patient-years ) and 588 atenolol patients ( 27.9 per 1000 patient-years ; relative risk 0.87 , 95 % CI 0.77 - 0.98 , p=0.021 ) . 204 losartan and 234 atenolol patients died from cardiovascular disease ( 0.89 , 0.73 - 1.07 , p=0.206 ) ; 232 and 309 , respectively , had fatal or non-fatal stroke ( 0.75 , 0.63 - 0.89 , p=0.001 ) ; and myocardial infa rct ion ( non-fatal and fatal ) occurred in 198 and 188 , respectively ( 1.07 , 0.88 - 1.31 , p=0.491 ) . New-onset diabetes was less frequent with losartan . Interpretation Losartan prevents more cardiovascular morbidity and death than atenolol for a similar reduction in blood pressure and is better tolerated . Losartan seems to confer benefits beyond reduction in blood pressure",
"The Oslo Hypertension Study began in 1972 ; patients were followed for an average of 66 months ( range : 60 to 78 ) . A total of 785 healthy men , aged 40 to 49 , with mild hypertension was r and omly assigned to either a drug-treated group or to an untreated control group . Hydrochlorothiazide was used alone in 36 percent of patients , in combination with propranolol in 26 percent , and with methyldopa in 20 percent . Other drugs , including combinations with hydrochlorothiazide , were used in 18 percent . A total of 95 percent of patients in the drug-treated group received hydrochlorothiazide . Complications of hypertension such as stroke and aneurysm occurred only in the control group . Coronary events were more numerous in the drug-treated group ; thus , the total incidence of cardiovascular complications did not significantly differ between the treated and untreated groups . After five and 10 years , total mortality was the same in both groups . However , the coronary heart disease mortality rate at 10 years was significantly greater in the drug-treated group than in the untreated control group ( 14 versus three , p less than 0.01 ) . This article presents possible reasons for the failure of antihypertensive drug therapy to prevent coronary heart disease . The adverse effect of diuretics and beta-adrenergic blockers , both on lipid and carbohydrate metabolism , is contrasted with the effect of the alpha-adrenergic blocker prazosin , which has been shown to have no adverse effect on the blood lipid profile . In a short-term trial that was part of the Oslo Study , prazosin was found to reduce total serum cholesterol by 9 percent , low-density lipoprotein and very-low-density lipoprotein cholesterol by 10 percent , and total triglycerides by 16 percent . All these changes are statistically significant",
"The Systolic Hypertension in the Elderly Program ( SHEP ) is a r and omized double-blind placebo-controlled trial to determine if antihypertensive treatment of isolated systolic hypertension ( ISH ) [ systolic blood pressure ( SBP ) greater than or equal to 160 mmHg , diastolic blood pressure ( DBP ) less than 90 mmHg ] reduces the 5 year incidence of fatal and nonfatal stroke . Between March 1 , 1985 and January 15 , 1988 , 4736 persons ( target 4800 ) with ISH , age 60 years and over , were enrolled . Potential participants met blood pressure ( BP ) and age criteria . Those on antihypertensive medication prior to enrollment without documented diastolic hypertension had their medication tapered and discontinued , and then met BP criteria ( 33 % of cohort ) . Stepped-care therapy with chlorthalidone and atenolol ( alternative , reserpine ) or matching placebos was initiated as first and second steps . At baseline the trial population was 43.1 % male , 56.9 % female ; 13.9 % black , 86.1 % non-black . Also , the mean age was 71.6 years ; the mean SBP was 170.3 mmHg and the mean DBP was 76.6 mmHg ; 59.8 % had codeable resting electrocardiographic abnormalities . The trial is now in follow-up phase with scheduled termination in 1991",
"Objective To compare the incidence of stroke and other cardiovascular events in hypertensive patients receiving a low-dose diuretic and low-dose calcium antagonist combination with those receiving low-dose diuretic monotherapy , and assess the effects of a small blood pressure difference at achieved levels lower than those achieved in previous placebo-controlled trials . Methods The Felodipine Event Reduction ( FEVER ) trial was an investigator- design ed , prospect i ve , multicentre , double-blind , r and omized , placebo-controlled , parallel group trial . It enrolled 9800 Chinese patients , of either sex , aged 50–79 years , with one or two additional cardiovascular risk factors or disease , whose blood pressure , 6 weeks after switching from previous antihypertensive therapy to low-dose ( 12.5 mg a day ) hydrochlorothiazide , was in the range 140–180 mmHg ( systolic ) or 90–100 mmHg ( diastolic ) . These patients were r and omly assigned either to low-dose felodipine extended release or placebo , and followed at 3-month intervals for an average of 40 months . Results The intention-to-treat analysis included 9711 r and omly selected patients with only 30 ( 0.3 % ) lost to follow-up . A total of 31 842 patient-years of follow-up were accumulated , with 85.9 % of patients remaining on blinded r and omized treatment . Add-on therapy was given to 33.9 % of the hydrochlorothiazide – felodipine patients and to 42.3 % of the hydrochlorothiazide – placebo patients . In the felodipine group , systolic blood pressure (SBP)/diastolic blood pressure ( DBP ) decreased ( from r and omization to study end ) from 154.2/91.0 to 137.3/82.5 mmHg , and in the placebo group from 154.4/91.3 to 142.5/85.0 mmHg , with an average difference throughout the trial of 4.2/2.1 mmHg . In the felodipine group , the primary endpoint ( fatal and non-fatal stroke ) was reduced by 27 % ( P = 0.001 ) . Among secondary endpoints , all cardiovascular events were reduced by 27 % ( P by 35 % ( P = 0.012 ) , death by any cause by 31 % ( P = 0.006 ) , coronary events by 32 % ( P = 0.024 ) , heart failure by 30 % ( P = 0.239 ) , cardiovascular death by 33 % ( P = 0.019 ) , cancer by 36 % ( P = 0.017 ) in the felodipine group . No significant differences were found in new-onset diabetes . Both treatments were very well tolerated . Conclusions In moderately complicated hypertensive patients from China even a difference in SBP/DBP as small as 4/2 mmHg , such as that induced by adding low-dose felodipine to low-dose hydrochlorothiazide , is associated with very substantial reductions in the incidence of most types of cardiovascular events . As the SBP achieved in the felodipine group was below the recommended goal of less than 140 mmHg , and SBP in the placebo group was slightly above that level , FEVER provides the required evidence in support of the guidelines recommended goal , even for a hypertensive population not entirely consisting of patients with diabetes or previous cardiovascular events ",
"The pilot phase of the British multicentre r and omized controlled trial of treatment for mild hypertension has shown : ( 1 ) that unselected subjects , aged 35 - 64 years , with mild hypertension are willing to enter and remain in a long-term trial even though asymptomatic ; ( 2 ) that the differences of mean systolic and mean diastolic pressure achieved between treated and control subjects is sufficient to produce the expected difference in terminating events with the 18000 patients calculated as needed for the full-scale trial ; ( 3 ) that side effects with the two selected active primary regimens ( bendrofluazide and propranolol ) are common but mild ( no serious side effects or toxic reactions have been reported ) ; ( 4 ) that the work load imposed by the trial , though considerable during screening and the initiation of patients into the trial , can largely be taken by specially trained nursing staff , and when screening is completed the trial does not impose a heavy burden of follow-up examinations ; ( 5 ) that there are no adverse psychological effects caused by alerting asymptomatic people to their raised pressure and enrolling them into a prolonged programme of clinical attendance ; ( 6 ) that the total costs of carrying out a full-scale trial -- estimated at about lb.2 m ( $ U.S. 4m)--are commensurate with the potential annual savings in health service expenditure whether the trial shows treatment to be effective or unwarranted",
"As sub studies of the Medical Research Council 's trials of treatment of mild hypertension and of hypertension in the elderly , two studies were carried out comparing the effects of different doses of two diuretics on blood pressure , concentrations of some biochemical variables , and the incidence of subjective adverse reactions . In one study , in which 484 patients with mild hypertension participated , daily doses of bendrofluazide 5 mg and 10 mg , with and without oral potassium supplements , were compared . In the second , involving 701 elderly patients with hypertension , daily doses of hydrochlorothiazide 25 mg together with amiloride 2.5 mg were compared with hydrochlorothiazide 50 mg together with amiloride 5 mg . The mean ( + /- SD ) duration s of treatment were 35 + /- 17 months in the first study and 10 + /- 7 months in the second . Neither study showed any significant difference in blood pressure response to the two doses of diuretic , whereas biochemical changes and the reported incidence of subjective adverse reactions were dose-related . In the first study , potassium supplementation with potassium chloride 16.8 or 33.6 mmol did not have a significant effect on the fall in serum potassium level , which was only slightly reduced , and did not have any significant effect on the antihypertensive effect of either dose of bendrofluazide",
"OBJECTIVE The objective of this study was to examine the prevalence and correlates of postural hypotension ( defined as a drop in systolic blood pressure of greater than or equal to 20 mm Hg ) in a cohort of elderly persons with isolated systolic hypertension ( ISH ) . DESIGN Baseline cross-sectional analysis of the 4,736 persons r and omized in the Systolic Hypertension in the Elderly Program ( SHEP ) . SETTING A r and omized multi-center double-blind outpatient clinical trial of the impact of treating ISH . PARTICIPANTS Men and women age greater than or equal to 60 years with the systolic blood pressure ( SBP ) greater than or equal to 160 mm Hg and diastolic blood pressure ( DBP ) less than 90 mm Hg . MEASURES Medical histories were obtained using interviewer-administered , st and ardized clinical history forms . At entry into the study , seated and st and ing BP was measured by certified BP technicians using a r and om zero sphygmomanometer . Postural hypotension ( PH ) was assessed at 1 and 3 minutes after the participant arose from a seated position . MAIN RESULTS PH was found in 10.4 % of participants at 1 minute and in 12.0 % of participants at 3 minutes . 5.3 % of participants demonstrated PH at both time intervals while 17.3 % demonstrated PH at either or both of the time intervals . Factors significantly ( P less than 0.05 ) associated with the presence of PH were higher mean SBP and a lower mean body mass index . CONCLUSIONS Somewhat different persons were defined as having PH based upon the 1 minute and 3 minute st and ing measures of BP , and prevalence estimates of PH can vary depending on whether one or more intervals of measurement are used . Cross-sectional data analysis indicated that PH , in healthy community-dwelling older persons with ISH , may not be associated with a history of disorders or problems usually thought to be related to PH . However , prospect i ve data are needed to determine the prognostic significance of PH , and whether one or multiple measurements carry more significance",
"The never-treated control group in the Oslo Study hypertension trial of middle-aged men 40 - 49 years old at entry ( n = 379 ) was studied with respect to five-year change in blood pressure and its correlates . The study began in 1972 and ended in 1979 , and each patient was followed for five years . Both baseline and rate of change of correlates were analyzed as independent variables versus rate of change in blood pressure as the dependent variable . Rate of change in serum triglycerides were found to be the strongest correlate of rate of change in blood pressure in this population of healthy mild hypertensives . In addition , rate of change in serum cholesterol and body weight made significant contributions in some analyses , but to a lower degree than did rate of change in triglycerides . The model predicts a substantial decrease in blood pressure if lipids and body weight are reduced . Rate of change in sodium , uric acid , and chloride concentrations were also associated with blood pressure change , but total degree of explanation of all explaining variables only accounted for 11 - 15 % of total variation in annual blood pressure change",
"Summary The Oslo Hypertension Study started in 1972 and lasted for 66 ( range 60–78 ) months . A total of 785 healthy men , aged 40 to 49 years , with mild hypertension were r and omised to a drug-treated group and to an untreated , control group . The drugs used for treatment were hydrochlorothiazide alone in 36 % , hydrochlorothiazide and propranolol in 26 % , hydrochlorothiazide and methyldopa in 20 % , and other drugs in 18%.A total of 95 % in the drug-treated group received hydrochlorothiazide . Pressure complications , such as stroke and aneurysms , only occurred in the control group . Coronary events were more numerous in the drug-treated group , so that the total incidence of cardiovascular complications did not significantly differ between the treated and untreated groups . After 5 and 10 years , total mortality was found to be the same in both groups . However , the 10-year coronary heart disease mortality was significantly higher in the drug-treated group than in the untreated controls ( 14 vs 3 , p of hypertension on coronary heart disease is discussed , and attention is drawn to the adverse effect of diuretics and β-adrenergic blockers , both on lipid and carbohydrate metabolism . This is in contrast to the α-adrenergic blocker , prazosin , which has been shown to improve the blood lipid profile ",
"Information on indices of coronary heart disease ( CHD ) and myocardial infa rct ion ( MI ) ( angina pectoris by Rose Question naire , MI by Rose Question naire , history , and electrocardiogram ) was obtained in the Hypertension Detection and Follow-Up Program ( U.S. National Institutes of Health ) at baseline , Year 2 , and Year 5 of follow-up . The presence of any of these findings at baseline markedly increased all-cause mortality during the 5 years of observation . In individuals with negative findings at baseline , the 5-year incidence of MI and angina pectoris by these indices was less in the Stepped Care than Referred Care cohort . These results are compatible with the conclusion that antihypertensive therapy reduces the incidence of symptomatic CHD",
"Because many r and omized clinical trials study more than one important outcome variable , evaluation of efficacy is often difficult and not completely satisfactory . This paper considers the use of a procedure for endpoint determination described by Follmann et al. , that allows raters to integrate subjectively all relevant information about an individual 's clinical course into a single univariate assessment . To explore the method 's feasibility , we tested the procedure with data from a completed clinical trial , the Systolic Hypertension in the Elderly Program ( SHEP ) . We provided raters blinded to treatment assignment with cards that schematically represent the clinical trajectories of SHEP study participants . The raters independently ranked these trajectories . The method combined ranks across raters to determine a single rank for each study participant ; we used a rank procedure to test treatment effect . The major findings were : ( i ) the raters showed a high level of concordance of rankings ; ( ii ) tests of treatment effect were highly statistically significant ; ( iii ) three statistical methods were effective for implementing the ranking in the large study size case . These methods were use of : ( a ) scoring rules ; ( b ) incomplete block design s , and ( c ) categorical ranking",
"BACKGROUND Despite treatment , there is often a higher incidence of cardiovascular complications in patients with hypertension than in normotensive individuals . Inadequate reduction of their blood pressure is a likely cause , but the optimum target blood pressure is not known . The impact of acetylsalicylic acid ( aspirin ) has never been investigated in patients with hypertension . We aim ed to assess the optimum target diastolic blood pressure and the potential benefit of a low dose of acetylsalicylic acid in the treatment of hypertension . METHODS 18790 patients , from 26 countries , aged 50 - 80 years ( mean 61.5 years ) with hypertension and diastolic blood pressure between 100 mm Hg and 115 mm Hg ( mean 105 mm Hg ) were r and omly assigned a target diastolic blood pressure . 6264 patients were allocated to the target pressure Felodipine was given as baseline therapy with the addition of other agents , according to a five-step regimen . In addition , 9399 patients were r and omly assigned 75 mg/day acetylsalicylic acid ( Bamycor , Astra ) and 9391 patients were assigned placebo . FINDINGS Diastolic blood pressure was reduced by 20.3 mm Hg , 22.3 mm Hg , and 24.3 mm Hg , in the major cardiovascular events occurred at a mean achieved diastolic blood pressure of 82.6 mm Hg ; the lowest risk of cardiovascular mortality occurred at 86.5 mm Hg . Further reduction below these blood pressures was safe . In patients with diabetes mellitus there was a 51 % reduction in major cardiovascular events in target group Acetylsalicylic acid reduced major cardiovascular events by 15 % ( p=0.03 ) and all myocardial infa rct ion by 36 % ( p=0.002 ) , with no effect on stroke . There were seven fatal bleeds in the acetylsalicylic acid group and eight in the placebo group , and 129 versus 70 non-fatal major bleeds in the two groups , respectively ( p patients with hypertension was associated with a low rate of cardiovascular events . The HOT Study shows the benefits of lowering the diastolic blood pressure down to 82.6 mm Hg . Acetylsalicylic acid significantly reduced major cardiovascular events with the greatest benefit seen in all myocardial infa rct ion . There was no effect on the incidence of stroke or fatal bleeds , but non-fatal major bleeds were twice as common",
"BACKGROUND The association of serum lipids with coronary heart disease has been studied extensively in middle-aged men and , to a lesser extent , in similar women . Less well defined are lipid variables predictive of CHD in individuals of age > or = 60 years . METHODS AND RESULTS The Systolic Hypertension in the Elderly Program recruited 4736 persons ( mean age , 72 years ; 14 % were black ; and 43 % were men ) . Mean systolic and diastolic blood pressures were 170 and 77 mm Hg , respectively . Baseline mean total cholesterol was 6.11 mmol/L ( 236 mg/dL ) ; HDL cholesterol , 1.39 mmol/L ( 54 mg/dL ) ; and non-HDL cholesterol , 4.72 mmol/L ( 182 mg/dL ) . Triglyceride levels were 1.62 mmol/L ( 144 mg/dL ) for fasting participants and 1.78 mmol/L for the total group . LDL cholesterol , estimated in fasting sample s with triglycerides of baseline total , non-HDL , and LDL cholesterol levels and the ratios of total , non-HDL , and LDL to HDL cholesterol were significantly related to CHD incidence . HDL cholesterol and triglycerides were not significant in these analyses . In fasting participants with triglyceride levels of total , non-HDL , or LDL cholesterol was associated with a 30 % to 35 % higher CHD event rate . CONCLUSIONS The results of this study support the concept that serum lipids are CHD risk factors in older Americans",
"Ventricular ectopic activity was recorded at baseline in 5.6 % of the 12-lead electrocardiograms and 8.2 % of the 2-minute rhythm strips of 4674 subjects with isolated systolic hypertension ( systolic blood pressure 160 to 219 mm Hg , diastolic blood pressure In this study 1.3 % had 6 to 10 ventricular premature beats ( VPB ) , and 0.7 % had > 10 VPB on the 2-minute rhythm strip . Correlates of VPB presence on the 12-lead ECG were older-age male sex , presence of Q/QS pattern and higher heart rate . Participants with serum potassium prevalence of VPB . Similarly , the number of VPB on the 2-minute rhythm strip was associated with male sex , increasing age , with lower serum potassium , history of palpitations , and presence of Q/QS patterns",
"A r and omised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years . The principal antihypertensive agents were atenolol and bendrofluazide . There was a reduction in the rate of fatal stroke in the treatment group to 30 % of that in the control group ( 95 % confidence interval 11 - 84 % , p less than 0.025 ) . The rate of all strokes ( fatal and non-fatal ) in the treatment group was 58 % of that in the control group ( 95 % confidence interval 35 - 96 % , p less than 0.03 ) . The incidence of myocardial infa rct ion and total mortality was unaffected by treatment . Question naires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment",
"In 1972 - -1973 , 785 symptom-free men , aged 40 to 49 years , without target organ damage , with systolic blood pressures between 150 and 179 mm Hg and diastolic blood pressure below 110 mm Hg , were assigned at r and om to one of two groups : ( 406 to a drug treatment group and 379 to a control group ) for a five-year controlled drug treatment trial to evaluate the effect of therapy on cardiovascular complications . Drug treatment started with hydrochlorothiazide . If systolic blood pressure remained above 140 mm Hg and /or diastolic blood pressure above 90 mm Hg , alphamethyldopa was added . If there were side effects , methyldopa was replaced with propranolol . The control group was not given a placebo . The mean observation time was 66 months ( range 60 to 78 months ) . A difference in blood pressure between groups of about 17 mm Hg systolic and 10 mm Hg diastolic was maintained throughout the study . The study protocol had a rather low \" ethical \" blood pressure roof , 180 mm Hg systolic and /or 110 mm Hg diastolic . Seventeen percent of the control group had an increase in blood pressure above this level during the trial , and drug treatment was started . There was no effect on major cardiovascular morbidity comparing groups as established by r and omization , with 18 events in the treatment group and 20 events in the control group . There was no difference between the groups in total mortality and mortality from cardiovascular events . However , in the subgroups with diastolic blood pressure greater than or equal to 100 mm Hg before r and omization , there was a probable reduction in total morbidity from cardiovascular events in favor or the group receiving drug therapy , 7.6 and 16.4 percent events in the treated and control groups , respectively . Cerebrovascular events occurred only in the control group , 7 versus 0 . Two cases of fatal aortic aneurysms also occurred in the control group . Other \" pressure \" complications , such as marked left ventricular hypertrophy in the electrocardiogram and left ventricular failure , occurred only in the control group . However , regarding coronary heart disease , including sudden death , the incidence tended to be higher in the treated group , although it was not statistically significant . Only 13 men ( 1.7 percent ) failed to meet for regular examinations . At the end of the study these men were also followed up with regard to possible cardiovascular events",
"OBJECTIVES To assess the risk of total and cardiovascular mortality in older adults with systolic hypertension and with a low ankle-arm index ( AAI ) as a marker of sub clinical peripheral arterial disease ( PAD ) . DESIGN Prospect i ve observational study PARTICIPANTS A subgroup of 1537 participants in the Systolic Hypertension in the Elderly Program ( SHEP ) were screened for lower extremity arterial disease using the AAI . Participants were evaluated at 4 years to determine vital status and cause of death . Total and cardiovascular disease ( CVD ) mortality rates were assessed in relationship to clinical CVD at baseline , cardiovascular risk factors and the presence of a low AAI ( sub clinical PAD ) . RESULTS Total mortality rates increased as the AAI decreased in those with and without clinical CVD at baseline . In those without clinical CVD at baseline , the presence of an AAI total mortality in men and 2.67 in women . Results were similar for CVD mortality and persisted after adjustment for cardiovascular risk factors including the presence of an abnormal electrocardiogram . CONCLUSIONS A low ankle arm-index predicted a two to three-fold increase in total and cardiovascular mortality in older adults with systolic hypertension of risk for incident cardiovascular disease . In this study of older adults with systolic hypertension , 19.7 % of the participants had sub clinical PAD . Risk factor modification could be targeted to older adults based on markers of asymptomatic atherosclerosis",
"BACKGROUND The optimal combination drug therapy for hypertension is not established , although current U.S. guidelines recommend inclusion of a diuretic . We hypothesized that treatment with the combination of an angiotensin-converting-enzyme ( ACE ) inhibitor and a dihydropyridine calcium-channel blocker would be more effective in reducing the rate of cardiovascular events than treatment with an ACE inhibitor plus a thiazide diuretic . METHODS In a r and omized , double-blind trial , we assigned 11,506 patients with hypertension who were at high risk for cardiovascular events to receive treatment with either benazepril plus amlodipine or benazepril plus hydrochlorothiazide . The primary end point was the composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for angina , resuscitation after sudden cardiac arrest , and coronary revascularization . RESULTS The baseline characteristics of the two groups were similar . The trial was terminated early after a mean follow-up of 36 months , when the boundary of the prespecified stopping rule was exceeded . Mean blood pressures after dose adjustment were 131.6/73.3 mm Hg in the benazepril-amlodipine group and 132.5/74.4 mm Hg in the benazepril-hydrochlorothiazide group . There were 552 primary - outcome events in the benazepril-amlodipine group ( 9.6 % ) and 679 in the benazepril-hydrochlorothiazide group ( 11.8 % ) , representing an absolute risk reduction with benazepril-amlodipine therapy of 2.2 % and a relative risk reduction of 19.6 % ( hazard ratio , 0.80 , 95 % confidence interval [ CI ] , 0.72 to 0.90 ; P death from cardiovascular causes , nonfatal myocardial infa rct ion , and nonfatal stroke , the hazard ratio was 0.79 ( 95 % CI , 0.67 to 0.92 ; P=0.002 ) . Rates of adverse events were consistent with those observed from clinical experience with the study drugs . CONCLUSIONS The benazepril-amlodipine combination was superior to the benazepril-hydrochlorothiazide combination in reducing cardiovascular events in patients with hypertension who were at high risk for such events . ( Clinical Trials.gov number , NCT00170950 .",
"Context Experts debate the consequences of excessive lowering of diastolic pressure in patients with hypertension and coronary artery disease . Contribution This report is a secondary analysis of data from a large trial of 2 antihypertensive drug regimens in patients with known coronary artery disease . The authors found a J-shaped relationship between diastolic blood pressure and all-cause death and myocardial infa rct ion , with the increased risk occurring at diastolic blood pressures below 70 to 80 mm Hg , that is , the lower the diastolic pressure , the higher the risk . Caution s The study examined associations between blood pressure and outcomes ; it could not prove that the antihypertensive therapy that lowered diastolic pressure too much caused the adverse outcomes . The Editors For 2 decades , the hypertension literature has been haunted by the phenomenon of a paradoxical increase in morbidity and mortality with an excessive decrease in blood pressure ( J-curve ) . Indeed , several reports have shown that low diastolic pressure is associated with an increased risk for coronary heart disease and related mortality in older adults and in patients taking antihypertensive medications ( 1 - 13 ) . After doing a review and meta- analysis of pertinent studies , Farnett and colleagues ( 14 ) concluded that although there was no consistent J-shaped relationship between stroke and systolic or diastolic pressure , there was a consistent J-shaped relationship for cardiac events and diastolic pressure . These authors stated that this dichotomy in the relationship between diastolic pressure and target organ disease may leave a clinician with the uncomfortable choice of whether to prevent stroke or renal disease at the expense of coronary heart disease . These findings were at variance with the generally accepted dogma formulated by the sixth report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) ( 15 ) , which stated that the relationship between pressure and risk was strong , continuous , independent , predictive and etiologically significant . Within the past decade , the phenomenon of a J-curve has been studied in several large trials of normotensive and hypertensive patients ( 16 - 30 ) . Not surprisingly , arguments regarding whether a J-curve could be clinical ly significant have become somewhat contentious . That is , some rely on evidence that on-treatment diastolic pressure below 70 mm Hg does not increase risk for cardiovascular disease and thus deny an impairment of vital organ perfusion within the usual values achievable by antihypertensive treatment . Others , however , consider the J-curve a more real possibility , particularly for the heart . In contrast to other organs , the heart is perfused mostly during diastole and thus could be more vulnerable to diastolic pressure reduction . If a J-curve did exist , it should be most evident in patients with limited coronary perfusion , in other words , in those with manifest coronary artery disease ( CAD ) . Optimal blood pressure in patients with hypertension and CAD remains controversial because few r and omized clinical trials have been done in this population ( 31 , 32 ) . The International Verapamil-Tr and olapril Study ( INVEST ) ( 33 ) , a r and omized trial , evaluated more than 22000 patients with CAD and hypertension . This patient profile , together with unprecedented levels of blood pressure control , provided a unique opportunity to critically investigate the hypothesis that the risk for CAD would increase with an excessive decrease in diastolic pressure . Methods Study Design and Intervention The INVEST design , methods , and principal results have been previously published ( 33 ) . The trial used an open design with blinded end point assessment . In brief , clinical ly stable patients with CAD and hypertension were r and omly assigned to a verapamil sustained-releasebased or atenolol-based strategy . Patients with previous myocardial infa rct ion ( MI ) within 3 months of enrollment or class IV or V congestive heart failure were excluded . Blood pressure goals were based on JNC VI ( systolic pressure tr and olapril or hydrochlorothiazide was recommended when necessary to achieve blood pressure goals . Tr and olapril was also recommended for patients with heart failure , diabetes , or renal impairment . Documented CAD was defined as any of the following : remote ( 3 months before enrollment ) confirmed MI , coronary angiography showing more than 50 % narrowing of at least 1 major coronary artery , diagnosis of classic angina pectoris , or concordant abnormalities on 2 different signals ( electrocardiography , echocardiography , or radionuclide scans ) from stress test findings concordant for ischemia ( for example , ST-segment depression or perfusion defects on radionuclide scanning or wall-motion abnormalities on echocardiography or radionuclide scanning ) . Patient Monitoring and Follow-up Protocol visits were scheduled every 6 weeks for the first 6 months and then biannually until 2 years after the last patient was enrolled . Patients were assessed for response to treatment , symptoms , treatment adherence , and adverse effects at each visit and at the end of the study as detailed elsewhere ( 33 ) . Patient follow-up was complete when we received a final assessment form through the online data system or a death report . The Internet-based electronic data collection method used in INVEST did not accept the entry until all required fields were complete . Blood pressure was measured by using a st and ard mercury sphygmomanometer with an appropriately sized cuff applied to the upper nondominant arm at heart level . By auscultation at the brachial artery , systolic pressure was recorded at the first Korotkoff sound and diastolic pressure was recorded at the disappearance of the fifth Korotkoff sound . Blood pressure was measured twice , at least 2 minutes apart , and the measurements were averaged . Study Outcomes The primary outcome was the first occurrence of all-cause death , nonfatal MI , or nonfatal stroke by intention-to-treat analysis . The MI and stroke definitions are detailed elsewhere ( 34 ) . These 3 components individually were the main secondary outcomes . For this analysis , additional outcomes included fatal and nonfatal MI , fatal and nonfatal stroke , and average on-treatment blood pressure before outcome or censoring . Ascertainment and blinded adjudication of outcomes were described previously ( 32 ) . Follow-up data were available for 22008 ( 97.5 % ) patients . Statistical Analysis The main conclusions of INVEST were that the 2 treatment strategies were equivalent with respect to the primary outcome , main secondary outcomes , and on-treatment systolic and diastolic pressures . Thus , data for all enrolled patients were combined and included in these analyses following the intention-to-treat principle . A P value of 0.05 or less was considered statistically significant . Patients without a primary outcome event were censored at their latest follow-up visit . Average follow-up systolic and diastolic pressures were calculated for each patient by using all post-baseline results , up to the date of primary outcome or censoring . The baseline value was substituted for patients with no post-baseline data ( n= 1154 ) . In this exploratory analysis , the proportions of patients were pooled by 10 mm Hg strata of average follow-up systolic pressure , and the distribution of primary outcome event rate was evaluated to determine whether the relationship was linear . A similar presentation was prepared for diastolic pressure . Because the frequency distributions seemed consistent with a quadratic curve , a quadratic Cox proportional hazards model was formed for the time to primary outcome for each blood pressure variable , with factors for blood pressure and blood pressure squared . Similarly , the relationship between each 10 mm Hg stratum of average systolic pressure and diastolic pressure and all-cause death , fatal and nonfatal MI , and fatal and nonfatal stroke was evaluated . For the time to primary outcome , a second model was fitted , adjusting for the following baseline covariates : age ( 10-year increments ) , sex , race and ethnicity ( white , Asian , black , Hispanic , multiracial , or other ) , previous MI , heart failure ( classes I to III ) , body mass index in increments of 5 kg/m2 , U.S. residency , renal impairment , peripheral vascular disease , left ventricular hypertrophy , smoking history , coronary revascularization , dyslipidemia , stroke or transient ischemic attack , angina pectoris , arrhythmia , diabetes , cancer , aspirin use , and average systolic pressure or diastolic pressure and systolic pressure squared or diastolic pressure squared . To identify clinical ly relevant interactions between the J-shaped curve and baseline diastolic pressure , demographic characteristics , and comorbid conditions for the primary outcome , a 2-step procedure was used . First , baseline covariates were tested individually by adding the variable and 2 interaction terms ( variablediastolic pressure and variable[diastolic pressure squared ] ) to the Cox proportional hazards model . Variables included were age older than 70 years , sex , previous MI , heart failure ( classes I to III ) , previous stroke or transient ischemic attack , diabetes , cancer , renal impairment , hypercholesterolemia , peripheral vascular disease , smoking history , U.S. residency , body mass index greater than 29 kg/m2 ( mean baseline body mass index ) , and diastolic pressure greater than 86 mm Hg ( mean baseline diastolic pressure ) . The change in log likelihood was used to assess the significance of simultaneously adding the 2 interaction terms . The second step in identifying clinical ly relevant interactions between the J-shaped curve and baseline covariates was to plot the hazard ratios for the primary outcome versus diastolic pressure in the",
"The Australian Therapeutic Trial in Mild Hypertension was a controlled trial in which mildly hypertensive patients , aged between 35 and 65 years ( diastolic blood pressure 95 - 109 ) were r and omly assigned to take antihypertensive drugs or matched placebos for periods of up to 6 years . The overall data showed that the treated group had a lower incidence of both death and of nonfatal cardiovascular events . The differences in the incidence of noncardiovascular deaths did not differ significantly between the two groups . Univariate analysis of possible prognostic factors at the time of entry into the study showed a higher incidence of trial endpoints -- mostly events due to ischemic heart disease and cerebrovascular disease -- in older subjects , men , cigarette smokers and those with higher systolic blood pressures , and in thinner subjects than in others . There was a lower incidence of these events in actively treated persons than in control subjects at each level of incidence of each covariate measured . Treatment benefit was greatest in persons with lower systolic blood pressures and lower serum cholesterol levels . Multivariate regression analyses confirmed that the incidence of trial endpoints increased with age and with systolic blood pressures . There was a higher incidence in smokers than in nonsmokers , especially in those with low body weights . Treatment benefited thin smokers most , and the effects of treatment seemed to be reduced in those with higher serum cholesterol levels . There was a substantial fall in blood pressure in many of the placebo group",
"The main aim of the trial was to determine whether drug treatment of mild hypertension ( phase V diastolic pressure 90 - 109 mm Hg ) reduced the rates of stroke , of death due to hypertension , and of coronary events , in men and women aged 35 - 64 years . A total of 17,354 patients was recruited , and 85,572 patient-years of observation accrued . Patients were r and omly allocated at entry to take bendrofluazide or placebo , or propranolol or placebo . The stroke rate was reduced with treatment ( 60 strokes , vs 109 in the placebo groups ) , being 1.4 and 2.6 per 1,000 patient-years of observation , respectively ( p less than 0.01 ) , but overall rates of coronary events were not different ( 222 with treatment and 234 with placebos ) . The incidence of all cardiovascular events was reduced with treatment ( 286 events , vs 352 with placebos ; p less than 0.05 ) . For rates of mortality from all causes , treatment made no difference . Several post hoc analyses of subgroup results were performed . The all-cause mortality was reduced in men on treatment ( 157 deaths , vs 181 in placebo groups ) but increased in women on treatment ( 91 deaths , vs 72 with placebos ) ; this difference between the sexes was significant ( p = 0.05 ) . The reduction in stroke rate was greater with bendrofluazide than with propranolol ( p = 0.002 ) . The rate of strokes was reduced in both smokers and non-smokers taking bendrofluazide , but only in non-smokers taking propranolol ; this difference between the drugs was significant ( p = 0.03 ) . The coronary-event rate was not reduced by bendrofluazide , whatever the smoking habit , nor in smokers taking propranolol , but it was reduced in non-smokers taking propranolol . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In the Hypertension Detection and Follow-up Program , 7825 ( 71.5 per cent ) of the 10,940 participants had diastolic blood pressures averaging between 90 and 104 mm Hg on entry into the study and were design ated Stratum 1 . Half were referred to their usual source of care in the community ( the referred-care group ) , and half were treated intensively in special clinics ( the stepped-care group ) . Five-year mortality in the Stratum 1 patients given stepped care was 20.3 per cent lower than in those given referred care ( P less than 0.01 ) . Particularly noteworthy was the beneficial effect of stepped-care treatment on persons with diastolic pressures of 90 to 104 mm Hg who had no evidence of end-organ damage and were not receiving antihypertensive medication when they entered the study . This subgroup had 28.6 per cent fewer deaths at five years among those treated with stepped care than among those treated with referred care ( P less than 0.01 ) . These findings support a recommendation that in patients with mild hypertension , treatment should be considered early , before damage to end organs occurs",
"OBJECTIVE To determine the relationship between increasing depressive symptoms and cardiovascular events or mortality . DESIGN Cohort analytic study of data from r and omized placebo-controlled double-blind clinical trial of antihypertensive therapy . Depressive symptoms were assessed semi-annually with the Center for Epidemiological Studies -Depression ( CES-D ) scale during an average follow-up of 4.5 years . SETTING Ambulatory patients in 16 clinical centers of the Systolic Hypertension in the Elderly Program . PATIENTS Generally healthy men and women aged 60 years or older r and omized to active antihypertensive drug therapy or placebo who were 70 % white and 53 % women and had follow-up CES-D scores and no outcome events during the first 6 months ( N=4367 ) . MAIN OUTCOME MEASURES All-cause mortality , fatal or nonfatal stroke , or myocardial infa rct ion . RESULTS Baseline depressive symptoms were not related to subsequent events ; however , an increase in depression was prognostic . Cox proportional hazards regression analyses with the CES-D scale as a time-dependent variable , controlling for multiple covariates , indicated a 25 % increased risk of death per 5-unit increase in the CES-D score ( relative risk [ RR ] , 1.25;95 % confidence interval [ CI ] , 1.15 to 1.36 ) . The RR for stroke or myocardial infa rct ion was 1.18(95%CI,1.08 to 1.30 ) . Increase in CES-D score was an independent predictor in both placebo and active drug groups , and it was strongest as a risk factor for stroke among women ( RR,1.29;95%CI,1.07 to 1.34 ) . CONCLUSIONS Among elderly persons , a significant and substantial excess risk of death and stroke or myocardial infa rct ion was associated with an increase in depressive symptoms over time , which may be a marker for subsequent major disease events and warrants the attention of physicians to such mood changes . However , further studies of casual pathways are needed before wide-spread screening for depression in clinical practice is to be recommended",
"BACKGROUND There is no evidence from r and omized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus . We investigated whether therapy targeting normal systolic pressure ( i.e. , participants with type 2 diabetes at high risk for cardiovascular events . METHODS A total of 4733 participants with type 2 diabetes were r and omly assigned to intensive therapy , targeting a systolic pressure of less than 120 mm Hg , or st and ard therapy , targeting a systolic pressure of less than 140 mm Hg . The primary composite outcome was nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS After 1 year , the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the st and ard-therapy group . The annual rate of the primary outcome was 1.87 % in the intensive-therapy group and 2.09 % in the st and ard-therapy group ( hazard ratio with intensive therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.73 to 1.06 ; P=0.20 ) . The annual rates of death from any cause were 1.28 % and 1.19 % in the two groups , respectively ( hazard ratio , 1.07 ; 95 % CI , 0.85 to 1.35 ; P=0.55 ) . The annual rates of stroke , a prespecified secondary outcome , were 0.32 % and 0.53 % in the two groups , respectively ( hazard ratio , 0.59 ; 95 % CI , 0.39 to 0.89 ; P=0.01 ) . Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group ( 3.3 % ) and 30 of the 2371 participants in the st and ard-therapy group ( 1.3 % ) ( P patients with type 2 diabetes at high risk for cardiovascular events , targeting a systolic blood pressure of less than 120 mm Hg , as compared with less than 140 mm Hg , did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events . ( Clinical Trials.gov number , NCT00000620 .",
"Objective To assess longitudinally the association of serum uric acid and its change due to diuretic treatment with cardiovascular events in hypertensive patients . Design Cohort study in a r and omized trial . Setting Cohort of hypertensive patients . Participants A total of 4327 men and women , aged ≥ 60 years , with isolated systolic hypertension , r and omized to placebo or chlorthalidone , with the addition of atenolol or reserpine if needed , were observed for 5 years . Main outcome measures Major cardiovascular events , coronary events , stroke and all-cause mortality . Results Cardiovascular event rates for quartiles of baseline serum uric acid were : I , 32.7 per 1000 person-years ; II , 34.5 per 1000 person-years ; III , 38.1 per 1000 person-years ; and IV , 41.4 per 1000 person-years ( P for trend = 0.02 ) . The adjusted hazard ratio ( HR ) , of cardiovascular events for the highest quartile of serum uric acid versus the lowest quartile was 1.32 ( 95 % CI , 1.03–1.69 ) . The benefit of active treatment was not affected by baseline serum uric acid . After r and omization , an increase of serum uric acid with a HR of 0.58 ( 0.37–0.92 ) for coronary events compared with those with a serum uric acid increase ≥ 0.06 mmol/l . This difference was not explained by blood pressure effects . Those with a serum uric acid increase ≥ 0.06 mmol/l in the active treatment group had a similar risk of coronary events as the placebo group . Conclusions Serum uric acid independently predicts cardiovascular events in older persons with isolated systolic hypertension . Monitoring serum uric acid change during diuretic treatment may help to identify patients who will most benefit from treatment",
"Despite the clear-cut result of the Australian Therapeutic Trial in Mild Hypertension , which demonstrated prospect ively the benefit of treatment of diastolic blood pressure in the range of 95 to 109 mm Hg , a retrospective analysis that classified subjects by the average diastolic pressure level attained during the trial purported to show an absence of treatment benefit at lower average diastolic pressures and a negative treatment effect at higher levels . However , the method of classification by average attained diastolic pressure introduced substantial selection bias , invalidating the retrospective analysis and rendering as spurious both the deleterious treatment effect and its lack of efficacy at lower diastolic levels",
"Serum glucose levels , triglyceride levels , and body weight are reported from a controlled drug trial in men , aged 40 to 49 , with uncomplicated mild hypertension . The drug treatment started with hydrochlorothiazide alone , and methyldopa was added when necessary . If side effects occurred , methyldopa was replaced by propranolol . No detailed advice about diet , smoking , or weight reduction was given to any group . The untreated control subjects had a small increase in serum glucose levels during five years , from 6.08 to 6.21 mmol/liter . Those treated with hydrochlorothiazide alone and those treated with hydrochlorothiazide plus methyldopa had a small increase in serum glucose levels of the same order as that in the control subjects . However , those receiving the thiazide/propranolol combination experienced a sizeable increase in glucose levels , from 5.96 to 6.53 mmol/liter ( p less than 0.001 ) . This increase was significantly greater than the increase in the other groups ( p less than 0.001 ) . The thiazide/propranolol group also showed a significant increase in serum triglyceride levels ( p less than 0.05 ) . There was no difference in serum potassium levels in the different drug groups . The results indicate that moderate thiazide doses do not have significant effects on serum glucose levels in this age group . Propranolol in combination with thiazide seems to increase the level of serum glucose",
"A feasibility trial to investigate the practicality of determining the advantages and disadvantages of prompt pharmacologic treatment for mild hypertension was jointly funded by the Veterans Administration and the National Heart , Lung and Blood Institute . Its clinical phase has been completed , and it demonstrated 1 . that the required relatively young asymptomatic population could be enrolled in the study and 2 . that it could be persuaded to adhere to the protocol for 2 years ; however , it was evident that intensive efforts would be required in both areas . The feasibility trial screened almost 120,000 potential subjects over a period of 16 months to r and omize about 1,000 subjects at four clinical centers . These men and women were 21 to 50 years old , had diastolic pressures from 85 to 105 mm Hg as out patients , and had no evidence of cardiovascular renal abnormalities . They were r and omized in double-blind fashion into active drug therapy and placebo groups . Stepped care therapy involved 50 mg chlorthalidone ( Step 1 ) , 100 mg chlorthalidone ( Step 2 ) and 100 chlorthalidone plus 0.25 mg reserpine ( Step 3 ) . Death , myocardial infa rct ion , stroke , angina pectoris , and congestive heart failure were the \" major \" morbid events that were looked for ; also recorded were \" minor \" morbid events consisting primarily of electrocardiographic arrhythmias . The development of significant hypertension was considered a treatment failure . Side effects were carefully tabulated in both active drug and placebo groups . The study revealed an average drop in diastolic pressure of almost 12 mm Hg for active drug group and less than half of that for the placebo group ; once established 6 months after r and omization , the new pressure levels persisted almost without change throughout the study . Although the feasibility trial was not design ed to answer the primary question regarding the benefits of treatment , the events were tabulated for each group . A total of 12 placebo-treated subjects developed significant hypertension and were put on active drug . There was not a significant difference between the two groups in the incidence of \" major \" morbid events ; a total of eight active and five placebo patients developed myocardial infa rct ion or died suddenly . There , however , was an excess of arrhythmias among the active drug subjects ( 17 in the active group versus 8 in the placebo group on the basis of preliminary data ) . Finally , there were twice as many side effects and 20 times as many chemical abnormalities among the active as among the placebo subjects . A protocol for a full scale study of the benefits of pharmacologic therapy in mild hypertensives has been prepared and is ready for implementation as needed ; it involves relatively minor modifications of the protocol tested in the feasibility trial",
"In an ancillary study of the Systolic Hypertension in the Elderly Program ( SHEP ) , the effects of diuretics on ventricular ectopic activity were investigated in 186 patients with isolated systolic hypertension . Ventricular premature complexes ( VPCs ) were examined as the number of VPCs/24 hours , presence of > or = 1 VPC , presence of > or = 10 VPCs/24 hours , and presence of VPC pairs or ventricular tachycardia . Significant changes in VPCs were not observed either in the 92 patients r and omized to chlorthalidone stepped-care ( 12.5 and 25 mg/day ) or in the 94 placebo-treated patients ( p > 0.1 for all VPC definitions and both groups ) . Serum potassium decreased from 4.4 + /- 0.5 to 4.1 + /- 0.5 mEq/liter ( p = 0.002 ) in the chlorthalidone group and did not change ( 4.4 + /- 0.5 to 4.5 + /- 0.4 mEq/liter ) in the placebo group . Potassium was prescribed routinely for confirmed hypokalemia serum potassium and VPC or change in serum potassium and change in VPC was not observed in the chlorthalidone group . In summary , in patients with isolated systolic hypertension , chlorthalidone in doses that are effective in decreasing stroke and cardiovascular event rates ( 12.5 or 25 mg/day ) , did not increase VPCs"
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Background : Endothelial function ( EF ) and arterial stiffness ( AS ) are predictors of cardiovascular disease . As previous research concerning the effect of coffee intake on EF and AS was controversial , we conducted a systematic review and meta- analysis to synthesize research . Methods : We performed a systematic search in PubMed , Scopus and Web of Science to find clinical trials investigating the effect of coffee intake on EF or AS up to March 2020.R and om-effects models were used to estimate the pooled weighted mean difference ( WMD ) between intervention and control groups for r and omized controlled trials ( RCTs ) . Between study heterogeneity was estimated using Cochran 's Q and the I2-inconsistency index . Internal validity of included r and omized trials was determined with the Cochrane Collaboration 's tool for assessing the risk of bias . Results : Twenty-three articles were included for qualitative and 11 articles for quantitative synthesis . Meta- analysis of 14 RCTs ( nine articles ) indicated a positive short-term ( postpr and ial ) effect of coffee intake on flow-mediated dilation ( FMD ) as a measure of EF ( WMD : 1.93%[95 % CI : 1.10 - 2.75 ] ; I2= 97.9 % ) . Meta- analysis of three long-term RCTs ( two articles ) found no such effect on FMD ( WMD : -0.08 % [ -3.82 to 3.66 ] ; I2= 61.4%).Most short-term information was from studies at low or unclear risk of bias , while the proportion of long-term information from studies at high risk of bias was considerable . Conclusion : The results from this meta- analysis suggest a beneficial short-term effect of coffee intake on EF as measured by FMD . Base on systematic review results acute and chronic intake of coffee products may exerts an unfavorable effect on AS . While we found no such effect concerning long-term coffee intake , this latter finding must be interpreted cautiously as the number of studies were low and included studies had a considerable risk of bias
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"Background / Objectives : Coffee is the most widely consumed beverage in the world , but its effect on the cardiovascular system has not been fully understood . Coffee contains caffeine and antioxidants , which may influence endothelial function , both of which have not yet been investigated . The objective of this study was to investigate the acute effects of coffee on endothelial function measured by brachial artery flow-mediated dilation (FMD).Subjects/ Methods : A total of 20 ( 10 males and 10 females ) healthy non-obese subjects underwent a double-blind , crossover study . Subjects ingested one cup of caffeinated ( CC ) and one cup of decaffeinated ( DC ) Italian espresso coffee in r and om order at 5- to 7-day intervals . Results : Following CC ingestion , FMD decreased progressively and significantly ( mean±s.e.m . : 0 min , 7.7±0.6 ; 30 min , 6.3±0.7 ; 60 min , 6.0±0.8 % ; ANOVA ( analysis of variance ) , P significantly increased both systolic and diastolic blood pressure ; this effect was not observed after DC ingestion . Blood glucose concentrations remained unchanged after ingestion of both CC and DC , but insulin ( 0 min , 15.8±0.9 ; 60 min , 15.0±0.8 μU/ml ; P and C-peptide ( 0 min , 1.25±0.09 ; 60 min , 1.18±0.09 ng/ml ; P blood concentrations decreased significantly only after CC ingestion . Conclusions : CC acutely induced unfavorable cardiovascular effects , especially on endothelial function . In the fasting state , insulin secretion is also likely reduced after CC ingestion . Future studies will determine whether CC has detrimental clinical ly relevant effects , especially in unhealthy subjects",
"Food and beverages rich in polyphenols with antioxidant activity are highlighted as a potential factor for risk reduction of lifestyle related diseases . This study was conducted to eluci date total polyphenol consumption from beverages in Japanese people . Total polyphenol ( TP ) contents in beverages were measured using a modified Folin-Ciocalteu method removing the interference of reduced sugars by using reverse-phase column chromatography . A beverage consumption survey was conducted in the Tokyo and Osaka areas in 2004 . R and omly selected male and female subjects ( 10 - 59 years old , n = 8768 ) recorded the amounts and types of all nonalcoholic beverages consumed in a week . Concentration of TP in coffee , green tea , black tea , Oolong tea , barley tea , fruit juice , tomato/vegetable juice , and cocoa drinks were at 200 , 115 , 96 , 39 , 9 , 34 , 69 , and 62 mg/100 mL , respectively . Total consumption of beverages in a Japanese population was 1.11 + /- 0.51 L/day , and TP contents from beverages was 853 + /- 512 mg/day . Coffee and green tea shared 50 % and 34 % of TP consumption in beverages , respectively , and contribution of each of the other beverages was less than 10 % . TP contents in 20 major vegetables and 5 fruits were 0 - 49 mg and 2 - 55 mg/100 g , respectively . Antioxidant activities , Cu reducing power , and scavenging activities for DPPH and superoxide , of those sample s correlated to the TP contents ( p Beverages , especially coffee , contributed to a large share of the consumption of polyphenols , as antioxidants , in the Japanese diet",
"Epidemiological studies indicate that habitual coffee consumption lowers the risk of diabetes and cardiovascular diseases . Postpr and ial hyperglycemia is a direct and independent risk factor for cardiovascular diseases . We previously demonstrated that coffee polyphenol ingestion increased secretion of Glucagon-like peptide 1 ( GLP-1 ) , which has been shown to exhibit anti-diabetic and cardiovascular effects . We hypothesized coffee polyphenol consumption may improve postpr and ial hyperglycemia and vascular endothelial function by increasing GLP-1 release and /or reducing oxidative stress . To examine this hypothesis , we conducted a r and omized , acute , crossover , intervention study in healthy male adults , measuring blood parameters and flow-mediated dilation ( FMD ) after ingestion of a meal with or without coffee polyphenol extract ( CPE ) . Nineteen subjects consumed a test meal with either a placebo- or CPE-containing beverage . Blood biomarkers and FMD were measured at fasting and up to 180 minutes postpr and ially . The CPE beverage led to a significantly lower peak postpr and ial increase in blood glucose and diacron-reactive oxygen metabolite , and significantly higher postpr and ial FMD than the placebo beverage . Postpr and ial blood GLP-1 increase tended to be higher after ingestion of the CPE beverage , compared with placebo . Subclass analysis revealed that the CPE beverage significantly improved postpr and ial blood GLP-1 response and reduced blood glucose increase in the subjects with a lower insulinogenic index . Correlation analysis showed postpr and ial FMD was negatively associated with blood glucose increase after ingestion of the CPE beverage . In conclusion , these results suggest that coffee polyphenol consumption improves postpr and ial hyperglycemia and vascular endothelial function , which is associated with increased GLP-1 secretion and decreased oxidative stress in healthy humans",
"Caffeine acutely increases blood pressure and peripheral vascular resistance , in part because of sympathetic stimulation . Its effects on large artery properties are largely unknown . In a double-blind crossover study , 7 healthy subjects 26±2.6 years of age ( mean±SEM ) were studied for 90 minutes while in the supine position on 2 occasions separated by a week in r and om order after ingestion of 250 mL caffeinated ( 150 mg ) and decaffeinated ( Compared with baseline , arterial stiffness measured by carotid femoral pulse wave velocity increased progressively from 7.2±0.41 to 8.0±0.6 m/s ( P addition , arterial wave reflection , measured by applanation tonometry from the aortic pressure waveform , also increased from −5.7±7.6 % to 5.28%±5.6 ( P were seen with decaffeinated coffee intake . Although the integral of the brachial systolic and diastolic blood pressure values over the 90 minutes was larger ( P after caffeinated than decaffeinated coffee intake , the effect on aortic systolic and diastolic blood pressures was more pronounced ( P arterial tone and function and suggest that caffeine acutely increases arterial stiffness ",
"OBJECTIVES We investigated the acute and chronic combined effect of cigarette smoking and caffeine intake on aortic stiffness and wave reflections . BACKGROUND We have shown that smoking and caffeine separately increase arterial stiffness . Aortic stiffness and wave reflections are important determinants of the efficient performance of the cardiovascular system and prognosticators of cardiovascular risk . METHODS The acute effects of smoking ( one cigarette ) , caffeine ( 200 mg , equivalent to 2 cups of coffee ) , and smoking plus caffeine were studied in 24 healthy subjects according to a r and omized , placebo- and sham procedure-controlled crossover design . The chronic effect of smoking and caffeine was studied in a population study that enrolled 160 healthy subjects . RESULTS Acute study : there was a significant interaction between caffeine and smoking with regard to pulse-wave velocity ( p augmentation index ( p pulse-wave velocity and augmentation index increased further by 0.52 m/s and 13.4 % , respectively , reaching a total of 0.85 m/s and 17.4 % , 0.17 m/s and 9.2 % in excess of the mere sum of caffeine effect ( 0.33 m/s and 4 % ) alone and smoking effect alone ( 0.35 m/s and 4.2 % ) . Population study : there was a significant interaction of chronic coffee consumption and smoking regarding pulse-wave velocity ( p augmentation index ( p = 0.001 ) . CONCLUSIONS The present study shows , for the first time , that when smoking and caffeine intake are combined , they interact and exert a synergistic , unfavorable effect on aortic stiffness and wave reflections on both an acute and chronic basis",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"There is mounting evidence that specific dietary polyphenols can enhance vascular health by augmenting nitric oxide . Our aim was to investigate the acute effects of chlorogenic acid , an important dietary phenolic acid present in coffee ( 400 mg , equivalent to 2 cups of coffee ) , on nitric oxide status , endothelial function , and blood pressure . Healthy men and women ( n = 23 ) were recruited to a r and omized , double-blind , placebo-controlled , crossover trial . Chlorogenic acid result ed in significantly higher plasma concentrations of chlorogenic acid ( P systolic blood pressure ( -2.41 mmHg , 95 % CI : -0.03 , -4.78 ; P = 0.05 ) and diastolic blood pressure ( -1.53 mmHg , 95 % CI : -0.05 , -3.01 ; P = 0.04 ) were significantly lower with chlorogenic acid . Markers of nitric oxide status ( P > 0.10 ) and the measure of endothelial function ( P = 0.60 ) were not significantly influenced . Chlorogenic acid can lower blood pressure acutely , an effect that , if sustained , would benefit cardiovascular health",
"Although coffee is a widely used , pharmacologically active beverage , its impact on the cardiovascular system is controversial . To explore the effect of acute caffeine ingestion on brachial artery flow-mediated dilation ( FMD ) in subjects without coronary artery disease ( CAD ; controls ) and patients with CAD , we prospect ively assessed brachial artery FMD in 40 controls and 40 age- and gender-matched patients with documented stable CAD on 2 separate mornings 1 week to 2 weeks apart . After overnight fasting , discontinuation of all medications for ≥12 hours , and absence of caffeine for > 48 hours , participants received capsules with caffeine 200 mg or placebo . One hour after drug ingestion , participants underwent brachial artery FMD and nitroglycerin-mediated dilation ( NTG ) using high-resolution ultrasound . As expected , patients with CAD were more often diabetic , hypertensive , obese , dyslipidemic , and smoked more than controls ( p ) . Aspirin , Clopidogrel , angiotensin-converting enzyme inhibitors , β blockers , and statins were significantly more common in patients with CAD than in controls ( p ) . At baseline , FMD , but not NTG , was significantly lower in patients with CAD compared to controls . Acute caffeine ingestion significantly increased FMD ( patients with CAD 5.6 ± 5.0 % vs 14.6 ± 5.0 % , controls 8.4 ± 2.9 % vs 18.6 ± 6.8 % , p comparisons ) but not NTG ( patients with CAD 13.0 ± 5.2 % vs 13.8 ± 6.1 % , controls 12.9 ± 3.9 % vs 13.9 ± 5.8 % , p = NS for all comparisons ) and significantly decreased high-sensitivity C-reactive protein ( patients with CAD 2.6 ± 1.4 vs 1.4 ± 1.2 mg/L , controls 3.4 ± 3.0 vs 1.2 ± 1.0 mg/L , p conclusion , acute caffeine ingestion significantly improved endothelial function assessed by brachial artery FMD in subjects with and without CAD and was associated with lower plasma markers of inflammation",
"BACKGROUND Caffeine is the most widely used pharmacologic substance . Aortic stiffness is an important factor for cardiovascular system performance and a prognosticator of cardiovascular risk . We investigated the effect of caffeine on aortic stiffness in treated hypertensive patients . METHODS We studied the effect of caffeine ( 250 mg ) in 12 treated hypertensive patients according to a r and omized , placebo-controlled , double-blind , cross-over design during a 3-h period . Aortic stiffness was evaluated by carotid-femoral pulse wave velocity . RESULTS Systolic blood pressure ( BP ) and pulse pressure increased significantly throughout the study ( by 12.3 and 7.4 mm Hg , P = .005 and P diastolic BP did not change . Pulse wave velocity increased ( by 0.57 m/sec , P aortic stiffness . This effect of caffeine lasted throughout the study ( 3 h ) , peaking at 60 min and decreasing progressively thereafter . CONCLUSIONS These results demonstrate , for the first time , that caffeine exerts an acute unfavorable effect on aortic stiffness in treated hypertensive patients . This finding has important implication s for the impact of caffeine consumption on cardiovascular risk in hypertension",
"BACKGROUND Epidemiologic studies suggest that high flavonoid intake confers a benefit on cardiovascular outcome . Endothelial function , arterial stiffness , and wave reflections are important determinants of cardiovascular performance and are predictors of cardiovascular risk . METHODS The effect of flavonoid-rich dark chocolate ( 100 g ) on endothelial function , aortic stiffness , wave reflections , and oxidant status were studied for 3 h in 17 young healthy volunteers according to a r and omized , single-blind , sham procedure-controlled , cross-over protocol . Flow-mediated dilation ( FMD ) of the brachial artery , aortic augmentation index ( AIx ) , and carotid-femoral pulse wave velocity ( PWV ) were used as measures of endothelial function , wave reflections , and aortic stiffness , respectively . Plasma oxidant status was evaluated with measurement of plasma malondialdehyde ( MDA ) and total antioxidant capacity ( TAC ) . RESULTS Chocolate led to a significant increase in resting and hyperemic brachial artery diameter throughout the study ( maximum increase by 0.15 mm and 0.18 mm , respectively , P FMD increased significantly at 60 min ( absolute increase 1.43 % , P AIx was significantly decreased with chocolate throughout the study ( maximum absolute decrease 7.8 % , P Plasma MDA and TAC did not change after chocolate , indicating no alterations in plasma oxidant status . CONCLUSIONS Our study shows for the first time that consumption of dark chocolate acutely decreases wave reflections , that it does not affect aortic stiffness , and that it may exert a beneficial effect on endothelial function in healthy adults . Chocolate consumption may exert a protective effect on the cardiovascular system ; further studies are warranted to assess any long-term effects",
"Recent studies suggest that chlorogenic acids , which are the main components of the polyphenol class in coffee , decrease blood pressure , and that hydroxyhydroquinone ( HHQ ) , which is generated by roasting coffee beans , inhibits the antihypertensive effect of chlorogenic acids in brewed coffee . Here , we examined the vasoreactivity and antihypertensive effects of HHQ-reduced coffee in mild hypertension . The study design was a double blind , r and omized , placebo-controlled intervention study , with a 4-week run-in period , followed by an 8-week test beverage ingestion period . The subjects were Japanese men and women with mild hypertension and vascular failure , who were not taking any antihypertensive drugs . During the test beverage ingestion period , the subjects ingested either active or placebo HHQ-reduced coffee ( chlorogenic acids per 184 ml of coffee : active , 300 mg ; and placebo , 0 mg ) daily . Subjects were r and omly divided into two groups : active group ( n=9 ) and placebo group ( n=12 ) . In the active beverage group , endothelium-dependent , flow-mediated vasodilation impairment was significantly ameliorated and systolic blood pressure was significantly decreased from the baseline , but not in the placebo group . There were no test beverage consumption-related changes in other parameters that may influence blood pressure , such as pulse , cardiac output , body weight or 24-h urine volume . Ingestion of the active beverage significantly decreased urinary isoprostane levels , suggesting a reduced oxidative stress . These findings indicate that HHQ-reduced coffee decreased blood pressure in subjects with mild hypertension . The decreased blood pressure was associated with improved vascular endothelial function",
"Background / Objectives : Coffee is known to contain antioxidant substances whose effects may be blunted because of caffeine that may unfavorably affect the cardiovascular system . This study was design ed to investigate the acute dose-dependent effects of decaffeinated coffee ( DC ) on endothelial function measured by the brachial artery flow-mediated dilation (FMD).Subjects/ Methods : A total of 15 ( 8 men and 7 women ) healthy nonobese subjects underwent a single-blind , crossover study . Subjects ingested one and two cups of decaffeinated Italian espresso coffee in r and om order at 5- to 7-day intervals . Results : In the hour following the ingestion of two cups of DC , FMD increased ( mean±s.e.m . ) : 0 min , 7.4±0.7 % ; 30 min , 8.0±0.6 % ; 60 min , 10.8±0.8 % ; P DC ( 0 min , 6.9±0.7 % ; 30 min , 8.4±1.2 % ; 60 min , 8.5±1.1 % ; 3 × 2 repeated- measures analysis of variance : P=0.037 for time × treatment effect ) . Blood pressure did not differ between groups , and basal heart rate was lower in the two-cup group at baseline and 60 min . Conclusions : The present study demonstrated a significant acute favorable dose-dependent effect of decaffeinated espresso coffee on endothelial function . Further studies are needed to investigate the effects of chronic use of DC especially with respect to caffeinated coffee and in subjects with cardiovascular diseases",
"Our previous study revealed the antihypertensive effects of green coffee bean extract ( GCE ) ingestion in spontaneously hypertensive rats . We suggested that this antihypertensive action was due to the fact that GCE contains chlorogenic acid ( CQA ) as a major phenolic compound , and CQA in turn contains ferulic acid as a metabolic component that acts on nitric oxide ( NO ) derived from the vascular endothelium . In this study , the effects of GCE on blood vessels were evaluated in healthy males . The subjects were 20 healthy males with reduced vasodilation responses measured by strain gauge plethysmograms ( SPG ) to ischemic reactive hyperemia . Of the 20 subjects , 10 ( mean age , 37.2 years ) ingested a test drink containing GCE ( CQA : 140 mg/day ) , and the other 10 ( mean age , 34.8 years ) ingested a placebo drink for 4 months . During the ingestion period , SPG , pulse wave velocity ( PWV ) , and serum biochemical parameters were measured , and acceleration plethysmograms ( APG ) were taken . The reactive hyperemia ratio ( RHR ) in the test drink group began to increase after ingestion for 1 month and was significantly higher ( p plasma total homocysteine level compared with the pre-ingestion level . However , there were no significant differences in PWV or APG between the test drink group and the placebo drink group . The improvement in RHR after ingestion of a drink containing GCE suggested an improvement in vasoreactivity by this component",
"BACKGROUND Coffee , a source of antioxidants , has controversial effects on cardiovascular health . OBJECTIVE We evaluated the bioavailability of chlorogenic acids ( CGAs ) in 2 coffees and the effects of their consumption on the plasma antioxidant capacity ( AC ) , the serum lipid profile , and the vascular function in healthy adults . METHODS Thirty-eight men and 37 women with a mean ± SD age of 38.5 ± 9 y and body mass index of 24.1 ± 2.6 kg/m(2 ) were r and omly assigned to 3 groups : a control group that did not consume coffee or a placebo and 2 groups that consumed 400 mL coffee/d for 8 wk containing a medium ( MCCGA ; 420 mg ) or high ( HCCGA ; 780 mg ) CGA content . Both were low in diterpenes ( 0.83 mg/d ) and caffeine ( 193 mg/d ) . Plasma caffeic and ferulic acid concentrations were measured by GC , and the plasma AC was evaluated with use of the ferric-reducing antioxidant power method . The serum lipid profile , nitric oxide ( NO ) plasma metabolites , vascular endothelial function ( flow-mediated dilation ; FMD ) , and blood pressure ( BP ) were evaluated . RESULTS After coffee consumption ( 1 h and 8 wk ) , caffeic and ferulic acid concentrations increased in the coffee-drinking groups , although the values of the 2 groups were significantly different ( P 0.001 ) ; caffeic and ferulic acid concentrations were undetectable in the control group . At 1 h after consumption , the plasma AC in the control group was significantly lower than the baseline value ( -2 % ) and significantly increased in the MCCGA ( 6 % ) and HCCGA ( 5 % ) groups ( P differences in the lipid , FMD , BP , or NO plasma metabolite values were observed between the groups . CONCLUSIONS Both coffees , which contained CGAs and were low in diterpenes and caffeine , provided bioavailable CGAs and had a positive acute effect on the plasma AC in healthy adults and no effect on blood lipids or vascular function . The group that did not drink coffee showed no improvement in serum lipid profile , FMD , BP , or NO plasma metabolites . This trial was registered at registroclinico.sld.cu as RPCEC00000168",
"Coffee is one of the most widely used pharmacologically active beverages . The present study was design ed to evaluate the acute effect of coffee ingestion on endothelial function in healthy individuals , and the potential role of caffeine . We studied 17 healthy young adults ( 28.9+/-3.0 years old ; nine men ) , who were regular non-heavy coffee drinkers . The endothelial performance was estimated by endothelium-dependent FMD ( flow-mediated dilatation ) of the brachial artery before and 30 , 60 , 90 and 120 min after ingestion of a cup of caffeinated coffee ( 80 mg of caffeine ) or the corresponding decaffeinated beverage ( 2 mg of caffeine ) in two separate sessions , following a r and omized single-blind cross-over design . There was no difference in baseline FMD values between the two sessions [ 7.78 compared with 7.07 % after caffeinated and decaffeinated coffee respectively ; P = NS ( not significant ) ] . Caffeinated coffee led to a decline of FMD ( 7.78 , 2.86 , 2.12 , 4.44 and 4.57 % at baseline , 30 , 60 , 90 and 120 min respectively ; P adverse effect was focused at 30 ( P = 0.004 ) and 60 min ( P FMD was found with the decaffeinated coffee session ( 7.07 , 6.24 , 5.21 , 7.41 and 5.20 % ; P = NS ) . The composite effect of the type of coffee consumed over time on FMD was significantly different ( P = 0.021 ) . In conclusion , coffee exerts an acute unfavourable effect on the endothelial function in healthy adults , lasting for at least 1 h after intake . This effect might be attributed to caffeine , given that decaffeinated coffee was not associated with any change in the endothelial performance",
"Objective Caffeine is the most widely used pharmacologically active substance . Aortic elastic properties and arterial wave reflection are important factors for the efficient performance of the cardiovascular system , as well as prognosticators of cardiovascular risk . We investigated the effect of caffeine on aortic elastic properties and wave reflection . Design We studied the effect of caffeine ( 250 mg ) in 20 healthy subjects according to a r and omized , placebo-controlled , double-blind , cross-over design . Methods Aortic stiffness was evaluated with carotid-femoral pulse wave velocity and wave reflection with augmentation index of the aortic pressure waveform . Results Pulse wave velocity increased ( by 0.51 m/s , P aortic stiffness . Augmentation index and augmented pressure increased ( by 6.8 % , and by 4.4 mmHg , respectively , P reflections . Concurrently , both radial and aortic systolic , diastolic and pulse pressure increased significantly . However , this increase was 20 and 9 % larger for aortic systolic pressure ( at 30 and 60 min , P aortic pulse pressure ( at 30 min , P Caffeine affects unfavorably aortic stiffness and enhances wave reflections . This finding has implication s for the impact of caffeine consumption on cardiovascular risk",
"BACKGROUND Data concerning blood pressure changes , acutely induced by caffeine consumption , are conflicting . Furthermore , limited data exist regarding central hemodynamic response to caffeine ingestion by healthy young subjects . We investigated the acute effect of coffee ( 80 mg of caffeine ) and decaffeinated coffee on peripheral and central hemodynamics , as well as on wave reflections . SUBJECTS For this purpose , 16 healthy volunteers ( eight females and eight males , mean age 29+/-3.2 years ) were investigated . METHODS Repeated measurements were performed at baseline and 30 , 60 , 90 and 120 min after oral administration of each beverage in a double-blind crossover design . Aortic blood pressures , augmentation index ( AI ) and pressure ( AP ) and timing of reflected waves were evaluated by using applanation tonometry and pulse wave analysis . RESULTS Regular coffee increased central systolic ( SBP ) and diastolic pressure ( DBP ) from 96.2+/-9.9 to 101.1+/-10.1 mmHg , p=0.011 and from 72.6+/-9.4 to 76.5+/-9.0 mmHg , p=0.027 , respectively , but no change was observed following consumption of decaffeinated coffee . Peripheral systolic blood pressure did not change significantly after the administration of either coffee . Augmentation index increased significantly following regular coffee consumption . The change in AI was significantly higher following regular compared to decaffeinated coffee consumption as shown by analysis of variance ( ANOVA ) for repeated measures ( p=0.001 ) . CONCLUSIONS These caffeine effects reveal an unfavourable effect on wave reflections and therefore on left ventricular ( LV ) pulsatile afterload . It also revealed a significant acute effect of caffeine consumption on central hemodynamics which is not observed at peripheral pressures",
"Caffeine increases blood pressure ( BP ) . In men , acute BP elevations after caffeine intake are due to an increase in vascular resistance , with no change in cardiac output . The hemodynamic effects of caffeine have not been studied in women . Accordingly , BP and hemodynamic responses to caffeine were measured in a double-blind trial comparing age-matched men and women at rest and during mental stress . Caffeine ( 3.3 mg/kg , equivalent to 2 to 3 cups of brewed coffee ) or placebo was given to separate groups of women ( n = 21 and 21 ) and men ( n = 16 and 19 ) ( mean ages 29 and 27 years , respectively ) . BP , cardiac output , and vascular resistance were observed at rest , during a stressful public-speaking simulation , reading aloud , and recovery . Caffeine caused nearly identical systolic and diastolic BP elevations in women ( 4.5 and 3.3 mm Hg , respectively ) and men ( 4.1 and 3.8 mm Hg , respectively ) . Men given caffeine versus placebo showed the expected elevation in vascular resistance throughout the remainder of the protocol ( p cardiac output . In contrast , women responded to caffeine with increases in stroke volume ( p cardiac output ( p vascular resistance from women taking placebo . Men and women have similar BP responses to caffeine , but the BP responses may arise from different hemodynamic mechanisms . Women who consume a dietary dose of caffeine showed an increase in cardiac output , whereas men showed increased vascular resistance",
"Purpose The purpose of this study was to evaluate acute effects of coffee with a high content of chlorogenic acids and different hydroxyhydroquinone contents on postpr and ial endothelial dysfunction . Methods This was a single-blind , r and omized , placebo-controlled , crossover-within-subject clinical trial . A total of 37 patients with borderline or stage 1 hypertension were r and omized to two study groups . The participants consumed a test meal with a single intake of the test coffee . Subjects in the Study 1 group were r and omized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or coffee with a high content of chlorogenic acids and a high content of hydroxyhydroquinone with crossover . Subjects in the Study 2 group were r and omized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or placebo coffee with crossover . Endothelial function assessed by flow-mediated vasodilation and plasma concentration of 8-isoprostanes were measured at baseline and at 1 and 2 h after coffee intake . Results Compared with baseline values , single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone , but not coffee with a high content of chlorogenic acids and high content of hydroxyhydroquinone or placebo coffee , significantly improved postpr and ial flow-mediated vasodilation and decreased circulating 8-isoprostane levels . Conclusions These findings suggest that a single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone is effective for improving postpr and ial endothelial dysfunction . Clinical Trial Registration URL for Clinical Trial : https://upload.umin.ac.jp ; Registration Number for Clinical Trial : UMIN000013283",
"Coffee is a rich source of polyphenols , primarily chlorogenic acids ( CGA ) . Certain polyphenols and polyphenol-rich foods and beverages have been shown to improve endothelial function and lower blood pressure ( BP ) . The aim of the present study was to investigate the acute effect of two doses of CGA ( 5-CGA ) on endothelial function and BP . In a cross-over study , 16 healthy men and women received : ( i ) 0 mg purified 5-CGA ( control group ) ; ( ii ) 450 mg purified 5-CGA ; ( iii ) 900 mg purified 5-CGA ; and ( iv ) 200 mg purified (-)-epicatechin ( positive control ) in r and om order one week apart . Peak and continuous mean ( 60 to 240 s post ischaemia ) flow-mediated dilation ( FMD ) was measured at baseline , 1 h and 4 h. BP was measured at baseline and every 30 min to 4 h. Plasma CGA and epicatechin levels were significantly increased at both 1 h and 4 h post their respective treatments . Peak FMD was not significantly altered by either dose of 5-CGA or the epicatechin , relative to control ( p > 0.05 ) . Relative to control , effects on continuous mean FMD response following 450 mg 5-CGA and 900 mg of 5-CGA ( 0.47 ± 0.16 % , p = 0.016 and 0.65 ± 0.16 % , p BP . In conclusion , the present study has found no significant effect of 5-CGA , at 450 and 900 mg , on peak FMD response . However , there were significant improvements in mean post-ischaemic FMD response , particularly at the 1 h time point in this group of healthy individuals"
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Studies on the effect of the Nordic diet ( ND ) on body weight and adiposity indices were conflicting . This study targeted to perform a systematic review and meta- analysis of r and omized controlled clinical trials ( RCTs ) examined the effect of the ND on body weight and composition . PubMed , Scopus , ISI web of Science , ProQuest and Google Scholar were search ed for the eligible studies up to August 2019 . The weighted mean difference ( WMD ) in body weight and composition indices between the ND and control groups/periods was derived using r and om-effects model . In total , seven studies ( n = 774 participants ) were included in the present study . Five studies had illustrated the effect of the ND on weight , three on waist circumference ( WC ) , two on body fat , and two on body mass index ( BMI ) . The pooled analysis of eligible trials showed that those adhered to the ND lost 1.83 kg [ 95 % confidence interval ( CI ) − 2.94 , − 0.73 , P = 0.001 ] more weight compared to controls . Qualitative assessment of other anthropometric indices also showed a beneficial effect of this dietary pattern in improving body fat and BMI values ; however , these findings are not conclusive because of limited number of studies . Adherence to the ND significantly improves body weight ; however , there is also no certainty that this diet is effective for improving other anthropometric indices . Future studies regarding the effect of the ND on weight and body composition in population s other than Nordic population s are highly recommended . Level of evidence Level I , systematic review s and meta-analyses
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"BACKGROUND Ad libitum , low-carbohydrate diets decrease caloric intake and cause weight loss . It is unclear whether these effects are due to the reduced carbohydrate content of such diets or to their associated increase in protein intake . OBJECTIVE We tested the hypothesis that increasing the protein content while maintaining the carbohydrate content of the diet lowers body weight by decreasing appetite and spontaneous caloric intake . DESIGN Appetite , caloric intake , body weight , and fat mass were measured in 19 subjects placed sequentially on the following diets : a weight-maintaining diet ( 15 % protein , 35 % fat , and 50 % carbohydrate ) for 2 wk , an isocaloric diet ( 30 % protein , 20 % fat , and 50 % carbohydrate ) for 2 wk , and an ad libitum diet ( 30 % protein , 20 % fat , and 50 % carbohydrate ) for 12 wk . Blood was sample d frequently at the end of each diet phase to measure the area under the plasma concentration versus time curve ( AUC ) for insulin , leptin , and ghrelin . RESULTS Satiety was markedly increased with the isocaloric high-protein diet despite an unchanged leptin AUC . Mean ( + /-SE ) spontaneous energy intake decreased by 441 + /- 63 kcal/d , body weight decreased by 4.9 + /- 0.5 kg , and fat mass decreased by 3.7 + /- 0.4 kg with the ad libitum , high-protein diet , despite a significantly decreased leptin AUC and increased ghrelin AUC . CONCLUSIONS An increase in dietary protein from 15 % to 30 % of energy at a constant carbohydrate intake produces a sustained decrease in ad libitum caloric intake that may be mediated by increased central nervous system leptin sensitivity and results in significant weight loss . This anorexic effect of protein may contribute to the weight loss produced by low-carbohydrate diets",
"BACKGROUND Reproduction has been identified as an important factor for long-term weight gain among women . A previous efficacy trial has successfully produced postpartum weight loss ; however , the effectiveness of this intervention needs to be established . OBJECTIVE This study was design ed to evaluate the short- and long-term effectiveness of a diet behavior modification treatment to produce weight loss in postpartum women within the primary health care setting in Sweden . DESIGN During 2011 - 2014 , 110 women with a self-reported body mass index ( BMI ; in kg/m(2 ) ) of ≥27 at 6 - 15 wk postpartum were r and omly assigned to the diet behavior modification group ( D group ) or the control group ( C group ) . Women r and omly assigned to the D group ( n = 54 ) received a structured 12-wk diet behavior modification treatment by a dietitian and were instructed to gradually implement a diet plan based on the Nordic Nutrition Recommendations and to self-weigh ≥3 times/wk . Women r and omly assigned to the C group ( n = 56 ) were given a brochure on healthy eating . The primary outcome was change in body weight after 12 wk and 1 y. The retention rate was 91 % and 85 % at 12 wk and 1 y , respectively . RESULTS At baseline , women had a median ( 1st , 3rd quartile ) BMI of 31.0 ( 28.8 , 33.6 ) , and 84 % were breastfeeding . After 12 wk , median weight change in the D group was -6.1 kg ( -8.4 , -3.2 kg ) compared with -1.6 kg ( -3.5 , -0.4 kg ) in the C group ( P reduced BMI , waist circumference , hip circumference , and body fat percentage more than did the C group at both 12 wk and 1 y ( all P A low-intensity diet treatment delivered by a dietitian within the primary health care setting can produce clinical ly relevant and sustainable weight loss in postpartum women with overweight and obesity . This trial was registered at clinical trials.gov as NCT01949558",
"BACKGROUND The regional Mediterranean Diet has been associated with lower risk of disease . OBJECTIVE We tested the health effects of the New Nordic Diet ( NND ) , which is a gastronomically driven regional , organic , and environmentally friendly diet , in a carefully controlled but free-living setting . DESIGN A total of 181 central ly obese men and women , with a mean ( range ) age of 42 y ( 20 - 66 y ) , body mass index ( in kg/m(2 ) ) of 30.2 ( 22.6 - 47.3 ) , and waist circumference of 100 cm ( 80 - 138 cm ) were r and omly assigned to receive either the NND ( high in fruit , vegetables , whole grains , and fish ) or an average Danish diet ( ADD ) for 26 wk . Participants received cookbooks and all foods ad libitum and free of charge by using a shop model . The primary endpoint was the weight change analyzed by both completer and intention-to-treat analyses . RESULTS A total of 147 subjects [ 81 % ( NND 81 % ; ADD 82 % ) ] completed the intervention . A high dietary compliance was achieved , with significant differences in dietary intakes between groups . The mean ( ±SEM ) weight change was -4.7 ± 0.5 kg for the NND compared with -1.5 ± 0.5 kg for the ADD ( adjusted difference : -3.2 kg ; 95 % CI : -4.6 , -1.8 kg ; P greater reductions in systolic blood pressure ( adjusted difference : -5.1 mm Hg ; 95 % CI : -8.2 , -2.1 mm Hg ) and diastolic blood pressure ( adjusted difference : -3.2 mm Hg ; 95 % CI : -5.7 , -0.8 mm Hg ) than did the ADD . CONCLUSION An ad libitum NND produces weight loss and blood pressure reduction in central ly obese individuals . This trial was registered at www . clinical trials.gov as NCT01195610",
"Objective : It has been suggested that overweight is negatively associated with cognitive functions . The aim of this study was to investigate whether a reduction in body weight by dietary interventions could improve episodic memory performance and alter associated functional brain responses in overweight and obese women . Methods : 20 overweight postmenopausal women were r and omized to either a modified paleolithic diet or a st and ard diet adhering to the Nordic Nutrition Recommendations for 6 months . We used functional magnetic resonance imaging to examine brain function during an episodic memory task as well as anthropometric and biochemical data before and after the interventions . Results : Episodic memory performance improved significantly ( p = 0.010 ) after the dietary interventions . Concomitantly , brain activity increased in the anterior part of the right hippocampus during memory encoding , without differences between diets . This was associated with decreased levels of plasma free fatty acids ( FFA ) . Brain activity increased in pre-frontal cortex and superior/middle temporal gyri . The magnitude of increase correlated with waist circumference reduction . During episodic retrieval , brain activity decreased in inferior and middle frontal gyri , and increased in middle/superior temporal gyri . Conclusions : Diet-induced weight loss , associated with decreased levels of plasma FFA , improves episodic memory linked to increased hippocampal activity",
"Abstract Purpose The New Nordic Diet ( NND ) has induced weight loss in a 26-week controlled intervention . We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects . Methods After 26 weeks of intervention with NND or Average Danish Diet ( ADD ) , 147 participants ( mean age 43 years and mean BMI 29.1 kg/m2 ) were followed for further 52 weeks . All participants were encouraged to follow NND but without further guidance . The study is registered with Clinical Trials.gov , study i d NCT01195610 . Results One hundred and ten participants ( 75 % ) completed the follow-up . Among participants previously r and omised to NND ( NND group ) , dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0 , respectively ( both p satisfaction with NND was significantly higher than with ADD during follow-up ( 3.3 vs. 2.5 , p = 0.026 ) . Weight losses during intervention of −6.2 kg and −3.0 kg were followed by regains of 4.6 kg ( SE 0.5 ) and 1.1 kg ( SE 0.7 ) for the NND group and ADD group , respectively [ adjusted difference ; mean ( 95 % CI ) : 1.8 kg ( 0.1–3.4 ) , p = 0.041 ] . Across diet groups , every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026 ) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p Conclusions NND provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity",
"In 1997 , the World Health Organization published a l and mark document recognizing obesity as a worldwide disease that poses a serious threat to public health ( 1 ) . Persons who are overweight or obese have substantially increased risk for morbidity from numerous chronic disorders , such as diabetes ( 2 , 3 ) , hypertension ( 4 , 5 ) , and cardiovascular disease ( 6 , 7 ) . Obesity-related health risk is greater when excess fat is deposited in the abdomen region because this phenotype is a stronger predictor of cardiovascular disease and type 2 diabetes mellitus than general obesity is ( 8 - 11 ) . This may be partially explained by excess accumulation of visceral fat , an independent correlate of insulin resistance ( 9 - 11 ) and dyslipidemia ( 8 , 9 ) . These observations highlight the need to identify appropriate treatment strategies to prevent and reduce obesity and suggest that the effectiveness of these treatments would be enhanced if abdominal obesity , particularly visceral fat , was substantially reduced . Diet restriction remains the most common method of obesity reduction ( 12 ) . Despite the observation that low levels of physical activity are a major cause of obesity ( 13 ) , increased physical activity alone is not thought to be a useful strategy for obesity reduction . Some reports have suggested that physical activity in obese adults results in only modest weight loss ( approximately 1 to 2 kg ) independent of the effects of diet restriction ( 14 ) . However , these conclusions are drawn from studies in which individual energy intake and expenditure were not rigorously controlled or accurately measured ( 15 - 17 ) . Moreover , in most studies , the negative energy balance induced by exercise was modest enough that substantial weight loss was not expected ( 15 - 17 ) . Currently , no compelling evidence supports the observation that exercise alone is not a useful method for reducing total or abdominal obesity . It is well known that a single exercise session is associated with a significant improvement in insulin-stimulated glucose uptake ( 18 , 19 ) . It is also clear that weight loss is associated with an improvement in insulin action ( 20 - 24 ) . It is unclear , however , whether regular exercise improves glucose metabolism after the short-term effects of exercise and changes in body fat distribution are considered . Segal and colleagues ( 25 ) controlled for the confounding effect of the last exercise session and body composition changes and found that exercise had no independent effect on insulin sensitivity ( 25 ) . Given the established importance of insulin resistance as an antecedent to both cardiovascular disease and type 2 diabetes mellitus ( 26 ) , it is important to clarify whether exercise improves insulin action independent of fat loss . We performed a r and omized , controlled trial to determine the independent effect of diet-induced or exercise-induced weight loss on obesity and insulin resistance in moderately obese men . We also evaluated whether exercise without weight loss was associated with reductions in abdominal obesity and insulin resistance . Methods Participants Participants were recruited from Kingston , Ontario , Canada , a typical suburban region , through the general media . We selected men with a body mass index greater than 27 kg/m2 and a waist circumference greater than 100 cm whose weight had been stable ( 2 kg ) for 6 months before study entry . Participants were nonsmokers who consumed an average of fewer than two alcoholic beverages per day , had a sedentary lifestyle , and took no medications known to affect the principal outcome measures . All participants had a preparticipation medical examination that included screening for normal glucose tolerance and plasma lipid profile . A computer program was used to r and omly assign eligible men to one of the following four groups : control , diet-induced weight loss , exercise-induced weight loss , and exercise without weight loss ( Figure 1 ) . Of the 101 participants who were r and omly assigned to groups , 34 chose not to participate because they were dissatisfied with their assigned group , 5 were diabetic or dyslipidemic , and 3 were relocated because of job transfers . Those who chose not to participate and those who completed the trial were similar with regard to anthropometric variables . In addition , those who completed the trial were similar to those who did not in each group ( P > 0.10 ) . Baseline characteristics among groups were similar for all participants ( Table 1 ) . All participants gave fully informed written consent . The study was conducted in accordance with the ethical guidelines of Queen 's University . The participants did not receive monetary compensation . Figure 1 . Flow of participants through the study . Table 1 . Selected Anthropometric , Magnetic Resonance Imaging , and Metabolic Variables before Treatment and 3 Months after Treatment Diet and Exercise Regimen During the baseline period , daily energy requirements for all participants were determined by estimating resting energy expenditure and multiplying the obtained value by a factor of 1.5 ( 27 ) . All participants followed a weight maintenance diet ( 55 % to 60 % carbohydrate , 15 % to 20 % protein , and 20 % to 25 % fat ) for a 4- to 5-week baseline period . During this period , body weight was monitored to determine the accuracy of the prescribed energy requirement , which was adjusted accordingly to maintain body weight . Controls were asked to maintain body weight throughout the 12-week treatment period . Participants in the diet-induced weight loss group were asked to reduce the isocaloric diet by 700 kcal/d during the treatment period to achieve a weekly weight loss of approximately 0.6 kg . To lose the same amount of weight , participants in the exercise-induced weight loss group were asked to maintain the isocaloric diet for the duration of the treatment period and to perform exercise that expended 700 kcal/d . Participants assigned to exercise without weight loss were asked to maintain body weight . Therefore , they consumed enough calories to compensate for the energy expended during the daily exercise sessions ( approximately 700 kcal ) . At the end of the treatment period , isocaloric requirements were determined and prescribed for a 2-week weight stabilization period . All participants were free-living and consumed self-selected foods . No vitamins or other nutritional supplements were prescribed . Each person participated in a series of weekly 1-hour seminars in which a dietitian taught proper food selection and preparation . Participants were told that the composition of the maintenance and energy-reduced diets should be approximately 55 % to 60 % carbohydrate , 15 % to 20 % protein , and 20 % to 25 % fat . Participants kept and analyzed daily , detailed food records for the duration of the study period ( approximately 20 weeks ) ; the study dietitian also review ed these records . For the 2-week period during which doubly labeled water measurements were acquired ( weeks 6 and 7 ) , the diet records were analyzed by using a computerized program ( Food Processor , Esha Research , Salem , Oregon ) . Participants in both exercise groups performed daily exercise ( brisk walking or light jogging ) on a motorized treadmill for the duration of the 12-week trial . The length of each exercise session was determined by the time required to expend 700 kcal . Participants were asked to exercise at an intensity not greater than 70 % of their peak oxygen uptake ( Vo 2 ) ( approximately 80 % of maximal heart rate ) . Energy expenditure was determined by using the heart rate and oxygen consumption data that were obtained from the pretreatment grade d exercise test and were adjusted according to the results of two subsequent tests performed at weeks 4 and 8 . During each session , heart rate was monitored every 5 minutes by using an automated heart rate monitor ( Polar Oy , Kempele , Finl and ) . All exercise sessions were by appointment and were supervised . Peak Vo 2 was determined by using a grade d treadmill test and st and ard open-circuit spirometry techniques ( SensorMedics , Yorba Linda , California ) . Energy Expenditure Total energy expenditure for 14 days was measured by using a two-point doubly labeled water method ( 28 ) . Deuterium enrichment was analyzed by using a 903 deuterium dual-inlet isotope ratio mass spectrometer ( VG Isogas , Cheshire , United Kingdom ) . Oxygen-18 was determined by using a SIRA 12 isotope ratio mass spectrometer ( VG Isogas ) . Total energy expenditure was calculated by using the DeWeir formula ( 29 ) . After an overnight stay in the hospital , resting metabolic rate was measured at 7:00 a.m. by using indirect calorimetry with a modified mask system ( Teem 100 , Aerosport , Inc. , Ann Arbor , Michigan ) . Values were obtained for 30 minutes , and the last 25 minutes were used to determine resting metabolic rate . Resting systolic and diastolic blood pressure were measured when the participant was supine . Magnetic Resonance Imaging and Anthropometric Measurements Whole-body data from magnetic resonance imaging ( approximately 45 equidistant images ) were obtained with a General Electric 1.5-Tesla magnet ( Milwaukee , Wisconsin ) by using an established protocol described in detail elsewhere ( 30 ) . Once acquired , the data were transferred to a st and -alone work station ( Silicon Graphics , Mountain View , California ) for analysis with specially design ed computer software ( Tomovision , Inc. , Montreal , Canada ) , the procedures for which are described elsewhere ( 31 ) . For adipose tissue ( fat ) and skeletal muscle , volume units ( L ) were converted to mass units ( kg ) by multiplying the volumes by the assumed constant density for fat ( 0.92 kg/L ) and fat-free skeletal muscle ( 1.04 kg/L ) ( 32 ) . All anthropometric circumference measurements were obtained by using st and ard procedures described elsewhere ( 30 ) . Insulin Sensitivity and Glucose Tolerance Participants consumed a weight-maintenance diet consisting of at least 200 g of carbohydrate for a minimum of 4 days and were asked to avoid strenuous physical activity for 3 days before insulin",
"Background : Population s eating mainly vegetarian diets have lower blood pressure levels than those eating omnivorous diets . Epidemiologic findings suggest that eating fruits and vegetables lowers blood pressure",
"BACKGROUND Accumulation of myocardial triglycerides ( MTG ) is associated with impaired left ventricular ( LV ) remodelling and function in obese and diabetic subjects . The role of MTG accumulation in development of heart failure in this group of patients is unknown . Short-term studies suggest that diets that lead to weight loss could mobilize MTG , with a favourable effect on cardiac remodelling . In a 24-month , r and omized , investigator-blinded study , we assessed the effect of two different diets and subsequent weight loss on cardiac function and MTG in postmenopausal women . METHODS Sixty-eight healthy postmenopausal women with body mass index [ BMI ] ≥27kg/m(2 ) were r and omized to an ad libitum Palaeolithic diet ( PD ) or a Nordic Nutrition Recommendation ( NNR ) diet for 24months . Morphology , cardiac function , and MTG levels were measured using magnetic resonance ( MR ) scanning , including proton spectroscopy at baseline and 6 and 24months . RESULTS Despite mean weight losses of 4.9 ( 1.0 ) kg ( NNR ) and 7.8 ( 1.1 ) kg ( PD ) , the MTG content did not change over time ( p=0.98 in the NNR and p=0.11 in the PD group at 24months ) . Reduced left ventricular mass was observed in both diet groups over 24months . Blood pressure was reduced at 6months , but returned to baseline levels at 24months . End diastolic volume , stroke volume , and cardiac output decreased over time . No differences between diet groups were observed . CONCLUSIONS Diet intervention and moderate weight loss over 24months improved LV remodelling but did not alter MTG levels in overweight/obese postmenopausal women",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"OBJECTIVE the aim of this study was to investigate the effects of a healthy Nordic diet ( ND ) on cardiovascular risk factors . DESIGN AND SUBJECTS in a r and omized controlled trial ( NORDIET ) conducted in Sweden , 88 mildly hypercholesterolaemic subjects were r and omly assigned to an ad libitum ND or control diet ( subjects ' usual Western diet ) for 6 weeks . Participants in the ND group were provided with all meals and foods . Primary outcome measurements were low-density lipoprotein ( LDL ) cholesterol , and secondary outcomes were blood pressure ( BP ) and insulin sensitivity ( fasting insulin and homeostatic model assessment -insulin resistance ) . The ND was rich in high-fibre plant foods , fruits , berries , vegetables , whole grains , rapeseed oil , nuts , fish and low-fat milk products , but low in salt , added sugars and saturated fats . RESULTS the ND contained 27 % , 52 % , 19 % and 2 % of energy from fat , carbohydrate , protein and alcohol , respectively . In total , 86 of 88 subjects r and omly assigned to diet completed the study . Compared with controls , there was a decrease in plasma cholesterol ( -16 % , P , LDL cholesterol ( -21 % , P , high-density lipoprotein ( HDL ) cholesterol ( -5 % , P , LDL/HDL ( -14 % , P and apolipoprotein (apo)B/apoA1 ( -1 % , P reduced insulin ( -9 % , P = 0.01 ) and systolic BP by -6.6 ± 13.2 mmHg ( -5 % , P body weight decreased after 6 weeks in the ND compared with the control group ( -4 % , P for blood lipids , but not for insulin sensitivity or BP . There were no significant differences in diastolic BP or triglyceride or glucose concentrations . CONCLUSIONS a healthy ND improves blood lipid profile and insulin sensitivity and lowers blood pressure at clinical ly relevant levels in hypercholesterolaemic subjects",
"Background / Objectives : Our objective was to investigate changes in liver fat and insulin sensitivity during a 2-year diet intervention . An ad libitum Paleolithic diet ( PD ) was compared with a conventional low-fat diet (LFD).Subjects/ Methods : Seventy healthy , obese , postmenopausal women were r and omized to either a PD or a conventional LFD . Diet intakes were ad libitum . Liver fat was measured with proton magnetic resonance spectroscopy . Insulin sensitivity was evaluated with oral glucose tolerance tests and calculated as homeostasis model assessment -insulin resistance (HOMA-IR)/liver insulin resistance ( Liver IR ) index for hepatic insulin sensitivity and oral glucose insulin sensitivity (OGIS)/Matsuda for peripheral insulin sensitivity . All measurements were performed at 0 , 6 and 24 months . Forty-one women completed the examinations for liver fat and were included . Results : Liver fat decreased after 6 months by 64 % ( 95 % confidence interval : 54–74 % ) in the PD group and by 43 % ( 27–59 % ) in the LFD group ( P months , liver fat decreased 50 % ( 25–75 % ) in the PD group and 49 % ( 27–71 % ) in the LFD group . Weight reduction between baseline and 6 months was correlated to liver fat improvement in the LFD group ( rs=0.66 , P Hepatic insulin sensitivity improved during the first 6 months in the PD group ( P A PD with ad libitum intake had a significant and persistent effect on liver fat and differed significantly from a conventional LFD at 6 months . This difference may be due to food quality , for example , a higher content of mono- and polyunsaturated fatty acids in the PD . Changes in liver fat did not associate with alterations in insulin sensitivity ",
"OBJECTIVE Abdominal fat accumulation after menopause is associated with low- grade inflammation and increased risk of metabolic disorders . Effective long-term lifestyle treatment is therefore needed . METHODS Seventy healthy postmenopausal women ( age 60 ± 5.6 years ) with BMI 32.5 ± 5.5 were r and omized to a Paleolithic-type diet ( PD ) or a prudent control diet ( CD ) for 24 months . Blood sample s and fat biopsies were collected at baseline , 6 months , and 24 months to analyze inflammation-related parameters . RESULTS And roid fat decreased significantly more in the PD group ( P = 0.009 ) during the first 6 months with weight maintenance at 24 months in both groups . Long-term significant effects ( P adipose gene expression were found for toll-like receptor 4 ( decreased at 24 months ) and macrophage migration inhibitory factor ( increased at 24 months ) in both groups . Serum interleukin 6 ( IL-6 ) and tumor necrosis factor α levels were decreased at 24 months in both groups ( P P = 0.022 ) . High-sensitivity C-reactive protein was decreased in the PD group at 24 months ( P = 0.001 ) . CONCLUSIONS A reduction of abdominal obesity in postmenopausal women is linked to specific changes in inflammation-related adipose gene expression"
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Reaction time ( RT ) deficits are reported following concussion , but it is unknown when these deficits normalize to pre-injury status . It is also unclear how factors such as RT measurement technique and participant characteristics influence post-concussion RT . The purpose of this systematic review and meta- analysis was to ( 1 ) characterize acute post-concussion ( 0–3 days ) RT impairments , ( 2 ) examine RT recovery over time , and ( 3 ) explore moderating factors related to acute RT impairment following concussion . Data base search es ( PubMed , CINAHL , EBSCOhost ) were conducted according to PRISMA guidelines for articles published in English from January 2002 to March 2019 . Studies compared baseline-to-post-injury RT within individuals ( within-subject ) and /or RT in concussed individuals to non-concussed controls ( between-subject ) . Sixty studies met inclusion criteria , reporting on a total of 9688 participants with 214 discrete RT effects ( Hedges ’ d ; between-subject : N = 29 , k = 129 ; within-subject : N = 42 , k = 85 ) . Of the 214 effects , 93 occurred in the acute ( 0–3 days ) post-injury timeframe ( k = 47 between-subject ) . Numerous demographic [ sex , age , concussion history , population type ( athlete , military , and general population ) , athlete level ( high school , college ) , and sport ] , and method -based ( RT test and measure type , computerized neurocognitive testing platform , concussion definition , and time post-injury ) moderators were examined for mean effect influence . Mixed-effects multi-level modeling with restricted-maximum-likelihood estimation was used to account for nested effects and high heterogeneity for the pooled effect size ( D+ ) . Significant medium-magnitude RT deficits were observed acutely for between- ( D+ = − 0.7279 , 95 % CI − 0.9919 , − 0.4639 , I2 = 88.66 , p . RT deficits were present at the sub-acute and intermediate-term timeframes for between-subject effects ( sub-acute : D+ = − 0.5655 , 95 % CI − 0.6958 , − 0.4352 , p 0.0245 ) . No significant RT mean effect was observed for the between-subject model at the long-term timeframe , indicating RT recovery among concussed participants relative to controls ( D+ = 0.3505 , 95 % CI − 0.4787 , 1.1797 , p = 0.3639 ) . Sex was a significant moderator for between-subject effects , with every 1 % male sample size increase demonstrating − 0.0171 ( 95 % CI − 0.0312 , − 0.0029 , p = 0.0193 ) larger RT deficits . Within-subject effect models result ed in RT measure type ( simple : [ D+ = − 0.9826 ] vs. mixed : [ D+ = − 0.6557 ] , p = 0.0438 ) and computerized neurocognitive testing platforms ( ANAM : [ D+ = − 0.3735 ] vs. HeadMinder CRI : [ D+ = − 1.4799 ] vs. ImPACT : [ D+ = − 0.6749 ] , p = 0.0004 ) having significantly different RT-deficit magnitudes . No other moderators produced significantly different RT-deficit magnitudes ( between-subject : [ p ≥ 0.0763 ] , within-subject : [ p ≥ 0.1723 ] ) . Robust RT deficits were observed acutely following concussion . Minimal magnitude differences were noted when comparing between- and within-subject effects , suggesting that pre-injury baselines may not add clinical value in determining post-injury RT impairment . RT deficits persisted up till the intermediate-term ( 21–59 days post-injury ) timeframe and indicate lingering deficits exist . Mean effect size differences were observed between RT measure types and computerized neurocognitive testing platforms ; however , all categories displayed negative effects consistent with impaired RT following concussion . Clinical interpretation suggests that measuring RT post-concussion is more important than considering the RT method employed so long as reliable and valid tools are used . PROSPERO Registration # CRD42019119323
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"Background Neurocognitive testing has been endorsed as a “ cornerstone ’ of concussion management by recent Vienna and Prague meetings of the Concussion in Sport Group . Neurocognitive testing is important given the potential unreliability of athlete self-report after injury . Relying only on athletes'ormalities after injury . Study Design Case control study ; Level of evidence , 3 . Methods High school and college athletes with a diagnosed concussion were tested 2 days after injury . Postinjury neurocognitive performance ( Immediate Postconcussion Assessment and Cognitive Testing ) and symptom ( postconcussion symptom ) scores were compared with preinjury ( baseline ) scores and with those of an agex and education-matched noninjured athlete control group . “ Abnormal ” test performance was determined statistically with Reliable Change Index scores . Results Sixty-four percent of concussed athletes reported a significant increase in symptoms , as judged by postconcussion symptom scores , compared with preinjury baseline at 2 days after injury . Eighty-three percent of the concussed sample demonstrated significantly poorer neurocognitive test results relative to their own baseline performance . The addition of neurocognitive testing result ed in a net increase in sensitivity of 19 % . Ninety-three percent of the sample had either abnormal neurocognitive test results or a significant increase in symptoms , relative to their own baseline ; 30 % of a control group demonstrated either abnormalities in neurocognitive testing or elevated symptoms , as judged by postconcussion symptom scores . For the concussed group , use of symptom and neurocognitive test results result ed in an increased yield of 29 % overreliance on symptoms alone . In contrast , 0 % of the control group had both symptoms and abnormal neurocognitive testing . Conclusion Reliance on patients ’ self-reported symptoms after concussion is likely to result in underdiagnosis of concussion and may result in premature return to play . Neurocognitive testing increases diagnostic accuracy when used in conjunction with self-reported symptoms",
"This study explored the diagnostic utility of the composite scores of Immediate Post-Concussion Assessment and Cognitive Testing ( ImPACT ) and Post Concussion Symptom Scale scores ( PCSS ) . Recently concussed high school athletes ( N=72 ) were tested within 72 h of sustaining a concussion , and data were compared to non-concussed high school athletes with no history of concussion ( N=66 ) . Between-groups MANOVA revealed a significant multivariate effect of concussion on test performance ( p ImPACT composite scores , as well as the PCSS to classify concussion status . One discriminant function was identified that consisted of the Visual Memory , Processing Speed , and Impulse Control composite scores PCSS , which correctly classified 85.5 % of the cases . Approximately 82 % of participants in the concussion group and 89 % of participants in the control group were correctly classified . Using these data , the sensitivity of ImPACT was 81.9 % , and the specificity was 89.4 % . As part of a formal concussion management program , ImPACT is a useful tool for the assessment of the neurocognitive and neurobehavioral sequelae of concussion , and can also provide post-injury cognitive and symptom data that can assist a practitioner in making safer return to play decisions",
"Objective Computerized neurocognitive assessment tools ( NCATS ) are often used as a screening tool to identify cognitive deficits after mild traumatic brain injury ( mTBI ) . However , differing methodology across studies renders it difficult to identify a consensus regarding the validity of NCATs . Thus , studies where multiple NCATs are administered in the same sample using the same methodology are warranted . Method We investigated the validity of four NCATs : the ANAM4 , CNS-VS , CogState , and ImPACT . Two NCATs were r and omly assigned and a battery of traditional neuropsychological ( NP ) tests administered to healthy control active duty service members ( n = 272 ) and to service members within 7 days of an mTBI ( n = 231 ) . Analyses included correlations between NCAT and the NP test scores to investigate convergent and discriminant validity , and regression analyses to identify the unique variance in NCAT and NP scores attributed to group status . Effect sizes ( Cohen 's f2 ) were calculated to guide interpretation of data . Results Only 37 ( 0.6 % ) of the 5,655 correlations calculated between NCATs and NP tests are large ( i.e. r ≥ 0.50 ) . The majority of correlations are small ( i.e. 0.30 > r ≥ 0.10 ) , with no clear patterns suggestive of convergent or discriminant validity between the NCATs and NP tests . Though there are statistically significant group differences across most NCAT and NP test scores , the unique variance accounted for by group status is minimal ( i.e. semipartial R2 ≤ 0.033 , 0.024 , 0.062 , and 0.011 for ANAM4 , CNS-VS , CogState , and ImPACT , respectively ) , with effect sizes indicating small to no meaningful effect . Conclusion Though the results are not overly promising for the validity of the four NCATs we investigated , traditional methods of investigating psychometric properties may not be appropriate for computerized tests . We offer several conceptual and method ological considerations for future studies regarding the validity of NCATs",
"OBJECTIVES To prospect ively examine the relationship of sport-related concussion with depression and neurocognitive performance and symptoms among male and female high school and college athletes . A secondary objective was to explore age and sex differences . DESIGN Pretest , multiple posttest , repeated- measures design . SETTING Laboratory . PARTICIPANTS High school and collegiate athletes ( N=75 ) with a diagnosed concussion . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Beck Depression Inventory-II and computerized neurocognitive test battery ( Immediate Post-concussion Assessment and Cognitive Test ) , which includes concussion symptoms ( Post-concussion Symptom Scale ) at baseline and at 2 , 7 , and 14 days postinjury . RESULTS Concussed athletes exhibited significantly higher levels of depression from baseline at 2 days ( P≤.001 ) , 7 days ( P=.006 ) , and 14 days postconcussion ( P=.04 ) . Collegiate athletes demonstrated a significant increase in depression at 14 days postconcussion than did high school athletes ( P=.03 ) . There were no sex differences in depression levels . Neurocognitive decrements at 14 days were supported for reaction time ( P=.001 ) and visual memory ( P=.001 ) . Somatic depression at 7 days postconcussion was related to slower reaction time at 7 days postconcussion . Somatic depression at 14 days postinjury was related to lower visual memory scores at 14 days postinjury . CONCLUSIONS Although not clinical ly significant , athletes experienced increased depression scores up to 14 days after concussion that coincided with neurocognitive decrements in reaction time and visual memory . Somatic depression appears to be most salient with regard to lower neurocognitive performance . Mood assessment s after concussion are warranted to help monitor and enhance recovery",
"Introduction Quality assessment of included studies is an important component of systematic review s. Objective The authors investigated inter-rater and test – retest reliability for quality assessment s conducted by inexperienced student raters . Design Student raters received a training session on quality assessment using the Jadad Scale for r and omised controlled trials and the Newcastle – Ottawa Scale ( NOS ) for observational studies . Raters were r and omly assigned into five pairs and they each independently rated the quality of 13–20 articles . These articles were drawn from a pool of 78 papers examining cognitive impairment following electroconvulsive therapy to treat major depressive disorder . The articles were r and omly distributed to the raters . Two months later , each rater re-assessed the quality of half of their assigned articles . Setting McMaster Integrative Neuroscience Discovery and Study Program . Participants 10 students taking McMaster Integrative Neuroscience Discovery and Study Program courses . Main outcome measures The authors measured inter-rater reliability using κ and the intraclass correlation coefficient type 2,1 or ICC(2,1 ) . The authors measured test – retest reliability using ICC(2,1 ) . Results Inter-rater reliability varied by scale question . For the six-item Jadad Scale , question -specific κs ranged from 0.13 ( 95 % CI −0.11 to 0.37 ) to 0.56 ( 95 % CI 0.29 to 0.83 ) . The ranges were −0.14 ( 95 % CI −0.28 to 0.00 ) to 0.39 ( 95 % CI −0.02 to 0.81 ) for the NOS cohort and −0.20 ( 95 % CI −0.49 to 0.09 ) to 1.00 ( 95 % CI 1.00 to 1.00 ) for the NOS case – control . For overall scores on the six-item Jadad Scale , ICC(2,1)s for inter-rater and test – retest reliability ( accounting for systematic differences between raters ) were 0.32 ( 95 % CI 0.08 to 0.52 ) and 0.55 ( 95 % CI 0.41 to 0.67 ) , respectively . Corresponding ICC(2,1)s for the NOS cohort were −0.19 ( 95 % CI −0.67 to 0.35 ) and 0.62 ( 95 % CI 0.25 to 0.83 ) , and for the NOS case – control , the ICC(2,1)s were 0.46 ( 95 % CI −0.13 to 0.92 ) and 0.83 ( 95 % CI 0.48 to 0.95 ) . Conclusions Inter-rater reliability was generally poor to fair and test – retest reliability was fair to excellent . A pilot rating phase following rater training may be one way to improve agreement",
"OBJECTIVE Our purpose was to determine whether sex differences exist with respect to post-concussion symptoms and neurocognitive function in concussed collegiate athletes . METHODS A prospect i ve dependent- sample cohort design was used to compare baseline and post-concussion neuropsychological test scores and endorsed symptoms as functions of serial post-concussion assessment with respect to time and sex . The Immediate Post-concussion Assessment and Cognitive Testing ( ImPACT ) battery was administered to a multicenter analysis group of 79 concussed athletes . This computerized neuropsychological test was given to the athletes during the preseason and , on average , 2 and 8 days postinjury . RESULTS Multivariate analyses revealed no significant between-group differences on baseline test performance with respect to sex on any of the ImPACT composite scores or on the total symptom score . Multivariate analyses of post-concussion data revealed a significant main effect of time on ImPACT scores , but no main effect of sex was identified , and no time-by-sex interaction existed . Post hoc analysis revealed that concussed female athletes performed significantly worse than concussed male athletes on visual memory tasks ( P = 0.001 ) , and analysis of endorsed post-concussion symptoms revealed that concussed men were significantly more likely than concussed women to report post-concussion symptoms of vomiting ( P = 0.001 ) and sadness ( P = 0.017 ) . Athletes ' scores were examined individually using the reliable-change methodology . At 2 days post-injury , 58 % of concussed athletes had one or more reliable incidents of performance decline or increases in symptom reporting . At 8 days post-concussion , 30 % of concussed athletes were still showing one or more reliable change from preseason values . CONCLUSIONS College athletes exhibit differences on visual memory composite scores and symptoms post-concussion as a function of sex . These data support the importance of evaluating neuropsychological status and post-concussion symptoms in concussed athletes . In addition , these data illustrate the importance of analyzing an individual athlete 's recovery pattern , because individual differences in recovery trajectories may be overshadowed by global norm-group comparisons",
"The purpose of the current study was to explore potential differences in pre- and post-concussion performance on a computerized neurocognitive concussion test between African American and White high-school and collegiate student-athletes . A prospect i ve case-control design was used to compare baseline and 2- and 7-day post-concussion computerized neurocognitive performance and symptoms between 48 White and 48 African American athletes matched for age , gender , and concussion history . The Immediate Post-Concussion Assessment Cognitive Test ( ImPACT ) version 2.0 ( NeuroHealth System , LLC , Pittsburgh , PA , USA ) computer software program was used to assess neurocognitive function ( i.e. , verbal and visual memory , motor processing speed , and reaction time ) and concussion symptoms . Regardless of race/ethnicity , there were significant decrements in computerized neurocognitive performance and increased symptoms following a concussion for the entire sample . African Americans and Whites did not differ significantly on baseline or post-concussion verbal memory , visual memory , reaction time , and total reported symptoms . However , African American participants were 2.4 × more likely to have at least one clinical ly significant cognitive decline on ImPACT at 7 days post-concussion and scored lower at 7 days post-concussion compared with baseline on processing speed than White participants . The authors concluded that the baseline ImPACT test was culturally equivalent and construct valid for use with these two racial/ethnic groups . However , in contrast , the findings support deleterious performance for the African American athletes compared with the White athletes on the ImPACT post-concussion evaluation that is of critical clinical relevance and warrants further research",
"The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted",
"BACKGROUND Head trauma in adolescents has been linked with deficits in attention and executive function that can compromise the performance of everyday tasks . Although previous research has examined this issue using computerized neuropsychological testing , little work has been done using laboratory-based measurements of attention and executive function in this population . A longitudinal analysis of recovery patterns of these measures among adolescents is central to underst and ing the effects of concussions across the age spectrum . PURPOSE This study prospect ively and longitudinally examined laboratory-based measures of attention and executive function in concussed adolescents sequentially during a 2-month period after injury . METHODS Two measures of attention and executive function , the Attentional Network Test and the Task-Switching Test , were administered to 20 concussed adolescents within 72 h postinjury as well as at 1 wk , 2 wk , 1 month , and 2 months postinjury . Twenty healthy , matched control subjects were similarly assessed at the same time intervals . Data were analyzed by two-way , mixed-effects ANOVA to determine the effect of group and time on the dependent variables . RESULTS Compared with control subjects , the concussed group exhibited a significantly greater switch cost on the Task-Switching Test ( P = 0.038 , mean difference value = 38 ms ) and a significantly greater reaction time for the Attentional Network Test conflict effect component ( P = 0.015 , mean difference value = 34 ms ) for up to 2 months after injury . CONCLUSIONS Concussed adolescents have difficulty recovering executive function after injury and may require extended recuperation time before full recovery is achieved . Evaluations focusing on attention and executive function can be useful additions in the assessment and follow-up after head injury",
"BACKGROUND Concussion is a common neurological injury occurring during contact sport . Current guidelines recommend that no athlete should return to play while symptomatic or displaying cognitive dysfunction . This study compared post-concussion cognitive function in recently concussed athletes who were symptomatic/asymptomatic at the time of assessment with that of non-injured ( control ) athletes . METHODS Prospect i ve study of 615 male Australian Rules footballers . Before the season , all participants ( while healthy ) completed a battery of baseline computerised ( CogSport ) and paper and pencil cognitive tasks . Sixty one injured athletes ( symptomatic = 25 and asymptomatic = 36 ) were reassessed within 11 days of being concussed ; 84 controls were also reassessed . The serial cognitive function of the three groups was compared using analysis of variance . RESULTS The performance of the symptomatic group declined at the post-concussion assessment on computerised tests of simple , choice , and complex reaction times compared with the asymptomatic and control groups . The magnitude of changes was large according to conventional statistical criteria . On paper and pencil tests , the symptomatic group displayed no change at re assessment , whereas large improvements were seen in the other two groups . CONCLUSION Injured athletes experiencing symptoms of concussion displayed impaired motor function and attention , although their learning and memory were preserved . These athletes displayed no change in performance on paper and pencil tests in contrast with the improvement observed in asymptomatic and non-injured athletes . Athletes experiencing symptoms of concussion should be withheld from training and competition until both symptoms and cognitive dysfunction have resolved",
"Objective To investigate the clinical utility and sensitivity of a portable , automatic , frontal quantitative electroencephalographic ( QEEG ) acquisition device currently in development in detecting abnormal brain electrical activity after sport-related concussion . Design This was a prospect i ve , non-r and omized study of 396 high school and college football players , including cohorts of 28 athletes with concussion and 28 matched controls . All subjects underwent preseason baseline testing on measures of postconcussive symptoms , postural stability , and cognitive functioning , as well as QEEG . Clinical testing and QEEG were repeated on day of injury and days 8 and 45 postinjury for the concussion and control groups . Main Outcomes and Results The injured group reported more significant postconcussive symptoms during the first 3 days postinjury , which resolved by days 5 and 8 . Injured subjects also performed poorer than controls on neurocognitive testing on the day of injury , but no differences were evident on day 8 or day 45 . QEEG studies revealed significant abnormalities in electrical brain activity in the injured group on day of injury and day 8 postinjury , but not on day 45 . Conclusions Results from the current study on clinical recovery after sport-related concussion are consistent with early reports indicating a typical course of full recovery in symptoms and cognitive dysfunction within the first week of injury . QEEG results , however , suggest that the duration of physiological recovery after concussion may extend longer than observed clinical recovery . Further study is required to replicate and extend these findings in a larger clinical sample , and further demonstrate the utility of QEEG as a marker of recovery after sport-related concussion",
"INTRODUCTION Mild traumatic brain injury ( mTBI ) has traditionally been considered to cause no significant brain damage since symptoms spontaneously remit after a few days . However , this idea is facing increasing scrutiny . The purpose of this study is to demonstrate the presence of early cognitive alterations in a series of patients with mTBI and to link these findings to different markers of brain damage . METHODS We conducted a prospect i ve study of a consecutive series of patients with mTBI who were evaluated over a 12-month period . Forty-one ( 3.7 % ) of the 1144 included patients had experienced a concussion . Patients underwent a routine clinical evaluation and a brain computed tomography ( CT ) scan , and were also administered a st and ardised test for post-concussion symptoms within the first 24hours of mTBI and also 1 to 2 weeks later . The second assessment also included a neuropsychological test battery . The results of these studies were compared to those of a control group of 28 healthy volunteers with similar characteristics . Twenty patients underwent an MRI scan . RESULTS Verbal memory and learning were the cognitive functions most affected by mTBI . Seven out of the 20 patients with normal CT findings displayed structural alterations on MR images , which were compatible with diffuse axonal injury in 2 cases . CONCLUSIONS Results from this pilot study suggest that early cognitive alterations and structural brain lesions affect a considerable percentage of patients with post-concussion syndrome following mTBI",
"IMPORTANCE Animal models suggest that reduced cerebral blood flow ( CBF ) is one of the most enduring physiological deficits following concussion . Despite this , longitudinal studies documenting serial changes in regional CBF following human concussion have yet to be performed . OBJECTIVE To longitudinally assess the recovery of CBF in a carefully selected sample of collegiate athletes and compare time course of CBF recovery with that of cognitive and behavioral symptoms . DESIGN , SETTING , AND PARTICIPANTS A cohort of collegiate football athletes ( N = 44 ) participated in this mixed longitudinal and cross-sectional study at a private research institute specializing in neuroimaging between March 2012 and December 2013 . Serial imaging occurred approximately 1 day , 1 week , and 1 month postconcussion for a subset of participants ( n = 17 ) . All athletes reported no premorbid mood disorders , anxiety disorders , substance abuse , or alcohol abuse . MAIN OUTCOMES AND MEASURES Arterial spin labeling magnetic resonance imaging was used to collect voxelwise relative CBF at each visit . Neuropsychiatric evaluations and a brief cognitive screen were also performed at all 3 points . Clinicians trained in sports medicine provided an independent measure of real-world concussion outcome ( ie , number of days withheld from competition ) . RESULTS The results indicated both cognitive ( simple reaction time ) and neuropsychiatric symptoms at 1 day postinjury that resolved at either 1 week ( cognitive ; P CBF recovery in the right insular and superior temporal cortex . Importantly , CBF in the dorsal midinsular cortex was both decreased at 1 month postconcussion in slower-to-recover athletes ( t11 = 3.45 ; P = .005 ) and was inversely related to the magnitude of initial psychiatric symptoms ( Hamilton Depression Scale : r = -0.64 , P = .02 ; Hamilton Anxiety Scale : r = -0.56 , P = .046 ) , suggesting a potential prognostic indication for CBF as a biomarker . CONCLUSIONS AND RELEVANCE To our knowledge , these results provide the first prospect i ve evidence of reduced CBF in human concussion and subsequent recovery . The resolution of CBF abnormalities closely mirrors previous reports from the animal literature and show real-world validity for predicting outcome following concussion",
"There is a subset of patients with mild traumatic brain injury ( mTBI ) who report persistent symptoms that impair their functioning and quality of life . Being able to predict which patients will experience prolonged symptom recovery would help clinicians target re sources for clinical follow-up to those most in need , and would facilitate research to develop precision medicine treatments for mTBI . The purpose of this study was to investigate the predictors of symptom recovery in a prospect i ve sample of emergency department trauma patients with either mTBI or non-mTBI injuries . Subjects were examined at several time points from within 72 h to 45 days post-injury . We quantified and compared the value of a variety of demographic , injury , and clinical assessment ( symptom , neurocognitive ) variables for predicting self-reported symptom duration in both mTBI ( n = 89 ) and trauma control ( n = 73 ) patients . Several injury-related and neuropsychological variables assessed acutely ( symptom duration , particularly loss of consciousness ( mTBI group ) , acute somatic symptom burden ( both groups ) , and acute reaction time ( both groups ) , with reasonably good model fit when including all of these variables ( area under the receiver operating characteristic curve [ AUC ] = 0.76 ) . Incorporating self-reported litigation involvement modestly increased prediction further ( AUC = 0.80 ) . The results highlight the multifactorial nature of mTBI recovery , and injury recovery more generally , and the need to incorporate a variety of variables to achieve adequate prediction . Further research to improve this model and vali date it in new and more diverse trauma sample s will be useful to build a neurobiopsychosocial model of recovery that informs treatment development",
"OBJECTIVES To evaluate the effect of concussion on clinical ly measured reaction time ( RT(clin ) ) and in comparison to a computerized reaction time measure ( RT(comp ) ) . DESIGN Prospect i ve , repeated measures observational study . SETTING Athletic training clinic at a National Collegiate Athletic Association ( NCAA ) Division I university . PARTICIPANTS Data are reported for 9 collegiate athletes with acute concussion who were part of a larger cohort of 209 athletes recruited from the university 's football , women 's soccer , and wrestling teams before the start of their respective athletic seasons . METHODS Baseline RT(clin ) and RT(comp ) were measured during preparticipation physical examinations . RT(clin ) measured the time required to catch a suspended vertical shaft by h and closure after its release by the examiner . RT(comp ) was derived from the simple RT component of the CogState-Sport computerized neurocognitive test battery . Athletes who subsequently sustained a physician-diagnosed concussion underwent repeated RT(clin ) and RT(comp ) testing within 72 hours of injury . A Wilcoxon signed rank test was used to compare baseline and after-injury RTs . MAIN OUTCOME MEASUREMENTS After-injury changes in RT(clin ) and RT(comp ) were calculated with respect to each athlete 's own preseason baseline value . RESULTS After-injury RT(clin ) was prolonged in 8 of the 9 athletes with concussions , whereas RT(comp ) was prolonged in 5 of the 9 athletes with concussions . The mean ( st and ard deviation ) RT(clin ) increased from 193 ± 21 ms to 219 ± 31 ms ( P = .050 ) , and mean RT(comp ) increased from 247 ± 75 to 462 ± 120 ms ( P = .214 ) . CONCLUSIONS We concluded that RT(clin ) appears to be sensitive to the known prolongation of RT after concussion and compares favorably with an accepted computerized RT measure . This study supports the potential utility of RT(clin ) as part of a multifaceted concussion assessment battery",
"CONTEXT Athletic trainers ( ATs ) are often the first health care providers to conduct concussion assessment s and carry out postinjury management . Best practice s for concussion evaluation and management have changed rapidly in recent years , outdating previous reports of ATs ' concussion practice s. OBJECTIVE To examine ATs ' current concussion- assessment and -management techniques . DESIGN Cross-sectional study . SETTING Web-based survey . PATIENTS OR OTHER PARTICIPANTS A r and om convenience sample of 8777 ATs ( response rate = 15.0 % [ n = 1307 ] ; years certified = 15.0 ± 10.6 ) from the National Athletic Trainers ' Association membership . MAIN OUTCOME MEASURE(S ) Survey Web links were e-mailed to prospect i ve participants , with 2 follow-up e-mails sent by the National Athletic Trainers ' Association . The survey collected demographic information , the number of concussions assessed , the concussion-recovery patterns , and the assessment and return-to-participation ( RTP ) decision-making methods used . RESULTS The ATs reported assessing a median of 12.0 ( range = 0 - 218 ) concussions per year . A total of 95.3 % ( 953/1000 ) ATs cited clinical examination as the most frequently used concussion- assessment tool , followed by symptom assessment ( 86.7 % ; 867/1000 ) . A total of 52.7 % ( 527/1000 ) ATs described a 3-domain minimum multidimensional concussion- assessment battery . Published RTP guidelines were the most common RTP decision-making tool ( 91.0 % ; 864/949 ) , followed by clinical examination ( 88.2 % ; 837/949 ) . The ATs with master 's degrees were 1.36 times ( 95 % confidence interval [ CI ] = 1.02 , 1.81 ) more likely to use a 3-domain concussion- assessment battery than ATs with only bachelor 's degrees ( χ2 = 4.44 , P = .05 ) . Collegiate ATs were 2.12 ( 95 % CI = 1.59 , 2.84 ) and 1.63 ( 95 % CI = 1.03 , 2.59 ) times more likely to use a 3-domain concussion- assessment battery than high school and clinic-based ATs , respectively ( χ2 = 26.29 , P assessment tools , and a 3-domain concussion- assessment -battery approach more frequently in clinical practice than previously reported . However , despite practice improvements , nearly half of ATs were not using a 3-domain minimum concussion- assessment battery . Clinicians should strive to implement multidimensional concussion assessment s in their practice s to ensure optimal diagnosis and management",
"ABSTRACT Purpose This study aim ed to examine the association between clinical and functional reaction time ( RT ) assessment s with and without simultaneous cognitive tasks among healthy individuals . Methods Participants ( n = 41 , 49 % female ; 22.5 ± 2.1 yr ; 172.5 ± 11.9 cm ; 71.0 ± 13.7 kg ) completed clinical ( drop stick , Stroop ) and functional ( gait , jump l and ing , single-leg hop , anticipated cut , unanticipated cut ) RT assessment s in r and om order . All RT assessment s , except Stroop and unanticipated cut , were completed under single- ( movement only ) and dual-task conditions ( movement and subtracting by 6s or 7s ) . Drop stick involved catching a r and omly dropped rod embedded in a weighted disk . Stroop assessed RT via computerized neurocognitive testing . An instrumented walkway measured gait RT when center-of-pressure moved after r and om stimulus . All other functional RT assessment s involved participants jumping forward and performing a vertical jump ( jump l and ing ) , balancing on one leg ( single-leg hop ) , or a 45 ° cut in a known ( anticipated cut ) or unknown ( unanticipated cut ) direction . RT was determined when the sacrum moved following r and om visual stimulus . Pearson correlation coefficients and a 5 × 2 repeated- measures ANOVA compared RT assessment s and cognitive conditions . Results Stroop RT outcomes did not significantly correlate with functional RT assessment s ( r range = −0.10 to 0.24 ) . A significant assessment by cognitive task interaction ( F4,160 = 14.01 ; P faster single-task RT among all assessment s compared with dual-task ( mean differences , −0.11 to −0.09 s ; P ) . Single-leg hop ( 0.58 ± 0.11 s ) was significantly slower compared with jump l and ing ( 0.53 ± 0.10 s ) , anticipated cut ( 0.49 ± 0.09 s ) , gait ( 0.29 ± 0.07 s ) , and drop stick ( 0.21 ± 0.03 s ; P values ≤ 0.001 ) . Dual-task assessment s were significantly slower than single-task assessment s ( mean difference , 0.08 s ; P Clinical and functional RT assessment s were not correlated with each other , suggesting that sport-like RT is not being assessed after concussion . Functional and dual-task RT assessment s may add clinical value and warrant further exploration after concussion"
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BACKGROUND Skeletal muscle dysfunction is a common feature in chronic obstructive pulmonary disease ( COPD ) which is associated with intrinsic muscular abnormalities . One of the most consistently reported alterations is a shift from fibre type I to II in the vastus lateralis of these patients . Surprisingly , the relationship between this shift and the severity and phenotype of COPD remains unclear . A study was conducted to determine whether vastus lateralis muscle fibre type proportions are associated with COPD disease severity and to provide reference values for the proportions of fibre types in the vastus lateralis in COPD . METHODS A systematic review and a meta- analysis were conducted in which muscle fibre type data and markers of disease severity were collected from the literature . RESULTS The forced expiratory volume in 1 s ( FEV(1 ) ) , the ratio of FEV(1 ) to forced vital capacity ( FVC ) and body mass index were positively associated with the proportion of type I fibres in COPD . A proportion of 51 % for vastus lateralis fibre type I and 13 % for fibre type IIX were calculated from the combined data as normal values for patients with typical GOLD stage 3 - 4 COPD aged 60 - 70 years . Based on these reference values , a proportion of fibre type I 29 % were defined as pathologically abnormal . CONCLUSIONS This review sheds new light on the relationship between skeletal muscle abnormalities and important hallmarks of the disease in severe COPD , and identifies absence of data in GOLD stages 1 - 2 . This review also provides reference values on fibre type composition for diagnostic purpose s in COPD
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"The study of the peripheral skeletal muscle function in patients with chronic obstructive pulmonary disease ( COPD ) is of growing interest , but often requires biopsies , usually with the Bergström technique . The current study was design ed to test the validity of a minimally invasive technique : the microbiopsy . In 17 patients with COPD and four normal subjects , two specimens of the vastus lateralis were taken percutaneously under local anaesthesia , one with a 16-gauge needle ( microbiopsy ) and the other with the Bergström needle . The enzymatic activity of citrate synthase ( CS ) and phosphofructokinase ( PFK ) , and the myosin heavy chain ( MyoHC ) composition were measured for both techniques . The subjects reported no pain or much less with the microbiopsy compared with the Bergström biopsy . The microbiopsy sample weight reached 55±17 mg . The two techniques showed excellent agreement for CS activity and MyoHC composition . The PFK activity did not differ statistically between the techniques , but the agreement was moderate . The agreement between both biopsy techniques was stable over time . The median ( range ) fibre number within the microbiopsy specimens was 144 ( 38–286 ) . In conclusion , the current study shows the feasibility and validity of a minimally invasive muscle biopsy technique that appears more comfortable for subjects , compared with the Bergström technique ",
"We hypothesized that patients with chronic obstructive pulmonary disease developing contractile fatigue of the quadriceps during cycle exercise may have characteristic metabolic and muscle features that could increase their susceptibility to fatigue , thus differentiating them from those who do not develop fatigue . We examined , in 32 patients , the fiber-type proportion , enzymatic activities , and capillary density in the vastus lateralis and the arterial blood lactate level during constant work-rate cycling exercise . Contractile fatigue was defined as a postexercise fall in quadriceps twitch force greater than 15 % of resting values . Twenty-two patients developed contractile fatigue after exercise . No significant differences were found between fatiguers and non-fatiguers for the endurance time , fiber-type proportion , and oxidative enzyme activities . The lactate dehydrogenase activity was significantly higher ( p muscle capillarization significantly reduced in fatiguers ( p arterial lactate level during exercise was significantly higher in fatiguers ( p in quadriceps twitch force and lactate dehydrogenase activity , capillary/fiber ratio , and blood lactate level . We conclude that changes in muscle enzymatic profile and capillarization with a greater reliance on glycolytic metabolism during exercise are associated with contractile fatigue in patients with chronic obstructive pulmonary disease",
"This study aim ed to investigate the relationship between skeletal muscle , fibre type composition , functional respiratory impairment and exercise tolerance in patients with moderate to severe chronic obstructive pulmonary disease ( COPD ) . A group of 22 COPD patients and 10 healthy control subjects were studied . In COPD patients , vital capacity ( VC ) and forced expiratory volume in one second ( FEV1 ) were reduced to 79 % and 51 % , respectively . Diffusion indices ( transfer factor of the lung for carbon monoxide ( TL , CO ) and carbon monoxide transfer coefficient ( KCO ) ) were also reduced . Arterial oxygen tension ( Pa , O2 ) was normal or slightly altered . A maximal exercise test was performed and anaerobic threshold was calculated . Muscle sample s from vastus lateralis were obtained by needle biopsy . Myosin heavy chain ( MHC ) and light chain ( MLC ) isoforms were separated by gel electrophoresis and quantified by densitometry . MHC isoforms were considered as molecular markers of fibre types . The proportion of the fast MHC-2B isoform was increased in COPD patients . TL , CO , KCO , VC and FEV1 were positively correlated with slow MHC isoform content . TL , CO and KCO were also negatively correlated with the content of the fast MHC-2B isoform . No correlation was found between exercise parameters and MHC isoform composition . The co-ordinated expression between MHC and MLC isoforms was altered in COPD patients . We conclude that reduced oxygen availability , probably in combination with muscle disuse , may determine muscle alterations in chronic obstructive pulmonary disease patients . The altered correlations between myosin heavy chain and light chain isoforms suggest that co-ordinated protein expression is lost in chronic obstructive pulmonary disease muscles",
"Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels",
"Oxidative capacity and uncoupling protein-3 ( UCP3 ) content are reduced in limb muscles of patients with chronic obstructive pulmonary disease ( COPD ) . It has been hypothesized that the physiological role of UCP3 is to protect mitochondria against lipotoxicity in cases where fatty acid influx exceeds the capacity to oxidize them . Exercise training improves oxidative capacity and reduces UCP3 protein content in healthy subjects , but the response of UCP3 to training in COPD is unknown . We studied the effect of exercise training on UCP3 content in limb muscles of COPD patients . For this , seven healthy age-matched subjects and thirteen patients with COPD were studied . All patients were admitted to an 8-wk exercise training intervention . Exercise capacity was assessed by means of an incremental cycle ergometry test . Biopsies were taken from the vastus lateralis in which UCP3 and lipid peroxidation levels were determined by Western blotting . Citrate synthase and 3-hydroxyacyl-CoA dehydrogenase ( HAD ; an enzyme involved in fatty acid oxidation ) were measured as indexes of muscle oxidative capacity . UCP3 in COPD was approximately 50 % lower compared with healthy age-matched controls . In COPD , training induced upregulation of UCP3 [ from 67.7 ( SD 41.8 ) to 113.8 ( SD 104.2 ) arbitrary units ( AU ) , P = 0.062 ] , especially in the patients who showed no increase in HAD activity [ from 80.9 ( SD 52.6 ) to 167.9 ( SD 109.1 ) AU , P = 0.028 ] , whereas lipid peroxidation levels remained unaltered . We conclude that exercise-training can restore muscle UCP3 protein level in COPD , and the nature of this response complies with the hypothesis that UCP3 may protect against lipotoxicity",
"The present study was aim ed at evaluating the effects of a specific inspiratory muscle training protocol on the structure of inspiratory muscles in patients with chronic obstructive pulmonary disease . Fourteen patients ( males , FEV1 , 24 + /- 7 % predicted ) were r and omized to either inspiratory muscle or sham training groups . Supervised breathing using a threshold inspiratory device was performed 30 minutes per day , five times a week , for 5 consecutive weeks . The inspiratory training group was subjected to inspiratory loading equivalent to 40 to 50 % of their maximal inspiratory pressure . Biopsies from external intercostal muscles and vastus lateralis ( control muscle ) were taken before and after the training period . Muscle sample s were processed for morphometric analyses using monoclonal antibodies against myosin heavy chain isoforms I and II . Increases in both the strength and endurance of the inspiratory muscles were observed in the inspiratory training group . This improvement was associated with increases in the proportion of type I fibers ( by approximately 38 % , p size of type II fibers ( by approximately 21 % , p functional improvement of the inspiratory muscles and adaptive changes in the structure of external intercostal muscles",
"STUDY OBJECTIVES To investigate the response to interval exercise ( IE ) training by looking at changes in morphologic and biochemical characteristics of the vastus lateralis muscle , and to compare these changes to those incurred after constant-load exercise ( CLE ) training . DESIGN R and omized , controlled , parallel , two-group study ( IE vs CLE training ) . SETTING Multidisciplinary , outpatient , hospital-based , pulmonary rehabilitation program . PATIENTS Nineteen patients with stable advanced COPD ( mean + /- SEM FEV1 , 40 + /- 4 % predicted ) . INTERVENTIONS Patients ( n = 10 ) assigned to IE training exercised at a mean intensity of 124 + /- 15 % of baseline peak exercise capacity ( peak work rate [ Wpeak ] ) with 30-s work periods interspersed with 30-s rest periods for 45 min/d . Patients ( n = 9 ) allocated to CLE training exercised at a mean intensity of 75 + /- 5 % Wpeak for 30 min/d . Patients exercised 3 d/wk for 10 weeks . MEASUREMENTS AND RESULTS Needle biopsies of the right vastus lateralis muscle were performed before and after rehabilitation . After IE training , the cross-sectional areas of type I and IIa fibers were significantly increased ( type I before , 3,972 + /- 455 microm2 ; after , 4,934 + /- 467 microm2 [ p = 0.004 ] ; type IIa before , 3,695 + /- 372 microm2 ; after , 4,486 + /- 346 microm2 [ p = 0.008 ] ) , whereas the capillary-to-fiber ratio was significantly enlarged ( from 1.13 + /- 0.08 to 1.24 + /- 0.07 [ p = 0.013 ] ) . Citrate synthase activity increased ( from 14.3 + /- 1.4 to 20.5 + /- 4.2 micromol/min/g ) , albeit not significantly ( p = 0.097 ) . There was also a significant improvement in Wpeak ( by 19 + /- 5 % ; p = 0.04 ) and in lactate threshold ( by 17 + /- 5 % ; p = 0.02 ) . The magnitude of changes in all the above variables was not significantly different compared to that incurred after CLE training . During training sessions , however , ratings of dyspnea and leg discomfort , expressed as fraction of values achieved at baseline Wpeak , were significantly lower ( p IE training ( 73 + /- 9 % and 60 + /- 8 % , respectively ) compared to CLE training ( 83 + /- 10 % and 87 + /- 13 % , respectively ) . CONCLUSIONS High-intensity IE training is equally effective to moderately intense CLE training in inducing peripheral muscle adaptations ; however , IE is associated with fewer training symptoms"
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PURPOSE This systematic literature review aim ed at examining the validity and applicability in everyday clinical rehabilitation practise of methods for the assessment of back muscle fatiguability in patients with chronic non-specific low back pain ( CNSLBP ) . METHODS Extensive research was performed in MEDLINE , Cumulative Index of Nursing and Allied Health Literature ( CINAHL ) , Embase , Physiotherapy Evidence Data base ( PEDro ) and Cochrane Central Register of Controlled Trials ( CENTRAL ) data bases from their inception to September 2014 . Potentially relevant articles were also manually looked for in the reference lists of the identified publications . Studies examining lumbar muscle fatigue in people with CNSLBP were selected . Two review ers independently selected the articles , carried out the study quality assessment and extracted the results . A modified Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) scale was used to evaluate the scientific rigour of the selected works . RESULTS Twenty-four studies fulfilled the selection criteria and were included in the systematic review . We found conflicting data regarding the validity of methods used to examine back muscle fatigue . The Biering-Sorensen test , performed in conjunction with surface electromyography spectral analysis , turned out to be the most widely used and comparatively , the most optimal modality currently available to assess objective back muscle fatigue in daily clinical practise , even though critical limitations are discussed . CONCLUSIONS Future research should address the identification of an advanced method for lower back fatigue assessment in patients with CNSLBP which , eventually , might provide physical therapists with an objective and reliable test usable in everyday clinical practise . Implication s for Rehabilitation Despite its limitations , the Biering-Sorensen test is currently the most used , convenient and easily available fatiguing test for lumbar muscles . To increase validity and reliability of the Biering-Sorensen test , concomitant activation of synergistic muscles should be taken into account . Pooled mean frequency and half-width of the spectrum are currently the most valid electromyographic parameters to assess fatigue in chronic non-specific low back pain . Body mass index , grading of pain and level of disability of the study population should be reported to enhance research quality
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"Spectral parameters of the surface electromyographic ( EMG ) signal from lumbar back muscles assessed during a fatiguing isometric contraction can be used to classify different categories of low back pain ( LBP ) subjects and control subjects without LBP . In the test protocol currently used at the NeuroMuscular Research Center at Boston University , subjects contract their back muscles at 80 % of their maximal voluntary contraction ( MVC ) force . This fatigue-based protocol has been successfully applied to persons with subacute or chronic LBP ; those in acute pain , however , have not been included because of their inability to perform a maximal exertion . In this paper we will examine the force sensitivity of the currently used EMG parameters and also give an overview of some of our efforts to develop new test procedures . Our goal is to develop force-insensitive surface EMG parameters that can be used for classification purpose s in population s of subjects who develop low trunk extension forces . In addition , the development of a model to predict MVC from anthropometrical measurements will be presented",
"AIM The aim of this study was to investigate the effect of continuous ultrasound ( US ) plus exercise on the endurance of paravertebral muscles of patients with chronic non specific low back pain ( CNSLBP ) . METHODS AND MATERIAL S In this pilot , pretest-posttest study , 22 patients with CNSLBP participated . Patients received 10 sessions of treatment , including continuous US plus exercise therapy , over a period of four consecutive weeks . Median frequency slopes of Iliocostalis and Multifidus muscles as well as holding time during Biering-Sorensen test were measured using surface electromyography . In addition , function and pain were measured using Functional Rating Index ( FRI ) question naire and VAS . RESULTS Five females and 15 males with a mean age of 31.7 years completed the treatment . Descriptive data showed a decrease of 0.01 and 0.02 mean in median frequency slope of right and left Iliocostalis respectively and a mean of 0.08 decrease for both right and left Multifidus muscles . Endurance time increased 1.8 seconds mean . Both function ( 17 % ) and pain ( 24 % ) improved post treatment . CONCLUSION Larger population studies in the context of high quality , r and omized clinical trial are needed to vali date the results",
"The rate of decline in the median frequency ( MF ) of the surface EMG power spectrum ( MFgrad ) has been evaluated for its use in monitoring the fatigability of the erector spinae muscles during the performance of submaximal isometric contractions . MFgrad consistently displayed a highly significant relationship with endurance time for the task ( p mean MFgrad values recorded from the right and left erector spinae muscles , at either thoracic or lumbar levels . The back extensor muscles of men were more fatigable than those of women , and this has been discussed in relation to corresponding differences in muscle fiber type relative size . Greater erector spinae muscle fatigability was associated with both the existence of , and the risk of developing , serious low back pain . Possible mechanisms for the association , from retrospective and prospect i ve points of view , have been advanced",
"OBJECTIVE The aim was to explore the validity and reliability of EMG for assessing lumbar muscle fatigue . DESIGN Patients with long-term low-back trouble ( n=57 ) were compared to a healthy reference group ( n=55 ) . Back muscle fatigue and recovery were studied in relation to health-related factors . BACKGROUND EMG spectral variables are important tools in the assessment of patients with low-back trouble . The influence of disability on these variables needs further investigation . METHODS EMG from the lower back muscles was recorded during a 45 s trunk extension at 80 % of maximal voluntary contraction torque and during recovery . Disability was studied using question naires . RESULTS The reliability was high for maximal voluntary contraction torque and EMG initial median frequency , lower for the median frequency slope , and insufficient for median frequency recovery half-time . The patients had lower maximal voluntary contraction torque , higher initial median frequency at L5 level , flatter slope , and longer recovery half-time than the healthy subjects did . However , for subjects with significantly negative slope , indicating fatigue , there was no significant difference in slope between patients and healthy subjects , while , for subjects without such fatigue , patients showed significantly flatter slopes at L5 . The sensitivity/specificity of the test was 86%/78 % . The most significant variables selected with logistic regression were maximal voluntary contraction torque and initial median frequency at L5 . Patients without significantly negative slopes during contraction and /or not exponential-like EMG recovery scored worse on several items concerning disability and self-efficacy . CONCLUSIONS EMG spectral variables in combination with torque might be used for classification . For patients with long-term low-back trouble , the ability to fatigue the lumbar muscles sufficiently to obtain a significantly negative slope during an 80 % maximal voluntary contraction may be a sign of better functioning . RELEVANCE The ability to fatigue the back muscles during a test requiring a high force output might be achieved with back muscle training focused on increasing strength and self-efficacy",
"PURPOSE To determine whether dynamic back muscle endurance exercises in a semisitting position induce more fatigue in back muscles than that in hip extensors in healthy controls as well as in patients with nonspecific chronic low back pain . METHODS Sixteen healthy volunteers and 18 volunteers with nonspecific chronic low back pain performed trunk flexion-extension cycles until exhaustion at 60 % of their strength in a machine design ed for back exercise in a semisitting position with knees ' angle at 135 degrees . The number of cycles and perceived muscle fatigue ( Borg CR-10 scale ) at five areas ( upper and lower back , gluteus , hamstrings , and quadriceps ) were used as fatigue criteria . EMG signals were recorded bilaterally on four back muscles , two hip extensors ( gluteus maximus and biceps femoris ) , and the vastus medialis . The slope values of the instantaneous median frequency values computed over time were retained as EMG indices of fatigue . RESULTS The number of cycles was equivalent in healthy controls ( n = 23 + /- 13 ) and patients with back pain ( n = 27 + /- 16 ) . EMG indices of fatigue disclosed evidence of muscle fatigue in all the back muscles and the vastus medialis , contrary to hip extensors . EMG revealed significantly more muscle fatigue of lower back muscles , which was further corroborated by the Borg scale assessment . No between-group difference was obtained in any EMG comparison . CONCLUSION These results showed that this type of exercise machine can specifically train the back muscles , and this as much in subjects with nonspecific chronic low back pain as in healthy controls . This has implication s for the training of back muscle endurance , especially in patients with back pain for whom poor back muscle endurance is sometimes of concern",
"PURPOSE Roman chair exercises are popular for improving back muscle endurance but do not specifically target back muscles . This study aim ed to determine whether an adaptation of the Roman chair exercise would induce more fatigue in back muscles than in hip extensors . METHODS For this study , 16 healthy subjects and 18 patients with nonspecific chronic low back pain performed trunk flexion-extension cycles until exhaustion in a Roman chair with hips flexed at 40 ° . Surface EMG signals were recorded bilaterally on four back muscles and two hip extensors ( gluteus maximus and biceps femoris ) . Motion analysis of the trunk segments ( pelvis , lumbar , and thoracic spines ) was also carried out . RESULTS In both groups , EMG revealed clear evidence of muscle fatigue for the gluteus maximus , less clear evidence of fatigue for the lower back muscles , and motor unit recruitment ( without fatigue ) for the upper back muscles and biceps femoris . A change of muscle activation pattern was emphasized throughout the exercise bout , with some lower back muscles showing an increase followed by a decrease or leveling off of activation and with upper back muscles showing an increased activation at the end . Kinematic analyses revealed a progressive decrease ( 11 ° ) in the lumbar range of motion ( ROM ) and a progressive increase in hip ( 2 ° ) and thoracic ( 7 ° ) ROM during the exercise bout . CONCLUSIONS Roman chairs allow more freedom to change the kinematics of the spine during the exercise ( less lumbar and more thoracic motion ) to delay lower back muscle fatigue by sharing the load between the lower and upper back muscles . Even with adaptations to reduce hip extensors fatigue , this may make this exercise not as specific as wanted for fatiguing lower back muscles",
"Study Design . Investigative case control study . Objectives . To determine whether excessive paraspinal muscle fatigue in chronic low back pain results from a paucity of muscle type I fiber content . Summary of Background Data . Paraspinal muscle function is vital for spinal protection . Prospect i ve studies suggest that excessive paraspinal muscle fatigability may increase risk of first-time low back pain . As contractile performance of the paraspinal muscles is governed by their constitutionally determined fiber composition , the question arises whether a constitutionally determined “ adverse ” composition could predispose to low back pain through impaired spinal protection . Methods . Thirty-five male patients with chronic low back pain were compared with 32 male control patients of similar age and anthropometry . During Sorensen and 60 % of maximum voluntary isometric contraction fatigue tests , median frequency declines in the paraspinal muscle surface electromyograph signal were monitored and correlated with muscle histomorphometry . Results . Patients were weaker than controls during maximum voluntary isometric contractions ( 84.47 [28.44]vs . 98.74 [ 18.11 ] kg , respectively ; P = 0.02 ) and more fatigable during their Sorensen tests ( endurance time 105.29 [28.53]vs . 137.50 [ 40.38 ] sec , respectively ; P in median frequency declines during the Sorensen ( −0.37 [0.16]vs . −0.36 [0.12]%.sec−1 ) or 60 % maximum voluntary isometric contraction ( −0.42 [0.31]vs . −0.51 [0.29]%.sec−1 ) tests , for patients and controls , respectively . There were no between-group differences in the percent number of paraspinal muscle type I fibers ( 64 [11]vs . 64 [9]% ) or the percent area occupied by type I fibers ( 67 [11]vs . 69 [9]% ) , for patients and controls , respectively . Type I and II muscle fiber narrow diameters were similar for both groups . Conclusion . In the patients with chronic low back pain tested , their associated paraspinal muscle dysfunctionwas not the result of a constitutionally determined “ adverse ” fiber type composition",
"Abstract Of the various methods for measuring pain the visual analogue scale seems to be the most sensitive . For assessing response to treatment a pain-relief scale has advantages over a pain scale . Pain can not be said to have been relieved unless pain or pain relief has been directly measured",
"& NA ; We asked 78 chronic low back pain patients to report on their usual pain intensity , and on the lifestyle changes caused by their pain , on a horizontally‐oriented visual analogue scale ( VAS ) . Also , the usual and the current pain intensities were examined on a vertical VAS . Statistical analysis showed normal distribution of data in the measurement of usual pain on the horizontal VAS , but no homogeneous distribution on the vertical VAS . Therefore , in the measurement of chronic low back pain VAS should be used horizontally rather than vertically , because of higher sensitivity . The intensity of usual pain was significantly correlated with the degree of lifestyle change . No correlation was found between current and usual pain . There was no significant difference in the failure rate between the vertical and horizontal VAS . Also , there was no reduction of the failure rate by giving additional oral explanations in the use of the scale to the patient . Owing to a negative influence in distribution of rates and an increase in the failure rate , complex questions should be avoided . A short written introduction to the scale is sufficient , and oral explanations are not essential",
"The paravertebral muscles ( PM ) act together with the hamstrings and calf muscles as important postural muscles . Both the histochemistry , biochemistry , strength and endurance of the PM were studied . Moreover attention was drawn to the exposure of PM , in particular the internal exposure level but to a certain degree repetitiveness and duration , in various job elements , and their various physiological acute responses . The thesis also deal with possible relations between the function of the PM and the magnitude of low-back trouble ( LBP ) , and if PM muscle fatigue may play a role as a mediating factor for the occurrence of work related LBP . The lumbar PM is dominated by relatively small ST fibers with a well-developed network of capillaries , especially distinct in the central sections of PM ( lumbar longissimus muscle ) in females . It is remarkable that ST fibers are of the same size or larger compared to the FT fibers even in well-trained subjects . Further on PM is characterized by high activity levels of enzymes , oxidative as well as non-oxidative , important for the re synthesis of ATP and CrP. Also the level of muscles glycogen concentration is high . Altogether the PM have seemingly a potential for different metabolic pathways which may be selectively activated for a given activity . The average trunk extensor MVC varies in the different studies from 194 - 342 Nm and 252 - 450 Nm in females and males respectively . This is in accordance with predictions based specific strength , muscle cross sections and lever arms from the literature . The large range in strength due to dimension , age and training have to be considered when such data are used for e.g. ergonomic st and ardization and biomechanical modelling . The sex difference is smaller ( female : male trunk extensor strength ratio = 0.7 - 0.8 ) than reported earlier . The small age reduction ( 25 - 60 year ) of the trunk extensor strength , 0.5 % per year , is probably caused by the fact that the ST dominated musculature is less sensitive to atrophy . The results indicate that a secular reduction of the trunk extensor strength has occurred during the last 2 - 3 decades possibly caused by a more sedentary lifestyle , both in working life due to mechanization introduced gradually during that period , and in leisure time activity . An important finding is that the static endurance time is significantly larger in the trunk extensors compared to other muscles , and larger in females than males . Possible explanations for the findings include 1 ) the reported histo- and biochemical results , 2 ) favorable blood flow conditions and 3 ) specific activation strategies of the muscles constituting the PM . In the vocational studies manifest signs of fatigue in the lumbar paravertebral muscles , are seen , including changes in both the energy spectra of the surface EMG towards lower frequencies and increases in the RMS amplitude , reduction of the static endurance time , and increase in the rate of perceived exertion during a working day in bricklayers performing highly repetitive work with their trunk extensors ( 1000:1200 bricks per day ) . Similar events do also occur during st and ing letter sorting with a very low close to static exposure of PM . Ergonomic arrangements may have a marked reducing effect on the internal exposure of PM especially if the job include manual h and ling operations ( e.g. forest work , aircraft loading ) , but it is not possible to compensate for repetitiveness , and long task duration by so-called \" good \" ergonomics ( e.g. introducing mats or shoes in upright working operations ) . The chronic effects ( i.e . LBP ) are also studied . It is found that trunk extensor static endurance time in 77 postmen was related to the degree of LPB , but this was not the case for strength of the trunk-extensors and flexors . Thus , it is shown that a broad variety of work related exposures may cause muscle fatigue in PM . The possible aetiological role of muscle fatigue is however not explained . ( ABSTRACT TRUNCATED",
"Study Design . Cross-sectional study of 50 individuals with nonspecific low back pain ( LBP ) . Objective . To evaluate the relationship between active and neural measurements in individuals with nonspecific LBP . Summary of Background Data . The Panjabi model for spinal stability consists of 3 interacting subsystems . Specific musculoskeletal measurements can be identified within the active and neural systems . The relationships among measures within this model have not been identified . Methods . A total of 50 individuals with nonspecific LBP were evaluated for measures of the active and neural stability systems , and analyzed using a canonical correlation analysis , which is used to measure the relationship between 2 multidimensional variables . Results . There were 2 significant relationships identified . The first identified a relationship among fatigue , flexion relation , and the feedforward abdominal response ( r = 0.764 , P Sorenson endurance test and feedforward abdominal response ( r = 0.697 , P = 0.006 ) . Conclusion . Identification of relationships between back pain measurements may allow discrimination between individuals with different histology and pain levels . This process may assist the specificity of treatment programs prescribed for patients with back pain"
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41164f52-06ff-11f0-808a-c43d1ab1c353
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Background In the last two decades , there has been a significant increase in the diagnosis of Bipolar Disorder ( BD ) in children . The notion of prepubertal onsets of BD is not without controversy , with research ers debating whether paediatric cases have a distinct symptom profile or follow a different illness trajectory from other forms of BD . The latter issue is difficult to address without long-term prospect i ve follow-up studies . However , in the interim , it is useful to consider the phenomenology observed in groups of cases with different ages of onset and particularly to compare manic symptoms in children diagnosed with BD compared to cases presenting with BD in adolescence and adulthood . This review systematic ally explores the phenomenology of manic or hypomanic episodes in groups defined by age at onset of BD ( children , adolescents and adults ; or combined age groups e.g. children and adolescents versus adults ) . Methods Literature review s of PubMed and Scopus were conducted to identify publications which directly compared the frequency or severity of manic symptoms in individuals with BD presenting with a first episode of mania in childhood , adolescence or adulthood . Results Of 304 studies identified , 55 texts warranted detailed review , but only nine studies met eligibility criteria for inclusion . Comparison of manic symptoms across age groups suggested that irritability is a key feature of BD with an onset in childhood , activity is the most prominent in adolescent-onset BD and pressure of speech is more characteristic of adult-onset BD . However , none of the eligible studies made a direct comparison of phenomenology in children versus adults . Assessment procedures varied in quality and undermined the reliability of cross- study comparisons . Other limitations were : the scarcity of comparative studies , the geographic bias ( most studies originated in the USA ) , the failure to fully consider the impact of psychiatric comorbidities on recorded symptoms and method ological heterogeneity . Conclusions Despite frequent discussion of similarities and differences in phenomenology of mania presenting in different age groups , systematic research is lacking and studies are still required to reliably establish whether the frequency and severity of manic symptoms varies . Such information has implication s for clinical practice and the classification of mental disorders
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"OBJECTIVE To examine the representativeness of a r and omized controlled trial ( RCT ) sample versus one obtained by consecutive new case ascertainment , for subjects with child bipolar I disorder . METHOD Subjects ( N = 247 ) were out patients who participated in either the National Institute of Mental Health-funded Phenomenology and Course of Pediatric Bipolar Disorders study or the Treatment of Early Age Mania ( TEAM ) study . Both studies required that subjects have current DSM-IV bipolar I disorder ( manic or mixed phase ) and a Children 's Global Assessment Scale ( CGAS ) score or=60 . All subjects had elation and /or gr and iosity . Subjects in the Phenomenology study were obtained from 1995 to 1998 by consecutive new case ascertainment from design ated pediatric and psychiatric facilities . Subjects in the TEAM RCT were recruited from media and community sources between March 2003 and March 2005 . Assessment instruments included the Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia , given separately to parents about their children and to children about themselves , and the CGAS . Logistic regression was used for comparisons . RESULTS The TEAM and Phenomenology groups were similar in age ( 10.4 [ SD = 2.3 ] , 10.9 [ SD = 2.3 ] years , respectively ) and other demography . Both had long current episode duration ( 4.8 [ SD = 2.4 ] , 3.2 [ SD = 2.3 ] years ) and low lifetime use of any mood stabilizer ( 23.6 % , 35.0 % ) . Many mania symptoms and ultradian rapid cycling , psychosis , and suicidality were significantly more prevalent in the RCT sample . CONCLUSIONS Generalization of the RCT sample was supported , because only 7.8 % of Phenomenology subjects did not fit the RCT criteria . Nevertheless , because the RCT subjects were more severely ill , it is unclear if treatment findings from the RCT will be applicable to children with less severe mania . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00057681 ( TEAM study )",
"BACKGROUND The diagnosis of pediatric bipolar disorders is a controversial topic . If this is mainly due to a bias against a diagnosis in younger children , then just changing the information about the age of a patient should influence the likelihood of a diagnosis despite otherwise identical symptoms . Therefore , we design ed a study to test if the age of a patient will influence diagnostic decisions . We further attempted to replicate an earlier result with regard to \" decreased need for sleep \" as a salient symptom for mania . METHODS We r and omly sent 1 of 4 case vignettes describing a person with current mania to child/adolescents psychiatrists in Germany . This vignette was systematic ally varied with respect to age of the patient ( 6 vs 16 years ) and the presence/absence of decreased need for sleep but always included sufficient criteria to diagnose a mania . RESULTS One hundred sixteen responded and , overall , 63.8 % of the respondents diagnosed a bipolar disorder in the person described in the vignette . Although age did not affect the likelihood of a bipolar diagnosis , the presence of decreased need for sleep did increase its likelihood . Furthermore , the number of core symptoms identified by the clinicians was closely linked to the likelihood of assigning a bipolar diagnosis . CONCLUSION Certain symptoms such as the decreased need for sleep , and also elated mood and gr and iosity , seem to be salient for some clinicians and influence their diagnoses . Biological age of the patient , however , does not seem to cause a systematic bias against a diagnosis of bipolar disorder in children",
"BACKGROUND Diagnosis of child mania has been contentious . OBJECTIVE To investigate natural history and prospect i ve validation of the existence and long-episode duration of mania in children . DESIGN Four-year prospect i ve longitudinal study of 86 subjects with intake episode mania who were all assessed at 6 , 12 , 18 , 24 , 36 , and 48 months . The phenotype was defined as DSM-IV bipolar I disorder ( manic or mixed ) with at least 1 cardinal symptom ( elation and /or gr and iosity ) to ensure differentiation from attention-deficit/hyperactivity disorder . Parent and child informants were separately interviewed , by highly experienced research nurses , using the Washington University in St Louis Kiddie Schedule for Affective Disorders and Schizophrenia ( WASH-U-KSADS ) . A Children 's Global Assessment Scale score of 60 or less was needed to establish definite impairment . Treatment was by subjects ' community practitioners . SETTING Research unit in a university medical school . PARTICIPANTS Subjects were obtained from psychiatric and pediatric sites by consecutive new case ascertainment , and their baseline age was 10.8 + /- 2.7 years . Onset of the baseline episode was 7.4 + /- 3.5 years . ( Data are given as mean + /- SD . ) MAIN OUTCOME MEASURES Episode duration , weeks ill , recovery/relapse rates , and outcome predictors . RESULTS Prospect i ve episode duration of manic diagnoses , using onset of mania as baseline date , was 79.2 + /- 66.7 consecutive weeks . Any bipolar disorder diagnosis occurred during 67.1 % + /- 28.5 % of total weeks , during the 209.4 + /- 3.3 weeks of follow-up . Subjects spent 56.9 % + /- 28.8 % of total weeks with mania or hypomania ( unipolar or mixed ) , and 38.7 % + /- 28.8 % of these were with mania . Major or minor depression and dysthymia ( unipolar or mixed ) occurred during 47.1 % + /- 30.4 % of total weeks . Polarity switches occurred 1.1 + /- 0.7 times per year . Low maternal warmth predicted faster relapse after recovery from mania ( chi(2 ) = 13.6 , P = .0002 ) , and psychosis predicted more weeks ill with mania or hypomania ( F(1,80 ) = 12.2 , P = .0008 ) . Pubertal status and sex were not predictive . ( Data are given as mean + /- SD . ) CONCLUSIONS These findings vali date the existence , long-episode duration , and chronicity of child mania . Differences from the natural history of adult bipolar disorder are discussed"
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41164f84-06ff-11f0-808a-c43d1ab1c353
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Balneotherapy is appreciated as a traditional treatment modality in medicine . Hungary is rich in thermal mineral waters . Balneotherapy has been in extensive use for centuries and its effects have been studied in detail . Here , we present a systematic review and meta- analysis of clinical trials conducted with Hungarian thermal mineral waters , the findings of which have been published by Hungarian authors in English . The 122 studies identified in different data bases include 18 clinical trials . Five of these evaluated the effect of hydro- and balneotherapy on chronic low back pain , four on osteoarthritis of the knee , and two on osteoarthritis of the h and . One of the remaining seven trials evaluated balneotherapy in chronic inflammatory pelvic diseases , while six studies explored its effect on various laboratory parameters . Out of the 18 studies , 9 met the predefined criteria for meta- analysis . The results confirmed the beneficial effect of balneotherapy on pain with weight bearing and at rest in patients with degenerative joint and spinal diseases . A similar effect has been found in chronic pelvic inflammatory disease . The review also revealed that balneotherapy has some beneficial effects on antioxidant status , and on metabolic and inflammatory parameters . Based on the results , we conclude that balneotherapy with Hungarian thermal-mineral waters is an effective remedy for lower back pain , as well as for knee and h and osteoarthritis
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"The aim of the study was to demonstrate the effectiveness of sulphurous water in patients with osteoarthritis of the h and . Forty-seven patients with osteoarthritis of the h and were enrolled into the double-blind , r and omized , controlled study , satisfying ACR criteria . One group of the patients ( n = 24 ) received balneotherapy , bathing in sulphurous thermal water for 20 min per occasion , 15 times in all during a period of 3 weeks . The control group ( n = 21 ) had a bath exclusively in warm tap water . Assessment s were carried out in both groups on four occasions : at the beginning and at the end of the treatment , and 3 and 6 months after the beginning of the treatment . The parameters studied were the following : pain in the h and , morning stiffness in the joints , grip strength of both h and s , and Health Assessment Question naire Disability Index ( HAQ ) and AUSCAN H and Osteoarthritis Index and EuroQol quality of life question naire . At the end of treatment , the improvement was more pronounced in the patient group treated with the sulphurous water . After 3 months , significant improvement could be detected in all parameters , except the morning stiffness and EQ5D . After 6 months , the values of pain , HAQ and AUSCAN continued to be significantly better in comparison with the baseline values . The improvement in quality of life was significant only at the end of the treatment , 6 months later not any longer . The difference between the two groups was significant after 3 months in point of pain and EQVAS . Balneotherapy and within this the sulphurous spa water alone may be effective for the attenuation of pain in patients with h and osteoarthrosis",
"An increasing body of evidence substantiating the effectiveness of balneotherapy has accumulated during recent decades . In the present study , 42 ambulatory patients ( 23 males and 19 females , mean age 59.5 years ) with degenerative musculoskeletal disease were r and omised into one of two groups — bathing in tap water or in mineral water at the same temperature— and subjected to 30-min balneotherapy sessions on 15 occasions . Study parameters comprised serum levels of sensitised C-reactive protein ( CRP ) , plasma lipids , heat shock protein ( HSP-60 ) and total antioxidant status ( TAS ) . In both groups , CRP levels followed a decreasing tendency , which still persisted 3 months later . At 3 months after balneotherapy , serum cholesterol levels were still decreasing in patients who had used medicinal water , but exhibited a trend towards an increase in the control group . Triglyceride levels followed a decreasing trend in both patient groups . TAS showed a declining tendency in both groups . No changes of HSP-60 levels were observed in either group . Balneotherapy with the thermal water from Hajdúszoboszló spa had a more pronounced physiological effect compared to that seen in the control group treated with tap water in a 3 month period",
"Effect of thermal water with high mineral content on clinical parameters and quality of life of patients with chronic low back pain was studied . In this r and omized controlled , single-blind , follow-up study , 60 patients with chronic low back pain were r and omized into two groups . The treatment group received balneotherapy with thermal-mineral water , and the control group bathed in tap water . Changes of the followings were evaluated : visual analogue scale ( VAS ) for pain , range of motion for the lumbar spine , Oswestry index , EuroQol-5D and Short Form-36 question naires . In the treatment group , the mobility of the lumbar spine , the Oswestry index , the VAS scores and the EuroQoL-5D index improved significantly . SF-36 items improved significantly in the treated group compared with baseline except for two parameters . Our study demonstrated the beneficial effect of balneotherapy with thermal mineral versus tap water on clinical parameters , along with improvements in quality of life",
"Three treatments for non-specific lumbar pain -- balneotherapy , underwater traction bath , and underwater massage -- were assessed in a r and omised prospect i ve controlled trial in 158 out patients . Each group was treated for four weeks and patients were review ed at the end of this period and at 12 months after entry to the trial . The prescription of analgesics and the pain score were significantly reduced in all three treated groups , but there was no difference between the three groups . No significant change occurred in spinal motion and the straight leg raising test . After one year only the analgesic consumption was significantly lower than in the control group",
"Objective : Balneotherapy , a domain of medical science , focuses on utilizing the beneficial effects of medicinal waters . Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime . Although small in number , all controlled studies published on this subject have demonstrated the benefits of balneotherapy . This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain . Patients and Methods : A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain . 30 subjects took baths in reduced sulphurous mineral water , whereas the other 30 patients used modified tap water of matching odor . Parameters determined at baseline , after balneo-/hydrotherapy , and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale ( VAS ) score , the modified Oswestry index , mobility of the spine , antalgic posture , tenderness of the paravertebral muscles on palpation , the dose requirements for analgesics , and the efficacy assessed by the investigators and by the patients . Results : Bathing in mineral water result ed in a statistically significant improvement . This was reflected by the VAS ( p muscle spasm ( p alleviation of local tenderness ( p enhanced flexion-extension and rotation of the spine ( p Schober ’s index ( p balneotherapy . By contrast , hydrotherapy with tap water result ed only in the temporary improvement of just a single parameter : the VAS score improved significantly ( p Balneotherapy in itself can alleviate low back pain . As demonstrated by this study , the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior to that afforded by hydrotherapy with tap water . Our results clearly establish the beneficial effects of mineral water . Moreover , it is a valuable adjunct to other forms of physical treatment as well as to pharmacotherapy",
"To study the effect of thermal mineral water of Nagybaracska ( Hungary ) on patients with primary knee osteoarthritis in a r and omized , double-blind clinical trial , 64 patients with nonsurgical knee joint osteoarthritis were r and omly selected either into the thermal mineral water or into the tap water group in a non-spa resort village . The patients of both groups received 30-min sessions of bathing , 5 days a week for four consecutive weeks . The patients were evaluated by a blind observer immediately before and at the end of the trial using Western Ontario and McMaster Osteoarthritis ( WOMAC ) indices and follow-up assessment 3 months later . Twenty-seven patients of the 32 patients who received thermal mineral water and 25 of the 32 of those treated with tap water completed the trial . The WOMAC activity , pain , and total scores improved significantly in the thermal mineral-water-treated group . The improvement remained also at the end of the 3-month follow-up . The WOMAC activity , pain , and total scores improved significantly also in the tap water group at the end of the treatment course , but no improvement was detected at the end of the 3-month follow-up period . The treatment with the thermal mineral water of Nagybaracska significantly improved activity , pain , and total WOMAC scores of patients with nonsurgical OA of the knee . Even after 3 months , significant improvement was observed compared to the scores before the treatment or to tap water treatment",
"Objective To determine whether spa therapy , plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment , in the management of knee osteoarthritis . Methods Large multicentre r and omised prospect i ve clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria , attending French spa resorts as out patients between June 2006 and April 2007 . Zelen r and omisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating . The main endpoint criteria were patient self-assessed . All patients continued usual treatments and performed daily st and ardised home exercises . The spa therapy group also received 18 days of spa therapy ( massages , showers , mud and pool sessions ) . Main Endpoint The number of patients achieving minimal clinical ly important improvement ( MCII ) at 6 months , defined as ≥19.9 mm on the visual analogue pain scale and /or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery . Results The intention to treat analysis included 187 controls and 195 spa therapy patients . At 6 months , 99/195 ( 50.8 % ) spa group patients had MCII and 68/187 ( 36.4 % ) controls ( χ2=8.05 ; df=1 ; p=0.005 ) . However , no improvement in quality of life ( Short Form 36 ) or patient acceptable symptom state was observed at 6 months . Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone , and is well tolerated . Trial registration number NCT00348777",
"BACKGROUND Balneotherapy is an established treatment modality for musculoskeletal disease , but few studies have examined the efficacy of spa therapy in elderly patients with degenerative spine and joint diseases . OBJECTIVES To assess the effects of balneotherapy on chronic musculoskeletal pain , functional capacity , and quality of life in elderly patients with osteoarthritis of the knee or with chronic low back pain . METHODS The 81 patients in the study group underwent a 1 day course of 30 minute daily baths in mineral water . Changes were evaluated in the following parameters : pain intensity , functional capacity , quality of life , use of non-steroidal anti-inflammatory or analgesic drugs , subjective disease severity perceived by the patients , investigator-rated disease severity , and severity of pain perceived by the patients . We analyzed the results of 76 subjects as 5 did not complete the study . RESULTS Compared to baseline , all monitored parameters were significantly improved by balneotherapy in both investigated groups . Moreover , the favorable effect was prolonged for 3 months after treatment . CONCLUSIONS This study showed that balneotherapy is an effective treatment modality in elderly patients with osteoarthritis of the knee or with chronic low back pain , and its benefits last for at least 3 months after treatment",
"Objective : To evaluate the effectiveness of thermal mineral water compared with magnetotherapy without balneotherapy as control , in the treatment of h and osteoarthritis . Design : R and omized controlled single-blind follow-up study . Setting : Rheumatology specialist clinic of Gunaras Health Spa . Subjects : Patients between 50 and 70 years of age with h and osteoarthritis , r and omly assigned into three groups . Interventions : The subjects in the first two groups bathed in thermal mineral water of two different temperatures ( 36 ° C and 38 ° C ) for three weeks five times a week for 20 minutes a day and received magnetotherapy to their h and s three times weekly . The third group received only magnetotherapy . Outcome measures : Visual analogue scale scores , h and grip strength , pinchgrip strength , the number of swollen and tender joints of the h and , the duration of morning joint stiffness , Health Assessment Question naire , and Short Form-36 question naire . The study parameters were administered at baseline , immediately after treatment and after 13 weeks . Results : The study included 63 patients . Statistically significant improvement was observed in several studied parameters after the treatment and during the follow-up study in the thermal water groups versus the control group . The 38 ° C thermal water treatment significantly improved the pinch strength of the right h and ( 0.6 ( 95 % confidence interval ( CI ) 0.2 to 1.1 ) vs. 0.03 ( 95 % CI −0.3 to 0.4 ) , P the Health Assessment Question naire parameters ( −0.4 ( 95 % CI −0.6 to −0.2 ) vs. −0.1 ( 95 % CI −0.2 to 0.1 ) , P Conclusions : Balneotherapy combined with magnetotherapy improved the pain and function as well as the quality of life in patients with h and osteoarthritis",
"The therapeutic modalities available for the conservative management of chronic cervical and lumbar pain include underwater traction , the usefulness of which is not universally acknowledged . No reports have been published on clinical trials evaluating underwater traction . This study was intended to ascertain any beneficial impact of weightbath therapy on the clinical parameters and quality of life of patients with cervical/lumbar discopathy . The study population comprised 72 subjects . Two groups of 18 patients each received underwater traction therapy of the cervical or lumbar spine with add-on McKenzie exercises and iontophoresis . The remaining two groups , treated with exercises and iontophoresis , served as controls . VAS and SF36 scores , range of motion were monitored to appraise therapeutic efficacy in cervical discopathy , whereas these parameters were supplemented by the Oswestry index in lumbar discopathy . A MRI scan was done at baseline and after 3 months of follow-up . Underwater cervical or lumbar traction therapy for discopathy achieved significant improvement of all study parameters , which was still evident 3 months later . Among the controls , significant improvement of just a single parameter was seen in patients with lumbar , and of two parameters in those with cervical discopathy . Underwater traction therapy effectively mitigates pain , enhances joint flexibility , and improves the quality of life of patients with cervical or lumbar discopathy . The equipment required to administer weightbath therapy is simple to install and treatment technique is straightforward",
"INTRODUCTION Preliminary studies have suggested that balneotherapy ( BT ) is an effective and well-tolerated treatment for generalized anxiety disorder ( GAD ) and psychotropic medication withdrawal syndrome . We carried out a study in 4 spa resorts to assess the efficacy of BT in GAD . METHOD We compared BT to paroxetine in terms of efficacy and safety in a r and omized multicentre study lasting 8 weeks . Patients meeting the diagnostic criteria of GAD ( DSM-IV ) were recruited . Assessment s were conducted using the Hamilton Rating Scale for Anxiety ( HAM-A ) and other scales , by a specifically trained and independent physician . The primary outcome measure was the change in the total HAM-A score between baseline and week 8 . RESULTS A total of 237 out patients were enrolled in four centres ; 117 were assigned r and omly to BT and 120 to paroxetine . The mean change in HAM-A scores showed an improvement in both groups with a significant advantage of BT compared to paroxetine ( -12.0 vs -8.7 ; p Remission and sustained response rates were also significantly higher in the BT group ( respectively 19 % vs 7 % and 51 % vs 28 % ) . CONCLUSION BT is an interesting way of treating GAD . Due to its safety profile it could also be tested in resistant forms of generalized anxiety and in patients who do not tolerate or are reluctant to use pharmacotherapies",
"Abstract To differentiate between the effect of cold and hydrostatic pressure on hormone and cardiovascular functions of man , a group of young men was examined during 1-h head-out immersions in water of different temperatures ( 32 ° C , 20 ° C and 14 ° C ) . Immersion in water at 32 ° C did not change rectal temperature and metabolic rate , but lowered heart rate ( by 15 % ) and systolic and diastolic blood pressures ( by 11 % , or 12 % , respectively ) , compared to controls at ambient air temperature . Plasma renin activity , plasma cortisol and aldosterone concentrations were also lowered ( by 46 % , 34 % , and 17 % , respectively ) , while diuresis was increased by 107 % . Immersion at 20 ° C induced a similar decrease in plasma renin activity , heart rate and systolic and diastolic blood pressures as immersion at thermoneutrality , in spite of lowered rectal temperature and an increased metabolic rate by 93 % . Plasma cortisol concentrations tended to decrease , while plasma aldosterone concentration was unchanged . Diuresis was increased by 89 % . No significant differences in changes in diuresis , plasma renin activity and aldosterone concentration compared to subjects immersed to 32 ° C were observed . Cold water immersion ( 14 ° C ) lowered rectal temperature and increased metabolic rate ( by 350 % ) , heart rate and systolic and diastolic blood pressure ( by 5 % , 7 % , and 8 % , respectively ) . Plasma noradrenaline and dopamine concentrations were increased by 530 % and by 250 % respectively , while diuresis increased by 163 % ( more than at 32 ° C ) . Plasma aldosterone concentrations increased by 23 % . Plasma renin activity was reduced as during immersion in water at the highest temperature . Cortisol concentrations tended to decrease . Plasma adrenaline concentrations remained unchanged . Changes in plasma renin activity were not related to changes in aldosterone concentrations . Immersion in water of different temperatures did not increase blood concentrations of cortisol . There was no correlation between changes in rectal temperature and changes in hormone production . Our data supported the hypothesis that physiological changes induced by water immersion are mediated by humoral control mechanisms , while responses induced by cold are mainly due to increased activity of the sympathetic nervous system",
"Abstract . The effects of thermal water from Cserkeszölö in Hungary were appraised in a r and omised , double blind study conducted on 58 patients with osteoarthritis of the knee . Balneotherapy was delivered as a 15-day course of 30-min daily sessions performed with thermal water ( active treatment ) or tap water of similar colour and odour ( placebo treatment ) . The musculoskeletal status of participants was evaluated at baseline , at the end of the balneotherapy course , and 3 months later . Study endpoints ( initial pain , range of motion , tenderness on palpation , stair climbing , physicians ' opinion and subjective rating by patients , and ambulation ) were assessed using visual analogue scales and symptom scores . Both groups improved ; however , the magnitude of improvement was significantly greater in patients treated with thermal water from Cserkeszölö",
"OBJECTIVE The aim of this study was to evaluate the effectiveness of thermal mineral water , compared with tap water in the treatment of low back pain . METHODS This r and omized , double-blind , controlled , follow-up study included 71 patients who underwent 20-minute daily treatment sessions with medicinal water or with tap water , both at a temperature of 34 degrees C , on 21 occasions . Both groups underwent additional adjunctive electrotherapy . Outcome measures were visual analogue scale scores , Schober 's sign , Domján 's signs , Oswestry disability and Short Form-36 question naire . The study parameters were administered at baseline , immediately after treatment , and after 15 weeks . RESULTS After treatment , there was a significant improvement in all parameters in the thermal water group . This improvement was still evident after 15 weeks . The improvement in the control group was less substantial compared with baseline values . Comparison of the 2 treatments revealed a statistically significant difference in 3 outcome parameters ( visual analogue scale scores III , IV and Schober 's index ) . In the subset of patients who completed the study according to the protocol , the greater efficacy of treatment with thermal water was also confirmed by the other study parameters . CONCLUSION In the group treated with thermal water , improvement occurred earlier , lasted longer and was statistically significant",
"OBJECTIVE To evaluate whether low concentrated saline spa water baths followed by ultraviolet B ( LC-SSW-UVB ) are superior to UVB alone in moderate to severe psoriasis . BACKGROUND There is a lack of sufficiently large r and omized controlled clinical trial evaluating the additional benefit of saltwater baths followed by UVB compared to UVB only in psoriasis . STUDY DESIGN Partly evaluator blind , multicentre , pragmatic , r and omized controlled trial . SETTING Five German spa centres . SUBJECTS One hundred and forty-three adults with stable psoriasis during the last month and a Psoriasis Area and Severity Index ( PASI ) of > 10 and /or an affected body surface area of > 15 % . INTERVENTIONS LC-SSW-UVB or UVB thrice a week until remission ( PASI Sodium chloride concentrations of natural springs varied between 4.5 % and 12 % . Conventional UVB ( broadb and UVB or selective UVB phototherapy ) was used as irradiation source . MAIN OUTCOME Reduction of PASI and /or affected body surface area of 50 % at the end of the intervention period ( PASI-50 ) . Only participants receiving at least one intervention were included in the primary analysis . RESULTS Patients allocated to LC-SSP-UVB attained a statistically significantly higher rate of PASI-50 at the end of the intervention period than patients allocated to UVB [ 58/79 ( 73 % ) vs. 32/64 ( 50 % ) ; P = 0.01 ; NNT , 4.3 , 95 % CI , 2.4 - 18.1 ] . Benefit persisted until 3 months only for one of two secondary outcomes considered . CONCLUSIONS In routine clinical practice balneophototherapy using conventional UVB is superior to conventional UVB only at the end of a 6-week treatment course",
"BACKGROUND Balneotherapy is among the most widely used modalities of physical therapy in countries rich in mineral waters . This trial was intended to ascertain whether balneotherapy ( i.e. , therapeutic bath in mineral water ) has any influence on the antioxidant system and whether there are any differences compared to bathing in tap water . METHODS The ten subjects in Group I bathed in alkaline thermal water , Group II used alkaline , chlorine-containing mineral water , whereas Group III bathed in tap water . Catalase , superoxide dismutase , malondialdehyde protein and glutathione peroxidase levels were measured at baseline and after concluding the course of balneotherapy . RESULTS Balneotherapy with either of the two mineral waters reduced the activity of all four enzymes studied . Using tap water , however , had no influence on either catalase or superoxide dismutase activity after one session or glutathione peroxidase levels after a course of ten balneotherapy treatments . CONCLUSIONS Thermal water may have a beneficial effect on the formation of free radicals . The therapeutic efficacy of mineral vs. tap water is different , although bathing in hot water itself reduces enzyme activity",
"BACKGROUND / PURPOSE Previous studies suggested that beta-endorphin has a pathogenic role in psoriasis : its increased plasma concentration may play a role in the neuroimmunological processes in the pathomechanism of the disease , and plasma beta-endorphin levels should reflect the changes in the patients ' skin status . The purpose of this study was to investigate the changes of peripheral blood beta-endorphin levels in psoriatic patients in conjunction with changes in their skin symptoms after synchronous balneophototherapy . METHODS With synchronous balneophototherapy , 12 patients with extended skin symptoms of psoriasis were treated . The therapy followed the Regensburg protocol , consisting of a basic course of 35 sessions . Patients ' skin status was characterized by evaluating the Psoriasis Area and Severity Index score before and after the therapy course . Blood sample s were taken before treatment , and 1 day after the last session , with symptom-free skin . Plasma beta-endorphin levels were measured by a specific radioimmunoassay developed by the authors . RESULTS There was no significant change in plasma levels of beta-endorphin after clinical clearance of psoriatic skin symptoms . CONCLUSION In this non-r and omized , uncontrolled study no significant difference could be detected between plasma beta-endorphin levels before and after a basic course of synchronous balneophototherapy in patients with psoriasis . Although beta-endorphin has many neuroimmunological effects , the changes of its plasma level do not consistently reflect the skin status . Inflammation in psoriatic skin lesions is probably not mediated directly by circulating beta-endorphin",
"THE AUTHORS examined the effectiveness of the thermal water of Puspokladany on 62 patients suffering from osteoarthritis of the knee in a double-blind , placebo controlled study . Thermal water decreased pain in movement and tenderness of the knee significantly compared to that of the control group . Bath-reaction ( increase of ESR , leukocyte number and spontaneous pain ) was observed only in the group treated with thermal water . The results indi cate , that the thermal water of Puspokladany is suitable for treating patients suffering from degenerative arthopathies . In a previous announcement , Varga and his colleagues had established that a 20-days bath treat ment in the thermal water of Puspokladany signifi cantly reduced the pain of spondylosis patients when the treatment was applied in the undiluted thermal water . Bath reaction was shown on the patients who were treated in the undiluted thermal water , which was proved by the significant increase of the leucocyte number . The present paper deals with the study and tests we conducted to establish the effect of Puspokla dany 's thermal water on patients with osteoarthritis of the knee",
"Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders . The present study was conducted to ascertain whether baths of relatively low ( 80 Bq/l ) radon concentration have any influence on the functioning of the endocrine system . In the study , a non-r and omized pilot study , 27 patients with degenerative musculoskeletal disorders received 30-min radon baths ( of 31–32 ° C temperature and 80 Bq/l average radon concentration ) daily , for 15 days . Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol , using thermal water with negligible radon content ( 6 Bq/l ) . Serum thyroid stimulating hormone , prolactin , cortisol , adrenocorticotropic hormone , and dehydroepi and rosterone levels were measured before and after a balneotherapy course of 15 sessions . Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups . It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known , only few data have been published in the literature on its effect on endocrine functions . The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system",
"BACKGROUND This r and omized , double blind trial determined the short and long-term clinical and hemodynamic vasodilator effects induced by percutaneous applications of natural CO2 gas in patients with moderate Fontaine stage II . PATIENTS AND METHODS 62 patients with intermittent claudication ( 100 - 500 meters ) were r and omized to 18 consecutive days of CO2 treatment or placebo ( air ) . The gas fluids were applied at a constant temperature of 30 degrees C on pre-humidified skin . The effects of the treatment were evaluated by total distance walked ( primary criterion ) and hemodynamic and microcirculatory findings . Patients also answered a quality of life question naire . RESULTS The Str and ness test showed a significant increase in total distance walked ( + 131 meters , 66 % ; p = 0.001 ) and pain-free distance ( + 81 meters , 73 % ; p = 0.02 ) after 18 days of CO2 treatment . The improvement was maintained 3 and 12 months later . The systolic pressure index ( ABI ) increased by 37 % ( p = 0.001 ) 1 minute after treadmill walking and ABI recovery time decreased significantly by 38 % ( p = 0.002 ) . Microcirculatory findings showed an increase in systolic pressure of the great toe ( 13 % ; p baseline pO2 ( 20 % ; p = 0.01 ) and in vasomotion ( 78 % ; p = 0.001 ) in the treatment group . The improvement in total walking distance was correlated with the increase in ABI and peripheral cutaneous oxygenation . Patients ' subjective assessment s corroborated the benefits . No significant change was observed in the placebo group . CONCLUSIONS This study demonstrates that 18 consecutive days of percutaneous CO2 treatment significantly increases walking distance in patients with moderate intermittent claudication . This effect , which was associated with an increase in peripheral systolic pressure and pO2 , is evidence of a better ability to withst and effort"
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INTRODUCTION The aims of this study were to systematic ally review the available literature regarding in-vitro orthodontic shear bond strength testing and to analyze the influence of test conditions on bond strength . METHODS Our data sources were Embase and Medline . Relevant studies were selected based on predefined criteria . Study test conditions that might influence in-vitro bond strength were independently assessed by 2 observers . Studies reporting a minimum number of test conditions were included for meta- analysis by using a multilevel model with 3 levels , with author as the highest level , study as the second level , and specimens in the study as the lowest level . The primary outcome measure was bond strength . RESULTS We identified 121 relevant studies , of which 24 were included in the meta- analysis . Method ologic drawbacks of the excluded studies were generally related to inadequate reporting of test conditions and specimen storage . The meta- analysis demonstrated that 3 experimental conditions significantly affect in-vitro bond strength testing . Although water storage decreased bond strength on average by 10.7 MPa , each second of photopolymerization time and each millimeter per minute of greater crosshead speed increased bond strength by 0.077 and 1.3 MPa , respectively . CONCLUSIONS Many studies on in-vitro orthodontic bond strength fail to report test conditions that could significantly affect their outcomes
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"This study evaluated the shear bond strength of stainless steel brackets bonded to enamel with a new fluoride-releasing orthodontic adhesive system . A total of 140 extracted human bicuspids were r and omly divided into four groups . Group I ( Transbond XT ) was a control group in which enamel was etched with phosphoric acid . For the remaining groups , enamel was conditioned with a self-etching primer ( SEP ) : Group II ( Transbond Plus ) , Group III ( BeautyOrtho Bond ) , and Group IV ( BeautyOrtho Bond + Salivatect ) . Stainless steel brackets were bonded to all tooth sample s. After which , the sample s were stored , thermocycled , tested , and statistically analyzed . Besides bond strength evaluation , the adhesive remnant index ( ARI ) was also evaluated . The shear bond strengths of Groups II , III , and IV were significantly lower than Group I , and Group II was significantly greater than that of Group III . Concerning ARI scores , no significant differences were found between the groups . Further , no enamel fracture was observed during shear bond test with the new SEP . In conclusion , when enamel was conditioned with the new SEP , the mean values of shear bond strength yielded were lower than when it was etched with 37 % phosphoric acid . Nonetheless , these mean values were higher than the average suggested by Reynolds as optimum for clinical treatment",
"The purpose of this study was to determine the effect of changing the crosshead speed of the testing machine on the shear bond strength of orthodontic brackets to enamel while st and ardizing all the other variables . Forty freshly extracted human molars were bonded using the Transbond XT adhesive system ( 3 M Unitek , Monrovia , Calif ) . The teeth were r and omly divided into two groups . In group I , the shear bond strength was measured at a crosshead speed of 5.0 mm/min , and in group II the shear bond strength was measured at a crosshead speed of 0.5 mm/ min . Within half an hour from the initial bonding of each tooth , an occlusogingival load was applied to the bracket , producing a shear force at the bracket-tooth interface . This was accomplished by using the flattened end of a steel rod attached to the crosshead of a Universal Test Machine ( Zwick GmbH & Co , Ulm , Germany ) . The t-test results ( t = 2.71 ) indicated that there was a significant difference ( P = .014 ) in the shear bond strengths between the group tested at a crosshead speed of 5.0 mm/min and the group tested at a crosshead speed of 0.5 mm/min . The mean shear bond strengths for the two groups were 7.0 + /- 4.6 MPa and 12.2 + /- 4.0 MPa , respectively . These findings indicated that it is important to identify the parameters included in shear bond testing in order to enable meaningful comparisons of the performance of different material",
"The purpose of our study was to determine the effect of a 35 % hydrogen peroxide bleaching agent on the shear bond strength of metallic orthodontic brackets . Sixty premolars were r and omly divided into 3 groups of 20 each . Teeth in group A were etched with 37 % phosphoric acid before bonding metallic premolar brackets . Teeth in the other 2 groups were bleached with a 35 % hydrogen peroxide in-office bleaching agent according to the manufacturer 's recommendations . Twenty bleached teeth ( group B ) were bonded immediately , and the other 20 ( group C ) were stored in artificial saliva for 30 days before bonding . Shear bond strength of these brackets was measured on a universal testing machine and recorded in MPa . Adhesive remnant index ( ARI ) scores were determined after the brackets failed . Data were analyzed with analysis of variance ( ANOVA ) and chi-square tests . The shear bond strength values of groups A , B , and C were 12.9 + /- 3.4 , 12.0 + /- 4.6 , and 14.8 + /- 4.0 MPa , respectively . Results of ANOVA showed no statistically significant differences in shear bond strengths between groups ( P > .05 ) . ARI scores were significantly different in all groups . The unbleached group 's failures were primarily at the bracket/adhesive interface , whereas the bleached groups either showed cohesive failures within the adhesive or failed at the adhesive/enamel interface . The results of this study suggest that office bleaching with hydrogen peroxide does not adversely affect the bond strengths of brackets bonded immediately after bleaching or 30 days after bleaching , even though bleaching can result in differences in the failure site",
"The objective of this in vitro bonding study was to evaluate the effectiveness of 2 moisture-insensitive primers , Assure ( Reliance Orthodontic Products , Itasca , Ill ) and MIP ( 3 M Unitek , Monrovia , Calif ) compared with a control hydrophobic primer , Transbond XT ( 3 M Unitek ) . Six groups of 40 premolars were acid etched and bonded using metal orthodontic brackets with the following in vitro protocol s : ( 1 ) Transbond XT primer and adhesive applied to a noncontaminated surface ; ( 2 ) Assure primer applied after saliva contamination ; ( 3 ) MIP primer applied after saliva contamination ; ( 4 ) Assure primer reapplied after saliva contamination ; ( 5 ) MIP reapplied after saliva contamination ; and ( 6 ) Assure adhesive applied after saliva contamination of the primer . All bonded specimens were stored in deionized water at 37 degrees C for 30 days and thermocycled for 24 hours before debonding . Brackets were debonded using a shear-peel load on a testing machine , bond strength was measured in megapascals , and bond failure was analyzed by using the adhesive remnant index . In vitro shear-peel bond strengths were acceptable for all groups , and the bond strengths for Assure and MIP were not significantly affected by saliva contamination . The mean shear-peel bond strength of the control ( 14.82 MPa ) was significantly higher ( P values of the Assure primer and adhesive were less than the MIP primer and its respective adhesive ; however , the hydrophilic Assure adhesive resin applied to a saliva-contaminated surface had acceptable bond strength . Bond failure analysis ( adhesive remnant index ) mainly showed adhesive bond failures . An increased frequency of enamel fractures at debond was noted , with the control group ( 1 ) and the MIP groups ( 3 and 5 ) having 22.5 % , 12.5 % , and 15 % , respectively . The Assure groups had no enamel fractures",
"It has been cl aim ed that different ion solutions containing sulfate induce crystal growth and might be a better alternative than conventional acid etching for enamel pretreatment in bracket bonding . It should thus combine optimal bond strength with easy and quick debonding . Two clinical experiments were performed to test this hypothesis . The first experiment dealt with the debonding procedure . Following conditioning with dilute sulfuric acid which contained sodium sulfate ( to be termed solution A ) on one side of the mouth and etching with 37 % phosphoric acid on the other , brackets were bonded on the maxillary and m and ibular incisors of twenty dental nurse students . Debracketing and a subsequent cleanup procedure were performed after 2 days . The mode of loosening was mainly between the enamel surface and adhesive on the crystal-growth-conditioned teeth and between the bracket mesh and adhesive on the teeth etched with phosphoric acid . This difference in mode of loosening was statistically significant ( P less than 0.001 ) . In the second experiment , which dealt with the clinical bond strength , 250 brackets were bonded in forty patients . One side served as a control and was conventionally acid etched . On the experimental side conditioning was done with solution A in thirty patients . In ten patients , 10 % phosphoric acid was added to the dilute sulfuric acid used ( to be termed solution B ) . Failure rates and modes of failure were recorded for a 6-month period . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Currently introduced self-etching primers combine conditioning and priming agents into a single product . The purpose of this study was to determine the effects of using three self-etching primers on the shear bond strength ( SBS ) of orthodontic brackets and on the bracket/adhesive failure mode . Brackets were bonded to extracted human teeth according to one of four protocol s. In the control group , teeth were etched with 37 % phosphoric acid . In the experimental groups , the enamel was conditioned with three different self-etching primers , Clearfil SE Bond ( CSE ) , Etch & Prime 3.0 ( EP3 ) , or Transbond Plus ( TBP ) , as suggested by the manufacturer . The brackets were then bonded with Transbond XT in all groups . The present in vitro findings indicate that conditioning with TBP before bonding orthodontic brackets to the enamel surface result ed in a significantly ( P SBS ( mean , 16.0 + /- 4.5 MPa ) than that found in CSE , EP3 , and the control ( acid-etched [ AE ] ) groups . CSE produced bond strength values ( mean 11.5 + /- 3.3 MPa ) that are statistically comparable to those produced by acid etching ( mean 13.1 + /- 3.1 MPa ) . The use of EP3 for enamel conditioning result ed in the lowest mean SBS value ( mean 9.9 + /- 4.0 MPa ) . A comparison of the adhesive remnant index scores indicated that there was more residual adhesive remaining on the teeth that were treated with conventional acid etching than in the CSE and EP3 groups . In the TBP group , the failure sites were similar to those of the AE group but different from those of the CSE group",
"Many bracket base design s and adhesive material s are in clinical use today . Bases have evolved from perforated metal bases to the present foil mesh bases , and treatments range from none , to spraying metal alloy onto the base , to the most common treatment of microetching . The purpose of this study was to determine the effect of orthodontic bracket base design on mean shear bond strength 1 hour or 24 hours after bonding . For each time group , 12 specimens of 6 types of metal brackets were bonded to bovine incisors with Transbond XT ( 3 M Unitek , Monrovia , Calif ) light-cured composite resin . Brackets were debonded 1 hour or 24 hours later , and the shear bond strength was recorded . Six debonded brackets of each type from each time group were selected at r and om and s and blasted . All the teeth were cleaned , and half were rebonded with used brackets , and half were rebonded with new brackets . Bond strength was measured again , 1 hour or 24 hours later . Representative specimens were inspected under the scanning electron microscope . Bracket base design significantly affected mean shear bond strength . Speed ( 60-gauge , microetched foil-mesh base ; Strite Industries , Cambridge , Ontario , Canada ) had the highest bond strength at 1 hour ; followed by Time ( machined , integral , microetched base with mechanical undercuts ; American Orthodontics , Sheboygan , Wis ) ; American Master Series ( 80-gauge foil-mesh base ; American Orthodontics ) ; Ovation Roth ( 80-gauge layered onto 150-gauge , microetched foil-mesh base ; GAC , Central Islip , NY ) ; Orthos Optimesh XRT ( 100-gauge microetched foil-mesh base ; Ormco , Orange , Calif ) ; and , finally , the nickel-free brackets ( injection molded , 100-gauge , microetched , foil-mesh base ; World Class Technology , McMinnville , Ore ) . The 24-hour results were similar except that Time had the highest mean shear bond strength ( ANOVA , P mean shear bond strengths ( ANOVA , P < .05 ) . S and blasting appears to be an effective method of cleaning bracket bases before rebonding",
"INTRODUCTION This study assessed in-vitro shear bond strength and in-vivo survival rate of orthodontic brackets bonded with either a halogen or a plasma arc light . METHODS Ninety extracted premolars were divided into 6 groups of 15 . Stainless steel brackets were bonded to the teeth by using either a halogen light with a 20-second curing time or a plasma arc light with a 2- , 6- , or 10-second curing time . Brackets were debonded either within 30 minutes of bonding or after thermocycling for 24 hours . Bond strengths were tested on a testing machine at a crosshead speed of 1 mm/minute . The bracket failure interface was measured with a modified adhesive remnant index score . Data were analyzed by using ANOVA and Tukey-Kramer multiple comparison tests . For the in-vivo study , a split-arch design was used to determine the bracket-failure rate and distribution in 25 patients . The patients were followed for a mean period of 1.1 years ( 386 days ) . Survival analysis was carried out to compare the failure rates of the 2 techniques . RESULTS No significant differences in bond strengths were found 30 minutes after bonding between the halogen light ( 13.6 + /- 3.8 MPa ) and the plasma arc light with 2- , 6- , or 10-second curing times ( 9.6 + /- 2.9 , 14.2 + /- 4.6 , 16.0 + /- 3.0 MPa , respectively ) . Similar bond strengths were also found between the halogen light with a 20-second ( 16.1 + /- 3.6 MPa ) curing time and plasma arc light with 6 seconds ( 18.2 + /- 4.6 MPa ) of curing time after 24 hours of thermocycling . For the in-vivo study , no significant difference was found in bracket failure rates between the 2 light sources ( 4.9 % in both groups ) . No significant differences were found between ARI scores for the halogen light and the plasma arc light at either 30 minutes or 24 hours after debonding . CONCLUSIONS These results indicate that the plasma arc light with a 6-second curing time can produce similar bond strength and bracket-failure rates as the halogen light that requires a longer curing time",
"The purpose of this study was to compare the shear bond strengths and enamel surface structure after debonding a conventional metal bracket and a polycrystalline ceramic bracket bonded with a bipolar zinc oxide-polyvinyl cement ( F-21 ) or a light-cured resin cement ( Transbond ) . Forty extracted human premolars were used . The buccal enamel surfaces were used , and the teeth r and omly divided into four groups of 10 teeth each : group 1 : conventional metal bracket ( Unitek ) bonded with Transbond ; group 2 : metal bracket bonded with F-21 ; group 3 : ceramic bracket ( Transcend 2000 ) bonded with Transbond ; and group 4 : ceramic bracket bonded with F-21 . The brackets were bonded to the etched enamel surfaces according to manufacturer 's instructions . All specimens were stored in distilled water for 24 hours and then thermocycled for 300 cycles between 5 degrees C and 55 degrees C. The specimens were mounted in dental stone and placed in the Instron at a crosshead speed of 0.5 mm/min with a knife-edged blade . Immediately after debonding , the enamel surface and bracket-enamel interface were evaluated visually and with a stereomicroscope . Representative sample s were then examined with the scanning electron microscope . The analysis of variance and Student-Newman-Keuls tests were performed . The results in megapascals were Group 1 : 19,6 ( + /- 9,6 ) ; group 2 : 14,3 ( + /- 4,6 ) ; group 3 : 28,8 ( + /- 12,6 ) ; and group 4 : 18,5 ( + /- 7,5 ) . Group 3 was statistically significantly different ( P < 0.008 ) from all other groups . Groups 1 , 2 , and 4 were not significantly different . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The aim of the study was to evaluate and compare the clinical performance of adhesive precoated brackets ( APC ) with that of two types of uncoated bracket bases , Straight-Wire and Dyna-Lock , bonded using two types of orthodontic adhesives , Transbond XT , and Right-On . Forty consecutive orthodontic patients entered the trial and 607 brackets were bonded . The incidence and site of first time bond failures were recorded over a period of 1 year . The time required for bonding was also recorded . The overall bond failure rate was 6.6 per cent . There were no significant differences between the failure rates of the five groups , or between the upper and lower arch . However , significantly more brackets failed on the left side than on the right . Premolar brackets were lost most often , whilst incisor brackets failed least . No association was found between bond failure and time elapsed since bonding . Bonding time was least with Right-On adhesive . There were no significant differences between bonding times using APC or Transbond . Results of the present study conflict with those of a previous ex vivo study by the authors , using the same material s and bonding technique . Suggested reasons for this are discussed",
"OBJECTIVE To evaluate and compare the shear bond strengths of two adhesives using two types of brackets : a conventional and a self-ligating bracket system . MATERIAL S AND METHODS Sixty extracted human premolars were collected . The premolars were r and omly divided into three groups of 20 teeth . All three groups were direct bonded . Groups 1 and 2 used light-cured adhesive and primer ( Transbond XT ) with a conventional ( Orthos ) and a self-ligating bracket ( Damon 2 ) , respectively . Group 3 used a light-cured primer ( Orthosolo ) and a light-cured adhesive ( Blūgloo ) with a self-ligating bracket ( Damon 2 ) . The specimens were stored in distilled water at 37 degrees C for 40 + /- 2 hours , after which they were debonded and inspected for Adhesive Remnant Index ( ARI ) scoring . RESULTS The mean shear bond strength was 15.2 MPa for group 1 , 23.2 MPa for group 2 , and 24.8 MPa for group 3 . A one-way analysis of variance and post hoc Tukey test showed significant differences in bond strength ( P .05 ) between groups 2 and 3 . A Weibull analysis demonstrated that all three groups provided sufficient bond strength with over 90 % survival rate at normal masticatory and orthodontic force levels . A Kruskal-Wallis test showed no significant difference ( P > .05 ) in ARI scores among all three groups . CONCLUSIONS All three groups demonstrated clinical ly acceptable bond strength . The Damon 2 self-ligating bracket exhibited satisfactory in vitro bond strength with both adhesive systems used",
"A new flowable composite , Denfil Flow , has shown an acceptable shear bond strength for bonding orthodontic brackets , when used with an intermediate , unfilled , low-viscosity resin . According to the manufacturer , it also shows a good viscosity for use with no preliminary adhesive . This could reduce the total time of bonding procedure while maintaining clinical ly useful bond strength . The aim of the current research was to assess this property . Eighty extracted human premolars were r and omly divided into four equal groups . Stainless steel brackets were bonded to etched enamel using ( 1 ) Denfil Flow , ( 2 ) a traditional flowable composite ( Dyract Flow ) , ( 3 ) Denfil Flow composite resin and an intermediate liquid resin , and ( 4 ) Transbond XT adhesive . Debonding was performed with a shearing force . The residual adhesive on the enamel surface was evaluated using the adhesive remnant index . The bond strength of Denfil Flow ( 34.8 MPa ) showed no significant difference with the other control groups and was clinical ly acceptable . Denfil Flow and Dyract Flow tended to display cohesive failure within the adhesive . Denfil Flow can be used without liquid resin to reduce the bonding procedure time while maintaining acceptable bond strength . Further studies are required to evaluate the enamel surface of the teeth after the same polishing procedure in the four groups",
"One of the solutions for the problem of white spot lesions has been the application of a polymer coating to the labial enamel surface . The aim of this study is to find out whether the liquid polish BisCover affects the bond strength of brackets bonded with a light-cured system ( Transbond XT ) and a no-mix system ( Unite ) . St and ard stainless steel premolar brackets were bonded to 100 permanent human premolars r and omly divided into five equal groups . Two different enamel surface conditions were studied : dry and varnished with BisCover . For each enamel surface condition , two orthodontic adhesive systems were used : a light-cured system ( Transbond XT ) and a no-mix system ( Unite ) . All teeth were conditioned with 37 % phosphoric acid for 30 seconds , followed by thorough washing and drying . The teeth in groups 1 and 2 were bonded with Transbond XT and Unite , respectively . For groups 3 , 4 , and 5 , a thin layer of BisCover was applied to the etched enamel with a brush and light cured for 15 seconds . In group 3 , a thin layer of Transbond XT primer was applied , whereas in group 5 , no additional primer was used on BisCover . In groups 3 and 5 , the brackets were bonded with Transbond XT adhesive resin . Group 4 was bonded with no-mix Unite . Shear forces were applied to the sample s by a Zwick Universal test machine , and bond strengths measured in megapascals . The results revealed that shear bond strengths of the groups did not differ significantly from each other",
"OBJECTIVE The purpose of the present study was to analyze the influence of debonding force location in shear bond strength testing of orthodontic brackets in vitro . METHODS Ninety extracted permanent bovine m and ibular incisors were r and omly divided into 3 groups of 30 specimens each . Teeth were bonded with stainless steel orthodontic brackets . Enamel surfaces were etched with 37 % phosphoric acid for 30s and bonded with a composite adhesive . Debonding force measurements were performed with a universal testing machine . Location of the debonding force was : bracket base ( group A ) , ligature groove ( group B ) , occlusal bracket wings ( group C ) . RESULTS Mean shear bond strength measurements were as follows : 22.70(4.23)MPa ( group A ) , 11.52(2.74)MPa ( group B ) , 9.44(2.96)MPa ( group C ) . Analysis of variance indicated that there were significant differences in shear bond strength . Post-hoc Tukey tests showed that bond strength measurements of group A were significantly different from those of groups B and C. The adhesive remnant index also showed significant differences and ranged from a mean of 1.53 in group A to a mean of 2.10 in group C. SIGNIFICANCE Debonding force location had a significant influence on shear bond strength measurements and bond failure pattern , indicating that this parameter needs to be taken into consideration for inter study comparison of in vitro results",
"OBJECTIVE The aim of this study was to investigate the influence of cross-head speed on debonding force of orthodontic brackets . METHODS One hundred and twenty extracted permanent bovine m and ibular incisors were r and omly divided into 4 groups of 30 specimens each . Teeth were bonded with stainless steel orthodontic brackets . Enamel surfaces were etched with 37 % phosphoric acid for 30 seconds and bonded with a composite adhesive . Debonding force measurements were performed with a universal testing machine Zwicki Z 2.5 ( Zwick , Germany ) . Cross-head speeds of the four groups were : 0.1 mm s-1 ( group A ) , 0.5 mm s-1 ( group B ) , 1.0 mm s-1 ( group C ) , 5.0 mm s-1 ( group D ) . RESULTS Mean debonding force measurements were as follows : 215.35 ( 39.09 ) N ( group A ) , 231.79 ( 48.62 ) N ( group B ) , 236.64 ( 39.26 ) N ( group C ) , 224.95 ( 34.67 ) N ( group D ) . Analysis of variance indicated that there were no significant differences in debonding forces between the groups investigated . The adhesive remnant index showed a median value of 2.0 for all groups . SIGNIFICANCE Cross-head speed variation between 0.1 and 5 mm min-1 does not seem to influence debonding force measurements or failure mode of brackets bonded to enamel with a composite adhesive",
"The aim of this study was to compare , by shear testing , the bond strengths after 1 and 24 hours of a light-cured resin ( Enlight ) and a light-cured glass ionomer cement GIC ( Fuji Ortho LC ) using various polymerization lamps ( halogen , high performance halogen , xenon , and diode ) for the direct bonding of brackets . The self-curing resin ( Concise ) was used as the control . The analysis was carried out using the SPSS program . For group comparison purpose s , the single factor variance analysis ( ANOVA ) and the post-hoc test ( Tukey 's HSD ) were used . The level of significance was established at P bond strength of 5 - 8 MPa . With Enlight LV , bond strength was dependent on curing time ( the halogen lamp achieved the highest bond strength of 10.0 MPa , P mode of cure ( the highest bond strength values were achieved by four-sided curing , P= 0.04 ) . Fuji Ortho LC , on the other h and , was independent of the duration of light curing and the type of lamp used . The bond strengths of the resin-modified glass ionomer cement ( RMGIC ) were similar to or somewhat higher than those achieved with light-cured composite resin ( P = 0.039 ) when lamps with short polymerization times were used , but were significantly lower ( P bond strengths of all adhesives showed a significant increase : Enlight 19 per cent , Fuji Ortho LC 6.6 per cent , Concise 16 per cent . Bond failure occurred for Enlight at the bracket-composite resin adhesive interface in 90 per cent and with Concise in 57 per cent . However , Fuji Ortho LC showed far more cohesive and mixed failures , indicating an improved bond between bracket and cement"
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QUESTION Does mechanically assisted walking with body weight support result in more independent walking and is it detrimental to walking speed or capacity in non-ambulatory patients early after stroke ? DESIGN Systematic review with meta- analysis of r and omised trials . PARTICIPANTS Non-ambulatory adult patients undergoing inpatient rehabilitation up to 3 months after stroke . INTERVENTION Mechanically assisted walking ( eg , treadmill , electromechanical gait trainer , robotic device , servo-motor ) with body weight support ( eg , harness with or without h and rail , but not h and rail alone ) versus assisted overground walking of longer than 15 min duration . OUTCOME MEASURES The primary outcome was the proportion of participants achieving independent walking . Secondary outcomes were walking speed measured as m/s during the 10-m Walk Test and walking capacity measured as distance in m during the 6-min Walk Test . RESULTS Six studies comprising 549 participants were identified and included in meta-analyses . Mechanically assisted walking with body weight support result ed in more people walking independently at 4 weeks ( RD 0.23 , 95 % CI 0.15 to 0.30 ) and at 6 months ( RD 0.23 , 95 % CI 0.07 to 0.39 ) , faster walking at 6 months ( MD 0.12 m/s , 95 % CI 0.02 to 0.21 ) , and further walking at 6 months ( MD 55 m , 95 % CI 15 to 96 ) than assisted overground walking . CONCLUSION Mechanically assisted walking with body weight support is more effective than overground walking at increasing independent walking in non-ambulatory patients early after stroke . Furthermore , it is not detrimental to walking speed or capacity and clinicians should therefore be confident about implementing this intervention
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"Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke ",
"Objective : To evaluate the effect of repetitive locomotor training on an electromechanical gait trainer plus physiotherapy in subacute stroke patients . Design : R and omized controlled trial . Setting : Four German neurological rehabilitation centres . Subjects : One hundred and fifty-five non-ambulatory patients ( first-time stroke Intervention : Group A received 20 min locomotor training and 25 min physiotherapy ; group B had 45 min physiotherapy every week day for four weeks . Main outcome measures : Primary variables were gait ability ( Functional Ambulation Category , 0 - 5 ) and the Barthel Index ( 0 - 100 ) , blindly assessed at study onset , end , and six months later for follow-up . Responders to the therapy had to become ambulatory ( Functional Ambulation Category 4 or 5 ) or reach a Barthel Index of ≥ 75 . Secondary variables were walking velocity , endurance , mobility and leg power . Results : The intention-to-treat analysis revealed that significantly greater number of patients in group A could walk independently : 41 of 77 versus 17 of 78 in group B ( P B a Barthel Index ≥ 75 : 44 of 77 versus 21 of 78 ( P B superior gait ability in group A persisted ( 54 of 77 versus 28 of 78 , P B Conclusions : Intensive locomotor training plus physiotherapy result ed in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone",
"Background and Purpose — The success of gait rehabilitation after stroke depends on active walking exercises . However , the disabling after-effects of stroke often make such exercises impossible at the onset of therapy . To facilitate treadmill training of paraparetic patients , a robot-driven gait orthosis ( Lokomat ) was developed . We investigated the effects of the Lokomat when used with hemiparetic patients . Methods — The authors conducted a r and omized , controlled pilot study of 30 acute stroke survivors . The treatment group received 30 minutes of robotic training daily and the control group 30 minutes of conventional physiotherapy daily in addition to 30 minutes of conventional physiotherapy for each group . Outcome measures were independence of gait , gait speed , gait parameters , and body tissue composition . Results — After 4 weeks of therapy , the walking ability of the Lokomat group and the control group expressed as the functional ambulation classification was significantly improved . The functional ambulation category ( median± interquartile range ) was at baseline 0±0 in control and 0±1 in the therapy group and increased after therapy to 1±3 in both groups significantly ( P=0.01 ) . There was no significant difference in gain of these parameters between the groups . The Lokomat group had a significantly longer single stance phase ( sec ; mean±SEM ) on the paretic leg when walking on the floor . At baseline , it was 0.19±0.17 and after therapy 0.49±0.07 ( P=0.014 ) . The control group had increased their body weight approximately 1.33±1.40 kg ( mean±SEM ; P=0.046 ) , mostly as fat mass , whereas the Lokomat group had lost fat mass approximately −2.9±1.0 kg ( mean±SEM ; P=0.016 ) and increased their muscle mass approximately 3.36±1.4 kg ( mean± SEM ; P=0.031 ) . Conclusions — This pilot study indicates that Lokomat therapy is a promising intervention for gait rehabilitation . Although there was no difference between groups in gain of functional scores , the Lokomat group showed an advantage of robotic training over conventional physiotherapy in improvement of gait abnormality and body tissue composition",
"Objective . To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke . Methods . A total of 63 participants All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training . Outcome measures were evaluated prior to training , after 12 and 24 sessions , and at a 3-month follow-up exam . Self-selected overground walking speed and distance walked in 6 minutes were the primary outcome measures , whereas secondary outcome measures included balance , mobility and function , cadence and symmetry , level of disability , and quality of life measures . Results . Participants who received conventional gait training experienced significantly greater gains in walking speed ( P = .002 ) and distance ( P = .03 ) than those trained on the Lokomat . These differences were maintained at the 3-month follow-up evaluation . Secondary measures were not different between the 2 groups , although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group . Conclusions . For subacute stroke participants with moderate to severe gait impairments , the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability",
"Background and Purpose — The main objective of this r and omized trial was to determine whether treadmill walking with body weight support was effective at establishing independent walking more often and earlier than current physiotherapy intervention for nonambulatory stroke patients . Methods — A r and omized trial with concealed allocation , blinded assessment , and intention-to-treat analysis was conducted . One hundred twenty-six stroke patients who were unable to walk were recruited and r and omly allocated to an experimental or a control group within 4 weeks of stroke . The experimental group undertook up to 30 minutes per day of treadmill walking with body weight support via an overhead harness whereas the control group undertook up to 30 minutes of overground walking . The primary outcome was the proportion of participants achieving independent walking within 6 months . Results — Kaplan – Meier estimates of the proportion of experimental participants who achieved independent walking were 37 % compared with 26 % of the control group at 1 month , 66 % compared with 55 % at 2 months , and 71 % compared with 60 % at 6 months ( P=0.13 ) . The experimental group walked 2 weeks earlier , with a median time to independent walking of 5 weeks compared to 7 weeks for the control group . In addition , 14 % ( 95 % CI , −1–28 ) more of the experimental group were discharged home . Conclusions — Treadmill walking with body weight support is feasible , safe , and tends to result in more people walking independently and earlier after stroke . Trial Registration — NN Clinical Trial.gov ( NCT00167531 )",
"Background Gait restoration is an integral part of rehabilitation of brain lesioned patients . Modern concepts favour a task-specific repetitive approach , i.e. who wants to regain walking has to walk , while tone-inhibiting and gait preparatory manoeuvres had dominated therapy before . Following the first mobilization out of the bed , the wheelchair-bound patient should have the possibility to practise complex gait cycles as soon as possible . Steps in this direction were treadmill training with partial body weight support and most recently gait machines enabling the repetitive training of even surface gait and even of stair climbing . Results With treadmill training harness-secured and partially relieved wheelchair-mobilised patients could practise up to 1000 steps per session for the first time . Controlled trials in stroke and SCI patients , however , failed to show a superior result when compared to walking exercise on the floor . Most likely explanation was the effort for the therapists , e.g. manually setting the paretic limbs during the swing phase result ing in a too little gait intensity . The next steps were gait machines , either consisting of a powered exoskeleton and a treadmill ( Lokomat , AutoAmbulator ) or an electromechanical solution with the harness secured patient placed on movable foot plates ( Gait Trainer GT I ) . For the latter , a large multi-centre trial with 155 non-ambulatory stroke patients ( DEGAS ) revealed a superior gait ability and competence in basic activities of living in the experimental group . The HapticWalker continued the end effector concept of movable foot plates , now fully programmable and equipped with 6 DOF force sensors . This device for the first time enables training of arbitrary walking situations , hence not only the simulation of floor walking but also for example of stair climbing and perturbations . Conclusion Locomotor therapy is a fascinating new tool in rehabilitation , which is in line with modern principles of motor relearning promoting a task-specific repetitive approach . Sophisticated technical developments and positive r and omized controlled trials form the basis of a growing acceptance worldwide to the benefits or our patients",
"OBJECTIVE To analyse the effects of gait therapy for patients after acute stroke in a r and omized controlled trial . METHODS Fifty-six patients with a mean of 8 days post-stroke participated in : ( i ) gait trainer exercise ; ( ii ) walking training over ground ; or ( iii ) conventional treatment . Patients in the gait trainer exercise and walking groups practice d gait for 15 sessions over 3 weeks and received additional physiotherapy . Functional Ambulatory Category and several secondary outcome measures assessing gait and mobility were administered before and after rehabilitation and at 6-month follow-up . Patients also evaluated their own effort . RESULTS Walking ability improved more with intensive walk training compared with conventional treatment ; median Functional Ambulatory Category was zero in all patients at the start of the study , but it was 3 in both walk-training groups and 0.5 in the conventional treatment group at the end of the therapy . Median Functional Ambulatory Category was 4 in both walk-training groups and 2.5 in conventional treatment group at 6-month follow-up . Mean accomplished walking distance was not different between the gait trainer exercise and over ground walking groups . Borg scale indicated more effort in over ground walking . Secondary outcomes also indicated improvements . CONCLUSION Exercise therapy with walking training improved gait function irrespective of the method used , but the time and effort required to achieve the results favour the gait trainer exercise . Early intensive gait training result ed in better walking ability than did conventional treatment",
"The purpose of this r and omised controlled trial was to evaluate the effects of two different exercise approaches during the first 12 months post stroke on Instrumental Activities of Daily Living ( IADL ) , motor function , gait performance , balance , grip strength , and muscle tone . This study is a double-blind longitudinal r and omised trial of first-time-ever stroke patients . Seventy-five patients were included : 35 in an intervention group and 40 in a self-initiated exercise group . After discharge from acute rehabilitation , patients assigned in the intervention group had physiotherapy for a minimum amount of 80 hours during the first year . Patients in the self-initiated exercise group were not recommended any specific therapy besides treatment when needed . Main outcome measures were Instrumental Activities of Daily Living according to Fillenbaum , Motor Assessment Scale , 6-Minute Walk Test , Berg Balance Scale , Timed Up- and -Go Test , grip strength , Modified Ashworth Scale , and pulse monitoring . The patients were tested on admission , at discharge , and after 3 , 6 , and 12 months post stroke by an experienced investigator , blinded to group assignment . Twelve months post stroke showed higher levels of independence in all items of the Instrumental Activities of Daily Living Test and improvements in the results of Motor Assessment Scale , 6-Minute Walk Test , Berg Balance Scale , Timed Up- and -Go , and grip strength in both groups . Only a few significant differences were seen between groups , and they were in favour of the self-initiated exercise group ( e.g. , ability to use the telephone independently ) . Attending examination sessions following each intervention phase appeared to be strong motivators for training , irrespective of group allocation",
"Walking tests , frequently used to document effects of treatment on exercise capacity , have never been st and ardised . We studied the effects of encouragement on walking test performance in a r and omised study that controlled for the nature of the underlying disease , time of day , and order effects . We r and omised 43 patients with chronic airflow limitation or chronic heart failure or both to receive or not receive encouragement as they performed serial two and six minute walks every fortnight for 10 weeks . Simple encouragement improved performance ( p less than 0.02 for the six minute walk ) , and the magnitude of the effect was similar to that reported for patients in studies purporting to show beneficial effects of therapeutic manoeuvres . Age and test repetition also affected performance . These results demonstrate the need for careful st and ardisation of the performance of walking tests , and suggest caution in interpreting studies in which st and ardisation is not a major feature of the study design",
"Background and Purpose — This study aim ed to assess the effectiveness of gait training using an electromechanical gait trainer with or without functional electrical stimulation for people with subacute stroke . Methods — This was a nonblinded r and omized controlled trial with a 6-month follow-up . Fifty-four subjects were recruited within 6 weeks after stroke onset and were r and omly assigned to 1 of 3 gait intervention groups : conventional overground gait training treatment ( CT , n=21 ) , electromechanical gait trainer ( GT , n=17 ) and , electromechanical gait trainer with functional electrical stimulation ( GT-FES , n=16 ) . All subjects were to undergo an assigned intervention program comprising a 20-minute session every weekday for 4 weeks . The outcome measures were Functional Independence Measure , Barthel Index , Motricity Index leg subscale , Elderly Mobility Scale ( EMS ) , Berg Balance Scale , Functional Ambulatory Category ( FAC ) , and 5-meter walking speed test . Assessment s were made at baseline , at the end of the 4-week intervention program , and 6 months after the program ended . Results — By intention-to-treat and multivariate analysis , statistically significant differences showed up in EMS ( Wilks ' & lgr;=0.743 , P=0.005 ) , FAC ( Wilks ' & lgr;=0.744 , P=0.005 ) and gait speed ( Wilks ' & lgr;=0.658 , P<0.0001 ) . Post hoc analysis ( univariate 2-way ANCOVA ) revealed that the GT and GT-FES groups showed significantly better improvement in comparison with the CT group at the end of the 4 weeks of training and in the 6-month follow-up . Conclusions — For the early stage after stroke , this study indicated a higher effectiveness in poststroke gait training that used an electromechanical gait trainer compared with conventional overground gait training . The training effect was sustained through to the 6-month follow-up after the intervention",
"Purpose : To test the hypothesis that partial body weight-supportcd treadmill training ( PBWSTT ) provides more effective gait training than an equally supportive but less physiologic aggressive bracing assisted walking ( ABAW ) program . Methods : Following informed consent , patients participating in an inpatient re habilitation program with significant leg weakness and need for at least moderate as sistance for walking , without orthostatic hypotension , symptomatic dyspnea , or angina pectoris were r and omized to receive PBWSTT vs. ABAW . PBWSTT was provided by a commercially available , overhead motorized hoist attached to a parachute-type body harness , which provided partial support of the patient 's weight over a treadmill . Ther apists assisted with weight shifting , leg advancement , and foot placement as needed . ABAW included aggressive early therapist-assisted ambulation using knee-ankle com bination bracing and hemi-bar if needed . Treatment sessions of up to 45 minutes per day , five days per week were given as tolerated for the duration of the inpatient stay or until patients could walk over-ground unassisted . All patients had an additional 45- minute session of functionally oriented physical therapy each day with or without brac ing as judged appropriate by the patient 's individual therapist . Results : Fifty-six patients a mean age of 71 ±1 SEM were enrolled 40 ± 3 days post stroke . Although die outcome of the two groups as a whole did not differ , a subgroup with major hemispheric stroke defined by the presence of hemiparesis , hemianopic vi sual deficit , and hemihypesthesia who received more than 12 treatment sessions showed significantly better over-ground endurance ( 90 ± 34 vs. 44 ± 10 meters ) and speed scores ( 12 ± 4 vs. 8 ± 2 meters/minute ) for PBWSTT vs. ABAW , respectively . Conclusions : PBWSTT and ABAW are equally effective gait training techniques except for a subset of patients with major hemispheric stroke who are difficult to mo bilize using ABAW alone",
"OBJECTIVE To compare body weight-supported exercise on a gait trainer with walking exercise overground . DESIGN R and omized controlled trial . SETTING Rehabilitation hospital . PARTICIPANTS Forty-five ambulatory patients with chronic stroke . INTERVENTIONS Patients were r and omized to 3 groups : ( 1 ) gait trainer exercise with functional electric stimulation ( GTstim ) , ( 2 ) gait trainer exercise without stimulation ( GT ) , and ( 3 ) walking overground ( WALK ) . All patients practice d gait for 15 sessions during 3 weeks ( each session , 20 min ) , and they received additional physiotherapy 55 minutes daily . MAIN OUTCOME MEASURES Ten-meter walk test ( 10MWT ) , six-minute walk test ( 6MWT ) , lower-limb spasticity and muscle force , postural sway tests , Modified Motor Assessment Scale ( MMAS ) , and FIM instrument scores were recorded before , during , and after the rehabilitation and at 6 months follow-up . RESULTS The mean walking distance using the gait trainer was 6900+/-1200 m in the GTstim group and 6500+/-1700 m in GT group . In the WALK group , the distance was 4800+/-2800 m , which was less than the walking distance obtained in the GTstim group ( P=.027 ) . The body-weight support was individually reduced from 30 % to 9 % of the body weight over the course of the program . In the pooled 45 patients , the 10MWT ( P 6MWT ( P MMAS ( P dynamic balance test time ( P test trip ( P=.005 ) scores improved ; however , no differences were found between the groups . CONCLUSIONS Both the body weight-supported training and walking exercise training programs result ed in faster gait after the intensive rehabilitation program . Patients ' motor performance remained improved at the follow-up",
"Objective : This pilot r and omized controlled trial evaluated an assistant-led , community-based intervention to improve community mobility and participation after stroke , and examined the potential for independent community ambulation in people with subacute stroke who present with moderate gait deficit . Design : A multicentre , pilot r and omized controlled trial . Setting : Three hospitals and three community setting s in New Zeal and . Subjects : Thirty post-acute , home-dwelling stroke survivors were r and omly allocated to receive intervention in the community ( n = 14 ) or as hospital out patients ( n = 16 ) twice a week for seven weeks . Interventions : The community intervention involved practice of functional gait activities in community environments relevant to each participant . Hospital-based physiotherapy was based upon a Motor Relearning approach . Main measures : The primary outcome measure was gait speed ( m/min ) . Secondary outcomes included endurance ( six-minute walk time ) , Activities-specific Confidence Balance Scale , and the Subjective Index of Physical and Social Outcomes measured at baseline , post intervention and six months . Results : Large gains in gait speed were obtained for participants in both groups : community group mean ( SD ) 16 ( 16.1 ) m/min ; physiotherapy group mean ( SD ) 15.9 ( 16.1 ) m/min , maintained at six months . There were no significant differences between groups for primary and secondary outcomes after treatment ( P = 0.86 ANOVA ) or at six months ( P = 0.83 ANOVA ) . Only 11 participants reported independent community ambulation . Levels of social integration were low to moderate . Conclusions : A community-based gait recovery programme appears a practicable alternative to routine physiotherapy , however independent community ambulation is a challenging rehabilitation goal",
"OBJECTIVE To evaluate the effectiveness of early and prolonged locomotor treatment with the use of a robotic-assisted gait training ( RAGT ) device ( Lokomat ; Hocoma Inc. , Zurich , Switzerl and ) on the functional outcomes of patients after subacute stroke . DESIGN A nonblinded prospect i ve , r and omized , controlled study . SETTING Rehabilitation department in tertiary university medical center . PATIENTS Sixty-seven patients in the first 3 months after subacute stroke were r and omized into 2 groups as follows . Thirty-seven patients were treated with RAGT , and 30 were treated with regular physiotherapy . Inclusion criteria were first stroke , independent ambulation before the stroke , and neurological severity between 6 and 20 according to the National Institutes of Health Stroke Scale ( NIHSS ) . INTERVENTION RAGT treatment was administered 3 times a week for 30 minutes , combined with regular physiotherapy for 6 weeks . Control patients received the equivalent additional time of regular physiotherapy . MAIN OUTCOME MEASUREMENTS The primary outcome was the ability to walk independently , as assessed by use of the functional ambulatory capacity scale . The secondary outcomes included the neurological status according to the NIHSS ; functional motor assessment ( determined by use of the stroke activity scale ) ; and gait parameters , including gait velocity , endurance , and number of climbed stairs . RESULTS In the intention-to-treat analysis , subjects in the RAGT group exhibited greater gains than the control group in their ability to walk independently , as expressed by a greater functional ambulatory capacity score ( P neurological status according to NIHSS ( P independent walking , nonsignificant differences between groups were noted according to secondary outcome measures of gait parameters except from step climbing . CONCLUSION This controlled study showed , at the end of a 6-week trial , that locomotor therapy with the use of RAGT combined with regular physiotherapy produced promising effects on functional and motor outcomes in patients after subacute stroke as compared with regular physiotherapy alone",
"Objective . Treadmill training with partial body weight support has been suggested as a useful strategy for gait rehabilitation after stroke . This prospect i ve , blinded , r and omized controlled study of gait retraining tested the feasibility and potential efficacy of using an electromechanical-driven gait orthosis ( Lokomat ) for treadmill training . Methods . Sixteen stroke patients , mostly within 3 months after onset , were r and omized into 2 treatment groups , ABA or BAB ( A = 3 weeks of Lokomat training , B = 3 weeks of conventional physical therapy ) for 9 weeks of treatment . The outcome measures were the EU-Walking Scale , Rivermead Motor Assessment Scale , 10-m timed walking speed , 6-minute timed walking distance , Motricity Index , Medical Research Council Scale of strength , and Ashworth Scale of tone . Results . The EU-Walking Scale , Rivermead Motor Assessment Scale , 6-minute timed walking distance , Medical Research Council Scale , and Ashworth Scale demonstrated significantly more improvement during the Lokomat training phase than during the conventional physical therapy phase within each 3-week interval . Conclusions . Despite the small number of patients , the present data suggest that the Lokomat robotic assistive device provides innovative possibilities for gait training in stroke rehabilitation while eliminating prolonged repetitive movements in a nonergonomic position on the part of the physical therapist",
"Objective : To compare the effect of walking training on a treadmill with body weight support ( BWS ) and walking training on the ground at an early stage of rehabilitation in patients with hemiparesis after stroke . Design : R and omized controlled experimental study . Setting : Multicentre design ; three departments of rehabilitation medicine . Subjects : Seventy-three consecutive first stroke patients admitted to a rehabilitation clinic were r and omized into a treatment group and a control group . Interventions : The treatment group received walking training on a treadmill with BWS for 30 minutes , 5 days a week . The control group received walking training according to the Motor Relearning Programme ( MRP ) on the ground for 30 minutes 5 days a week , not including treadmill training . During the time in the rehabilitation department ( about two months ) , all patients in the study also received professional stroke rehabilitation besides the walking training in the two groups . Main outcome measures : Functional Independence Measure ( FIM ) , walking velocity for 10 m , Functional Ambulation Classification ( FAC ) , Fugl-Meyer Stroke Assessment and Berg 's Balance Scale . The assessment s were performed at admission , at discharge and at 10-month follow-up . Results : There were no statistically significant differences between the groups at discharge or at the 10-month follow-up with regard to FIM , walking velocity , FAC , Fugl-Meyer Stroke Assessment , and Berg 's Balance Scale . Patients in both groups improved in these variables from admission to the 10-month follow-up . Conclusions : Treadmill training with BWS at an early stage of rehabilitation after stroke is a comparable choice to walking training on the ground",
"OBJECTIVE To investigate gait outcomes with supported treadmill ambulation training ( STAT ) associated with regular rehabilitation in acute stroke survivors . DESIGN R and omized controlled trial , pilot study . SETTING Rehabilitation medicine service at a Veterans Affairs medical center . PARTICIPANTS Seven acute stroke survivors assigned to regular intervention group and 6 patients assigned to STAT intervention . INTERVENTIONS Regular intervention consisted of 3 hours daily of physical therapy , kinesiotherapy , and occupational therapy . STAT group received regular rehabilitation with STAT substituted for usual gait training . Participants were tested at baseline , treated for an average of 3 weeks , and retested on discharge . The analysis of covariance procedure was used to test for differences between the 2 approaches . MAIN OUTCOME MEASURES Functional Ambulation Category Scale , gait speed , walking distance , gait energy expenditure , and gait energy cost . RESULTS The small sample size did not generate enough power to detect significant differences in any variable . However , medium to large effect sizes of 0.7 and 1.16 st and ard deviation units were observed for gait energy cost and walk distance , respectively . CONCLUSIONS This pilot study indicated that STAT is a safe , feasible , and promising intervention for acute stroke survivors . A larger trial is warranted for statistical relevance",
"A r and omized controlled pilot trial was conducted to estimate the effects of early , intensive , gait-focused physical therapy on ambulatory ability in acute , stroke patients . Twenty-seven patients with middle cerebral artery infa rct of thromboembolic origin confirmed by computed axial tomography scan were stratified and r and omly assigned to the experimental group , to a control group that received early , intensive and conventional therapy , or to a group receiving routine conventional therapy that started later and was not intense . Assessment s at entry , six weeks , and three and six months by independent evaluators permitted comparisons with reference to clinical measures of motor performance , balance , and functional capacity , and laboratory measures of gait movements . Group results at six weeks demonstrated that gait velocity was similar in the two conventional groups thereby eliminating the timing of the interventions as an important factor . At that point , gait velocity was faster in the experimental group . The difference translated into a moderate effect size of 0.58 . The time dedicated to gait training but not to total therapy time was correlated ( rs = 0.63 ) to gait velocity . This effect disappeared at three and six months after stroke . These pilot results justify planning a large trial to test the effectiveness of a therapeutic protocol that focuses on early and intense gait therapy in an effort to facilitate early ambulation following stroke",
"OBJECTIVE To compare the therapeutic effects of conventional gait training ( CGT ) , gait training using an electromechanical gait trainer ( EGT ) , and gait training using an electromechanical gait trainer with functional electric stimulation ( EGT-FES ) in people with subacute stroke . DESIGN Nonblinded r and omized controlled trial . SETTING Rehabilitation hospital for adults . PARTICIPANTS Fifty patients were recruited within 6 weeks after stroke onset ; 46 of these completed the 4-week training period . INTERVENTION Participants were r and omly assigned to 1 of 3 gait intervention groups : CGT , EGT , or EGT-FES . The experimental intervention was a 20-minute session per day , 5 days a week ( weekdays ) for 4 weeks . In addition , all participants received their 40-minute sessions of regular physical therapy every weekday as part of their treatment by the hospital . MAIN OUTCOME MEASURES Five-meter walking speed test , Elderly Mobility Scale ( EMS ) , Berg Balance Scale , Functional Ambulatory Category ( FAC ) , Motricity Index leg subscale , FIM instrument score , and Barthel Index . RESULTS The EGT and EGT-FES groups had statistically significantly more improvement than the CGT group in the 5-m walking speed test ( CGT vs EGT , P=.011 ; CGT vs EGT-FES , P=.001 ) , Motricity Index ( CGT vs EGT-FES , P=.011 ) , EMS ( CGT vs EGT , P=.006 ; CGT vs EGT-FES , P=.009 ) , and FAC ( CGT vs EGT , P=.005 ; CGT vs EGT-FES , P=.002 ) after the 4 weeks of training . No statistically significant differences were found between the EGT and EGT-FES groups in all outcome measures . CONCLUSIONS In this sample with subacute stroke , participants who trained on the electromechanical gait trainer with body-weight support , with or without FES , had a faster gait , better mobility , and improvement in functional ambulation than participants who underwent conventional gait training . Future studies with assessor blinding and larger sample sizes are warranted"
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Introduction In the present systematic review and meta- analysis , we assessed the effectiveness of different forms of balneotherapy ( BT ) and hydrotherapy ( HT ) in the management of fibromyalgia syndrome ( FMS ) . Methods A s ystematic literature search was conducted through April 2013 ( Medline via Pubmed , Cochrane Central Register of Controlled Trials , EMBASE , and CAMBASE ) . St and ardized mean differences ( SMDs ) and 95 % confidence intervals ( CIs ) were calculated using a r and om-effects model . Results Meta- analysis showed moderate-to-strong evidence for a small reduction in pain ( SMD −0.42 ; 95 % CI [ −0.61 , −0.24 ] ; P 8 studies , 462 participants ; 3 low-risk studies , 223 participants ) , and moderate-to-strong evidence for a small improvement in health-related quality of life ( HRQOL ; 7 studies , 398 participants ; 3 low-risk studies , 223 participants ) at the end of treatment ( SMD −0.40 ; 95 % CI [ −0.62 , −0.18 ] ; P = 0.0004 ; I2 = 15 % ) . No effect was seen at the end of treatment for depressive symptoms and tender point count (TPC).BT in mineral/thermal water ( 5 studies , 177 participants ; 3 high-risk and 2 unclear risk studies ) showed moderate evidence for a medium-to-large size reduction in pain and TPC at the end of treatment : SMD −0.84 ; 95 % CI [ −1.36 , −0.31 ] ; P = 0.002 ; I2 = 63 % and SMD −0.83 ; 95 % CI [ −1.42 , −0.24 ] ; P = 0.006 ; I2 = 71 % . After sensitivity analysis , and excluding one study , the effect size for pain decreased : SMD −0.58 ; 95 % CI [ −0.91 , −0.26 ] , P = 0.0004 ; I2 = 0 . Moderate evidence is given for a medium improvement of HRQOL ( SMD −0.78 ; 95 % CI [ −1.13 , −0.43 ] ; P effect on depressive symptoms was not found . The improvements for pain could be maintained at follow-up with smaller effects . Conclusions High- quality studies with larger sample sizes are needed to confirm the therapeutic benefit of BT and HT , with focus on long-term results and maintenance of the beneficial effects
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"OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life",
"OBJECTIVES To estimate the cost-effectiveness of an adjuvant treatment course of spa treatment compared with usual care only in patients with fibromyalgia syndrome ( FM ) . METHODS 134 patients with FM , selected from a rheumatology outpatient department and from members of the Dutch FM patient association were r and omly assigned to a 2(1/2 ) week spa treatment course in Tunisia or to usual care only . Results are expressed as quality -adjusted life years ( QALYs ) for a 6-month as well as a 12-month time horizon . Utilities were derived form the Short Form 6D ( SF-6D ) scores and the visual analogue scale ( VAS ) rating general health . Costs were reported from societal perspective . Mean incremental cost per patient and the incremental cost utility ratio ( ICER ) were calculated ; 95 % confidence intervals ( CIs ) were estimated using double-sided bootstrapping . RESULTS The data of 128 ( 55 spa and 73 controls ) of the 134 patients ( 96 % ) could be used for analysis . Improvement in general health was found in the spa group until 6 months of follow-up by both the SF-6D ( AUC 0.32 vs 0.30 , P Mean incremental cost of spa treatment was 1311 Euro per patient ( 95 % CI 369 - 2439 ) , equalling the cost of the intervention ( thalassotherapy including airfare and lodging ) , or 885 Euro per patient based on a more realistic cost estimate . CONCLUSIONS The temporary improvement in quality of life due to an adjuvant treatment course of spa therapy for patients with FM is associated with limited incremental costs per patient",
"Perspectives of patients with fibromyalgia influence their likelihood of participating in r and omized placebo-controlled trials and potentially clash with current , well-established methodology of r and omized controlled trial design . M and ates to use only acetaminophen for breakthrough pain and that require discontinuation of concomitant medications , especially in studies lacking an active comparator arm , could bias a trial cohort to thereby reduce the generalizability of study findings and conclusions . This study evaluates factors affecting willingness to participate in such clinical trials , including the impact of altruism , payment , study duration , forced discontinuation of specific medications , and subject demographics for patients seen by rheumatologists proficient and avidly interested in treating fibromyalgia",
"We aim ed to evaluate the effectiveness of balneotherapy in fibromyalgia management . Fifty women with fibromyalgia under pharmacological treatment were r and omly assigned to either the balneotherapy ( 25 ) or the control ( 25 ) group . Four patients from the balneotherapy group and one patient from the control group left the study after r and omization . The patients in the balneotherapy group ( 21 ) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center . The patients in the control group ( 24 ) continued to have their medical treatment and routine daily life . An investigator who was blinded to the study arms assessed the patients . All patients were assessed four times ; at the beginning of the study , at the end of the 2nd week , the 1st month , and the 3rd month after balneotherapy . Outcome measures of the study were pain intensity , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory ( BDI ) , patient ’s global assessment , investigator ’s global assessment , SF-36 scores , and tender point count . Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity , FIQ , Beck Depression Inventory , patient ’s global assessment , investigator ’s global assessment scores , and tender point count as compared to the control group . The superiority of balneotherapy lasted up to the end of the 3rd month , except for the Beck Depression Inventory score and the investigator ’s global assessment score . Significant improvements were observed in PF , GH , and MH subscales of SF-36 during the study period in the balneotherapy group ; however , no such improvement was observed in the control group . Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls . It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia",
"OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes",
"OBJECTIVE To evaluate the effects of pool exercise in patients with fibromyalgia and chronic widespread pain and to determine characteristics influencing the effects of treatment . METHODS A total of 134 women with fibromyalgia and 32 with chronic widespread pain were r and omized to a 20-session pool exercise and a 6-session education programme or to a control group undertaking the same education programme . The primary outcomes were the Fibromyalgia Impact Question naire ( FIQ ) total score and the 6-minute walk test ( 6MWT ) . FIQ Pain and other health variables were included . RESULTS The FIQ total ( p = 0.04 ) improved in the intervention group , with an effect size of 0.32 . Patients who had participated in at least 60 % of the exercise sessions improved in the FIQ total ( effect size 0.44 ) , the 6MWT ( effect size 0.43 ) and FIQ Pain ( effect size 0.69 ) compared with controls ( p 6MWT among the active participants ( p patients with milder stress , pain or depression improved most by treatment on the FIQ total ( effect size > 0.50 , p exercise-education programme showed significant , but small , improvement in health status in patients with fibromyalgia and chronic widespread pain , compared with education only . Patients with milder symptoms improved most with this treatment",
"BACKGROUND A one-week booster group treatment in rheumatic diseases ( rheumatoid arthritis , spondylarthropathies , fibromyalgia ) was developed in order to stabilize rehabilitation effects after medical rehabilitation . The program took place in an inpatient setting 3 - 5 months after rehabilitation , aim ed at refreshing and deepening already learnt contents as well as teaching new subjects ( e. g. about dietetics ) . Training and educational elements are given priority in this concept . METHOD A total of 140 patients participated in 19 booster weeks . At the end of each booster week the acceptance was assessed by question naire and in a round-table discussion . RESULTS Comprehensibility and group atmosphere were judged very positively . The course was also considered very helpful , helpfulness being rated with marks about 2 ( 1 = very helpful , 6 = not at all helpful ) . Participants especially appreciated the course 's framework as a group setting emphasising the exchange of experience with co- patients . At the same time , however , participants wished more individualized treatment such as physiotherapy or massage . With regard to the quantity of the various therapy elements , participants would have preferred more traditional spa therapy , more medical treatment by a physician , more group physiotherapy and sports . They would also have liked more breaks . In general fewer psychological elements , less discussion and reflection but more physical activity was wished for . Little difference was found between the various diagnoses , but the program was rated slightly more positively by the patients with spondylarthropathies . CONCLUSION Overall , the great number of people participating in the program and their acceptance of the booster week are positive . Patients appreciated the group setting and the possibilities of exchanging experience on a high level . But it was difficult to change patients ' traditional expectations concerning medical rehabilitation to a behaviour-orientated course like ours . It is worth thinking about whether this concept should play a greater role in traditional medical inpatient rehabilitation programming",
"Evidence -based recommendations support the use of multimodal therapy and hydrotherapy for fibromyalgia syndrome ; however , there is little st and ardisation of such programmes . The aim of the study was to assess the effectiveness of a pool-based exercise using deep water running ( DWR ) as part of a multimodal physiotherapy programme for patients with fibromyalgia syndrome . For a non-r and omised clinical study , 44 patients diagnosed with fibromyalgia were recruited from primary care . Patients in the experimental group received a multimodal programme incorporating pool-based exercise using DWR three times a week for an 8-week period . The control group received a leaflet containing advice and continued with normal activities . Patients were evaluated for physical function ( Fibromyalgia Impact Question naire , FIQ ) , pain , general health ( Short Form-12 Health Survey ) and quality of life ( European Quality of Life Scale-5D ) pre- and post intervention . Statistically significant results were found for the experimental group for FIQ total score , incorporating physical function , pain , fatigue , stiffness and psychological variables ( p general health ( p quality of life ( p compliance and adherence and low level of attrition suggest that this multimodal programme incorporating DWR is a safe and effective intervention for fibromyalgia syndrome that is acceptable to patients",
"Fibromyalgia is characterized by chronic and extended musculoskeletal pain . The combination of exercise therapy with the warm water may be an appropriate treatment . However , studies focusing on the analysis of immediate pain during and after an exercise session are rare . This study aim ed to determine the immediate changes of a warm water pool-based exercise program ( 12 weeks ) on pain ( before vs. after session ) in female fibromyalgia patients . 33 Spanish women with fibromyalgia were selected to participate in a 12 weeks ( 2 sessions/week ) low-moderate intensity warm water pool-based program . We assessed pain by means of a Visual Analogue Scale before and after each single session ( i. e. , 24 sessions ) . We observed immediate benefits on pain with a mean decrease ~15 % in all sessions , except in the fourth one . There was an association of pain difference ( pre-post ) session with pain pre session ( p=0.005 ; β=0.097±0.034 ) and with age ( p on pain , pre session , post session , and pre-post changes ( all p>0.05 ) . Therefore this study showed that a warm water pool-based exercise program for 12 weeks ( 2 times/week ) led to a positive immediate decrease in level of pain in female patients with fibromyalgia . Improvements were higher in older women and in those with more intense pain",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations . Six months after programme completion , significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ ( total score p = 0.025 ; fatigue p = 0.003 ; depression p = 0.031 ) and PGWB ( total score p = 0.032 ; anxiety p = 0.011 ; vitality p = 0.013 , ) . All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups ; between-group differences were statistically significant for “ control of symptoms ” , “ psychosocial factors ” , and “ physical therapy ” No change in pain was seen . Conclusion : A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment . These improvements are sustained for at least 6 months after programme completion",
"The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience .",
"OBJECTIVE To evaluate the effectiveness and tolerability of two pool-based physical therapies , stretching and Ai Chi , in fibromyalgia symptomatology and sleep quality . METHODS Eighty-one patients , r and omly assigned to stretching ( n=39 ) or Ai Chi ( n=42 ) , received 18 physiotherapy sessions and were evaluated at baseline , at treatment termination , and after 4 and 12 weeks of follow-up . Main outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) and the Pittsburgh Sleep Quality Index ( PSQI ) . Secondary outcome measures included the Beck Depression Inventory ( BDI ) , the State and Trait Anxiety Inventory ( STAI ) , and the SF-12 Health Survey ( SF-12 ) . Data analysis was done with repeated measures ANOVA and effect size estimation . RESULTS No differences were found between groups but significant reduction in the FIQ and the PSQI scores were observed in Ai Chi but not in stretching group , with larger effect sizes and longer effect duration on sleep measures . BDI scores decreased in stretching but not in Ai Chi group with small effect sizes . Trait-anxiety scores decreased in both groups also with small effect sizes . The mental component summary of the SF-12 increased only in stretching group with effect sizes moderate to large . CONCLUSIONS Although no global differences were found between groups , Ai Chi significantly improved fibromyalgia symptomatology and sleep quality , whereas stretching only improved subjects ' psychological well-being",
"Introduction Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia , but its efficiency remains largely unknown . Should patients or health care managers invest in this therapy ? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia . Methods Costs to the health care system and to society were considered in this study that included 33 participants , r and omly assigned to the experimental group ( n = 17 ) or a control group ( n = 16 ) . The intervention in the experimental group consisted of a 1-h , supervised , water-based exercise sessions , three times per week for 8 months . The main outcome measures were the health care costs and the number of quality -adjusted life-years ( QALYs ) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument . Sensitivity analyses were performed for variations in staff salary , number of women attending sessions and time spent going to the pool . The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique . Results The mean incremental treatment costs exceeded those for usual care per patient by € 517 for health care costs and € 1,032 for societal costs . The mean incremental QALY associated with the intervention was 0.131 ( 95 % CI : 0.011 to 0.290 ) . Each QALY gained in association with the exercise programme cost an additional € 3,947/QALY ( 95 % CI : 1,782 to 47,000 ) for a health care perspective and € 7,878/QALY ( 3,559 to 93,818 ) from a societal perspective . The curves showed a 95 % probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is € 14,200/QALY from a health care perspective and € 28,300/QALY from a societal perspective . Conclusion The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs . However , the characteristics of facilities ( distance from the patients ' homes and number of patients that can be accommo date d per session ) are major determinants to consider before investing in such a programme . Trial registration Current controlled trials IS RCT N53367487",
"The purpose of this study was to investigate the clinical effects of balneotherapy in the treatment of Fibromyalgia Syndrome ( FMS ) and to determine if balneotherapy influences serum levels of inflammation markers , IL-1 , PGE2 and LTB4 . 24 primary fibromyalgia female patients diagnosed according to American College of Rheumatology criteria were included to the study . Their ages ranged between 33 and 55 years . FMS patients were r and omly assigned in two groups as , group 1 ( n = 12 ) and group 2 ( n = 12 ) . Group 1 received 20-min bathing , once in a day for five days per week . Patients participated in the study for 3 weeks ( total of 15 sessions ) in Denizli . Group 2 did not receive balneotherapy . FMS patients were evaluated by tenderness measurements ( tender point count and algometry ) , Visual Analogue Scale , Beck ’s Depression Index , Fibromyalgia Impact Question naire . Ten healthy women recruited group three as the controls . Serum PGE2 , LTB4 and IL1-α levels were measured in all three groups . The biochemical measurements and clinical assessment s were performed before and at the end of general period of therapy . Statistically significant alterations in algometric score , Visual Analogue score , Beck ’s Depression Index and PGE2 levels ( P ) , numbers of tender points ( P and Fibromyalgia Impact Question naire score ( P balneotherapy between group 1 and 2 . Mean PGE2 level of FMS patients were higher compared to healthy control group ( P After balneotherapy IL-1 and LTB4 significantly decreased in group 1 ( P balneotherapy is an effective choice of treatment in patients with FMS relieving the clinical symptoms , and possibly influencing the inflammatory mediators",
"OBJECTIVE To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome ( FM ) . METHODS The study population comprised 58 patients , r and omized to a treatment or a control group . Patients were instructed to match the pool exercises to their threshold of pain and fatigue . The education focused on strategies for coping with symptoms and encouragement of physical activity . The primary outcome measurements were the total score of the Fibromyalgia Impact Question naire ( FIQ ) and the 6 min walk test , recorded at study start and after 6 mo . Several other tests and instruments assessing functional limitations , severity of symptoms , disabilities , and quality of life were also applied . RESULTS Significant differences between the treatment group and the control group were found for the FIQ total score ( p = 0.017 ) and the 6 min walk test ( p physical function , grip strength , pain severity , social functioning , psychological distress , and quality of life . CONCLUSION The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM",
"The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia ( FM ) . A total of 46 patients were r and omly allocated into two groups : pool group ( 23 patients ) and sea group ( 23 patients ) that performed the same aerobic exercise program . Patients were evaluated baseline and after 12 weeks using : VAS , number of tender points , FIQ , SF-36 , PSQI , and BDI . Both groups improved significantly in post-treatment for all the evaluated variables . There were no significant differences between two groups , except for BDI ( F = 2.418 , P Aerobic exercise program performed in water ( pool or sea ) was effective for patients with FM . However , sea water exercises have been shown to bring more advantages related to emotional aspects . Then , exercise performed sea water ( thalassotherapy ) is an option for effective treatment with low cost for patients with FM",
"OBJECTIVE To measure mood and physical function of individuals with fibromyalgia , 6 and 12 months following 23 weeks of supervised aerobic exercise . METHODS This is a followup report of individuals who were previously enrolled in 23 weeks of l and -based and water-based aerobic exercise classes . Outcomes included the 6-minute walk test , Beck Depression Inventory ( BDI ) , State-Trait Anxiety Inventory , Arthritis Self-Efficacy Scale ( ASES ) , Fibromyalgia Impact Question naire ( FIQ ) , tender point count , patient global assessment score , and exercise compliance . Outcomes were measured at the start and end of the exercise classes and 6 and 12 months later . RESULTS Analyses were conducted on 29 ( intent-to-treat ) or 18 ( efficacy ) subjects . Six-minute walk distances and BDI total scores were improved at followup ( all analyses ) . BDI cognitive/affective scores were improved at the end of 23 weeks of exercise ( both analyses ) and at the 12-month followup ( efficacy analysis only ) . BDI somatic scores were improved at 6-month ( both analyses ) and 12-month followup ( intent-to-treat only ) . FIQ and ASES function were improved at all followup points . ASES pain was improved in efficacy analyses only ( all followup points ) . Tender points were unchanged after 23 weeks of exercise and at followup . Exercise duration at followup ( total minutes of aerobic plus anaerobic exercise in the preceding week ) was related to gains in physical function ( 6- and 12-month followup ) and mood ( 6-month followup ) . CONCLUSION Exercise can improve physical function , mood , symptom severity , and aspects of self efficacy for at least 12 months . Exercising at followup was related to improvements in physical function and perhaps mood",
"OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice",
"Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group . All participants stayed for 10 days at a Dead Sea spa . Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients",
"OBJECTIVE To evaluate the efficacy of a 6-week exercise and educational program for patients with fibromyalgia . METHODS Forty-one subjects were r and omly assigned to the program or served as waiting list controls . Program outcome was assessed with a 6-minute walk test , the Fibromyalgia Impact Question naire , a Self-Efficacy Scale , and a \" knowledge \" question naire ( based on information provided during the educational sessions ) . Waiting list control subjects subsequently completed the program . Program outcome was reassessed 3 or 6 months post-program . RESULTS The program produced significant improvements in 6-minute walk distance , well-being , fatigue , self-efficacy ( for controlling pain and other symptoms ) , and knowledge . At followup , immediate gains in walk distance , well-being , and self-efficacy were maintained , but gains in fatigue and knowledge were lost . CONCLUSION Short-term exercise and educational programs can produce immediate and sustained benefits for patients with fibromyalgia . The benefits of our program may be due to exercise or education since both interventions were given",
"Fibromyalgia ( FM ) is a nonarticular rheumatological syndrome associated with diverse clinical and psychological features . One of the major complaints in FM is reduced pain tolerance , especially in tender points ( TP ) for which patients derive significant benefit from nonsteroidal antiinflammatory drugs or corticosteroids . Patients with FM also have altered reactivity of the hypothalamic pituitary adrenal ( HPA ) axis where the predominant feature is reduced containment of the stress response system through diminished adrenocortical output and feedback resistance . Our results show that mud packs together with antidepressant treatment are able to influence the HPA axis , stimulating increased levels of adrenocorticotropic hormone , cortisol and beta-endorphin serum levels . The discharge of corticoids in the blood and the increase in beta-endorphin serum levels are followed by a reduction in pain symptoms , which is closely related to an improvement in disability , depression and quality of life . It seems that the synergic association between a pharmacological treatment ( trazodone ) and mud packs acts by helping the physiological responses to achieve homeostasis and to rebalance the stress response system . To clarify and optimize the effectiveness of this synergic association , studies involving a larger number of FM patients and a different pharmacological treatment are needed",
"Abstract : Fibromyalgia ( FS ) is an idiopathic chronic pain syndrome defined by widespread non-articular musculoskeletal pain and generalised tender points . As there is no effective treatment , patients with this condition have impaired quality of life ( QoL ) . The aim of this study was to assess the possible effect of balneotherapy at the Dead Sea area on the QoL of patients with FS . Forty-eight subjects participated in the study ; half of them received balneotherapy , and half did not . Their QoL ( using SF-36 ) , psychological well-being and FS-related symptoms were assessed prior to arrival at the spa hotel in the Dead Sea area , at the end of the 10-day stay , and 1 and 3 months later . A significant improvement was reported on most subscales of the SF-36 and on most symptoms . The improvement in physical aspects of QoL lasted usually 3 months , but on psychological measures the improvement was shorter . Subjects in the balneotherapy group reported higher and longer-lasting improvement than subjects in the control group . In conclusion , staying at the Dead Sea spa , in addition to balneotherapy , can transiently improve the QoL of patients with FS . Other studies with longer follow-up are needed to support our findings",
"The administration of ibuprofen potentiates and prolongs the analgesic effect of meptazinol when the two drugs are given simultaneously to mice . A double-blind three-way crossover study of placebo , ibuprofen ( 1600 mg/day ) and ibuprofen ( 1600 mg/day ) plus meptazinol ( 400 mg/day ) was carried out in 45 patients with soft tissue rheumatism to see if the same potentiation could be demonstrated in man . Treatment order was r and omized and each regimen was given for 2 weeks preceded by 1 week on paracetamol alone . Assessment s were made , on entry and after each treatment period , of pain parameters using visual analogue or verbal rating scales . Patients ' overall impression and final preference showed both active treatments to be better than placebo and demonstrated a slight preference for the combination",
"Objective . To follow patients with fibromyalgia six and 24 months after they finished a six-month treatment programme . The programme comprised pool exercise therapy , adjusted to the patients ' limitations , and education based on their health problems . Methods . Twenty-six patients were examined six and 24 months after the completion of the treatment programme with the Fibromyalgia Impact Question naire ( FIQ ) , SF-36 , the 6-minute walk test , and the Grippit measure . The values obtained at the follow-up examinations were compared with the baseline and post-treatment values . Results . As compared with baseline , symptom severity ( FIQ , SF-36 ) , physical function ( FIQ , SF-36 , 6-minute walk test ) and quality of life ( SF-36 ) still showed improvements six months after the completion of treatment ( p Pain ( FIQ , SF-36 ) , fatigue ( FIQ , SF-36 ) , walking ability , and social function ( SF-36 ) still showed improvements 2 years after the completion of the programme as compared with the baseline values ( p symptom severity , physical function and social function were still found six and 24 months after the completed treatment programme",
"Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary",
"OBJECTIVE We studied whether whirl baths with plain water or with water containing pine oil or valerian have a different influence on pain , disturbed sleep or tender point count . METHODS A r and omized , comparative and investigator-blinded study was performed . Out- patients with generalized fibromyalgia were r and omized into three treatment groups . INTERVENTIONS Therapy consisted of either whirl bath with plain water or with the addition of pine oil or valerian . The baths were carried out 10 times , three times a week . MAIN OUTCOME MEASURES General pain , change of pain intensity during the day , general well-being and occurrence of disturbed sleep were recorded before and after the therapy . The number of tender points was assessed by digital palpation , the pain threshold on the shinbone and the middle part of the deltoid muscle was measured by the dolorimeter of A. Fischer . The same instrument was used for recording pain threshold and pain tolerance of both trapezius muscles . The tissue compliance of these muscles was measured as well . RESULTS 30 out of 39 patients included in the study were evaluated statistically . After treatment with valerian bath ( n = 12 ) well-being and sleep were significantly improved and also the tender point count decreased significantly . Pine oil added to the bath water ( n = 7 ) result ed in a significant improvement of well-being , but unfortunately also in a significant decrease of pain threshold of the shinbone and the right deltoid muscle . Whirl bath in plain water ( n = 11 ) reduced general and maximum pain intensity significantly . CONCLUSIONS Our cautious conclusion of this study is - with respect to the small number of treated patients - that different effects of whirl baths with or without medicinal bath oils can be detected in fibromyalgia patients . Plain water baths modify the pain intensity , medicinal baths improve well-being and sleep",
"OBJECTIVE To evaluate the short- and long-term efficacy of exercise therapy in a warm , waist-high pool in women with fibromyalgia . METHODS Thirty-four women ( mean + /- SD tender points 17 + /- 1 ) were r and omly assigned to either an exercise group ( n = 17 ) to perform 3 weekly sessions of training including aerobic , proprioceptive , and strengthening exercises during 12 weeks , or to a control group ( n = 17 ) . Maximal unilateral isokinetic strength was measured in the knee extensors and flexors in concentric and eccentric actions at 60 degrees /second and 210 degrees /second , and in the shoulder abductors and adductors in concentric contractions . Health-related quality of life ( HRQOL ) was assessed using the EQ-5D question naire ; pain was assessed on a visual analog scale . All were measured at baseline , posttreatment , and after 6 months . RESULTS The strength of the knee extensors in concentric actions increased by 20 % in both limbs after the training period , and these improvements were maintained after the de-training period in the exercise group . The strength of other muscle actions measured did not change . HRQOL improved by 93 % ( P = 0.007 ) and pain was reduced by 29 % ( P = 0.012 ) in the exercise group during the training , but pain returned close to the pretraining level during the subsequent de-training . However , there were no changes in the control group during the entire period . CONCLUSION The therapy relieved pain and improved HRQOL and muscle strength in the lower limbs at low velocity in patients with initial low muscle strength and high number of tender points . Most of these improvements were maintained long term",
"OBJECTIVE It is a traditional practice in the Alpine region of Trentino and Alto Adige ( Italy ) to use phytothermotherapeutic treatment with fermenting grass ( \" hay baths \" ) for rheumatic diseases . However , despite its long history and popularity , a clinical validation of the efficacy and tolerability of the treatment has yet to be found in current literature . Fibromyalgia syndrome ( FMS ) is characterised by generalised musculoskeletal pain , high tender point counts , sleep disturbance , fatigue , headaches , irritable bowel syndrome , frequent psychological distress and depressed mood . There is no st and ard therapy regime for FMS and the variety of medical treatments used have given limited benefits . The aim of this study was to assess the efficacy and tolerability of a cycle of phytothermotherapy through a single-blind , controlled , r and omised trial , in patients with primary FMS . METHODS Fifty-six patients with primary FMS according to the ACR criteria were r and omly allocated to two groups : 30 were su bmi tted to phytothermotherapy at the thermal resort of Garniga Terme ( Trento , Italy ) and the other 26 were considered as controls . All patients were evaluated by FIQ , Tender Points Count , HAQ and AIMS 1 at baseline , after 10 days , then after 12 and 24 weeks . RESULTS Patients su bmi tted to phytothermotherapy showed visible and significant improvement of all evaluation parameters at the end of the treatment , which persisted during the follow-up period . No significant difference was found in the control group . Regarding the tolerability , none of the patients presented side effects . CONCLUSIONS Our results suggest the efficacy and the tolerability of phytothermotherapy in patients with primary FMS",
" Fibromyalgia syndrome ( FMS ) is a chronic disorder that is characterized by widespread pain with localized tenderness . We aim ed to investigate whether thermal therapy combining sauna therapy and underwater exercise improved pain , symptoms , and quality of life ( QOL ) in FMS patients . Forty-four female FMS patients who fulfilled the American College of Rheumatology ( ACR ) criteria received 12-week thermal therapy program comprising sauna therapy once daily for 3 days/week and underwater exercise once daily for 2 days/week . Pain , symptoms , and QOL were assessed using a pain visual analog scale ( VAS ) , a fibromyalgia impact question naire ( FIQ ) , and a short form 36-item question naire ( SF-36 ) , respectively . All of the patients reported significant reductions in pain and symptoms of 31 - 77 % after the 12-week thermal therapy program , which remained relatively stable ( 28 - 68 % ) during the 6-month follow-up period ( that is , the thermal therapy program improved both the short-term and the long-term VAS and FIQ scores ) . Improvements were also observed in the SF-36 score . Thermal therapy combining sauna therapy and underwater exercise improved the QOL as well as the pain and symptoms of FMS patients",
"The efficacy of balneotherapy in fibromyalgia syndrome ( FS ) has been well demonstrated , while controlled studies using mud packs are lacking . We performed a r and omized clinical trial to evaluate the effects and the tolerability of mud-bath treatment in FS patients , who are poor responders to pharmacological therapy . Eighty patients with primary FS , according to ACR criteria , were r and omly allocated to two groups : 40 were su bmi tted to a cycle of 12 mud packs and thermal baths , and 40 were considered as controls . At baseline , after thermal treatment and after 16 weeks , patients were evaluated by FIQ , tender points count , VAS for “ minor ” symptoms , AIMS 1 and HAQ . Control patients were assessed at the same time periods . A significant improvement of all evaluation parameters after mud-bath therapy and after 16 weeks was observed . Mud packs were well tolerated and no drop-outs were recorded . Our results suggest the efficacy and the tolerability of mud-bath treatment in primary FS",
"OBJECTIVE To compare hydrotherapy ( HT ) and conventional physiotherapy ( CP ) in the treatment of fibromyalgia ( FM ) , regarding quality of life ( QOL ) , total sleep time ( TST ) , and total nap time ( TNT ) . METHODS Fifty out patients , all female , 30 - 60 years old , diagnosed with FM , were r and omly assigned to two groups to carry out 3 weeks of treatment with HT or CP . In the beginning and in the end of treatment , patients were evaluated with the SF-36 question naire to measure QOL and the sleep diary for TST and TNT . Data analyses were blind . RESULTS All 24 HT patients increased 1h in TST compared to 19 CP patients . TNT decreased in the HT group . QOL improved for the two groups in all domains when pre- and post-intervention were compared , but there was no difference between groups . CONCLUSION HT is more effective than CP to improve TST and to decrease TNT in FM patients",
"In a cross-over study , the short-term efficacy of whole-body cold therapy and hot mud packs in patients with generalized tendomyopathy ( fibromyalgia ) was compared . As a pain assessment , visual analog scale and so-called pain score were measured ; dolorimetry of the 24 tender points and eight control points was performed as well . Using these methods , we found that there is a significant improvement of all parameters examined during a 2-h period of measurements after cold application , and a marked improvement was also detectable 24 h after this therapy . In contrast , only pain score values showed a slight decrease immediately after hot mud-pack therapy , and no significant differences were found in visual analog scale and pressure tenderness as measured dolorimetrically . Central inhibition of nociceptors as a result of an activation of A-delta system as well as a blockade of gamma-motoneurons are discussed to be a mechanism of action of whole-body cold therapy , result ing in a decrease in muscle tonus . Long-term studies are needed to determine , if there is any enduring effect of whole-body cold therapy on pain in the patients with generalized tendomyopathy",
"OBJECTIVES To compare the cognitive function performance in patients with fibromyalgia ( FM ) with respect healthy controls and to evaluate the short-term efficacy of exercise therapy in a warm , chest-high pool on pain and cognitive function in women with FM . METHODS Sixty middle-aged women with FM were r and omly assigned to either an exercise training group ( n = 35 ) to perform 3 sessions per week of aquatic training ( 32 degrees C ) including mobility , aerobic , strengthening , and relaxation exercises for 16 weeks , or a control group ( n = 25 ) . Twenty-five healthy women matched for age , weight , body mass index , and educational and physical activity levels were recruited . Pain was assessed in patients using a syringe calibrated like a pressure dolorimeter , and a visual analog scale . The severity of FM was evaluated using the Fibromyalgia Impact Question naire . Cognitive function was measured in healthy individuals and patients using several st and ardized neuropsychological tests . All patients were measured at baseline and post-treatment . RESULTS At baseline , the healthy group evidence d cognitive performance that was significantly superior to the group of patients with FM in all of the neuropsychological tests . The exercise group significantly improved their pain threshold , tender point count , self-reported pain , severity of FM , and cognitive function , while in the control group the differences were not significant . CONCLUSION An exercise therapy three times per week for 16 weeks in a warm-water pool is an adequate treatment to decrease the pain and severity of FM well as to improve cognitive function in previously unfit women with FM and heightened painful symptomatology",
"OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold . Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered \" much better \" at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations",
"The purpose of this study was to assess the effectiveness of Stanger bath on the treatment of fibromyalgia ( FM ) . Fifty women with FM were r and omly divided into two groups . The first group ( n=25 ) was treated with amitriptyline , 10 mg/day for 8 weeks , and Stanger bath , 20 min daily for ten sessions . The second group ( n=25 ) only had amitriptyline , 10 mg/day for 8 weeks . In the first group the assessment parameters were measured before ( t1 ) , at the end ( t2 ) , and 2 months after the hydrotherapy ( t3 ) . In the second group these parameters were examined before ( T1 ) and 2 months after the treatment ( T2 ) . Patients were evaluated by number of tender points and Fibromyalgia Impact Question naire ( FIQ ) scores . There was significant improvement in number of tender points between t1 and t2 ( P the Stanger bath group . In addition , there was significant improvement in FIQ scores between t1 and t2 ( P the Stanger bath group . In the second group we observed significant improvement in FIQ scores and tender point numbers between T1 and T2 ( P=0.00 ) . We did not find any difference between groups in tender point number percent change ( p=0.074 ) . However , we observed statistically significant improvement in percent change of FIQ scores in Stanger bath group ( −30±16.7 ) when compared to group 2 ( −19.3±13 ) ( p=0.016 ) . We conclude that Stanger bath therapy when combined with amitriptyline has a long lasting effect and better outcome in FM patients",
"OBJECTIVE To evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia . METHODS Subjects were r and omly assigned to an exercise ( EX ) or control ( CTL ) group . EX subjects participated in 3 30-minute exercise classes per week for 23 weeks . Subjects were tested at entry and at 6 , 12 , and 23 weeks . Tests included the Beck Depression Inventory ( BDI ) , 6-minute walk , State-Trait Anxiety Inventory ( STAI ) , Mental Health Inventory ( MHI ) , Fibromyalgia Impact Question naire ( FIQ ) , Arthritis Self-Efficacy Scale ( ASES ) , and a measure of tender points and knee strength . RESULTS Fifty subjects ( 27 EX , 23 CTL ) completed the study , and 31 ( 15 EX , 16 CTL ) met criteria for efficacy analyses . In efficacy analyses , significant improvements were seen for EX subjects in 6-minute walk distances , BDI ( total , cognitive/ affective ) , STAI , FIQ , ASES , and MHI ( 3 of 5 subscales ) scores . These effects were reduced but remained during intent-to-treat analyses . CONCLUSION Exercise can improve the mood and physical function of individuals with fibromyalgia",
"PURPOSE To evaluate the effects of a 12-wk period of aquatic training and subsequent detraining on health-related quality of life ( HRQOL ) and physical fitness in females with fibromyalgia . METHODS Thirty-four females with fibromyalgia were r and omly assigned into two groups : an exercise group , who exercised for 60 min in warm water , three times a week ( N = 17 ) ; and a control group , who continued their habitual leisure-time activities ( N = 17 ) . HRQOL was assessed using the Short Form 36 question naire and the Fibromyalgia Impact Question naire . Physical fitness was measured using the following tests : Canadian Aerobic Fitness , h and grip dynamometry , 10-m walking , 10-step stair climbing , and blind one-leg stance . Outcomes were measured at baseline , after treatment , and after 3 months of detraining . RESULTS After 12 wk of aquatic exercise , significant positive effects of aquatic training were found in physical function , body pain , general health perception , vitality , social function , role emotional problems and mental health , balance , and stair climbing . After the detraining period , only the improvements in body pain and role emotional problems were maintained . CONCLUSION The present water exercise protocol improved some components of HRQOL , balance , and stair climbing in females with fibromyalgia , but regular exercise and higher intensities may be required to preserve most of these gains",
"OBJECTIVE To evaluate whether changes in muscle strength due to 32 weeks of supervised aquatic training predicted improvements on health-related quality of life ( HRQOL ) . METHODS Thirty women with FM aged 50.8 + /- 8.7 years were r and omly assigned to an experimental group ( n = 15 ) , performing 3 weekly sessions of 60 min of warm-water exercise ; or to a control group ( n = 15 ) . HRQOL was evaluated using the Short Form 36 Health Survey ( SF-36 ) . Maximal unilateral isokinetic strength was measured at 60 degrees/s and 210 degrees/s in the knee extensors and flexors in concentric action and at 60 degrees/s in knee extensors eccentric action . Postural balance was evaluated using the one-leg stance , eyes closed . RESULTS After 32 weeks of water exercise therapy , statistically significant improvements occurred in concentric knee flexors and extensors strength at 60 degrees/s , in eccentric knee extensors and in postural balance . The treatment led to additional improvements in physical function , role physical problems , body pain , general health , vitality , role emotional problems and mental health dimensions of SF-36 . Gains in the concentric knee flexors strength predicted improvements in role of physical problems , whereas those in concentric knee extensors did the same for mental health and role emotional problems . Gains in eccentric knee extensors strength predicted improvements in postural balance . CONCLUSIONS A long-lasting exercise therapy in warm water produced relevant gains in muscle strength at low velocities of movements , some of which predicted improvements in physical problems , emotional problems , mental health and balance . TRIAL REGISTRATION International St and ard R and omized Controlled Trial Number IS RCT N53367487 , information available in http://www.controlled-trials.com/IS RCT N53367487",
"Objective : The aim of the present study is to evaluate the effectiveness of spa therapy in the management of fibromyalgia . Methods : Thirty women with fibromyalgia were r and omly assigned to either a spa therapy group or a control group . The spa therapy group ( n = 16 ) had spa treatment for 2 weeks in addition to their medical treatment . The control group ( n = 14 ) continued to have their medical treatment and /or daily exercises . An investigator who was blinded for the intervention assessed all the patients for 9 months . Improvements in Fibromyalgia Impact Question naire ( FIQ ) , pain and number of tender points were primary outcomes . Secondary outcome measures were improvement in sleep disturbance , fatigue , gastrointestinal symptoms , anxiety , Beck Depression Inventory and patient ’s global evaluation . Results : the spa group was found to be superior to the control group at the end of intervention in terms of FIQ , pain , tender point count , fatigue and patients ’ global assessment . This superiority remained for 6 months in FIQ , 1 month in pain and tender point count . Conclusion : It was concluded that the addition of spa therapy to medical therapy has both short- and long-term beneficial effects in female patients with fibromyalgia",
"Over a 2-year period , to evaluate the efficacy and safety of biologic agents , etanercept ( 25 mg twice per week , s.c . ) was used to treat 57 rheumatoid arthritis ( RA ) patients , 9 ankylosing spondylitis ( AS ) patients , 6 psoriatic arthritis ( PSA ) patients , and 4 juvenile rheumatoid arthritis ( JRA ) patients . In addition to inflammatory arthritis , I have used this tumor necrosis factor ( TNF ) blocker in other rheumatic diseases including idiopathic thrombocytopenic purpura ( ITP ) , Behçet 's disease with intractable oral ulcer , fibromyalgia syndrome , and systemic lupus erythematosis with intractable pleural effusion and acute lumbar disc herniation . For RA , after 6 months of etanercept treatment , all the parameters including number of swollen joints , number of tender joints , disease activity score , erythrocyte sedimentation rate , C-reactive protein , and global health status were rapidly improved ( P anticyclic citrullinated peptide ( anti-CCP ) antibody and rheumatoid factor also significantly declined . For spondyloarthropathy , it also gave a similar effect as to RA . Both Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index also improved . One of the two cases with Behçet 's disease with intractable oral ulcer had a long-term remission after etanercept . The other Behçet 's disease patient with oral ulcer and another with ITP obtained a good response temporarily . The short-term use of etanercept ( fibromyalgia syndrome , pleural effusion , and lumbar disc herniation . In conclusion , a dramatic and rapid clinical response in different kinds of arthritis patients can be achieved by etanercept . Moreover , the TNF-α inhibitor also can treat other severe rheumatic-related symptoms . In general , except for a few cases with infection and two cases with malignancy , etanercept was safe in our arthritis patients . We need to study a larger number of patients in order to better underst and the efficacy and safety of etanercept",
"OBJECTIVE The objective of this study is to investigate the effect of low-power gallium-arsenide laser treatment on the patients with shoulder pain . BACKGROUND DATA Low-energy laser therapy has recently been popularized in the treatment of various rheumatologic , neurologic , and musculoskeletal disorders such as osteoarthritis , rheumatoid arthritis , fibromyalgia , carpal tunnel syndrome , rotator cuff tendinitis , and chronic back pain syndromes . METHODS A total of 40 patients who applied to our clinic with shoulder pain and complied with the selection criteria were included in the study . The patients were r and omly assigned into Group I ( n = 20 , laser treatment ) and Group II ( n = 20 , control ) . In Group I , patients were given laser treatment and an exercise protocol for 10 sessions during a period of 2 weeks . Laser was applied over tuberculum majus and minus , bicipital groove , and anterior and posterior faces of the capsule , regardless of the existence of sensitivity , for 1 min at each location at each session with a frequency of 2000 Hz using a GaAs diode laser instrument ( Rol and Serie Elettronica Pagani , wavelength 904 nm , frequency range of 5 - 7000 Hz , and maximum peak power of 27 W , 50 W , or 27 x 4 W ) . In Group II , placebo laser and the same exercise protocol was given for the same period . Patients were evaluated according to the parameters of pain , palpation sensitivity , algometric sensitivity , and shoulder joint range of motion before and after treatment . RESULTS Analysis of measurement results within each group showed a significant posttreatment improvement for some active and passive movements in both groups , and also for algometric sensitivity in Group I ( p palpation sensitivity values showed improvement in 17 patients ( 85 % ) for Group I and six patients ( 30 % ) for Group II . Comparison between two groups showed superior results ( p passive extension and palpation sensitivity but no significant difference for other parameters . CONCLUSIONS The results of our study have shown better results in palpation sensitivity and passive extension , but no significant improvement in pain , active range , and algometric sensitivity in laser treatment group compared to the control group in the patients with shoulder pain",
"Abstract . Fibromyalgia syndrome ( FMS ) is a very common rheumatological diagnosis . There are various treatment modalities . This study was planned to investigate the effects of balneotherapy in the treatment of FMS . A total of 42 primary fibromyalgia patients diagnosed according to American College of Rheumatology criteria were included in the study . Their ages ranged between 30 and 55 years . Patients were r and omly assigned to two groups . None of them had had a cardiovascular disease before . Group 1 ( n=22 ) received 20-min bathing , once a day and five times per week . Patients participated in the study for 3 weeks ( total of 15 sessions ) . Group 2 ( n=20 ) was accepted as the control group . Patients were evaluated by the number of tender points , Visual Analogue Scale for pain , Beck 's Depression Index for depression , and Fibromyalgia Impact Question naire for functional capacity . Measurements were assessed initially , after the therapy , and at the end of the 6th month . In group 1 , there were statistically significant differences in numbers of tender points , Visual Analogue scores , Beck 's Depression Index , and Fibromyalgia Impact Question naire scores after the therapy program ( P number of tender points ( P Visual Analogue scores , and Fibromyalgia Impact Question naire ( P Beck 's Depression Index scores compared to the control group ( P>0.05 ) . Patients with FMS mostly complain about pain , anxiety , and the difficulty in daily living activities . This study shows that balneotherapy is effective and may be an alternative method in treating fibromyalgia patients",
"The objective of this article is to show the effect of the Ai Chi method , as an alternative form of hydrotherapeutic approach in fibromyalgia syndrome patients . Ten patients were studied , four were part of the experiment group and five of the control group , with one desistance . The patients were evaluated through the Fibromyalgia Impact Question naire ( QIF ) and Scale of Intensity and Index of pain in Sensible Points . Two evaluations were performed , before and after the treatment . The patients were su bmi tted to ten sessions of the Ai Chi method during 40 minutes . The scale of intensity of pain in sensible points presented an improvement in the intensity of pain after the intervention , while quality of life remained without alteration . Regarding the quality of life , it was observed that the groups had similar results , because of the fact that patients had not presented improvement at depressive state . It was also verified a difference in the index of the sensible points between the groups ; the explanation for this difference might be because of the benefits of the immersion in warm water and the effect of the Ai Chi method . There was no significant difference between the groups , which can be attributed to its limitations . In this way , new studies referring to the application of the Ai Chi method in patients carrying fibromyalgia syndrome become relevant",
"BACKGROUND Balneotherapy has been successfully used to treat various rheumatic diseases , but has only recently been evaluated for the treatment of fibromyalgia . Since no effective treatment exists for this common rheumatic disease , complementary methods of treatment have been attempted . OBJECTIVES To assess the effectiveness of balneotherapy at the Dead Sea area in the treatment of patients suffering from both fibromyalgia and psoriatic arthritis . METHODS Twenty-eight patients with psoriatic arthritis and fibromyalgia were treated with various modalities of balneotherapy at the Dead Sea area . Clinical indices assessed were duration of morning stiffness , number of active joints , a point count of 18 fibrositic tender points , and determination of the threshold of tenderness in nine fibrositic and in four control points using a dolorimeter . RESULTS The number of active joints was reduced from 18.4 + /- 10.9 to 9 + /- 8.2 ( P number of tender points was reduced from 12.6 + /- 2 to 7.1 + /- 5 in men ( P dolorimetric threshold readings after the treatment period in women ( P number of active joints and the reduction in the number of tender points in the same patients ( r = 0.2 ) . CONCLUSIONS Balneotherapy at the Dead Sea area appears to produce a statistically significant substantial improvement in the number of active joints and tender points in both male and female patients with fibromyalgia and psoriatic arthritis . Further research is needed to eluci date the distinction between the benefits of staying at the Dead Sea area without balneotherapy and the effects of balneotherapy in the study population",
"Objectives To evaluate whether mild water-filtered near infrared whole-body hyperthermia ( NI-WBH ) produces an additional benefit when applied as an adjunct to a st and ard multimodal rehabilitation ( MR ) compared with MR only in patients with fibromyalgia ( FM ) . Methods One hundred thirty-nine patients of a German inpatient rehabilitation hospital meeting the ACR 1990 criteria for FM were r and omly allocated to NI-WBH ( heating-up to 38.1 degrees C body core temperature followed by a 15 min heat retention period ) and MR or MR only , twice a week over 3 weeks . Main outcome measures were affective and sensory pain assessed by a German version of the McGill Pain Question naire , measured at baseline , postintervention , 3 and 6 months postintervention and analyzed by intention to treat . Results Repeated measures analysis of covariance showed significant differences between groups for both primary outcome measures in favor of NI-WBH and MR compared with MR only ( P affective pain , P=0.001 for sensory pain ) . Secondary analyses on pain intensity , FM-related quality of life and tender point assessment yielded similar results . Moderate effect sizes were observed for all outcome measures considered ( range , 0.41 to 0.75 ) . NI-WBH related side effects were observed in 14 of 69 participants ( 20 % ) but all disappeared in less than 30 minutes . Discussion The study indicates that NI-WBH is a worthwhile adjunct to MR in the treatment of FM"
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The aim of this review was to identify the effectiveness of therapies added on to conventional exercise training to maximise exercise capacity in patients with chronic obstructive pulmonary disease ( COPD ) . Electronic data bases were search ed , identifying trials comparing exercise training with exercise training plus " add-on " therapy . Outcomes included peak oxygen uptake ( V'O2peak ) , work rate and incremental/endurance cycle and field walking tests . Individual trial effects on exercise capacity were extracted and collated into eight subgroups and pooled for meta- analysis . Sensitivity analyses were conducted to explore the stability of effect estimates across studies employing patient-centred design s and those deemed to be of " high " quality ( PEDro score > 5 out of 10 ) . 74 studies ( 2506 subjects ) met review inclusion criteria . Interventions spanned a broad scope of clinical practice and were most commonly evaluated via the 6-min walking distance and V'O2peak . Meta- analysis revealed few clinical ly relevant and statistically significant benefits of " add-on " therapies on exercise performance compared with exercise training . Benefits favouring " add-on " therapies were observed across six different interventions ( additional exercise training , noninvasive ventilation , bronchodilator therapy , growth hormone , vitamin D and nutritional supplementation ) . The sensitivity analyses included considerably fewer studies , but revealed minimal differences to the primary analysis . The lack of systematic benefits of " add-on " interventions is a probable reflection of method ological limitations , such as " one size fits all " eligibility criteria , that are inherent in many of the included studies of " add-on " therapies . Future clarification regarding the exact value of such therapies may only arise from adequately powered , multicentre clinical trials of tailored interventions for carefully selected COPD patient subgroups defined according to distinct clinical phenotypes
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"A prospect i ve , r and omized and controlled study has been performed in 28 patients with severe COPD . A group of 14 has been trained with their lower limbs ( LL ) , while another similar group of 14 patients was also trained with their upper limbs ( UL ) . Results showed improvement in both groups in the endurance test for LL , dyspnea scale , efficiency and muscular working capacity . A considerable improvement was observed in the oxygen uptake at the anerobic threshold ( VO2AT ) which suggests a training effect , expressed through an improvement in exercise tolerance . Only the group who trained UL showed a remarkable improvement in the dyspnea scale , endurance test and maximal static mouth pressure , showing a better intrinsic working capacity and participation of the UL muscles producing those manoeuvres . At the end of training , quality of life was significantly increased and the hospitalization rate was lower in both groups . According to these findings , it is suggested that patients with severe COPD included in training programmes add UL exercises to the LL usually carried out",
"BACKGROUND Supplemental oxygen in patients with chronic obstructive pulmonary disease ( COPD ) and exercise hypoxaemia improves exercise capacity and dyspnoea . However , the benefit of oxygen during pulmonary rehabilitation in these patients is still unknown . METHODS Twenty five patients with stable COPD ( mean ( SD ) forced expiratory volume in one second ( FEV1 ) 0.76 ( 0.29 ) l and 30.0 (9.89)% predicted , arterial oxygen tension ( Pao 2 ) 8.46 ( 1.22 ) kPa , arterial carbon dioxide tension ( Paco 2 ) 6.32 ( 1.01 ) kPa ) and significant arterial desaturation on exercise ( 82.0 (10.4)% ) were entered onto a pulmonary rehabilitation programme . Patients were r and omised to train whilst breathing oxygen ( OT ) ( n = 13 ) or air ( AT ) ( n = 12 ) , both at 4 l/min . Assessment s included exercise tolerance and associated dyspnoea using the shuttle walk test ( SWT ) and Borg dyspnoea score , health status , mood state , and performance during daily activities . RESULTS The OT group showed a significant reduction in dyspnoea after rehabilitation compared with the AT group ( Borg mean difference –1.46 ( 95 % CI –2.72 to –0.19 ) ) but there were no differences in other outcome measures : SWT difference –23.6 m ( 95 % CI –70.7 to 23.5 ) , Chronic Respiratory Disease Question naire 3.67 ( 95 % CI –7.70 to 15.1 ) , Hospital Anxiety and Depression Scale 1.73 ( 95 % CI –2.32 to 5.78 ) , and London Chest Activity of Daily Living Scale –2.18 ( 95 % CI –7.15 to 2.79 ) . At baseline oxygen significantly improved SWT ( mean difference 27.3 m ( 95 % CI 14.7 to 39.8 ) and dyspnoea ( –0.68 ( 95 % CI –1.05 to –0.31 ) ) compared with placebo air . CONCLUSIONS This study suggests that supplemental oxygen during training does little to enhance exercise tolerance although there is a small benefit in terms of dyspnoea . Patients with severe disabling dyspnoea may find symptomatic relief with supplemental oxygen ",
"RATIONALE Exercise-induced dynamic hyperinflation contributes to decreased exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . It is unknown whether respiratory retraining ( ventilation-feedback [ VF ] training ) can affect exercise-induced dynamic hyperinflation and increase exercise tolerance . OBJECTIVES To determine whether patients with COPD would achieve longer exercise duration if r and omized to a combination of exercise training plus VF training than either form of training on its own . METHODS A total of 64 patients r and omized to 1 of 3 groups : VF plus exercise ( n = 22 ) , exercise alone ( n = 20 ) , and VF alone ( n = 22 ) . MEASUREMENTS AND MAIN RESULTS Exercise duration before and after 36 training sessions and exercise-induced dynamic hyperinflation and respiratory pattern before and after training were measured . In the 49 patients who completed training , duration of constant work-rate exercise was 40.0 ( + /- 20.4 ) minutes ( mean + /- SD ) with VF plus exercise , 31.5 ( + /- 17.3 ) minutes with exercise alone , and 16.1 ( + /- 19.3 ) minutes with VF alone . Exercise duration was longer in VF plus exercise than in VF alone ( P VF plus exercise was compared with exercise alone ( P = 0.022 ) ( because of multiple comparisons , P exercise-induced dynamic hyperinflation , measured at isotime , in VF plus exercise was less than in exercise alone ( P = 0.014 for between-group changes ) and less than in VF alone ( P = 0.019 for between-group changes ) . After training , expiratory time was longer in VF plus exercise training ( P VF plus exercise training decreases exercise-induced dynamic hyperinflation and increases exercise duration more than VF alone . An additive effect to exercise training from VF was not demonstrated by predetermined statistical criteria",
"Supplemental oxygen improves exercise tolerance of normoxemic and hypoxemic chronic obstructive pulmonary disease ( COPD ) patients . We determined whether nonhypoxemic COPD patients undergoing exercise training while breathing supplemental oxygen achieve higher intensity and therefore improve exercise capacity more than patients breathing air . A double-blinded trial was performed involving 29 nonhypoxemic patients ( 67 years , exercise SaO2 > 88 % ) with COPD ( FEV1 = 36 % predicted ) . All exercised on cycle ergometers for 45 minutes , 3 times per week for 7 weeks at high-intensity targets . During exercise , they received oxygen ( 3 L/minute ) ( n = 14 ) or compressed air ( 3 L/minute ) ( n = 15 ) . Both groups had a higher exercise tolerance after training and when breathing oxygen . However , the oxygen-trained group increased the training work rate more rapidly than the air-trained group . The mean + /- SD work rate during the last week was 62 + /- 19 W ( oxygen-trained group ) and 52 + /- 22 W ( air-trained group ) ( p endurance in constant work rate tests increased more in the oxygen-trained group ( 14.5 minutes ) than in the air-trained group ( 10.5 minutes ) ( p breathing rate decreased four breaths per minute in the oxygen-trained group and one breath per minute in the air-trained group ( p = 0.001 ) . We conclude that supplemental oxygen provided during high-intensity training yields higher training intensity and evidence of gains in exercise tolerance in laboratory testing",
"Most pulmonary rehabilitation ( PR ) programs do not currently incorporate IMT in their PR programs for COPD patients . The aim of the present study was to assess the influence of adding IMT to the patients already involved in a rehabilitation program . Thirty-four patients with significant COPD were recruited for the study . All patients participated in a general exercise reconditioning ( GER ) program for 12 weeks . The patients were then r and omized to receive IMT or sham IMT , in addition to GER for the next 6 months . Following three months of GER training there was a significant increase in the 6-min walk test ( 6MWT ) ( from mean+/-SEM 254+/-38 to 322+/-42 m , p non-significant decreases in the perception of dyspnea ( POD ) , and in the St. George Respiratory Question naire score ( SGRQ ) . Following the addition of IMT to the GER program there was a significant increase in the PI(max ) in the GER+IMT group ( from 66+/-4.7 to 78+/-4.5 cm H(2)O , p POD and a further significant improvement in the SGRQ score . IMT provides additional benefits to patients undergoing PR program and is worthwhile even in patients who have already undergone a GER program",
"PURPOSE The primary goal of pulmonary rehabilitation ( PR ) is for patients to achieve and maintain their maximum level of independence and functioning in the community . Traditional PR uses a predominantly aerobic/endurance approach to rehabilitation with little or no inclusion of exercises to increase strength . Few studies have investigated the impact of resistance training on PR despite growing evidence supporting its efficacy to improve physical function ( functional fitness ) in both healthy individuals and those with chronic disease . The purpose of this study was to investigate the effect of single-set resistance training on strength and functional fitness outcomes in PR patients . METHODS Twenty PR patients , 60 to 81 years old , were r and omly assigned to an 8-week endurance-based PR program ( ET ) or an ET plus resistance training program ( RT ) . RESULTS Strength increased in RT ( P decreased in ET for both upper and lower body . Functional fitness improved ( P RT compared with 2 tests for ET . CONCLUSIONS Single set RT can elicit significant improvements in both strength and functional fitness , which is not obtained by traditional PR alone . Our results are comparable to other studies with similar outcomes using multiple-set RT protocol s. These findings may have important implication s for program design , application , and adherence in PR",
"Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT ",
"Background : Conventional pulmonary rehabilitation programs improve exercise tolerance but have no effect on pulmonary function in patients with chronic obstructive pulmonary disease ( COPD ) . The role of controlled breathing using respiratory biofeedback during rehabilitation of patients with COPD remains unclear . Objectives : To compare the effects of a conventional 4-week pulmonary rehabilitation program with those of rehabilitation plus controlled breathing interventions . Methods : A r and omized controlled trial was performed . Pulmonary function ( FEV1 ) , exercise capacity ( 6-min walking distance , 6MWD ) , health-related quality of life ( chronic respiratory question naire , CRQ ) and cardiac autonomic function ( rMSSD ) were evaluated . Results : Forty COPD patients ( mean ± SD age 66.1 ± 6.4 , FEV1 45.9 ± 17.4 % predicted ) were r and omized to rehabilitation ( n = 20 ) or rehabilitation plus controlled breathing ( n = 20 ) . There were no statistically significant differences between the two groups regarding the change in FEV1 ( mean difference –0.8 % predicted , 95 % CI –4.4 to 2.9 % predicted , p = 0.33 ) , 6MWD ( mean difference 12.2 m , 95 % CI –37.4 to 12.2 m , p = 0.16 ) , CRQ ( mean difference in total score 0.2 , 95 % CI –0.1 to 0.4 , p = 0.11 ) and rMSSD ( mean difference 2.2 ms , 95 % CI –20.8 to 25.1 ms , p = 0.51 ) . Conclusions : In patients with COPD undergoing a pulmonary rehabilitation program , controlled breathing using respiratory biofeedback has no effect on exercise capacity , pulmonary function , quality of life or cardiac autonomic function",
"Background : Long-term non-invasive positive pressure ventilation ( NIPPV ) might improve the outcomes of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease ( COPD ) with chronic respiratory failure . A study was undertaken to investigate whether nocturnal NIPPV in addition to pulmonary rehabilitation improves health-related quality of life , functional status and gas exchange compared with pulmonary rehabilitation alone in patients with COPD with chronic hypercapnic respiratory failure . Methods : 72 patients with COPD were r and omly assigned to nocturnal NIPPV in addition to rehabilitation ( n = 37 ) or rehabilitation alone ( n = 35 ) . Outcome measures were assessed before and after the 3-month intervention period . Results : The Chronic Respiratory Question naire total score improved 15.1 points with NIPPV + rehabilitation compared with 8.7 points with rehabilitation alone . The difference of 7.5 points was not significant ( p = 0.08 ) . However , compared with rehabilitation alone , the difference in the fatigue domain was greater with NIPPV + rehabilitation ( mean difference 3.3 points , p the Maugeri Respiratory Failure question naire total score ( mean difference −10 % , p its cognition domain ( mean difference −22 % , p improved daytime arterial carbon dioxide pressure ( mean difference −0.3 kPa ; p and daily step count ( mean difference 1269 steps/day , p increased daytime minute ventilation ( mean difference 1.4 l ; p Conclusion : Non-invasive ventilation augments the benefits of pulmonary rehabilitation in patients with COPD with chronic hypercapnic respiratory failure as it improves several measures of health-related quality of life , functional status and gas exchange . Trial registration number : NCT00135538",
"Objectives : To study the effect of unsupported upper limb and lower limb exercise training and their combined influence on the exercise performance and health-related quality of life in COPD patients . Material s and Methods : Thirty patients were r and omly assigned to one of the three groups , through block r and omization . Of the three groups , group A received upper limb training , group B received lower limb training , and group C received both upper and lower limb training . Patients in group A , B , and C underwent exercise training five times a week for four weeks . The outcome measures used in the study were unsupported upper limb endurance test ( UULEX ) , Six-Minute Walk Test ( 6-MWT ) , and a Chronic Respiratory Question naire . Statistical analysis was performed with analysis of variance , Wilcoxon scale , and a Kruskal Wallis one way ANOVA test , and a P value of .05 was used in the study . Conclusion : The combined upper limb and lower limb training group showed a significant improvement in the exercise performance and health-related quality of life",
"The effect of ambulatory oxygen use during pulmonary rehabilitation ( PR ) has not yet been clearly established , but many studies have shown benefit from oxygen acutely . Two small studies to date demonstrated no clear benefit when oxygen was used in patients who desaturated on exertion during a PR programme . One study showed the benefit of using oxygen during PR in patients who were normoxic at rest and desaturated to a minimum of 88 % on exertion . We conducted a single-blind , r and omised controlled trial comparing PR undertaken either with or without ambulatory oxygen , in those with demonstrable benefit from oxygen at baseline . Subjects from three PR services were recruited who , during baseline assessment , desaturated by more than 4 % and to less than 90 % on exertion , and walked 10 % or more further with ambulatory oxygen on endurance shuttle walk test . Patients were r and omised to either room air or oxygen via portable cylinder , titrated to optimise pulse oxygen saturation but up to a maximum flow rate of 6 L/min . All patients then completed a twice weekly , 6- to 7-week PR programme . Data were analysed as per protocol . Totally 51 patients completed the study . At the end of PR , both groups improved with PR , with patients in the oxygen group demonstrating a highly statistically significantly greater mean improvement in endurance walking distance than the controls , 490 m ( 95 % confidence interval 228–750 ; p ≤ 0.001 ) , as well as clinical ly , although not statistically , significant changes in quality of life . The use of ambulatory oxygen during a 6- to 7-week PR programme greatly improved endurance walking distance in patients who desaturated on exertion with a positive acute response to ambulatory oxygen at baseline",
"STUDY OBJECTIVES The purpose of this study was to compare the effects of endurance training only to endurance plus strength ( combined ) training in a r and omized trial of patients with COPD . METHODS Twenty-four patients completed the study : 11 patients in the combined training group ( FEV(1 ) 45 + /- 5 % predicted ) , and 13 patients in the endurance training group ( FEV(1 ) 40 + /- 4 % predicted ) [ mean + /- SE ] . Muscle strength , quality of life , exercise performance , and quadriceps fatigability were measured before and after rehabilitation . RESULTS Combined training led to significant improvements in quadriceps ( 23.6 % ) , hamstring ( 26.7 ) , pectoralis major ( 17.5 % ) , and latissimus dorsi ( 20 % ) muscle strength . Endurance training alone did not produce significant improvements in muscle strength : quadriceps ( 1.1 % decrease ) , hamstring ( 12.2 % increase ) , pectoralis major ( 7.8 % increase ) , and latissimus dorsi ( 2.8 % decrease ) . The increase in strength after training was significantly greater in the combined group compared to the endurance group for the quadriceps and latissimus dorsi muscles but not for the hamstring and pectoralis major muscles . Six-minute walk distance , endurance exercise time , and quality of life ( as measured by the Chronic Respiratory Question naire ) significantly increased in both groups after rehabilitation with no significant differences in the extent of improvement between groups . The extent of improvement in quadriceps fatigability after training ( assessed by quadriceps twitch force before and after exercise ) was not significantly different between groups . CONCLUSION Strength training can lead to significant improvement in muscle strength in elderly patients with COPD . However , this improvement in muscle strength does not translate into additional improvement in quality of life , exercise performance or quadriceps fatigability compared to that achieved by endurance exercise alone",
"The effects of adding L-carnitine to a whole-body and respiratory training program were determined in moderate-to-severe chronic obstructive pulmonary disease ( COPD ) patients . Sixteen COPD patients ( 66 + /- 7 years ) were r and omly assigned to L-carnitine ( CG ) or placebo group ( PG ) that received either L-carnitine or saline solution ( 2 g/day , orally ) for 6 weeks ( forced expiratory volume on first second was 38 + /- 16 and 36 + /- 12 % , respectively ) . Both groups participated in three weekly 30-min treadmill and threshold inspiratory muscle training sessions , with 3 sets of 10 loaded inspirations ( 40 % ) at maximal inspiratory pressure . Nutritional status , exercise tolerance on a treadmill and six-minute walking test , blood lactate , heart rate , blood pressure , and respiratory muscle strength were determined as baseline and on day 42 . Maximal capacity in the incremental exercise test was significantly improved in both groups ( P Blood lactate , blood pressure , oxygen saturation , and heart rate at identical exercise levels were lower in CG after training ( P Inspiratory muscle strength and walking test tolerance were significantly improved in both groups , but the gains of CG were significantly higher than those of PG ( 40 + /- 14 vs 14 + /- 5 cmH2O , and 87 + /- 30 vs 34 + /- 29 m , respectively ; P Blood lactate concentration was significantly lower in CG than in PG ( 1.6 + /- 0.7 vs 2.3 + /- 0.7 mM , P exercise tolerance and inspiratory muscle strength in COPD patients , as well as reduce lactate production",
"STUDY OBJECTIVE To determine whether exercise training with coaching is more effective than exercise training alone in reducing dyspnea and the anxiety and distress associated with it and improving exercise performance , self-efficacy for walking , and dyspnea with activities of daily living . DESIGN R and omized clinical trial of 51 dyspnea-limited patients with COPD assigned to monitored ( n = 27 ) or coached ( n = 24 ) exercise groups . SETTING Outpatient area of university teaching hospital . INTERVENTION Both groups completed 12 supervised treadmill training sessions ( phase 1 ) over 4 weeks followed by 8 weeks of home walking ( phase 2 ) . The CE group also received coaching during training . MEASUREMENTS Perceived work of breathing , dyspnea intensity , distress associated with dyspnea , and anxiety associated with dyspnea were rated on a visual analog scale during incremental treadmill testing and after 6-min walks before and after phase 1 . Dyspnea with activities of daily living , self-efficacy for walking , state anxiety , and 6-min walks were measured before and after both phases . RESULTS Dyspnea and the associated distress and anxiety improved significantly for both groups relative to work performed and in relation to ventilation ( p laboratory dyspnea was accompanied by improvements in dyspnea with activities of daily living ( p self-efficacy for home walking ( p Coaching with exercise training was no more effective than exercise training alone in improving exercise performance , dyspnea , and the anxiety and distress associated with it , dyspnea with activities , and self-efficacy for walking",
"OBJECTIVE To evaluate the influence of physical training with or without noninvasive ventilation at 2 levels of pressure in the airways ( BiPAP ) in patients with chronic obstructive pulmonary disease . METHODS Eighteen patients with FEV(1 ) = 34 + /- 8 % of predicted values , mean age of 68 + /- 9 years were r and omly distributed into 2 groups , one group performing physical training on a treadmill and the other group performing physical training associated with BiPAP ( physical training+B ) , for 30 minutes , 3 times a week for 12 weeks . The training velocity was based on a test of cardiopulmonary force performed pre- and postintervention , which registered the values for heart rate , systolic blood pressure , diastolic blood pressure , peripheral oxygen saturation , blood lactate , sensation of dyspnea , respiratory muscle strength , and analysis of gases expired such as oxygen consumption and the production of carbon dioxide . RESULTS For both groups , there was a significant improvement in dyspnea and peripheral oxygen saturation at identical levels of physical exercise , in distance walked during the physical training , and in respiratory muscle strength ( P training+B group had a significant improvement in heart rate , systolic blood pressure , and oxygen consumption after training ( P blood lactate were observed at identical levels of exercise in physical training+B when compared to isolated physical training ( from 1.3 + /- 0.7 mMol/L versus 2.5 + /- 0.9 mMol/L , ( P Physical training associated with BiPAP enhanced the oxidative muscular capacity and could be an adjunctive recourse for physical rehabilitation in patients with chronic obstructive pulmonary disease",
"A r and omized , controlled , single-blind study was performed on 20 patients with chronic obstructive pulmonary disease and exercise-induced hypoxaemia . Ten patients each were r and omly assigned to one of two groups , one training with air and the other training with oxygen . There were no significant differences between the groups regarding values measured prior to the study . The patients trained 3 times per week for 30 minutes each time for a duration of 8 weeks . The training consisted of interval walking on a treadmill ( intensity set according to Borg ratings ) with either air or oxygen administered through a nasal cannula at a rate of 5 l/min . Training significantly improved the 6-minute walking distance by 20 % and 14 % in the air and oxygen group , respectively , when the patients were tested on air . In the same test the air group significantly decreased Borg ratings for perceived exertion . Borg ratings for dyspnoea and perceived exertion significantly decreased in the oxygen group when they were tested on oxygen . It was concluded that oxygen supplementation did not further improve the training effect , compared with training with air , in patients with chronic obstructive pulmonary disease and exercise-induced hypoxaemia",
"Supplemental oxygen has acute beneficial effects on exercise performance in patients with chronic obstructive pulmonary disease ( COPD ) . The purpose of this study was to investigate whether oxygen-supplemented training enhances the effects of training while breathing room air in patients with severe COPD . A r and omized controlled trial was performed in 24 patients with severe COPD who developed hypoxaemia during incremental cycle exercise ( arterial oxygen saturation ( Sa , O2 ) All patients participated in an in-patient pulmonary rehabilitation programme of 10 weeks duration . They were assigned either to general exercise training while breathing room air ( GET/RA group : forced expiratory volume in one second ( FEV1 ) 38 % of predicted ; arterial oxygen tension ( Pa , O2 ) 10.5 kPa at rest ; Pa , O2 7.3 kPa at peak exercise ) , or to GET while breathing supplemental oxygen ( GET/O2 group : FEV1 29 % pred ; Pa , O2 10.2 kPa at rest ; Pa , O2 7.2 kPa at peak exercise ) . Sa , O2 was not allowed to fall below 90 % during the training . The effects on exercise performance while breathing air and oxygen , and on quality of life were compared . Maximum workload ( Wmax ) significantly increased in the GET/RA group ( mean ( SD ) 17 ( 15 ) W , p Six minute walking distance ( 6MWD ) , stair-climbing , weight-lifting exercise ( all while breathing room air ) and quality of life significantly increased in both groups . Acute administration of oxygen improved exercise performance before and after training . Training significantly increased Wmax , peak carbon dioxide production ( V'CO2 ) and 6MWD while breathing oxygen in both groups . Differences between groups were not significant . Pulmonary rehabilitation improved exercise performance and quality of life in both groups . Supplementation of oxygen during the training did not add to the effects of training on room air",
"BACKGROUND Muscle wasting and decreased muscle oxidative capacity commonly occur in patients with chronic obstructive pulmonary disease ( COPD ) . Polyunsaturated fatty acids ( PUFA ) have been shown to mediate several inflammatory and metabolic pathways which may be involved in the pathogenesis of muscle impairment in COPD . The aim of this study was to investigate the effect of PUFA modulation on systemic inflammation , reversal of muscle wasting , and functional status in COPD . METHODS Eighty patients with COPD ( 57 men ) with forced expiratory volume in 1 second ( FEV1 ) 37.3 (13.8)% predicted received 9 g PUFA or placebo daily in a double blind r and omised fashion during an 8 week rehabilitation programme . Body composition ( bioelectrical impedance ) , functional capacity ( lung function , incremental cycle ergometry test , submaximal cycle test , isokinetic quadriceps strength ) and inflammatory markers ( C-reactive protein ( CRP ) , interleukin (IL)-6 and tumour necrosis factor (TNF)-alpha ) were assessed at baseline and after 8 weeks . RESULTS Both groups had similar increases in weight , fat-free mass ( FFM ) , and muscle strength . The peak load of the incremental exercise test increased more in the PUFA group than in the placebo group ( difference in increase 9.7 W ( 95 % CI 2.5 to 17.0 ) , p = 0.009 ) even after adjustment for FFM . The duration of the constant work rate test also increased more in patients receiving PUFA ( difference in increase 4.3 min ( 95 % CI 0.6 to 7.9 ) , p = 0.023 ) . The positive effects of PUFA could not be attributed to a decrease in systemic levels of CRP , IL-6 and TNF-alpha . CONCLUSIONS This is the first study to show beneficial effects of PUFA on exercise capacity in patients with COPD",
"BACKGROUND Low-density gas mixtures and oxygen ( O₂ ) supplementation are known to improve physical performance and ventilatory adaptation during incremental maximal exercise in COPD . We investigated whether their combined use during intense physical training is also effective in ameliorating exercise tolerance in patients affected by moderate to severe COPD . METHODS Thirty patients ( FEV₁ 2-month rehabilitation program . Leg-cycle training was conducted thrice weekly at 80 % of the initial peak work rate for at least 20 min breathing room air , a 60 % helium and 40 % O₂ mixture , or supplemental O₂ ( 40 % ) inhaled from a Douglas bag . The study was r and omized with a double-blind design . Before and at the end of the training period the subjects were tested for spirometry , arterial gas tension , diffusing lung capacity for CO , and incremental and constant work rate exercise test on a cycle ergometer . RESULTS Physical training result ed in a significant improvement in peak oxygen consumption and power output ( P in exercise endurance time ( P in lung function tests or gas exchange . CONCLUSIONS We concluded that the use of a low-density gas mixture or O₂ supplementation does not contribute to improved exercise performance in patients with moderate to severe COPD without a significantly decreased diffusion lung capacity for CO who are able to tolerate intense physical training",
"Study objectives Patients with chronic obstructive pulmonary disease ( COPD ) have low exercise capacity and low content of high energetic phosphates in their skeletal muscles . The aim of the present study was to investigate whether creatine supplementation together with exercise training may increase physical performance compared with exercise training in patients with COPD . Design In a r and omized , double-blind , placebo-controlled study , 23 patients with COPD ( forced expiratory volume in one second [ FEV1 ] were r and omized to oral creatine ( n = 13 ) or placebo ( n = 10 ) supplementation during an 8-week rehabilitation programme including exercise training . Physical performance was assessed by Endurance Shuttle Walking Test ( ESWT ) , dyspnea and leg fatigue with Borg CR-10 , quality of life with St George ’s Respiratory Question naire ( SGRQ ) . In addition , lung function test , artery blood gases , grip strength test , muscle strength and fatigue in knee extensors were measured . Results COPD patients receiving creatine supplementation increased their average walking time by 61 % ( ESWT ) ( p Rated dyspnea directly after the ESWT decreased significantly from 7 to 5 ( p walking time nor in rated dyspnea . Creatine supplementation did not increase the health related quality of life , lung function , artery blood gases , grip strength and knee extensor strength/fatigue . Conclusions Oral creatine supplementation in combination with exercise training showed no significant improvement in physical performance , measured as ESWT , in patients with COPD compared with exercise training alone",
"PURPOSE : Chronic obstructive pulmonary disease ( COPD ) is characterized by airflow limitation and by both systemic and airway inflammation . In COPD , acupuncture has been shown to improve quality -of-life scores and decrease breathlessness ; similar findings have also been reported after pulmonary rehabilitation ( PR ) . The hypothesis of this study was that acupuncture in conjunction with pulmonary rehabilitation would improve COPD outcome measures compared to pulmonary rehabilitation alone . METHODS : The design was a r and omized prospect i ve study ; all subjects had COPD . There were 19 controls , 25 who underwent PR , and 16 who had both acupuncture and PR . The primary outcome measure was a change in measures of systemic inflammation at the end of PR and at 3 month followup . Lung function , including maximum inspiratory pressure ( PiMax ) , quality -of-life scores , functional capacity including steps taken , dyspnea scores , and exercise capacity , were secondary endpoints . RESULTS : After PR , both groups had significantly improved quality -of-life scores , reduced dyspnea scores , improved exercise capacity , and PiMax , but no change in measures of systemic inflammation compared with the controls . There were no differences in most of the outcome measures between the 2 treatment groups except that subjects who had both acupuncture and PR remained less breathless for a longer period . CONCLUSION : The addition of acupuncture to PR did not add significant benefit in most of the outcomes measured",
"Background Pulmonary cachexia is common in advanced chronic obstructive pulmonary disease ( COPD ) , culminating in exercise intolerance and a poor prognosis . Ghrelin is a novel growth hormone (GH)-releasing peptide with GH-independent effects . The efficacy and safety of adding ghrelin to pulmonary rehabilitation ( PR ) in cachectic COPD patients were investigated . Methodology /Principal Findings In a multicenter , r and omized , double-blind , placebo-controlled trial , 33 cachectic COPD patients were r and omly assigned PR with intravenous ghrelin ( 2 µg/kg ) or placebo twice daily for 3 weeks in hospital . The primary outcomes were changes in 6-min walk distance ( 6-MWD ) and the St. George Respiratory Question naire ( SGRQ ) score . Secondary outcomes included changes in the Medical Research Council ( MRC ) scale , and respiratory muscle strength . At pre-treatment , serum GH levels were increased from baseline levels by a single dose of ghrelin ( mean change , + 46.5 ng/ml ; between-group p mean change from pre-treatment in 6-MWD was improved at Week 3 ( + 40 m , within-group p = 0.033 ) and was maintained at Week 7 ( + 47 m , within-group p = 0.017 ) , although the difference between ghrelin and placebo was not significant . At Week 7 , the mean changes in SGRQ symptoms ( between-group p = 0.026 ) , in MRC ( between-group p = 0.030 ) , and in maximal expiratory pressure ( MEP ; between-group p = 0.015 ) were better in the ghrelin group than in the placebo group . Additionally , repeated- measures analysis of variance ( ANOVA ) indicated significant time course effects of ghrelin versus placebo in SGRQ symptoms ( p = 0.049 ) and MEP ( p = 0.021 ) . Ghrelin treatment was well tolerated . Conclusions / Significance In cachectic COPD patients , with the safety profile , ghrelin administration provided improvements in symptoms and respiratory strength , despite the lack of a significant between-group difference in 6-MWD . Trial Registration UMIN Clinical Trial Registry",
"Background : Pulmonary rehabilitation is effective in improving exercise performance and health status in chronic obstructive pulmonary disease ( COPD ) . However , the role of nutritional support in the enhancement of the benefits of exercise training has not been explored . A double blind , r and omised , controlled trial of carbohydrate supplementation was undertaken in patients attending outpatient pulmonary rehabilitation . Methods : 85 patients with COPD were r and omised to receive a 570 kcal carbohydrate rich supplement or a non-nutritive placebo daily for the duration of a 7 week outpatient pulmonary rehabilitation programme . Primary outcome measures were peak and submaximal exercise performance using the shuttle walk tests . Changes in health status , body composition , muscle strength , and dietary macronutrient intake were also measured . Results : Patients in both the supplement and placebo groups increased shuttle walking performance and health status significantly . There was no statistically significant difference between treatment groups in these outcomes . Patients receiving placebo lost weight whereas supplemented patients gained weight . In well nourished patients ( BMI > 19 kg/m2 ) improvement in incremental shuttle performance was significantly greater in the supplemented group ( mean difference between groups : 27 ( 95 % CI 1 to 53 ) m , p incremental shuttle performance correlated with increases in total carbohydrate intake . Conclusions : When universally prescribed , carbohydrate supplementation does not enhance the rehabilitation of patients with COPD . This study suggests that exercise training results in negative energy balance that can be overcome by supplementation and that , in selected patients , this may improve the outcome of training . The finding of benefit in well nourished patients may suggest a role for nutritional supplementation beyond the treatment of weight loss in COPD",
"STUDY OBJECTIVES We sought to determine whether breathing heliox or using nasal noninvasive positive pressure ventilation ( NIPPV ) would produce immediate improvements in exercise capability in patients with COPD , and whether training for 6 weeks with one of these modalities would result in greater exercise improvement than with training unassisted . SETTING US military medical center . METHODS Thirty-nine patients with severe COPD ( mean FEV1 of 33.5 % predicted ) underwent three incremental treadmill tests to exhaustion unassisted , breathing heliox , or breathing with NIPPV . They were then r and omized to undergo 6 weeks of twice-weekly rehabilitation with unassisted exercise training ( UT group ) , training while breathing heliox ( HT group ) , or training while breathing with NIPPV ( NT group ) . The three exercise tests were then repeated . RESULTS Heliox treatment did not produce any immediate benefit in exercise time or maximum workload in the 39 patients initially tested , the 32 patients who completed the protocol , or the HT group . Furthermore , no training advantage was evident in the HT group ( n = 10 ) compared to the UT group ( n = 11 ) . NIPPV did not produce an immediate benefit in the initial tests , but produced a small increase in exercise time in the 32 patients completing the protocol in the final tests . This effect was primarily because of the NT group , who exercised significantly longer ( mean + /- SD , 16.8 + /- 4.9 min vs 14.2 + /- 5.6 min , p = 0.0045 ) and to a higher workload ( 4.46 + /- 1.55 metabolic equivalents [ METs ] vs 4.09 + /- 1.75 METs , respectively ; p = 0.038 ) when tested using the ventilator . Compared to the UT group , the NT group started out with a lower exercise time ( 7.9 + /- 3.5 min vs 12.3 + /- 5.2 min , p = 0.031 ) in preliminary testing , but the statistical difference was eliminated in the final tests ( 14.2 + /- 5.6 min vs 16.0 + /- 5.8 min , respectively ; p = 0.451 ) . The NT group actually slightly exceeded the UT group when they used the ventilator in final testing , although this was not statistically significant ( 16.8 + /- 4.9 min vs 16.0 + /- 5.8 min , respectively ) . CONCLUSION Heliox treatment does not appear to offer an immediate or training advantage with exercise in patients with COPD . For patients who have undergone regular exercise conditioning with NIPPV , use of the ventilator produces an immediate improvement in both exercise time and maximum workload attained , and it may confer a training advantage",
"Rationale Pulmonary rehabilitation is an important treatment for patients with Chronic Obstructive Pulmonary Disease , who are often vitamin D deficient . As vitamin D status is linked to skeletal muscle function , we aim ed to explore if high dose vitamin D supplementation can improve the outcomes of rehabilitation in Chronic Obstructive Pulmonary Disease . Material and methods This study is a post-hoc subgroup analysis of a larger r and omized trial comparing a monthly dose of 100.000 IU of vitamin D with placebo to reduce exacerbations . 50 Subjects who followed a rehabilitation program during the trial are included in this analysis . We report changes from baseline in muscle strength and exercise performance between both study arms after 3 months of rehabilitation . Results Vitamin D intervention result ed in significantly higher median vitamin D levels compared to placebo ( 51 [ 44 - 62 ] ng/ml vs 15 [ 13 - 30 ] ng/ml ; p receiving vitamin D had significantly larger improvements in inspiratory muscle strength ( -11±12 cmH2O vs 0±14 cmH2O ; p = 0.004 ) and maximal oxygen uptake ( 110±211 ml/min vs -20±187 ml/min ; p = 0.029 ) . Improvements in quadriceps strength ( 15±16 Nm ) or six minutes walking distance ( 40±55 meter ) were not significantly different from the effects in the placebo group ( 7±19 Nm and 11±74 meter ; p>0.050 ) . Conclusion High dose vitamin D supplementation during rehabilitation may have mild additional benefits to training",
"In patients with chronic obstructive pulmonary disease ( COPD ) the intensity of aerobic training is limited by dyspnea . Improving strength of the inspiratory muscles could enhance aerobic exercise training by reducing exercise-related dyspnea . We examined effects of home-based inspiratory muscle training ( IMT ) and cycle ergometry training ( CET ) in 53 patients with moderate to severe COPD ( FEV(1)% pred , 50 + /- 17 [ mean + /- SD ] ) . Patients were r and omly assigned to 4 mo of training in one of four groups : IMT , CET , CET + IMT , or health education ( ED ) . Patients were encouraged to train to the limits of their dyspnea . Inspiratory muscle strength and endurance increased in IMT and CET + IMT groups compared with CET and ED groups ( p Peak oxygen uptake increased and heart rate , minute ventilation , dyspnea , and leg fatigue decreased at submaximal work rates in the CET and CET + IMT groups compared with the IMT and ED groups ( p physiological training effect and reduced exercise-related symptoms while IMT increased respiratory muscle strength and endurance . The combination of CET and IMT did not produce additional benefits in exercise performance and exercise-related symptoms . This is the first study to demonstrate a physiological training effect with home-based exercise training",
"BACKGROUND Respiratory muscle endurance training ( hyperpnea training ) has been shown to have beneficial effects in patients with COPD . STUDY OBJECTIVES The purpose of this study was to determine whether hyperpnea training , when added to an endurance exercise training program , would lead to additional benefits compared with endurance training alone in patients with COPD . SETTING AND PARTICIPANTS Patients with COPD entering an 8-week outpatient pulmonary rehabilitation program . Fifteen patients ( mean [ + /- SE ] FEV1 , 45 + /- 6 % predicted ) were r and omized to combined therapy , and 14 patients ( mean FEV1 , 44 + /- 4 % predicted ) were r and omized to endurance training . METHODS Peak exercise capacity , exercise endurance time during constant workload cycle exercise , 6-min walk distance , quality of life as measured by the chronic respiratory question naire , respiratory muscle strength and endurance , and quadriceps fatigability were measured before and after endurance or combined training . RESULTS After rehabilitation , peak exercise capacity , exercise endurance time , 6-min walk distance , and quality of life all increased in both groups , but there was no significant difference in the extent of improvement between groups . Mean respiratory muscle endurance increased to a significantly greater extent in the combined therapy group ( 17.5 + /- 2.7 vs 8.5 + /- 2.5 min , respectively ; p = 0.02 ) . Respiratory muscle strength was significantly increased , and quadriceps fatigability was significantly reduced after rehabilitation in the combined therapy group but not in the endurance training group , but the difference between groups did not reach statistical significance . CONCLUSION The endurance of the respiratory muscles can be improved by specific training beyond that achieved by endurance training alone in patients with COPD . However , this improvement did not translate into additional improvement in quality of life or exercise performance",
"BACKGROUND Current guidelines on pulmonary rehabilitation ( PR ) recommend upper extremity exercise training ( UEET ) in patients with COPD . However , the literature still questions the effectiveness of systematic UEET in this population . We studied the effects of 15 sessions of unsupported UEET on functional exercise capacity , the ability to perform activities of daily living ( ADL ) , and symptoms perceived during activities involving arms in patients with COPD . METHODS We conducted a r and omized trial that consisted of 3 weeks of inpatient PR , comparing the short-term effects of unsupported UEET plus PR ( intervention group ) to those of PR alone ( control group ) . A change in the 6-min ring test ( 6MRT ) was the primary outcome ; the ADL field test ( four shuttle stations ) , the dyspnea score as assessed by the Medical Research Council scale , the London Chest Activity of Daily Living scale ( LCADL ) , and the distance walked in 6 min served as secondary outcomes of the study . At the 6-month follow-up , we repeated the 6MRT and the LCADL . RESULTS Fifty patients with COPD were r and omly assigned to the two groups and completed the study . At the end of the study period , patients in the intervention group improved in the 6MRT and ADL field test compared with those patients in the control group ( p = 0.018 and p = 0.010 , respectively ) with reduced perception of fatigue ( p 6MRT ( p = 0.001 ) and LCADL ( p = 0.039 ) scores were still significantly better in the intervention group compared with the control group . CONCLUSIONS Our trial corroborates the effectiveness of unsupported UEET in specifically improving functional exercise capacity of patients with COPD . Moreover , it also provides evidence that this training modality may ameliorate and maintain the patients ' autonomy over and above st and ard PR . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00825032",
"This study evaluates the effects of training with noninvasive ventilatory support in patients with chronic obstructive pulmonary disease in a r and omised , controlled , observer-blinded trial . Twenty-nine patients with chronic obstructive pulmonary disease and with a ventilatory limited exercise capacity ( forced expiratory volume in one second completed an 8-week supervised outpatient cycle exercise programme . Fourteen patients were r and omised to training with inspiratory pressure support of 10 cmH2O and 15 patients to training with control ( sham ) inspiratory pressure support of 5 cmH2O . Outcome measures were the incremental shuttle walking test and a constant-load cycle endurance test at 75 % of peak work rate including the measurement of physiological responses , and health status measured using the St. George 's Respiratory Question naire . Statistically significant between-group differences were found in favour of the inspiratory pressure support of 10 cmH2O group for improvement in shuttle walking distance ( 16±17 versus 3±13 % ) , cycle endurance ( 164±124 versus 88±128 % ) , and the reduction in minute ventilation during exercise ( -11±10 versus -2±9 % ) . It was concluded that exercise training with inspiratory pressure support of 10 cmH2O result ed in statistically significantly larger improvements in exercise performance than training with inspiratory pressure support of 5 cmH2O in patients with chronic obstructive pulmonary disease suffering from a ventilatory limited exercise capacity . Inspiratory pressure support of 10 cmH2O may be considered as adjunct during high-intensity exercise training",
"Background The aim of this sub study of the ghrelin treatment , multicenter , r and omized , double-blind , placebo-controlled trial was to investigate the effects of ghrelin administration on exercise capacity and the underlying mechanisms in underweight patients with chronic obstructive pulmonary disease ( COPD ) using cardiopulmonary exercise testing . Methods Twenty underweight COPD patients were r and omized to pulmonary rehabilitation with intravenous ghrelin ( 2 μg/kg , n = 10 ) or placebo ( n = 10 ) twice daily for 3 weeks in a double-blind fashion . The primary outcome was changes in peak oxygen uptake V•o2 . Secondary outcomes included changes in exertional cardio-respiratory functions : O2-pulse , physiologic dead space/tidal volume-ratio ( VD/VT ) , ventilatory equivalent for oxygen V•E/V•o2 , and ventilatory equivalent for carbon dioxide V•E/V•co2 . Results With incremental exercise , at peak exercise , there was a significant difference in the mean difference ( ghrelin minus placebo ) , i.e. , treatment effect in : i ) peak V•o2 ( 1.2 mL/kg/min , 95 % CI : 0.2 - 2.3 mL/kg/min , between-group p = 0.025 ) ; ii ) V•E/V•o2 ( -4.2 , 95 % CI : -7.9 to -0.5 , between-group p = 0.030 ) ; iii ) V•E/V•co2 ( -4.1 , 95 % CI : -8.2 to -0.1 , between-group p = 0.045 ) ; iv ) VD/VT ( -0.04 , 95 % CI : -0.08 to -0.00 , between-group p = 0.041 ) ; and v ) O2-pulse ( 0.7 mL/beat , 95 % CI : 0.3 to 1.2 mL/beat , between-group p = 0.003 ) . Additionally , repeated- measures analysis of variance ( ANOVA ) indicated a significant time-course effect of ghrelin versus placebo in the peak V•o2 ( p = 0.025 ) . Conclusion Ghrelin administration was associated with improved exertional capacity and improvements in ventilatory-cardiac parameters . Trial registration UMIN ( University Hospital Medical Information Network in Japan )",
"Pulmonary hypertension is a serious complication of chronic obstructive pulmonary disease ( COPD ) that currently has no established pharmacological treatment . This study aim ed to assess whether concomitant treatment with sildenafil would enhance the results of pulmonary rehabilitation in patients with COPD and increased pulmonary arterial pressure ( PAP ) . In this double-blind , r and omised controlled trial patients received 20 mg sildenafil or placebo three times daily and underwent pulmonary rehabilitation for 3 months . The primary end-point was the gain in the cycle endurance time at a constant work-rate . Secondary end-points included performance in the incremental exercise test , 6-min walk distance and quality of life . 63 patients with severe COPD and moderately increased PAP were r and omised . Cycle endurance time increased by 149 s ( 95 % CI 26–518 s ) in the sildenafil group and by 169 s ( 95 % CI 0–768 s ) in the placebo group ( median change difference -7 s , 95 % CI -540–244 s ; p=0.77 ) . Gains in the incremental exercise test , 6-min walk distance and quality of life at the end of the study did not differ between groups . Measurements of arterial oxygenation and adverse events were similar in both groups . In patients with severe COPD and moderately increased PAP , concomitant treatment with sildenafil does not improve the results of pulmonary rehabilitation in exercise tolerance . Sildenafil did not improve respiratory rehabilitation outcomes in patients with severe COPD and moderately increased PAP ",
"STUDY OBJECTIVES Pulmonary rehabilitation ( PR ) improves exercise tolerance in COPD patients . Tiotropium is a once-daily , inhaled anticholinergic bronchodilator that provides sustained 24-h improvements in airflow and lung hyperinflation reduction . We hypothesized that ventilatory mechanics improvements from tiotropium would permit enhanced ability to train muscles of ambulation and therefore augment exercise tolerance benefits of PR . DESIGN In a r and omized , double-blind , placebo-controlled trial ( tiotropium , n = 47 ; placebo , n = 44 ) , tiotropium ( 18 microg qd ) was administered to COPD patients participating in 8 weeks of PR ( treadmill training three times a week ; > /= 30 min per session ) at 17 sites . Study drug was administered 5 weeks prior to , 8 weeks during , and 12 weeks following PR . The primary end point was treadmill walking ( 0 % incline ) endurance time at 80 % of maximum speed attained in an initial incremental test . The transition dyspnea index ( TDI ) , St. George 's respiratory question naire ( SGRQ ) , and rescue albuterol use were secondary end points . PARTICIPANTS Mean age of the 93 participants was 67 years , 57 % were men , and mean FEV(1 ) was 0.88 L ( 34 % predicted ) . RESULTS Mean endurance time differences ( tiotropium minus placebo ) prior to PR , at the end of PR , and 12 weeks after PR were 1.65 min ( p = 0.183 ) , 5.35 min ( p = 0.025 ) , and 6.60 min ( p = 0.018 ) , respectively . Mean TDI focal scores at the end of PR were 1.75 for tiotropium and 0.91 for placebo ( p > 0.05 ) . At 12 weeks after PR , TDI focal scores were 1.75 for tiotropium and 0.08 for placebo ( p placebo , tiotropium improved SGRQ total scores by 3.86 at the end of PR and 4.44 at 12 weeks after PR ( p > 0.05 ) . Mean albuterol use declined following PR plus tiotropium , compared to PR alone ( p Tiotropium in combination with PR improved endurance of a constant work rate treadmill task and produced clinical ly meaningful improvements in dyspnea and health status compared to PR alone . Improvements with tiotropium were sustained for 3 months following PR completion",
"BACKGROUND Inhaled hypertonic saline is used for bronchial challenge and sputum induction in patients with chronic obstructive pulmonary disease ( COPD ) . We studied the effects of saline aerosol inhalation before each exercise session in an 8-week pulmonary rehabilitation program . METHODS This was a double-blind r and omized parallel controlled trial , conducted at an out-patient clinic . Sixty-eight subjects with COPD ( mean age 67 + /- 6.5 y , percent of predicted FEV(1 ) 47 + /- 21 ) were r and omized to inhale either 3 % hypertonic saline ( 34 subjects ) or normal saline ( 34 subjects ) before each exercise session in an 8-week exercise program that had 3 sessions per week . We measured 6-min walk distance , dyspnea , and quality of life ( with the Medical Outcomes Study 36-item short-form health survey ) . RESULTS After the 8-week exercise program , both groups ' mean 6-min walk distance had significantly increased : from 195 + /- 92 m to 251 + /- 97 m ( P Dyspnea score improved from 3.1 + /- 0.9 to 2.3 + /- 0.8 ( P Quality of life also significantly improved , except for the physical-functioning and social aspect domains in the hypertonic-saline group . Adverse effects ( cough or bronchospasm ) occurred in 4 patients ( 12 % ) in the hypertonic-saline group . CONCLUSIONS The improvement in 6-min walk distance was greater with normal saline than with hypertonic saline . Hypertonic saline was associated with adverse effects . It is unclear whether the only predictor of improved functional exercise capacity was exercise training . ( Clinical Trials.gov number , NCT00639236 . )",
"Cycle ergometer training plays an important role in the rehabilitation of patients with chronic obstructive pulmonary disease ( COPD ) , but the usefulness of specific inspiratory muscle training as part of pulmonary rehabilitation remains uncertain . To determine whether inspiratory muscle training could intensify the known beneficial effects of cycle ergometer training on exercise performance in these patients , we compared the effect of an 8 week inspiratory muscle training combined with cycle ergometer training with that of an 8 week cycle ergometer training alone on inspiratory muscle performance and general exercise capacity . Patients were r and omly assigned to the two training groups ; 21 patients received additional inspiratory muscle training ( Group 1 ) and 21 did not ( Group 2 ) . Maximal sniff assessed oesophageal and transdiaphragmatic pressures served as parameters for global inspiratory muscle strength and diaphragmatic strength , respectively . The duration for which the patient could breathe against a constant inspiratory pressure load was used as an index of inspiratory muscle endurance . Exercise capacity was determined by an incremental symptom-limited cycle ergometer test . After the training period , inspiratory muscle performance improved significantly in the patients with inspiratory muscle training , but not in those without . Both training regimens increased maximal power output and oxygen uptake , but this improvement was significantly greater in the patients with inspiratory muscle training than in those without . ( ABSTRACT TRUNCATED AT 250 WORDS",
"QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis",
"& NA ; The purpose of this study was to compare the effects of a strength training‐enhanced program and a traditional pulmonary rehabilitation ( PR ) program on functional fitness ( FF ) in older patients with chronic obstructive pulmonary disease ( COPD ) , using the Senior Fitness Test . Twenty patients were recruited from an outpatient PR program . After completing baseline measures , including muscular strength and the Senior Fitness Test , patients were r and omly assigned to the strength training program ( TR+ST , n = 10 ) or traditional PR program ( TR , n = 10 ) . Patients completed 16 exercise sessions that were conducted twice a week for 8–10 weeks , after which patients repeated outcome measurements . Independent t tests were conducted to determine whether groups differed between measures . Both the TR+ST and TR groups improved on all FF measures . Moderate effect sizes were found for two of the FF measures when the groups were compared . The addition of strength training to PR may have a favorable impact on FF in older patients with COPD",
"Disability and exertional dyspnea associated with chronic obstructive pulmonary disease has led to the development of rehabilitation programmes that aim to increase exercise tolerance and relief of dyspnea . To evaluate whether aerobic training ( training groups P1 and P4 ) , strength training ( P2 and P5 ) or a combination of both ( P4 and P6 ) is useful , 69 patients ( 44 m/25 f ) with moderate to severe COPD were r and omised to a three week inpatient training program . The training consisted of three weekly twenty minute exercise sessions without ( P1 - P3 ) or with supplemental oxygen ( P4 - P6 ) on a calibrated ergocycle ( 70 % W(max ) ) or three weekly sessions of 20 - 25 repetitions of 2 - 4 training series ( 40 % W(max ) ) or a combination of both . In general , the programme failed to demonstrate significant changes in lung function and arterial blood gases . Evaluation of exercise capacity via the six-minute-walking test ( 6MT ) yielded a significant increase of the walking distance in all groups except P2 ( 60 - 83 m ) , The time to finish a test-set of daily activities ( TAF ) was reduced in all groups ( 5 - 58 sec ) and reached significance in P1 , P3 , P5 and P6 . After the 6MT , exertional dyspnea improved in all groups except P4 and was significant in P1 and P3 ; after the TAF , dyspnea again was reduced in all groups with a significant change in P2 and P5 . These data support the hypotheses that a short term inpatient training programme is suitable to improve exercise-capacity and dyspnea . Patients with advanced disease ( P4 - P6 ) show greater benefits with strength training ( alone or in combination with aerobic training ) while for patients with moderate disease ( P1 - P3 ) aerobic training is favourable . These changes may translate into improved performance of daily activities and general well-being",
"Background : Skeletal muscle wasting and dysfunction are strong independent predictors of mortality in patients with chronic obstructive pulmonary disease ( COPD ) . Creatine nutritional supplementation produces increased muscle mass and exercise performance in health . A controlled study was performed to look for similar effects in 38 patients with COPD . Methods : Thirty eight patients with COPD ( mean ( SD ) forced expiratory volume in 1 second ( FEV1 ) 46 (15)% predicted ) were r and omised to receive placebo ( glucose polymer 40.7 g ) or creatine ( creatine monohydrate 5.7 g , glucose 35 g ) supplements in a double blind trial . After 2 weeks loading ( one dose three times daily ) , patients participated in an outpatient pulmonary rehabilitation programme combined with maintenance ( once daily ) supplementation . Pulmonary function , body composition , and exercise performance ( peripheral muscle strength and endurance , shuttle walking , cycle ergometry ) took place at baseline ( n = 38 ) , post loading ( n = 36 ) , and post rehabilitation ( n = 25 ) . Results : No difference was found in whole body exercise performance between the groups : for example , incremental shuttle walk distance mean −23.1 m ( 95 % CI −71.7 to 25.5 ) post loading and −21.5 m ( 95 % CI −90.6 to 47.7 ) post rehabilitation . Creatine increased fat-free mass by 1.09 kg ( 95 % CI 0.43 to 1.74 ) post loading and 1.62 kg ( 95 % CI 0.47 to 2.77 ) post rehabilitation . Peripheral muscle performance improved : knee extensor strength 4.2 N.m ( 95 % CI 1.4 to 7.1 ) and endurance 411.1 J ( 95 % CI 129.9 to 692.4 ) post loading , knee extensor strength 7.3 N.m ( 95 % CI 0.69 to 13.92 ) and endurance 854.3 J ( 95 % CI 131.3 to 1577.4 ) post rehabilitation . Creatine improved health status between baseline and post rehabilitation ( St George ’s Respiratory Question naire total score −7.7 ( 95 % CI −14.9 to −0.5 ) ) . Conclusions : Creatine supplementation led to increases in fat-free mass , peripheral muscle strength and endurance , health status , but not exercise capacity . Creatine may constitute a new ergogenic treatment in COPD",
"RATIONALE Skeletal muscle strength and bulk are reduced in patients with chronic obstructive pulmonary disease ( COPD ) and influence quality of life , survival , and utilization of health care re sources . Exercise training during pulmonary rehabilitation ( PR ) can reverse some of these effects . In athletes and healthy elderly individuals , dietary creatine supplementation ( CrS ) has been shown to augment high-intensity exercise training , thereby increasing muscle mass . OBJECTIVES This article examines the effect of CrS on functional exercise capacity and muscle performance in people with COPD . METHODS One hundred subjects with COPD ( mean [ SD ] age , 68.2 [ 8.2 ] yr ; FEV(1 ) , 44.0 [ 19.6 ] % predicted ) were r and omized to a double-blind , placebo-controlled , parallel group trial of CrS during 7 weeks of PR encompassing aerobic and resistance exercises . Subjects ingested creatine ( 22 g/d loading for 5 d ; maintenance , 3.76 g/d throughout PR ) or placebo . Baseline , postloading , and postrehabilitation measurements included pulmonary function , body composition , peripheral muscle strength , and functional performance ( shuttle walking tests ) . A volunteer subgroup ( n = 44 ) had pre- and postloading quadriceps muscle biopsies . MEASUREMENTS AND MAIN RESULTS Eighty subjects completed the trial ( 38 creatine , 42 placebo ) . All outcome measures significantly improved after PR . There were no significant differences between groups post-PR ( mean [ SD ] change in incremental shuttle walk distance , 84 [ 79 ] m in the creatine group vs. 83.8 [ 60 ] m in the placebo group ; P = 1.0 ; knee extensor work , 19.2 [ 16 ] Nm [ Newton meters ] in the creatine group vs. 19.5 [ 17 ] Nm in the placebo group ; P = 0.9 ) . Muscle biopsies showed evidence of creatine uptake . CONCLUSIONS This adequately powered , r and omized , placebo-controlled trial shows that CrS does not augment the substantial training effect of multidisciplinary PR for patients with COPD . Clinical trial registered with https://portal.nihr.ac.uk/Pages/NRRArchive Search .aspx ( NO123138126 )",
"BACKGROUND One mechanism that may limit training effect in chronic obstructive pulmonary disease is the ventilatory limitation and associated dyspnea . OBJECTIVES To minimize ventilatory limitation during training of patients with severe COPD by applying bi-level positive pressure ventilation during training in order to augment training intensity ( and effect ) . METHODS The study group comprised 19 patients ( 18 males , 1 female ) with a mean age of 64 + /- 9 years . Mean forced expiratory volume in 1 second was 32 + /- 4 % of predicted , and all were ventilatory-limited ( exercise breathing reserve 3 + /- 9 L/min , normal > 15 L/min ) . The patients were r and omized : 9 were assigned to training with BiPAP and 10 to st and ard training . All were trained on a treadmill for 2 months , twice a week , 45 minutes each time , at maximal tolerated load . Incremental maximal unsupported exercise test was performed before and at the end of the training period . RESULTS BiPAP result ed in an increment of 94 + /- 53 % in training speed during these 2 months , as compared to 41 + /- 19 % increment in the control group ( P Training with BiPAP yielded an average increase in maximal oxygen uptake of 23 + /- 16 % ( P anaerobic threshold of 11 + /- 12 % ( P peak O2 pulse of 20 + /- 19 % ( P peak exercise lactate concentration was not higher after training . Interestingly , in the BiPAP group , peak exercise ventilation was also 17 + /- 20 % higher after training ( P work rate , ventilation ( and tidal volume ) in the BiPAP group was higher in the post-training test as compared to the pre-training test , and the end tidal partial pressure of CO2 at 55 watts was lower , 40 + /- 4 and 38 + /- 4 mmHg respectively ( P exercise capacity was observed after this short training period in the control group . CONCLUSION Pressure-supported ventilation during training is feasible in patients with severe COPD and it augments the training effect . The improved exercise tolerance was associated with higher ventilatory response and therefore lower P(ET)CO2 at equal work rates after training",
"INTRODUCTION To date endurance and strength training are established and evidence -based exercise methods in patients with chronic obstructive pulmonary disease ( COPD ) . There is an unmet need for further research in new and complementary exercise modalities . Additional whole body vibration training during pulmonary rehabilitation may be such a new approach that has not yet been investigated in patients with COPD . METHODS Eighty-two patients ( 65 ± 9 yrs , FEV(1 ) pred . 38 ± 11 % , female 51 % ) with COPD in GOLD stage III to IV assessed for a 3-week inpatient multidisciplinary rehabilitation program were on top r and omly assigned to one of two intervention groups : ( 1 ) 3 × 3 min of bilateral dynamic squat exercises on a side-alternating vibration platform at 24 - 26 Hz three times per week ( WBV ) and ( 2 ) a control group ( CON ) with the same amount of exercise time without WBV . RESULTS Thirty-six patients completed the study in each group . The improvement in 6-min walking distance was significantly higher in the WBV-group when compared to the CON-group ( WBV : 64 ± 59 m , CON : 37 ± 52 m with a between-group difference of 27 m [ 95 % CI , 1 - 53 ] , p = 0.046 ) . The time required for a sit-to-st and test also decreased more markedly in the WBV-group than in the CON-group ( WBV : -4.0 ± 4.8 s , CON : -2.0 ± 3.1 s with a between-group difference of -1.9 s [ 95 % CI , -4.0 to 0.1 ] , p = 0.067 ) . Improvements in health-related quality of life were similar in both groups . CONCLUSIONS WBV training seems to be a promising new exercise modality for patients with COPD and may enhance the effects of a multidisciplinary rehabilitation program",
"The purpose of this study was to evaluate whether strength training is a useful addition to aerobic training in patients with chronic obstructive pulmonary disease ( COPD ) . Forty-five patients with moderate to severe COPD were r and omized to 12 wk of aerobic training alone ( AERO ) or combined with strength training ( AERO + ST ) . The AERO regimen consisted of three weekly 30-min exercise sessions on a calibrated ergocycle , and the ST regimen included three series of eight to 10 repetitions of four weight lifting exercises . Measurements of peripheral muscle strength , thigh muscle cross-sectional area ( MCSA ) by computed tomographic scanning , maximal exercise capacity , 6-min walking distance ( 6MWD ) , and quality of life with the chronic respiratory question naire were obtained at baseline and after training . Thirty-six patients completed the program and constituted the study group . The strength of the quadriceps femoris increased significantly in both groups ( p thigh MCSA and strength of the pectoralis major muscle increased in the AERO + ST group by 8 + /- 13 % and 15 + /- 9 % , respectively ( p 0.05 ) . These changes were significantly different in the two study groups ( p increase in strength of the latissimus dorsi muscle after training was modest and of similar magnitude for both groups . The changes in peak exercise work rate , 6MWD , and quality of life were comparable in the two groups . In conclusion , the addition of strength training to aerobic training in patients with COPD is associated with significantly greater increases in muscle strength and mass , but does not provide additional improvement in exercise capacity or quality of life",
"OBJECTIVES Few and contrastingly data are available about use of osteopathic manipulative treatment ( OMT ) in patients with chronic obstructive pulmonary disease ( COPD ) . DESIGN Comparing the effects of the combination of pulmonary rehabilitation and OMT compared with pulmonary rehabilitation ( PR ) in patients with severely impaired COPD . SETTING Rehabilitative pulmonary department . INTERVENTIONS Patients underwent exercise training , OMT , educational support and nutritional and psychological counselling . MAIN OUTCOMES MEASURES Exercise capacity through 6 min walk test ( 6MWT-- primary outcome ) and pulmonary function test ( secondary outcomes ) were evaluated at the beginning and at the end of the training . Patients were r and omly assigned to receive PR+soft manipulation ( G1 ) or OMT+PR ( G2 ) for 5 days/week for 4 weeks . RESULTS 20 stable COPD patients ( 5 female -- mean age , 63.8±5.1 years ; FEV1 26.9±6.3 % of predicted ) referred for in-patient pulmonary rehabilitation were evaluated . Respect to the baseline , 6 MWT statistically improved in both group . In particular , G2 group gained 72.5±7.5 m ( p=0.01 ) and G1 group 23.7±9.7 m. Between group comparison showed a difference of 48.8 m ( 95 % CI : 17 to 80.6 m , p=0.04 ) . Moreover , in G2 group we showed a decrease in residual volume ( RV -- from 4.4±1.5 l to 3.9±1.5 l , p=0.05 ) . Between group comparison showed an important difference ( -0.44 l ; 95 % CI : -0.26 to -0.62 l , p=0.001 ) . Furthermore , only in G2 group we showed an increase in FEV1 . CONCLUSIONS This study suggests that OMT+PR may improve exercise capacity and reduce RV in severely impaired COPD patients with respect to PR alone",
"A study was undertaken to determine the usefulness of ubidecarenone in pulmonary rehabilitation in exercise training programs in the management of chronic obstructive pulmonary disease ( COPD ) . The subjects were 20 patients with COPD who had been participating in an exercise training program for at least four weeks . The patients were r and omly assigned either to receive 50 mg of oral ubidecarenone daily or to enter a control group during the program . Oxygen consumption , expired volume , and heart rate were measured during exercise tests before and after training . Maximum oxygen consumption increased 13 % in the ubidecarenone-treated patients and 7 % in the controls , and maximum expired volume increased 10 % in each group . The increases were significant in the ubidecarenone group but not in the controls . Heart rate increased 2 % in both groups . It is concluded that ubidecarenone deserves further evaluation in exercise training programs for patients with COPD",
"BACKGROUND The synergistic interactions between pharmacotherapy and pulmonary rehabilitation has been provided , but it remains to be established whether this may also apply to more severe patients . OBJECTIVES We have examined whether tiotropium enhances the effects of exercise training in patients with advanced COPD ( FEV(1) hypoxemia at rest corrected with oxygen supplementation , and limitations of physical activity ) . METHODS We enrolled 22 patients that were r and omised to tiotropium 18mug or placebo inhalation capsules taken once daily . Both groups ( 11 patients in each group ) underwent an in patient pulmonary rehabilitation program and were under regular treatment with salmeterol/fluticasone twice daily . Each rehabilitation session was held 5 days per week ( 3h/day ) for a total of 4 weeks . RESULTS Compared to placebo , tiotropium had larger impact on pulmonary function ( FEV(1)+0.164L , FVC + 0.112L , RV -0.544L after tiotropium , FEV(1)+0.084L , FVC -0.039L , RV -0.036L after placebo ) . The addition of tiotropium allowed a longer distance walked in 6min ( 82.3 m vs. 67.7 m after placebo ) and reduced dyspnoea ( Borg score ) ( -0.4 vs. + 0.18 after placebo ) when compared with baseline ( pre pulmonary rehabilitation program ) . The changes in SGRQ from baseline to the end of treatment were : total score -28.3U , activity -27.8U , impact -14.5U , and symptoms -33.4U in the placebo group ; and total score -19.1U , activity -18.9U , impact -16.4U , and symptoms -33.8U in the tiotropium group . CONCLUSIONS Our study clearly indicates that there is an advantage in combining pulmonary rehabilitation with an aggressive drug therapy in more severe patients",
"Pressurized whey supplementation , by its antioxidant and nutritional properties , may improve exercise tolerance and potentiate the effects of exercise training in patients with chronic obstructive pulmonary disease ( COPD ) . In this r and omized , double-blind , placebo-controlled study , 22 patients with COPD were allocated to receive active pressurized whey or placebo ( casein ) dietary supplementation for a 16-week period . Patients continued their usual physical activities for the first 8 weeks , whereas they were subjected to an exercise training program for the remaining 8 weeks of the study . Patients were evaluated at baseline , after 8 weeks of supplementation alone ( time point , 8 weeks ) , and after 8 weeks of its combination with exercise training ( time point , 16 weeks ) . The constant workrate cycle endurance test ( CET ) , potentiated quadriceps twitch force , mid-thigh cross-sectional area , and Chronic Respiratory Question naire ( CRQ ) were used to evaluate the effects of treatments . The inflammatory ( C-reactive protein and interleukin-6 ) and oxidant/antioxidant ( protein oxidation and glutathione ) blood profiles were also characterized . At week 8 , there was no increase in CET time in either group . At week 16 , there was a statistically significant increase in CET time in the whey-only group ( P Dyspnea and the Mastery scales of the CRQ in both groups . Also , the Fatigue and Emotional Control scales of the CRQ showed clinical ly significant improvement in the whey-only group . Study interventions did not modify significantly the systemic inflammatory and oxidative stress markers that were assessed . Thus dietary supplementation with pressurized whey may potentiate the effects of exercise training on exercise tolerance and quality of life in patients with COPD",
"STUDY OBJECTIVE To evaluate the influence of oral anabolic steroids on body mass index ( BMI ) , lean body mass , anthropometric measures , respiratory muscle strength , and functional exercise capacity among subjects with COPD . DESIGN Prospect i ve , r and omized , controlled , double-blind study . SETTING Pulmonary rehabilitation program . PARTICIPANTS Twenty-three undernourished male COPD patients in whom BMI was below 20 kg/m2 and the maximal inspiratory pressure ( PImax ) was below 60 % of the predicted value . INTERVENTION The study group received 250 mg of testosterone i.m . at baseline and 12 mg of oral stanozolol a day for 27 weeks , during which time the control group received placebo . Both groups participated in inspiratory muscle exercises during weeks 9 to 27 and cycle ergometer exercises during weeks 18 to 27 . MEASUREMENTS AND RESULTS Seventeen of 23 subjects completed the study . Weight increased in nine of 10 subjects who received anabolic steroids ( mean , + 1.8+/-0.5 kg ; p lost weight ( -0.4+/-0.2 kg ) . The study group 's increase in BMI differed significantly from that of the control group from weeks 3 to 27 ( p Lean body mass increased in the study group at weeks 9 and 18 ( p Arm muscle circumference and thigh circumference also differed between groups ( p PImax ( study group , 41 % ; control group , 20 % ) were not statistically significant . No changes in the 6-min walk distance or in maximal exercise capacity were identified in either group . CONCLUSION The administration of oral anabolic steroids for 27 weeks to malnourished male subjects with COPD was free of clinical or biochemical side effects . It was associated with increases in BMI , lean body mass , and anthropometric measures of arm and thigh circumference , with no significant changes in endurance exercise capacity",
"BACKGROUND AND OBJECTIVE Nutritional depletion in chronic obstructive pulmonary disease ( COPD ) adversely affects health status and mortality . We aim ed to evaluate the effects of nutritional supplementation ( NS ) with pulmonary rehabilitation ( PR ) on body composition , mid-thigh cross-sectional area ( CSA ) , dyspnoea , exercise capacity , health-related quality of life , anxiety and depression in advanced COPD patients . METHODS Forty-six patients were r and omized to PR and nutritional support ( PRNS ) , PR or the control group . Dyspnoea was measured with Medical Research Council and BORG scales . Exercise capacity was measured through 6-min walk test and shuttle tests ; health-related quality of life was assessed with St. George 's Respiratory Question naire . Psychological status was measured with Hospital Anxiety and Depression Scale . Body weight and body mass indexes ( BMI ) were also evaluated . Fat-free mass was measured through bioelectrical impedance analyser . The CSA of quadriceps was calculated in mid-level of the thigh with magnetic resonance imaging . RESULTS Dyspnoea and total scores of St. George 's Respiratory Question naire improved in both groups ( P Six-minute walk test and incremental shuttle walk test distances in PRNS and PR patients increased significantly as ( 62.6 ± 42.4 m , 43.3 ± 59.2 m , both P = 0.001 ; and 63.3 ± 70.1 m and 69.3 ± 69.7 m , both P = 0.001 ) . Although anxiety improved in both groups ( P no change in depression . Body weight , BMI and fat-free mass index ( FFMI ) ( 1.1 ± 0.9 kg , 0.2 ± 1.4 kg/m(2 ) and 0.6 ± 0.5 kg/m(2 ) , P whereas body weight and FFMI ( 0.6 ± 0.7 kg , 0.1 ± 0.6 kg/m(2 ) P increased in PR after the intervention . There was a significant increase in mid-thigh CSA ( 2.5 ± 4.1 cm(2 ) ) only in PRNS ( P = 0.04 ) . CONCLUSION The combination of NS with PR result ed in improvements particularly in lean body mass and mid-thigh CSA . This study suggests combining NS with PR in reversing weight loss and muscle wasting in COPD ",
"Background : The effects of providing ventilatory assistance to patients with severe chronic obstructive pulmonary disease ( COPD ) during a high intensity outpatient cycle exercise programme were examined . Methods : Nineteen patients ( 17 men ) with severe COPD ( mean ( SD ) forced expiratory volume in 1 second ( FEV1 ) 27 (7)% predicted ) underwent a 6 week supervised outpatient cycle exercise programme . Ten patients were r and omised to exercise with ventilatory assistance using proportional assist ventilation ( PAV ) and nine ( two women ) to exercise unaided . Before and after training patients performed a maximal symptom limited incremental cycle test to determine peak work rate ( Wpeak ) followed by a constant work rate ( CWR ) test at 70 % of Wpeak achieved in the baseline incremental test . Minute ventilation ( Ve ) , heart rate , and arterialised venous plasma lactate concentration [ La+ ] were measured before and after each test . Results : Mean training intensity ( Wt/Wpeak ) at 6 weeks was 15.2 % ( 95 % CI 3.2 to 27.1 ) higher in the group that used ventilatory assistance ( p=0.016 ) . Peak work rate after training was 18.4 % ( 95 % CI 6.4 to 30.5 ) higher ( p=0.005 ) in the assisted group ( p=0.09 ) . [ La+ ] at an identical workload after training was reduced by 30 % ( 95 % CI 16 to 44 ) in the assisted group ( p=0.002 compared with baseline ) and by 11 % ( 95 % CI –7 to 31 ) ( p=0.08 compared with baseline ) in the unassisted group ( mean difference 18.4 % ( 95 % CI 3.3 to 40 ) , p=0.09 ) . A significant inverse relationship was found between reduction in plasma lactate concentration ( ΔL ) at an equivalent workload after training during the CWR test and Wt/Wpeak achieved during the last week of training ( r=–0.7 , p=0.0006 ) . Conclusions : PAV enables a higher intensity of training in patients with severe COPD , leading to greater improvements in maximum exercise capacity with evidence of true physiological adaptation",
"The addition of noninvasive positive pressure ventilation ( NPPV ) to an exercise training ( ET ) program in severe chronic obstructive pulmonary disease ( COPD ) may produce greater benefits in exercise tolerance and quality of life than after training alone . Forty-five patients with severe stable COPD -mean ( SD ) FEV(1 ) 0.96 ( 0.31 ) L , Pa(O(2 ) ) 65.4 ( 9.07 ) mm Hg , Pa(CO(2 ) ) 45.6 ( 7.89 ) mm Hg-were r and omized to domiciliary NPPV + ET ( n = 23 ) or ET alone ( n = 22 ) . Exercise capacity and health status were assessed at baseline and after an 8-wk training program . There was a significant improvement in mean shuttle walk test ( SWT ) in the NPPV + ET group : from 169 ( 112 ) to 269 ( 124 ) m ( p = 0.001 ) , compared with the ET group : 205 ( 100 ) to 233 ( 123 ) m ( p = 0.19 ) ; mean difference ( 95 % confidence interval [ CI ] ) : 72 ( 12.9 to 131 ) m. Repeated measures analysis of variance ( ANOVA ) showed that the differences between the two groups became evident only in the final 4 wk of the training program with a mean end study difference ( 95 % 1CI ) of 65.8 ( 17.1 to 114 ) m. There was a significant improvement in the Chronic Respiratory Disease Question naire ( CRDQ ) of mean ( SD ) 24.0 ( 17.4 ) ( p = NPPV + ET group and 11.8 ( 15.8 ) ( p = 0.003 ) points in the ET group ; mean difference : 12.3 ( 1.19 to 23.4 ) . Only the NPPV + ET group demonstrated a significant improvement in arterial oxygenation ; mean difference : 3.70 mm Hg ( 0.37 to 7.27 ) . This study suggests that domiciliary NPPV can be used successfully to augment the effects of rehabilitation in severe COPD",
"BACKGROUND AND OBJECTIVE Skeletal muscle dysfunction contributes to exercise limitation in patients with chronic obstructive pulmonary disease ( COPD ) . Strength training increases muscle strength and muscle mass , but there is an ongoing debate on the additional effect concerning the exercise capacity . The purpose of this study was to compare the effects of three different exercise modalities in patients with COPD including endurance training ( ET ) , progressive strength training ( ST ) and the combination of strength training and endurance training ( CT ) . DESIGN A prospect i ve r and omized trial . METHODS Thirty-six patients with COPD were r and omly allocated either to ET , ST , or CT . Muscle strength , cardiopulmonary exercise testing , lung function testing and quality of life were assessed before and after a 12-week training period . RESULTS Exercise capacity ( Wmax ) increased significantly in all three training groups with increase of peak oxygen uptake ( VO2peak ) in all three groups , reaching statistical significance in the ET group and the CT group . Muscle strength ( leg press , bench press , bench pull ) improved in all three training groups , with a higher improvement in the ST ( + 39.3 % , + 20.9 % , + 20.3 % ) and the CT group ( + 43.3 % , + 18.1 % , + 21.6 % ) compared to the ET group ( + 20.4 % , + 6.4 % , + 12.1 % ) . CONCLUSIONS Progressive strength training alone increases not only muscle strength and quality of life , but also exercise capacity in patients with COPD , which may have implication s in prescription of training modality . CLINICAL TRIALS.GOV IDENTIFIER : NCT01091623",
"Purpose : This r and omized controlled trial examined the effect harmonica playing has on various clinical , psychosocial , and functional outcomes among chronic obstructive pulmonary disease ( COPD ) patients in pulmonary rehabilitation ( PR ) . Method : Twenty‐eight participants ( Age 69.9 ± 1.8 ; FEV1 Predicted 41.9 ± 2.0 % ) were recruited from an outpatient PR program . Participants were r and omly assigned to one of two groups , traditional PR ( C ; n = 16 ) or traditional PR plus harmonica playing ( HT ; n = 9 ) . The HT group was provided a harmonica and one‐on‐one instruction by PR staff . Patients were given practice exercises to perform for at least 5 minutes , but not exceeding 20 minutes twice/day , 5 days/week . Results : No significant differences were found between groups . The combined sample improved significantly in their perception of shortness of breath , quality of life , and distance walked in 6 minutes . Conclusion : Harmonica playing does not significantly affect the clinical , psychosocial , or functional status of COPD patients enrolled in PR",
"OBJECTIVE To assess the effect of psychotherapy on the anxiety and depression levels of patients with chronic obstructive pulmonary disease ( COPD ) . DESIGN A blind , r and omized , controlled trial . SETTING Outpatient university pulmonary rehabilitation program in Brazil . PARTICIPANTS Thirty patients with COPD ( mean age , 60.33y ; 22 men ) attending a pulmonary rehabilitation program were r and omized into 2 groups : experimental group ( G1 ) and control group ( G2 ) . Both groups underwent a 12-week treatment program . INTERVENTIONS Group 1 ( n=14 ) participated in 24 sessions of physical exercise , 24 sessions of physiotherapy , 12 psychologic sessions , and 3 educational sessions . Group 2 did not participate in psychotherapy sessions . MAIN OUTCOME MEASURES All patients were evaluated at baseline and at completion of the pulmonary rehabilitation program by using 3 instruments : the Beck Anxiety Inventory ( BAI ) , Beck Depression Inventory ( BDI ) , and 6-minute walk distance ( 6MWD ) . RESULTS Both groups showed statistically significant improvements on the 6MWD ( G1 , P anxiety and depression levels ( G1 : BAI , P psychotherapy in a pulmonary rehabilitation program for COPD reduced patients ' anxiety and depression levels but did not modify 6MWD performance ",
"The effects of additional target-flow inspiratory muscle training ( TF-IMT ) on the performance of the inspiratory muscles , on general exercise capacity , and on psychologic parameters during a pulmonary rehabilitation program ( PR ) were studied in 40 patients with COPD selected for ventilatory limitation during exercise . The mean age of the patients was 59 years , and the mean FEV1 was approximately 50 percent of predicted . All patients participated in a ten-week PR program . They were r and omized to receive either additional TF-IMT ( PR + IMT ) or not ( PR ) . The TF-IMT was performed by means of a target-flow resistive device ; the generated mouth pressure and the duration of inspiration and of the respiratory cycle were imposed . After the training period , maximal inspiratory mouth pressure and EMG-fatigability of the diaphragm were significantly better in the PR + IMT group than in the PR group . Maximal work load and psychologic symptoms increased to the same extent in both groups . The 12-minute walking distance also increased in both groups , but it increased significantly more in the PR + IMT group than in the PR group . We believe that additional TF-IMT during PR in a selected group of patients with COPD who have ventilatory limitation has an extra beneficial effect on the performance of the inspiratory muscles and on exercise performance ",
"PURPOSE Many patients with chronic obstructive pulmonary disease ( COPD ) report dyspnea and fatigue when performing upper limb activities . Unsupported upper limb training has been shown to improve upper limb endurance , but its effects on symptoms and quality of life have not been examined . The aim of this study was to compare the effects of upper limb and lower limb training with lower limb training alone on exercise capacity , symptoms , and quality of life with COPD . METHODS For this study , 38 patients with moderate to severe COPD were r and omly allocated to unsupported upper limb endurance training or to a control group that completed a sham training task . All the patients underwent lower limb endurance training . The 6-minute walk test , the Incremental Unsupported Upper Limb Exercise Test , and the Chronic Respiratory Disease Question naire ( CRQ ) were completed before training and then 6 weeks afterward . Both patients and assessors were blinded to group allocation . RESULTS All the patients reported symptoms associated with upper limb activities on the initial CRQ . Both groups showed significant improvements in all domains of the CRQ and in the 6-minute walk test after training . Only the upper limb training group showed improvement in upper limb endurance time ( 57 + /- 75 vs 2 + /- 58 seconds ; P = .02 ) . There were no significant differences between the groups for 6-minute walk test or any domain of the CRQ . CONCLUSIONS Unsupported upper limb training for patients COPD improves upper limb exercise capacity , but has no additional effect on symptoms or quality of life , as compared with leg training alone . This type of upper limb training may not adequately address the complex interaction between respiratory mechanics and upper limb function",
"STUDY OBJECTIVES To study the short-term and long-term effects of combining activity training or lectures to exercise training on quality of life , functional status , and exercise tolerance . DESIGN R and omized clinical trial . SETTING Outpatient pulmonary rehabilitation center . PARTICIPANTS Forty-three out patients with COPD . INTERVENTIONS Patients were r and omized to one of three treatment groups : exercise training alone , exercise training plus activity training , and exercise training plus a lecture series . The mean treatment period was 10 weeks . MEASUREMENT The Chronic Respiratory Disease Question naire , the modified version of the Pulmonary Functional Status and Dyspnea Question naire , and the COPD Self-Efficacy Scale were administered at baseline , and 6 , 12 , 18 , and 24 weeks from the beginning of the rehabilitation program . The 6-min walk test was used to measure exercise tolerance . RESULTS Benefits of activity training combined with exercise included less dyspnea ( p fatigue ( p activity involvement ( p total functional status ( p participants . Compared to the lecture series adjunct , the activity training adjunct result ed in significantly higher gains in total quality of life ( p = 0.04 ) maintained at 24 weeks . Significantly worse emotional function and functional status result ed from the lecture series adjunct in the oldest participants ( p exercise tolerance or self-efficacy . CONCLUSIONS Evidence for additional benefits of activity-specific training combined with exercise was found . A behavioral method emphasizing structured controlled breathing and supervised physical activity was statistically significantly more effective than didactic instruction in facilitating additional gains and meeting participants ' learning needs",
"Patients with chronic obstructive pulmonary disease ( COPD ) often develop weight loss , which is associated with increased mortality . Recombinant human growth hormone ( rhGH ) treatment has been proposed to improve nitrogen balance and to increase muscle strength in these patients . The aim of this study was to assess the effects of rhGH administration on the nutritional status , resting metabolism , muscle strength , exercise tolerance , dyspnea , and subjective well-being of underweight patients with stable COPD . Sixteen patients attending a pulmonary rehabilitation program ( age : 66 + /- 9 yr ; weight : 77 + /- 7 % of ideal body weight ; FEV1 : 39 + /- 13 % of predicted ) were r and omly treated daily with either 0.15 IU/kg rhGH or placebo during 3 wk in a double-blind fashion . Measurements were made at the beginning ( DO ) and at the end ( D21 ) of treatment and 2 mo later ( D81 ) . Body weight was similar in the two groups during the study , but lean body mass was significantly higher in the rhGH group at D21 ( p in lean body mass was 2.3 + /- 1.6 kg in the rhGH group and 1.1 + /- 0.9 kg in the control group at D21 and 1.9 + /- 1.6 kg in the rhGH group and 0.7 + /- 2.1 kg in the control group at D81 . At D21 , the resting energy expenditure was increased in the rhGH group ( 107.8 % of DO , p in maximal respiratory pressures , h and grip strength , maximal exercise capacity , and subjective well-being were similar in the two groups . At D21 , the 6-min walking distance decreased in the rhGH group ( -13 + /- 31 % ) and increased in the control group ( + 10 + /- 14 % ; p rhGH during 3 wk increases lean body mass but does not improve muscle strength or exercise tolerance in underweight patients with COPD",
"BACKGROUND The aim of this work was to improve the efficacy of rehabilitation by retraining , by oral supply in branched-chain aminoacids ( BCAA ) . Patients with chronic respiratory insufficiency mainly suffer from obstructive bronchitis due to tobacco or asthma . Nutritional assessment is one of the components of respiratory rehabilitation , with retraining . Intense physical training for several days negativates the nitrogen balance , the beginning of a training programme for sedentary patients increases their need in proteins . An additional supply in branched-chain aminoacids increases proteic anabolism , by synthesis increase and catabolism slackening of proteins . Moreover it is known that exposure to high altitude reduces lean mass by inducing a muscular atrophy , which can be avoided by the BCAA provided . This leads to wonder if extra supply of BCAA could play similar role in muscular mass loss induced by pathological chronic hypoxia . METHODS The prospect i ve and comparative survey carried out in Toki-Eder ( private hospital in Cambo ) consisted in supplying ( during five weeks or more ) 30 retrained patients suffering from chronic obstructive bronchitis , and in matching them with 30 witnesses ( obstructive patients retrained without additional supply in BCAA ) . Their mean hypoxemia amounted to 7 torr for age . RESULTS Each of them improved their reached maximal power , and their VO2 SL , very highly significantly . Each of them developed a moderate metabolic acidosis ( whose possible mechanisms are discussed ) and slightly increased their ventilation at rest . On the other h and only the supplied patients improved their PaO2 at rest highly significantly , a result which poses the question of the responsible mechanism , most likely a decrease of pulmonary shunt effect . The hypotheses concerning the acid load due to BCAA ingestion are discussed . Only the supplied patients developed hypocapnia expressing a gaseous alkalosis which might be due to a direct effect of BCAA on the respiratory centers . CONCLUSIONS This observation could have practical outcomes in the management of rehabilitation of chronic respiratory insufficiency : it should be useful to systematic ally supplement the patients with BCAA during their retraining in order to obtain a more effective improvement of their respiratory function",
"Different modalities of assisted ventilation improve breathlessness and exercise tolerance in patients with chronic obstructive pulmonary disease ( COPD ) . The aim of this study was to evaluate the effects of the addition of assisted ventilation during exercise training on the outcome of a structured pulmonary rehabilitation programme ( PRP ) in COPD patients . Thirty-three male patients with stable COPD ( mean ( SD ) forced expiratory volume in 1 s ( FEV1 ) 44 ( 16 ) % pred ) , without chronic ventilatory failure , undergoing a 6-week multidisciplinary outpatient PRP including exercise training , were r and omised to training during either mask proportional assist ventilation ( PAV : 18 patients ) or spontaneous breathing ( SB : 15 patients ) . Assessment included exercise tolerance , dyspnoea , leg fatigue , and health-related quality of life ( HRQL ) . Five out of 18 patients ( 28 % ) in the PAV group dropped out due to lack of compliance with the equipment . Both groups showed significant post-PRP improvements in exercise tolerance ( peak work rate difference : 20 ( 95 % Cl 2.4 - 37.6 ) and 14 ( 3.8 % CI to 24.2 ) W in PAV and SB group , respectively ) , dyspnoea and leg fatigue , but not in HRQL , without any significant difference between groups . It is concluded that with the modality and in the patients assessed in this study assisted ventilation during training sessions included in a multidisciplinary PRP was not well tolerated by all patients and gave no additional physiological benefit in comparison with exercise training alone",
"STUDY OBJECTIVES Low body weight in COPD patients is associated with worsening dyspnea , reduced leg strength , and poor prognosis . Classical rehabilitation strategies are then limited by reduced exercise tolerance . Thus , we proposed to evaluate whether electrostimulation ( ES ) was a beneficial technique in the rehabilitation programs for severely deconditioned COPD patients after an acute exacerbation . DESIGN R and omized , controlled study . SETTING Pulmonary rehabilitation center . PATIENTS Seventeen patients with severe COPD ( mean [ + /- SD ] FEV(1 ) , 30 + /- 3 % predicted ) and low body mass index ( BMI ) [ 18 + /- 2.5 kg/m(2 ) ] . METHODS Patients were r and omly assigned either to usual rehabilitation ( UR ) alone or to a UR-plus-ES program for 4 weeks . Quadriceps muscle strength , total muscle mass ( MM ) , exercise capacity , and health-related quality of life were measured before and after rehabilitation . RESULTS The training with ES plus UR induced a significant twofold improvement in the mean number of maximal voluntary contraction ( MVC ) compared to UR alone ( 97 + /- 71 vs 36 + /- 34 contractions , respectively ; p = 0.03 ) and result ed in a more significant improvement in dyspnea when performing daily tasks ( decrease in the dyspnea domain score of the 28-item Maugeri Foundation Respiratory Failure question naire , -1.7 + /- 1.0 vs -0.2 + /- 1.2 points , respectively ; p = 0.05 ) . There was also a significant increase in walking distance ( 63 + /- 40 m ; p = 0.01 ) and BMI ( 0.6 + /- 0.5 kg/m(2 ) ; p = 0.02 ) after training in the ES + UR group . A significant relationship was found between changes in MVC and changes in MM after training in the ES + UR group ( r = 0.94 ; p = 0.03 ) . CONCLUSIONS The combination of ES and UR was associated with greater improvement in quadriceps strength and dyspnea during the performance of daily tasks than UR alone in severely disabled COPD patients with low BMI . In this population , ES has been revealed as a useful procedure , complementing the usual pulmonary rehabilitation",
"The oxygen cost of eccentric exercise is lower than that of concentric exercise at similar work-loads . In this study , the response to eccentric cycle exercise training ( EET ) in addition to general exercise training ( GET ) on exercise performance and quality of life was investigated in 24 patients with severe chronic obstructive pulmonary disease ( COPD ) . All patients had a normal resting PaO2 and an arterial oxygen saturation ( SaO2 ) below 90 % at Wmax , achieved during a maximal incremental concentric cycle exercise test . The patients participated in a comprehensive inpatient pulmonary rehabilitation programme of 10 weeks . They were r and omly assigned either to GET ( GET group : mean FEV1 38 % predicted ) or to GET and additional EET ( GET/EET group : FEV1 45 % predicted ) . During EET , the patients were able to cycle eccentrically for 15 min continuously at a mean of 160 ( 69 % ) of Wmax whereas the Borg dyspnoea score did not exceed 3.0 and SaO2 did not fall below 90 % . Parameters of cardiocirculatory fitness and gas exchange improved in the GET/EET group but no further improvement in exercise capacity occurred compared to GET . It is concluded that eccentric cycle exercise is a safe and attractive training modality for patients with severe COPD and can be performed at a high intensity without the patient becoming out of breath or needing supplemental oxygen",
"To examine the efficacy of targeted inspiratory muscle training ( IMT ) , 25 patients with moderate COPD were r and omly assigned to one of three groups . Eight patients received IMT along with general exercise reconditioning , GER+IMT ; nine patients received general exercise reconditioning , GER ; eight patients received sham breathing exercises , CONTROL . All groups used a spring-loaded inspiratory muscle trainer ; however , the GER and CONTROL groups breathed through these devices at only 15 % of their maximal inspiratory pressure . The GER+IMT group increased the load on these devices until at 6 wk the load was equal to 80 % of their maximal inspiratory pressure . All patients exercised three times per week for a 12-wk period in supervised sessions . Analysis of covariance revealed no significant differences in spirometric measurements , maximal inspiratory pressure , or maximal oxygen consumption among any of the three groups after the intervention ( p > 0.05 ) . Twelve-minute walk distance was significantly greater in the GER+IMT and GER groups than in the CONTROL group ( p = 0.03 ) . After the intervention , there was a trend ( p = 0.08 ) for treadmill time to be greater for the GER+IMT and GER groups than for the CONTROL group . Dyspnea ratings at different exercise intensities were not found to be significantly different among the three groups after the intervention . These results demonstrate that GER+IMT and GER alone are equally effective in improving exercise performance in patients with COPD . Additionally , the combination of GER and IMT does not appear to provide any clinical ly significant improvements in exercise performance or perceptions of dyspnea during exercise when compared with GER alone",
"We compared , in a controlled clinical trial , the effect of specific inspiratory muscle training combined with general exercise reconditioning , for six months , with that of general exercise reconditioning alone on inspiratory muscle strength , endurance , and exercise performance in patients with COPD . Thirty-six patients were recruited into three groups ; 12 patients received specific inspiratory muscle training combined with general exercise reconditioning , 12 patients underwent general exercise reconditioning alone , and the remaining 12 patients received no training . Specific inspiratory muscle training , for six months , improved the inspiratory muscle strength and endurance in patients with COPD . This training combined with general exercise reconditioning also provided improvement in exercise tolerance , and this improvement was significantly greater than that of general exercise reconditioning alone",
"STUDY OBJECTIVES Skeletal muscle weakness commonly occurs in patients with COPD . Long-term use of systemic glucocorticosteroids further contributes to muscle weakness . Anabolic steroids could be an additional mode of intervention to improve outcome of pulmonary rehabilitation by increasing physiologic functioning , possibly mediated by increasing erythropoietic function . PATIENTS AND METHODS We r and omly assigned 63 male patients with COPD to receive on days 1 , 15 , 29 , and 43 a deep IM injection of 50 mg of n and rolone decanoate ( ND ) [ Deca-Durabolin ; N.V. Organon ; Oss , The Netherl and s ] in 1 mL of arachis oil , or 1 mL of arachis oil alone ( placebo ) in a double-blind design . All patients participated in a st and ardized pulmonary rehabilitation program . Outcome measures were body composition by deuterium and bromide dilution , respiratory and peripheral muscle function , incremental exercise testing , and health status by the St. George 's Respiratory Question naire . RESULTS Treatment with ND relative to placebo result ed in higher increases in fat-free mass ( FFM ; mean , 1.7 kg [ SD , 2.5 ] vs 0.3 kg [ SD , 1.9 ] ; p = 0.015 ) owing to a rise in intracellular mass ( mean , 1.8 kg [ SD , 3.1 ] vs - 0.5 kg [ SD , 3.1 ] ; p = 0.002 ) . Muscle function , exercise capacity , and health status improved in both groups to the same extent . Only after ND were increases in erythropoietic parameters seen ( erythropoietin : mean , 2.08 U/L [ SD , 5.56 ] , p = 0.067 ; hemoglobin : mean , 0.29 mmol/L [ SD , 0.73 ] , p = 0.055 ) . In the total group , the changes in maximal inspiratory mouth pressure ( PImax ) and peak workload were positively correlated with the change in hemoglobin ( r = 0.30 , p = 0.032 , and r = 0.34 , p = 0.016 , respectively ) , whereas the change in isokinetic leg work was correlated with the change in erythropoietin ( r = 0.38 , p = 0.013 ) . In the patients receiving maintenance treatment with low-dose oral glucocorticosteroids ( 31 of 63 patients ; mean , 7.5 mg/24 h [ SD , 2.4 ] ) , greater improvements in PImax ( mean , 6.0 cm H(2)O [ SD , 8.82 ] vs - 2.18 cm H(2)O [ SD , 11.08 ] , p = 0.046 ) , and peak workload ( mean , 20.47 W [ SD , 19.82 ] vs 4.80 W [ SD , 7.74 ] , p = 0.023 ) were seen after 8 weeks of treatment with ND vs placebo . CONCLUSIONS In conclusion , a short-term course of ND had an overall positive effect relative to placebo on FFM without exp and ing extracellular water in patients with COPD . In the total group , the improvements in muscle function and exercise capacity were associated with improvements in erythropoietic parameters . The use of low-dose oral glucocorticosteroids as maintenance medication significantly impaired the response to pulmonary rehabilitation with respect to respiratory muscle function and exercise capacity , which could be restored by ND treatment",
"PURPOSE : Chronic lung diseases are typically associated with impaired quality of life , stress , and anxiety . Written disclosure therapy ( WDT ) reduces stress in patients with a variety of chronic illnesses . We sought to determine whether WDT benefits patients with chronic lung disease . METHODS : A prospect i ve , r and omized , controlled trial was performed to evaluate the effect of using WDT in patients ( N = 66 ) participating in a pulmonary rehabilitation program . Patients were r and omly assigned to write about a particularly traumatic life event ( WDT group ) or to write about an emotionally neutral subject ( control group ) . Exercise capacity , dyspnea and quality of life , and values of spirometry were recorded at baseline , at the end of the program , and at 6 months . RESULTS : The 6-minute walk distance ( 6MWD ) significantly improved in both groups at 2 months , from 278 to 327 m in WDT and from 269 to 314 m in control groups ( P in 6MWD between groups ( P = .88 ) . At 6 months , the gains made in 6MWD were no longer present . Dyspnea severity , as well as most of the other domains of the Chronic Respiratory Disease Question naire and the St. George 's Respiratory Question naire , showed improvement within each group , but not between WDT and control groups . CONCLUSION : WDT did not add any additional benefit in patients with chronic obstructive pulmonary disease or idiopathic pulmonary fibrosis when included as a component of pulmonary rehabilitation . These results are in contrast to previously seen benefits in patients with asthma",
"BACKGROUND Helium-hyperoxia ( HH ) reduces dyspnea and increases exercise tolerance in patients with COPD . We investigated whether breathing HH would allow patients to perform a greater intensity of exercise and improve the benefits of a pulmonary rehabilitation program . METHODS Thirty-eight nonhypoxemic patients with COPD ( FEV(1)=47 + /- 17%(pred ) ) were r and omized to rehabilitation breathing HH ( 60:40 He : O(2 ) ; n = 19 ) or air ( n = 19 ) . Patients cycled for 30 min , 3 days/week for 6 weeks breathing the assigned gas . Exercise intensity was prescribed from baseline , gas-specific , incremental exercise tests and was advanced as tolerated . The primary outcome was exercise tolerance assessed as a change in constant-load exercise time ( CLT ) following rehabilitation . Secondary outcomes were changes in exertional symptoms , health related quality of life ( as assessed by the Short-form 36 and St George respiratory question naires ) , and peak oxygen consumption during an incremental exercise test . RESULTS The HH group had a greater change in CLT following rehabilitation compared to the air group ( 9.5 + /- 9.1 vs 4.3 + /- 6.3 min , p dyspnea was significantly reduced in both groups , while leg discomfort only decreased in the HH group . The changes in exertional symptoms and peak oxygen consumption were not different between groups . Health-related quality of life significantly improved in both groups ; however , the change in St. George respiratory question naire total score was greater with HH ( -7.6 + /- 6.4 vs -3.6 + /- 5.6 , p exercise intensity and training duration throughout the program ( p CLT for patients with COPD"
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OBJECTIVE This systematic review aims to evaluate the scientific evidence on the efficacy in the surgical protocol s design ed for preserving the alveolar ridge after tooth extraction and to evaluate how these techniques affect the placement of dental implants and the final implant supported restoration . MATERIAL AND METHODS A thorough search in MEDLINE - PubMed , Embase and the Cochrane Central Register of controlled trials ( CENTRAL ) was conducted up to February 2011 . R and omized clinical trials and prospect i ve cohort studies with a follow-up of at least 3 months reporting changes on both the hard and soft tissues ( height and /or width ) of the alveolar process ( mm or % ) after tooth extraction were considered for inclusion . RESULTS The screening of titles and abstract s result ed in 14 publications meeting the eligibility criteria . Data from nine of these 14 studies could be grouped in the meta-analyses . Results from the meta-analyses showed a statistically significant greater ridge reduction in bone height for control groups as compared to test groups ( weighted mean differences , WMD = -1.47 mm ; 95 % CI [ -1.982 , -0.953 ] ; P greater reduction in bone width for control groups compared to the test groups ( WMD = -1.830 mm ; 95 % CI [ -2.947 , -0.732 ] ; P = 0.001 ; heterogeneity : I(2 ) = 0 % ; χ(2 ) P-value = 0.837 ) . Subgroup analysis was based on the surgical protocol used for the socket preservation ( flapless/flapped , barrier membrane/no membrane , primary intention healing/no primary healing ) and on the measurement method utilized to evaluate morphological changes . Meta-regression analyses demonstrated a statistically significant difference favoring the flapped subgroup in terms of bone width ( meta-regression ; slope = 2.26 ; 95 % IC [ 1.01 ; 3.51 ] ; P = 0.003 ) . CONCLUSIONS The potential benefit of socket preservation therapies was demonstrated result ing in significantly less vertical and horizontal contraction of the alveolar bone crest . The scientific evidence does not provide clear guidelines in regards to the type of bio material , or surgical procedure , although a significant positive effect of the flapped surgery was observed . There are no data available to draw conclusions on the consequences of such benefits on the long-term outcomes of implant therapy
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"OBJECTIVES The aim of the following study was to assess contour changes after socket preservation techniques . MATERIAL AND METHODS In five beagle dogs , the distal root of the third and fourth m and ibular premolars was extracted . The following treatments ( Tx ) were r and omly assigned for the extraction socket . Tx 1 : BioOss Collagen . Tx 2 : BioOss Collagen and a free soft tissue graft . Tx 3 : No treatment . Tx 4 : The internal buccal aspect was covered with an experimental collagen membrane , the extraction socket was filled with BioOss Collagen and the membrane folded on top of the graft . Impressions were obtained at baseline , 2 and 4 months after surgery . Bucco-lingual measurements were performed using digital imaging analysis . RESULTS All groups displayed contour shrinkage at the buccal aspect . Only the differences between the two test groups ( Tx 1 , Tx 2 ) and the control group ( Tx 3 ) were significant at the buccal aspect ( p Socket preservation techniques , used in the present experiment , were not able to entirely compensate for the alterations after tooth extraction . Yet , incorporation of BioOss Collagen seems to have the potential to limit but not avoid the post-operative contour shrinkage",
"BACKGROUND Reduction of alveolar height and width after tooth extraction may present problems for implant placement , especially in the anterior maxilla where bone volume is important for biologic and esthetic reasons . Different graft material s have been proposed to minimize the reduction in ridge volume . The aim of this study was to compare radiographic and histomorphometric results of magnesium-enriched hydroxyapatite ( MHA ) and calcium sulfate ( CS ) grafts in fresh sockets after tooth extraction s. METHODS Forty-five fresh extraction sockets with three bone walls were selected in 15 patients . A split-mouth design was used : 15 sockets on the right side of the jaw received MHA , 15 sockets on the left side received CS , and 15 r and om unfilled sockets were considered the control ( C ) group . Intraoral digital radiographs were taken at baseline and at 3 months after graft material placement . At 3 months , cylinder bone sample s were obtained for histology and histomorphometry analysis . RESULTS The difference in mean radiographic vertical bone level from baseline to 3 months was -2.48 + /- 0.65 mm in the CS group , -0.48 + /- 0.21 mm in the MHA group , and -3.75 + /- 0.63 mm in the unfilled C group . Statistically significant differences ( P CS and MHA groups and between MHA and C groups . Histologic examination revealed bone formation in all treated sites ; trabecular bone assessment did not differ among apical , mesial , and coronal portions of the specimens . Mean vital bone measurements for CS , MHA , and C groups were 45.0 % + /- 6.5 % , 40.0 % + /- 2.7 % , and 32.8 % + /- 5.8 % , respectively . Statistically significant differences ( P Connective tissue percentages averaged 41.5 % + /- 6.7 % for the CS group , 41.3 % + /- 1.3 % for the MHA group , and 64.6 % + /- 6.8 % for the C group . Statistically significant differences ( P CS and C groups and between MHA and C groups . The CS-grafted sockets showed 13.9 % + /- 3.4 % residual implant material , whereas the MHA-treated sockets showed 20.2 % + /- 3.2 % residual material . The difference between the groups was statistically significant ( P alveolar ridge in the CS group than in the MHA group . Histologic examination showed more bone formation and faster resorption in the CS group and more residual implant material in the MHA group",
"BACKGROUND The placement of different graft material s and /or the use of occlusive membranes to cover the extraction socket entrance are techniques aim ed at preserving/reducing alveolar ridge resorption . The use of grafting material s in fresh extraction sockets has , however , been question ed because particles of the grafted material have been found in alveolar sockets 6 - 9 months following their insertion . AIM The aims of the study were to ( i ) . evaluate whether alveolar ridge resorption following tooth extraction could be prevented or reduced by the application of a bioabsorbable polylactide-polyglycolide sponge used as a space filler , compared to natural healing by clot formation , and ( ii ) . evaluate histologically the amount and quality of bone tissue formed in the sockets , 6 months after the use of the bioabsorbable material . MATERIAL AND METHODS Thirty-six patients , undergoing periodontal therapy , participated in this study . All patients were scheduled for extraction of one or more compromised teeth . Following elevation of full-thickness flaps and extraction of teeth , measurements were taken to evaluate the distance between three l and marks ( mesio-buccal , mid-buccal , disto-buccal ) on individually prefabricated stents , and the alveolar crest . Twenty-six alveolar sockets ( test ) were filled with a bioabsorbable polylactide-polyglycolide acid sponge ( Fisiograft ) , while 13 sockets ( controls ) were allowed to heal without any filling material . The flaps were sutured with no attempt to achieve primary closure of the surgical wound . Re-entry for implant surgery was performed 6 months following the extraction s. Thirteen biopsies ( 10 test and three control sites ) were harvested from the sites scheduled for implant placement . RESULTS The clinical measurements at 6 months revealed , in the mesial-buccal site , a loss of bone height of 0.2 mm ( 1.4 SD ) in the test and 0.6 mm ( 1.1 SD ) in the controls ; in the mid-buccal portion a gain of 1.3 mm ( 1.9 SD ) in the test and a loss of 0.8 mm ( 1.6 SD ) in the controls ; and in the distal portion a loss of 0.1 mm ( 1.1 SD ) in the test and of 0.8 ( 1.5 SD ) mm in the controls . The biopsies harvested from the test sites revealed that the new bone formed at 6 months was mineralized , mature and well structured . Particles of the grafted material could not be identified in any of the 10 test biopsies . The bone formed in the control sites was also mature and well structured . CONCLUSION The results of this study indicate that alveolar bone resorption following tooth extraction may be prevented or reduced by the use of a bioabsorbable synthetic sponge of polylactide-polyglycolide acid . The quality of bone formed seemed to be optimal for dental implant insertion",
"BACKGROUND Different approaches were advocated to preserve or improve the dimension and contour of the ridge following tooth extraction . In some of studies , socket ' flapless extraction ' apparently had a successful outcome . AIM The objective of the present experiment was to compare hard tissue healing following tooth extraction with or without the prior elevation of mucosal full-thickness flaps . MATERIAL AND METHODS Five mongrel dogs were used . The two second m and ibular premolars ( (2)P(2 ) ) were hemi-sected . The mesial roots were retained . By r and om selection the distal root in one side was removed after the elevation of full-thickness flaps while on the contralateral side , root extraction was performed in a flapless procedure . The soft tissue wound was closed with interrupted sutures . After 6 months of healing , the dogs were euthanized and biopsies were sample d. From each experimental site , four ground sections - two from the mesial root and two from the healed socket - were prepared , stained and examined in the microscope . RESULTS The data showed that the removal of a single tooth ( root ) during healing caused a marked change in the edentulous ridge . In the apical and middle portions of the socket site minor dimensional alterations occurred while in the coronal portion of the ridge the reduction of the hard tissue volume was substantial . Similar amounts of hard tissue loss occurred during healing irrespective of the procedure used to remove the tooth was , i.e. flapless or following flap elevation . CONCLUSION Tooth loss ( extraction ) result ed in marked alterations of the ridge . The size of the alveolar process was reduced . The procedure used for tooth extraction - flapless or following flap elevation - apparently did not influence the more long-term outcome of healing",
"The purpose of this study was to evaluate the clinical effectiveness of a bioabsorbable membrane made of glycolide and lactide polymers in preserving alveolar ridges following tooth extraction using a surgical technique based on the principles of guided bone regeneration . Sixteen patients requiring extraction s of 2 anterior teeth or bicuspids participated in the study ( split-mouth design ) . Following elevation of buccal and lingual full-thickness flaps and extraction of teeth , experimental sites were covered with bioabsorbable membranes ; control sites did not receive any membrane . Titanium pins served as fixed reference points for measurements . Flaps were advanced in order to achieve primary closure of the surgical wound . No membrane became exposed in the course of healing . Reentry surgeries were performed at 6 months . Results showed that experimental sites presented with significantly less loss of alveolar bone height , more internal socket bone fill , and less horizontal resorption of the alveolar bone ridge . This study suggests that treatment of extraction sockets with membranes made of glycolide and lactide polymers is valuable in preserving alveolar bone in extraction sockets and preventing alveolar ridge defects",
"The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience .",
"The aim of this study was to investigate the healing of human extraction sockets filled with Bio-Oss particles ( Geistlich Pharma AG , Wolhusen , Switzerl and ) . In 21 subjects , providing a total of 31 healing sites , at least one tooth was scheduled for extraction and the extraction sites for implant therapy . The dimensions of the alveolar ridge at the extraction sites were considered insufficient and required augmentation concomitant with tooth extraction . There were three treatment groups . In group A , the extraction sockets were covered with a Bio-Gide membrane ( Geistlich Pharma AG ) and in group B the extraction sockets were filled with Bio-Oss . The extraction sockets in group C were left to heal spontaneously . Biopsies from the extraction sites were collected at the time of implant installation . Sample s from group A showed large amounts of lamellar bone and bone marrow and small proportions of woven bone . Sites grafted with Bio-Oss ( group B ) were comprised of connective tissue and small amounts of newly formed bone surrounding the graft particles . Only 40 % of the circumference of the Bio-Oss particles was in contact with woven bone . Sites from group C were characterized by the presence of mineralized bone and bone marrow",
"BACKGROUND Various material s have been used immediately following tooth extraction to fill and /or cover the socket in an attempt to limit or prevent ridge resorption . The purpose of the present pilot study was to establish a reliable model to investigate the effect of various bone graft and bone replacement material s on extraction socket healing . This study also compared healing extraction sockets 6 to 8 months postimplantation of a bioactive glass ( BG ) or demineralized freeze-dried bone allograft ( DFDBA ) to an unfilled socket control ( C ) . METHODS Following tooth extraction , a total of 30 sockets in 19 patients were r and omly divided into 3 treatment groups : 10 sockets received BG , 10 sockets DFDBA , and 10 sockets served as unfilled controls . Primary coverage was achieved by flap advancement over each socket . Six to 8 months post extraction at time of implant placement , histological cores of the treatment sites were obtained . These cores were processed , undecalcified sections prepared and stained with Stevenel blue/van Gieson 's picric fuchsin , and histomorphometrically analyzed . Vital bone , connective tissue and marrow , and residual graft particles were reported as a percentage of the total core . RESULTS A model system was described in humans and used to evaluate the healing response in the 3 treatment groups . Results concluded that mean vital bone present was 59.5 % for BG- , 34.7 % for DFDBA- , and 32.4 % for C-treated sites . These differences were not statistically significant . However , the residual implant material was significantly higher in DFDBA-treated ( 13.5 % ) versus BG-treated sockets ( 5.5 % ) . CONCLUSIONS Although the differences in percent vital bone were not statistically significant among the 3 treatment groups in this pilot study , BG material was observed to act as an osteoconductive material which had a positive effect on socket healing at 6 to 8 months post extraction . Further research following implant placement in treated and control sockets is warranted to determine if bone implant contact is improved in BG-filled versus unfilled sockets",
"BACKGROUND Barrier membranes have been used to promote bone ingrowth on implants with dehiscences and fenestrations . Membranes also have been used to protect defects adjacent to implants placed at the time of extraction . The concept of guided bone regeneration relates to preferentially allowing cells from bone to migrate into various defects while excluding fibrous tissue and epithelium . The purpose of these procedures is to enhance bone-to-implant contact at the treated sites and to prevent mucosal complications . PURPOSE The purpose of this article is to report clinical outcomes for implants placed at the time of extraction and augmented with exp and ed polytetrafluoroethylene ( ePTFE ) and followed for 5 years . The outcomes for implants with dehiscences and fenestrations augmented with ePTFE barriers and followed up to 5 years also are reported . METHODS AND MATERIAL S Four treatment centers participated in this study ( Tucson , Gothenburg , Spokane , and Leuven ) . In the extraction group , teeth were removed for varying reasons , and Brånemark implants were placed and stabilized within the host bone . Defects present at the coronal implant aspect were covered with ePTFE barrier membranes . Flaps were rotated to cover the membrane-treated sites . If exposure of the material occurred prior to second-stage surgery , the membranes were removed . Barriers remaining unexposed were removed at second-stage surgery . The implants were followed up to 5 years . In the fenestration and dehiscence group , implants with exposed threads were augmented with ePTFE barrier membranes . The barriers were removed at appropriate intervals , and the patients were followed up to 5 years . Radiographic measurements were made from nonst and ardized periapical radiographs at abutment connection and 1 , 3 , and 5-year follow-up visits . RESULTS Forty patients participated in the extraction group . They received a total of 49 implants . Three implants failed prior to loading . The 5-year cumulative survival rates for implants placed at the time of extraction were 93.9 % and 93.8 % , respectively , for maxillary and m and ibular implants . The average maxillary mesial and distal marginal bone loss ( 1 - 5 yr ) was 0.3 mm ( st and ard deviation [ SD ] = 1.5 ) and 0.3 mm ( SD = 1.0 ) . In m and ibles , the average mesial and distal bone loss ( 1 - 5 yr ) was -0.2 mm ( SD = 0.5 ) and -0.05 mm ( SD = 0.6 ) , respectively . The dehiscence and fenestration group included 44 patients . Twenty-six were followed for up to 5 years . Eight patients experienced total implant failure . For dehiscences and fenestrations , the cumulative survival rates were 76.8 % and 83.8 % for maxillary and m and ibular implants , respectively . The average maxillary mesial and distal bone loss ( 1 - 5 yr ) was 0.4 mm ( SD = 0.8 ) and 0.2 mm ( SD = 0.9 ) , respectively . In m and ibles , the average mesial and distal marginal bone loss was 0.3 mm ( SD = 0.9 ) and 0.3 mm ( SD = 0.8 ) , respectively . CONCLUSIONS Implants placed at the time of extraction and augmented with ePTFE barrier membranes have favorable long-term predictability . On the other h and , long-term evaluation of implant dehiscences and fenestrations augmented with barrier membranes indicates that they have less favorable 5-year survival rates . Membrane augmentation of these may be question ed",
"BACKGROUND Tooth extraction typically leads to loss of ridge width and height . The primary aim of this 6-month r and omized , controlled , blinded , clinical study was to determine whether ridge preservation would prevent post- extraction resorptive changes as assessed by clinical and histologic parameters . METHODS Twenty-four patients , 10 males and 14 females , aged 28 to 76 ( mean 51.5 + /- 13.6 ) , requiring a non-molar extraction and delayed implant placement were r and omly selected to receive either extraction alone ( EXT ) or ridge preservation ( RP ) using tetracycline hydrated freeze-dried bone allograft ( FDBA ) and a collagen membrane . A replaced flap , which did not completely cover the sockets , was used . Following extraction , horizontal and vertical ridge dimensions were determined using a modified digital caliper and an acrylic stent , respectively . Prior to implant placement , a 2.7 x 6.0 mm trephine core was obtained and preserved in formalin for histologic analysis . RESULTS The width of the RP group decreased from 9.2 + /- 1.2 mm to 8.0 + /- 1.4 mm ( P ridge width , although an improved result was obtained in the RP group . Most of the resorption occurred from the buccal ; maxillary sites lost more width than m and ibular sites . The vertical change for the RP group was a gain of 1.3 + /- 2.0 mm versus a loss of 0.9 + /- 1.6 mm for the EXT group ( P bone in the RP group : about 65 + /- 10 % versus 54 + /- 12 % in the EXT group . The RP group included both vital bone ( 28 % ) and non-vital ( 37 % ) FDBA fragments . CONCLUSIONS Ridge preservation using FDBA and a collagen membrane improved ridge height and width dimensions when compared to extraction alone . These dimensions may be more suitable for implant placement , especially in areas where loss of ridge height would compromise the esthetic result . The quantity of bone observed on histologic analysis was slightly greater in preservation sites , although these sites included both vital and non-vital bone . The most predictable maintenance of ridge width , height , and position was achieved when a ridge preservation procedure was employed",
"Immediate m and ibular complete dentures were placed in 18 patients . To prevent ridge resorption , bone grafts with hard tissue replacement synthetic bone were placed in sockets on one side of the m and ible . The untreated sockets on the contralateral side served as controls . Bone density as shown in panoramic radiographs was reported at the time of placement , at 5 months to 6 months postsurgery , at 12 months to 14 months postsurgery , and at 20 months to 24 months postsurgery . The sites treated with hard tissue replacement synthetic bone not only prevented ridge resorption but also showed increased optical ( socket ) density of regenerating bone in the initial phase of the study , and maintained that elevated level at 24 months post extraction",
"BACKGROUND Early implantation may preserve the alveolar anatomy , and the placement of a fixture in a fresh extraction socket helps to maintain the bony crest . Although a number of clinical studies exist , no histological reports show the outcome of implantation in fresh extraction sockets without the use of membranes in humans compared to implants placed in mature bone . METHODS Forty-eight healthy patients , receiving at least 4 fixtures in each of 2 symmetrical quadrants , underwent placement of 1 experimental fixture placed in a fresh extraction socket ( TI ) and 1 contralateral fixture in mature bone ( CI ) . TI were placed after atraumatical tooth extraction , with a surgical site at the apex of the socket and a tight contact between the fixture and the socket 's walls , but without the use of filling material s or membranes . The flap was coronally repositioned to obtain primary wound closure . Immediately after surgical intervention , a st and ardized periapical radiograph was taken . Second-stage surgery was done after 6 months . Six months after the second surgery , a second st and ardized periapical radiograph was taken and clinical parameters ( bleeding and plaque index ) recorded . Marginal bone loss ( MBL ) from the time of implant placement to the time of fixture removal was calculated by comparing periapical radiographs . TI and CI were then removed by a hollow drill to obtain histological specimens . Non-demineralized sections were stained by acid fuchsin and toluidine blue , and by von Kossa to evaluate the degree of bone mineralization . The percentage of direct implant-bone contact ( DBC ) was calculated by a computerized microscopic digitizer . RESULTS No significant differences in the clinical and radiographic parameters were observed between the 2 experimental categories . There was no statistically significant difference between TI and CI for DBC either in the maxilla or in the m and ible . No connective or fibrous tissues were present around TI or CI . Bone resorption was not present in any of the histological sections . CONCLUSIONS The present study shows that when a screw-type dental implant is placed without the use of barrier membranes or other regenerative material s into a fresh extraction socket with a bone-to-implant gap of 2 mm or less , the clinical outcome and degree of osteointegration does not differ from implants placed in healed , mature bone",
"BACKGROUND The preservation of bone volume immediately after tooth removal might be necessary to optimize the success of implant placement in terms of esthetics and function . The objectives of this r and omized clinical trial were two-fold : 1 ) to compare the bone dimensional changes following tooth extraction with extraction plus ridge preservation using corticocancellous porcine bone and a collagen membrane ; and 2 ) to analyze and compare histologic and histomorphometric aspects of the extraction -alone sites to the grafted sites . METHODS Forty subjects who required tooth extraction and implant placement were enrolled in this study . Using a computer-generated r and omization list , the subjects were r and omly assigned to the control group ( EXT ; extraction alone ) or to the test group ( RP ; ridge-preservation procedure with corticocancellous porcine bone and collagen membrane ) . The following parameters were assessed immediately after extraction and 7 months prior to implant placement : plaque index , gingival index , bleeding on probing , horizontal ridge width , and vertical ridge changes . A bone biopsy was taken from the control and test sites 7 months after the surgical treatment . Histologic and histomorphometric analyses were also performed . RESULTS A significantly greater horizontal reabsorption was observed at EXT sites ( 4.3+/-0.8 mm ) compared to RP sites ( 2.5+/-1.2 mm ) . The ridge height reduction at the buccal side was 3.6+/-1.5 mm for the extraction -alone group , whereas it was 0.7+/-1.4 mm for the ridge-preservation group . Moreover , the vertical change at the lingual sites was 0.4 mm in the ridge-preservation group and 3 mm in the extraction -alone group . Forty biopsies were harvested from the experimental sites ( test and control sites ) . The biopsies harvested from the grafted sites revealed the presence of trabecular bone , which was highly mineralized and well structured . Particles of the grafted material could be identified in all sample s. The bone formed in the control sites was also well structured with a minor percentage of mineralized bone . The amount of connective tissue was significantly higher in the extraction -alone group than in the ridge-preservation group . CONCLUSIONS The ridge-preservation approach using porcine bone in combination with collagen membrane significantly limited the resorption of hard tissue ridge after tooth extraction compared to extraction alone . Furthermore , the histologic analysis showed a significantly higher percentage of trabecular bone and total mineralized tissue in ridge-preservation sites compared to extraction -alone sites 7 months after tooth removal",
"BACKGROUND Conventional dentoalveolar osseous reconstruction often involves the use of grafting material s with or without barrier membranes . The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) delivered on a bioabsorbable collagen sponge ( ACS ) compared to placebo ( ACS alone ) and no treatment in a human buccal wall defect model following tooth extraction . METHODS Eighty patients requiring local alveolar ridge augmentation for buccal wall defects ( > or = 50 % buccal bone loss of the extraction socket ) of the maxillary teeth ( bicuspids forward ) immediately following tooth extraction were enrolled . Two sequential cohorts of 40 patients each were r and omized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS , placebo ( ACS alone ) , or no treatment in a 2:1:1 ratio . Efficacy was assessed by evaluating the amount of bone induction , the adequacy of the alveolar bone volume to support an endosseous dental implant , and the need for a secondary augmentation . RESULTS Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls ( P adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo . In addition , bone density and histology revealed no differences between newly induced and native bone . CONCLUSION The data from this r and omized , masked , placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants",
"PURPOSE The purpose of this investigation was to compare the efficacy of two therapeutic options-immediate implant placement and ridge preservation with delayed implant placement-in maintaining the position of the soft tissue margins following tooth extraction . MATERIAL S AND METHODS This r and omized controlled study evaluated apicocoronal changes in the midbuccal and proximal mucosal positions at implant placement sites from tooth extraction to 3 and 6 months following extraction . Twenty-four patients ( 26 sites ) r and omly received either immediate implant placement or ridge preservation ( grafting with freeze-dried bone allograft and a collagen membrane ) followed by implant placement 3 months later . Immediate placement sites received bone grafting for horizontal defects > 2 mm ( from implant to cortical wall ) . Soft tissue measurements , vertical measurements , and ridge width measurements were performed and compared for immediate versus delayed implants and thin versus thick biotype . RESULTS The midbuccal soft tissue margins showed minimal recession over 6 months from the time of extraction ( mean 0.17 + /- 0.47 mm ) , with no differences between treatment groups . Interproximal tissue height decreased significantly from extraction to 6 months ( mesial , 1.73 + /- 0.71 mm ; distal , 1.48 + /- 0.80 mm ) , with no significant differences between immediate and delayed placement . Immediate implant sites had greater reductions in ridge width 6 months after extraction than delayed placement sites . Tissue biotype failed to show any significant relationship with the changes identified . CONCLUSIONS This r and omized controlled study comparing soft tissue changes following extraction failed to identify differences between patients treated with immediate or delayed approaches for midbuccal or interproximal soft tissue margins , although greater decreases in ridge width were observed in sites lacking bone grafting . Both immediate and delayed treatment approaches appear to be appropriate following tooth extraction , with the preferred treatment based on factors other than result ant soft tissue changes",
"AIM To identify factors that may influence ridge alterations occurring at the buccal aspect of the extraction site following immediate implant placement . MATERIAL AND METHODS In 93 subjects , single-tooth implants were placed immediately into extraction sockets in the maxilla ( tooth locations 15 - 25 ) . A series of measurements describing the extraction site were made immediately after implant installation and at re-entry , 16 weeks later . The implant sites were stratified according to four factors : ( i ) implant location ( anterior/posterior ) , ( ii ) cause of tooth extraction ( periodontitis/non-periodontitis ) , ( iii ) thickness of the buccal bone walls ( 1 mm ) and ( iv ) the dimension of the horizontal buccal gap ( 1 mm ) . RESULTS ( i ) The location where the implant was placed ( anterior/posterior ) as well as ( ii ) the thickness of the buccal bone crest and ( iii ) the size of the horizontal buccal gap significantly influenced the amount of hard tissue alteration that occurred during a 4-month period of healing . At implant sites in the premolar segment , the fill of the horizontal gap was more pronounced than in the incisor-canine segment , while the vertical crest reduction was significantly smaller . Furthermore , at sites where the buccal bone wall was thick ( > 1 mm ) and where the horizontal gap was large ( > 1 mm ) , the degree of gap fill was substantial . CONCLUSIONS The thickness of the buccal bone wall as well as the dimension of the horizontal gap influenced the hard tissue alterations that occur following immediate implant placement into extraction sockets",
"BACKGROUND Preservation of the alveolar process after tooth extraction is desirable because it facilitates placement of endosseous implants and minimizes adverse esthetic results associated with fixed partial dentures . The purpose of this study was to evaluate the clinical effectiveness of bioactive glass used as a graft material combined with calcium sulfate used in the form of a mechanical barrier in preserving alveolar ridges after tooth extraction . METHODS Sixteen patients who required extraction of 2 anterior teeth or bicuspids participated in the study ( split mouth design ) . After tooth extraction and elevation of a buccal full-thickness flap , experimental sockets were filled with bioactive glass , which in turn was covered with a layer of calcium sulfate . Control sites did not receive any graft or calcium sulfate . Titanium pins served as fixed reference points for measurements . No attempt was made to advance the flap to cover the socket areas on control or experimental sites ( open socket approach ) . Reentry surgeries were performed at 6 months . RESULTS Reentry surgeries showed that experimental sites presented with ( 1 ) significantly more internal socket bone fill ( 6.43 + /- 2.78 mm vs 4.00 + /- 2.33 mm on control sites ) , ( 2 ) less ( although not statistically significantly less ) resorption of alveolar bone height ( 0.38 + /- 3.18 mm vs 1.00 + /- 2 . 25 mm on control sites ) , and ( 3 ) similar degree of horizontal resorption of the alveolar bony ridge as compared with controls ( 3 . 48 + /- 2.68 mm vs 3.06 + /- 2.41 mm on control sites ) . CONCLUSIONS This study suggests that treatment of extraction sockets with a combination of bioactive glass and calcium sulfate is of some benefit in preserving alveolar ridge dimensions after tooth extraction",
"This paper presents the results of a study to observe the effect on bone resorption and residual alveolar ridge form , of placement of dense non-resorbable hydroxyapatite granules into fresh canine sockets , at the time of immediate denture provision . Thirty five subjects were r and omly divided into two groups cross matched for age and sex . All subjects required bilateral extraction of at least a lower canine and an adjacent tooth . Results demonstrate that six months post- extraction the control group had lost four times more bone than the implant group . These results were highly significant ( P=0.000 , LHS and P=0.001 , RHS )",
"Extraction of a tooth necessitated by factors such as developmental problems , trauma , severe periodontal disease and endodontic problems often causes deformities of the residual alveolar ridge in the maxillary anterior region . These cases are usually difficult to restore prosthetically and they result in poor esthetics and insufficient occlusal function . This study investigated the efficacy of root form bioactive glass cones implanted into ( a ) artificial sockets produced by bone splitting of previous extraction sites ( group BS ) and ( b ) fresh extraction sockets ( group FES ) . We included conventional extraction sockets sutured without implanting the root form bioactive glass cones as a control ( group C ) . A total of 16 patients were treated for whom extraction s had been indicated due to severe periodontitis . 6 patients with 7 implant sites having Class II or III alveolar ridge deformities comprised the BS group . 5 patients with 10 implant sites comprised the FES group . Group C , comprised 5 patients with 10 extraction sites . Alveolar ridge width and height measurements were obtained using study casts preoperatively , immediately postoperatively , and at 3 and 12 months after operation . In the BS group , while the width of the alveolar ridge increased by 2.8+/-1.18 mm immediately after ridge augmentation procedure and by 2.4+/-0.93 mm at 1 year after operation ( p height of the alveolar ridge increased by 1.8+/-1.99 mm and 1.4+/-1.74 mm respectively ( p original ridge height and width and postoperative measurements were not statistically significant , which demonstrated the efficiency of this method in preserving the alveolar ridge . In group C , while alveolar ridge width after 12 months had not significantly changed , alveolar ridge height decreased significantly ( 1.35+/-1.05 mm , p dehiscences were detected and the differences in height between the groups remained significant . The results of this study indicate that this procedure is efficient in reconstructing alveolar ridges deformed as a result of extraction , particularly relevant in relation to preparation for subsequent restorative treatment"
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411650f6-06ff-11f0-808a-c43d1ab1c353
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Summary Back schools are high frequency-low cost interventions . Their effectiveness has lately been regarded with skepticism . The variety of back school programs makes an over-all evaluation difficult . The number of evaluative publications has increased dramatically during the last 10 years , including 18 r and omized controlled trials . Results of these studies have been contradictory . The results of two lately published r and omized controlled trials , of 18 r and omized controlled trials , of five systematic review s , two publications conducting metaanalyses , and five task forces presenting guidelines for clinical practice are reported . According to the conclusions of the review s there is limited to strong evidence for the effectiveness of back schools for chronic back pain . The metaanalyses show clear effects for knowledge and behavior change up to 6 months . Three of five task forces recommend back schools for acute pain respectively at worksite . Summarizing the results of the given evidence based recommendations it is concluded that back schools at work sites and back schools with intensive training is effective . There is still need to prove the effectiveness of single elements of the back school programs , of strategies to increase long term effects , the effectiveness for subtypes of patients and the effectiveness of back schools as part of a comprehensive orthopedic pain therapy . ZusammenfassungRückenschulen sind inzwischen weit verbreitete Programme , deren Wirksamkeit in letzter Zeit kritisch diskutiert wurde . Die Heterogenität der Programme i m Hinblick auf Ziele , Inhalte und Vermittlungsformen erschweren allgemeine Aussagen zur Wirksamkeit . Es liegt eine nahezu unüberschaubare Anzahl an Publikationen zur Evaluation von Rückenschulen vor , die unterschiedliche Wirksamkeitskriterien erhoben haben . Die vorliegenden Einzelstudien , darunter 18 mit einem kontrollierten r and omisierten Versuchsplan , kommen zu teilweise widersprechenden Result aten . Um dennoch zu einer allgemeinen Bewertung der Ergebnislage zu kommen , werden 2 jüngere Einzelstudien exemplarisch beschrieben , ebenso wie eine Übersicht über 18 r and omisierte kontrollierte Studien , Schlußfolgerungen von 5 Sammelreferaten , 2 Metaananalysen und 5 Expertenkommissionen , die „ Evidence based-Leitlinien “ zur Beh and lung von Rückenbeschwerden veröffentlichen . Von den Sammelreferaten kommt eines zu keinem Ergebnis , 3 beschreiben eine eingeschränkte Wirksamkeit und eines begründet eine starke Evidenz für die Wirksamkeit von Rückenschulen bei chronischen Beschwerden . Eine Metaanalyse errechnet große Effekte für Verhaltensänderungen und Kenntnisgewinn , die and ere größere Effekte für Rückenschulen als Teil von umfassenden Rehabilitationsprogrammen , 2 der Expertenkommissionen sehen keine Evidenz für die Wirksamkeit von Rückenschulen , 3 sehen die Wirksamkeit bei akuten Beschwerden bzw . am Arbeitsplatz als erwiesen . In der Gesamtbewertung erscheint die Wirksamkeit von Rückenschulprogrammen gesichert , die am Arbeitsplatz durchgeführt werden und die eine intensive Schulung beinhalten . Darüber hinaus muß die Wirkung der Rückenschulen noch deutlicher belegt werden , u. a. die isolierte Wirkung einzelner Bausteine , von Maßnahmen zur Steigerung der Dauerhaftigkeit , der Indikation für bestimmte Patientengruppen und Wirkungen der Rückenschule als Best and teil der Orthopädischen Schmerztherapie
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[
"The purpose of this study was to assess the effects of two different treatment modalities on the rehabilitation process of chronic sacroiliac joint patients . The treatment modalities included spinal manipulative therapy given by a chiropractor and a program of back school therapy given by a physiotherapist . The rehabilitation process was assessed using clinical and biomechanical measures . It was found that back school therapy was a better treatment modality than the spinal manipulative therapy , according to the clinical measures of rehabilitation . Precisely the opposite result was found for the biomechanical measures",
"A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity",
"Ninety-two chronic low back pain patients were r and omly allocated to two groups to evaluate the effectiveness of a back school compared with an exercise-only regimen according to specified outcome variables . The data from 78 patients with 7 years mean duration of symptoms was analyzed . Three assessment s were made : before treatment and 6 and 16 weeks after treatment . Changes in patients ' levels of pain , functional disability , and other related variables were compared in the two groups . Almost all variables showed an improvement at 6 weeks . At 16 weeks , functional disability and pain levels showed a significant difference . Back school patients continued to make an improvement . This method of managing low back pain makes maximal use of limited re sources and appears to be effective , especially in the longer term",
"The long-term outcome results of inpatient and outpatient treatment of low back pain ( LBP ) were studied in 476 subjects ( aged 35 - 54 , 63 % men ) r and omly assigned to three study groups : in patients ( n = 157 ) , out patients ( n = 159 ) , and controls ( n = 160 ) . The study included changes in the severity of low back pain , grade and disability , compliance with self-care , data on disability pensions , and days of sickness allowance during a 2.5-year follow-up period . These variables were used as outcome criteria . Pain and disability had decreased significantly in the two treated groups up to the 3-month follow-up . LBP was still a little slighter in the in patients at the 1.5-year and 22-month follow-ups , but there were no significant differences between the groups in disability caused by LBP . The refresher programme carried out 1.5 years after the first one did not bring about as clear short-term improvement in pain and disability as the first treatment . During the whole 2.5-year follow-up compliance with self-care was better in the two treated groups , especially in the in patients . Days of sickness allowance had increased somewhat more in the controls than in the in patients during the follow-up . No differences between the groups were found in the number of disability pensions granted",
"Because back pain is a widespread and costly condition that tends to recur , treatment must focus on both the amelioration of acute symptoms and prevention over the long term . This paper reports a longitudinal evaluation of a program from a community hospital that emphasizes both these aspects . One hundred twenty patients routinely admitted to this program were r and omly assigned to treatment and control groups . These groups were assessed for differences in demonstrated physical strength , mobility , body mechanics , and self-care knowledge , and in levels of self-reported exercise , anxiety , and pain . There were significant immediate gains on physical measures of fitness and in observed body mechanics ; patients also reported significant gains in physical capabilities at home and in leisure activities . Self-care knowledge also improved . When assessed one year later , original gains in physical strength and mobility were being maintained , and self-reported physical capabilities also remained high . Although demonstrated knowledge of correct body mechanics declined over this period , it was still significantly greater than before the program . In light of these results , we believe that outpatient programs like the one reported here merit careful consideration in an era of concern about rising costs for primary health care",
"Study Design . Prospect i ve , r and omized trial . Objectives . To compare the McKenzie method of treatment of acute low back pain with patient education in “ mini back school ” after 5 years ; the 1-year results have already been published . Summary of Background Data . The 5-year results after the initial treatment are presented in this study of 89 subjects . Included in the study were 22 women and 67 men with an average age of 39.6 ± 10.5 years ( range 22–66 years ) . Methods . Sixty-two subjects ( 70 % ) were interviewed by telephone , while the remaining 27 subjects ( 30 % ) were examined and interviewed personally . Information of sick leave was obtained from the Swedish National Health Insurance Office . Results . The results showed that subjects who received treatment according to the McKenzie principle 5 years earlier had significantly less recurrences of pain and fewer were on sick leave compared with the subjects who received education in mini back school . The other variables did not show any statistically significant differences . Conclusions . The difference between the two treatments was much less after 5 years compared with the 1-year results",
"BACKGROUND Low back injuries are common and costly , accounting for 15 to 25 percent of injuries covered by workers ' compensation and 30 to 40 percent of the payments made under that program . The high costs of injury , the lack of effective treatment . and the evidence that there are behavioral risk factors have led to widespread use of employee education programs that teach safe lifting and h and ling . The effectiveness of those programs , however , has received little rigorous evaluation . METHODS We evaluated an educational program design ed to prevent low back injury in a r and omized , controlled trial involving about 4000 postal workers . The program , similar to that in wide use in so-called back schools , was taught by experienced physical therapists . Work units of workers and supervisors were trained in a two-session back school ( three hours of training ) , followed by three to four reinforcement sessions over the succeeding few years . Injured subjects ( from both the intervention and the control groups ) were r and omized a second time to receive either training or no training after their return to work . RESULTS Physical therapists trained 2534 postal workers and 134 supervisors . Over 5.5 years of follow-up , 360 workers reported low back injuries , for a rate of 21.2 injuries per 1000 worker-years of risk . The median time off from work per injury was 14 days ( range , 0 to 1717 ) ; the median cost was $ 204 ( range , zero to $ 190,380 ) . After their return to work , 75 workers were injured again . Our comparison of the intervention and control groups found that the education program did not reduce the rate of low back injury , the median cost per injury , the time off from work per injury , the rate of related musculoskeletal injuries , or the rate of repeated injury after return to work ; only the subjects ' knowledge of safe behavior was increased by the training . CONCLUSIONS A large-scale , r and omized , controlled trial of an educational program to prevent work-associated low back injury found no long-term benefits associated with training",
"& NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems",
"A prospect i ve controlled study of the effect of the Swedish Back School in chronic idiopathic Low Back Pain was conducted . Forty-eight patients entered the study . There were no significant pre-treatment differences between the experimental group members who attended the four lessons of the Back School , and the control group who received four detuned shortwave applications to the low back . Forty-three patients ( 21 in the experimental and 22 in the control group ) completed the study . Subjects were repeatedly tested for one year . The following assessment s were made : 1 ) subjective scores of pain and functional capacity , and 2 ) objective measurements of spinal mobility . After one year , no statistically significant differences between the two groups were observed . Given the proven efficacy of the Back School in (sub)acute Low Back Pain , it should be administered when it is most beneficial , i.e. in the early phase of Low Back Pain",
"Study Design This study involved a post‐test only , control group design . Objectives To analyze the learning effects of back education programs ( video and classroom learning ) . Summary of Background Data Previous research has examined lost work time and workers ' compensation costs but has not addressed the learning effects of back schools . This study used the American Back School as the education intervention . The American Back School teaches students to maintain the lumbar lordosis while lifting . Methods The subjects ( n = 205 ) were assigned to three groups through modified r and omization . Three employees who previously sustained low back injury were placed in the back school group . The back school group , Group I , ( n = 74 ) attended a back school program that included cognitive learning strategies and practice in correct lifting . A video group , Group II , ( n = 64 ) viewed a similar program that consisted of spinal anatomy and biomechanics and instruction in correct lifting technique . A control group , Group III , ( n = 67 ) received no back education . One week after the education intervention , 145 of the subjects from the three groups had the lumbar lordosis measured with a flexible ruler while assuming a lifting position . The ruler was placed over the lumbar spinous processes , and the lordotic angle was calculated . A 12‐item multiple choice test and a 10‐item Likert scale were administered to 199 of the subjects in the three groups to determine the cognitive learning effect and the perceived relevance of the program , respectively . Results Multivariate analysis of variance was used and demonstrated significant differences between the back school group and the control group on the cognitive , psychomotor , and affective measures at the 0.001 level . No significant differences were found between the video and control groups on the measures with additional univariate testing . Conclusions The results indicate that the back school is an effective tool for influencing lifting posture and conveying information regarding spinal mechanics and lifting technique . In addition , the back school videos may not be an effective means of preventing low back injury",
"The use of an education program for patients with chronic low back pain ( Back School ) has been investigated . The effect evaluation is based on a pretest-post-test-control group design , including a follow-up after 8 weeks . The Maastricht Back School is based on the theory that pain is also maintained by emotional , cognitive and environmental factors . Information and training are given on these and physical factors . The purpose of the course is to teach patients to manage their own pain problem . The results suggest that the Back School program for patients with chronic low back pain can have a positive effect"
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41165132-06ff-11f0-808a-c43d1ab1c353
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Background Fibromyalgia ( FM ) is characterized by chronic and generalized musculoskeletal pain . There is currently no cure for FM , but palliative treatments are available . One type of treatment is strength training ( ST ) . However , there is a need for more information on optimal training protocol s , intensity , and volume needed to improve symptoms . The aim of this study was to analyze the effects of ST in the treatment of FM through a systematic review of experimental research . Methods Medical Subject Headings search terms and electronic data bases including Scientific Electronic Library Online , PubMed , Science Direct , Web of Science , and Physiotherapy Evidence Data base were used to identify studies . Results The inclusion criteria were met by 22 eligible studies . Most of the studies were conducted in the United States ( 36 % ) , Finl and ( 23 % ) , Brazil ( 18 % ) , and Sweden ( 18 % ) . The studies showed that ST reduces the number of tender points , fatigue , depression , and anxiety , and improves sleep quality and quality of life in patients with FM . The intervention period ranged from 3 to 21 weeks , with sessions performed 2 times a week in 81.81 % of the studies , at initial intensities of 40 % of 1-repetition maximum . The repetitions ranged from 4 to 20 , with no specific protocol defined for ST in FM . Conclusion The main results included reduction in pain , fatigue , number of tender points , depression , and anxiety , with increased functional capacity and quality of life . Current evidence demonstrates that ST is beneficial and can be used to treat FM.Trial registration CRD42016048480
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"The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia",
"Background Health and physical capacity are commonly associated with disease , age , and socioeconomic factors . The primary objective of this study was to investigate the degree to which physical capacity , defined as muscle strength and walking ability , is decreased in women with fibromyalgia ( FM ) , as compared to healthy women , who are matched for age and level of education . The secondary aim was to investigate whether muscle strength and walking ability are associated with age , symptom duration , activity limitations and , Body Mass Index ( BMI ) in women with FM and control subjects . Methods This controlled , cross-sectional , multi-center study comprised 118 women with FM and 93 age- and education-level-matched healthy women . The outcome measures were isometric knee-extension force , isometric elbow-flexion force , isometric h and -grip force , and walking ability . Differences between the groups were calculated , and for the women with FM analyses of correlations between the measures of physical capacity and variables were performed . Results The women with FM showed 20 % ( p lower isometric knee-extension force , 36 % ( p lower isometric elbow-flexion force , 34 % ( p lower isometric h and -grip force , and 16 % lower walking ability ( p All measures of muscle strength in women with FM showed significant weak to moderate relationship to symptom duration ( rs = − 0.23–0.32 ) and walking ability ( rs = 0.25–0.36 ) . Isometric knee-extension force correlated with activity limitations , as measured using the SF-36 Physical function subscale ( rs=0.23 , p = 0.011 ) . Conclusions Physical capacity was considerably decreased in the women with FM , as compared to the age- and education-level-matched control group . All measures of physical capacity showed a significant association with symptom duration . Knee-extension force and walking ability were significantly associated with activity limitations , age , and BMI . It seems important to address this problem and to target interventions to prevent decline in muscle strength . Assessment s of muscle strength and walking ability are easy to administer and should be routinely carried out in the clinical setting for women with FM.Trial registration Clinical Trials.gov identification number : NCT01226784 , Oct 21 , 2010",
"OBJECTIVE To test the hypothesis that autonomic modulation after resistance exercise ( RE ) would be reduced in women with fibromyalgia ( FM ) compared with controls . DESIGN Before-after trial . SETTING Testing occurred in a university setting . PARTICIPANTS Women with FM ( n=9 ) and healthy controls ( n=9 ) underwent testing before ( pre ) and 20 minutes after ( post ) RE . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Normalized low-frequency ( LFnu ) and normalized high-frequency ( HFnu ) oscillations and the LFnu/HFnu ratio were indicative of sympathetic modulation , parasympathetic modulation , and sympathovagal balance , respectively . Baroreceptor reflex sensitivity ( BRS ) was also measured . RESULTS Variables were similar in both groups at rest . HFnu decreased in controls ( pre , 55.0+/-4.2 % ; post , 35.0+/-4.7 % ; P women with FM ( pre , 57.0+/-5.7 % ; post , 63.2+/-4.6 % ; P LFnu increased in controls ( pre , 43.3+/-4.4 % ; post , 63.2+/-4.8 % ; P FM ( pre , 41.8+/-5.6 % ; post , 35.6+/-4.7 % ; P LFnu/HFnu ratio increased in controls ( pre , 0.89+/-0.17 ; post , 2.43+/-0.64 ; P FM ( pre , 0.90+/-0.22 ; post , 0.64+/-0.13 ; P=.13 ) . BRS decreased in controls ( pre , 8.78+/-1.42 ms/mmHg ; post , 5.49+/-0.66 ms/mmHg ; P . These postexercise responses may be attributed to the altered autonomic responsiveness to physiologic stress that characterizes FM",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Background Fibromyalgia ( FM ) affects approximately 1–3 % of the general population . Fatigue limits the work ability and social life of patients with FM . A few studies of physical exercise have included measures of fatigue in FM , indicating that exercise can decrease fatigue levels . There is limited knowledge about the effects of resistance exercise on multiple dimensions of fatigue in FM . The present study is a sub- study of a multicenter r and omized controlled trial in women with FM . The purpose of the present sub- study was to examine the effects of a person-centered progressive resistance exercise program on multiple dimensions of fatigue in women with FM , and to investigate predictors of the potential change in fatigue . Methods A total of 130 women with FM ( age 22–64 years ) were included in this assessor-blinded r and omized controlled multicenter trial examining the effects of person-centered progressive resistance exercise compared with an active control group . The intervention was performed twice a week for 15 weeks . Outcomes were five dimensions of fatigue measured with the Multidimensional Fatigue Inventory ( MFI-20 ) . Information about background was collected and the women also completed several health-related question naires . Multiple linear stepwise regression was used to analyze predictors of change in fatigue in the total population . Results A higher improvement was found at the post-treatment examination for change in the resistance exercise group , as compared to change in the active control group in the MFI-20 subscale of physical fatigue ( resistance group Δ –1.7 , SD 4.3 , controls Δ 0.0 , SD 2.7 , p = 0.013 ) , with an effect size of 0.33 . Sleep efficiency was the strongest predictor of change in the MFI-20 subscale general fatigue ( beta = −0.54 , p = 0.031 , R2 = 0.05 ) . Participating in resistance exercise ( beta = 1.90 , p = 0.010 ) and working fewer hours per week ( beta = 0.84 , p = 0.005 ) were independent significant predictors of change in physical fatigue ( R2 = 0.14 ) . Conclusions Person-centered progressive resistance exercise improved physical fatigue in women with FM when compared to an active control group . Trial registration Clinical Trials.gov NCT01226784 . Registered 21 October 2010",
"Introduction Fibromyalgia ( FM ) is characterized by persistent widespread pain , increased pain sensitivity and tenderness . Muscle strength in women with FM is reduced compared to healthy women . The aim of this study was to examine the effects of a progressive resistance exercise program on muscle strength , health status , and current pain intensity in women with FM . Methods A total of 130 women with FM ( age 22–64 years , symptom duration 0–35 years ) were included in this assessor-blinded r and omized controlled multi-center trial examining the effects of progressive resistance group exercise compared with an active control group . A person-centred model of exercise was used to support the participants ’ self-confidence for management of exercise because of known risks of activity-induced pain in FM . The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists . Primary outcome measure was isometric knee-extension force ( Steve Strong ® ) , secondary outcome measures were health status ( FIQ total score ) , current pain intensity ( VAS ) , 6MWT , isometric elbow-flexion force , h and -grip force , health related quality of life , pain disability , pain acceptance , fear avoidance beliefs , and patient global impression of change ( PGIC ) . Outcomes were assessed at baseline and immediately after the intervention . Long-term follow up comprised the self-reported question naires only and was conducted after 13–18 months . Between-group and within-group differences were calculated using non-parametric statistics . Results Significant improvements were found for isometric knee-extension force ( p = 0.010 ) , health status ( p = 0.038 ) , current pain intensity ( p = 0.033 ) , 6MWT ( p = 0.003 ) , isometric elbow flexion force ( p = 0.02 ) , pain disability ( p = 0.005 ) , and pain acceptance ( p = 0.043 ) in the resistance exercise group ( n = 56 ) when compared to the control group ( n = 49 ) . PGIC differed significantly ( p = 0.001 ) in favor of the resistance exercise group at post-treatment examinations . No significant differences between the resistance exercise group and the active control group were found regarding change in self-reported question naires from baseline to 13–18 months . Conclusions Person-centered progressive resistance exercise was found to be a feasible mode of exercise for women with FM , improving muscle strength , health status , and current pain intensity when assessed immediately after the intervention . Trial registration Clinical Trials.gov identification number : NCT01226784 , Oct 21 , 2010",
"Objective Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia ( FM ) . Exercise is an effective treatment , with benefits potentially mediated through changes in autonomic modulation . Strengthening is one of the less studied exercises in FM , and the acute and chronic effects of strengthening on the autonomic system remain unknown . The objective of this study was to assess the chronic effects of strengthening exercises ( STRE ) on autonomic modulation , pain perception and the quality of life ( QOL ) of FM patients . Methods Eighty sedentary women with FM ( ACR 1990 ) were r and omly selected to participate in STRE or flexibility ( FLEX ) exercises in a blinded controlled trial . The intensity of STRE was set at 45 % of the estimated load of 1 Repetition Maximum ( RM ) in 12 different exercises . Outcomes were Visual Analog Scale ( VAS ) for pain , Heart Rate Variability ( HRV ) analysis , treadmill test , the sit and reach test ( Wells and Dillon ’s Bench ) , maximal repetitions test and h and grip dynamometry ; and quality of life by the Fibromyalgia Impact Question naire ( FIQ ) , the Beck and I date Trait-State Inventory ( I DATE ) , a short-form health survey ( SF-36 ) . Results The STRE group was more effective to strength gain for all muscles and pain control after 4 and 16 weeks ( p anxiety ( p QOL , and there was no significant difference observed between the groups . There was no change in the HRV of the STRE and FLEX groups . Conclusions Strengthening exercises show greater and more rapid improvements in pain and strength than flexibility exercises . Despite the benefits in fitness , pain , depression , anxiety and quality of life , no effect was observed on the autonomic modulation in both groups . This observation suggests that changes in autonomic modulation are not a target tobe clinical ly achieved in fibromyalgia . Trial Registration Clinical Trials.gov",
"Background Fibromyalgia ( FM ) is characterized by persistent widespread pain , increased pain sensitivity and tenderness . Women with FM also report disability , in terms of negative consequences on activities of daily living . Our recent r and omized controlled trial ( RCT ) is the first study of resistance exercise to show positive effects on pain disability . The resistance exercise program of our RCT emphasized active involvement of participants in planning and progression of the exercise , using the principles of person-centeredness , to support each participant ’s ability to manage the exercise and the progress of it . The aim of this sub- study was to investigate explanatory factors for reduced pain disability in women with FM participating in a 15-week person-centered progressive resistance exercise program . Methods A total of 67 women with FM were included in this sub- study of an RCT examining the effects of person-centered progressive resistance exercise performed twice a week for 15 weeks . Tests of physical capacity and health-related question naires were assessed at baseline and after the intervention period . Multivariable stepwise regression was used to analyze explanatory factors for improvements in pain disability . Results Reduced pain disability was explained by higher pain disability at baseline together with decreased fear avoidance beliefs about physical activity ( R2 = 28 , p = 0.005 ) . The improvements in the disability domains of recreation and social activity were explained by decreased fear avoidance beliefs about physical activity together with higher baseline values of each disability domain respectively ( R2 = 32 , p = 0.025 and R2 = 30 , p = 0.017 ) . The improvement in occupational disability was explained by higher baseline values of occupational disability ( R2 = 19 , p = 0.001 ) . Conclusion The person-centered resistance exercise intervention , based on principles of self-efficacy , had a positive effect on recreational , social and occupational disability . The reduced pain disability seemed to be mediated by decreased fear avoidance beliefs . Age , symptom duration , pain intensity , and muscle strength at baseline had no explanatory value for reduced pain disability , indicating that the person-centered resistance exercise program has the potential to work for anyone with FM who has interest in physical exercise . The trial was registered on October 21 , 2010 with Clinical Trials.gov identification number : NCT01226784",
"OBJECTIVE To determine the effectiveness of a muscle strengthening program compared to a stretching program in women with fibromyalgia ( FM ) . METHODS Sixty-eight women with FM were r and omly assigned to a 12 week , twice weekly exercise program consisting of either muscle strengthening or stretching . Outcome measures included muscle strength ( main outcome variable ) , flexibility , weight , body fat , tender point count , and disease and symptom severity scales . RESULTS No statistically significant differences between groups were found on independent t tests . Paired t tests revealed twice the number of significant improvements in the strengthening group compared to the stretching group . Effect size scores indicated that the magnitude of change was generally greater in the strengthening group than the stretching group . CONCLUSION Patients with FM can engage in a specially tailored muscle strengthening program and experience an improvement in overall disease activity , without a significant exercise induced flare in pain . Flexibility training alone also results in overall improvements , albeit of a lesser degree",
"BACKGROUND Self-management has increasingly been recommended as part of st and ard care for fibromyalgia , a common , poorly understood condition with limited treatment options . Data that assess popular self-management recommendations are scarce . We evaluated and compared the effectiveness of 4 common self-management treatments on function , symptoms , and self-efficacy in women with fibromyalgia . METHODS A total of 207 women with confirmed fibromyalgia were recruited from September 16 , 2002 , through November 30 , 2004 , and r and omly assigned to 16 weeks of ( 1 ) aerobic and flexibility exercise ( AE ) ; ( 2 ) strength training , aerobic , and flexibility exercise ( ST ) ; ( 3 ) the Fibromyalgia Self-Help Course ( FSHC ) ; or ( 4 ) a combination of ST and FSHC ( ST-FSHC ) . The primary outcome was change in physical function from baseline to completion of the intervention . Secondary outcomes included social and emotional function , symptoms , and self-efficacy . RESULTS Improvements in the mean Fibromyalgia Impact Question naire score in the 4 groups were -12.7 for the ST-FSHC group , -8.2 for the AE group , -6.6 for the ST group , and -0.3 for the FSHC group . The ST-FSHC group demonstrated greater improvement than the FSHC group ( mean difference , -12.4 ; 95 % confidence interval [ CI ] , -23.1 to -1.7 ) . The ST-FSHC ( mean difference , 13.6 ; 95 % CI , 2.3 to 24.9 ) and AE ( mean difference , 13.1 ; 95 % CI , 1.6 to 25.6 ) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey . Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC ( 14.8 ) , AE ( 13.2 ) , and ST ( 5.7 ) groups . Social function , mental health , fatigue , depression , and self-efficacy also improved . The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months . CONCLUSIONS Progressive walking , simple strength training movements , and stretching activities improve functional status , key symptoms , and self-efficacy in women with fibromyalgia actively being treated with medication . The benefits of exercise are enhanced when combined with targeted self-management education . Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia",
"OBJECTIVE The objective of this study was to evaluate resistance training ( RES ) and RES combined with chiropractic treatment ( RES-C ) on fibromyalgia ( FM ) impact and functionality in women with FM . DESIGN The design of the study was a r and omized control trial . SETTING Testing and training were completed at the university and chiropractic treatment was completed at chiropractic clinics . PARTICIPANTS Participants ( 48 + /- 9 years ; mean + /- st and ard deviation ) were r and omly assigned to RES ( n = 10 ) or RES-C ( n = 11 ) . INTERVENTION Both groups completed 16 weeks of RES consisting of 10 exercises performed two times per week . RES-C received RES plus chiropractic treatment two times per week . OUTCOME MEASURES Strength was assessed using one repetition maximum for the chest press and leg extension . FM impact was measured using the FM impact question naire , myalgic score , and the number of active tender points . Functionality was assessed using the 10-item Continuous Scale Physical Functional Performance test . Analyses of variance with repeated measures compared groups before and after the intervention . RESULTS Six ( 6 ) participants discontinued the study : 5 from RES and 1 from RES-C. Adherence to training was significantly higher in RES-C ( 92.0 + /- 7.5 % ) than in RES ( 82.8 + /- 7.5 % ) . Both groups increased ( p upper and lower body strength . There were similar improvements in FM impact in both groups . There were no group interactions for the functionality measures . Both groups improved in the strength domains ; however , only RES-C significantly improved in the pre- to postfunctional domains of flexibility , balance and coordination , and endurance . CONCLUSIONS In women with FM , resistance training improves strength , FM impact , and strength domains of functionality . The addition of chiropractic treatment improved adherence and dropout rates to the resistance training and facilitated greater improvements in the domains of functionality",
"Objective : To examine the effects of strength training on maximal force , cross‐sectional area ( CSA ) , and electromyographic ( EMG ) activity of muscles and serum hormone concentrations in elderly females with fibromyalgia ( FM ) . Methods : Twenty‐six patients with FM were r and omly assigned to a training ( FMT ; n = 13 ; mean age 60 years ) or a control ( FMC ; n = 13 ; 59 years ) group . FMT performed progressive strength training twice a week for 21 weeks . The measurements included maximal isometric and concentric leg extension forces , EMG activity of the vastus lateralis and medialis , CSA of the quadriceps femoris , and serum concentrations of testosterone ( T ) , free testosterone ( FT ) , growth hormone ( GH ) , insulin‐like growth factor‐1 ( IGF‐1 ) , dehydroepi and rosterone sulfate ( DHEAS ) , and cortisol . Subjectively perceived symptoms of FM were also assessed . Results : All patients were able to complete the training . In FMT strength training led to increases of 36 % ( p in maximal isometric and concentric forces , respectively . The CSA increased by 5 % ( p and the EMG activity in isometric action by 47 % ( p ) . Basal serum hormone concentrations remained unaltered during strength training . The subjective perceived symptoms showed a minor decreasing tendency ( ns ) . No statistically significant changes occurred in any of these parameters in FMC . Conclusion : Progressive strength training increases strength , CSA , and voluntary activation of the trained muscles in elderly women with FM , while the measured basal serum hormone concentrations remain unaltered . Strength training benefits the overall physical fitness of the patients without adverse effects or any exacerbation of symptoms and should be included in the rehabilitation programmes of elderly patients with FM",
"OBJECTIVE To determine whether women with fibromyalgia benefit from strength training . DESIGN R and omized controlled trial . SETTING Testing was completed at the university and training was completed at a local community wellness facility . PARTICIPANTS Twenty-nine women ( age range , 18 - 54 y ) with fibromyalgia participated . Subjects were r and omly assigned to a control ( n=14 ; wait-listed for exercise ) or strength ( n=15 ) group . After the first 4 weeks , 7 ( 47 % ) women dropped from the strength group . INTERVENTION Subjects underwent 12 weeks of training on 11 exercises , 2 times a week , performing 1 set of 8 to 12 repetitions at 40 % to 60 % of their maximal lifts and were progressed to 60 % to 80 % . MAIN OUTCOME MEASURES Subjects were measured for strength , functionality , tender point sensitivity , and fibromyalgia impact . RESULTS The strength group significantly ( P upper- ( strength , 39+/-11 to 42+/-12 kg ; control , 38+/-13 to 38+/-12 kg ) and lower- ( strength , 68+/-28 to 82+/-25 kg ; control , 61+/-25 to 61+/-26 kg ) body strength . Upper-body functionality measured by the Continuous-Scale Physical Functional Performance test improved significantly ( strength , 44+/-11 to 50+/-16U ; control , 51+/-11 to 49+/-13U ) after training . Tender point sensitivity and fibromyalgia impact did not change . CONCLUSIONS Strength training improved strength and some functionality in women with fibromyalgia . Interventions with resistance have important implication s on independence and quality of life issues for women with fibromyalgia ",
"Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions",
"OBJECTIVE To investigate the effects of 21 weeks ' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia ( FM ) . METHODS Twenty one women with FM were r and omly assigned to experimental ( FMT ) or control ( FMC ) groups . Twelve healthy women served as training controls ( HT ) . The FMT and HT groups carried out progressive strength training twice a week for 21 weeks . The major outcome measures were muscle strength and electromyographic ( EMG ) recordings . Secondary outcome measures were pain , sleep , fatigue , physical function capacity ( Stanford Health Assessment Question naire ) , and mood ( short version of Beck 's depression index ) . RESULTS Female FMT subjects increased their maximal and explosive strength and EMG activity to the same extent as the HT group . Moreover , the progressive strength training showed immediate benefits on subjectively perceived fatigue , depression , and neck pain of training patients with FM . CONCLUSIONS The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women . Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system , perceived symptoms , and functional capacity . These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis",
"OBJECTIVE To examine the effects of strength training on basal concentrations and acute responses of serum hormones , and their possible interrelationships with training induced muscle hypertrophy and strength gains of the knee extensor muscles in women with fibromyalgia ( FM ) and healthy controls . METHODS Twenty-one premenopausal women with FM were r and omized to 21 week strength training ( FMT ; n = 11 ) or control ( FMC ; n = 10 ) groups . Twelve premenopausal sedentary healthy women served as controls ( HC ) . Surface electromyographic ( EMG ) activity , maximal unilateral isometric force of the right knee extensors , and muscle cross-sectional area ( CSA ) of the quadriceps femoris throughout the lengths of 3/12 to 12/15 of the femur ( Lf ) were measured . Serum concentrations of total and free testosterone and growth hormone ( GH ) were analyzed at rest and in pre- and post-exercise conditions , while levels of insulin-like growth factor and dehydroepi and rosterone sulfate were measured at rest only . RESULTS Mean ( SD ) maximal force increased by 18 % ( 10 % ) ( p Maximum integrated EMG of the agonists ( VL + VM/2 ) increased in HC by 22 % ( p CSA of the QF were observed at 5 to 12/15 Lf in FMT ( p serum hormones examined . A significant acute increase took place in the mean concentration of GH at pre-training in HC ( p women with FM were completely comparable to those taking place in healthy women . Basal levels of the anabolic hormones seem to be similar in women with FM compared to age matched healthy women . Observations recorded during the acute loading conditions might be considered an indication of the training induced adaptation of the endocrine system , showing that the acute GH response may become systematic after strength training in both women with FM and controls ",
"The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises ( MS ) and a walking program ( WA ) in reducing pain in patients with fibromyalgia . Ninety women , 30–55 years of age , diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria , were r and omized into 3 groups : WA Group , MS Group , and control group . Pain ( visual analog scale ) was evaluated as the primary outcome . Physical functioning ( Fibromyalgia Impact Question naire , FIQ ) , health-related quality of life ( Short-Form 36 Health Survey , SF-36 ) , and use of medication were evaluated as secondary outcomes . Assessment s were performed at baseline , 8 , 16 , and 28 weeks . Intention-to-treat and efficacy analyses were conducted . Sixty-eight patients completed the treatment protocol . All 3 groups showed improvement after the 16-week treatment compared to baseline . At the 28-week follow-up , pain reduction was similar for the WA and MS groups ( P = 0.39 ) , but different from the control group ( P = 0.01 ) . At the end of the treatment , 80 % of subjects in the control group took pain medication , but only 46.7 % in the WA and 41.4 % in the MS groups . Mean FIQ total scores were lower for the WA and MS groups ( P = 0.96 ) compared with the control group ( P the WA and MS groups reported higher scores ( better health status ) than controls in almost all SF-36 subscales . MS was as effective as WA in reducing pain regarding all study variables ; however , symptoms management during the follow-up period was more efficient in the WA group",
"OBJECTIVE To determine the safety , feasibility and consequences of a program of progressive strength training and cardiovascular exercise in women with fibromyalgia syndrome ( FMS ) . METHODS Fifteen women with confirmed FMS were monitored for injury and exercise compliance , and assessed for muscle strength ( 1-repetition maximum technique ) , cardiovascular endurance ( 6-minute walk test ) , and functional status ( Fibromyalgia Impact Question naire [ FIQ ] ) before and after a 20-week exercise intervention . RESULTS Zero injuries and an 81 % compliance rate occurred during training . Improvement was seen in muscle strength of the lower ( 191 + /- 75 to 265 + /- 67 pounds ; P body , 6-minute walk distance ( 530 + /- 80 to 629 + /- 74 meters ; P FIQ score ( 44 + /- 9 to 32 + /- 14 ; P program of progressive strength training and cardiovascular exercise can be safe , well tolerated , and effective at improving muscle strength , cardiovascular endurance and functional status in women with FMS without exacerbating symptoms . This program may also contribute to a reduction in the severity of several symptoms",
"Summary Strengthening and aerobic exercise had equivalent effects on reducing pain severity in patients with fibromyalgia . Abstract Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia . However , the equivalence of strengthening and aerobic exercise has not been reported . The primary aim of this r and omized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening ( n = 36 ) and aerobic ( n = 36 ) exercise have equivalent effects ( 95 % confidence interval within an equivalence margin ±8 ) on pain , as measured by the pain severity subscale of the Multidimensional Pain Inventory . Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo2 uptake , leg strength , and pressure pain thresholds . In an intent‐to‐treat analysis , the mean ( ± st and ard deviation ) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9 , respectively . The group difference was −3.2 ( 95 % confidence interval , −8.7 to 2.3 ) , which was within the equivalence margin of Δ8 . Significant improvements in pain severity ( P ( P that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia",
"Fibromyalgia ( FM ) is characterized by generalized muscle pain , low muscle strength and autonomic dysfunction . Heart rate ( HR ) variability ( HRV ) is reduced in individuals with FM increasing their risk for cardiovascular morbidity and mortality . We tested the hypothesis that resistance exercise training ( RET ) improves HRV , baroreflex sensitivity ( BRS ) and muscle strength in women with FM . Women with FM ( n = 10 ) and healthy controls ( n = 9 ) , aged 27–60 years , were compared at baseline . Only women with FM underwent supervised RET 2 days per week for 16 weeks . Baseline and post‐training measurements included HRV and spontaneous baroreflex sensitivity ( BRS , alpha index ) from continuous electrocardiogram and blood pressure ( BP ) recorded with finger plethysmography during 5 min in the supine position . RR interval , total power , log transformed ( Ln ) squared root of the st and ard deviation of RR interval ( RMSSD ) , low‐frequency power and BRS were lower ( P and HR and pulse pressure were higher ( P , mean ( SEM ) total power increased ( 387 ± 170 ms2 , P ) , RMSSD increased ( 0·18 ± 0·08 Ln ms , P of high‐frequency power increased ( 0·54 ± 0·27 Ln ms2 , P = 0·08 ) in women with FM . Upper and lower body muscle strength increased by 63 % and 49 % ( P perception decreased by 39 % in women with FM . There were no changes in BRS , HR and BP after RET . Our study demonstrates that RET improves total power , cardiac parasympathetic tone , pain perception and muscle strength in women with FM who had autonomic dysfunction before the exercise programme",
"BACKGROUND Exercise therapy is an effective component of fibromyalgia ( FM ) treatment . However , it is important to know the effects and specificities of the different types of exercise : muscle stretching and resistance training . AIM To verify and compare the effectiveness of muscle stretching exercise and resistance training for symptoms and quality of life in FM patients . DESIGN R and omized controlled trial . SETTING Physical therapy service , FM outpatient clinic . POPULATION Forty-four women with FM ( 79 screened ) . METHODS Patients were r and omly allocated into a stretching group ( N.=14 ) , resistance group ( N.=16 ) , and control group ( N.=14 ) . Pain was assessed using the visual analog scale , pain threshold using a Fischer dolorimeter , FM symptoms using the Fibromyalgia Impact Question naire ( FIQ ) , and quality of life using the Medical Outcomes Study 36-item Short-Form Health Survey ( SF-36 ) . The three intervention groups continued with usual medical treatment . In addition , the stretching and resistance groups performed two different exercise programs twice a week for 12 weeks . RESULTS After treatment , the stretching group showed the highest SF-36 physical functioning score ( P=0.01 ) and the lowest bodily pain score ( P=0.01 ) . The resistance group had the lowest FIQ depression score ( P=0.02 ) . The control group had the highest score for FIQ morning tiredness and stiffness , and the lowest score for SF-36 vitality . In clinical analyses , the stretching group had significant improvement in quality of life for all SF-36 domains , and the resistance group had significant improvement in FM symptoms and in quality of life for SF-36 domains of physical functioning , vitality , social function , emotional role , and mental health . CONCLUSIONS Muscle stretching exercise was the most effective modality in improving quality of life , especially with regard to physical functioning and pain , and resistance training was the most effective modality in reducing depression . CLINICAL REHABILITATION IMPACT The trial included a control group and two intervention groups , both of which received exercise programs created specifically for patients with FM . In clinical practice , we suggest including both modalities in an exercise therapy program for FM"
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BACKGROUND Older adults with multiple chronic diseases commonly require complex medication regimes . When combined with frailty , cognitive impairment , and changing pharmacological prescriptions , older adults ' polymedication regimes increase the risk of medication-related problems ( MRPs ) and hospitalization . Effective , well-organized medication management could avoid MRPs and their clinical outcomes . OBJECTIVE Identify medication management models and analyze their impact on managing and preventing MRPs for polymedicated , home-dwelling older adults . METHODS We will conduct a systematic review of published articles in relevant professional scientific journals from inception until March 31 , 2019 , in the following electronic data bases , : Embase ; Medline OvidSP ; PubMed ( NOT Medline [ sb ] ) ; Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) EBSCO ; PsycINFO OvidSP ; Cochrane Library , Wiley ; and Web of Science . We will also h and search the bibliographies of all the relevant articles found and search for unpublished studies . We will consider publications in English , French , German , Spanish , Italian , and Portuguese . Retrieved articles will be screened for eligibility . Statistical analyses will be conducted following the recommendations of the Cochrane H and book for Systematic Review s of Interventions , the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) , and Meta- analysis Of Observational Studies in Epidemiology ( MOOSE ) statements . Data will be analyzed using SPSS Statistics for Windows , version 25.0 ( IBM Corp ) , and Review Manager , version 5.5 ( The Nordic Cochrane Centre , The Cochrane Collaboration ) . RESULTS A preliminary search in Embase delivered 3272 references . This preliminary search allows us to complete our research strategy with equation development and to search the other data bases . Relevant articles identified will allow for search ing the reference lists for unpublished studies . The inclusion and exclusion criteria will be rigorously respected in the study selection . The entire study is expected to be completed by January 2020 . CONCLUSIONS This review will provide an exhaustive view of medication management models that could be effective for polymedicated , home-dwelling older adults and will allow us to analyze their impact on managing and preventing MRPs . TRIAL REGISTRATION PROSPERO CRD42018117287 ; https://www.crd.york.ac.uk/ prospero /display_record.php?RecordID=117287 ( Archived by WebCite at http://www.webcitation.org/77fCfbCjT ) . INTERNATIONAL REGISTERED REPORT IDENTIFIER ( IRRID ) DERR1 - 10.2196/13582
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"Background Since drug-related emergency department ( ED ) visits are common among older adults , the objectives of our study were to identify the frequency of drug-related problems ( DRPs ) among patients presenting to the ED with non-specific complaints ( NSC ) , such as generalized weakness and to evaluate responsible drug classes . Methods Delayed type cross-sectional diagnostic study with a prospect i ve 30 day follow-up in the ED of the University Hospital Basel , Switzerl and . From May 2007 until April 2009 , all non-trauma patients presenting to the ED with an Emergency Severity Index ( ESI ) of 2 or 3 were screened and included , if they presented with non-specific complaints . After having obtained complete 30-day follow-up , two outcome assessors review ed all available information , judged whether the initial presentation was a DRP and compared their judgment with the initial ED diagnosis . Acute morbidity ( “ serious condition ” ) was allocated to individual cases according to predefined criteria . Results The study population consisted of 633 patients with NSC . Median age was 81 years ( IQR 72/87 ) , and the mean Charlson comorbidity index was 2.5 ( IQR 1/4 ) . DRPs were identified in 77 of the 633 cases ( 12.2 % ) . At the initial assessment , only 40 % of the DRPs were correctly identified . 64 of the 77 identified DRPs ( 83 % ) fulfilled the criteria “ serious condition ” . Polypharmacy and certain drug classes ( thiazides , antidepressants , benzodiazepines , anticonvulsants ) were associated with DRPs . Conclusion Elderly patients with non-specific complaints need to be screened systematic ally for drug-related problems . Trial Registration Clinical Trials.gov :",
"Trialists and epidemiologists often employ different terminology to refer to biases in r and omized trials and observational studies , even though many biases have a similar structure in both types of study . We use causal diagrams to represent the structure of biases , as described by Cochrane for r and omized trials , and provide a translation to the usual epidemiologic terms of confounding , selection bias , and measurement bias . This structural approach clarifies that an explicit description of the inferential goal -the intention-to-treat effect or the per- protocol effect-is necessary to assess risk of bias in the estimates . Being aware of each other 's terminologies will enhance communication between trialists and epidemiologists when considering key concepts and methods for causal inference",
"Background Team based care has been used internationally to improve the delivery of best practice primary health care . The WentWest General Practice Pharmacist Project , involving the integration of pharmacists within general practice teams , was commissioned to improve medication management of general practice patients . A particular focus of the project was the performance of medication review to allow the detection and resolution of drug related problems ( DRPs ) . Objective The objectives of this 6-month study ( October 2016–March 2017 ) were to : ( 1 ) identify and classify the DRPs detected as a result of pharmacist activities within a general practice primary care setting . ( 2 ) compare the number of pharmacist recommendations and GP acceptance rates as a result of pharmacist patient consultations across multiple general practice sites . Setting 15 general practice primary care sites in Western Sydney NSW Australia . A multi-centre prospect i ve observational study conducted over a 6-month period from October 2016 to March 2017 . Main outcome measure Drug-related problems ( DRPs ) . Results Six pharmacists recorded the results from 493 patient consultations . The pharmacists identified 1124 DRPs and made 984 recommendations , of which 685 ( 70 % ) were recorded as accepted by the GP . Conclusion Pharmacists have a valuable role to play in the detection and resolution of DRP as part of the general practice team",
"Background The magnitude of safety risks related to medications of the older adults has been evidence d by numerous studies , but less is known of how to manage and prevent these risks in different health care setting s. The aim of this study was to coordinate re sources for prospect i ve medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure . Methods Health care units involved in the study are from primary care in Lohja , Southern Finl and : home care ( 191 consented clients ) , the public healthcare center , and a private community pharmacy . System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession ’s existing re sources in medication risk management of older home care clients . An inventory of clinical measures in usual clinical practice and systematic review of rigorous study design s was utilized in effectiveness study design . Discussion The new coordinated medication management model ( CoMM ) has the following 5 stages : 1 ) practical nurses are trained to identify clinical ly significant drug-related problems ( DRPs ) during home visits and report those to the clinical pharmacist . Clinical pharmacist prepares the cases for 2 ) an interprofessional triage meeting ( 50–70 cases/meeting of 2 h ) where decisions are made on further action , e.g. , more detailed medication review s , 3 ) community pharmacists conduct necessary medication review s and each patients ’ physician makes final decisions on medication changes needed . The final stages concern 4 ) implementation and 5 ) follow-up of medication changes . R and omized controlled trial ( RCT ) was developed to demonstrate the effectiveness of the procedure . The developed procedure is feasible for screening and review ing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care re sources .Trial registration The study is registered in the Clinical Trials.gov ( NCT02545257 ) . Registration date September 9 2015",
"Abstract Background : Increased life expectancy is associated with an increased prevalence of chronic diseases and drug consumption . Changes often occur in the medication regimen after hospitalization . The extent and nature of these changes and the adherence of elderly patients have not yet been fully investigated . Objective : To investigate the extent and reasons for modifications to the medication regimens of elderly patients and their adherence to treatment during the first month following hospital discharge . Methods : This was a prospect i ve cohort study of 198 patients aged ≥65 years in the Acute Geriatric Ward , Beilinson Hospital , Rabin Medical Center , Israel . Clinical , demographic and medication regimen data were recorded for all patients at an interview conducted prior to discharge . After 1 month , the patient , caregiver or general practitioner ( GP ) were interviewed regarding the extent and reasons for modifications to the medication regimen and adherence to treatment . Results : At 1-month post-discharge , on average , 36.7 % of patient medications had been modified compared with the discharge prescription . No modification was found in 16 % of patients . During the observation month , 62 % of prescribed long-term medications were taken without modification as recommended at discharge and during follow-up , 50 % of all changes were characterized by the addition of a drug or an increase in dosage , and 26 % , 16 % and 8 % consisted of cancelling , omission or switching within the same medication type , respectively . Seventy percent of medication regimen changes were based on specialists ’ recommendations or secondary to a change in the patients ’ medical state , and 13 % , 8 % , 3 % and 6 % were as a result of poor adherence , adverse effects , administrative restrictions and other reasons , respectively . There was no correlation between medication regimen change and age , gender , physical function , cognitive function and length of hospital stay . Patients discharged home experienced less regimen modification than those discharged elsewhere ( p = 0.02 ) . Patients who visited their GP only once experienced less regimen modification ( p = 0.03 ) . Regression analysis showed that the only factors affecting medication regimen changes were GP visits and chronic diseases ( p The overall mean adherence among 145 home-dwelling patients was 96.7 % . Twenty-seven percent and 6 % were under- and over-adherent , respectively , to at least one drug ; under-adherence was more widespread than over-adherence . No correlation was found between the overall mean adherence and other clinical parameters or regimen change . However , non-adherence to at least one drug was associated with more medication regimen changes ( p = 0.001 ) , was more common in patients discharged with prescriptions for seven or more drug types per day ( p = 0.01 ) and was associated with failing to visit the patient ’s GP 1 month after discharge ( p = 0.02 ) . Conclusion : The majority of elderly patients experienced modifications in their medication regimen during the first month following hospital discharge . Thirty percent of patients were non-adherent to at least one drug . To improve adherence to a hospital medication regimen , patients should be encouraged to visit their GP and the number of long-term drugs should be reduced",
"OBJECTIVE To examine the reliability and validity of the Medication Adherence Individual Review -Screening Tool ( MedAdhIR-ST ) for assessing medication adherence in a community-dwelling elderly population . DESIGN A prospect i ve , observational pilot study comparing the reliability and validity of the MedAdhIR-ST and the Medication Adherence Question naire ( MAQ ) . SETTING Independent senior-housing apartments and senior centers in Wake County , North Carolina . PARTICIPANTS Eligible subjects included individuals 60 years of age or older who were living in the community and managing their own medication regimens . INTERVENTIONS Each subject was asked to participate in two assessment visits , two weeks ( + /- 3 days ) apart , in which the questions of the MedAdhIR-ST and MAQ were administered . MAIN OUTCOME MEASURE Medication adherence . RESULTS Both tools showed moderate-to-high test/retest reliability in the study population ( correlation coefficient of 0.632 for MAQ , and 0.699 for MedAdhIR-ST ) , and moderate internal consistency ( Cronbach 's a of 0.551 and 0.584 , respectively ) . Moderate concordance in the ability to assess adherence was observed between MedAdhIR-ST and MAQ ( positive correlation coefficient of 0.450 ) . When compared with refill records , MedAdhIR-ST was slightly more sensitive ( 67 % vs. 43 % ) and specific ( 60 % vs. 50 % ) for detecting adherence and nonadherence , respectively , compared with MAQ . Exploratory factor analysis indicated that MedAdhIR-ST is multidimensional . CONCLUSION MedAdhIR-ST appears to be a reliable and valid tool for screening nonadherence in a community-dwelling elderly population",
"Objectives The aim of this study was to demonstrate the existence of systematic associations in drug prescription that lead to the establishment of patterns of polypharmacy , and the clinical interpretation of the associations found in each pattern . Methods A cross-sectional study was conducted based on information obtained from electronic medical records and the primary care pharmacy data base in 2008 . An exploratory factor analysis of drug dispensing information regarding 79,089 adult patients was performed to identify the patterns of polypharmacy . The analysis was stratified by age and sex . Results Seven patterns of polypharmacy were identified , which may be classified depending on the type of disease they are intended to treat : cardiovascular , depression-anxiety , acute respiratory infection ( ARI ) , chronic obstructive pulmonary disease ( COPD ) , rhinitis-asthma , pain , and menopause . Some of these patterns revealed a clear clinical consistency and included drugs that are prescribed together for the same clinical indication ( i.e. , ARI and COPD patterns ) . Other patterns were more complex but also clinical ly consistent : in the cardiovascular pattern , drugs for the treatment of known risk factors — such as hypertension or dyslipidemia — were combined with other medications for the treatment of diabetes or established cardiovascular pathology ( e.g. , antiplatelet agents ) . Almost all of the patterns included drugs for preventing or treating potential side effects of other drugs in the same pattern . Conclusions The present study demonstrated the existence of non-r and om associations in drug prescription , result ing in patterns of polypharmacy that are sound from the pharmacological and clinical viewpoints and that exist in a significant proportion of the population . This finding necessitates future longitudinal studies to confirm some of the proposed causal associations . The information discovered would further the development and /or adaptation of clinical patient guidelines to patients with multimorbidity who are taking multiple drugs",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"Background One quality indicator of hospital care , which can be used to judge the process of care , is the prevalence of hospital readmission because it reflects the impact of hospital care on the patient ’s condition after discharge . The purpose s of the study were to measure the prevalence of hospital readmissions , to identify possible factors that influence such readmission and to measure the prevalence of readmissions potentially avoidable in Italy . Methods A sample of 2289 medical records of patients aged 18 and over admitted for medical or surgical illness at one 502-bed community non-teaching hospital were r and omly selected . Results A total of 2252 patients were included in the final analysis , equaling a response rate of 98.4 % . The overall hospital readmission prevalence within 30 days of discharge was 10.2 % . Multivariate logistic regression analysis revealed that the proportion of patients readmitted within 30 days of discharge significantly increased regardless of Charlson et al. comorbidity score , among unemployed or retired patients , and in patients in general surgery . A total of 43.7 % hospital readmissions were judged to be potentially avoidable . Multivariate logistic regression analysis showed that potentially avoidable readmissions were significantly higher in general surgery , in patients referred to hospital by an emergency department physician , and in those with a shortened time between discharge and readmission . Conclusion Additional research on intervention or bundle of interventions applicable to acute inpatient population s that aim to reduce potentially avoidable readmissions is strongly needed , and health care providers are urged to implement evidence -based programs for more cost-effective delivery of health care",
"Introduction Drug-related problems ( DRPs ) are common in the elderly , leading to suboptimal therapy , hospitalisations and increased mortality . The integrated medicines management ( IMM ) model is a multifactorial interdisciplinary methodology aim ing to optimise individual medication therapy throughout the hospital stay . IMM has been shown to reduce readmissions and drug-related hospital readmissions . Using the IMM model as a template , we have design ed an intervention aim ing both to improve medication safety in hospitals , and communication across the secondary and primary care interface . This paper presents the study protocol to explore the effects of the intervention with regard to healthcare use , health-related quality of life ( HRQoL ) and medication appropriateness in elderly patients . Methods and analysis A total of 500 patients aged ≥70 years will be included and r and omised to control ( st and ard care ) or intervention group ( 1:1 ) . The intervention comprises five steps mainly performed by pharmacists : ( 1 ) medication reconciliation at admission , ( 2 ) medication review during hospital stay , ( 3 ) patient counselling about the use of medicines , ( 4 ) a comprehensible and patient-friendly medication list with explanations in discharge summary and ( 5 ) postdischarge phone calls to the primary care level . The primary outcome is the difference between intervention and control patients in the rate of emergency medical visits ( acute readmissions and visits to emergency department ) 12 months after discharge . Secondary outcomes include length of index hospital stay , time to first readmission , mortality , hip fractures , strokes , medication changes , HRQoL and medication appropriateness . Patient inclusion started in September 2016 . Ethics and dissemination The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority . We aim to publish the results in international peer- review ed open access journals , at national and international conferences , and as part of two PhD theses . Trial registration number NCT02816086",
"Background : Hospital discharge poses a significant threat to the continuity of medication therapy and frequently results in drug‐related problems post‐discharge . Therefore , establishing continuity of care by realizing optimal collaboration between hospital and community pharmacists is of utmost importance . Objective : To evaluate the collaboration between hospital and community pharmacists on addressing drug‐related problems after hospital discharge . Methods : A prospect i ve follow‐up study was conducted between November 2013–December 2014 in a general hospital and all affiliated community pharmacies . Adult patients , admitted for ≥48 h to the neurology or pulmonology ward were eligible if they used ≥3 chronic prescription drugs and lived in the community pharmacies ' service area . The HomeCoMe intervention program was comprised of medication verification and counseling at admission , medication screening by the hospital pharmacist during admission , outpatient pharmacy discharge consultation and support , and a community pharmacist home visit within one week post‐discharge . Results : The mean age of the 152 included patients was 67.0 ± 12.6 years and 56.6 % were female . A total of 745 DRPs ( 4.9 ± 2.2 DRPs per patient , range : 0–11 ) were identified with the need for additional “ Education or information ” ( 36.1 % ) and “ Compliance ” ( 16.4 % ) issues as most common DRP‐types . This led to a total of 928 recommendations ( 6.1 ± 3.0 per patient , range : 1–19 ) to solve the DRP . The majority of DRPs were identified ( 83.6 % , n = 623 ) and solved ( 91.6 % , n = 682 ) by the community pharmacist during the home visit . Furthermore , 52.5 % ( n = 64 ) of the DRPs identified during hospitalization were solved during the post‐discharge home visit . Conclusions : Collaboration between hospital and community pharmacists from hospital admission to readmission to primary care is crucial to establish continuity of care . A post‐discharge community pharmacist home visit is a valuable addition to in‐hospital transitional care to identify and solve drug‐related problems",
"BACKGROUND A major issue in any systematic review is deciding which trials or studies to include and which to exclude . The Cochrane Collaboration and similar respected organizations have traditionally viewed the r and omized trial ( RCT ) as the only acceptable evidence on treatment outcome . However , many systematic review s are indeterminate because they include insufficient RCTs whilst they reject large numbers of non-r and omized controlled studies . This is particularly true in forensic mental health , a domain where RCT methodology can be problematic . Systematic review s could become more informative if review ers knew when , and under what circumstances , non-r and omized design s are acceptable for inclusion alongside RCTs . METHOD This pilot study explores whether good- quality , controlled , non-r and omized studies can be reliable surrogates for RCTs . We examined two published review s from the Cochrane Schizophrenia Group . We compared outcomes between ( a ) r and omized trials ( that had been included ) and non-r and omized studies ( that had been excluded ) , and ( b ) between high- and low- quality studies using an established quality checklist . RESULTS In the first review , effect scores were similar for r and omized and non-r and omized studies and relatively insensitive to study quality . In the second review , the treatment effect was considerably lower for the RCT group - here , however , studies of high- quality showed much smaller effect scores than those of low- quality on two separate outcomes . CONCLUSIONS Non-r and omized controlled studies of high quality can produce outcomes that approximate to those found in RCTs . Trial quality may have a greater impact on treatment effect size than r and omization alone , suggesting that r and omization should not be seen as a reliable proxy for overall quality . The problems and issues still to be resolved are discussed with recommendations for future research",
"Research ers investigated whether a low cost public campaign by local health authorities reduced antibiotic prescribing for out patients . A non-r and omised controlled trial study design was used . The intervention was multifaceted and included posters , brochures , and advertisements on local media , plus a newsletter on local antibiotic resistance targeted at doctors and pharmacists . The campaign focused primarily on the prescription of antibiotics for upper respiratory tract infections . The trial was based in Emilia-Romagna in northern Italy . The provinces of Modena and Parma ( about 1 150 000 residents ) were chosen for implementation of the intervention between November 2011 and February 2012 . The provinces where the campaign was not implemented , with no information provided to doctors and pharmacists , formed the control group ( about 3 250 000 residents ) . The primary outcome was the change in prescribing rates of antibiotics for out patients over five months.1 The research ers reported that a low cost community based public campaign targeted at residents , combined with a newsletter on local antibiotic resistance for doctors and pharmacists , was associated with a significantly decreased total rate of antibiotic prescribing . However , the campaign did not affect the participants ’ knowledge and attitudes about antibiotic resistance . Which of the following statements , if any , are true",
"OBJECTIVES ( 1 ) To develop a model for the identification and resolution of problems associated with suboptimal medication use in elderly patients receiving home health care ; ( 2 ) To select the most important identifiable problems and develop structured procedures for their resolution . DESIGN Expert panel review , problem selection , and development of a problem resolution model and guidelines . SETTING Home health care . PARTICIPANTS A panel with expertise in home health nursing , pharmacy , clinical pharmacology , gerontology , pharmacoepidemiology , and health services research . INTERVENTIONS A list of potential problems associated with the most frequently used classes of drugs was compiled for review by the panel . Problems that were controversial or that could not be identified in the home care setting were excluded . Panel members individually ranked the remainder . Detailed procedures for identification and resolution of the 15 top-ranking problems were developed . MAIN OUTCOME MEASURES Not applicable . RESULTS Potential medication problems were defined by both drug use and symptoms or clinical signs associated with specific adverse effects , to ensure that clinical ly relevant problems would be identified . The model developed for problem assessment and resolution was centered on the drug utilization review ( DUR ) coordinator and the attending home health nurse . Following guidelines developed by the panel , the DUR coordinator advises the home health nurse about identified problems and how to resolve them . One of these practitioners , usually the nurse , then contacts the attending physician to explain their concerns , offer potential solutions , and request instructions . CONCLUSION A potentially useful model for the identification and resolution of medication problems in the home health care setting was developed . This model is currently being evaluated in a r and omized controlled trial"
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INTRODUCTION osteoarthritis ( OA ) of knee has been reported as a risk factor for falls and reduced balance in the elderly . This systematic review evaluated the effectiveness of physical therapies in improving balance and reducing falls risk among patients with knee OA . METHODS a computerised search was performed to identify relevant studies up to November 2013 . Two investigators identified eligible studies and extracted data independently . The quality of the included studies was assessed by the PeDro score . RESULTS a total of 15 r and omised controlled trials involving 1482 patients were identified . The mean PeDro score was 7 . The pooled st and ardised mean difference in balance outcome for strength training = 0.3346 ( 95 % CI : 0.3207 - 0.60 , P = 0.01 Tai Chi = 0.7597 ( 95 % CI : 0.5130 - 1.2043 , P and aerobic exercises = 0.6880 ( 95 % CI : 0.5704 - 1.302 , P falls risk outcomes in , strength training , Tai chi and aerobics also showed a significant reduction in reduced risk of falls significantly with pooled result 0.55 ( 95 % CI : 0.41 - 0.68 , P CONCLUSION strength training , Tai Chi and aerobics exercises improved balance and falls risk in older individuals with knee OA , while water-based exercises and light treatment did not significantly improve balance outcomes . Strength training , Tai Chi and aerobics exercises can therefore be recommended as falls prevention strategies for individuals with OA . However , a large r and omised controlled study using actual falls outcomes is recommended to determine the appropriate dosage and to measure the potential benefits in falls reduction
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"The purpose of this study was to determine the efficacy of a home-based kinesthesia , balance and agility ( KBA ) exercise program to improve symptoms among persons age ≥ 50 years with knee osteoarthritis ( OA ) . Forty-four persons were r and omly assigned to 8-weeks , 3 times per week KBA , resistance training ( RT ) , KBA + RT , or Control . KBA utilized walking agility exercises and single-leg static and dynamic balancing . RT used elastic resistance b and s for open chain lower extremity exercises . KBA + RT performed selected exercises from each technique . Control applied inert lotion daily . Outcomes included the OA specific WOMAC Index of Pain , Stiffness , and Physical Function ( PF ) , community activity level , exercise self-efficacy , self-report knee stability , and 15 m get up & go walk ( GUG ) . Thirty-three participants [ 70.7 ( SD 8.5 ) years ] completed the trial . Analysis of variance comparing baseline , mid-point , and follow-up measures revealed significant ( p in WOMAC scores among KBA , RT , KBA + RT , and Control , with no differences between groups . However , Control WOMAC improvements peaked at mid-point , whereas improvement in the exercise conditions continued at 8-weeks . There were no significant changes in community activity level . Only Control improved exercise self-efficacy . Knee stability was improved in RT and Control . GUG improved in RT and KBA+RT . These results indicate that KBA , RT , or a combination of the two administered as home exercise programs are effective in improving symptoms and quality of life among persons with knee OA . Control results indicate a strong placebo effect in the short term . A combination of KBA and RT should be considered as part of the rehabilitation program , but KBA or RT alone may be appropriate for some patients . Studies with more statistical power are needed to confirm or refute these results . Patient presentation , preferences , costs , and convenience should be considered when choosing an exercise rehabilitation approach for persons with knee OA",
"OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme",
"PURPOSE Individuals with osteoarthritis can experience difficulty walking and poor strength , possibly leading to falls and fractures . Exercise has been found to increase strength and bone mineral density . The purpose of this study was to determine the effects of 6 months of t'ai chi on knee muscle strength , bone mineral density , and fear of falling in older women with osteoarthritis . METHODS Eighty-two ( 82 ) women with osteoarthritis , recruited from outpatient clinics and community health centers , were r and omly assigned to either a t'ai chi group and took part in a t'ai chi program , or a control group . Of these , 30 subjects ( mean age = 63 years ) in the t'ai chi group and 35 ( mean age = 61 years ) in the control group completed post-test measures at 6 months . RESULTS After the 6-month study period , subjects in the t'ai chi program had significantly greater knee extensor endurance ( pre- to post-test mean increase = 36.4 W/kg , versus 1.1 W/kg for the controls ) , and significantly greater bone mineral density in the neck of the proximal femur ( mean change = 0.09 , versus -0.10 for the controls ) , Ward 's triangle ( mean change = 0.04 , versus -0.04 for the controls ) , and trochanter ( mean change = 0.07 , versus -0.05 for the controls ) than the controls . However , knee extensor and flexor strength did not differ significantly between the groups . The fear of falling during daily activities reduced significantly more in the t'ai chi group ( mean change = -2.40 , versus 0.66 for the controls ) . CONCLUSIONS T'ai chi increased knee extensor muscle endurance and bone mineral density in older women with osteoarthritis , and decreased their fear of falling during daily activities . Further study with long-term follow-up is needed to substantiate the role of t'ai chi exercise in the prevention of fall and its related fracture",
"The aim of this study was to evaluate effects of electrical stimulation combined with continuous passive motion ( CPM – ES ) versus isometric exercise on symptoms , functional capacity , quality of life , muscle strength , knee and thigh circle measurements , and balance in knee osteoarthritis ( OA ) . This is a r and omized clinical trial . The study was done in Gulhane Military Medical Academy ( GMMA ) Rehabilitation Center . Forty patients with knee OA were included in this study . Participants were r and omly assigned to two groups : 20 patients placed in Group 1 were treated with conventional physical therapy and CPM – ES combination ; 20 patients in Group 2 were treated with conventional physical therapy and isometric exercise . Therapies were applied 3 weeks , 5 days per week . The following main outcome measures were done : values of pain ( VAS was used ) , WOMAC , SF-36 , knee and thigh circle measurements , isokinetic tests , dynamic and static balance tests were determined at baseline and after the treatment . There were no statistically significant differences in the tested variables between the groups for post-treatment values . Dynamic and static balance test improved statistically strongly significantly in both groups . The findings of this study demonstrate that knee OA patients could improve their balance function in both static and dynamic conditions after CPM – ES combination or isometric exercise therapy . The improvement might prevent knee OA patients from falling down and increase their sense of security during physical activities",
"OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA",
"BACKGROUND The prevention of disability in activities of daily living ( ADL ) may prolong older persons ' autonomy ( older persons are defined in this study as those aged > or = 60 years ) . However , proved preventive strategies for ADL disability are lacking . A sedentary lifestyle is an important cause of disability . This study examines whether an exercise program can prevent ADL disability . METHODS A 2-center , r and omized , single-blind , controlled trial was conducted in which participants were assigned to an aerobic exercise program , a resistance exercise program , or an attention control group . Of the 439 community-dwelling persons aged 60 years or older with knee osteoarthritis originally recruited , the 250 participants initially free of ADL disability were used for this study . Incident ADL disability , defined as developing difficulty in transferring from a bed to a chair , eating , dressing , using the toilet , or bathing , was assessed quarterly during 18 months of follow-up . RESULTS The cumulative incidence of ADL disability was lower in the exercise groups ( 37.1 % ) than in the attention control group ( 52.5 % ) ( P = .02 ) . After adjustment for demographics and baseline physical function , the relative risk of incident ADL disability for assignment to exercise was 0.57 ( 95 % confidence interval , 0.38 - 0.85 ; P = .006 ) . Both exercise programs prevented ADL disability ; the relative risks were 0.60 ( 95 % confidence interval , 0.38 - 0.97 ; P = .04 ) for resistance exercise and 0.53 ( 95 % confidence interval , 0.33 - 0.85 ; P = .009 ) for aerobic exercise . The lowest ADL disability risks were found for participants with the highest compliance to exercise . CONCLUSIONS Aerobic and resistance exercise may reduce the incidence of ADL disability in older persons with knee osteoarthritis . Exercise may be an effective strategy for preventing ADL disability and , consequently , may prolong older persons ' autonomy",
"Background Little is known regarding how impairment-based exercises may improve performance of specific functional tasks in people with knee osteoarthritis ( OA ) . Objective The purpose of this study was to compare the probability that participation in an impairment-based exercise program or the same impairment-based program supplemented with agility and perturbation training will improve patient-reported function on specific functional tasks . Design This study was a secondary analysis of data from a r and omized clinical trial . Setting The study was conducted in the outpatient physical therapy clinic of a large , university-based health center . Participants One hundred eighty-three people with knee OA ( 122 women , 61 men ) participated . Interventions Participants were r and omly assigned to either a group that received agility and perturbation training with st and ard exercise therapy or a group that received only the st and ard exercise . Measurements Specific functional items were taken from the physical function subscale of the Western Ontario and McMasters Universities Osteoarthritis Index , the Lower Extremity Function Scale , and the Activities of Daily Living Scale of the Knee Outcome Survey . Results The probability of self-reported improvement in a variety of specific functional tasks was low following participation in either of the exercise programs . When only participants with moderate to severe difficulty performing specific functional tasks were considered in the analysis , the probability of success improved but was still limited . Limitations The results are generalizable only to self-reported assessment of performance of specific functional tasks . Conclusions Impairment-based exercise may not be enough to make substantial improvement in performance of specific functional tasks . Task-specific exercise approaches need to be explored for people with knee OA",
"Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response",
"The aim of this study was to investigate the effect of adding whole-body vibration ( WBV ; frequency = 35 to 40 Hz ; amplitude = 4 mm ) to squat training on the T-cell proliferative response of elderly patients with osteoarthritis ( OA ) of the knee . This study was a r and omized controlled trial in which the selected variables were assessed before and after 12 weeks of training . Twenty-six subjects ( 72 ± 5 years of age ) were divided into three groups : 1 ) squat training with WBV ( WBV , N = 8) ; 2 ) squat training without WBV ( N = 10 ) , and 3 ) a control group ( N = 8) . Women who were ≥60 years of age and had been diagnosed with OA in at least one knee were eligible . The intervention consisted of 12 uninterrupted weeks of squatting exercise training performed 3 times/week . Peripheral blood mononuclear cells were obtained from peripheral blood collected before and after training . The proliferation of TCD4 + and TCD8 + cells was evaluated by flow cytometry measuring the carboxyfluorescein succinimidyl ester fluorescence decay before and after the intervention ( Δ ) . The proliferative response of TCD4 + cells ( P = 0.02 , effect size = 1.0 ) showed a significant decrease ( 23 % ) in the WBV group compared to the control group , while there was no difference between groups regarding the proliferative response of TCD8 + cells ( P = 0.12 , effect size = 2.23 ) . The data suggest that the addition of WBV to squat exercise training might modulate T-cell-mediated immunity , minimizing or slowing disease progression in elderly patients with OA of the knee",
"Objective : To investigate whether a four-week walking exercise programme in patients with knee osteoarthritis improves the ability of dual-task performance in older adults with knee osteoarthritis . Design : A r and omized controlled trial with two groups : a walking group and a control group . Subjects : Forty older adults with knee osteoarthritis , 20 participants in each group . Intervention : The walking intervention was design ed to increase the number of steps walked daily . The walking group was instructed to increase their number of steps to 3000 steps more than before the intervention . Main outcome measures : Dual-task performance was computed by an automaticity index : the walking velocity under single-task condition/under dual-task conditions × 100 ( % ) , defined as automaticity . The nearer to 100 % automaticity , the better the dual-task performance . Decrease of the Trail Making Test ( TMT ) performance was defined as ΔTMT . ΔTMT was calculated as the difference between times ( part B – part A ) as a measure of executive function . In addition , functional ability was measured by the Japanese Knee Osteoarthritis Measure . Results : The walking group improved significantly in automaticity ( P ( 10.4 ) , ΔTMT ( P ) and Japanese Knee Osteoarthritis Measure score ( P found that walking exercise improves executive function and dual-task performance ",
"Abstract . Osteoarthritis ( OA ) of the knee is a very common rheumatological disease , and there are various treatment modalities for it . The aim of this study was to investigate the effects of home-based exercise and walking programs in the treatment of OA . A total of 90 patients with knee osteoarthritis were included . Their ages ranged between 48 and 71 years . The patients were separated into three groups . None of them had practice d a daily simple exercise program during the previous year . Group 1 ( n=30 ) was given a home-based exercise program . Group 2 ( n=30 ) had regular a walking program three times per week , starting with 10-min duration . Group 3 ( n=30 ) was accepted as the control group . Patients were assessed according to pain , functional capacity , and quality of life parameters . Pain was evaluated by the Western Ontario McMaster osteoarthritis index ( WOMAC ) of pain score and visual analogue scale ( VAS ) . Functional capacity was measured by WOMAC physical function index . Quality of life was assessed by the Nottingham Health Profile question naire ( NHP ) . All groups continued the program for 3 months . At the end of the therapy , the patients were called and 81 were accepted to come to the hospital . Although WOMAC pain and physical functional scores and VAS scores were statistically lower in both groups than in the control group ( P0.05 ) . But the result of the NHP showed a statistically significant improvement in the walking group when compared to the home-based exercise and control groups ( P home-based exercise therapy and a regular walking program are effective in treating the symptoms of OA",
"BACKGROUND AND PURPOSE Manual therapy and exercise have not previously been compared with a home exercise program for patients with osteoarthritis ( OA ) of the knee . The purpose of this study was to compare outcomes between a home-based physical therapy program and a clinical ly based physical therapy program . SUBJECTS One hundred thirty-four subjects with OA of the knee were r and omly assigned to a clinic treatment group ( n=66 ; 61 % female , 39 % male ; mean age [+/-SD]=64+/-10 years ) or a home exercise group ( n=68 , 71 % female , 29 % male ; mean age [+/-SD]=62+/-9 years ) . METHODS Subjects in the clinic treatment group received supervised exercise , individualized manual therapy , and a home exercise program over a 4-week period . Subjects in the home exercise group received the same home exercise program initially , reinforced at a clinic visit 2 weeks later . Measured outcomes were the distance walked in 6 minutes and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . RESULTS Both groups showed clinical ly and statistically significant improvements in 6-minute walk distances and WOMAC scores at 4 weeks ; improvements were still evident in both groups at 8 weeks . By 4 weeks , WOMAC scores had improved by 52 % in the clinic treatment group and by 26 % in the home exercise group . Average 6-minute walk distances had improved about 10 % in both groups . At 1 year , both groups were substantially and about equally improved over baseline measurements . Subjects in the clinic treatment group were less likely to be taking medications for their arthritis and were more satisfied with the overall outcome of their rehabilitative treatment compared with subjects in the home exercise group . DISCUSSION AND CONCLUSION Although both groups improved by 1 month , subjects in the clinic treatment group achieved about twice as much improvement in WOMAC scores than subjects who performed similar unsupervised exercises at home . Equivalent maintenance of improvements at 1 year was presumably due to both groups continuing the identical home exercise program . The results indicate that a home exercise program for patients with OA of the knee provides important benefit . Adding a small number of additional clinical visits for the application of manual therapy and supervised exercise adds greater symptomatic relief",
"CONTEXT AND OBJECTIVE Neuromuscular electrical stimulation ( NMES ) has been used in rehabilitation protocol s for patients suffering from muscle weakness result ing from knee osteoarthritis . The purpose of the present study was to assess the effectiveness of an eight-week treatment program of NMES combined with exercises , for improving pain and function among patients with knee osteoarthritis . DESIGN AND SETTING R and omized clinical trial at Interlagos Specialty Ambulatory Clinic , Sao Paulo , Brazil . METHODS One hundred were r and omized into two groups : NMES group and control group . The following evaluation measurements were used : numerical pain scale from 0 to 10 , timed up and go ( TUG ) test , Lequesne index and activities of daily living ( ADL ) scale . RESULTS Eighty-two patients completed the study . From intention-to-treat ( ITT ) analysis comparing the groups , the NMES group showed a statistically significant improvement in relation to the control group , regarding pain intensity ( difference between means : 1.67 [ 0.31 to 3.02 ] ; P = 0.01 ) , Lequesne index ( difference between means : 1.98 [ 0.15 to 3.79 ] ; P = 0.03 ) and ADL scale ( difference between means : -11.23 [ -19.88 to -2.57 ] ; P = 0.01 ) . CONCLUSION NMES , within a rehabilitation protocol for patients with knee osteoarthritis , is effective for improving pain , function and activities of daily living , in comparison with a group that received an orientation program . CLINICAL TRIAL REGISTRATION ACTRN012607000357459",
"OBJECTIVE To evaluate the effectiveness of Tai Chi in the treatment of knee osteoarthritis ( OA ) symptoms . METHODS We conducted a prospect i ve , single-blind , r and omized controlled trial of 40 individuals with symptomatic tibiofemoral OA . Patients were r and omly assigned to 60 minutes of Tai Chi ( 10 modified forms from classic Yang style ) or attention control ( wellness education and stretching ) twice weekly for 12 weeks . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain score at 12 weeks . Secondary outcomes included WOMAC function , patient and physician global assessment s , timed chair st and , depression index , self-efficacy scale , and quality of life . We repeated these assessment s at 24 and 48 weeks . Analyses were compared by intent-to-treat principles . RESULTS The 40 patients had a mean age of 65 years and a mean body mass index of 30.0 kg/m(2 ) . Compared with the controls , patients assigned to Tai Chi exhibited significantly greater improvement in WOMAC pain ( mean difference at 12 weeks -118.80 mm [ 95 % confidence interval ( 95 % CI ) -183.66 , -53.94 ; P = 0.0005 ] ) , WOMAC physical function ( -324.60 mm [ 95 % CI -513.98 , -135.22 ; P = 0.001 ] ) , patient global visual analog scale ( VAS ; -2.15 cm [ 95 % CI -3.82 , -0.49 ; P = 0.01 ] ) , physician global VAS ( -1.71 cm [ 95 % CI -2.75 , -0.66 ; P = 0.002 ] ) , chair st and time ( -10.88 seconds [ 95 % CI -15.91 , -5.84 ; P = 0.00005 ] ) , Center for Epidemiologic Studies Depression Scale ( -6.70 [ 95 % CI -11.63 , -1.77 ; P = 0.009 ] ) , self-efficacy score ( 0.71 [ 95 % CI 0.03 , 1.39 ; P = 0.04 ] ) , and Short Form 36 physical component summary ( 7.43 [ 95 % CI 2.50 , 12.36 ; P = 0.004 ] ) . No severe adverse events were observed . CONCLUSION Tai Chi reduces pain and improves physical function , self-efficacy , depression , and health-related quality of life for knee OA",
"OBJECTIVE To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis ( OA ) . DESIGN Single blind , three arm , r and omised controlled trial . SUBJECTS 105 community living participants aged 50 years and over with clinical OA of the hip or knee . METHODS Participants were r and omised into one of three groups : hydrotherapy ( n = 35 ) , gym ( n = 35 ) , or control ( n = 35 ) . The two exercising groups had three exercise sessions a week for six weeks . At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessment s ( muscle strength dynamometry , six minute walk test , WOMAC OA Index , total drugs , SF-12 quality of life , Adelaide Activities Profile , and the Arthritis Self-Efficacy Scale ) . RESULTS In the gym group both left and right quadriceps significantly increased in strength compared with the control group , and right quadriceps strength was also significantly better than in the hydrotherapy group . The hydrotherapy group increased left quadriceps strength only at follow up , and this was significantly different from the control group . The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12 . The gym group was significantly different from the control group for walk speed and self efficacy satisfaction . Compliance rates were similar for both exercise groups , with 84 % of hydrotherapy and 75 % of gym sessions attended . There were no differences in drug use between groups over the study period . CONCLUSION Functional gains were achieved with both exercise programmes compared with the control group",
"AIMS The study aims to compare changes over time among three study groups on the primary outcome , pain , as well as on the secondary outcomes , other symptoms , activities of daily living function , sport and recreation function , knee-related quality of life , knee range of motions and the six-minute walk test and to investigate whether aquatic exercises would be superior compared with l and exercise on pain reduction . BACKGROUND Osteoarthritis is a prevalent musculoskeletal disorder . Appropriate exercise may prevent osteoarthritis-associated disabilities and increase life quality . To date , research that compares the effects of different types of exercise for knee osteoarthritis has been limited . DESIGN The study is a r and omised trial . METHODS Eighty-four participants with knee osteoarthritis were recruited from local community centres . Participants were r and omly assigned to the control , aquatic or l and -based exercise group . Exercise in both groups ran for 60 minutes , three times a week for 12 weeks . Data were collected at baseline , week 6 and week 12 during 2006 - 2007 . The instruments included the Knee Injury and Osteoarthritis Outcome Score , a st and ard plastic goniometer and the six-minute walk test . Generalised estimation equations were used to compare changes over time among groups for key outcomes . RESULTS Results showed statistically significant group-by-time interactions in pain , symptoms , sport/recreation and knee-related quality of life dimensions of Knee Injury and Osteoarthritis Outcome Score , knee range of motions and the six-minute walk test . However , the aquatic group did not show any significant difference from the l and group at both weeks 12 and 6 . CONCLUSIONS Both aquatic and l and -based exercise programmes are effective in reducing pain , improving knee range of motions , six-minute walk test and knee-related quality of life in people with knee osteoarthritis . The aquatic exercise is not superior to l and -based exercise in pain reduction . RELEVANCE TO CLINICAL PRACTICE Similar outcomes could be possible with the two programmes . Health care professionals may consider suggesting well- design ed aquatic or l and -based exercise classes for patients with osteoarthritis , based on their preferences and convenience",
"To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"OBJECTIVE To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis ( OA ) result in measurable clinical benefits . METHODS A r and omized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA . Participants were r and omly allocated for 12 weeks to hydrotherapy classes ( n = 55 ) , Tai Chi classes ( n = 56 ) , or a waiting list control group ( n = 41 ) . Outcomes were assessed 12 and 24 weeks after r and omization and included pain and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index ) , general health status ( Medical Outcomes Study Short Form 12 Health Survey [ SF-12 ] , version 2 ) , psychological well-being , and physical performance ( Up and Go test , 50-foot walk time , timed stair climb ) . RESULTS At 12 weeks , compared with controls , participants allocated to hydrotherapy classes demonstrated mean improvements ( 95 % confidence interval ) of 6.5 ( 0.4 , 12.7 ) and 10.5 ( 3.6 , 14.5 ) for pain and physical function scores ( range 0 - 100 ) , respectively , whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 ( -0.8 , 11.1 ) and 9.7 ( 2.8 , 16.7 ) , respectively . Both class allocations achieved significant improvements in the SF-12 physical component summary score , but only allocation to hydrotherapy achieved significant improvements in the physical performance measures . All significant improvements were sustained at 24 weeks . In this almost exclusively white sample , class attendance was higher for hydrotherapy , with 81 % attending at least half of the available 24 classes , compared with 61 % for Tai Chi . CONCLUSION Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older , sedentary individuals with chronic hip or knee OA",
"The objective of this study was to examine the short- and long-term effects of a home-based , 12-week neuromuscular electrical stimulation ( NMES ) of the quadriceps femoris to decrease arthritis knee pain in older adults with osteoarthritis of the knee . The study sample ( N = 38 ) was r and omly assigned to the NMES treatment plus education group or the arthritis education-only group . Pain was measured in both groups with the McGill Pain Question naire ( MPQ ) at baseline , during the intervention at weeks 4 , 8 , 12 , and at follow-up and with the Arthritis Impact Measurement Scale 2-Pain Subscale ( AIMS 2-PS ) at baseline and week 12 . The NMES Pain Diary ( PD ) was completed 15 minutes before and after each stimulation session . There was a significant 22 % decline in pain 15 minutes after as compared with immediately before each NMES treatment ( p NMES intervention reduced arthritis knee pain 15 minutes after a NMES treatment",
"OBJECTIVE Twelve forms of Sun-style tai chi exercise have been developed specifically to reduce the symptoms and improve the physical functioning of arthritic patients , and this r and omized study examined the changes in symptoms and physical characteristics in older women with osteoarthritis ( OA ) at the completion of a 12-week tai chi exercise program . METHODS Seventy-two patients with OA were r and omly assigned into 2 groups . Due to a 41 % overall dropout rate , 22 experimental subjects and 21 controls completed pre- and post-test measures over a 12 week interval . Outcome variables were physical symptoms and fitness , body mass index , cardiovascular functioning , and perceived difficulties in physical functioning . The independent t test was used to examine group differences . RESULTS The homogeneity test confirmed that there were no significant group differences in demographic data and pretest measures . Mean comparisons of the change scores revealed that the experimental group perceived significantly less pain ( t = -2.19 , p = 0.034 ) and stiffness ( t = -2.13 , p = 0.039 ) in their joints , and reported fewer perceived difficulties in physical functioning ( t = -2.81 , p = 0.008 ) , while the control group showed no change or even deterioration in physical functioning after 12 weeks . In the physical fitness test , there were significant improvements in balance ( t = 3.34 , p = 0.002 ) and abdominal muscle strength ( t = 2.74 , p = 0.009 ) for the tai chi exercise group . No significant group differences were found in flexibility and upper-body or knee muscle strength in the post-test scores . CONCLUSION Older women with OA were able to safely perform the 12 forms of Sun-style tai chi exercise for 12 weeks , and this was effective in improving their arthritic symptoms , balance , and physical functioning . A longitudinal study with a larger sample size is now needed to confirm the potential use of tai chi exercise in arthritis management",
"The purpose of this study was to assess the effect of whole body vibration ( WBV ) exercise on muscle strength and proprioception in female patients with osteoarthritis in the knee ( knee-OA ) . A single blinded , r and omised , controlled trial was performed in an outpatient clinic on 52 female patients diagnosed with knee-OA ( mean age 60.4 years+/-9.6 ) . They were r and omly assigned to one of 3 groups : 1 . WBV-exercise on a stable platform ( VibM ; n=17 ( mean age , 61.5+/-9.2 ) ) , WBV-exercise on a balance board ( VibF ; n=18 ( mean age , 58.7+/-11.0 ) ) , or control group ( Con ; n=18 ( mean age , 61.1+/-8.5 ) ) . The WBV groups trained twice a week for 8 weeks , with a progressively increasing intensity . The WBV groups performed unloaded static WBV exercise . The following were measured : knee muscle strength ( extension/flexion ) and proprioception ( threshold for detection of passive movement ( TDPM ) ) . Self-reported disease status was measured using WOMAC . It was found that muscle strength increased significantly ( p Isometric knee-extension significantly increased ( p=0.021 ) in VibM compared to Con . TDPM was significantly improved ( p=0.033 ) in VibF compared to Con , while there was a tendency ( p=0.051 ) for VibM to perform better compared to Con . There were no effects in the self-reported disease status measures . This study showed that the WBV-exercise regime on a stable platform ( VibM ) yielded increased muscle strength , while the WBV-exercise on a balance board ( VibF ) showed improved TDPM . The WBV-exercise is a time-saving and safe method for rehabilitation of women with knee-OA",
"OBJECTIVE To investigate the effects of squat exercises combined with whole-body vibration on the plasma concentration of inflammatory markers and the functional performance of elderly individuals with knee osteoarthritis ( OA ) . DESIGN Clinical , prospect i ve , r and omized , single-blinded study . SETTING Exercise physiology laboratory . PARTICIPANTS Elderly subjects with knee OA ( N=32 ) were divided into 3 groups : ( 1 ) squat exercises on a vibratory platform ( platform group , n=11 ) ; ( 2 ) squat exercises without vibration ( squat group , n=10 ) ; and ( 3 ) the control group ( n=11 ) . INTERVENTIONS The structured program of squat exercises in the platform and squat groups was conducted 3 times per week , on alternate days , for 12 weeks . MAIN OUTCOME MEASURES Plasma soluble tumor necrosis factor-α receptors 1 ( sTNFR1 ) and 2 ( sTNFR2 ) were measured using immunoassays ( the enzyme-linked immunosorbent assay method ) . The Western Ontario and McMaster Universities Osteoarthritis Index question naire was used to evaluate self-reported physical function , pain , and stiffness . The 6-minute walk test , the Berg Balance Scale , and gait speed were used to evaluate physical function . RESULTS In the platform group , there were significant reductions in the plasma concentrations of the inflammatory markers sTNFR1 and sTNFR2 ( P and self-reported pain ( P increase in balance ( P and speed and distance walked ( P improves self-perception of pain , balance , gait quality , and inflammatory markers in elderly subjects with knee OA",
"Objectives To gain an underst and ing of elderly people ’s fear of falling by exploring the prevalence and determinants of perceived and physiological fall risk and to underst and the role of disparities in perceived and physiological risk in the cause of falls . Design Prospect i ve cohort study . Setting Community sample drawn from eastern Sydney , Australia . Participants 500 men and women aged 70–90 years . Main outcome measures Baseline assessment of medical , physiological , and neuropsychological measures , with physiological fall risk estimated with the physiological profile assessment , and perceived fall risk estimated with the falls efficacy scale international . Participants were followed up monthly for falls over one year . Results Multivariate logistic regression analyses showed that perceived and physiological fall risk were both independent predictors of future falls . Classification tree analysis was used to split the sample into four groups ( vigorous , anxious , stoic , and aware ) based on the disparity between physiological and perceived risk of falling . Perceived fall risk was congruent with physiological fall risk in the vigorous ( 144 ( 29 % ) ) and aware ( 202 ( 40 % ) ) groups . The anxious group ( 54 ( 11 % ) ) had a low physiological risk but high perceived fall risk , which was related to depressive symptoms ( P=0.029 ) , neurotic personality traits ( P=0.026 ) , and decreased executive functioning ( P=0.010 ) . The stoic group ( 100 ( 20 % ) ) had a high physiological risk but low perceived fall risk , which was protective for falling and mediated through a positive outlook on life ( P=0.001 ) and maintained physical activity and community participation ( P=0.048 ) . Conclusion Many elderly people underestimated or overestimated their risk of falling . Such disparities between perceived and physiological fall risk were primarily associated with psychological measures and strongly influenced the probability of falling . Measures of both physiological and perceived fall risk should be included in fall risk assessment s to allow tailoring of interventions for preventing falls in elderly people",
"OBJECTIVE To investigate whether weight-bearing ( WB ) exercise enhances functional capacity to a greater extent than nonweight-bearing ( NWB ) exercise in participants with knee osteoarthritis . DESIGN R and omized controlled trial . SETTING Kinesiology laboratory . PARTICIPANTS Participants ( N=106 ) were r and omly assigned to WB exercise , NWB exercise , or a control group ( no exercise ) . INTERVENTION WB exercise and NWB exercise groups underwent an 8-week knee extension-flexion exercise program . MAIN OUTCOME MEASURES Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) function scale , walking speed , muscle torque , and knee reposition error were assessed before and after intervention . RESULTS Equally significant improvements were apparent for all outcomes after WB exercise and NWB exercise , except for reposition error , for which improvement was greater in the WB exercise group . In contrast , there were no improvements in the control group . CONCLUSIONS Simple knee flexion and extension exercises ( WB and NWB ) performed over 8 weeks result ed in significant improvement in the WOMAC function scale and knee strength compared with the control group . NWB exercise alone may be sufficient enough to improve function and muscle strength . The additional benefit of WB exercise was improved position sense , which may enhance complex walking tasks ( walking on figure of 8 route and spongy surface )",
"OBJECTIVE To investigate the efficacy of a water-based exercise program specifically targeting balance to reduce falls risk and improve measures of balance and physical function in older adults with osteoarthritis ( OA ) . DESIGN R and omized controlled trial . SETTING Community . PARTICIPANTS Persons ( N=39 ; mean±SD age , 74±6y ; 26 women ) with mild to moderate OA and at risk for falling met study criteria , were measured at baseline , and were r and omly assigned to the intervention ( n=23 ) and control groups ( n=16 ) . INTERVENTIONS Water-based program ( 12wk , twice weekly ; intervention group ) or a time-matched computer training program ( control group ) . MAIN OUTCOME MEASURE The primary outcome was the short-form Physiological Profile Assessment ( PPA ) . Secondary outcomes included the Step Test , Timed Up and Go Test , Western Ontario and McMaster Universities OA Index ( Likert 3.0 version ) , Arthritis Impact Measurement Scales 2 , and Activity-specific Balance Confidence Scale . RESULTS No statistically significant between-group differences were found for any outcome measured ( n=35 ; 4 lost to follow-up ) . Within-group analysis indicated that Step Test results improved significantly in both groups ( mean change : control group , left leg , 2.07 ; 95 % confidence interval , 3.19-.95 ; P=.002 ; intervention group , 2.14 ; 95 % confidence interval , 3.20 - 1.08 ; P=.000 ) . Two PPA item scores ( reaction time , contrast sensitivity ) improved significantly ( 86.83 ; 95 % confidence interval , 9.86 - 163.79 ; P=.03 ; 1.43 ; 95 % confidence interval , 2.35-.50 ; P=.005 , respectively ) in the control group , result ing in a lower falls risk score . CONCLUSIONS Water-based exercise did not reduce falls risk in our sample compared with attending a computer skills training class . Our study is , to our knowledge , the first to compare water-based exercise in this population with a control group that attended a time-dose-equivalent seated community-based activity . Whether gaining computer skills and going out into the community twice weekly is adequate stimulus to reduce falls risk in people with OA requires further investigation",
"OBJECTIVE To investigate the effects of short-term light therapy with 890-nm radiation on pain , physical activity , and postural stability in patients with knee osteoarthritis ( OA ) . DESIGN A double-blind , r and omized , placebo-controlled study . SETTING Rehabilitation clinic . PARTICIPANTS Women ( n=62 ) and men ( n=10 ) with a mean age of 61.2 years ( range , 40 - 88y ) . All patients fulfilled the combined clinical and radiographic criteria for knee OA as established by the American College of Rheumatology , and all had obtained a Kellgren-Lawrence score of 2 or more . INTERVENTIONS Participants received 6 sessions , lasting 40 minutes each , of active or placebo radiation treatment over the knee joints for 2 weeks ( wavelength , 890 nm ; radiant power output , 6.24W ; power density , 34.7mW/cm(2 ) for 40 minutes ; total energy , 41.6J/cm(2 ) per knee per session ) . MAIN OUTCOME MEASURES Participants were assessed weekly over 4 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) for pain , stiffness , and physical function . Physical activity ( timed stair climbing , 10-m fast-speed walking , and chair-rising time ) and postural stability ( using the postural stability evaluation system ) were also assessed . The pain score on WOMAC was the primary outcome variable . Data were analyzed by repeated- measures analysis of covariance . RESULTS Compared with baseline , no significant improvement was observed between groups for pain ( P=.546 ) , stiffness ( P=.573 ) , or physical function ( P=.904 ) . No significant improvement was noted for physical activity including the 10-m fast-speed walking time ( P=.284 ) , stair-climbing time ( P=.202 ) , stair-descending time ( P=.468 ) , chair-rising time ( P=.499 ) , or postural stability ( P=.986 ) at the 4 follow-up assessment s. Follow-up assessment s were conducted after 1 week of treatment ( thus , after 3 treatments ) ; after 2 weeks of treatment ( thus , after 6 treatments ) ; and 1 and 2 weeks , respectively , after treatment was terminated . Although we found a significant time effect for the 10-m fast-speed walking time ( P stair-climbing time in the treatment group ( P=.032 ) , the group × time interaction effects were not significant . CONCLUSIONS Short-term 890-nm radiation therapy for patients with knee OA provided no beneficial effect in improving pain , physical activity , and postural stability"
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411651e6-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The 6-minute walk test ( 6MWT ) is a common outcome measurement in cardiac rehabilitation . However , a search of the literature found no established guidelines for use of the 6MWT in cardiac rehabilitation . OBJECTIVES Systematic review of the validity , reliability and responsiveness of the 6MWT in cardiac rehabilitation . DATA SOURCES Ovid MEDLINE , SPORTd iscus , EMBASE , CINAHL , Cochrane Review s and Cochrane Clinical Trials between January 1948 and April 2011 . ELIGIBILITY CRITERIA Studies using 6MWTs in subjects with coronary artery disease undergoing cardiac rehabilitation on an outpatient basis , published in English , were included . STUDY APPRAISAL AND METHODS : Quantitative and qualitative analyses were conducted , including quality assessment of methodology , meta- analysis and assessment against level of evidence criteria . RESULTS Fifteen articles met the inclusion criteria . One high- quality study was identified for reliability , six high- quality studies were identified for validity and 11 high- quality studies were identified for responsiveness . The meta- analysis found strong evidence that the 6MWT was responsive to change in clinical status following cardiac rehabilitation , with an estimated mean difference in 6-minute walk distance of 60.43 m ( 95 % confidence interval 54.57 to 66.30 m ; P repeatability of the 6MWT in patients undergoing cardiac rehabilitation , for a 2 % to 8 % learning effect between repeated 6MWTs , for a relationship between peak heart rate during the 6MWT and during cycle exercise at the ventilatory threshold , and for moderate-to-high correlation between the 6-minute walk distance and maximum metabolic equivalents achieved on symptom-limited exercise tests . LIMITATIONS Few studies assessed similar aspects of validity for the 6MWT . CONCLUSION Strong evidence suggests that the 6MWT is responsive to clinical change following cardiac rehabilitation . Intra- and intertester reliability of the 6MWT and its validity in patients undergoing cardiac rehabilitation requires further research
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"PURPOSE We evaluated the value of resistance training on measures of physical performance in disabled older women with coronary heart disease ( CHD ) . METHODS The study intervention consisted of a 6-month program of resistance training in a r and omized controlled trial format . Training intensity was at 80 % of the single-repetition maximal lift . Control patients performed light yoga and breathing exercises . Study participants included 42 women with CHD , all > or= 65 yr of age and community dwelling . Subjects were screened by question naire to have low self-reported physical function . The primary study measurements related to the performance of 16 household activities of the Continuous Scale Physical Functional Performance test ( CSPFP ) . These ranged from dressing , to kitchen and cleaning activities , to carrying groceries and walking onto a bus with luggage , and a 6-min walk . Activities were measured in time to complete a task , weight carried during a task , or distance walked . Other measures included body composition , measures of aerobic fitness and strength , and question naire-based measures of physical function and depression score . RESULTS Study groups were similar at baseline by age , aerobic capacity , strength , body composition , and in performing the CSPFP . After conditioning , 13 of 16 measured activities were performed more rapidly , or with increased weight carried , compared with the control group ( all P Maximal power for activities that involved weight-bearing over a distance , increased by 40 % ( P Disabled older women with CHD who participate in an intense resistance-training program improve physical capacity over a wide range of household physical activities . Benefits extend beyond strength-related activities , as endurance , balance , coordination , and flexibility all improved . Strength training should be considered an important component in the rehabilitation of older women with CHD",
"Gremeaux V , Deley G , Duclay J , Antoine D , Hannequin A , Casillas JM : The 200-m fast-walk test compared with the 6-min walk test and the maximal cardiopulmonary test : A pilot study . Objective : The 200-m fast-walk test has been proposed as a high- intensity performance test in healthy , elderly subjects . Adaptation of low-risk coronary artery disease patients during this test were compared with those in a 6-min walk test and a maximal cardiopulmonary exercise test . Design : Thirty patients with stable coronary artery disease ( 51.9 ± 8.7 yrs ) , referred to the cardiac rehabilitation department , performed a cardiopulmonary exercise test , then a 200-m fast-walk test and a 6-min walk test in a r and om order , before and after the training period ( 6 wks , 3 days per week ) . Heart rate was monitored during each test . Peak workload of cardiopulmonary exercise test , distance walked on the 6-min walk test , and time to perform the 200-m fast-walk test were measured . A sub sample of ten patients performed the exercise test with gas exchange measurements , with ventilatory threshold determination . Results : All subjects completed walk tests without complaint or incidents . Compared with the cardiopulmonary exercise test , the cardiac relative intensity was higher during the 200-m fast-walk test than during the 6-min walk test , both before ( 89.6 % vs. 78.1 % of cardiopulmonary exercise test maximal heart rate ; P fast-walk test heart rate was significantly higher than the ventilatory threshold heart rate , which did not differ from the 6-min walk test heart rate . The 200-m fast-walk test time significantly decreased after training ( −9.1 % , P patients with coronary artery disease at low risk , the 200-m fast-walk test explores higher levels of cardiorespiratory capacity than the 6-min walk test . Thus , this could be a useful field test in complement to the cardiopulmonary exercise test to assess functional capacity improvement and up date training targets regularly during the course of high-intensity rehabilitation programs in this population",
"The 6-minute walk test is used in clinical practice and clinical trials of lung diseases ; however , it is not clear whether replicate tests need to be performed to assess performance . Furthermore , little is known about the impact of walking course layout on test performance . We conducted 6-minute walks on 761 patients with severe emphysema ( mean + /- SD FEV1 % predicted = 26.3 + /- 7.2 ) who were participants in the National Emphysema Treatment Trial . Four hundred seventy participants had repeated walks on a separate day . The second test was improved by an average of 7.0 + /- 15.2 % ( 66.1 + /- 146 feet , p distance walked . Participants tested on continuous ( circular or oval ) courses had a 92.2-foot longer walking distance than those tested on straight ( out and back ) courses . Course length had no significant effect on walking distance . The training effect found in these patients with severe emphysema is less than in previous reports of patients with chronic obstructive pulmonary disease . Furthermore , the layout of the track may influence the 6-minute walk performance",
"OBJECTIVE To estimate the minimal clinical ly important difference ( MCID ) for the 6-minute walk test ( 6MWT ) and the 200-m fast-walk test ( FWT ) in patients with coronary artery disease ( CAD ) during a cardiac rehabilitation program . DESIGN Prospect i ve study using distribution- and anchor-based methods . SETTING Out patients from a cardiac rehabilitation unit . PARTICIPANTS Stable patients with CAD ( N=81 ; 77 men ; mean±SD age , 58.1±8.7y ) enrolled 31±12.1 days after an acute coronary syndrome ( ACS ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES 6MWT and 200-m FWT results before and after an 8-week cardiac rehabilitation program and at the 6th and 12th sessions . Patients and physiotherapists who supervised the training were asked to provide a global rating of perceived change in walking ability while blinded to changes in walk test performances . RESULTS Mean change in 6MWT distance ( 6MWD ) in patients who reported no change was -6.5 m versus 23.3 m in those who believed their performance had improved ( P the MCID determined by using the distribution method ( 23 m ) . Considering a 25-m cutoff , positive and negative predictive values were 0.9 and .63 , respectively . Conversely , there was no difference in 200-m FWT performance between these 2 groups ( 0.1 vs -1.4s , respectively ) . There was poor agreement with the physiotherapist 's perceived change . CONCLUSIONS The MCID for 6MWD in patients with CAD after ACS was 25 m . This result will help physicians interpret 6MWD change and help research ers estimate sample sizes in further studies using 6MWD as an endpoint",
"BACKGROUND Older women with coronary artery disease ( CAD ) have reduced peak aerobic power ( Vo(2)peak ) , muscle strength , and quality of life ( QOL ) . Exercise interventions that can improve Vo(2)peak and muscle strength may also result in an improvement in QOL . This study compared the effect of aerobic training ( AT ) or combined aerobic and strength training ( COMT ) on Vo(2)peak , distance walked in 6 min , upper- and lower-extremity maximal strength , and QOL in 18 women ( age range , 60 to 80 years ) with documented CAD . METHODS After baseline testing , subjects were r and omly assigned to AT ( treadmill and cycle exercise , n = 9 ) or COMT ( treadmill and cycle exercise plus upper- and lower-extremity strength training , n = 9 ) , and each group exercised 3 d/wk for 8 weeks . RESULTS Both AT and COMT result ed in a similar increase in Vo(2)peak , distance walked in 6 min , lower-extremity strength , and emotional and global QOL . COMT improved upper-extremity strength , and physical and social QOL , which was unchanged after AT . CONCLUSIONS Older women with CAD should perform aerobic and strength training to attain optimal improvements in overall physical fitness and QOL",
"Objective : To examine the utility of the six-minute walk test ( 6′WT ) , in assessing the effectiveness of a six-week cardiac rehabilitation programme , of which exercise training was an integral part . Setting : Royal Liverpool and Broad Green Hospitals Rehabilitation Unit . Design : Two hundred and thirty-nine consecutive patients referred for cardiac rehabilitation were allocated to one of two groups . In group A 209 entered and 159 completed the usual rehabilitation programme whilst group B patients ( n = 30 ) acted as a control by deferring entry to the programme for six weeks , continuing only activities of daily living . Outcome measures : Both groups were assessed using the 6′WT , peak expiratory flow rate ( PEFR ) and isometric grip strength at enrolment and six weeks . Results : At baseline , groups A and B were demographically identical without significant differences in terms of 6′WT , PEFR or grip strength . Following the study period , group A showed a significant increase in 6′WT from 314.7 ± 76.2 to 377.3 ± 78.6 m , in PEFR from 406.9 ± 115.9 to 437.8 ± 118.6 litres per minute and in grip strength from 28.8 ± 9.31 to 30.3 ± 8.93 kg , all p patients performing cardiac rehabilitation . The clinical programme investigated successfully increased patients ' functional capacity as assessed by the 6′WT . Significant improvement in PEFR and grip strength was also demonstrated , compared with a control population",
"AIMS The 6-min walk test may serve as a more simple clinical tool to assess functional capacity in congestive heart failure than determination of peak oxygen uptake by cardiopulmonary exercise testing . The purpose of the study was to prospect ively examine whether the distance ambulated during a 6-min walk test ( i ) correlates with peak oxygen uptake , ( ii ) allows peak oxygen uptake to be predicted , and ( iii ) provides prognostic information similar to peak oxygen uptake in patients with dilated cardiomyopathy and left ventricular ejection fraction METHODS AND RESULTS In 113 patients ( age : 54+/-12 years , NYHA : 2.2+/-0.8 ) with dilated cardiomyopathy ( left ventricular ejection fraction 19+/-7 % ) a 6-min walk test and cardiopulmonary exercise testing were performed . The 6-min walk test and peak oxygen uptake were closely correlated at the initial visit ( r=0.68 , n=113 ) , as well as after 263+/-114 ( r=0.71 , n=28 ) and 381+/-170 days ( r=0.74 , n=14 ) . During serial exercise testing the 6-min walk test allowed peak oxygen uptake to be reliably predicted ( r=0.76 between calculated and real peak oxygen uptake ) . After 528+/-234 days , 42 patients were hospitalized due to worsening heart failure and /or died from cardiovascular causes . Compared to clinical ly stable patients , these 42 patients walked a shorter distance ( 423+/-104 vs 501+/-95 m , P peak oxygen uptake ( 12.7+/-4.0 vs 17.4 + 5.6 ml x min(-1 ) x kg(-1 ) , P 6-min walk test outperformed other prognostic parameters such as left ventricular ejection fraction , cardiac index and plasma norepinephrine concentration and conferred a prognostic power similar to peak oxygen uptake . This predictive value could be further improved in a multivariate model , by combining the 6-min walk test with independent variables , such as left ventricular ejection fraction or cardiac index . CONCLUSION The 6-min walk test correlated with peak oxygen uptake when tested serially over the course of the disease . Although both tests define two distinct domains of functional capacity , the 6-min walk test provides prognostic information very similar to peak oxygen uptake in congestive heart failure patients with dilated cardiomyopathy",
"OBJECTIVE The purpose s of this study were ( 1 ) . to determine if six-minute walk ( 6MW ) performance improved after short-term cardiac rehabilitation ( CR ) across multiple outpatient programs ; ( 2 ) . to examine differences in 6MW performance by patient age , sex , and race ; and ( 3 ) . to determine what relationships existed , if any , between 6MW performance and subscales of the Ferrans and Powers ' Quality of Life Index-Cardiac Version III ( QOLI ) . DESIGN Study design was nonexperimental , prospect i ve , and comparative . SETTING Study setting included 14 outpatient CR programs from urban and rural setting s across North Carolina . PATIENTS Adults aged 40 to 89 years ( N = 630 ; men = 424 [ 67 % ] , women = 206 [ 33 % ] ; mean age , 61 + /- 10.32 years ) with medically or surgically treated coronary heart disease enrolled in outpatient CR . OUTCOME MEASURES Study measures included scores on the QOLI and distance walked ( feet ) on the 6MW test . RESULTS Six-minute walk tests and QOLI surveys were administered before and immediately after short-term CR participation . Six-minute walk distance increased for all patients in all age categories across programs after CR ( P improved 6MW distance by 15 % ( 1243.9 + /- 301.2 to 1435.3 + /- 298.1 ; P 6MW distance by 15 % ( 1463.3 + /- 339.5 to 1683.7 + /- 346.9 ; P 6MW scores between men and women aged 40 to 49 years ( n = 58 ) and 50 to 59 years ( n = 140 ; P = 0.54 ) . Both of these age groups had greater initial and discharge 6MW scores than those aged 70 to 79 years ( n = 183 ) and 80 to 89 years ( n = 22 ; P 6MW scores than those aged 40 to 49 years ( P = 0.001 ) and 50 to 59 years ( P follow-up 6MW scores than those aged 80 to 89 years(P 6MW performance were found in both white subjects ( n = 575 ; P 6MW performance and overall or Health and Function QOLI scores ( r outpatient CR improved 6MW performance in patients aged 40 to 89 years across 14 programs in North Carolina . No relationships were found between 6MW performance and any domain of the QOLI , including the Health and Function domain",
"PURPOSE This study contrasted the effect of a group-mediated cognitive-behavioral intervention ( GMCB ) versus traditional cardiac rehabilitation ( CRP ) upon changes in objective and self-reported physical function of older adults [ mean ( SD ) age of 64.7 ( 7.5 ) yr ] after 3 months of exercise therapy . METHODS This r and omized clinical trial enrolled 147 participants who were eligible for inclusion into cardiac rehabilitation . Baseline to 3-month changes in self-reported and performance related measures of physical function were assessed using a physical functioning question naire , a 6-min walk test , and measured MET levels . RESULTS Paired t-tests revealed that participants made improvements in all measures across the first 3 months of the study , irrespective of group treatment ( P lower functioning men in the GMCB treatment made greater improvements than any other subgroup on the two performance outcomes : 6-min walk and measured MET levels ( P self-reported level of physical function ( P > 0.05 ) ; however , the lower functioning participants in the GMCB intervention experienced greater improvements in self-reported physical function than those in CRP ( P Exercise therapy is a valuable intervention for improving physical function of older adults with cardiovascular disease ( CVD ) and those at increased risk for CVD . Baseline level of physical function and gender are important variables to consider when study ing the relationship between exercise therapy and improvements in physical function ",
"Background : Owing to a reported learning effect in patients with chronic cardiopulmonary disease , performance of at least two six-minute walk tests ( 6MWT ) are recommended as st and ard practice . Patients with chronic heart failure ( CHF ) are typically elderly and frail and it is unknown whether current guidelines are practical in a clinical setting . Aims : The aim of this study was to determine whether repeat performance of 6MWTs in patients with CHF is related to between-test interval or baseline performance . Methods : This was a multisite observational study enrolling participants entering into heart failure rehabilitation programmes . Participants performed two 6MWTs with r and omly allocated inter-test intervals between 15 and 90 minutes . Distance walked in the second test was compared with the first test using a paired t test . Results : Eighty-eight participants ( 45 females , age 65 ± 14 years ) with stable CHF were enrolled . Mean distance walked increased from 301 metres in test 1 to 313 metres in test 2 ( p tests had no significant effect on the distance walked . Conclusion : The change in 6MWT distance was significantly associated with better baseline performance but not with the interval between tests"
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BACKGROUND CONTEXT Pain innate to intervertebral disc , often referred to as discogenic pain , is suspected by some authors to be the major source of chronic low back and neck pain . Current management of suspected discogenic pain lacks st and ardized diagnosis , treatment , and terminology . PURPOSE In an attempt to determine whether patterns existed that may facilitate st and ardization of care , we sought to analyze the terminologies used and the various modes of diagnosis and treatment of suspected discogenic pain . STUDY DESIGN A systematic review of the recent literature . METHODS A Medline search was performed using the terms degenerative disc disease , discogenic pain , internal disc disruption while using the limits of human studies , English language , and clinical trials , for the last 10 years . The search led to a total of 149 distinct citations , of which 53 articles , where the intervertebral disc itself was considered the principal source of patient 's pain and was the main target of the treatment , were retained for further analysis . RESULTS The results of this review confirm and help quantify the significant differences that existed in the terminology and all the areas of diagnosis and treatment of presumed discogenic pain . CONCLUSIONS Our findings show that suspected discogenic pain , despite its extensive affirmation in the literature and enormous re sources regularly devoted to it , currently lacks clear diagnostic criteria and uniform treatment or terminology
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"Study Design . Prospect i ve longitudinal study with a minimum 2-year follow-up . Objective . To assess the long-term outcome of a group of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care and who were subsequently treated with intradiscal electrothermal therapy ( IDET ) . Summary of Background Data . Previous reports of patient outcomes at 1 year after IDET have demonstrated statistically significant improvement . Methods . The study group comprised 58 patients with chronic symptoms of more than 6 months who failed to improve with nonoperative care and subsequently underwent IDET . VAS pain scores , SF-36 scores , and sitting tolerance times were collected pretreatment and at 6 , 12 , and 24 months . Results . Mean duration of pre-IDET symptoms was 60.7 months . The minimum follow-up at data collection was 24 months . The study group ( n = 58 ) demonstrated a significant improvement in pain as demonstrated by statistically significant improvement in VAS scores and bodily pain SF-36 scores . The IDET-treated group demonstrated a significant improvement in physical function as noted by statistically significant improvement in sitting tolerance times and physical function SF-36 scores . Bodily pain and physical function scores demonstrated significant improvement between the 1- and 2-year observation points . Additionally , quality of life improvement was demonstrated by a statistically significant improvement in all the SF-36 subscales . Conclusions . A cohort of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care demonstrated a statistically significant improvement in pain , physical function , and quality of life at 2 years after IDET",
"BACKGROUND Numerous pre clinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing . The results in spinal fusion applications are limited and controversial . PURPOSE The purpose of the current prospect i ve clinical cohort study is to assess the effect of Autologous Growth Factors ( AGF ) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes . STUDY DESIGN / SETTING Prospect i ve clinical study PATIENT SAMPLE C and i date s for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and /or up to grade I spondylolytic spondylolisthesis based on positive provocative discography . OUTCOME MEASURES Clinical ( visual analogue pain scale/functional outcome assessment ) and radiographic outcomes ( fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months ) . METHODS Thirty-seven patients were assigned to st and ard anterior-posterior interbody fusion L2-S1 ( single or two-level ) using iliac crest bone graft ( autograft group : 22 patients with 32 levels operated ) or allograft combined with autogenous growth factors ( AGF group : 15 patients with 25 levels operated ) . Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs . Pre- and postoperative clinical outcome measures included visual analog scores ( VAS ) for back and leg pain ( 0 - 10 ) , SF-36 scores , and Oswestry disability determination . Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months ( 12 - 36 months ) and AGF was 25.7+/-7.5 ( 6 - 40 months ) . RESULTS Fusion incorporation at each end plate was determined at 56 % in both autograft and AGF ( p = NS ) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique . The 12- and 24-month radiographic results confirmed an 85 % arthrodesis rate for the autograft patients , whereas the AGF patients had an 89 % fusion rate ( p = NS ) . Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements . CONCLUSIONS AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and , thus , eliminates any morbidity from iliac crest bone graft harvesting . AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies . Further research is still required to examine the optimum carriers , preparation and formulation , and platelet concentrations for this technology",
"Study Design . A prospect i ve double-blind r and omized trial in 28 patients . Objectives . To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain , functional disability , and physical impairment in patients with chronic discogenic low back pain . Summary of Background Data . Chronic discogenic low back pain is a challenging problem in western countries . A treatment option is radiofrequency heating of the affected disc . Its clinical efficacy has never been formally tested in a controlled trial . Methods . Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs . Only patients with one putative painful level were selected and r and omly assigned to one of two treatment groups . Each patient in the radiofrequency treatment group ( n = 13 ) received a 90-second 70 C lesion of the intervertebral disc . Patients in the control group ( n = 15 ) underwent the same procedure , but without use of radiofrequency current . Both the treating physician and the patients were blinded to the group assignment . Before treatment , physical impairment , rating of pain , the degree of disability , and quality of life were assessed by a blinded investigator . Results . Eight weeks after treatment , there was one success in the radiofrequency group ( n = 13 ) and two in the control group ( n = 15 ) . The adjusted and unadjusted odds ratio was 0.5 and 1.1 , respectively ( not significant ) . Also , visual analog scores for pain , global perceived effect , and the Oswestry disability scale showed no differences between the two groups . Conclusions . Percutaneous intradiscal radiofrequency thermocoagulation ( 90 seconds , 70 C ) is not effective in reducing chronic discogenic low back pain",
"Study Design . A prospect i ve , r and omized , multicenter , Food and Drug Administration-regulated Investigational Device Exemption clinical trial . Objective . To evaluate the safety and effectiveness of the ProDisc ® -L ( Synthes Spine , West Chester , PA ) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1 . Summary of Background Data . As part of the Investigational Device Exemption clinical trial , favorable single center results of lumbar total disc replacement with the ProDisc ® -L have been reported previously . Methods . Two hundred eighty-six ( 286 ) patients were treated on protocol . Patients were evaluated before and after surgery , at 6 weeks , 3 , 6 , 12 , 18 , and 24 months . Evaluation at each visit included patient self- assessment s , physical and neurologic examinations , and radiographic evaluation . Results . Safety of ProDisc ® -L implantation was demonstrated with 0 % major complications . At 24 months , 91.8 % of investigational and 84.5 % of control patients reported improvement in the Oswestry Low Back Pain Disability Question naire ( Oswestry Disability Index [ ODI ] ) from preoperative levels , and 77.2 % of investigational and 64.8 % of control patients met the ≥15 % Oswestry Disability Index improvement criteria . Overall neurologic success in the investigational group was superior to the control group ( 91.2 % investigational and 81.4 % control ; P = 0.0341 ) . At 6 weeks and 3 months follow-up time points , the ProDisc ® -L patients recorded SF-36 Health Survey scores significantly higher than the control group ( P = 0.018 , P = 0.0036 , respectively ) . The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment ( P satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group ( P = 0.015 ) . Radiographic range of motion was maintained within a normal functional range in 93.7 % of investigational patients and averaged 7.7 ° . Conclusions . ProDisc ® -L has been found to be safe and efficacious . In properly chosen patients , ProDisc ® -L has been shown to be superior to circumferential fusion by multiple clinical criteria",
"OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ; 265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF",
"Study Design . This was a prospect i ve multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years ’ follow-up . Objectives . To determine whether the early positive clinical results in fusions with lumbar cages , such as the Bagby and Kuslich ( BAK ) cage , are maintained beyond 2 years . Summary of Background Data . Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease . Concerns about the long-term clinical outcomes of this procedure have been posed , particularly regarding bony fusion viability , revision rates , potential adjacent level disease , and late complications . Methods . The study cohort was a 196-patient subset from a prospect i ve investigational device exemption . In addition to early postoperative examinations , these patients were examined biannually with a minimum of 4 years ’ follow-up . Patient outcome was assessed by a 6-point scale that evaluated pain relief , and functional improvement was determined by changes in activities of daily living . Fusion rates and return to work were determined . Complications and secondary operations were reported and categorized as non – device related or device related . Results . The patient cohort with 4-year follow-up represented 25.6 % of the original study population eligible at that time . Overall , the largest percentage of pain relief and functional improvements occurred by 3 months , and these improvements were maintained at each follow-up . Overall fusion rate was 91.7 % and 95.1 % at 2 and 4 years , respectively . In this cohort , 39.5 % of patients were working or were able to work within 3 months of surgery . After 4 years , 62.7 % of patients were gainfully employed or able to work . The late-occurring complication rate in this cohort was 13.8 % ( 27/196 ) . Complications necessitating a second operation occurred in 8.7 % ( 17/196 ) , whereas reoperations that were deemed device related were performed in 3.1 % ( 6/196 ) . Conclusions . This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity",
"Study Design . Prospect i ve nonr and omized clinical series . Objectives . To evaluate the efficacy of ProDisc lumbar artificial disc replacement ( ADR ) in smokers versus nonsmokers . Summary of Background Data . Smoking is a negative predictor in fusion surgery . To date , a prospect i ve study of the treatment of incapacitating discogenic low back pain using ADR in smokers versus nonsmokers has not been described . Methods . A prospect i ve analysis was performed on 104 patients with disabling discogenic low back pain treated with single-level lumbar ProDisc total disc arthroplasty . Smokers and nonsmokers were assessed before surgery and after surgery using patient satisfaction , Oswestry , and Visual Analog Scores . Additionally , preoperative and postoperative neurologic , radiographic , and pain medication assessment s were performed at similar postoperative intervals . Results . Oswestry , Visual Analog Scores , and patient satisfaction scores revealed statistical improvement beginning 3 months after surgery and were maintained at minimum 2-year follow-up . Patient satisfaction scores were higher in smokers ( 94 % ) than in nonsmokers ( 87 % ) at 2-year follow-up ( P = 0.07 ) . Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm ( P an affected disc motion from 3 ° to 7 ° ( P of loosening , dislodgment , mechanical failure , infection , or fusion of the affected segment occurred . Conclusions . The results of our study indicate that smokers do equally well compared with nonsmokers when ProDisc ADR is used in the treatment of debilitating lumbar spondylosis . Patient outcome and radiographic scores showed significant improvement compared with preoperative levels . Although not evident in our series , additional surveillance for intraoperative and postoperative vascular spasm and occlusion may be warranted in smokers",
"& NA ; A preliminary report of clinical study revealed that chronic discogenic low back pain could be treated by intradiscal methylene blue ( MB ) injection . We investigated the effect of intradiscal MB injection for the treatment of chronic discogenic low back pain in a r and omized placebo‐controlled trial . We recruited 136 patients who were found potentially eligible after clinical examination and 72 became eligible after discography . All the patients had discogenic low back pain lasting longer than 6 months , with no comorbidity . Thirty‐six were allocated to intradiscal MB injection and 36 to placebo treatment . The principal criteria to judge the effectiveness included alleviation of pain , assessed by a 101‐point numerical rating scale ( NRS‐101 ) , and improvement in disability , as assessed with the Oswestry Disability Index ( ODI ) for functional recovery . At the 24‐month follow‐up , both the groups differed substantially with respect to the primary outcomes . The patients in MB injection group showed a mean reduction in pain measured by NRS of 52.50 , a mean reduction in Oswestry disability scores of 35.58 , and satisfaction rates of 91.6 % , compared with 0.70 % , 1.68 % , and 14.3 % , respectively , in placebo treatment group ( p No adverse effects or complications were found in the group of patients treated with intradiscal MB injection . The current clinical trial indicates that the injection of methylene blue into the painful disc is a safe , effective and minimally invasive method for the treatment of intractable and incapacitating discogenic low back pain",
"Study Design . A prospect i ve r and omized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo . Objectives . To determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin . Summary of Background Data . Steroids have been used empirically in the treatment of back pain . They have been used in the epidural space and around nerve roots and have been used as an alternative to chymopapain within the disc . Previous studies have , however , shown variable results . Methods . A total of 120 patients with chronic low back pain of discogenic origin were enrolled in the study . At discography , if they had concordant pain , they were r and omized to injection of normal saline or methylprednisolone into the disc space . These patients were prospect ively followed up for 12 months , and they were asked to report pain according to a visual analogue score and their Oswestry Disability Index was recorded . The primary outcome measure was determined as a percentage change in disability , and the results were analyzed using independent sample s t test . The secondary outcome measure was a change in the pain score , and this was analyzed using the Mann-Whitney U test . Results . There was no significant difference in the primary outcome between the two groups ( P = 0.71 ) . The steroid group had a mean change of 2.28 ( SE 2.49 ) in percentage disability , while the saline group had a mean change of 3.42 ( SE 1.79 ) . With respect to the change in pain score , there was no significant difference between the two groups ( P = 0.72 ) . Those patients who had saline injection had a median change in pain score of 0 ( interquartile range −1 to 1 ) , whereas those given steroid treatment had a median change in pain score of 0 ( interquartile range −0.25 to 1 ) . Conclusions . This study demonstrates that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo",
"Twenty-two ProDisc II prostheses ( Spine Solutions , New York , New York ) were implanted in 21 patients with degenerative disk disease at L5-S1 ( 19 disks ) and L4-L5 ( 3 disks ) . After mean follow-up of 3.1 years ( range , 17 - 49 months ) , pain intensity in all but 3 patients had improved from an average of 7.7 preoperatively to 4.6 postoperatively ( P visual analog scale . Average Oswestry Disability Index score improved from 61 to 35 ( P Radiographic reconstruction of the disk space height was achieved in all cases . Previous diskectomy at the implanted level and disk degeneration adjacent to previous fusion negatively influenced the results",
"Symptomatic degenerative disc disease ( DDD ) may lead to significant deterioration of quality of life and increased disability . Intradiscal thermal annuloplasty ( IDTA ) is a minimally invasive treatment for painful DDD . We hypothesized that there may be an improvement in pain scores and the pain disability index ( PDI ) of patients who have multilevel DDD after IDTA . Patients 24–66 yr old , male and female with multilevel DDD ( MDDD ) and matched 1 or 2 level DDD ( 1,2-DDD ) patients were enrolled in the study . Visual analog pain scale ( VAS ) score and PDI were observed for 12 mo . The 1,2-DDD patient group had a 2.5 ± 2.4 VAS score at 12 mo after annuloplasty compared to 7.7 ± 2 before the procedure . The MDDD VAS score was 4.9 ± 2.9 at 12 mo compared to 7.4 ±1.8 before the procedure . Similar improvements in PDI were found . The pain relief and PDI were significantly better in patients with 1,2-DDD than in the MDDD group ( P = 0.0037 and P = 0.041 , respectively ) . We concluded that IDTA is an effective treatment of discogenic pain and that the number of discs affected by degeneration is an important determinant of the procedure outcome",
"Sixty patients with one-level discogenic pain confirmed by plain radiography , magnetic resonance imaging , and provocative discography for degenerative disc disease were r and omized : one-third BAK anterior interbody fusion and two-thirds anterior SB Charité artificial disc replacement . The mean age was 40.3 years ( range 21 - 56 years ) . Nineteen cases were at L4-L5 and 41 cases were at L5-S1 . Nineteen cases had BAK anterior interbody fusion and 41 cases were r and omized as SB Charité disc replacement . The length of surgery was mean 88.4 minutes ( range 54 - 137 minutes ) for both groups . The estimated blood loss was mean 289.5 mL ( range 50 - 1800 mL ) . The length of hospital stay was a mean of 3.03 days ( range 2 - 6 days ) . Oswestry Disability Index scores for the SB Charité disc ( aggregate study group ) were 50.0 + /- 14.3 preoperatively and 25.0 + /- 20.1 at 1 - 3 years ' follow-up ( P functional outcome measures in a prospect i ve r and omized design with disc arthroplasty treating primarily mechanical back pain and achieving comparable successful results to lumbar fusion-interbody fusion cage and BMP or interbody autograft and pedicle screw instrumentation",
"BACKGROUND CONTEXT For decades there has been a desire to restore motion of a painful degenerated spinal segment . Artificial discs have been used in Europe for almost 20 years . In the few reports available in the literature , the results have been promising . However , there have been no prospect i ve r and omized studies comparing artificial discs with spinal fusion . PURPOSE The purpose of this study was to determine if patients with symptomatic degenerative disc disease treated with Charite artificial disc ( DePuy Spine , Raynham , MA ) arthroplasty would show significant improvement in functional outcome measures and to compare these results to fusion . STUDY DESIGN / SETTING This was a prospect i ve r and omized clinical trial comparing total disc replacement with anterior lumbar interbody fusion using cages . The data reported were collected from two spine specialty centers participating in a Food and Drug Administration regulated trial . METHODS A consecutive series of 144 patients were r and omized using a 2:1 ratio of Charite versus BAK ( Zimmer Spine , Minneapolis , MN ) . All patients were being treated for single-level discogenic pain confirmed by plain radiography , magnetic resonance imaging and provocative discography . Data were collected at design ated follow-up periods for up to 24 months . RESULTS The mean age was 40.1 years ( range , 21 to 56 years ) . Forty-four cases had BAK anterior interbody fusion , and 100 cases were r and omized to Charite disc replacement . The mean operating time was 76.2 minutes ( range , 54 to 137 minutes ) for the Charite cases . The mean estimated blood loss was 196.2 cc ( range , 50 to 1,800 cc ) . Most patients were discharged in 1 to 2 days with a soft corset and returned to normal activities within 3 weeks if they underwent the disc replacement . The mean Oswestry Disability Index score for the BAK group was 69.6+/-12.8 preoperatively and 27.5+/-26.4 at 24-month follow-up ( p mean Oswestry score for the Charite disc patients was 70.9 preoperatively and 30.0 at 24-month follow-up ( p<.001 ) . CONCLUSIONS In this prospect i ve r and omized study , both surgical groups improved significantly . Complications of total disc replacement were similar to those encountered with anterior lumbar interbody fusion . Total disc replacement appears to be a viable alternative to fusion for the treatment of single-level symptomatic disc degeneration unresponsive to nonoperative management",
"The literature reports on the safety and efficacy of titanium cages ( TCs ) with additional posterior fixation for anterior lumbar interbody fusion . However , these papers are limited to prospect i ve cohort studies . The introduction of TCs for spinal fusion has result ed in increased costs , without evidence of superiority over the established practice . There are currently no prospect i ve controlled trials comparing TCs to femoral ring allografts ( FRAs ) for circumferential fusion in the literature . In this prospect i ve , r and omised controlled trial , our objective was to compare the clinical outcome following the use of FRA ( current practice ) to the use of TC in circumferential lumbar spinal fusion . Full ethical committee approval and institutional research and development departmental approval were obtained . Power calculations estimated a total of 80 patients ( 40 in each arm ) would be required to detect clinical ly relevant differences in functional outcome . Eighty-three patients were recruited for the study fulfilling strict entry requirements ( > 6 months chronic discogenic low back pain , failure of conservative treatment , one- or two-level discographically proven discogenic low back pain ) . The patients completed the Oswestry Disability Index ( ODI ) , Visual Analogue Score ( VAS ) for back and leg pain and the Short-Form 36 ( SF-36 ) preoperatively and also postoperatively at 6 , 12 and 24 months , respectively . The results were available for all the 83 patients with a mean follow-up of 28 months ( range 24–75 months ) . Five patients were excluded on the basis of technical infringements ( unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space ) . From the remaining 78 patients r and omised , 37 received the FRA and 41 received the TC . Posterior stabilisation was achieved with translaminar or pedicle screws . Baseline demographic data ( age , sex , smoking history , number of operated levels and preoperative outcome measures ) showed no statistical difference between groups ( p FRA , mean VAS ( back pain ) improved by 2.0 points ( p ) , mean ODI improved by 15 points ( p= ) and mean SF-36 scores improved by > 11 points in all domains ( p general health and emotional role . For patients who received the TC , mean VAS improved by 1.1 points ( p=0.004 ) , mean ODI improved by 6 points ( p=0.01 ) and SF-36 improved significantly in only two of the eight domains ( bodily pain and physical function ) . Revision procedures and complications were similar in both groups . In conclusion , this prospect i ve , r and omised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs . The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost",
"Abstract Vertebral axial decompression ( VAX-D ) is capable of reducing intradiscal pressure to the negative range . The purpose of this study was to compare the effects of two dosage regimens of VAX-D treatments on the level of low back pain in patients who were referred to a neurosurgical practice after failing st and ard medical therapy . In this study , one group of patients received an average course of treatment consisting of 18 daily sessions and another group received half that number of daily treatment sessions . The treatment parameters for all patients differed only in the number of sessions . Seventy-six percent of the higher dosage group achieved remission of low back pain compared to 43 % of the lower dosage group . Chi-squared analysis revealed that the differences in response in the two dosage groups were statistically significant at p < 0.0001",
"Abstract . Total disc replacement has become an option for the treatment of degenerative disc disease of the lumbar spine . A new generation of implants has been developed that can be implanted through minimally invasive anterior approaches to the lumbar levels L2/3 , L3/4 , L4/5 and L5/S1 . However mid- and long-term data are still lacking . This paper describes the minimally invasive surgical approach – techniques as well as the preliminary results of our first 34 consecutive patients . The intervertebral spaces L5/S1 , L4/5 , L3/4 and L2/3 were each approached through slightly different , but st and ardized , mini-laparotomies either through a retroperitoneal or a transperitoneal route . The clinical results with a follow-up of up to 1 year show satisfactory outcomes in about 80 % of the patients . Oswestry score as well as VAS values show significant changes during the postoperative course . There have been three complications ( 8.8 % ) , two of which were specific to the implantation process , but were resolved with a good clinical outcome in both patients . The preliminary results suggest that total disc replacement may become a reasonable alternative to spinal fusion under the selection criteria used in this study",
"An attempt was made to determine the relative contribution of various structures to chronic low back pain , including facet joint(s ) , disc(s ) , and sacroiliac joint(s ) in a prospect i ve evaluation . Precision diagnostic blocks , including disc injections , facet joint blocks , and sacroiliac joint injections , are frequently used . In contrast , selective nerve root blocks or transforaminal epidural injections are used occasionally to evaluate persistent or recurrent low back pain in patients without appropriate radiologic or neurophysiologic diagnosis . One hundred and twenty patients with a chief complaint of low back pain were evaluated with precision diagnostic injections , which included medial branch blocks , provocative discography and sacroiliac joint injections . In 40 % ( 95 % CL , 31 % , 49 % ) , of the patients , facet joint pain was diagnosed ; and in 26 % ( 95 % CL , 18 % , 34 % ) of the patients discogenic pain was diagnosed ; and 2 % of the patients were diagnosed with sacroiliac joint pain",
"Acquired degenerative disc disease causes gradual disc space collapse , concurrent discogenic or facet-induced pain , and possible compression radiculopathy . Surgical treatment aims to re-exp and the intervertebral space and stabilize the involved segment in balanced alignment until fusion is complete . The prevailing methods make use of a twin cage device of predetermined size . Their implantation requires extensive exposure , entailing the sacrifice of posterior stabilizing structures . The procedure also results in significant traction on the dural sac and the cauda equina and is thereby a potential source of neurologic damage . The new exp and able spinal spacer ( ESS ) was design ed to mitigate all the shortcomings alluded to above . A prospect i ve multicenter clinical study was conducted of 87 patients with chronic low back pain due to degenerative disc disease , treated by posterior lumbar interbody fusion ( PLIF ) using a newly design ed ESS . The study protocol was approved by the ethics committees of all the participating institutions . The objective was to test the safety and efficacy of the device . Each participant was followed periodically for > 1 postoperative year . The ongoing record included intraoperative difficulties and complications , if any , radiologic evidence of fusion and clinical outcome as scored by pre- and postoperative question naires pertaining to pain intensity and degree of disability . No dural lacerations or neurologic deficit occurred . There were no mechanical failures of the spacer . Radiologic study demonstrated fusion in all but one patient . Disc space height that averaged 7.53 ± 2.42 mm before surgery increased to 10.03 ± 2.00 mm at the time of surgery and stabilized at 9.47 ± 2.10 mm upon final follow-up . Visual Analog Scale and Oswestry Index decreased by 60 % and 58 % , respectively . PLIF using the ESS achieves the same ultimate outcome as do other methods currently in use but does not share the h and icaps and hazards and is more user-friendly to the surgeon",
"ABSTRACT The discTRODE ™ probe applies radiofrequency ( RF ) current , heating the annulus to treat chronic discogenic low back pain . R and omized controlled studies have not been published . We assessed the long‐term effect and safety aspects of percutaneous intradiscal radiofrequency thermocoagulation ( PIRFT ) with the discTRODE ™ probe in a prospect i ve parallel , r and omized and gender stratified , double‐blind placebo‐controlled study . Twenty selected patients with chronic low back pain and a positive one‐level pressure‐controlled provocation discography were r and omized to either intra‐annular PIRFT or intra‐annular sham treatment . A blinded interim analysis was performed when 20 patients had been followed for six months . The 6‐month analysis did not reveal any trend towards overall effect or difference between active and sham treatment for the primary endpoint : change in pain intensity ( 0–10 ) . The inclusion of patients was therefore discontinued . After 12 months the overall reduction from baseline pain had reached statistical significance , but there was no significant difference between the groups . The functional outcome measures ( Oswestry Disability Index , and SF 36 subscales and the relative change in pain ) appeared more promising , but did not reach statistical significance when compared with sham treatment . Two actively treated and two sham‐treated patients reported increased pain levels , and in both groups a higher number was unemployed after 12 months . The study did not find evidence for a benefit of PIRFT , although it can not rule out a moderate effect . Considering the high number , reporting increased pain in our study , we would not recommend intra‐annular thermal therapy with the discTRODE ™ probe",
"BACKGROUND On the basis of observational data , intradiscal electrothermal anuloplasty ( IDETA ) has been implemented as a treatment for back pain result ing from internal disc disruption . PURPOSE To assess the efficacy of IDETA . STUDY DESIGN Prospect i ve cohort study with comparison group and 2-year follow-up . PATIENT SAMPLE Of 53 patients who satisfied the diagnostic criteria for internal disc disruption , 36 were allocated to a treatment group and 17 to a comparison group , according to whether their insurer approved treatment with IDETA . OUTCOME MEASURES Outcomes were assessed in terms of relief of pain , return to work and use of opioids to treat persisting pain . METHODS The treatment group underwent IDETA . The comparison group underwent a conventional rehabilitation program . Outcomes were assessed at 3 months , 12 months and 2 years after treatment . RESULTS As a group , the comparison patients exhibited no significant improvement in their pain at any time . One was partially relieved , but no patient was completely relieved at either 12 or 24 months . The patients treated with IDETA exhibited significant improvements in their median pain scores , which were sustained at 12 and 24 months . At 24 months , 54 % of these patients had achieved at least 50 % relief of their pain , no longer used opioids and were at work . Seven patients ( 20 % ) were totally free of pain and at work at 24 months . CONCLUSIONS The long-term results of IDETA are stable and enduring . It is not universally successful , but 54 % of patients can reduce their pain by half , and one in five patients can expect to achieve complete relief of their pain",
"In a multicenter , prospect i ve , r and omized , nonblinded , 2-year study , 279 patients with degenerative lumbar disc disease were r and omly divided into two groups that underwent interbody fusion using two tapered threaded fusion cages . The investigational group ( 143 patients ) received rhBMP-2 on an absorbable collagen sponge , and a control group ( 136 patients ) received autogenous iliac crest bone graft . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 , and 24 months after surgery . Mean operative time ( 1.6 hours ) and blood loss ( 109.8 mL ) were less in the investigational rhBMP-2 group than in the autograft control group ( 2.0 hours and 153.1 mL ) . At 24 months the investigational group 's fusion rate ( 94.5 % ) remained higher than that of the control group ( 88.7 % ) . New bone formation occurred in all investigational patients . At all intervals , mean postoperative Oswestry , back pain , and leg pain scores and neurologic status improved in both treatment groups with similar outcomes . In the control group , eight adverse events related to the iliac crest graft harvest occurred ( 5.9 % ) , and at 24 months 32 % of patients reported graft site discomfort and 16 % were bothered by its appearance . Lumbar fusion using rhBMP-2 and a tapered titanium fusion cage can yield a solid union and eliminate the need for harvesting iliac crest bone graft",
"Abstract . In this prospect i ve study , a total of 134 prosthetic discs were replaced in 108 patients undergoing total disc replacement surgeries for degenerative disc disease . It was the aim of this study to correlate the clinical findings and the outcome of our patients treated with Prodisc II prostheses for various indications and to formulate indication criteria for disc replacement surgeries . The discs were implanted at L5/S1 in 61 patients , L5/L6 in 3 patients , L4/L5 in 31 patients , L3/L4 in 7 patients , and L2/L3 in 3 patients . There were 12 patients with two-level implants : from L4 to S1 in 11 of them and from L2 to L5 in the remaining one . Two patients also had three-level implants , from L3 to S1 . Follow-up evaluation included plain radiographs , physical evaluation , and subjective evaluation by the patient using the Oswestry scale , the visual analog pain scale , and the SF-36V2 well-being question naire . The evaluation exercise showed that 90.8 % of patients had excellent results , 7.4 % had good results and 1.8 % had fair results , with no poor results seen . Postoperatively , the average vertebral motion was increased in all patients at the operated level . Progression of disc degeneration at the adjacent levels was noted in ten patients . The average time to resuming activities of daily living unaided was 2.3 weeks . No implant failures or complications due to surgery were encountered in this study . Total prosthesis disc replacement for degenerative disc disease was found to be a good treatment modality , provided proper patient selection and criteria are adhered to . We were able to formulate indication criteria based on this",
"This article was a preliminary report of prospect i ve clinical trial of a group of patients with chronic discogenic low back pain who met the criteria for lumbar interbody fusion surgery but were treated instead with an intradiscal injection of methylene blue ( MB ) for the pain relief . Twenty-four patients with chronic discogenic low back pain underwent diagnostic discography with intradiscal injection of MB . The principal criteria to judge the effectiveness included alleviation of pain , assessed by visual analog scale ( VAS ) , and improvement in disability , as assessed with the Oswestry Disability Index ( ODI ) for functional recovery . The mean follow-up period was 18.2 months ( range 12–23 months ) . Of the 24 patients , 21 ( 87 % ) reported a disappearance or marked alleviation of low back pain , and experienced a definite improvement in physical function . A statistically significant and clinical ly meaningful improvement in the changes in the ODI and the VAS scores were obtained in the patients with chronic discogenic low back pain ( P=0.0001 ) after the treatment . The study suggests that the injection of MB into the painful disc may be a very effective alternative for the surgical treatment of chronic discogenic low back pain",
"CONTEXT Low back pain ( LBP ) has a major economic impact in the United States , with total costs related to this condition exceeding $ 100 billion per year . OBJECTIVE To estimate the cost of st and ard care compared to st and ard care plus osteopathic manipulative treatment ( OMT ) for acute LBP of less than 6 months ' duration . METHODS A retrospective review of electronic medical records from patients who visited Florida Hospital East Orl and o in Orl and o. All patients had LBP of less than 6 months ' duration and had received care between January 1 , 2002 , and December 31 , 2005 . The control group comprised patients who received st and ard care ; the study group consisted of patients who received OMT in addition to st and ard care . Healthcare utilization ( eg , radiologic scans , prescriptions ) was determined by \" episodes of care , \" and costs were averaged per patient . RESULTS A total of 1556 patients and 2030 episodes of care met inclusion criteria . Compared with subjects in the control group , individuals in the OMT group had an average of 0.5 more office visits per EOC , result ing in 38 % more office visits . However , OMT patients had 18.5 % fewer prescriptions written , 74.2 % fewer radiographs , 76.9 % fewer referrals , and 90 % fewer magnetic resonance imaging scans . In the OMT group , total average costs were $ 38.26 lower ( P=.02 ) , and average prescription costs were $ 19.53 lower ( P OMT group also had $ 63.81 less average radiologic costs ( P Osteopathic manipulative treatment may reduce costs for the management of acute LBP . Further research in a prospect i ve study is needed",
"Study Design . A prospect i ve , r and omized , controlled clinical trial comparing a cylindrical threaded titanium cage to a femoral ring allograft control for anterior lumbar interbody fusion . Objective . To compare these two implants with regard to arthrodesis . Secondary outcome measures included pain relief , neurological status , and general health status . Summary of Background Data . Anterior lumbar interbody fusion is a well-accepted procedure using trapezoidal femoral ring allografts or cylindrical titanium cages . Clinical and biomechanical studies evaluating these two distinct constructs are numerous ; however , no prospect i ve , r and omized study comparing them has been done . Methods . A multicenter trial of 140 patients : 78 were r and omized to the cylindrical threaded titanium cage device treatment arm and 62 patients r and omized into the control group . All had autogenous iliac crest bone graft packed into the device . All patients had a single-level st and -alone anterior lumbar interbody fusion at either the L4–L5 or L5–S1 interspace for symptomatic degenerative disc disease . Radiographic fusion data were collected as well as multiple types of outcome data , including pain/disability scores , neurologic status , and overall health . Results . At 12 months , 97 % of the cylindrical threaded titanium cage device group and 40 % of the control group demonstrated radiographic fusion . At 24 months , 97 % of the cylindrical threaded titanium cage group and 52 % of the control group showed radiographic fusion . These fusion rate differences are statistically significant ( P Oswestry and neurologic scores were not significantly different between groups . Discussion . This is the first prospect i ve , r and omized , multicenter clinical trial that compares fusion cage results to control data . Conclusion . Cylindrical threaded titanium cages have a higher fusion rate , comparable improvements in clinical outcome ( Oswestry , Low Back Pain Question naire , SF-36 ) , and fewer secondary supplemental fixation procedures compared to the femoral ring allograft control",
"Study Design . A prospect i ve nonr and omized clinical trial . Objective . To determine the outcome in a group of patients with chronic , function-limiting low back pain who met the criteria for interbody fusion surgery , but were instead treated with an intradiscal thermal catheter ( SpineCath , Oratec Interventions , Inc. , Menlo Park , CA ) . Summary of Background Data . This study represents the first reported trial of treatment for chronic discogenic low back pain with a novel thermal intradiscal catheter . Methods . The authors evaluated 25 consecutive patients . The minimum duration of nonoperative care with the authors was 6 months . The visual analog pain scores , sitting tolerance times , and SF-36 summary scores were tabulated . Results . The mean follow-up period was 7 months , and the mean duration of symptoms 58.5 months . Of the 25 patients , 20 ( 80 % ) reported a reduction of at least 2 points in visual analog pain scores , and 18 ( 72 % ) reported an improvement in sitting tolerance as well as reduction or discontinuance of analgesic medication . Visual analog pain scores improved by a mean reduction of 3.74 , a 51 % change ( P = 0.0001 ) . On the SF-36 physical function subscale , 72 % of the patients improved by a mean increase of 15 points ( P = 0.001 ) , a mean change of 38 % , and by a mean increase of 14 points on the bodily pain subscale ( P = 0.004 ) , a mean change of 48 % . Conclusions . A statistically significant improvement in functional outcome was obtained in patients with chronic discogenic low back pain treated thermally by the SpineCath",
"Study Design . Prospect i ve , match-cohort study of disc degeneration progression over 10 years with and without baseline discography . Objectives . To compare progression of common degenerative findings between lumbar discs injected 10 years earlier with those same disc levels in matched subjects not exposed to discography . Summary of Background Data . Experimental disc puncture in animal and in vivo studies have demonstrated accelerated disc degeneration . Whether intradiscal diagnostic or treatment procedures used in clinical practice causes any damage to the punctured discs over time is currently unknown . Methods . Seventy-five subjects without serious low back pain illness underwent a protocol MRI and an L3/4 , L4/5 , and L5/S1 discography examination in 1997 . A matched group was enrolled at the same time and underwent the same protocol MRI examination . Subjects were followed for 10 years . At 7 to 10 years after baseline assessment , eligible discography and controlled subjects underwent another protocol MRI examination . MRI grade rs , blind to group design ation , scored both groups for qualitative findings ( Pfirrmann grade , herniations , endplate changes , and high intensity zone ) . Loss of disc height and loss of disc signal were measured by quantitative methods . Results . Well matched cohorts , including 50 discography subjects and 52 control subjects , were contacted and met eligibility criteria for follow-up evaluation . In all grade d or measured parameters , discs that had been exposed to puncture and injection had greater progression of degenerative findings compared to control ( noninjected ) discs : progression of disc degeneration , 54 discs ( 35 % ) in the discography group compared to 21 ( 14 % ) in the control group ( P = 0.03 ) ; 55 new disc herniations in the discography group compared to 22 in the control group ( P = 0.0003 ) . New disc herniations were disproportionately found on the side of the anular puncture ( P = 0.0006 ) . The quantitative measures of disc height and disc signal also showed significantly greater loss of disc height ( P = 0.05 ) and signal intensity ( P = 0.001 ) in the discography disc compared to the control disc . Conclusion . Modern discography techniques using small gauge needle and limited pressurization result ed in accelerated disc degeneration , disc herniation , loss of disc height and signal and the development of reactive endplate changes compared to match-controls . Careful consideration of risk and benefit should be used in recommending procedures involving disc injection",
"OBJECTIVE Two minimally invasive techniques have been used more recently as a possible treatment for painful internal disk disruption ( IDD ) . Intradiscal thermal annuloplasty ( IDTA ) , known as IDET , has already shown promising results in pain reduction and functional restoration . The second technique , radiofrequency posterior annuloplasty ( RFA ) , is used in many interventional pain practice s , although studies on the technique 's efficacy are lacking . This study compares the effectiveness of those two methods . DESIGN AND PATIENTS We matched 42 patients ( 21 had IDTA and 21 radiofrequency annuloplasty ) for age , sex , weight , smoking history , manual labor , and number of intervertebral disks treated . Enrolled patients completed pain disability index ( PDI ) question naires before receiving either IDTA or RFA ; at 2 weeks ; and 2 , 3 , 6 , 9 , and 12 months following either treatment . RESULTS From the third to the twelfth month after the procedure , the IDTA group had significantly lower mean pain scores than the RFA group . Visual analog scale ( VAS ) pain scores decreased from 6.6 + /- 2.0 before to 4.4 + /- 2.4 at 1 year after radiofrequency annuloplasty ( P = 0.001 ) , while in the IDTA group the average VAS pain score decreased from 7.4 + /- 1.9 before IDTA to 1.4 + /- 1.9 at 1 year follow-up . Similarly , PDI scores in the IDTA group had a significantly larger improvement than those for patients who received radiofrequency annuloplasty . CONCLUSIONS This study shows significant improvement in pain scores and patients ' PDI following IDTA but not after RFA of the intervertebral disks . IDTA appears to be more efficacious than RFA based on PDI and VAS scores measured at 1 year following procedure",
"Study Design Single-arm , prospect i ve clinical trial . Objective To evaluate back pain severity , physical function , and quality of life outcomes in highly selected patients with lumbar discogenic pain treated with intradiscal electrothermal therapy ( IDET ) . Summary of Background Data Degeneration and disruption of the intervertebral disc can be the source of severe low back pain and the associated physical dysfunction . IDET is a minimally invasive treatment option in the continuum of care between conservative nonoperative management and spinal surgery . Methods Using magnetic resonance imaging , pressure-controlled discography , and postdiscogram computed tomography findings , 56 patients with lumbar discogenic pain were identified , underwent IDET treatment and followed for 20.5±4.4 months , on average . Outcomes included assessment s of back pain severity by visual analog scale , sitting , st and ing , and walking tolerances , and health-related quality of life using the SF-36 . Results Mean pain severity scores ( visual analog scale ) improved from 6.1±1.8 pretreatment to 2.4±2.6 at final follow-up ( P=0.0001 ) . Mean tolerance times ( minutes ) improved from 40.9±40.6 to 84.5±54.4 , 46.8±42.9 to 84.4±54.2 , and 39.2±39.6 to 77.9±50.8 between baseline and final follow-up for sitting , st and ing , and walking , respectively ( P=0.0001 for all comparisons ) . Seven of 8 quality of life domains showed significant ( P=0.0001 for all comparisons ) improvement over baseline . Forty-two patients ( 75 % ) were classified as a treatment success by virtue of a ≥2-point improvement in pain severity or a ≥10-point improvement in either the physical functioning or bodily pain domain of the SF-36 . Conclusions The findings of this study suggest that durable clinical improvements can be realized after IDET in highly selected patients with mild disc degeneration , confirmatory imaging evidence of annular disruption , and concordant pain provocation by low pressure discography",
"Study Design . Fifty-two patients with degenerative disc disease underwent single- or double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation as treatment for degenerative disc disease and were prospect ively followed for 4 years . Objectives . To test the clinical performance of anterior lumbar interbody fusion with SynCage , with emphasis on the safety and efficacy of the surgical procedure and the ability to restore anatomy and fuse the motion segment . Summary of Background Data . Anterior lumbar interbody fusion using femoral allograft and /or autologous bone has a high complication rate . With cage technology , some of these complications can be avoided . The design characteristics of the SynCage offer advantages in restoring and maintaining intervertebral height and restoration of lumbar lordosis . Methods . Thirty-three patients underwent single-level and 19 patients double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation ( translaminar screws , n = 32 or pedicle screws , n = 10 ) . Radiologic and functional results ( VAS and Oswestry score ) were evaluated . Results . Intervertebral height was corrected from an average of 8.7 to 17.6 mm . Lordosis of the fused segment was significantly increased ( average 10.6 ° for the fused segment and 8 ° for lumbosacral lordosis ) . After 2 years , there was radiologic evidence for fusion in 70 of 71 ( 98.6 % ) levels . Functional scores showed a significant improvement in pain and function up to the 2-year follow-up observation . At the 4-year follow-up observation , there was some loss of the initial improvement in VAS and Oswestry scores . Despite this loss , they remained significantly better than the preoperative scores . Conclusions . Anterior lumbar interbody fusion with SynCage and additional posterior fixation is a safe and effective procedure . Intervertebral height is corrected , and lumbosacral lordosis is restored . An initial improvement in VAS and Oswestry scores is partly lost at the 4-year follow-up observation , but 4-year results are still significantly better than the preoperative scores",
"Abstract . The goal of this study was to evaluate the short-term effects of intradiscal electrothermal treatment ( IDET ) for chronic discogenic low back pain . Twenty consecutive patients with symptomatic degenerative discs were treated with IDET and evaluated preoperatively , and 3 and 6 months postoperatively . Pain was measured with a 100-mm visual analog scale ( VAS ) and function was evaluated with the Oswestry score and SF-36 question naire . The VAS scores improved by 14 mm on average ( P=0.046 ) , but the individual scores show great variation . The Oswestry scores did not improve significantly . The SF-36 showed improvement , but only for the subscales vitality ( P=0.023 ) and bodily pain ( P=0.047 ) . Based on these results , we conclude that IDET is not effective in reducing pain and improving functional performance in a sample of 20 patients treated for chronic discogenic low back pain after 6 months follow-up",
"Objective The objective of this study was to determine the efficacy of percutaneous radiofrequency ( RF ) thermocoagulation of the ramus communicans nerve in patients suffering from chronic discogenic low back pain . Methods Forty-nine patients who suffered chronic discogenic low back pain at only 1 painful vertebral level , and whose pain continued after undergoing intradiscal electrothermal annuloplasty ( IDET ) , were r and omly assigned to 1 of 2 treatment groups . The lesion group ( n = 26 ) received RF thermocoagulation of the ramus communicans nerve . Patients in the control group ( n = 23 ) received an injection of lidocaine without radiofrequency . Visual analog scale ( VAS ) pain scores , analgesic requirements , SF-36 subscales , and the overall patient satisfaction with the procedure were tabulated . Results The average follow-up period was 4 months . The patient-reported VAS pain scores were significantly lower ( P bodily pain subscale , and by a mean increase of 12.4 points on the physical function subscale ( P VAS pain scores improved by a mean reduction of 3.32 ( P = 0.001 ) . The scores improved by a mean increase of 14.5 points ( P = 0.005 ) on the SF-36 bodily pain subscale and 15.2 points(P = 0.002 ) on the physical function subscale within the RF lesion group . One patient in the lesion group complained of mild lower limb weakness , but he completely recovered at postoperative 15 days without any serious problems . Discussion In patients with chronic discogenic low back pain , percutaneous RF denervation of the ramus communicans nerve should be considered as a treatment option",
"BACKGROUND CONTEXT In a large series of human patients undergoing open anterior lumbar interbody fusion with a tapered titanium fusion cage , recombinant human bone morphogenetic protein type 2 ( rhBMP-2 ) on an absorbable collagen sponge carrier has been shown to decrease operative time and blood loss , to promote osteoinduction and fusion and to be a safe and effective substitute for iliac crest harvesting . PURPOSE The purpose of the study was to determine the clinical and radiographic outcomes in patients treated for single-level degenerative lumbar disc disease with a posterior interbody fusion , using st and -alone cylindrical threaded titanium fusion cages with either autogenous bone graft or rhBMP-2 and an absorbable collagen sponge carrier . STUDY DESIGN / SETTING A prospect i ve , r and omized , nonblinded , 2-year pilot study at 14 investigational sites . PATIENT SAMPLE Between March 1999 and December 1999 , 67 patients with symptomatic , single-level degenerative lumbar disc disease of at least 6 months ' duration underwent a single-level posterior lumbar interbody fusion using two paired cylindrical threaded titanium fusion devices . Patients were r and omly assigned to one of two groups : one ( n=34 patients ) received rhBMP-2 on a collagen sponge carrier ; the other ( n=33 patients ) autogenous iliac crest bone graft . OUTCOME MEASURES Clinical outcomes were measured using low back and leg pain numerical rating scales , the Short Form (SF)-36 , Oswestry Low Back Pain Disability Question naire and work status . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 and 24 months after surgery . METHODS In this prospect i ve nonblinded study , 67 patients were r and omly assigned to one of two groups who underwent interbody fusion using two cylindrical threaded fusion cages : the investigational group ( 34 patients ) , who received rhBMP-2 on an absorbable collagen sponge , and a control group ( 33 patients ) , who received autogenous iliac crest bone graft . Clinical data were collected and analyzed by a commercial entity . RESULTS The mean operative time and blood loss for the investigational rhBMP-2 group was 2.6 hours and 322.8 ml , respectively . For the autograft control group , these values were 3.0 hours and 372.7 ml . The differences were not significant . Although not statistically different , at 24 months , the investigational group 's fusion rate of 92.3 % was higher than the control 's at 77.8 % . At all postoperative intervals , the mean Oswestry , back and leg pain scores and physical components of the SF-36 improved in both treatment groups compared with preoperative scores , but no significant differences were found between groups . A statistically significant difference in the change in back pain was found at 24 months for the investigational group . In the control group , two adverse events related to harvesting of the iliac crest graft occurred in two patients ( 6.1 % ) . CONCLUSIONS This small multicenter , r and omized , nonblinded trial showed few statistically significant differences between the study groups . Both groups showed comparable improvements on outcome scores . Overall results show that the use of rhBMP-2 can eliminate the need for harvesting iliac crest graft and may be an equivalent replacement for autograft for use in successful posterior lumbar interbody fusions . Further studies of the use of rhBMP-2 in posterior lumbar interbody fusion cage procedures are needed",
"Study Design . A prospect i ve , r and omized , multicenter , Food and Drug Administration-regulated Investigational Device Exemption clinical trial . Objectives . The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement , using the CHARITÉ ™ artificial disc ( DePuy Spine , Raynham , MA ) , with anterior lumbar interbody fusion , for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment . Summary of Background Data . Reported results of lumbar total disc replacement have been favorable , but studies have been limited to retrospective case series and /or small sample sizes . Methods . Three hundred four ( 304 ) patients were enrolled in the study at 14 centers across the United States and r and omized in a 2:1 ratio to treatment with the CHARITÉ ™ artificial disc or the control group , instrumented anterior lumbar interbody fusion . Data were collected pre- and perioperatively at 6 weeks and at 3 , 6 , 12 , and 24 months following surgery . The key clinical outcome measures were a Visual Analog Scale assessing back pain , the Oswestry Disability Index question naire , and the SF-36 Health Survey . Results . Patients in both groups improved significantly following surgery . Patients in the CHARITÉ ™ artificial disc group recovered faster than patients in the control group . Patients in the CHARITÉ ™ artificial discgroup had lower levels of disability at every time interval from 6 weeks to 24 months , compared with the control group , with statistically lower pain and disability scores at all but the 24 month follow-up ( P 0.05 ) . The hospital stay was significantly shorter in the CHARITÉ ™ artificial disc group ( P 0.05 ) . The complication rate was similar between both groups . Conclusions . This prospect i ve , r and omized , multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITÉ ™ artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion . These results support earlier reports in the literature that total disc replacement with the CHARITÉ ™ artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients . The CHARITÉ ™ artificial disc group demonstrated statistically significant superiority in two major economic areas , a 1-day shorter hospitalization , and a lower rate of reoperations ( 5.4 % compared with 9.1 % ) . At 24 months , the investigational group had a significantly higher rate of satisfaction ( 73.7 % ) than the 53.1 % rate of satisfaction in the control group ( P = 0.0011 ) . This prospect i ve r and omized multicenter study also demonstrated an increase in employment of 9.1 % in the investigational group and 7.2 % in the control group",
"Study Design . A prospect i ve , nonr and omized multicenter study of lumbar disc nucleus replacement using the DASCOR Disc Arthroplasty Device . An interim analysis of clinical results is presented , obtained from European patients enrolled in 2 studies . Objective . To determine the safety and efficacy of the DASCOR Device for the treatment of symptomatic single-level degenerative disc disease ( DDD ) . Summary of Background Data . Patients suffering from DDD have been limited to a choice between nonoperative therapies or invasive surgical treatments such as total disc replacement or spinal fusion . The DASCOR Device was developed to provide an alternative treatment with a less invasive surgical intervention . Methods . A total of 85 patients from 11 European centers were enrolled in 1 of 2 studies between February 2003 and July 31 , 2007 . Data were collected before surgery and after surgery at 6 weeks and at 3 , 6 , 12 , and 24 months . The clinical outcome measures were obtained from the Visual Analog Scale ( VAS ) for back pain , the Oswestry Disability Index ( ODI ) , radiographic assessment s , and records of analgesic medication use . Results . Mean VAS and ODI scores improved significantly after 6 weeks and throughout the 2 years . Radiographic results demonstrated , at a minimum , maintenance of disc height with no device expulsion and , despite Modic-Type 1 changes , no subsidence . Fourteen patients had serious adverse events including device explants in 7 patients ( 7 of 85 ) , in which the main complication was resumed back pain after time . Patients ’ rate of analgesic medication decreased dramatically over time , with all patients experiencing significant improvements after 3 months and nearly no analgesic medication or narcotic drug use at 2 years . Conclusion . The interim outcomes showed significant improvements in mean ODI and VAS scores . The results of these European studies suggest that the DASCOR Device may be a safe and effective less-invasive surgical option for patients with DDD",
"BACKGROUND This study 's goal was a retrospective chart audit of 100 out patients with discogenic low back pain ( LBP ) lasting more than 12 weeks treated with a 2-month course of motorized spinal decompression via the DRX9000 ( Axiom Worldwide , Tampa , FL , U.S.A. ) . METHODS Patients at a convenience sample of four clinics received 30-minute DRX9000 sessions daily for the first 2 weeks tapering to 1 session/week . Treatment protocol included lumbar stretching , myofascial release , or heat prior to treatment , with ice and /or muscle stimulation afterwards . Primary outcome was verbal numerical pain intensity rating ( NRS ) 0 to 10 before and after the 8-week treatment . RESULTS Of the 100 initial subjects , three withdrew their protected health information , and three were excluded because their LBP duration was less than 12 weeks . The remaining 94 subjects ( 63 % female , 95 % white , age = 55 ( SD 16 ) year , 52 % employed , 41 % retired , LBP median duration of 260 weeks ) had diagnoses of herniated disc ( 73 % of patients ) , degenerative disc disease ( 68 % ) , or both ( 27 % ) . Mean NRS equaled 6.05 ( SD 2.3 ) at presentation and decreased significantly to 0.89 ( SD 1.15 ) at end of 8-week treatment ( P Analgesic use also appeared to decrease ( charts with data = 20 ) and Activities of Daily Living improved ( charts with data = 38 ) . Follow-up ( mean 31 weeks ) on 29/94 patients reported mean 83 % LBP improvement , NRS of 1.7 ( SD 1.15 ) , and satisfaction of 8.55/10 ( median 9 ) . CONCLUSIONS This retrospective chart audit provides preliminary data that chronic LBP may improve with DRX9000 spinal decompression . R and omized double-blind trials are needed to measure the efficacy of such systems",
"BACKGROUND Intradiscal electrothermal therapy ( IDET ) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested . PURPOSE To compare the efficacy of IDET with that of a placebo treatment . STUDY DESIGN / SETTING R and omized , placebo-controlled , prospect i ve trial . PATIENT SAMPLE Patients were recruited by referral and the media . No inducements were provided to any patient in order to have them participate . Of 1,360 individuals who were prepared to su bmi t to r and omization , 260 were found potentially eligible after clinical examination and 64 became eligible after discography . All had discogenic low back pain lasting longer than 6 months , with no comorbidity . Thirty-seven were allocated to IDET and 27 to sham treatment . Both groups were satisfactorily matched for demographic and clinical features . METHODS IDET was performed using a st and ard protocol , in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure . Thirty-two ( 85 % ) of the patients r and omized to the IDET group and 24 ( 89 % ) of those assigned to the sham group complied fully with the protocol of the study , and complete follow-up data are available for all of these patients . OUTCOME MEASURES The principal outcome measures were pain and disability , assessed using a visual analog scale for pain , the Short Form (SF)-36 , and the Oswestry disability scale . RESULTS Patients in both groups exhibited improvements , but mean improvements in pain , disability and depression were significantly greater in the group treated with IDET . More patients deteriorated when subjected to sham treatment , whereas a greater proportion showed improvements in pain when treated with IDET . The number needed to treat , to achieve 75 % relief of pain , was five . Whereas approximately 40 % of the patients achieved greater than 50 % relief of their pain , approximately 50 % of the patients experienced no appreciable benefit . CONCLUSIONS Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET , but its efficacy can not be attributed wholly to a placebo effect . The results of this trial can not be generalized to patients who do not fit the strict inclusion criteria of this study , but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain",
"Study Design . Case-control study . Objectives . To determine the prima facie efficacy of intradiscal electrothermal anuloplasty ( IDTA ) . Summary of Background Data . Although it is being used increasingly as a putative treatment for internal disc disruption , no studies have been published on the efficacy of IDTA . Methods . Fifty-three patients with back pain determined by computed tomographic (CT)-discography to be due to internal disc disruption were offered treatment . The outcomes of 35 patients treated with IDTA were compared with those of a convenience sample of 17 patients treated with a physical rehabilitation program , by using a visual analog pain scale , use of analgesics , and return to work as measures . Results . At 3 months , only one control patient obtained any significant degree of relief of pain , compared with 23 in the index group . Relief of pain was sustained at 6 and 12 months and was associated with improvement in disability , reduced drug use , and a return to work rate of 53 % . Depending on the stringency of criteria used , the success rate of IDTA may be as low as 23 % or as high as 60 % with confidence intervals of ±16 % . Conclusions . In carefully selected cases , IDTA can eliminate or dramatically reduce the pain of internal disc disruption in a substantial proportion of patients and appears to be superior to conventional conservative care for internal disc disruption",
"BACKGROUND Intervertebral discs , facet joints , ligaments , fascia , muscles , and nerve root dura have been described as tissues capable of transmitting pain in the low back . The pathophysiology of spinal radicular pain is the subject of ongoing research and controversy with discogenic pain assuming a major role as a cause of non-specific low back pain . Even though epidural injections are frequently administered in managing axial low back pain , the evidence is lacking . STUDY DESIGN A r and omized , double-blind , equivalence trial . SETTING An interventional pain management practice , a specialty referral center , a private practice setting in the United States . OBJECTIVES To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back pain without disc herniation or radiculitis in providing effective and long-lasting pain relief and to evaluate the differences between local anesthetic with or without steroids . METHODS Patients were r and omly assigned to one of 2 groups , Group I patients received caudal epidural injections with local anesthetic ( lidocaine 0.5 % ) , whereas Group II patients received caudal epidural injections with 0.5 % lidocaine 9 mL mixed with 1 mL of steroid . R and omization was performed by computer-generated r and om allocation sequence by simple r and omization . OUTCOMES ASSESSMENT Multiple outcome measures were utilized which included the Numeric Rating Scale ( NRS ) , the Oswestry Disability Index 2.0 ( ODI ) , employment status , and opioid intake with assessment at 3 months , 6 months , and 12 months post-treatment . Significant pain relief was defined as 50 % or more , whereas significant improvement in disability score was defined as reduction of 40 % or more . RESULTS Significant pain relief ( > or = 50 % ) was demonstrated in 72 % to 81 % of patients and functional status improvement was demonstrated by a reduction of 40 % in the ODI scores in 81 % of the patients . The overall average procedures per year were 3.6 + /- 1.05 in Group I and 3.9 + /- 1.33 in Group II with an average total relief per year of 32.3 + /- 16.93 weeks in Group I and 30.7 + /- 17.94 weeks in Group II over a period of 52 weeks . LIMITATIONS The results of this study are limited by lack of a placebo group and a preliminary report of 36 patients in each group . CONCLUSION Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back pain without facet joint pain , disc herniation , and /or radiculitis in over 70 % of the patients",
"A lumbar total disc replacement ( TDR ) is believed to be a promising substitute in the surgical treatment for lumbar degenerative disc disease . The purpose of this study is to report the clinical and radiographic outcomes of 36 consecutive patients who underwent lumbar TDR using ProDisc II , and the factors associated with a better clinical outcome after a 2-year minimum follow-up . At the time of the latest follow-up , the success rate was 94 % of 36 patients according to the criteria of the US Food and Drug Administration . Of the 10 patients unable to work preoperatively , 7 patients returned to work . Moreover , mean score on the visual analog scale for low back and leg pain improved significantly from 7.5 and 4.7 to 3.0 and 1.2 , respectively ( P mean Oswestry disability index scores improved significantly from 69.2 to 21.0 ( P Mean disc height at the operative level increased significantly from 9.0 to 17.6 mm , and mean range of motion increased significantly from 9.7 to 12.7 degrees ( P better clinical outcome were single level , and a higher postoperative segmental ROM at the operative level . At a minimum follow-up of 2 years , the lumbar TDR using ProDisc II showed excellent clinical and radiographic outcomes without any significant complication . However , future efforts need to be directed toward the evaluation of a larger number of patients with longer follow-up",
"BACKGROUND No conclusive evidence exists to determine that spinal steroid injections give lasting improvement in patients with predominantly axial low back pain result ing from lumbar degenerative disc disease ( DDD ) . PURPOSE The objectives of the study were to determine the effect of epidural steroid injections ( ESIs ) and intradiscal steroid injections ( ISIs ) in patients who exhibit DDD symptoms for more than 1 year and to determine whether patients with inflammatory end-plate changes are a unique subgroup of DDD patients in terms of treatment response . STUDY DESIGN Pain and function in patients with DDD were prospect ively assessed by an outcomes question naire before and after various spinal injections . Further correlation was made with end-plate inflammatory ( Modic Type 1 ) changes identified on magnetic resonance imaging ( MRI ) . PATIENT SAMPLE ESI was performed in 232 patients who were referred for treatment of DDD , and discography with or without intradiscal steroid was performed in 171 patients who were possible spinal arthrodesis c and i date s. OUTCOME MEASURES Pain and function were determined by a self-administered outcomes question naire that consisted of a visual analog pain scale , pain drawing , Oswestry Disability Index , use of pain medication and opinion of treatment success . METHODS ESI was performed in 93 patients with DDD and inflammatory end-plate changes and in 139 patients without inflammatory end-plate changes . Patients with inflammatory end-plate changes ( n=78 ) or without inflammatory end-plate changes ( n=93 ) , all of whom were considered fusion c and i date s , underwent discography with or without intradiscal steroid in a r and omized fashion . Pain and function were prospect ively determined by a self-administered outcomes survey ( VAS pain , Oswestry Disability index [ ODI ] , pain diagram [ PD ] and opinion of success ) before and after the patients ' injection for a 2-year follow-up period . MRI and discography results were correlated with patient outcomes scores . RESULTS ESI was effective in improving pain and function , as assessed by outcomes scores at short-term follow-up . However , at 2 years , less than one-third had not had additional invasive treatment . Patients with inflammatory end-plate changes had greater improvement in ODI and PD scores in the first 6 months than did those patients without the end-plate changes . Intradiscal steroid injections into discs with concordant pain at the time of discography led to significant improvement in patients with inflammatory end-plate changes in all outcomes scales , but only minimal temporary improvement in patients without the end-plate changes . Disc pressure manometry at the time of discography found that discs with adjacent inflammatory end-plate changes reproduced symptoms at pressures significantly lower than those in other types of discs . CONCLUSIONS Spinal steroid injections , both ESI and ISI , are beneficial for a small number of patients with advanced DDD and chronic low back pain . For those patients in whom a beneficial effect is found , spinal steroid injection is a low-risk and rapid treatment option . Spinal steroid injections are more effective in patients with MRI findings of discogenic inflammation , specifically adjacent inflammatory end-plate changes",
"Study Design . R and omized , controlled study . Objective . To evaluate the diagnosis of discogenic low back pain ( LBP ) with discography and discoblock . Summary of Background Data . Discogenic LBP is usually diagnosed by magnetic resonance imaging and discography . However , the reliability of discography is controversial . Previously , we reported the usefulness of discoblock with bupivacaine for diagnosis , and discoblock improved the results of anterior interbody fusion surgery . However , that study was not a r and omized , controlled study . Therefore , the purpose of the current study was to compare the results of surgery after diagnosis of LBP by discography and discoblock . Methods . Patients ( n = 42 ) with severe LBP showing L4–L5 or L5–S1 disc degeneration on magnetic resonance imaging were evaluated by discography ( 1.5 mL of contrast medium ) or discoblock ( intradisc injection of 0.75 mL of 0.5 % bupivacaine ) . We r and omized the patients in turn . Anterior discectomy and interbody fusion were performed in patients who responded to the diagnostic procedures . The visual analogue scale score ( 0 , no pain ; 100 , worst pain ) , Japanese Orthopedic Association Score ( 0 , worst pain ; 3 , no pain ) , Oswestry Disability Index , and patient satisfaction before and 3 years after surgery were recorded and compared between groups . Results . Twelve patients did not show pain provocation by discography or pain relief by discoblock and were excluded . Fifteen patients who showed pain provocation by discography and 15 patients who experienced pain relief with discoblock were evaluated . Rates of improvement in the visual analogue scale score , Japanese Orthopedic Association Score , and Oswestry Disability Index score in the discoblock group were significantly higher than those in the discography group ( P dissatisfied with surgery after discography compared with one patient after discoblock . Conclusion . Pain relief after injection of a small amount of bupivacaine into the painful disc was a useful tool for the diagnosis of discogenic LBP compared with discography",
"OBJECT The authors conducted a prospect i ve longitudinal study to obtain outcome ( minimum follow-up period 2 years ) regarding the safety and efficacy of single-level lumbar disc ( ProDisc prosthesis ) replacement in patients 60 years of age or older . METHODS This prospect i ve analysis involved 22 patients treated in whom the lumbar ProDisc prosthesis was used for total disc arthroplasty . All patients presented with disabling discogenic low-back pain ( LBP ) with or without radicular pain . The involved segments ranged from L-2 to S-1 . Patients in whom there was no evidence of radiographic circumferential spinal stenosis and with minimal or no facet joint degeneration were included . Patients were assessed preoperatively and outcome was evaluated postoperatively at 3 , 6 , 12 , and 24 months by administration of st and ardized tests ( the visual analog scale [ VAS ] , Oswestry Disability Index [ ODI ] , and patient satisfaction ) . Secondary parameters included analysis of pre- and postoperative radiographic results of disc height at the affected level , adjacent-level disc height and motion , and complications . Twenty-two ( 100 % ) fulfilled all follow-up criteria . The median age of all patients was 63 years ( range 61 - 71 years ) . There were 17 single-level cases , four two-level cases , and one three-level case . Statistical improvements in VAS , ODI , and patient satisfaction scores were observed at 3 months postoperatively . These improvements were maintained at 24-month follow-up examination . Patient satisfaction rates were 94 % at 24 months ( compared with 95 % reported in a previously reported ProDisc study ) . Radicular pain also decreased significantly . Patients in whom bone mineral density was decreased underwent same-session vertebroplasty following implantation of the ProDisc device(s ) . There were two cases involving neurological deterioration : unilateral foot drop and loss of proprioception and vibration in one patient and unilateral foot drop in another patient . Both deficits occurred in patients in whom there was evidence preoperatively of circumferential spinal stenosis . There were two cases of implant subsidence and no thromboembolic phenomena . CONCLUSIONS Significant improvements in patient satisfaction and ODI scores were observed by 3 months postoperatively and these improvements were maintained at the 2-year follow-up examination . Although the authors ' early results indicate that the use of ProDisc lumbar total disc arthroplasty in patients older than 60 years of age reduces chronic LBP and improves clinical functional outcomes , they recommend the judicious use of artificial disc replacement in this age group . Until further findings are reported , the authors cautiously recommend the use of artificial disc replacement in the treatment of chronic discogenic LBP in patients older than age 60 years in whom bone quality is adequate in the absence of circumferential spinal stenosis",
"BACKGROUND Intradiscal radiofrequency , with the electrode placed in the center of the nucleus pulposus , has been a controversial procedure in patients with discogenic pain . Possibly the effect has not been due to the production of heat , but to exposure to electric fields . DESIGN We have investigated the effect of high-voltage , long- duration intradiscal pulsed radiofrequency in patients with one-level discogenic low back pain , as confirmed by discography . OUTCOME MEASURE The pain intensity score on a 0 - 10 numeric rating scale ( NRS ) was taken as outcome measure . PATIENTS Eight patients were reported . The mean duration of pain was 6.3 years ( range 0.5 - 16 , median 4 ) . The mean NRS score was 7.75 ( range 5 - 9 ) . Disc height was reduced 60 % in one patient and up to 30 % in the others . INTERVENTION A 15-cm , 20-gauge needle with a 15-mm active tip was placed central ly in the disc . Pulsed radiofrequency was applied for 20 min at a setting of 2 x 20 ms/s and 60 V. RESULTS There was a very significant fall in the NRS scores over the first 3 months ( P NRS score of at least 4 points at the 3-month follow-up . A follow-up of 12.8 months ( range 6 - 25 , median 9 ) was available for five patients . All these patients are now pain free , except for one patient with an NRS score of 2 . Conclusion . It is concluded that this method merits a controlled , prospect i ve study",
"Study Design . A prospect i ve r and omized trial . Objective . To evaluate the efficacy of percutaneous intradiscal radiofrequency thermocoagulation by modifying the duration of heating , using two different time methods , for relieving pain and improving functional disability . Summary of Background Data . Lumbar discogenic pain is the major problem in lumbar degenerative disc disease that percutaneous intradiscal radiofrequency thermocoagulation has been suggested for as a nonsurgical invasive treatment technique for lumbar discogenic pain . In a previous controlled study , this method was found to be ineffective with 8 weeks of follow-up . Material s and Methods . Sixty patients with chronic low back pain were selected for provocative discography to diagnose the discogenic pain and to locate the discs to be treated . From this group , 39 patients were r and omly selected and divided into two groups . In the first group , treatment was performed for 120 seconds , and in the second group for 360 seconds , both at 80C . Patients were assessed with a visual analogue scale for pain relief and functional improvement . Evaluations were performed before , immediately after treatment , at 1 and 2 weeks , and at 1 , 3 , and 6 months after the procedure . Results . A total of 39 patients with positive provocative discographies were found to eligible for the study . There were no statistical differences in pain relief and functional improvement between two groups ( P > 0.05 ) . The immediate , 1-week and 2-week , and 1-month visual analogue scale ( VAS ) scores were decreased significantly in both groups when comparing them with the pretreatment scores ( P 0.05 ) . Conclusion . Percutaneous intradiscal radiofrequency thermocoagulation has been suggested and performed to relieve discogenic pain . In the previous controlled study , no effective pain relief has been obtained . In this study , the authors increased the duration of radiofrequency thermocoagulation to improve the effectiveness of this method . Yet , the authors have not found any significant differences between the application of lesioning at two different times in percutaneous intradiscal radiofrequency thermocoagulation",
"The clinical benefits and complications of posterior lumbar interbody fusion ( PLIF ) have been studied over the past 60 years . In recent years , spine surgeons have had the option of treating low back pain caused by degenerative disc disease using PLIF with machined allograft spacers and posterior pedicle fixation . The purpose of this clinical series was to assess the clinical benefits of using a machined PLIF allograft spacer and posterior pedicle fixation to treat degenerative disc disease , both in terms of fusion rates and patient outcomes , and to compare these results with those in previous studies using autograft and metal interbody fusion devices . Results were also compared with results from studies using transverse process fusion . This prospect i ve , nonr and omized clinical series was conducted at 10 US medical centers . Eighty-nine ( 55 male , 34 female ) patients underwent PLIF with a presized , machined allograft spacer and posterior pedicle fixation between January 2000 and April 2003 . Their outcomes were compared with outcomes in previous series described in the literature . All patients had experienced at least 6 months of low back pain that had been unresponsive to nonsurgical treatment . Physical examinations were performed before surgery , after surgery , and at 4 follow-up visits ( 6 weeks , 6 months , 12 months , 24 months ) . At each interval , we obtained radiographs and patient outcome measures , including SF-36 Bodily Pain Score , visual analog scale pain rating , and Oswestry Disability Index . The primary outcome was fusion results at 12 and 24 months ; the secondary outcomes were pain , disability , function/ quality of life , and satisfaction . One-level PLIFs were performed in 65 patients , and 2-level PLIFs in 24 patients . Flexion-extension radiographs at 12 and 24 months revealed a 98 % fusion rate . Of the 72 patients who reached the 12-month follow-up , 86 % reported decreased pain and disability as measured with the Oswestry Disability Index . Decreased pain as measured with the SF-36 Bodily Pain Score was reported by 74 % of patients who reached the 12-month follow-up . The graft-related complication rate among all patients who underwent PLIF was 1.61 % . When performed with machined allograft spacers and posterior pedicle fixation , PLIF is a safe and effective surgical treatment for low back pain caused by degenerative disc disease . The patients in this clinical series had outcomes equal or superior to the outcomes in previous series",
"Study Design . A prospect i ve , r and omized , double-blind , placebo-controlled trial of intradiscal electrothermal therapy ( IDET ) for the treatment of chronic discogenic low back pain ( CDLBP ) . Objectives . To test the safety and efficacy of IDET compared with a sham treatment ( placebo ) . Summary of Background Data . In North America alone , more than 40,000 intradiscal catheters have been used to treat CDLBP . The evidence for efficacy of IDET is weak coming from retrospective and prospect i ve cohort studies providing only Class II and Class III evidence . There is one study published with Class I evidence . This demonstrates statistically significant improvements following IDET ; however , the clinical significance of these improvements is question able . Methods . Patients with CDLBP who failed to improve following conservative therapy were considered for this study . Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography ( CT ) discography . Patients were excluded if there was greater than 50 % loss of disc height or previous spinal surgery . Fifty-seven patients were r and omized with a 2:1 ratio : 38 to IDET and 19 to sham procedure ( placebo ) . In all cases , the IDET catheter was positioned to cover at least 75 % of the annular tear as defined by the CT discography . An independent technician connected the catheter to the generator and then either delivered electrothermal energy ( active group ) or did not ( sham group ) . Surgeon , patient , and independent outcome assessor were all blinded to the treatment . All patients followed a st and ard postprocedural rehabilitation program . Independent statistical analysis was performed . Outcome Measures . Low Back Outcome Score ( LBOS ) , Oswestry Disability Index ( ODI ) , Short Form 36 question naire ( SF-36 ) , Zung Depression Index ( ZDI ) , and Modified Somatic Perceptions Question naire ( MSPQ ) were measured at baseline and 6 months . Successful outcome was defined as : no neurologic deficit , improvement in LBOS of greater then 7 points , and improvement in SF-36 subsets ( physical function and bodily pain ) of greater than 1 st and ard deviation . Results . Baseline demographic data , initial LBOS , ODI , SF-36 , ZDI , and MSPQ were similar for both groups . No neurologic deficits occurred . No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 st and ard deviation in the specified domains of the SF-36 . Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group , compared with 40.74 at baseline and 41.58 at 6 months for the placebo group . There was no significant change in ZDI or MSPQ scores for either group . Conclusions . The IDET procedure appeared safe with no permanent complications . No subject in either arm met criteria for successful outcome . Further detailed analyses showed no significant change in outcome measures in either group at 6 months . This study demonstrates no significant benefit from IDET over placebo",
"Anterior discectomy and fusion to treat cervical degenerative disc disease is the preferred procedure for many spine surgeons . The ideal device for structural reconstruction of the anterior cervical spine remains controversial . The purpose of this prospect i ve study was to investigate the effectiveness of a non-threaded titanium cage in performing anterior spinal fusion for cervical degenerative disc disease . The clinical and radiologic data of 78 consecutive patients were review ed . Neurologic outcome was assessed using Odom 's criteria . Neck pain was grade d using a 10-point visual analog scale . The cervical spinal curvature , the height of foramina , and fusion status were evaluated on preoperative and postoperative radiographs . Mean follow-up was 24.9 ( range 18 - 35 ) months . An excellent or good result was found in 92 % of the patients with radiculopathy , 69 % of those with myelopathy , and 73 % of those with myeloradiculopathy . Statistical analyses also showed improvement of cervical pain after surgery ( P increase in foraminal height ( P = 0.035 ) . Cervical kyphosis was present in 27 ( 34 % ) patients before surgery ; it was corrected to lordosis in 9 . The fusion rate at 12 months and 24 months was 91 % and 95 % , respectively . No surgery or cage-related complication occurred in these patients . Non-threaded interbody cage fusion in this study achieved a high fusion rate and had a good neurologic outcome . These results suggest that non-threaded cage fusion is a safe and effective method for anterior cervical discectomy",
"OBJECT The authors of studies of anterior cervical fusion for disc-related disease have documented satisfying clinical results and infrequent complications . Recently , cervical disc arthroplasty has entered clinical trials as an alternative to fusion . Although the results of anecdotal reports and prospect i ve studies support this procedure , these studies have not conferred the validity of a controlled r and omized study . In the present study , the author presents data obtained in such a study . METHODS After symptoms failed to respond to conservative therapy , 46 patients with one-level discogenic cervical radiculopathy and /or myelopathy were r and omized to undergo arthroplasty or fusion as part of a US Food and Drug Administration medical device study . In all patients there was a minimum follow-up duration of 1 year . Equivalent results for the relief of arm pain and neck pain were noted in both treatment groups . Treatment parameters other than operative time were similar . No neurological or serious systemic complications occurred . CONCLUSIONS Although extended follow-up data and larger patient population s are needed , the results of this study indicate that arthroplasty is a viable alternative to cervical fusion",
"Combined anterior-posterior lumbar fusion across multiple levels is thought to be associated with increased perioperative morbidity and worse clinical outcomes when performed in elderly patients . We conducted a retrospective review of the medical , surgical , and radiological records of 73 patients who underwent multilevel anterior lumbar interbody fusion ( ALIF ) with posterolateral lumbar fusion with instrumentation for symptomatic lumbar degenerative disc disease . Mean follow-up was 19 months . Thirty patients were at least 65 years old and 43 patients were younger . There were no significant differences in the number of levels fused , operative time , mean length of hospital stay or perioperative complication rates in either group . Similarly , there were no statistically significant differences in the improvement in back pain or in the rates of fusion between the groups at last follow-up . Perioperative events , intermediate-term clinical outcomes , and fusion rates after multilevel 360-degree lumbar fusion in the elderly are comparable to those of younger patients"
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41165268-06ff-11f0-808a-c43d1ab1c353
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Disease and cancer treatment-related side effects such as decreased energy level , muscle weakness , and declines in functional status and body mass have been well documented . There is evidence that exercise , such as low intensity aerobics walking , Tai Chi , or cycling , results in an overall decrease in fatigue levels over the course of cancer treatment . Additionally , there is evidence that regular physical activity or exercise can decrease emotional stress , blood pressure , the duration of neutropenia , thrombocytopenia , and pain . Exercise also has been shown to increase quality of life and improve the maximal oxygen uptake during exertion , sleep patterns , and cognition . However , the majority of studies of exercise and cancer have been conducted with women with early stage breast cancer , limiting the generalizability of these studies to other cancer population s. The purpose of this systematic review is to provide a synthesis of the extant research evidence about th e benefits of exercise related to cancer recovery
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"PURPOSE / OBJECTIVES To evaluate the effects of 10 weeks of aerobic exercise on depressive and anxiety symptoms and self-esteem of breast cancer survivors . DESIGN Experimental , crossover . SETTING Midwestern university town . SAMPLE Twenty-four breast cancer survivors ( mean time following surgery 41.8 months ; ranging from 1 to 99 months ) recruited via mail and cancer support groups . The mean age of the sample was 48.9 years . METHODS Subjects were assigned r and omly into exercise ( EX ) , exercise-plus-behavior modification ( EX + BM ) , and control groups . EX and EX + BM groups exercised aerobically four days/week at > or = 60 % of age-predicted maximum heart rate for 10 weeks . Data were collected pretest , post-test , and crossover ( 12 weeks following post-test ) . Because pretest or post-test scores showed no statistical differences between EX and EX + BM groups , data were combined to form one group . MAIN RESEARCH VARIABLES Aerobic exercise ( four days/ week ; 30 - 40 minutes/session ) , depression , ( Beck Depression inventory ) , anxiety ( Speilberger State-Trait Anxiety Inventory ) , and self-esteem ( Rosenberg Self-Esteem Inventory ) . FINDINGS Pre- to post-test analyses revealed that women who exercised had significantly less depression and state and trait anxiety over time compared to controls . After the crossover , the control group demonstrated comparable improvements in both depressive and state anxiety scores . Self-esteem did not change significantly . Subjects who received exercise recommendations from their physicians exercised significantly more than subjects who received no recommendation . CONCLUSIONS Mild to moderate aerobic exercise may be of therapeutic value to breast cancer survivors with respect to depressive and anxiety symptoms but not to self-esteem . A physician 's recommendation to exercise appears to be an important factor in a patient 's exercise adherence . IMPLICATION S FOR NURSING PRACTICE To Improve depressive and anxiety symptoms following breast cancer surgery , healthcare professionals should consider recommending mild to moderate exercise",
"PURPOSE / OBJECTIVES To investigate the feasibility of an exercise program patterned after a phase II cardiac rehabilitation program to improve selected physiologic and psychological parameters of health in patients with cancer . DESIGN Prospect i ve , repeated measures study . SETTING Two major military medical centers in the southwestern United States . SAMPLE 62 patients diagnosed with cancer within the previous two years . Ages ranged from 24 - 83 ( meanX = 59 ) . Half of the participants were male and half were female . Minorities made up 29 % of the sample . Participants had a wide range of cancer diagnoses and all stages of cancer . Fifteen subjects were undergoing treatment when they enrolled in the study . More than half of the subjects exercised prior to their cancer diagnoses , but fewer than half were able to resume an exercise routine following their cancer diagnoses . METHODS Subjects met two days each week for 12 weeks for exercise and education . MAIN RESEARCH VARIABLES Exercise tolerance as measured with a grade d exercise test , activity and sleep patterns as measured with a wrist actigraph , and quality of life ( QOL ) as measured with the Cancer Rehabilitation Evaluation System-Short Form . FINDINGS Significant improvements were observed over time in exercise tolerance , selected activity and sleep patterns , and QOL among the 46 ( 74 % ) subjects who completed the program . CONCLUSIONS Patients with various types and stages of cancer can safely exercise using a cardiac rehabilitation model and can realize significant improvements in exercise tolerance , selected activity and sleep patterns , and QOL . IMPLICATION S FOR NURSING Most people are aware that regular exercise is part of a healthy lifestyle . After cancer diagnosis and treatment , patients experience uncertainty regarding how to resume exercise or how to begin an exercise program as part of their rehabilitation . Participation in a structured exercise program can provide patients with a safe environment within which to exercise at an intensity appropriate to their individual needs",
"PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment",
"PURPOSE / OBJECTIVES To examine the effects of a comprehensive rehabilitation program on facilitating physical and psychosocial adaptation of women with breast cancer who are receiving adjuvant chemotherapy . DESIGN Experimental . SETTING Breast evaluation clinics of two New Engl and medical centers with comprehensive cancer treatment programs . SAMPLE 14 women ( mean age = 44 years ) receiving adjuvant chemotherapy for breast cancer ( 86 % stage II ) following surgical treatment . METHODS Subjects were assigned r and omly to the experimental group or the usual care group . Experimental group members began a structured exercise program of walking and attended support group meetings . All subjects were tested before beginning chemotherapy , during the course of chemotherapy , and one month following chemotherapy completion . MAIN RESEARCH VARIABLES Performance status , physical functioning , psychosocial adjustment , self-concept and body image , and 12 symptoms ( e.g. , fatigue , nausea , anxiety ) . FINDINGS Measures of physical performance , psychosocial adjustment , and symptom intensity revealed improved adaptation in subjects who completed the walking/support group program . CONCLUSIONS Physical and psychosocial benefits from a modest walking exercise program and a support group are possible for patients receiving adjuvant chemotherapy . IMPLICATION S FOR NURSING PRACTICE Although more detailed research is necessary to answer some of the questions raised by this study , implementing the walking program and forming a support group are achievable in an outpatient setting",
"PURPOSE Despite the recognition of fatigue as a common and distressing symptom during cancer treatment , there are few evidence -based interventions available to manage such fatigue . The purpose of this multi-institutional pilot study was to explore the effects of a home-based moderate walking exercise intervention on fatigue , physical functioning , emotional distress , and quality of life ( QOL ) during breast cancer treatment . DESCRIPTION OF STUDY Fifty-two women were recruited from five university hospital outpatient departments for this pilot study with an experimental design . Subjects were r and omly assigned to the walking program or to usual care during adjuvant chemotherapy or radiation therapy for breast cancer . Symptoms , physical functioning , and QOL were measured at baseline , midtreatment , and at the end of treatment . RESULTS Women who exercised at least 90 minutes per week on 3 or more days reported significantly less fatigue and emotional distress as well as higher functional ability and QOL than women who were less active during treatment . CLINICAL IMPLICATION S A home-based walking exercise program is a potentially effective , low-cost , and safe intervention to manage fatigue and to improve QOL during adjuvant chemotherapy or radiation therapy for breast cancer . This health-promoting self-care activity needs further testing in large r and omized clinical trials",
"OBJECTIVE To evaluate the impact of a 2-year program of strength training on muscle strength , bone mineral density ( BMD ) , physical function , joint damage , and disease activity in patients with recent-onset ( METHODS In this prospect i ve trial , 70 RA patients were r and omly assigned to perform either strength training ( all major muscle groups of the lower and upper extremities and trunk , with loads of 50 - 70 % of repetition maximum ) or range of motion exercises ( without resistance ) twice a week ; all were encouraged to engage in recreational activities 2 - 3 times a week . All patients completed training diaries ( evaluated bi-monthly ) and were examined at 6-month intervals . All were treated with medications to achieve disease remission . Maximum strength of the knee extensors , trunk flexors and extensors , and grip strength was measured with dynamometers . BMD was measured at the femoral neck and lumbar spine by dual x-ray densitometry . Disease activity was determined by the Disease Activity Score , the extent of joint damage by the Larsen score , and functional capacity by the Health Assessment Question naire ( HAQ ) ; walking speed was also measured . RESULTS Sixty-two patients ( 31 per group ) completed the study . Strength training compliance averaged 1.4 - 1.5 times/week . The maximum strength of all muscle groups examined increased significantly ( 19 - 59 % ) in the strength-training group , with statistically significant improvements in clinical disease activity parameters , HAQ scores , and walking speed . While muscle strength , disease activity parameters , and physical function also improved significantly in the control group , the changes were not as great as those in the strength-training group . BMD in the femoral neck and spine increased by a mean + /- SD of 0.51 + /- 1.64 % and by 1.17 + /- 5.34 % , respectively , in the strength-training group , but decreased by 0.70 + /- 2.25 % and 0.91 + /- 4.07 % in the controls . Femoral neck BMD in the 17 patients with high initial disease activity ( and subsequent use of oral glucocorticoids ) remained constantly at a statistically significantly lower level than that in the other 45 patients . CONCLUSION Regular dynamic strength training combined with endurance-type physical activities improves muscle strength and physical function , but not BMD , in patients with early RA , without detrimental effects on disease activity",
"This study examined the effect of a supervised , aerobic exercise program on change in body weight and composition ( multi-site subcutaneous skinfold measures , percent body fat , and lean body weight ) of women undergoing adjuvant chemotherapy for breast cancer . Stage II patients with breast cancer ( N = 24 ) were r and omized to an exercise treatment group ( EG , n = 12 ) and a control group ( CG , n = 12 ) . The EG participated in the individualized Winningham Aerobic Interval Training ( WAIT ) exercise program with exertional levels set at 60%-85 % of maximal heart rate for 20 - 30 minutes , 3 times per week , for 10 - 12 weeks . The CG received no exercise treatment , but were asked to continue with their daily activities . Subjects were asked to maintain their customary eating patterns throughout their participation . Data were analyzed using covariate analysis , adjusting for age and pre-test values . Comparisons of pre- and post-test results indicated that exercise had a moderating effect on gain in body fat and altered the subcutaneous body fat profile in both obese ( OB ) and nonobese ( NOB ) subjects . Exercising OB subjects showed a greater increase in lean body weight than NOB subjects , indicating an increase in muscle tissue . Results from this study may be useful in design ing safe and effective weight-control programs for patients with breast cancer on chemotherapy",
"PURPOSE / OBJECTIVES To examine the effects of a seated exercise program on fatigue and quality of life ( QOL ) in women with metastatic breast cancer . DESIGN R and omized , controlled , longitudinal trial . SETTING Outpatient clinic of a comprehensive cancer center . SAMPLE Convenience sample of 38 women who were beginning outpatient chemotherapy . METHODS Subjects were r and omized to a control or intervention group ; the intervention was performance of a seated exercise program using home videotape three times per week for four cycles of chemotherapy . All subjects completed the Functional Assessment of Chronic Illness Therapy Fatigue Version IV ( FACIT F ) at baseline and at the time of the next three cycles . Subjects were asked to document the frequency , duration , and intensity of all exercise participation on monthly calendars . MAIN RESEARCH VARIABLES Exercise , fatigue , and QOL . FINDINGS 32 subjects , 16 per group , completed the study follow-up . With a mixed modeling approach , total FACIT F scores for the entire sample declined at a significant rate ( p = 0.003 ) beginning with cycle 3 but at a slower rate for the experimental group ( p = 0.02 ) . Fatigue scores indicated less increase and physical well-being subscale scores showed less decline for the experimental group ( p = 0.008 and p = 0.02 , respectively ) . CONCLUSIONS Women with advanced breast cancer r and omized to the seated exercise intervention had a slower decline in total and physical well-being and less increase in fatigue scores starting with the third cycle of chemotherapy . IMPLICATION S FOR NURSING Seated exercise may be a feasible exercise program for women with advanced cancer for controlling fatigue and improving physical well-being",
"PURPOSE Weight gain is a common side effect for women receiving adjuvant chemotherapy and may have negative long-term implication s for survival . The purpose of this study was to examine the effects of aerobic exercise on weight gain in women with breast cancer receiving adjuvant chemotherapy . DESCRIPTION OF STUDY Seventy-eight women who had recently received a diagnosis of breast cancer and who were beginning adjuvant chemotherapy were enrolled in a home-based exercise study during the first four cycles of chemotherapy . Weight change , body mass index , anorexia , nausea , fatigue , caloric expenditure during exercise , and functional ability were recorded . RESULTS Women who adhered to the exercise program maintained their body weight , while nonexercisers steadily gained weight ( P intensity of nausea or anorexia between the exercisers and nonexercisers . Women who exercised over the four cycles of chemotherapy improved their functional ability ( mean 23 % ) compared to the nonexercisers who showed significant declines in functional ability ( mean -15 % ) . CLINICAL IMPLICATION S Exercise may be an effective intervention to minimize weight gain in women with breast cancer who are receiving adjuvant chemotherapy . Preventing weight gain in these patients may be important in preventing recurrent disease and other comorbidities associated with excess weight",
"Sixteen female breast cancer patients who had been diagnosed ( 3.0 + /- 1.2 years previous to the study ) and undergone surgery , chemotherapy , and /or radiation treatment were r and omly assigned to exercise and nonexercise groups . Pre- and post- study measurements were taken for aerobic performance , leg strength , and concentrations of circulating lymphocyte subsets and natural killer cell cytotoxic activity ( NKCA ) . Exercise training consisted of 60 minutes of supervised weight training and aerobic activity three times each week for eight weeks . Although subjects in the exercise groups demonstrated some modest improvement in the various aerobic and strength tests , NKCA and concentrations of circulating T and NK cells were not significantly altered relative to the nonexercise group . This study suggests that moderate exercise over an eight-week period has no significant effect on the function of in vitro natural killer cells in breast cancer patients",
"PURPOSE And rogen deprivation therapy is a common treatment in men with prostate cancer that may cause fatigue , functional decline , increased body fatness , and loss of lean body tissue . These physical changes can negatively affect health-related quality of life . Resistance exercise may help to counter some of these side effects by reducing fatigue , elevating mood , building muscle mass , and reducing body fat . METHODS In a two-site study , 155 men with prostate cancer who were scheduled to receive and rogen deprivation therapy for at least 3 months after recruitment were r and omly assigned to an intervention group that participated in a resistance exercise program three times per week for 12 weeks ( 82 men ) or to a waiting list control group ( 73 men ) . The primary outcomes were fatigue and disease-specific quality of life as assessed by self-reported question naires after 12 weeks . Secondary outcomes were muscular fitness and body composition . RESULTS Men assigned to resistance exercise had less interference from fatigue on activities of daily living ( P = .002 ) and higher quality of life ( P = .001 ) than men in the control group . Men in the intervention group demonstrated higher levels of upper body ( P = .009 ) and lower body ( P muscular fitness than men in the control group . The 12-week resistance exercise intervention did not improve body composition as measured by changes in body weight , body mass index , waist circumference , or subcutaneous skinfolds . CONCLUSION Resistance exercise reduces fatigue and improves quality of life and muscular fitness in men with prostate cancer receiving and rogen deprivation therapy . This form of exercise can be an important component of supportive care for these patients",
"In a double-blind , crossover study , mazindol ( 1 mg ) at breakfast , lunch , and 4:00 PM was compared with a placebo to determine its efficacy for symptom control in 30 terminal cancer patients . In 26 evaluable patients , intensity of pain and analgesic consumption were significantly improved after mazindol , while anxiety , appetite , and food consumption were significantly worse . Activity and depression were not modified by mazindol . After the completion of the trial , mazindol was chosen as a more effective drug by the patients in ten cases ( 38 % ) and by the investigators in nine ( 35 % ) ; placebo was chosen by the patients in seven cases ( 27 % ) and by the investigators in 11 ( 42 % ) . Two patients ( 7 % ) developed delirium that required discontinuation of treatment . At the present time , there are no clearcut indications for mazindol in terminal cancer patients",
"The purpose was to determine the minimally important clinical difference ( MICD ) in fatigue as measured by the Profile of Mood States , Schwartz Cancer Fatigue Scale ( SCFS ) , General Fatigue Scale , and a 10-point single-item fatigue measure . The MICD is the smallest amount of change in a symptom ( e.g. , fatigue ) measure that signifies an important change in that symptom . Subjects rated the degree of change in their fatigue over 2 days on a Global Rating Scale . 103 patients were enrolled on this multisite prospect i ve repeated measures design . MICD was determined following established procedures at two time points . Statistically significant changes were observed for moderate and large changes in fatigue , but not for small changes . The scales were sensitive to increases in fatigue over time . The MICD , presented as mean change , for each scale and per item on each scale is : POMS = 5.6 , per item = 1.1 , SCFS = 5.0 , per item = 0.8 , GFS = 9.7 , per item = 1.0 , and the single item measure of fatigue was 2.4 points . This information may be useful in interpreting scale scores and planning studies using these measures",
"BACKGROUND Shoulder dysfunction remains a frequent complication after neck dissection procedures for head and neck cancer . METHODS We conducted a pilot study to evaluate the effects of progressive resistance exercise training ( PRET ) on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in patients with head and neck cancer . Twenty patients ( mean age , 61 + /- 7.7 years ) were r and omly assigned to PRET or st and ard care intervention . Subjects assigned to the PRET group exercised three times per week for 12 weeks . The goal of the exercise program was to enhance scapular stability and strength of the upper extremity . The resistance-training program was progressive in terms of number of sets and repetitions performed , as well as the amount of weight lifted , depending on performance status . RESULTS The completion rate for the trial was 85 % ( 17 of 20 ) . The exercise group completed 93 % of scheduled exercise sessions . Significant improvements were found in favor of the PRET group in active shoulder external rotation ( p = .001 ) , shoulder pain ( p = .038 ) , and overall score for shoulder pain and disability ( p = .045 ) . CONCLUSIONS The study results demonstrate a high rate of completion and adherence with our PRET program among patients with head and neck cancer . The preliminary findings , although limited , also suggest a potential therapeutic role for resistance exercise as an adjunct to st and ard physical therapy treatment",
"PURPOSE Physical exercise has been shown to help cancer survivors cope with treatment side effects . The purpose of this study was to examine the role of the oncologist in promoting exercise in cancer survivors . DESCRIPTION OF STUDY Cancer survivors who had recently completed treatment ( N = 311 ) were mailed a self-administered question naire that assessed the following : whether exercise was discussed during any of their treatment consultations ; whether they preferred that exercise be discussed during this time ; their perceived oncologist approval for exercise ; and the amount of exercise they performed during treatment . RESULTS Descriptive statistics showed that 28.4 % of cancer survivors reported that their oncologist initiated a discussion of exercise during their treatment consultation , that 13.9 % said that they initiated a discussion , and that 57.8 % said that exercise was not discussed . Survivors younger than 60 years of age were more likely to initiate a discussion of exercise than were older survivors . Survivors whose oncologist initiated a discussion of exercise also reported a stronger normative belief for exercise , performing more frequent exercise during treatment , and performing more total minutes of exercise during treatment . Most ( 82.2 % ) survivors preferred that the oncologist initiate the discussion of exercise . CLINICAL IMPLICATION S These findings indicate that most cancer survivors responding to this survey preferred that their oncologist initiate a discussion of exercise . Such a discussion appears to increase survivor exercise levels during treatment . If confirmed in a prospect i ve , r and omized , controlled trial , the implication is that an oncologist-initiated discussion of exercise during treatment consultations may be a cost-effective strategy for promoting exercise in cancer survivors",
"The effect of a 10-week aerobic interval-training cycle ergometer protocol on the functional capacity ( VO2Lmax ) of 45 women receiving chemotherapy for treatment of Stage II breast cancer was studied . Subjects were stratified by baseline functional capacity ( ± 1 MET ) and r and omized to experimental ( EX ) , placebo ( PL ) , and control ( CO ) groups . EX subjects completed a 10-week , 3 times/week exercise training program ; PL subjects participated in 10 weeks of nonaerobic stretching and flexibility exercises ; the CO group maintained normal activities . The EX group showed significant , p on pre- to posttest VO2Lmax as well as workload and test time compared to the PL and CO groups . The interval-training exercise intervention was effective in improving the functional capacity of Stage II breast cancer patients on adjuvant chemotherapy",
"Physical exercise has been shown to enhance quality of life ( QOL ) in cancer survivors using pretest-posttest design s and compared to usual care ( i.e. no intervention ) . In the present study , we conducted a r and omized controlled trial to determine if exercise could improve QOL in cancer survivors beyond the known benefits of group psychotherapy ( GP ) . We matched 22 GP classes ( N=108 ) on content and then r and omly assigned 11 ( n=48 ) to GP alone and 11 ( n=60 ) to GP plus home-based , moderate-intensity exercise ( GP+EX ) . Participants completed a physical fitness test and QOL measures ( e.g. Functional Assessment of Cancer Therapy scales ) at the beginning and end of GP classes ( about 10 weeks ) . We had excellent recruitment ( 81 % ) , retention ( 89 % ) , and adherence ( 84 % ) rates and a modest contamination ( 22 % ) rate . Using intention-to-treat repeated measures analyses of variance , we found significant Time by Condition interactions for functional well-being , fatigue , and sum of skinfolds . We also found borderline significant interactions for physical well-being , satisfaction with life , and flexibility . All interactions favored the GP+EX condition . We conclude that a home-based , moderate intensity exercise program may im-prove QOL in cancer survivors beyond the benefits of GP , particularly in relation to physical and functional well-being",
"Fatigue is a common and often severe problem in cancer patients undergoing chemotherapy . The authors postulated that physical activity training can reduce the intensity of fatigue in this group of patients",
"BACKGROUND Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people , the efficacy of interventions targeted specifically at these deficits has not been carefully studied . METHODS We conducted a r and omized , placebo-controlled trial comparing progressive resistance exercise training , multinutrient supplementation , both interventions , and neither in 100 frail nursing home residents over a 10-week period . RESULTS The mean ( + /- SE ) age of the 63 women and 37 men enrolled in the study was 87.1 + /- 0.6 years ( range , 72 to 98 ) ; 94 percent of the subjects completed the study . Muscle strength increased by 113 + /- 8 percent in the subjects who underwent exercise training , as compared with 3 + /- 9 percent in the nonexercising subjects ( P Gait velocity increased by 11.8 + /- 3.8 percent in the exercisers but declined by 1.0 + /- 3.8 percent in the nonexercisers ( P = 0.02 ) . Stair-climbing power also improved in the exercisers as compared with the nonexercisers ( by 28.4 + /- 6.6 percent vs. 3.6 + /- 6.7 percent , P = 0.01 ) , as did the level of spontaneous physical activity . Cross-sectional thigh-muscle area increased by 2.7 + /- 1.8 percent in the exercisers but declined by 1.8 + /- 2.0 percent in the nonexercisers ( P = 0.11 ) . The nutritional supplement had no effect on any primary outcome measure . Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation . CONCLUSIONS High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people . In contrast , multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty",
"Skeletal muscle protein loss occurs during marrow transplantation despite total parenteral nutrition . To determine if muscle atrophy could be minimized with exercise therapy , 30 patients undergoing marrow transplantation for acute leukemia completed a prospect i ve r and omized trial to receive : ( 1 ) no therapy ( controls ) , ( 2 ) physical therapy thrice weekly ( PT3 ) , or ( 3 ) physical therapy five times weekly ( PT5 ) . Patients were studied through 35 days posttransplant . Muscle protein status and turnover was assessed by weekly nitrogen balance , and creatinine and 3-methylhistidine excretion . Results favored a muscle protein-sparing effect of exercise , as a significant decrease in creatinine excretion in controls only suggested muscle protein loss associated with inactivity . Changes in arm muscle area correlated with energy , but not protein intake . Large individual variation , inadequate nutritional support and differences in admission arm muscle area may have clouded these results"
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4116529a-06ff-11f0-808a-c43d1ab1c353
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Background Anterior knee pain ( AKP ) or patellofemoral pain syndrome is common and may limit an individual 's ability to perform common activities of daily living such as stair climbing and prolonged sitting . The diagnosis is difficult as there are multiple definitions for this disorder and there are no accepted criteria for diagnosis . It is therefore most commonly a diagnosis that is made once other pathologies have been excluded . Objectives The aim of this study was to create an evidence -based checklist for research ers and clinicians to use for the diagnosis of AKP . Methods A systematic review was conducted in July 2016 , and an evidence -based checklist was created based on the subjective and objective findings most commonly used to diagnose AKP . For the subjective factors , two or more of the systematic review s needed to identify the factor as being important in the diagnosis of AKP . Results Two systematic review s , consisting of nine different diagnostic studies , were identified by our search methods . Diagnosis of AKP is based on the area of pain , age , duration of symptoms , common aggravating factors , manual palpation and exclusion of other pathologies . Of the functional tests , squatting demonstrated the highest sensitivity . Other useful tests include pain during stair climbing and prolonged sitting . The cluster of two out of three positive tests for squatting , isometric quadriceps contraction and palpation of the patella borders and the patella tilt test were also recommended as useful tests to include in the clinical assessment . Conclusion A diagnostic checklist is useful as it provides a structured method for diagnosing AKP in a clinical setting . Research is needed to establish the causes of AKP as it is difficult to diagnose a condition with unknown aetiology
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[
"OBJECTIVE To investigate the efficacy of patellar taping on pain control , patellar alignment , and neuromuscular control ( ie , vastus medialis oblique activation , knee extensor moment , etc ) in subjects with patellofemoral pain syndrome . DATA SOURCES We search ed MEDLINE , SPORT Discus , PEDro , and CINAHL through December 2004 , using the key words patellar taping , therapeutic taping , McConnell taping , taping , chronic injury , patellofemoral pain , and knee . STUDY SELECTION Criteria for inclusion criteria were studies that exclusively recruited patients diagnosed with patellofemoral pain syndrome or anterior knee pain and outcome measures specific to pain reduction , neuromuscular control , and patellar positioning . DATA EXTRACTION We identified and review ed 16 studies with an average PEDro score of 4.25/10 . Articles were divided into 3 categories based on primary outcome measures : 4 r and omized controlled trials on treatment methods and pain , 9 studies on neuromuscular control , and 3 on patellar positioning . DATA SYNTHESIS Although patellar taping seems to reduce pain and improve function in people with patellofemoral pain syndrome during activities of daily living and rehabilitation exercise , strong evidence to identify the underlying mechanisms is still not available",
"Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p 2 months and AKP Scale score individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749",
"Purpose There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome . However , what is unclear are the parameters underpinning this intervention . This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice . The aim of this review was to evaluate the parameters of exercise programs reported in primary research , to provide clinicians with evidence -based recommendations for exercise prescription for patellofemoral pain . Methods A systematic review of r and omized controlled trials was undertaken . Only trials that identified exercise to be effective in treating patellofemoral pain were included . Appropriate data bases and reference lists were search ed using established keywords . Data relating to common exercise parameters such as the type of exercise , length , and frequency of intervention , intensity , repetitions , sets , and specific technique were extracted , along with details of co- interventions that may have been used . Results A total of ten r and omized controlled trials were included in this review and from these trials 14 interventions arms were evaluated . All 14 interventions focused on active exercises , all but two of which also included a passive stretching component . The current body of evidence demonstrates positive results with exercise interventions such as knee extension , squats , stationary cycling , static quadriceps , active straight leg raise , leg press , and step-up and down exercises for patients with patellofemoral pain syndrome . A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more , combined with exercises to address flexibility of the lower limb musculature was commonly used . Conclusion Currently , the primary research on this topic supports the use of closed kinetic chain , strengthening exercises for musculature of the lower limb , combined with flexibility options . The current evidence base supports a prescription of daily exercises of two – four sets of ten or more repetitions over a period of 6 weeks or more",
"Data regarding validity of clinical and radiographic findings in diagnosing patellofemoral pain syndrome are inconclusive . We prospect ively assessed how sensitive and specific key patellofemoral physical examination tests are , and evaluated the prevalence of physical examination and radiographic findings . Sixty-one infantry soldiers with patellofemoral pain syndrome and 25 control subjects were evaluated . The sensitivity of the patellar tilt , active instability , patella alta , and apprehension tests was low ( less than 50 % ) ; specificity ranged between 72 % and 100 % . Although the prevalence of positive patellar tilt and active instability tests was significantly greater in subjects with patellofemoral pain syndrome , there were no significant differences between the groups in the results of the other two tests . Soldiers with patellofemoral pain syndrome presented with increased quadriceps angle , lateral and medial retinacular tenderness , patellofemoral crepitation , squinting patella , and reduced mobility of the patella . There were no differences between the groups in the prevalence of lower limb and foot posture alignment and knee effusion . Plain radiography showed increased patellar subluxation in soldiers with patellofemoral pain syndrome . Other radiographic measures ( sulcus angle , Laurin angle , Merchant angle , and Insall-Salvati index ) were similar in both groups . We provide evidence regarding the validity of clinical and radiographic features commonly used for diagnosing patellofemoral pain syndrome . Physical examinations were more useful than plain radiography . Level of Evidence : Diagnostic study , Level I. See the Guidelines for Authors for a complete description of levels of evidence",
"Patellofemoral pain syndrome ( PFPS ) is one of the most common musculoskeletal disorders . However , no consensus on the definition , classification , assessment , diagnosis , or management has been reached . We evaluated symptoms and clinical findings in subgroups of individuals with PFPS , classified on the basis of the findings in radiological examinations and compared the findings with knee-healthy subjects . An orthopedic surgeon and a physical therapist consecutively examined 80 patients clinical ly diagnosed as having PFPS and referred for physical therapy . The examination consisted of taking a case history and clinical tests . Radiography revealed pathology in 15 patients , and scintigraphic examination revealed focal uptake in 2 patients indicating pathology ( group C ) . Diffusely increased uptake was present in 29 patients ( group B ) . In the remaining 29 patients radiographic and scintigraphic examinations were normal ( group A ) . Knee-healthy controls ( group D ) reported no clinical symptoms . No symptom could be statistically demonstrated to differ between the three patient groups . Knee-healthy subjects differed significantly from the three patient groups in all clinical tests measuring pain in response to the provocations ; compression test , medial and lateral tenderness , passive gliding of the patella , but they also differed in Q angle . Differences in clinical tests between the patient groups were nonsignificant . The main finding in our study on patients clinical ly diagnosed with PFPS is that possible pathologies can not be detected from the patient 's history or from commonly used clinical tests",
"The current study is aim ed at examining the validity of five clinical patellofemoral tests used in the diagnosis of patellofemoral pain syndrome ( PFPS ) . Forty-five knee patients were divided into either the PFPS or the non-PFPS group , based on the fulfilment of the diagnostic criteria for PFPS . An investigator , blinded to the group assignment , performed the vastus medialis coordination test , patellar apprehension test , Waldron 's test , Clarke 's test , and the eccentric step test . The positive likelihood ratio was 2.26 for both the vastus medialis coordination test and the patellar apprehension test . For the eccentric step test , the positive likelihood ratio was 2.34 . A positive outcome on either the vastus medialis coordination test , the patellar apprehension test , or the eccentric step test increases the probability of PFPS to a small , but sometimes important , degree . For the remaining tests , the positive likelihood ratios were below the threshold value of 2 , indicating that given a positive test result , the probability that the patient has PFPS is altered to a small , and rarely important degree . The negative likelihood ratios for all tests exceeded the threshold value of 0.5 , suggestive of clinical ly irrelevant information . These data question the validity of clinical tests for the diagnosis of PFPS",
"Many variables have retrospectively been associated with the presence of anterior knee pain . Very few prospect i ve data exist , however , to determine which of these variables will lead to the development of anterior knee pain . It was our purpose in this study to determine the intrinsic risk factors for the development of anterior knee pain in an athletic population over a 2-year period . Before the start of training , 282 male and female students enrolled in physical education classes were evaluated for anthropometric variables , motor performance , general joint laxity , lower leg alignment characteristics , muscle length and strength , static and dynamic patellofemoral characteristics , and psychological parameters . During this 2-year follow-up study , 24 of the 282 students developed patellofemoral pain . Statistical analyses revealed a significant difference between those subjects who developed patellofemoral pain and those who did not concerning quadriceps and gastrocnemius muscle flexibility , explosive strength , thumb-forearm mobility , reflex response time of the vastus medialis obliquus and vastus lateralis muscles , and the psychological parameter of seeking social support . However , only a shortened quadriceps muscle , an altered vastus medialis obliquus muscle reflex response time , a decreased explosive strength , and a hypermobile patella had a significant correlation with the incidence of patellofemoral pain . We concluded that the latter four parameters play a dominant role in the genesis of anterior knee pain and we therefore deem them to be risk factors for this syndrome",
"PURPOSE To investigate the diagnostic accuracy and association to disability of selected functional findings or physical examination tests for patellofemoral pain syndrome ( PFPS ) in patients with anterior knee pain . METHODS A sample of 76 consecutive patients with anterior knee pain was further subdivided into PFPS and other diagnoses . Routine physical examination tests were examined in a prospect i ve , consecutive-subjects design for a cohort of patients with anterior knee pain . Diagnostic accuracy findings , including sensitivity , specificity , positive ( PPV ) and negative ( NPV ) predictive value , and positive ( LR+ ) and negative ( LR- ) likelihood ratios , were calculated for each test . PPV and NPV reflect the percentage of time of positive or a negative test ( respectively ) accurately captures the diagnosis of the condition . LR+ and LR- reflect alterations in post-test probability when the test is positive or negative ( respectively ) . Lastly , associations to disability ( International Knee Documentation Committee ( IKDC ) subjective form ) were calculated for each clinical finding . RESULTS Diagnostic accuracy analyses of individual functional assessment and situational phenomena suggest that the strongest diagnostic test is pain encountered during resisted muscle contraction of the knee ( PPV=82 % ; LR+=2.2 ; 95 % CI : 0.99 - 5.2 ) . Clusters of test findings were substantially more diagnostic , with any two of three positive findings of muscle contraction , pain during squatting , and pain during palpation yielding the following values : PPV=89 % ; LR+=4.0 ( 95 % CI : 1.8 - 10.3 ) . No individual or clustered test findings were significantly associated with the IKDC score . CONCLUSION Combinations of functional assessment tests and situational phenomena are diagnostic for PFPS and may serve to rule in and rule out the presence of PFPS . Single findings are not related to disability scores ( IKDC )"
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BACKGROUND There is little consistency in the measurement of outcome in acute stroke trials , and this may complicate interpretation of the results and reduce the likelihood of detecting worthwhile drug effects . This study aims to investigate empirically the measures used to date and to give recommendations for future studies . SUMMARY OF COMMENT A systematic review of all published r and omized studies of acute stroke drug intervention was undertaken , and the measures used were recorded . Fifty-one studies involving 57 214 subjects were identified . These studies used 14 different measures of impairment , 11 different measures of activity , 1 measure of " quality of life , " and 8 miscellaneous other measures . Timing of outcome assessment s varied from 1 week to 1 year , with the modal time being 3 months . Many studies used ordinal measures but dichotomized results for analysis . Of the 51 studies included in the review , only 21 demonstrated benefit with the defined primary outcome measure . In several studies , however , post hoc analysis using varied outcome measures or varied cut points for dichotomizing outcomes result ed in positive results , whereas the primary study analysis failed to do so . CONCLUSIONS There is no consensus on the level of outcome to be used , the method of measurement to be used , or the most appropriate timing of the assessment . It is recommended that future studies should include extended/instrumental activities and advanced mobility as components of the primary outcome measure , with outcome assessment being undertaken at 6 months . New initiatives in developing stroke-specific outcomes may address some of the current problems in the assessment of stroke
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"BACKGROUND AND PURPOSE The efficacy and safety of the neuroprotective drug clomethiazole was tested in a double blind placebo controlled trial in patients with a clinical diagnosis of acute hemispheric stroke . METHODS Patients with symptom onset of Clomethiazole ( 75 mg/kg ) or placebo was given as an intravenous infusion over a 24-hour period . Patients were followed up for 90 days . The primary efficacy variable was the proportion of patients reaching relative functional independence ( > /=60 points on the Barthel Index ) at 90 days . RESULTS A total of 1360 patients were included . In the main efficacy analysis ( n=1353 ) , 56.1 % of patients taking clomethiazole and 54.8 % of placebo patients reached relative functional independence . The difference was not statistically significant . An analysis of the effect of time since onset of symptoms showed no difference between the treatment groups . Clomethiazole was generally well tolerated and appeared safe in the population studied . Sedation was the most common adverse event , leading to treatment withdrawal that occurred in 15.6 % of clomethiazole-treated patients compared with 4.2 % of placebo-treated patients . In a subgroup classified before r and omization as having total anterior circulation syndrome ( TACS ) ( n=545 , or 40 % of all r and omized patients ) , the percentage of those reaching relative functional independence was 40.8 % on clomethiazole and 29.8 % on placebo , a difference of approximately 11 percentage units . TACS patients have clinical symptoms suggesting a \" large \" stroke . CONCLUSIONS Clomethiazole had no adverse or beneficial effect on long-term outcome for all patients but produced sedation . The hypothesis that clomethiazole is effective in patients with large strokes will be tested in a further study",
"Nimodipine is a 1,4-dihydropyridine derivative that shows a preferential cerebrovascular activity in experimental animals . Clinical data suggest that nimodipine has a beneficial effect on the neurologic outcome of patients suffering an acute ischemic stroke . Our double-blind placebo-controlled multicenter trial was design ed to assess the effects of oral nimodipine on the mortality rate and neurologic outcome of patients with an acute ischemic stroke . One hundred sixty-four patients were r and omly allocated to receive either nimodipine tablets ( 30 mg q.i.d . ) or identical placebo tablets for 28 days . Treatment was always started less than or equal to 48 hours after the acute event . The Mathew Scale , slightly modified by Gelmers et al , was used for neurologic assessment . Mortality rate and neurologic outcome after 28 days were used as evaluation criteria . We considered 123 patients to be valid for the analysis of efficacy . Mortality rates did not differ significantly between groups . Neurologic outcome after 28 days of therapy did not differ between groups . However , when only those patients most likely to benefit from any intervention ( Mathew Scale sum score of less than or equal to 65 at baseline ) were analyzed separately in post hoc-defined subgroups , the nimodipine-treated subgroups showed a significantly better neurologic outcome . This result suggests that some patients with acute ischemic stroke will benefit from treatment with nimodipine tablets",
"Naloxone was administered intravenously in a dose of 1.2 mg to 24 patients in the first 24 hours after they had suffered a stroke . Twenty patients were treated with placebo . In the naloxone-treated group a dose as low as 0.8 mg produced a slight but statistically significant improvement in neurologic status , and this improvement continued until the end of the observation period ( two weeks ) . In the placebo group neurologic improvement was slower and less pronounced . The present results support a previous observation that naloxone may be a valuable drug in the early stage of acute cerebrovascular disease",
"Background and Purpose The purpose of this study is to examine the impact of social support on outcome after first stroke in a prospect i ve cohort study . Although modest evidence exists for the importance of several psychosocial factors , studies have failed to use widely recognized measures of outcome and social support , have failed to control for time since onset , and have not used longitudinal techniques . Methods Forty-six surviving patients were followed for 6 months after stroke . Recovery was measured using repeated measures of functional status as indicated by the Barthel Index of activities of daily living . Perceived social support was measured at 1,3 , and 6 months after onset . Repeated- measures multivariate analysis of variance was used to analyze changes in functional status . Results Significant differences were found across levels of social support in trajectories of functional status ( p=0.002 ) . A significant three-way interaction between stroke severity , social support , and outcome was also found ( p=0.012 ) . Patients with more severe stroke and the largest amount of social support attained an average Barthel Index that was 68 points ( 65 % ) higher than the group reporting the least support . Conclusions High levels of social support were associated with faster and more extensive recovery of functional status after stroke . Social support may be an important prognostic factor in recovery from stroke . Socially isolated patients may be at particular risk for poor outcome",
"BACKGROUND AND PURPOSE It is not yet known which end points are the most suitable for evaluation of the effects of acute stroke intervention . The European Cooperative Acute Stroke Study ( ECASS ) I study used 2 primary end points . The study was powered to detect a 15 % improvement of the median of each primary end point . The study failed to show this effect and was negative in the intention-to-treat analysis . The National Institute of Neurological Disorders and Stroke ( NINDS ) study used 4 dichotomized end points and applied a global end-point analysis . This study was positive and led to FDA approval of thrombolytic therapy for acute ischemic stroke . This study was undertaken to answer the question of whether a different statistical design may have shown a positive results of the ECASS I trial . METHODS We performed a retrospective analysis of the ECASS I intention-to-treat data set ( 615 r and omized and treated patients , rtPA treatment versus placebo ) and post hoc application of the NINDS trial statistical methodology ( global end-point analysis ) . The scores of the modified Rankin Scale ( mRS ) , Barthel Index ( BI ) , and the National Institutes of Health Stroke Scale ( NIHSS ) were dichotomized according to the criteria used in the NINDS trial . Favorable outcome was defined as a score of 0 or 1 on mRS , a score of 95 or 100 on BI , and a score of 0 or 1 on NIHSS . RESULTS The number of patients reaching favorable outcome were higher in all 3 end points in the rtPA-treated group . The effect sizes were 8 % for mRS , 6 % for BI , and 14 % for NIHSS , respectively . The differences are statistically significant for the mRS ( P=0.044 ; odds ratio [ OR ] , 1 . 4 ; 95 % confidence interval [ CI ] , 1.0 to 2.0 ) and the NIHSS ( P=0.001 ; OR , 1.9 ; 95 % CI , 1.4 to 2.8 ) , while for the BI significance was missed ( P=0.102 ; OR , 1.3 ; 95 % CI , 0.9 to 1.8 ) . The global end-point statistics , however , shows a significant increase ( P=0.008 ; OR , 1.5 ; 95 % CI , 1.1 to 2.0 ) of favorable outcome in the rtPA-treated patient group . CONCLUSIONS Using the global end-point analysis , ECASS is positive in the intention-to-treat analysis . This may indicate that the time window for thrombolysis may be as long as 6 hours . Looking at the 3 dichotomized end points , the effect sizes for 2 end points , mRS and BI , are smaller in the ECASS 6-hour intention-to-treat population compared with the NINDS trial , whereas the effect size for the NIHSS is larger . While in the NINDS trial all 3 end points reveal statistically significant results , in ECASS only 2 of the 3 corresponding end points , mRS and NIHSS , were statistically significant . This finding underlines an important difference of a global end-point approach : it may show a positive overall result although one of the end points is not positive",
"The efficacy and safety of pentoxifylline were assessed in 297 adult patients with ischemic stroke in a multicenter , double-blind , r and omized and placebo-controlled trial . Treatment was started within 12 hours after the stroke onset . Study medication was administered intravenously continuously ( 16 mg/kg/day , maximum 1,200 mg/day ) for 3 days and per os ( 400 mg t.i.d . ) for the remainder of 28 days . Demographic data were comparable , and functional impairment and mortality ( pentoxifylline 12 % , placebo 10 % ) were not different between the two groups . Neurologic deficit scores improved from baseline admission scores during the 4-week study in both groups but did not differ between groups at admission or throughout the study except during the first few days when the consciousness level ( Days 1 and 2 ) , motor function ( Days 1 and 2 ) , cranial nerve function ( Days 1 - 4 ) , and total neurologic deficit scores ( Days 1 and 2 ) were better in the pentoxifylline group than in the placebo group , especially in a subset of patients with severe deficits at admission . Laboratory values and side effects were also comparable between groups . Our study indicates that pentoxifylline can be given safely in patients with acute ischemic stroke . Although pharmacologic effects were present during the first few days , the clinical benefits were small and not sustained",
"Despite the frequent use of clinical rating scales in multicenter therapeutic stroke trials , no generally acceptable method exists to train and certify investigators to use the instrument consistently . We desired to train investigators to use the National Institutes of Health Stroke Scale in a study of acute stroke therapy so that all examiners rated patients comparably . Methods We devised a two-camera videotape method that optimizes the visual presentation of examination findings . We then measured the effectiveness of the training by asking each investigator to evaluate a set of 11 patients , also on videotape . We tabulated the evaluations , devised a scoring system , and calculated measures of interobserver agreement among the participants in this study . Results We trained and certified 162 investigators . We found moderate to excellent agreement on most Stroke Scale items ( unweighted K>0.60 ) . TWO items , facial paresis and ataxia , exhibited poor agreement ( unweighted K video training compared with previous studies . Inclusion of the motor rating of the unaffected limbs in the total score did not affect reliability . Conclusions Video training and certification is a practical and effective method to st and ardize the use of examination scales . Two cameras must be used during the taping of patients to accurately present the clinical findings . This method is easily adapted to any study in which a large number of investigators will be enrolling patients at multiple clinical centers",
"BACKGROUND Despite doubts about their efficacy and concern about their safety , antithrombotic agents are often used to treat acute ischemic stroke . Recent experience in patients with other thromboembolic disorders suggests that low-molecular-weight heparin , which requires only subcutaneous administration once or twice daily , may be more effective and safer than st and ard ( unfractionated ) heparin . METHODS We conducted a r and omized , double-blind , placebo-controlled trial comparing two dosages of low-molecular-weight heparin with placebo in the treatment of ischemic stroke . Patients were r and omly assigned within 48 hours of the onset of symptoms to receive high-dose nadroparin ( 4100 anti-factor Xa IU twice daily ) , low-dose nadroparin ( 4100 IU once daily ) , or placebo subcutaneously for 10 days . The primary measure of outcome was death or dependency regarding activities of daily living six months after r and omization . Secondary outcomes were death , hemorrhagic transformation of the infa rct ion , and other complications at 10 days , and death or dependency at 3 months . RESULTS A total of 2750 patients were screened for the study . Among 312 patients r and omized , 306 had outcomes that were analyzed at six months . Forty-five patients ( 45 percent ) in the high-dose group , 53 patients ( 52 percent ) in the low-dose group , and 68 patients ( 65 percent ) in the placebo group died or became dependent . There was a significant dose-dependent effect among the three study groups in favor of low-molecular-weight heparin ( P = 0.005 by the chi-square test for trend ) . No significant differences among the groups in the occurrence of secondary outcomes were observed at 10 days . CONCLUSIONS For patients with ischemic stroke treated within 48 hours of the onset of symptoms , low-molecular-weight heparin was effective in improving outcomes at six months",
"BACKGROUND AND PURPOSE Adequate outcome assessment is crucial to r and omized trials . We wished to assess the types of outcomes used in acute stroke trials and the appropriateness of these outcomes and their analyses . METHODS Acute stroke trials from the Cochrane Stroke Group 's data base were included from 1955 to 1995 if they were published in full text in English . For each trial we collected year of publication , number of patients r and omized , blinding of outcome assessment , the specific outcome instruments used , the statistical methods used for analysis , and the significance of the results . The validity and reliability of each outcome measure were assessed by review of the literature . RESULTS Our study included 174 trials . Outcomes were assessed blindly in 69 % . Death was recorded in only 76 % of trials , impairment in 76 % , disability in 42 % , and h and icap or quality of life in only 2 % . Of the trials that measured impairment , 35 % used a measure of established validity or reliability . For disability and h and icap , the proportions with valid or reliable measures were 70 % and 25 % , respectively . Impairment and h and icap measures were primarily analyzed as continuous variables , while disability was mainly analyzed as a dichotomous variable . Continuous data were usually analyzed with inappropriate parametric statistics . There was no relationship between the method of analysis , the type of outcome , and the statistical significance of results . CONCLUSIONS Most acute stroke trials up to 1995 have used clinical outcome measures that were inadequate in terms of their content , reliability , validity , blinded assessment , and statistical analysis . This has important implication s for future stroke research",
"Summary A controlled study of the effect of hypervolaemic haemodilution on cerebral blood flow ( CBF ) was performed using 10 % hydroxyethylstarch ( HES ) in 27 patients with acute cerebral ischaemia . Of the patients , 12 were r and omly allocated as controls without HES infusion and 15 received 500 ml HES daily , infused over a period of 5–7h , for 7 days . CBF was measured on days 1 , 2 and 7 by the xenon 133 inhalation method and calculated as initial slope index . In the HES-treated group , CBF increased in both hemispheres ( P hemispheric flow of the involved side had decreased ( P the increase in flow was larger than in other regions in both groups . Regional flow had increased more in the HES-treated group than in controls at both day 2 ( P improve hemispheric and regional flow significantly , particularly in infa rct ed hemispheres and hypaemic regions with acute cerebral ischaemia",
"The therapeutic efficacy of prostacyclin in nonhemorrhagic cerebral infa rct ion was assessed in a placebo-controlled double-blind trial . A total of 80 patients with stroke onset within 24 hours were r and omized into placebo ( 37 patients ) and prostacyclin ( 43 patients ) groups . Demographic data and risk factors were comparable . Patients in the prostacyclin group received a continuous i.v . infusion of prostacyclin at an average rate of 8.5 ng/kg/min for an average of 64 hours . The placebo group received vehicle only in a similar fashion . During treatment hemodynamic changes were more prominent in the patients receiving prostacyclin and included reduction of systolic and diastolic blood pressure and increase in pulse rate . In contrast there was only a slight ( but significant ) reduction of diastolic blood pressure in the placebo group . Neurologic deficit scores were determined on admission , at Day 3 , and at Weeks 1 , 2 , and 4 . Mean neurologic deficit scores upon entry were comparable in the placebo and prostacyclin groups , and a significant improvement in the score for neurologic deficit was noted in both . The placebo group tended to fare better throughout the study , with a significant difference in neurologic deficit score favoring the placebo group at Week 2 ( p = 0.0048 ) . Two patients in the placebo and one in the prostacyclin group died . The only difference in adverse reactions was flushing ( 6 patients in prostacyclin vs. 0 in placebo group , p less than 0.05 ) . The results of this study suggest a lack of therapeutic efficacy of prostacyclin in a defined population of patients with nonhemorrhagic cerebral infa rct ion",
"Background and Purpose A r and omized , double‐blind , placebo‐controlled multicenter trial was conducted to test the hypothesis that nimodipine would improve the functional outcome in acute ischemic hemispheric stroke . Methods A total of 350 patients were r and omized to nimodipine 120 mg/d PO or matching placebo for 21 days . R and omization was stratified by onset of therapy , age , and stroke severity . Treatment was begun within 48 hours of onset . The patients had neurological evaluation on admission , on days 1 , 7 , and 21 , and at 3 and 12 months . The primary end points were Rankin grade , neurological score , and mobility at 12 months . Results We did not find any differences in the functional outcome between the treatment groups or between the stratified subgroups . We were also unable in post hoc analyses to find any groups of patients who benefited from nimodipine . During the first month and at 3 months the case‐fatality rate was higher in the nimodipine‐treated patients than in those on placebo ( P=.004 and P=.030 , respectively ) , but at the 1‐year follow‐up this difference had lost statistical significance . During the first week nimodipine had a statistically significant lowering effect on both systolic ( P=.005 ) and diastolic ( P=.013 ) blood pressure . Conclusions Nimodipine did not improve the functional outcome of acute ischemic hemispheric stroke . The early case‐fatality rate was higher in the nimodipine group , possibly due to the blood pressure‐lowering effect of nimodipine . ( Stroke . 1994;25:1348‐1353 .",
"The results of clinical trials investigating various therapies in acute ischemic stroke have been inconsistent . The effect of glycerol therapy and a combination therapy of glycerol and dextran was evaluated in a double-blind , placebo-controlled study . Repeated neurologic examinations ( Day 0 , Weeks 1 , 6 , 12 , and 24 ) according to a modified Mathew score were performed on 62 patients . Statistical analysis showed no superiority of either treatment compared with placebo in acute ischemic stroke . A retrospective estimation of the Type II error of the study yielded approximately p = 0.25 . A major side effect was hemolysis in 98 % of patients treated with glycerol",
"BACKGROUND AND PURPOSE To be useful for clinical research , an outcome measure must be feasible to administer and have sound psychometric attributes , including reliability , validity , and sensitivity to change . This study characterizes the psychometric properties of the Stroke Impact Scale ( SIS ) Version 2.0 . METHODS Version 2.0 of the SIS is a self-report measure that includes 64 items and assesses 8 domains ( strength , h and function , ADL/IADL , mobility , communication , emotion , memory and thinking , and participation ) . Subjects with mild and moderate strokes completed the SIS at 1 month ( n=91 ) , at 3 months ( n=80 ) , and at 6 months after stroke ( n=69 ) . Twenty-five subjects had a replicate administration of the SIS 1 week after the 3-month or 6-month test . We evaluated internal consistency and test-retest reliability . The validity of the SIS domains was examined by comparing the SIS to existing stroke measures and by comparing differences in SIS scores across Rankin scale levels . The mixed model procedure was used to evaluate responsiveness of the SIS domain scores to change . RESULTS Each of the 8 domains met or approached the st and ard of 0.9 alpha-coefficient for comparing the same patients across time . The intraclass correlation coefficients for test-retest reliability of SIS domains ranged from 0.70 to 0.92 , except for the emotion domain ( 0.57 ) . When the domains were compared with established outcome measures , the correlations were moderate to strong ( 0.44 to 0.84 ) . The participation domain was most strongly associated with SF-36 social role function . SIS domain scores discriminated across 4 Rankin levels . SIS domains are responsive to change due to ongoing recovery . Responsiveness to change is affected by stroke severity and time since stroke . CONCLUSIONS This new , stroke-specific outcome measure is reliable , valid , and sensitive to change . We are optimistic about the utility of measure . More studies are required to evaluate the SIS in larger and more heterogeneous population s and to evaluate the feasibility and validity of proxy responses for the most severely impaired patients",
"We design ed a 15-item neurologic examination stroke scale for use in acute stroke therapy trials . In a study of 24 stroke patients , interrater reliability for the scale was found to be high ( mean kappa = 0.69 ) , and test-retest reliability was also high ( mean kappa = 0.66 - 0.77 ) . Test-retest reliability did not differ significantly among a neurologist , a neurology house officer , a neurology nurse , or an emergency department nurse . The stroke scale validity was assessed by comparing the scale scores obtained prospect ively on 65 acute stroke patients to the patients ' infa rct ion size as measured by computed tomography scan at 1 week and to the patients ' clinical outcome as determined at 3 months . These correlations ( scale-lesion size r = 0.68 , scale- outcome r = 0.79 ) suggested acceptable examination and scale validity . Of the 15 test items , the most interrater reliable item ( pupillary response ) had low validity . Less reliable items such as upper or lower extremity motor function were more valid . We discuss methods for improving the reliability and validity of brief examination scales to be used in stroke therapy trials",
"The effect of hemodilution was studied in 106 acute ischaemic stroke patients ( 55 hemodiluted and 51 control subjects ) . The investigation did not show statistically significant differences between the two groups regarding the mortality rate and the degree of rehabilitation ( modified Rankin Scale ) but revealed a significant neurologic score ( proposed by the Sc and inavian Stroke Study Group ) in the hemodiluted group . A correlation between the favourable score modification and the degree of hematocrit modification was also observed",
"BACKGROUND AND PURPOSE The effect of ebselen , a seleno-organic compound with antioxidant activity through a glutathione peroxidase-like action , on the outcome of acute ischemic stroke was evaluated in a multicenter , placebo-controlled , double-blind clinical trial . METHODS Patients diagnosed as having acute ischemic stroke who could receive drug treatment within 48 hours of stroke onset were enrolled . Oral administration of ebselen granules suspended in water ( 150 mg BID ) or placebo was started immediately after admission and was continued for 2 weeks . The major end points were the Glasgow Outcome Scale scores at 1 month and 3 months after the start of treatment . The modified Mathew Scale and modified Barthel Index scores at 1 month and 3 months were also studied as secondary outcome measures . RESULTS Three hundred two patients were enrolled in the trial . Intent-to-treat analysis of 300 patients ( 151 given ebselen and 149 given placebo ) revealed that ebselen treatment achieved a significantly better outcome than placebo at 1 month ( P = .023 , Wilcoxon rank sum test ) but not at 3 months ( P = .056 , Wilcoxon rank sum test ) . The improvement was significant in patients who started ebselen within 24 hours of stroke onset but not in those who started treatment after 24 hours . There was a corresponding improvement in the modified Mathew Scale and modified Barthel Index scores . CONCLUSIONS Early treatment with ebselen improved the outcome of acute ischemic stroke . Ebselen may be a promising neuroprotective agent",
"BACKGROUND AND PURPOSE Visual analogue scales ( VAS ) have been used for the subjective measurement of mood , pain , and health status after stroke . In this study we investigated how stroke-related impairments could alter the ability of subjects to answer accurately . METHODS Consent was obtained from 96 subjects with a clinical stroke ( mean age , 72.5 years ; 50 men ) and 48 control subjects without cerebrovascular disease ( mean age , 71.5 years ; 29 men ) . Patients with reduced conscious level or severe dysphasia were excluded . Subjects were asked to rate the tightness that they could feel on the ( unaffected ) upper arm after 3 low-pressure inflations with a st and ard sphygmomanometer cuff , which followed a predetermined sequence ( 20 mm Hg , 40 mm Hg , 0 mm Hg ) . Immediately after each change , they rated the perceived tightness on 5 scales presented in a r and om order : 4-point rating scale ( none , mild , moderate , severe ) , 0 to 10 numerical rating scale , mechanical VAS , horizontal VAS , and vertical VAS . St and ard tests recorded deficits in language , cognition , and visuospatial awareness . RESULTS Inability to complete scales with the correct pattern was associated with any stroke ( P measurement scales , including VAS",
"Quantitative assessment of patient data is a pertinent part of controlled clinical studies . When several centers are involved , the degree of agreement between different observers becomes important . Therefore , in addition to developing a multicenter study on acute ischemic stroke , we have estimated the interobserver agreement expressed in terms of kappa statistics . Twelve patients suffering from neurologic deficits due to acute ischemic stroke were examined by four investigators , and the results were assessed using the Mathew scale . Considerable interobserver variability was found . Agreement on items based on subjective information from the patient was low , and it is also possible that this information changes with time . It is advised that in the development of assessment scales , items with low interobserver agreement should be avoided",
"CONTEXT Intravenous tissue-type plasminogen activator can be beneficial to some patients when given within 3 hours of stroke onset , but many patients present later after stroke onset and alternative treatments are needed . OBJECTIVE To determine the clinical efficacy and safety of intra-arterial ( IA ) recombinant prourokinase ( r-proUK ) in patients with acute stroke of less than 6 hours ' duration caused by middle cerebral artery ( MCA ) occlusion . DESIGN PROACT II ( Prolyse in Acute Cerebral Thromboembolism II ) , a r and omized , controlled , multicenter , open-label clinical trial with blinded follow-up conducted between February 1996 and August 1998 . SETTING Fifty-four centers in the United States and Canada . PATIENTS A total of 180 patients with acute ischemic stroke of less than 6 hours ' duration caused by angiographically proven occlusion of the MCA and without hemorrhage or major early infa rct ion signs on computed tomographic scan . INTERVENTION Patients were r and omized to receive 9 mg of IA r-proUK plus heparin ( n = 121 ) or heparin only ( n = 59 ) . MAIN OUTCOME MEASURES The primary outcome , analyzed by intention-to-treat , was based on the proportion of patients with slight or no neurological disability at 90 days as defined by a modified Rankin score of 2 or less . Secondary outcomes included MCA recanalization , the frequency of intracranial hemorrhage with neurological deterioration , and mortality . RESULTS For the primary analysis , 40 % of r-proUK patients and 25 % of control patients had a modified Rankin score of 2 or less ( P = .04 ) . Mortality was 25 % for the r-proUK group and 27 % for the control group . The recanalization rate was 66 % for the r-proUK group and 18 % for the control group ( P Intracranial hemorrhage with neurological deterioration within 24 hours occurred in 10 % of r-proUK patients and 2 % of control patients ( P = .06 ) . CONCLUSION Despite an increased frequency of early symptomatic intracranial hemorrhage , treatment with IA r-proUK within 6 hours of the onset of acute ischemic stroke caused by MCA occlusion significantly improved clinical outcome at 90 days",
"In a pilot study , 26 patients with acute completed strokes ( 48 hours to 5 days after cerebral infa rct ion ) were r and omly assigned to the prostacyclin ( PGI2 ) or placebo groups . PGI2 sodium salt ( Epoprostenol , Wellcome Research Laboratories and Upjohn Company ) or its solvent ( glycine buffer ) were infused into the subclavian vein for six-hour periods in five courses separated by six-hour intervals . Prostacyclin was administered at a rate of 2.5 - 5.0 ng/kg/min . A significant alleviation of neurological deficits occurred 6 and 54 hours after the treatment in patients receiving prostacyclin . This improvement lost its statistical significance at the end of a two-week observation period . It is concluded that further modified controlled studies are required to evaluate the therapeutic usefulness of PGI2 in the treatment of patients with cerebral ischaemia",
"Rapid hemodilution in the early phase of ischemic stroke by the combination of venesection ( 250 - 650 ml during the first 2 days ) and administration of low-molecular weight dextran was evaluated in a prospect i ve controlled trial . Fifty-two patients were r and omized to hemodilution therapy and 50 to a control group ; the two groups were comparable in important prognostic variables . Mean hemoglobin was reduced from 147 to 127 g/1 , hematocrit from 43 to 37 % and , in a sub sample of patients , whole-blood viscosity at a shear rate of 23 sec'1 from 7.0 to 4.3 cps over the first 2 days . Hemodilution was then maintained by repeated dextran infusions . Of the hemodiluted patients , 85 % improved in neurological scoring over the first 10 days as compared to 64 % of the control patients ( P case fatality rate during the first 3 months was little affected by hemodilution . Among the survivors , 8 % of the hemodiluted and 31 % of the non-hemodiluted patients were unable to walk at 3 months . The proportion of surviving patients still hospitalized at the 3-month follow-up was 13 % in the hemodilution group and 39 % in the control group ( P venesection and dextran 40 administration is thus an unsophisticated but effective way to achieve rapid hemodilution in patients with acute cerebral infa rct ion , and it improves the overall clinical outcome over the first 3 months . Stroke Vol 15 , No 6 ,",
"BACKGROUND AND PURPOSE The reliability of the EuroQol and SF-36 question naires after stroke is not known . We therefore aim ed to assess and compare the test-retest reliability of both instruments in a group of stroke patients . METHODS A total of 2253 patients with stroke entered by United Kingdom hospitals in the International Stroke Trial were r and omized to follow up with either the EuroQol or the SF-36 instruments . For both instruments , we r and omly selected one third of respondents and asked them to complete another , identical question naire . We assessed test-retest reliability using agreement statistics : unweighted kappa statistics for the categorical domains of the EuroQol and intraclass correlation coefficients for the EuroQol visual analog scale , utility scores , and SF-36 . RESULTS For the five categorical domains of the EuroQol , reproducibility was generally good ( kappa ranged from 0.63 to 0.80 ) . The reproducibility of the domains of the SF-36 was qualitatively similar for all the domains except mental health ( intraclass correlation coefficient=.28 ) . However , the 95 % confidence intervals for the difference in scores between test and retest were substantial . For both instruments , reproducibility was better when the patient completed the question naires than when a proxy did . CONCLUSIONS Both the EuroQol and SF-36 have acceptable and qualitatively similar test-retest reliability . Therefore , either instrument might function effectively as a discriminatory measure for assessing health-related quality -of-life outcomes in groups of patients after stroke . However , our data do not support the use of either instrument for serial assessment s in individual patients unless very large differences over time are expected",
"BACKGROUND AND PURPOSE It is often difficult to determine the health-related quality of life ( HRQoL ) of stroke patients because physical and cognitive problems limit their ability to complete complex question naires . A proxy , such as a family member or caregiver , may be able to give an estimate of the patients ' health status . We therefore examined the agreement between the HRQoL as assessed by a series of patients and that assessed by their proxies . METHODS We studied the validity of the EuroQol in a series of 152 patients from our prospect i ve registry of patients with first ( or recurrent ) stroke . We asked patients to ensure that a friend or relative ( a proxy ) who knew them well was available at the time of the interview . We asked each proxy to complete a EuroQol question naire independently on behalf of the patient . RESULTS Proxies completed forms for 130 patients ( 86 % ) . Agreement between responses from the patients and those from their proxies was better for patients who were able to self-complete the EuroQol than for patients who required the EuroQol to be administered by interview . For both groups , agreement was best for the self-care domain and worst for the domain that assessed psychological outcome . For the more severely affected patients , agreement was only fair for the pain and social functioning domains and no better than chance alone for the psychological functioning domain ( kappa = 0.05 , 95 % confidence interval , 0 to 0.43 ) . Patients tended to rate their own health status as better than their proxies did ( P EuroQol . Proxy agreement was less good for the more subjective domains . In health surveys , allowing responses by a proxy increases response rate . However , the disadvantages inherent in the use of proxy responses must be considered carefully . In general , some domains of HRQoL information obtained from a proxy may be sufficiently valid and unbiased to be useable in most types of trials and surveys",
"The beta blocker stroke ( \" BEST \" ) trial was design ed to see if the apparent protective effect of propranolol on cerebral function in patients with subarachnoid haemorrhage applied also to patients suffering from acute stroke . Three hundred and two conscious patients with clinical ly diagnosed hemispheric strokes sustained within the past 48 hours were r and omly assigned to receive atenolol , propranolol , or matching placebo capsules for three weeks . More early deaths occurred among the patients allocated to receive beta blockers , but this was largely explained by differences in the initial characteristics of the patients among the different treatment groups . By contrast , the outcome in a further 60 patients , who had been taking beta blockers at the time of their stroke but were otherwise similar to the patients in the trial , was considerably better , suggesting that prior treatment with beta blockers might be protective . The search for an effective medical treatment for acute stroke must continue . The approach used here , in which neurological outcome was assessed in a modest number of patients with a view to proceeding subsequently to a full scale trial of functional outcome , allows practical benefits of a treatment to be evaluated under realistic conditions and an ineffective treatment to be eliminated without undue cost",
"Citicoline ( CDP-choline ) is a key intermediary in the bio synthesis of phosphatidylcholine , an important component of the neural cell membrane . It has been shown to produce beneficial effects in both animal models and non-US clinical stroke trials . This study comprised a r and omized ( 3 doses of citicoline to 1 placebo ) , vehicle-controlled , double-blind trial at 21 US centers . Treatment was to be started within 24 hours of stroke onset and was continued orally for 6 weeks . Final outcome assessment s were at 12 weeks . Two hundred fifty-nine patients were enrolled , with approximately 65 in each of the four groups . Mean time from stroke onset to treatment was 14.5 hours , and there were no significant differences in baseline characteristics between the four groups except for patient weight . A significant difference between the groups , favoring citicoline treatment , was seen in terms of functional outcome as measured by the Barthel Index and Rankin scale , neurologic evaluation as measured by the National Institutes of Health ( NIH ) stroke scale , and cognitive function as measured by the Mini Mental Status Examination . When the baseline NIH stroke scale was used as a covariate , both the 500-mg citicoline group and the 2,000-mg citicoline group had a significant improvement in terms of the percent of patients who had a favorable outcome on the Barthel Index at 90 days . There were no drug-related serious adverse events or deaths in this study . This study suggests that oral citicoline can be used safely with minimal side effects in acute stroke treatment . Citicoline appears to improve functional outcome and reduce neurologic deficit with 500 mg of citicoline appearing to be the optimal dose",
"Recent investigations suggest that increased cellular calcium concentrations may be implicated in neuronal death after ischemia . To determine whether treatment with a calcium-channel blocker would improve survival and neurologic outcome in acute ischemic stroke , we enrolled 186 patients in a prospect i ve , double-blind , r and omized , placebo-controlled trial of nimodipine ( 30 mg every six hours ) , begun within 24 hours of the onset of symptoms of an acute ischemic stroke . During the four-week treatment period , mortality from all causes was significantly reduced with nimodipine as compared with placebo ( 8 deaths [ 8.6 percent ] vs. 19 [ 20.4 percent ] ) . The improvement in survival was restricted to men . During the follow-up period of six months , an additional eight patients in each group died . A significantly better neurologic outcome , as assessed by the Mathew scale of neurologic deficit , was also observed in the nimodipine group . The improvement in neurologic status was greatest in patients with a moderate to severe deficit at base line . There were no important side effects except for one episode of reversible azotemia that may have been related to treatment with nimodipine . Our data suggest that patients with acute ischemic stroke may benefit from early treatment with nimodipine , but this therapeutic effect appears to be limited to men",
"The aim of the present study was to investigate the predictive power of ratings of Barthel Index at Day 40 post stroke , compared with and /or combined with simultaneous ratings from a mobility scale ( EG motor index ) and a rather simple cognitive test scale ( CT50 ) . The parameter to be individually predicted was the need for special living facilities and support at discharge from a rehabilitation hospital , as well as six months later ; 53 stroke patients with age median 68 years were included in this prospect i ve study . It was shown that a combination of Barthel Index and CT50 had a stronger predictive power than Barthel Index alone . A combination of EG motor index and CT50 had at least the same predictive power as the combination of Barthel Index and CT50 . The usefulness of a simple diagram for individual prognostication was demonstrated",
"ABSTRACT — Nimodipine ( BAY e 9736 ) , a new dihydropyridine derivative , has been shown to reduce neurological deficits and mortality induced by acute cerebral ischemia in experimental studies . We investigated the effects of this calcium antagonist in patients with acute ischemic stroke through a r and omized , double‐blind , parallel‐ design ed trial in which nimodipine was compared with placebo . Forty‐one of 54 screened cases were found to fulfil the inclusion criteria ( sudden occurrence of a focal neurological deficit secondary to an acute ischemic event in the carotid area diagnosed after a complete neurological work‐up ) and entered the study . Nineteen of them were treated with nimodipine ( 40 mg t.i.d . administered for 28 days ) and the remaining 22 with placebo , given in identical tablets . In all patients the treatment started within 12 h after the onset of the symptoms . Course and intensity of the neurological deficit were evaluated by the Mathew Scale ( slightly modified ) . Forty patients concluded the trial . Nimodipine was withdrawn in one case following the occurrence of a skin rash whose causative relation with the test drug could not be clarified . Altogether , however , nimodipine was well tolerated and no severe cardiovascular adverse reactions were observed . In terms of efficacy , the scores obtained by the Mathew Scale showed a higher rate of improvement on nimodipine than on placebo , thus indicating that patients receiving the latter drug did not fare as well as those receiving the test medication . Our data suggest that nimodipine may be beneficial in the treatment of acute stroke",
"This article describes basic characteristics and primary outcomes of unselected patients with stroke . These patients were part of the Copenhagen Stroke Study , a prospect i ve , consecutive , and community-based study of 1197 acute stroke patients . The setting and care was multidisciplinary and all treatment was performed within the dedicated stroke unit . Neurologic impairment was measured at admission , weekly throughout the hospital stay , and again at the 6-month follow up . Basic activities of daily living , as measured by the Barthel Index , were assessed within the first week of admission , weekly throughout the hospital stay , and again after 6 months . Upon completion of the in-hospital rehabilitation , which averaged 37 days , two-thirds of surviving patients were discharged to their homes , with another 15 % being discharged to a nursing home . Only 4 % of the patients with very severe strokes reached independent function , as compared with 13 % of patients with severe stroke , 37 % of patients with moderate stroke , and 68 % of patients with mild stroke",
"Patients participating in a clinical trial of stroke therapy were assessed 3 months after r and omization using the Barthel Index , the Modified Rankin Scale , questions on activities of daily living , and extent of recovery . Those who needed help in performing the activities of daily living and had not recovered completely were classified as dependent . Self-reported dependency had a sensitivity of 94 % and specificity of 80 % against the Barthel Index dichotomized at 16 or below , or a sensitivity of 85 % and specificity of 87 % against the Modified Rankin Scale dichotomized at 2 or above",
"The effects of intravenous glycerol in elderly patients with recent onset of acute ischaemic stroke were evaluated in a double-blind r and omised controlled trial . 173 patients received either 500 ml of a 10 % solution of glycerol in physiological saline or 500 ml of physiological saline administered intravenously over 4 h daily for 6 consecutive days . The number of deaths within the first week was 10 ( 12 % ) in the glycerol group versus 26 ( 30 % ) in the controls . Subsequent mortality up to 12 months was similar in the two groups and a survival analysis confirmed a beneficial effect of treatment ( p less than 0.02 ) . The neurological and functional recovery of survivors , their length of hospital stay , and the proportion able to return to live in their own home were similar in the two groups . The improvement in survival time with glycerol was achieved without serious adverse effects and without an increase in the proportion of survivors with severe residual disability",
"Introduction ‐ An international , multicenter trial was conducted in 331 patients to determine the effect of a large dose of flunarizine ( a calcium entry blocker ) in the treatment of acute ischemic stroke in the territory of the Middle cerebral artery . Methods ‐ The administration of the trial medication should start within 24 h after the initial symptoms of stroke . According to a r and om schedule , the patients were assigned to a 4‐weeks double‐blind treatment with either flunarizine ( n= 166 ) or placebo ( n= 165 ) : one week intravenous administration ( 50 mg daily ) , followed by 3 weeks oral treatment ( week 2 , 21 mg daily ; week 3–4 , 7 mg daily ) . All patients had to be investigated by computerized tomography ( CT ) within 7 days after stroke onset ; 36 patients were secundarily excluded because the CT showed another pathology . During the treatment period , other “ stroke therapies ” were not allowed . Patients were followed up for 24 weeks . Results ‐ After the 24 weeks trial period , the percentage of patients who were dead or pendent ( modified Rankin score 3–5 ) was similar in both treatment groups ( flunarizine 67 % , placebo 65 % ) . During the trial , the scores for h and icap severity ( modified Rankin scale ) , neurological status ( Orgogozo ) and activities of daily living ( modified Barthel index ) strongly improved in both treatment groups , but no differences were found between the treatment groups . In this trial , the administration of trial treatment started relatively late after stroke onset ( flunarizine group : mean time interval 13.5 h ; placebo 12.3 h ) . A subgroup of patients received trial medication within 6 h after stroke onset ( flunarizine n= 31 ; placebo n= 29 ) . Also in this subgroup , no differences were found between the flunarizine and placebo group . Conclusion ‐ Flunarizine did not improve neurologic and functional outcome in patients with acute ischemic stroke",
"OBJECTIVE To determine the time course of both neurological and functional recovery from stroke . DESIGN Prospect i ve , consecutive , and community based . SETTING The stroke unit of a hospital in Copenhagen , Denmark . This setting receives all acute stroke patients admitted from a well-defined catchment area of 239,886 inhabitants within the city of Copenhagen . Acute treatment as well as all stages of rehabilitation are cared for within the stroke unit regardless of age , stroke severity , and premorbid condition . PATIENTS 1,197 patients with acute stroke . MAIN OUTCOME MEASURES Weekly examinations of neurological deficits ( using the Sc and inavian Neurological Stroke Scale ) and functional disabilities ( Activity of Daily Living ( ADL ) measured by the Barthel Index ) were performed from the time of acute admission to the end of rehabilitation . These evaluations were repeated 6 months poststroke . Time course of recovery was stratified according to initial stroke severity and disability . RESULTS Functional recovery was completed within 12.5 weeks ( 95 % confidence interval ( CI ) 11.6 to 13.4 ) from stroke onset in 95 % of the patients . However , 80 % of the patients had reached their best ADL function within 6 weeks ( CI 5.3 to 6.7 ) from onset . The time course of functional recovery was strongly related to initial stroke severity . Best ADL function was reached within 8.5 weeks ( CI 8 to 9 ) in patients with initially mild strokes , within 13 weeks ( CI 12 to 14 ) in patients with moderate strokes , within 17 weeks ( CI 15 to 19 ) in patients with severe strokes , and within 20 weeks ( CI 16 to 24 ) in patients with very severe strokes . After these time-points , no significant changes occurred . However , a valid prognosis of functional outcome can be made much earlier . Best ADL function was reached by 80 % of the patients with initially mild strokes within 3 weeks ( CI 2.6 to 3.4 ) , within 7 weeks ( CI 6 to 8) of the patients with moderate strokes , and within 11.5 weeks ( CI 10 to 13 ) of the patients with severe and very severe strokes . The time course of neurological recovery followed a pattern similar to that of functional recovery , but preceeded functional recovery by 2 weeks on average . CONCLUSIONS A reliable prognosis can in all stroke patients be made within 12 weeks from stroke onset . Even in patients with severe and very severe strokes , neurological and functional recovery should not be expected after the first 5 months",
"BACKGROUND AND PURPOSE The reliability of the National Institutes of Health Stroke Scale ( NIHSS ) has been established through testing its use in live and videotaped patients . This reliability testing has primarily focused on the use of the scale by neurologists . We sought to determine the reliability of the NIHSS as used by non-neurologists in the context of a clinical trial . METHODS In anticipation of the initiation of a r and omized trial of a new therapy for patients with acute ischemic stroke , 30 physician investigators ( 30 % of whom were not neurologists ) and 29 non-physician study coordinators were trained in the use of the NIHSS at an informational and training conference using st and ardized videotaped patient examinations . A series of 4 patients were rated initially . After 3 months , the same 4 patients were rerated , providing a measure of intraobserver reliability . An additional series of 4 new patients were also rated after 3 months and , with the initial 4 ratings , provided data for assessment of interobserver reliability . RESULTS Overall , 28 % of the raters had previous experience with the NIHSS , and 22 % had previously used the videotapes as used in the present trial . The coefficients of determination ( r2 ) were each greater than .95 when the means of the two ratings of the same 4 cases were compared between ( 1 ) neurologists and other types of physicians , ( 2 ) physicians and study coordinators , ( 3 ) raters who had prior experience with the NIHSS and those without prior experience , and ( 4 ) raters who had used the videotapes in the past and those who had never viewed the tapes . The calculated r2s were greater than .98 for the initial rating of the first 4 cases and for the later rating of the 4 new cases . The slopes of the regression lines were all near 1 , indicating that the raters were similarly calibrated . The intraclass correlation coefficients were .93 and .95 , reflecting high levels of intraobserver and interobserver reliability . CONCLUSIONS These data extend the previously demonstrated reliability of the NIHSS to non-neurologists and show that both a variety of physician investigators and nurse study coordinators can be rapidly trained to reliably apply the scale in the context of an actual clinical trial",
"Measurement of stroke recovery is complex because definition of successful recovery is highly variable across measures and cut-off points for defining successful outcomes vary . The purpose of this paper is to describe patterns of recovery in stroke patients of varying severity when different measures are used and when different cut-off points are selected . 459 individuals enrolled in a prospect i ve cohort study were assessed within 14 days post stroke and re-evaluated at 1 , 3 , and 6 months . Recovery was assessed using the NIH Stroke Scale , the Fugl-Meyer Assessment of Motor Recovery , the Barthel Index of Activities of Daily Living , the Physical Function Index of the SF-36 , and the Modified Rankin Outcome Scale . Subjects also defined their preference ( utility ) for their current health state with a time-trade off question . We compared patterns of recovery using the different measures and varying the cut-off points for defining successful recovery . The percentage of patients who are believed to have recovered depends on how recovery is defined . If recovery is defined at the disability level ( Barthel > 90 ) , the majority 57.3 % of stroke survivors experience a full recovery . Fewer individuals are considered to be fully recovered if impairments are measured ( NIH 90 , 36.8 % . Less than 25 % of stroke survivors are considered recovered if recovery is defined relative to reported prior function in higher levels of physical activity . Shifting the definition of recovery on the modified Rankin scale from disability , a higher proportion of the placebo group will achieve the outcome than if impairments are used to define recovery . The benchmarks for recovery in minor strokes must include measures of higher functioning ( e.g. the SF-36 physical functioning index or a Rankin 0 ( no symptoms )",
"The Australian Streptokinase Trial was a r and omized , double-blind , placebo-controlled trial , in which streptokinase ( SK , 1.5 million IU IV ) was given within 4 hours of stroke onset . In a subset of 37 patients , 99 m Tc-labeled D , L-hexamethylpropylene amine oxime single-photon emission computed tomography ( SPECT ) and /or transcranial Doppler ( TCD ) studies were performed before and after therapy to test the hypothesis that SK may improve the hemodynamic measures of reperfusion/recanalization rates(TCD parameter ) within 24 hours . Eighteen patients received SK and 19 placebo . Baseline characteristics were similar in both groups , and there were no differences in clinical outcomes assessed at 3 months after stroke . Although there was no increase in the group mean perfusion defect or volume on SPECT after thrombolytic therapy , a larger number of patients demonstrating the combined end point of reperfusion or recanalization was seen in the SK group ( 13/14 , 93 % ) than in the placebo group ( 7/14 , 50%;p = 0.01 ) . Although SK given within 4 hours of acute ischemic stroke appears to improve arterial patency/tissue reperfusion , this effect is neither early nor extensive enough to influence overall clinical outcome",
"OBJECTIVE To evaluate the efficacy and safety of intravenous thrombolysis using recombinant tissue plasminogen activator ( rt-PA ) in patients with acute ischemic stroke . DESIGN R and omized , prospect i ve , multicenter , double-blind , placebo-controlled clinical trial . SETTING A total of 75 hospitals in 14 European countries . PATIENTS A total of 620 patients with acute ischemic hemispheric stroke and moderate to severe neurologic deficit and without major early infa rct signs on initial computed tomography ( CT ) . INTERVENTION Patients were r and omized to treatment with 1.1 mg per kilogram of body weight of rt-PA ( alteplase ) or placebo within 6 hours from the onset of symptoms . OUTCOME MEASURES Primary end points included Barthel Index ( BI ) and modified Rankin Scale ( RS ) at 90 days . Secondary end points included combined BI and RS , Sc and inavian Stroke Scale ( SSS ) at 90 days , and 30-day mortality . Tertiary end points included early neurologic recovery ( SSS ) and duration of in-hospital stay . Safety parameters included mortality and incidence of intracranial or extracranial hemorrhage . RESULTS The distribution of demographic variables was similar among patients in the rt-PA and placebo treatment arms in both the intention-to-treat ( ITT ) analysis and the explanatory analysis for the target population ( TP ) . A total of 109 patients ( 17.4 % ) were included in the trial despite major protocol violations but excluded from the TP . There was no difference in the primary end points in the ITT analysis , while the TP analysis revealed a significant difference in the RS in favor of rt-PA-treated patients ( P = .035 ) . Of the secondary end points , the combined BI and RS showed a difference in favor of rt-PA-treated patients in both analyses ( P Neurologic recovery at 90 days was significantly better for rt-PA-treated patients in the TP ( P = .03 ) . The speed of neurologic recovery assessed by the SSS was significantly better up to 7 days in the ITT analysis and up to 30 days for the TP in the rt-PA treatment arm . In-hospital stay was significantly shorter in the rt-PA treatment arm in both analyses . There were no statistically significant differences in the mortality rate at 30 days or in the overall incidence of intracerebral hemorrhages among the rt-PA and placebo treatment arms in either analysis . However , the occurrence of large parenchymal hemorrhages was significantly more frequent in the rt-PA-treated patients . CONCLUSIONS Intravenous thrombolysis in acute ischemic stroke is effective in improving some functional measures and neurologic outcome in a defined subgroup of stroke patients with moderate to severe neurologic deficit and without extended infa rct signs on the initial CT scan . However , the identification of this subgroup is difficult and depends on recognition of early major CT signs of early infa rct ion . Therefore , since treating ineligible patients is associated with an unacceptable increase of hemorrhagic complications and death , intravenous thrombolysis can not currently be recommended for use in an unselected population of acute ischemic stroke patients",
"BACKGROUND AND PURPOSE To test the safety and recanalization efficacy of intra-arterial local delivery of plasminogen activators in acute ischemic stroke , a r and omized trial of recombinant pro-urokinase ( rpro-UK ) versus placebo was undertaken in patients with angiographically documented proximal middle cerebral artery occlusion . METHODS After exclusion of intracranial hemorrhage by CT scan , patients with abrupt onset of symptoms of focal ischemia likely to receive treatment within 6 hours who satisfied all clinical eligibility criteria underwent carotid angiography . Patients displaying Thrombolysis in Acute Myocardial Infa rct ion grade 0 or 1 occlusion of the M1 or M2 middle cerebral artery were r and omized 2:1 to receive rpro-UK ( 6 mg ) or placebo over 120 minutes into the proximal thrombus face . All patients received intravenous heparin . Recanalization efficacy was assessed at the end of the 2-hour infusion , and intracerebral hemorrhage causing neurological deterioration was assessed at 24 hours . RESULTS Of 105 patients who underwent angiography , 59 were excluded from r and omization . Among the 46 patients r and omized , 40 were treated with rpro-UK ( n=26 ) or placebo ( n=14 ) a median of 5.5 hours from symptom onset . Recanalization was significantly associated with rpro-UK ( 2P=.017 ) . Hemorrhagic transformation causing neurological deterioration within 24 hours of treatment occurred in 15.4 % of the rpro-UK-treated patients and 7.1 % of the placebo-treated patients ( 2P=.64 ) . Both recanalization and hemorrhage frequencies were influenced by heparin dose . CONCLUSIONS Intra-arterial local rpro-UK infusion was associated with superior recanalization in acute thrombotic/ thromboembolic stroke compared with placebo . In this regimen , heparin dose influenced hemorrhage frequency and recanalization . Although symptomatic hemorrhage remains a concern , this study suggests that recanalization is enhanced with rpro-UK and heparin",
" Thirty-two patients with acute cerebral infa rct ion received either prostacyclin or placebo intermittently for 65 hours . Pulse and blood pressure were not altered by prostacyclin . After infusion there was no change in infa rct volume or cerebral blood flow in either group . After normalisation for starting values , age and site of cerebral infa rct ion there was a greater than 10 % improvement in speech in the prostacyclin group , but minimal changes in neurological score or disability status . Age is related to neurological score at 14 days after stroke by decreasing improvement by 6.8 % for each additional 10 years . This study has not been able to demonstrate that prostacyclin is effective in the treatment of ischaemic stroke , but due to the sample size the chance of proving this statistically ( the power ) was small . Similarly any conclusion that prostacyclin is not effective may be wrong because of the Type II error probability being high",
"Selfotel , a selective competitive N-methyl-D-aspartate antagonist , has neuroprotective efficacy in animal models of focal and global ischaemia and traumatic brain injury . In these models , selfotel was shown to reduce ischaemia-induced neuronal cell death and infa rct size , and to attenuate neuronal injury . In a phase II study , an intravenous bolus dose of 1·5 mg/kg administered within 6 h of onset of acute ischaemic stroke was safe and potentially effective . To determine whether selfotel improved the outcome of acute ischaemic stroke and severe traumatic brain injury , two multinational placebo-controlled trials for each indication were initiated . After review of the aggregate data from the four trials and considering both safety and potential benefit , an independent Data and Safety Monitoring Board ( DSMB ) recommended that enrolment in the selfotel programme be suspended and that the trials be terminated . We report the results from these two stroke trials . The ASSIST ( Acute Stroke Studies Involving Selfotel Treatment ) programme involved two trials , one conducted in Europe , Australia , Argentina , and Canada ( Protocol 10 IC/STE1 ) , and the other in the USA and Israel ( Protocol 07 ) . The hypothesis tested in these double-blind , r and omised , placebo-controlled trials was that 1·5 mg/kg selfotel administered intravenously within 6 h of stroke onset would improve functional outcome at 3 months defined as the proportion of patients reaching a score of at least 60 on the Barthel Index ( BI ) . Patient accrual began in September , 1994 . By December , 1995 , 509 patients had been enrolled in the two trials and data from 476 patients ( 389 in Protocol 10 IC/STE1 and 87 in Protocol 07 ) were in the data base . Of these , 328 patients had 3-month outcome data available for analysis ( 274 in Protocol 10 IC/STE1 and 54 in Protocol 07 ) . Comparison of baseline demographic variables showed that the treatment groups were well-matched for sex , initial stroke severity ( based on the Sc and inavian Stroke Scale [ SSS ] ) , and time from stroke onset to therapy : 4000 mg/dL ) . Small bowel enteroclysis was normal . Body weight was 38 kg ( height 171 cm ) . After 3 months of tetracycline an increase of weight of 25 kg was noted . However , duodenal and intra-abdominal lymphoma were unchanged and IgA did not return to normal . Seven courses of polychemotherapy ( cychophosphamide , doxorubicin , vincristine , prednisone ) from November , 1992 , to June , 1993 , did not cause lymphoma regression . IgA did , alone , return to normal . Furthermore , the lymphoma was still detectable after administration of four courses of vinblastine , etoposide , epirubicin , and prednisone , and after abdominal irradiation ( 18 Gy ) . Diagnostic re-evaluation in May , 1995 , showed gastric metaplasia in the duodenal bulb infected with Helicobacter pylori and infiltrates of IPSID with monoclonal heavy-chain rearrangement . Omeprazole , amoxicillin , and clarithromycin were given for 7 days . For the first time the patient became symptom-free . Diagnostic work-up including endoscopic ultrasound and abdominal computed tomography in November , 1995 , and March , 1996 , confirmed complete lymphoma regression . Alkan and colleagues reported in this journal the disappearance of salivary gl and MALT lymphoma after Helicobacter pylori eradication . Contrary to their findings , in our study Helicobacter pylori infection was located in ( metaplastic ) gastric mucosa where it is known to be associated with the development of MALT-type lymphoma",
"Nimodipine is currently under investigation for the treatment of acute stroke . Although relatively specific for the cerebrovasculature , acute reductions in blood pressure after a dose may adversely affect neurologic outcome . We studied 29 consecutive acute ischemic stroke patients treated with placebo ( n = 9 ) or either 120 ( n = 10 ) or 240 ( n = 10 ) mg/day of nimodipine . Blood pressure was recorded before and 30 and 60 minutes after a dose for the first 8 days . Ten neurologic physicians were asked to predict the treatment group ( placebo or drug ) of r and omly selected patients based on blood pressure results . Only those patients on 240 mg/day of nimodipine had significant decreases in blood pressure after a dose ( p less than 0.001 ) ; however , these were minimal ( average 10 mm Hg systolic ) . Only 26 of 48 treatment predictions ( 54 % ) were correct . At the studied doses , nimodipine has a minimal effect on blood pressure in the acute stroke period",
"There is evidence to support the use of naftidrofuryl in acute stroke with cl aims of increased recovery , reduced fatality and reduced bed occupancy in patients treated with either oral or intravenous preparations . One hundred patients presenting with acute hemisphere stroke ( less than 72 hours ) were r and omized to receive either a new oral formulation of naftidrofuryl or placebo on a double-blind basis . Treatment was given for a total of 12 weeks and patients followed for 26 weeks with serial neurological and functional assessment s by a single observer . Cumulative fatality and hospital-bed occupancy were determined at each assessment interval . No significant difference was demonstrated in cumulative fatality , hospital-bed occupancy or recovery of motor function in patients treated with either naftidrofuryl or placebo . There is no evidence from this study to support the use of oral naftidrofuryl in acute stroke",
"BACKGROUND AND PURPOSE In animals , drugs that increase brain amine concentrations influence the rate and degree of recovery from cortical lesions . It is therefore conceivable that antidepressants may influence outcome after ischemic brain injury in humans . We evaluated the effects of the norepinephrine reuptake blocker maprotiline and the serotonin reuptake blocker fluoxetine on the motor/functional capacities of poststroke patients undergoing physical therapy . METHODS Fifty-two severely disabled hemiplegic subjects were r and omly assigned to three treatment groups ; during 3 months of physical therapy , patients were treated with placebo , maprotiline ( 150 mg/d ) , or fluoxetine ( 20 mg/d ) . Before and at the end of the observation period , we assessed activities of daily living by the Barthel Index , degree of neurological deficit by a neurological scale for hemiplegic subjects , and depressive symptomatology by the Hamilton Depression Rating Scale . RESULTS The diverse treatments ameliorated walking and activities of daily living capacities to different extents . The greatest improvements were observed in the fluoxetine-treated group and the lowest in the maprotiline-treated group . Furthermore , fluoxetine yielded a significantly larger number of patients with good recovery compared with maprotiline or placebo . These effects of the drugs were not related to their efficacy in treating depressive symptoms . CONCLUSIONS Fluoxetine may facilitate or , alternatively , maprotiline may hinder recovery in poststroke patients undergoing rehabilitation . The effects of fluoxetine as an adjunct to physical therapy warrant further investigation , since treatment with fluoxetine may result in a better functional outcome from stroke than physical therapy alone",
"In a r and omized , single-blind study , 30 patients with acute ischemic stroke were treated with either low-molecular weight dextran and mannitol alone ( group A , mean age , 63.3 + /- 11.8 years , n = 15 ) or in combination with the viper venom enzyme ancrod ( group B , mean age , 67.9 + /- 7.6 years , n = 15 ) . Lowering of plasma fibrinogen levels to 100 - 130 mg/dL with ancrod result ed in a significant reduction of the apparent blood viscosity , ie , of 37 % at a shear rate of 0.03 s-1 , compared with only 7 % in group A. Fibrin degradation products increased considerably from 3.1 + /- 0.4 to 154.3 + /- 31.6 mg/L on day 3 , while plasminogen decreased from 98.2 % + /- 2.0 % to 79.8 % + /- 2.9 % in group B. Global coagulation and platelet function tests were not influenced by either treatment . Neurological score improved by 1.1 arbitrary units ( AU ) in group A and by 2.6 AU in group B. Five patients in group A and two in group B died during the first two weeks . This preliminary study indicated a slightly better outcome in the ancrod treated patients . The beneficial effect may be due to the anticoagulative and fibrinolytic activity of ancrod rather than its effect on blood viscosity",
"OBJECTIVE To determine the efficacy and safety of methylpheni date in acute stroke rehabilitation . DESIGN A prospect i ve , r and omized , double-blind , placebo-controlled study . PATIENTS AND SETTING Twenty-one stroke patients consecutively admitted to a community-based rehabilitation unit . INTERVENTION Three-week treatment of methylpheni date ( or placebo ) in conjunction with physical therapy . Methylpheni date was started at 5 mg and increased gradually to 30 mg ( 15 mg at 8:00AM and 15 mg at 12:00 noon ) , and discontinued before discharge . MAIN OUTCOME MEASURES Mood measures included the Hamilton Depression Rating Scale ( HAM-D ) and Zung Self-Rating Depression Scale ( ZDS ) . Cognitive status was evaluated using the Mini-Mental State Exam ( MMSE ) . Motor functioning was assessed using the Fugl-Meyer Scale ( FMS ) and a modified version of the Functional Independence Measure ( M-FIM ) . All measures were administered pretreatment and weekly thereafter . Side effects were measured after each increase in dosage and weekly . RESULTS Patients receiving methylpheni date treatment scored lower on the HAM-D ( F(1,18)=5.714 , p=.028 ) , lower on the ZDS ( F(1,18)=4.206 , p=.055 ) , higher on the M-FIM ( F(1,18)=5.374 , p=.032 ) , and higher on the FMS ( F(1,9)=4.060 , p=.075 ) than patients receiving placebo . CONCLUSION Methylpheni date appears to be a safe and effective intervention in early poststroke rehabilitation that may expedite recovery",
"Objective : To investigate the influence of depression on functional recovery after stroke . Design : Multicentre cohort study of 85 patients admitted for clinical rehabilitation . A two-stage case-finding procedure was used to identify patients with depression . For the control group , consecutive nondepressed stroke patients were enrolled . Patients were interviewed at 3–6 weeks and six months after stroke onset . Setting : Three rehabilitation centres in the vicinity of Amsterdam . Main outcome measures : Functional outcome was determined by the Functional Independence Measure ( FIM ) and the Rehabilitation Activities Profile ( RAP ) . Results : The prevalence of depression ( 35 % ) was comparable with the findings of earlier studies in other setting s. Patients classified as depressed according to DSM III R criteria ( American Psychiatric Association Diagnostic and statistical manual of mental disorders ) had a significantly lower functional score , both at onset and after follow-up ( FIM and RAP ) . There was , however , no significant difference in functional improvement between the depressed and the nondepressed group . Mean functional improvement in the six patients treated with antidepressants was 30 % better than in the untreated ( depressed ) patients ; numbers were too small for the results to attain statistical significance . Subset analysis showed a significantly higher outcome for nondepressed patients for the FIM subitems personal care and transfers . However , functional improvement was not significantly different for any of the subitems in depressed versus nondepressed patients . Conclusion : Stroke patients with depression have significantly lower functional scores both at onset and after six months . Our results suggest under-recognition of post-stroke depression and a possible beneficial effect of antidepressant medication in depressed stroke patients . Further studies are required to determine the effect of antidepressants",
"Eleven of 31 clinical centers participating in the Italian Acute Stroke Study --Hemodilution carried out a preliminary study on the effectiveness of ganglioside GM1 in acute stroke ; 502 patients were r and omized to GM1 ( GM1 , n = 121 ) , GM1 plus hemodilution ( GM1 + H , n = 128 ) , placebo ( P , n = 130 ) , or placebo plus hemodilution ( P + H , n = 123 ) groups less than or equal to 12 hours after onset of a hemispheric cerebral infa rct . The patients were treated for 15 days and were evaluated on Days 21 and 120 after the onset of stroke . Intention-to-treat analysis failed to show any differences in neurologic deficit , mortality , or neurologic disability among the groups . Efficacy analysis showed a significantly higher degree of neurologic improvement in GM1 group patients compared with patients in the P group during the first 15 days . GM1-treated patients ( GM1 and GM1 + H groups ) showed a significantly higher degree of neurologic improvement during the first 10 days compared with the placebo-treated patients ( P and P + H groups ) . These differences were no longer statistically significant at Day 120 . Our results provide a rationale for the planning of a larger , multicenter trial of GM1 ganglioside in acute stroke",
"BACKGROUND AND PURPOSE Lubeluzole is a novel benzothiazole compound that has shown neuroprotective activity in pre clinical models of ischemic stroke . The present multicenter , double-blind , placebo-controlled study was conducted to assess the efficacy and safety of lubeluzole in the treatment of ischemic stroke . METHODS Seven hundred twenty-one patients with clinical symptoms of acute ischemic stroke were r and omized to receive either lubeluzole ( 7.5 mg over 1 hour , followed by a continuous daily infusion of 10 mg for up to 5 days ) or placebo . Treatment was initiated within 6 hours of symptom onset . Mortality at 12 weeks was the primary efficacy end point . Secondary efficacy end points included neurological recovery ( based on the National Institutes of Health Stroke Scale [ NIHSS ] ) , functional status ( based on the Barthel Index ) , and level of disability ( based on the Rankin Scale ) . Safety assessment s included st and ard and continuous electrocardiographic monitoring , physical examination , measurements of vital signs , clinical laboratory evaluation , and adverse events reports . RESULTS The overall mortality rate at 12 weeks for lubeluzole-treated patients was 20.7 % compared to 25.2 % for placebo-treated patients ( NS ) . Controlling for relevant covariates , the degree of neurological recovery ( NIHSS ) at week 12 significantly favored lubeluzole over placebo ( P = .033 ) . Lubeluzole treatment similarly result ed in significantly greater improvements in functional status ( Barthel Index ) ( P = .038 ) and overall disability ( Rankin Scale ) ( P = .034 ) after 12 weeks . A global test statistic confirmed that lubeluzole-treated patients had a more favorable clinical outcome at 12 weeks ( P = .041 ) . The safety profile of lubeluzole resembled that of placebo . CONCLUSIONS Treatment with lubeluzole within 6 hours of the onset of ischemic stroke had a nonsignificant effect on mortality and result ed in improved clinical outcome compared with placebo , with no safety concerns",
"Background and Purpose : Lubeluzole is a benzothiazole derivative that has shown neuroprotective properties in different experimental models . This multicentre , double-blind , placebo-controlled trial was conducted to assess the safety and efficacy of lubeluzole in patients with an acute ischaemic stroke . Methods : Patients who presented with clinical signs and symptoms of acute cerebral hemispheric ischaemic stroke were r and omised to intravenous therapy with placebo ( n = 360 ) or lubeluzole 7.5 mg over 1 h followed by 10 mg/day for up to 5 days ( n = 365 ) . Treatment was initiated within 6 h of symptom onset . Mortality at 12 weeks was the primary end point . Secondary end points included neurological status ( European Stroke Scale ) , functional outcome ( Barthel Index ) , and disability level ( Rankin Scale ) . The primary and secondary end points were all analysed using the protocol -defined Cochran-Mantel-Haenszel ’s general association test . An additional analysis , the logistic regression approach , that included risk factors of age , baseline stroke severity and their interactions with treatment , was used to analyze outcome measures at 3 months . Results : In the total ischaemic stroke population , the overall mortality rate at 3 months was similar for lubeluzole ( 21.0 % ) and placebo ( 21.4 % ) . The logistic regression model confirmed the effect of age on mortality risk , but showed that this was independent of treatment . Treatment benefit was related to stroke severity , as determined by the Clinical Global Impression rating , that is a pronounced clinical ly significant reduction in mortality was noted in the lubeluzole-treated patients for whom stroke severity was mild to moderate , but not in those for whom it was severe . This was found on the basis of a post hoc analysis not specified in the hypothesis . Lubeluzole did not increase morbidity among stroke survivors , as measured by the European Stroke Scale , Barthel Index and Rankin Scale . No safety concerns were seen with lubeluzole treatment . Conclusions : In the overall study population , treatment with intravenous lubeluzole within 6 h of the onset of ischaemic stroke did not affect mortality or clinical outcome . Among patients with mild to moderate ischaemic stroke , lubeluzole decreased mortality without increasing morbidity",
"We evaluated the effect of nimodipine ( 30 mg q.i.d . orally for 14 days ) on acute ischemic stroke of mild or moderate severity in a unicenter , double-blind , r and omized , placebo-controlled pilot study . Treatment had to be started after CT , within 48 h of infa rct in patients with a Mathew scale sum score between 50 and 75 . The duration of follow-up was 4 months . Eight of the 60 r and omized patients were excluded because of incorrect diagnosis . For the remaining 52 patients , 24 were allocated to nimodipine and 28 to placebo . Analysis of variance and covariance and repeated measurements of the Mathew scale scores showed no difference between the two groups , who had continuous and parallel improvement . There was no recurrent stroke , but 1 control died 4 weeks after stroke . Treatment with nimodipine was well tolerated ( hypotension : 1 treated patient , 3 controls ; bradycardia : 1 treated patient , 2 controls ; sGPT increase : 1 treated patient , 1 control ) . The lack of efficacy of nimodipine in this study may be due to : ( 1 ) the neurologic deficit not being severe enough , or ( 2 ) the delay before treatment was too long"
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41165312-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Anxiety disorders are a common occurrence in today 's society . There is interest from the community in the use of complementary therapies for anxiety disorders . This review examined the currently available evidence supporting the use of therapeutic touch in treating anxiety disorders . OBJECTIVES To examine the efficacy and adverse effects of therapeutic touch for anxiety disorders . SEARCH STRATEGY We search ed the Cochrane Collaboration Depression , Anxiety and Neurosis Controlled Trials Registers ( CCDANCTR- Studies and CCDANCTR-References ) ( search date 13/01/06 ) , the Controlled Trials website and Dissertation Abstract s International . Search es of reference lists of retrieved papers were also carried out and experts in the field were contacted . SELECTION CRITERIA Inclusion criteria included all published and unpublished r and omised and quasi-r and omised controlled trials comparing therapeutic touch with sham ( mimic ) TT , pharmacological therapy , psychological treatment , other treatment or no treatment /waiting list . The participants included adults with an anxiety disorder defined by the Diagnostic and Statistical Manual (DSM-IV),the International Classification of Diseases ( ICD-10 ) , vali date d diagnostic instruments , or other vali date d clinician or self-report instruments . DATA COLLECTION AND ANALYSIS Two review authors independently applied inclusion criteria . Further information was sought from trialists where papers contained insufficient information to make a decision about eligibility . MAIN RESULTS No r and omised or quasi-r and omised controlled trials of therapeutic touch for anxiety disorders were identified . AUTHORS ' CONCLUSIONS Given the high prevalence of anxiety disorders and the current paucity of evidence on therapeutic touch in this population , there is a need for well conducted r and omised controlled trials to examine the effectiveness of therapeutic touch for anxiety disorders
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"Nondirective ( ND ) , applied relaxation ( AR ) , and cognitive behavioral ( CBT ) therapies for generalized anxiety disorder ( GAD ) were compared . The latter 2 conditions were generally equivalent in outcome but superior to ND at post assessment . The 3 conditions did not differ on several process measures , and ND created the greatest depth of emotional processing . Follow-up results indicated losses in gains in ND , maintained gains in the other 2 conditions , especially CBT , and highest endstate functioning for CBT . AR and CBT thus contain active ingredients in the treatment of GAD ; support exists for further development of imagery exposure methods or cognitive therapy because of their likely role in promoting maintenance of change with this disorder . Expectancy for improvement was also associated with outcome , suggesting the need for further research on this construct for underst and ing the nature of GAD and its amelioration",
"This study examines the effects of two noninvasive procedures on experienced anxiety . Thirty-one in patients of a Veterans Administration psychiatric facility were r and omly assigned to one of two treatment conditions , ( therapeutic touch and relaxation therapy ) or to a therapeutic touch placebo condition . An additional 13 patients were excluded because of failure to meet criteria for the study or failure to complete the procedures . Each subject completed a self-report anxiety measure and was rated for amount of motor activity before and after each of two 15-minute treatment sessions in a 24-hour period . Subjects ' belief in the effectiveness of the intervention was measured . Expectancy did not correlate with outcome and was not analyzed further . Multivariate analysis of variance ( MANOVA ) showed that whereas relaxation therapy provided significant reduction of anxiety on the self-report measure and the movement measure , the nursing intervention of therapeutic touch result ed in significant reductions of reported anxiety . The control group showed small but nonsignificant effects . Results suggests that both relaxation and therapeutic touch are effective palliatives to experienced anxiety . Implication s for nursing theory are discussed",
"The purpose of this single-blinded r and omized clinical trial was to determine whether therapeutic touch ( TT ) versus sham TT could produce greater pain relief as an adjunct to narcotic analgesia , a greater reduction in anxiety , and alterations in plasma T-lymphocyte concentrations among burn patients . Therapeutic touch is an intervention in which human energies are therapeutically manipulated , a practice conceptually supported by Rogers ' ( 1970 ) theory of unitary human beings . Data were collected at a university burn centre in the south-eastern United States . The subjects were 99 men and women between the ages of 15 and 68 hospitalized for severe burns , and they received either TT or sham TT once a day for 5 days . Baseline data were collected on day 1 , data were collected before and after treatment on day 3 , and post-intervention data were collected on day 6 . Instruments included the McGill Pain Question naire , Visual Analogue Scales for Pain , Anxiety and Satisfaction with Therapy , and an Effectiveness of Therapy Form . Blood was drawn on days 1 and 6 for lymphocyte subset analysis . Medication usage for pain in mean morphine equivalents , and mean doses per day of sleep , anxiety and antidepressant medications were recorded . Subjects who received TT reported significantly greater reduction in pain on the McGill Pain Question naire Pain Rating Index and Number of Words Chosen and greater reduction in anxiety on the Visual Analogue Scale for Anxiety than did those who received sham TT . Lymphocyte subset analyses on blood from 11 subjects showed a decreasing total CD8 + lymphocyte concentration for the TT group . There was no statistically significant difference between groups on medication usage",
"This study replicated and extended previous published research which suggests that therapeutic touch involves an energy exchange . The theorem that eye and facial contact between therapeutic touch practitioners and subjects should not be necessary to produce the effect of anxiety reduction was deduced from the Rogerian conceptual system and tested . This theorem was not supported . Numerous explanations for the failure of the hypotheses to be supported are posited , among them the impact of the research design , effects related to the investigator as practitioner , and medication . The influence of medication in particular is so pervasive in the sample that it would seem to be the most reasonable explanation",
"Abstract This article reports the initial results of a prospect i ve study on the prevalence of psychiatric disorders in the Dutch population aged 18–64 . The objectives and the design of the study are described elsewhere in this issue . A total of 7076 people were interviewed in person in 1996 . The presence of the following disorders was determined by means of the CIDI : mood disorders , anxiety disorders , eating disorders , schizophrenia and other non-affective psychoses , and substance use disorders . Psychiatric disorders were found to be quite common . Some 41.2 % of the adult population under 65 had experienced at least one DSM-III-R disorder in their lifetime , among them 23.3 % within the preceding year . No gender differences were found in overall morbidity . Depression , anxiety , and alcohol abuse and dependence were most prevalent , and there was a high degree of comorbidity between them . The prevalence rate encountered for schizophrenia was lower ( 0.4 % lifetime ) than generally presumed . A comparison with findings from other countries is made . Relevant determinants of psychiatric morbidity were analysed",
"Chemical dependency is known to complicate about 3.8 % of pregnancies in Vancouver , British Columbia , Canada . In this study , 54 English-speaking , hospitalized women were r and omly assigned to receive either ( a ) daily Therapeutic Touch over a 7-day period for 20 minutes each day , ( b ) shared activity with a registered nurse for 20 minutes over a 7-day period , or ( c ) st and ard ward care . Anxiety was measured using Spielberger ’s State-Trait Anxiety Inventory . Withdrawal symptoms were measured using a st and ardized Symptom Checklist . Anxiety scores were significantly less on Days 1 , 2 , and 3 ( p Therapeutic Touch . Therapeutic Touch may be of value as an adjunctive measure in the treatment of chemical dependency among pregnant women",
"The purpose of this Rogerian study was to determine whether therapeutic touch improved functional ability in elders with arthritis as compared to routine treatment and progressive muscle relaxation . Eighty-two non-institutionalized elders were r and omly assigned to therapeutic touch or progressive muscle relaxation treatments . Subjects served as their own control for 4 weeks , then received six treatments at 1-week intervals . Pain , tension , mood , and satisfaction improved after therapeutic touch and progressive muscle relaxation . H and function proved after therapeutic touch ; walking and bending improved after progressive muscle relaxation . Functional ability was significantly different between the two groups for mobility and h and function . Lower scores ( indicating better function ) were attained by the therapeutic touch group",
"Previous investigators have suggested that the effects of therapeutic touch are the result of an energy exchange between the client and the nurse . In this investigation , the theory of energy exchange is viewed as part of the broader conceptual system proposed by Rogers . The theorem that the effects of therapeutic touch do not depend on actual physical contact is derived , tested , and supported via an experimental pretest-posttest design . Subjects treated with noncontract therapeutic touch demonstrated a significantly greater decrease in state anxiety than subjects treated with a mimic control intervention . Implication s for further theory development are presented",
"The White House Commission on Complementary Alternative Medicine ( CAM ) has recommended that safe and effective CAM practice s be evaluated to determine their role in maintaining wellness and promoting health . There is little research on individual bodywork/energy therapies and their effects on wellness . The purpose of this pilot study was to assess the effect of AMMA treatments on relaxation and anxiety in staff nurses , and to examine themes describing the nurses ' experiences . It was hypothesized that nurses receiving AMMA treatments would demonstrate reduced anxiety , as measured by a Visual Analog Scale ( VAS ) and increased relaxation , measured by physiologic parameters . The study was design ed as a prospect i ve , r and omized , blinded clinical trial , with convenience sampling of 24 nurses working 12-hour shifts . While both groups demonstrated decreased anxiety after intervention , the experimental group consistently showed greater differences between pre- and post-treatment anxiety scores . The mean change in physiologic parameters between groups was not significant . Themes derived from a final interview included : importance of touch in nursing care , stress reduction , increased self-awareness , the need for self-care and a new underst and ing of the mind-body connection . Outcomes suggest the need for further research with a larger population to assess this intervention 's impact on anxiety , stress , self-care and caring relationships",
"This four-group , repeated- measures experimental design divided 40 healthy professional caregivers/students into high- and low-anxiety groups and further into \" therapeutic touch \" and comparison groups . The effectiveness of the use of therapeutic touch in reducing anxiety was evaluated , as were the method ologies used . Three self-report measures of anxiety ( Profile of Mood States , Spielberger 's State/Trait Anxiety Inventory , and visual analogue scales ) were evaluated for equivalence and concurrent validity to determine their potential for use in future studies . The correlations among these instruments were highly significant . The small sample size prevented differences between groups from reaching statistical significance , but the reduction of anxiety in the high-anxiety group was greater for those who had received therapeutic touch than for those who did not . Using variability data , the sample size necessary to find statistically significant differences between those who had therapeutic touch and those who did not was determined"
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4116534e-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The beneficial effects of regular exercise for people living with or beyond cancer are becoming apparent . However , how to promote exercise behaviour in sedentary cancer cohorts is not as well understood . A large majority of people living with or recovering from cancer do not meet exercise recommendations . Hence , review ing the evidence on how to promote and sustain exercise behaviour is important . OBJECTIVES To assess the effects of interventions to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following questions : Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance ? What adverse effects are attributed to different exercise interventions ? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers ? Which interventions are most likely to promote long-term ( 12 months or longer ) exercise behaviour ? What frequency of contact with exercise professionals is associated with increased exercise behaviour ? What theoretical basis is most often associated with increased exercise behaviour ? What behaviour change techniques are most often associated with increased exercise behaviour ? SEARCH METHODS We search ed the following electronic data bases : Cochrane Central Register of Controlled Trials ( CENTRAL , The Cochrane Library , Issue 8 , 2012 ) , MEDLINE , EMBASE , AMED , CINAHL , PsycLIT/ PsycINFO , SportD iscus and PEDro from inception to August 2012 . We also search ed the grey literature , wrote to leading experts in the field , wrote to charities and search ed reference lists of other recent systematic review s. SELECTION CRITERIA We included only r and omised controlled trials ( RCTs ) that compared an exercise intervention with a usual care approach in sedentary people over the age of 18 with a homogenous primary cancer diagnosis . DATA COLLECTION AND ANALYSIS Two review authors working independently ( LB and KH ) screened all titles and abstract s to identify studies that might meet the inclusion criteria , or that can not be safely excluded without assessment of the full text ( e.g. when no abstract is available ) . All eligible papers were formally abstract ed by at least two members of the review author team working independently ( LB and KH ) and using the data collection form . When possible , and if appropriate , we performed a fixed-effect meta- analysis of study outcomes . For continuous outcomes ( e.g. cardiorespiratory fitness ) , we extracted the final value , the st and ard deviation of the outcome of interest and the number of participants assessed at follow-up in each treatment arm , to estimate st and ardised mean difference ( SMD ) between treatment arms . SMD was used , as investigators used heterogeneous methods to assess individual outcomes . If a meta- analysis was not possible or was not appropriate , we synthesis ed studies as a narrative . MAIN RESULTS Fourteen trials were included in this review , involving a total of 648 participants . Only studies involving breast , prostate or colorectal cancer were identified as eligible . Just six trials incorporated a target level of exercise that could meet current recommendations . Only three trials were identified that attempted to objective ly vali date independent exercise behaviour with accelerometers or heart rate monitoring . Adherence to exercise interventions , which is crucial for underst and ing treatment dose , is often poorly reported . It is important to note that the fundamental metrics of exercise behaviour ( i.e. frequency , intensity and duration , repetitions , sets and intensity of resistance training ) , although easy to devise and report , are seldom included in published clinical trials . None of the included trials reported that 75 % or greater adherence ( the stated primary outcome for this review ) of the intervention group met current aerobic exercise recommendations at any given follow-up . Just two trials reported six weeks of resistance exercise behaviour that would meet the guideline recommendations . However , three trials reported adherence of 75 % or greater to an aerobic exercise goal that was less than the current guideline recommendation of 150 minutes per week . All three incorporated both supervised and independent exercise components as part of the intervention , and none placed restrictions on the control group in terms of exercise behaviour . These three trials shared programme set goals and the following behaviour change techniques : generalisation of a target behaviour ; prompting of self-monitoring of behaviour ; and prompting of practise . Despite the uncertainty surrounding adherence in many of the included trials , interventions caused improvements in aerobic exercise tolerance at 8 to 12 weeks ( from 7 studies , SMD 0.73 , 95 % confidence interval ( CI ) 0.51 to 0.95 ) in intervention participants compared with controls . At six months , aerobic exercise tolerance was also improved ( from 5 studies , SMD 0.70 , 95 % CI 0.45 to 0.94 ) , but it should be noted that four of the five trials used in this analysis had a high risk of bias , hence caution is warranted in interpretation of results . Attrition over the course of these interventions is typically low ( median 6 % ) . AUTHORS ' CONCLUSIONS Interventions to promote exercise in cancer survivors who report better levels of adherence share some common behaviour change techniques . These involve setting programme goals , prompting practise and self-monitoring and encouraging participants to attempt to generalise behaviours learned in supervised exercise environments to other , non-supervised context s. However , expecting most sedentary survivors to achieve current guideline recommendations of at least 150 minutes per week of aerobic exercise is likely to be unrealistic . As with all well- design ed exercise programmes in any context , prescriptions should be design ed around individual capabilities , and frequency , duration and intensity or sets , repetitions , intensity or resistance training should be generated on this basis
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"Background Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy . Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects . To date , there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy . A r and omized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program . Methods / design This paper presents the study protocol : Patient Activation through Counseling and Exercise – Acute Leukemia ( PACE-AL ) trial , a two center , r and omized controlled trial of 70 patients with acute leukemia ( 35 patients / study arm ) following induction chemotherapy in the outpatient setting . Eligible patients will be r and omized to usual care or to the 12 week exercise and counseling program . The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training ( moderate to high intensity 70 - 80 % ) on an ergometer cycle , strength exercises using h and weights and relaxation exercise . Individual health counseling sessions include a self directed home walk program with a step counter . The primary endpoint is functional performance/exercise capacity ( 6 minute walk distance ) . The secondary endpoints are submaximal VO2 max test , sit to st and and bicep curl test , physical activity levels , patient reported outcomes ( quality of life , anxiety and depression , symptom prevalence , intensity and interference ) . Evaluation of clinical outcomes will be explored including incidence of infection , hospitalization days , body mass index , time to recurrence and survival . Qualitative exploration of patients ’ health behavior and experiences . Discussion PACE-AL will provide evidence of the effect of exercise and health promotion counseling on functional and physical capacity , the symptom burden and quality of life in patients with acute leukemia during out patient management . The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia . Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities . Trial registration Clinical Trials.gov Identifier : NCT01404520",
"Background : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7",
"PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs . Women who lead sedentary lifestyles may benefit from a structured exercise program that includes information and support related to exercise adherence strategies",
"OBJECTIVE To examine the changes from a combined exercise intervention after radical prostatectomy ( RP ) in elderly patients with prostate cancer , because r and omized controlled trials addressing exercise intervention after RP have been lacking . METHODS From May 2009 to May 2010 , all patients who underwent laparoscopic RP were assessed for eligibility . A total of 66 patients were r and omized to an exercise or a control group . The exercise group received a combined exercise intervention ( resistance , flexibility , and Kegel exercises ) twice a week for 12 weeks , and the control group received only Kegel exercises . The primary outcome was physical function , and the secondary outcomes were continence status and quality of life after the exercise intervention . RESULTS A total of 49 patients completed follow-up to the end of study . After the 12-week exercise intervention , except for grip strength , all physical functions were better in the exercise group than in the control group . The 24-hour pad test results ( 12.2 g in the exercise group , 46.2 g in the control group ) and continence rate ( 73.1 % in exercise group , 43.5 % in the control group ) recovered more promptly in the exercise group . On a question naire study using the International Consultation on Incontinence question naire , Beck Depression Inventory , and Medical Outcomes Study 36-item short-form health survey , only the exercise group showed improvement at the last follow-up visit . CONCLUSION A 12-week combined exercise intervention after RP results in improvement of physical function , continence rate , and quality of life . These results could help with prompt recovery of daily activities",
"This pilot study examined the efficacy of two home-based exercise programs on alleviating fatigue and improving functional capacity in breast cancer survivors . Participants were r and omly assigned into one of three groups : aerobic exercise ( AE ) , resistance exercise ( RE ) , or usual care control ( CON ) . After receiving individualized instruction and training , participants assigned to the AE and RE groups were asked to perform the prescribed exercise(s ) 3 times per week for 12 weeks at home . Both groups were instructed to keep their perceived exercise intensity in the \" fairly light \" to \" somewhat hard \" range using the Borg Perceived Exertion Scale . All participants completed the revised Piper Fatigue Scale ( PFS ) and the 6-minute walk test ( 6MWT ) at baseline and 12-week post-exercise program . Analysis of pre- and post-training data revealed a significant reduction in fatigue levels on the PFS among participants in the AE group ( Z=2.521 , one-tailed P=0.006 ) , and a significant improvement in the distance of the 6MWT for the RE group ( Z=2.366 , one-tailed P=0.009 ) at the end of 12-week study period . No significant changes in fatigue or functional status were observed in the CON group . Findings provide preliminary support for RE as a viable strategy for improving functional capacity in breast cancer survivors , while AE may be more effective in attenuating cancer-related fatigue . Incorporating RE training for future research may help advance the growing body of knowledge in symptom management for breast cancer survivors",
"Background To examine the effects of a 6 month lifestyle intervention on quality of life , depression , self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors . Methods Early stage endometrial cancer survivors were r and omized to intervention ( n = 23 ) or usual care ( n = 22 ) groups . Chi-square , Student 's t-test and repeated measures analysis of variance were used in intent-to-treat analyses . Outcomes were also examined according to weight loss . Results Morbidly obese patients had significantly lower self-efficacy , specifically when feeling physical discomfort . There was a significant improvement for self-efficacy related to social pressure ( p = .03 ) and restraint ( p = .02 ) in the LI group . There was a significant difference for emotional well-being quality of life ( p = .02 ) , self-efficacy related to negative emotions ( p food availability ( p = .03 ) , and physical discomfort ( p = .01 ) in women who lost weight as compared to women who gained weight . Improvement in restraint was also reported in women who lost weight ( p quality of life or depression but did improve self-efficacy and some eating behaviors . Trial Registration http://www . clinical trials.gov ;",
"BACKGROUND Telomeres are protective DNA-protein complexes at the end of linear chromosomes that promote chromosomal stability . Telomere shortness in human beings is emerging as a prognostic marker of disease risk , progression , and premature mortality in many types of cancer , including breast , prostate , colorectal , bladder , head and neck , lung , and renal cell . Telomere shortening is counteracted by the cellular enzyme telomerase . Lifestyle factors known to promote cancer and cardiovascular disease might also adversely affect telomerase function . However , previous studies have not addressed whether improvements in nutrition and lifestyle are associated with increases in telomerase activity . We aim ed to assess whether 3 months of intensive lifestyle changes increased telomerase activity in peripheral blood mononuclear cells ( P BMC ) . METHODS 30 men with biopsy-diagnosed low-risk prostate cancer were asked to make comprehensive lifestyle changes . The primary endpoint was telomerase enzymatic activity per viable cell , measured at baseline and after 3 months . 24 patients had sufficient P BMC s needed for longitudinal analysis . This study is registered on the Clinical Trials.gov website , number NCT00739791 . FINDINGS P BMC telomerase activity expressed as natural logarithms increased from 2.00 ( SD 0.44 ) to 2.22 ( SD 0.49 ; p=0.031 ) . Raw values of telomerase increased from 8.05 ( SD 3.50 ) st and ard arbitrary units to 10.38 ( SD 6.01 ) st and ard arbitrary units . The increases in telomerase activity were significantly associated with decreases in low-density lipoprotein ( LDL ) cholesterol ( r=-0.36 , p=0.041 ) and decreases in psychological distress ( r=-0.35 , p=0.047 ) . INTERPRETATION Comprehensive lifestyle changes significantly increase telomerase activity and consequently telomere maintenance capacity in human immune-system cells . Given this finding and the pilot nature of this study , we report these increases in telomerase activity as a significant association rather than inferring causation . Larger r and omised controlled trials are warranted to confirm the findings of this study",
"Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT",
"PURPOSE Self-directed and supervised exercise were compared with usual care in a clinical trial design ed to evaluate the effect of structured exercise on physical functioning and other dimensions of health-related quality of life in women with stages I and II breast cancer . PATIENTS AND METHODS One hundred twenty-three women with stages I and II breast cancer completed baseline evaluations of generic and disease- and site-specific health-related quality of life , aerobic capacity , and body weight . Participants were r and omly allocated to one of three intervention groups : usual care ( control group ) , self-directed exercise , or supervised exercise . Quality of life , aerobic capacity , and body weight measures were repeated at 26 weeks . The primary outcome was the change in the Short Form-36 physical functioning scale between baseline and 26 weeks . RESULTS Physical functioning in the control group decreased by 4.1 points , whereas it increased by 5.7 points and 2.2 points in the self-directed and supervised exercise groups , respectively ( P = .04 ) . Post hoc analysis showed a moderately large ( and clinical ly important ) difference between the self-directed and control groups ( 9.8 points ; P = .01 ) and a more modest difference between the supervised and control groups ( 6.3 points ; P = .09 ) . No significant differences between groups were observed for changes in quality of life scores . In a secondary analysis of participants stratified by type of adjuvant therapy , supervised exercise improved aerobic capacity ( + 3.5 mL/kg/min ; P = .01 ) and reduced body weight ( -4.8 kg ; P chemotherapy . CONCLUSION Physical exercise can blunt some of the negative side effects of breast cancer treatment , including reduced physical functioning . Self-directed exercise is an effective way to improve physical functioning compared with usual care . In participants not receiving chemotherapy , supervised exercise may increase aerobic capacity and reduce body weight compared with usual care",
"Epidemiological and prospect i ve studies indicate that comprehensive lifestyle changes may modify the progression of prostate cancer . However , the molecular mechanisms by which improvements in diet and lifestyle might affect the prostate microenvironment are poorly understood . We conducted a pilot study to examine changes in prostate gene expression in a unique population of men with low-risk prostate cancer who declined immediate surgery , hormonal therapy , or radiation and participated in an intensive nutrition and lifestyle intervention while undergoing careful surveillance for tumor progression . Consistent with previous studies , significant improvements in weight , abdominal obesity , blood pressure , and lipid profile were observed ( all P Gene expression profiles were obtained from 30 participants , pairing RNA sample s from control prostate needle biopsy taken before intervention to RNA from the same patient 's 3-month postintervention biopsy . Quantitative real-time PCR was used to vali date array observations for selected transcripts . Two-class paired analysis of global gene expression using significance analysis of microarrays detected 48 up-regulated and 453 down-regulated transcripts after the intervention . Pathway analysis identified significant modulation of biological processes that have critical roles in tumorigenesis , including protein metabolism and modification , intracellular protein traffic , and protein phosphorylation ( all P Intensive nutrition and lifestyle changes may modulate gene expression in the prostate . Underst and ing the prostate molecular response to comprehensive lifestyle changes may strengthen efforts to develop effective prevention and treatment . Larger clinical trials are warranted to confirm the results of this pilot study",
"BACKGROUND Lymphoma patients undergoing therapy must cope with the side-effects of the disease itself , therapy and associated immobility . Peripheral neuropathy ( PNP ) , loss of balance control and weakness not only diminishes patients ' quality of life ( QOL ) , it can also affect planning and the dosage of therapy . Exercise may enable patients to reverse these declines , improving their performance level and QOL . PATIENTS AND METHODS We carried out a r and omized , controlled trial , assigning 61 lymphoma patients either to a control group ( CG ; N=31 ) or to a 36-week intervention ( IG ; N=30 ) , consisting of sensorimotor- , endurance- and strength training twice a week . Primary end point was QOL ; secondary end points included movement coordination , endurance , strength and therapy-induced side-effects . RESULTS Intergroup comparison revealed improved QOL- ( ΔT1-T0 ; P=0.03 ) and PNP-related deep sensitivity in the IG : 87.5 % were able to reduce the symptom , compared with 0 % in the CG ( P change of balance control could be found between the groups , with the IG improving while the CG steadily declined ( monopedal static ΔT3-T0 ; P=0.03 ; dynamic ΔT3-T0 ; P=0.007 ; perturbed mono-ΔT3-T0 ; P=0.009 and bipedal ΔT3-T0 ; P=0.006 ) , failed attempts ( monopedal static ΔT3-T0 ; P=0.02 , dynamic ΔT3-T0 ; P improved time to regain balance ( ΔT3-T0 ; P=0.04 ) . Moreover , the change in the aerobic performance level ( ΔT3-T0 ; P=0.05 ) and additional amount of exercise carried out per week [ metabolic equivalent ( MET ) ; P=0.02 ] differed significantly across groups . CONCLUSIONS Exercise , especially sensorimotor training , is a feasible and promising method to support cancer patients during therapy . It improves patients QOL , reduces restrictions from side-effects such as PNP and improves patients ' balance control , physical performance level and mobility . GERMAN CLINICAL TRIALS REGISTER NUMBER DRKS00003894",
"To evaluate the efficacy and economic efficiency of a multimedia , multimodal physical activity program for women undergoing adjuvant therapy following surgery for breast cancer . We conducted a r and omized trial with concurrent incremental cost-effectiveness analysis and blinded baseline , 3 , 6 and 12-month follow-up assessment s amongst women undergoing adjuvant therapy following surgery for breast cancer ( n = 89 ) . The intervention was a multimedia , multimodal exercise program comprising strength , balance and endurance training elements . The control was sham flexibility and relaxation program delivered using similar material s. The primary outcome was health-related quality of life ( EQ-5D & VAS , EORTC C30 , BR23 ) . Economic outcomes included direct health care costs and productivity gains and losses . Participants in the intervention group demonstrated greater improvement in health-related quality of life between baseline and the 3-month assessment [ mean ( sd ) EQ-5D VAS ( 0–100 ) baseline : 72.6 ( 15.6 ) , 3 month : 80.6 ( 11.6 ) ] when compared to control group participants [ baseline : 77.5 ( 13.5 ) , 3 month : 74.1 ( 20.6 ) , P = 0.006 ] and also improved more in terms of physical function [ mean ( sd ) EORTC C30 physical function scale intervention ( 0–100 ) baseline : 84.9 ( 14.8 ) , 3 month : 86.9 ( 10.7 ) , control baseline : 91.3 ( 9.6 ) , 3 month : 86.7 ( 14.9 ) , P = 0.02 ] . These improvements were not sustained beyond this point . Upper limb volumes were also lower amongst intervention group participants . However , there was low probability that the intervention would be both less costly and more effective than the control condition ( range probability = 0.05–50.02 % depending on approach ) . Provision of multimodal exercise programs will improve the short-term health of women undergoing adjuvant therapy for breast cancer but are of question able economic efficiency ",
"Excess body weight at diagnosis and weight gain after breast cancer are associated with poorer long-term prognosis . This study investigated the effects of a lifestyle intervention on body weight and other health outcomes influencing long-term prognosis in overweight women ( BMI > 25.0 kg/m2 ) recovering from early-stage ( stage I – III ) breast cancer . A total of 90 women treated 3–18 months previously were r and omly allocated to a 6-month exercise and hypocaloric healthy eating program ( n = 47 , aged 55.6 ± 10.2 year ) or control group ( n = 43 , aged 55.9 ± 8.9 year ) . Women in the intervention group received three supervised exercise sessions per week and individualized dietary advice , supplemented by weekly nutrition seminars . Body weight , waist circumference , waist/hip ratio [ WHR ] , cardiorespiratory fitness , blood biomarkers associated with breast cancer recurrence and cardiovascular disease risk , and quality of life ( FACT-B ) were assessed at baseline and 6 months . Three-day diet diaries were used to assess macronutrient and energy intakes . A moderate reduction in body weight in the intervention group ( median difference from baseline of −1.09 kg ; IQR −0.15 to −2.90 kg ; p = 0.07 ) was accompanied by significant reductions in waist circumference ( p p = 0.005 ) , total ( p = 0.021 ) and saturated fat ( p = 0.006 ) intakes , leptin ( p = 0.005 ) , total cholesterol ( p = 0.046 ) , and resting diastolic blood pressure ( p = 0.03 ) . Cardiopulmonary fitness ( p life ( p = 0.004 ) also showed significant improvements in the intervention group . These findings suggest that an individualized exercise and a hypocaloric healthy eating program can positively impact upon health outcomes influencing long-term prognosis in overweight women recovering from early-stage breast cancer",
"Exercise is considered to be a key aspect of lymphoedema treatment , although there is little evidence for the therapeutic effect of exercise in managing breast cancer-related lymphoedema ( BCRL ) . This small r and omised controlled trial ( RCT ) was design ed to determine the feasibility , prior to undertaking a larger RCT , of research ing a daily home-based exercise programme to treat stable BCRL . An experimental design compared the exercise intervention combined with st and ard lymphoedema self-care to self-care alone over a 6-month period . Twenty-three women with stable unilateral BCRL of ≥10 % excess limb volume ( ELV ) were r and omly allocated to a daily home-based exercise programme and self-care ( n = 11 ) or self-care measures alone ( n = 12 ) . The primary objective was to determine difference in limb volume reduction for the two groups . Secondary objectives were to monitor change in other areas that impact BCRL : quality of life , arm function and range of shoulder movement . All 23 women completed the trial , providing full data for each time point . The intervention group showed a clinical ly and statistically significant improvement in relative ELV at week 26 ( 95 % confidence interval ( CI ) −26.57 to −5.12 ) , whereas the control group improvement crossed the line of no effect ( 95 % CI −17.71 to 1.1 ) . This study demonstrated the feasibility of conducting a RCT of exercise as a therapeutic intervention in the management of BCRL . Although the sample was small , the results support the findings of other exercise studies which have shown trends towards improvement",
"The aim of this study was to determine whether an exercise program , commencing 4–6 weeks post-operatively , reduces upper limb impairments in women treated for early breast cancer . Women ( n = 160 ) were r and omized to either an 8-week exercise program ( n = 81 ) or to a control group ( n = 79 ) following stratification for axillary surgery . The exercise program comprised a weekly session and home program of passive stretching and progressive resistance training for shoulder muscles . The control group attended fortnightly assessment s but no exercises were provided . The primary outcome was self-reported arm symptoms derived from the EORTC breast cancer-specific question naire ( BR23 ) , scored out of 100 with a low score indicative of fewer symptoms . The secondary outcomes included physical measures of shoulder range of motion , strength , and swelling ( i.e. , lymphedema ) . Women were assessed immediately following the intervention and at 6 months post-intervention . The change in symptoms from baseline was not significantly different between groups immediately following the intervention or at 6 m post-intervention . The between group difference immediately following the intervention was 4 ( 95 % CI −1 to 9 ) and 6 months post-intervention was 4 ( −2 to 10 ) . However , the change in range of motion for flexion and abduction was significantly greater in the exercise group immediately following the intervention , as was change in shoulder abductor strength . In conclusion , a supervised exercise program provided some , albeit small , additional benefit at 6 months post-intervention to women who had been provided with written information and reminders to use their arm . Both the groups reported few impairments including swelling immediately following the intervention and 6 months post-intervention . Notably , resistance training in the post-operative period did not precipitate lymphedema",
"BACKGROUND Weight lifting has generally been proscribed for women with breast-cancer-related lymphedema , preventing them from obtaining the well-established health benefits of weight lifting , including increases in bone density . METHODS We performed a r and omized , controlled trial of twice-weekly progressive weight lifting involving 141 breast-cancer survivors with stable lymphedema of the arm . The primary outcome was the change in arm and h and swelling at 1 year , as measured through displaced water volume of the affected and unaffected limbs . Secondary outcomes included the incidence of exacerbations of lymphedema , number and severity of lymphedema symptoms , and muscle strength . Participants were required to wear a well-fitted compression garment while weight lifting . RESULTS The proportion of women who had an increase of 5 % or more in limb swelling was similar in the weight-lifting group ( 11 % ) and the control group ( 12 % ) ( cumulative incidence ratio , 1.00 ; 95 % confidence interval , 0.88 to 1.13 ) . As compared with the control group , the weight-lifting group had greater improvements in self-reported severity of lymphedema symptoms ( P=0.03 ) and upper- and lower-body strength ( P of lymphedema exacerbations as assessed by a certified lymphedema specialist ( 14 % vs. 29 % , P=0.04 ) . There were no serious adverse events related to the intervention . CONCLUSIONS In breast-cancer survivors with lymphedema , slowly progressive weight lifting had no significant effect on limb swelling and result ed in a decreased incidence of exacerbations of lymphedema , reduced symptoms , and increased strength . ( Clinical Trials.gov number , NCT00194363 .",
"PURPOSE The purpose of this study was to identify the effects of a home based exercise program for patients with stomach cancer who were undergoing oral chemotherapy . METHODS The home-based exercise program was developed from the study findings of Winningham ( 1990 ) and data from the Korea Athletic Promotion Association ( 2007 ) . The home-based exercise program consisted of 8 weeks of individual exercise education and exercise adherence strategy . Participants were 24 patients with stomach cancer who were undergoing oral chemotherapy following surgery in 2007 or 2008 at a university hospital in Seoul . Patients were r and omly assigned to either the experimental group ( 11 ) or control group ( 13 ) . The effects of the home-based exercise program were measured by level of cancer related fatigue , NK cell ratio , anxiety , and quality of life . Data were analyzed using SPSS/WIN 13.0 version . RESULTS The degree of cancer related fatigue and anxiety in the experimental group decreased compared to the control group . The NK cell ratio and the degree of quality of life of experimental group increased while that of the control group decreased . CONCLUSION This study result indicate the importance of exercise and provide empirical evidence for continuation of safe exercise for patients with cancer during their chemotherapy",
"Background Physical activity improves health in prostate cancer survivors ; however , participation rates are low . Purpose This study aims to determine the effects of an implementation intention intervention on physical activity and quality of life in prostate cancer survivors . Methods Prostate cancer survivors ( N = 423 ) were r and omly assigned to a st and ard physical activity recommendation , a self-administered implementation intention , or a telephone-assisted implementation intention . Physical activity and quality of life were assessed at baseline , 1 , and 3 months . Results Analyses of covariance using multiple imputation showed that physical activity at 1 month increased by 86 min/week in the st and ard physical activity recommendation group compared with 168 min/week in the self-administered implementation intention group ( P = 0.023 ) and 105 min/week in the telephone-assisted implementation intention group ( P = 0.35 ) . Conclusions A self-administered implementation intention intervention result ed in a meaningful short-term increase in physical activity . Supplementation with additional intervention strategies and more frequent intervention may improve longer-term exercise . ( Clinical Trials.gov number NCT01410656 )",
"OBJECTIVE Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival . As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage , and have higher rates of obesity , effective weight loss strategies are needed . We piloted a r and omized , waitlist-controlled , crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic , African American and Afro-Caribbean breast cancer survivors . DESIGN AND METHODS Women with stage 0-IIIa breast cancer ≥ 6 months posttreatment , sedentary , and BMI ≥ 25 kg/m(2 ) were r and omized to the immediate arm ( IA ) : 6 months of the Curves program followed by 6 months of observation ; or the waitlist control arm ( WCA ) : 6 months of observation followed by 6 months of the Curves program . The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet . RESULTS A total of 42 women enrolled ( 79 % Hispanic , 21 % black ) , mean age 51 ( range 32 - 69 ) and mean BMI 33.2(± 5.9 ) kg/m(2 ) ; 91 % were retained at month 12 . At month 6 , women in the IA lost an average 3.3 % ( ± 3.5 % ) of body weight ( range : 1.7 % gain to 10.6 % loss ) , as compared with 1.8 % ( ± 2.9 % ) weight loss in the WCA ( P = 0.04 ) . At month 12 , on average women in the IA regained some but not all of the weight lost during the first 6 months ( P = 0.02 ) . CONCLUSIONS Minority breast cancer survivors were recruited and retained in a weight loss study . Six months of the Curves program result ed in moderate weight loss , but weight loss was not maintained postintervention . Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors",
"Physical activity has been studied in relation to prostate cancer risk , but the findings have been inconclusive . We prospect ively examined the association between self-reported recreational physical activity and overall risk of prostate cancer , risk of advanced disease and risk of prostate cancer death in a cohort of 29,110 Norwegian men . Incident prostate cancers were obtained from the Norwegian Cancer Registry , and prostate cancer deaths were obtained from the national Cause of Death Registry . During 17 years of follow-up , 957 incident cases were identified , 266 of them were advanced ( i.e. metastases at diagnosis ) and 354 of the incident cases died from prostate cancer . In multivariable analysis , frequency and duration of exercise were inversely associated with the risk of advanced prostate cancer ( p for trend = 0.04 and 0.02 ) . We computed a summary score that combined frequency , duration and intensity of exercise , and this score showed inverse associations with advanced prostate cancer risk and mortality ( p for trend = 0.02 and 0.07 ) . Compared to men who reported no activity , the relative risks ( 95 % confidence intervals ) among men in the highest category of physical exercise was 0.64 ( 0.43 - 0.95 ) for advanced prostate cancer and 0.67 ( 0.48 - 0.94 ) for prostate cancer death . We found no association between physical activity and overall risk of prostate cancer . We conclude that recreational physical exercise is associated with reduced risk of advanced prostate cancer and prostate cancer death",
"OBJECTIVE To improve mechanistic underst and ing , this pilot r and omized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors ( BCS ) . METHODS Forty-six postmenopausal BCS ( ≤Stage II , off primary treatment ) were r and omized to a 3-month exercise intervention or control group . Intervention included 160 min/week of moderate intensity aerobic walking , twice weekly resistance training ( resistance b and s ) , and six discussion groups ( to improve adherence ) . Blinded assessment s at baseline and post-intervention included sleep disturbance ( PSQI and PROMIS ® ) , objective sleep quality ( accelerometer ) , serum cytokines , accelerometer physical activity , cardiorespiratory fitness , body composition , fatigue , and psychosocial factors . Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests . RESULTS When compared with control , the intervention group demonstrated a significant increase in PSQI sleep duration ( i.e. , fewer hours of sleep/night ) ( d = 0.73 , p = .03 ) . Medium to large but non-significant st and ardized effect sizes were noted for PSQI daytime somnolence ( d = -0.63 , p = .05 ) and accelerometer latency ( d = -0.49 , p = .14 ) . No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency . Daytime somnolence was mediated by tumor necrosis factor-alpha ( mediated 23 % of intervention effect , p interleukin (IL)-6:IL-10 ( 16 % , p IL-8:IL-10 ( 26 % , p .01 ) , and fatigue ( 38 % , p accelerometer physical activity , PROMIS ® fatigue , exercise social support , and /or physical activity enjoyment . CONCLUSIONS Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention . Further study is warranted to confirm our results and translate our findings into more effective interventions aim ed at improving sleep quality in BCS",
"We describe adherence to a three group r and omised controlled trial that involved aerobic exercise therapy ( N=34 ) and exercise-placebo intervention ( N=36 ) or usual care ( N=38 ) in women treated for breast cancer . We also investigated relationships between routes of trial recruitment , socio-economic characteristics , health behaviours , cancer treatment regimen(s ) and subsequent adherence to the interventions . Women who had completed breast cancer treatment 12 - 36 months previously were r and omised to one of the groups . The intervention groups attended an exercise facility three times per week for eight weeks . A total of 77 % of the aerobic exercise therapy and 88.9 % of the exercise-placebo groups attended at least 70 % of prescribed sessions . The percentage of women achieving 30min of aerobic exercise per session steadily increased during the intervention but many women were not able to achieve this goal . Routes of trial recruitment , socio-economic characteristics , health behaviours and cancer treatment regimen(s ) were not related to intervention . Exercise therapy participants were able to comply with the progressive nature of the aerobic exercise intervention , although some women were not able to achieve 30min of aerobic exercise per session by intervention completion . Research is still required to tease out all the potential determinants of exercise in this population",
"OBJECTIVE The majority of endometrial cancer survivors ( ECS ) are obese and at risk for premature death . The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle . METHODS Early stage overweight and obese ( body mass index ≥ 25 ) ECS ( N=75 ) were r and omized to a 6-month lifestyle intervention ( LI ) or usual care ( UC ) . The LI group received education and counseling for six months ( 10 weekly followed by 6 bi-weekly sessions ) . Weight change at 12 months was the primary endpoint . Secondary outcomes included fruit/vegetable servings/day and physical activity ( PA ) . Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline . RESULTS Adherence was 84 % and follow-up data were available from 92 % of participants at 6 months and 79 % at 12 months . Mean [ 95 % CI ] difference in weight change between LI and UC groups at 6 months was -4.4 kg [ -5.3 , -3.5 ] , p in PA minutes between groups at 6 months was 100 [ 6 , 194 ] , p=0.038 and at 12 months was 89 [ 14 , 163 ] , p=0.020 . Mean difference in kilocalories consumed was -217.8 ( p months . Mean [ 95 % CI ] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months ( p CONCLUSIONS Behavior change and weight loss are achievable in overweight and obese ECS , however , the clinical implication s of these changes are unknown and require a larger trial with longer follow-up",
"OBJECTIVE To evaluate the effects of an 8-week water physical therapy program on cervical and shoulder pain , pressure sensitivity , and the presence of trigger points ( TrPs ) in breast cancer survivors . DESIGN R and omized , controlled trial . SETTING To date , no study has investigated effects of water therapy in breast cancer . PATIENTS Sixty-six breast cancer survivors were r and omly assigned into two groups : WATER group , who received a water exercise program or CONTROL group who received the usual care treatment for breast cancer . INTERVENTIONS The WATER therapy program consisted of 24 sessions ( 3 times/week over 8 weeks ) of low-intensity exercises in a warm pool ( 32 ° C ) . Each session included 10-minute warm-up period ; 35 minutes of aerobic , low-intensity endurance , and core stability training ; and a 15-minute cool-down period ( stretching and relaxation ) . OUTCOMES Neck and shoulder pain ( visual analog scale , 0 - 100 mm ) , pressure pain thresholds ( PPTs ) over C5-C6 zygapophyseal joints , deltoid muscles , second metacarpal , and tibialis anterior muscles , and the presence of TrPs in cervical-shoulder muscles were assessed at baseline and after the 8-week program by an assessor blinded to treatment allocation . RESULTS The WATER group demonstrated a between-group improvement for neck pain of -31 mm ( 95 % confidence interval [CI]-49 to -22 , P for shoulder-axillary of -19 mm ( -40 to -04 , P = 0.046 ; effect size 0.70 , 0.14 - 1.40 ) . Improvements were also noted for PPT levels over C5-C6 joints ( between-group differences , affected side : 27.7 kPa , 95 % CI 3.9 - 50.4 ; unaffected : 18.1 kPa , 95 % CI 6.1 - 52.2 ) . No between-group differences for PPT over the remaining points were observed ( P > 0.05 ) . Finally , patients in the WATER program showed a greater reduction of active TrPs as compared with the CONTROL group ( P water therapy program was effective for improving neck and shoulder/axillary pain , and reducing the presence of TrPs in breast cancer survivors as compared with usual care ; however , no significant changes in widespread pressure pain hyperalgesia were found",
"PURPOSE Men with prostate cancer are often advised to make changes in diet and lifestyle , although the impact of these changes has not been well documented . Therefore , we evaluated the effects of comprehensive lifestyle changes on prostate specific antigen ( PSA ) , treatment trends and serum stimulated LNCaP cell growth in men with early , biopsy proven prostate cancer after 1 year . MATERIAL S AND METHODS Patient recruitment was limited to men who had chosen not to undergo any conventional treatment , which provided an unusual opportunity to have a nonintervention r and omized control group to avoid the confounding effects of interventions such as radiation , surgery or and rogen deprivation therapy . A total of 93 volunteers with serum PSA 4 to 10 ng/ml and cancer Gleason scores less than 7 were r and omly assigned to an experimental group that was asked to make comprehensive lifestyle changes or to a usual care control group . RESULTS None of the experimental group patients but 6 control patients underwent conventional treatment due to an increase in PSA and /or progression of disease on magnetic resonance imaging . PSA decreased 4 % in the experimental group but increased 6 % in the control group ( p = 0.016 ) . The growth of LNCaP prostate cancer cells ( American Type Culture Collection , Manassas , Virginia ) was inhibited almost 8 times more by serum from the experimental than from the control group ( 70 % vs 9 % , p Changes in serum PSA and also in LNCaP cell growth were significantly associated with the degree of change in diet and lifestyle . CONCLUSIONS Intensive lifestyle changes may affect the progression of early , low grade prostate cancer in men . Further studies and longer term followup are warranted",
"Background : Healthy lifestyle behaviors could have a role in ameliorating some of the adverse effects of and rogen suppression therapy ( AST ) in men with prostate cancer . The primary aim of this study was to assess the feasibility of a tapered supervised exercise program in combination with dietary advice in men with advanced prostate cancer receiving AST . Methods : Advanced prostate cancer patients receiving AST for a minimum of 6 months were r and omized to a 12-week lifestyle program comprising aerobic and resistance exercise , plus dietary advice ( n = 25 ) , or st and ard care ( n = 25 ) . Exercise behavior , dietary macronutrient intake , quality of life , fatigue , functional fitness , and biomarkers associated with disease progression were assessed at baseline , after the intervention , and at 6 months . Results : The lifestyle group showed improvements in exercise behavior ( P dietary fat intake ( P = 0.001 ) , total energy intake ( P = 0.005 ) , fatigue ( P = 0.002 ) , aerobic exercise tolerance ( P and muscle strength ( P = 0.033 ) compared with st and ard care controls . Although a high rate of attrition ( 44 % ) was observed at 6 months , the improvements in key health outcomes were sustained . No effects on clinical prostate cancer disease markers were observed . Conclusions : This preliminary evidence suggests that pragmatic lifestyle interventions have potential to evoke improvements in exercise and dietary behavior , in addition to other important health outcomes in men with advanced prostate cancer receiving AST . Impact : This study shows for the first time that pragmatic lifestyle interventions are feasible and could have a positive impact on health behaviors and other key outcomes in men with advanced prostate cancer receiving AST . Cancer Epidemiol Biomarkers Prev ; 20(4 ) ; 647–57 . © 2011 AACR",
"The purpose of this study was to examine the effects of an exercise intervention on the total caloric intake ( TCI ) of breast cancer patients undergoing treatment . A secondary purpose was to determine whether or not a relationship existed between changes in TCI , body fat composition ( % BF ) , and fatigue during the study , which lasted 6 months . Twenty females recently diagnosed with breast cancer , scheduled to undergo chemotherapy or radiation , were assigned r and omly to an experimental ( N = 10 ) or control group ( N = 10 ) . Outcome measures included TCI ( 3-day food diary ) , % BF ( skinfolds ) , and fatigue ( revised Piper Fatigue Scale ) . Each exercise session was conducted as follows : initial cardiovascular activity ( 6 - 12 min ) , followed by stretching ( 5 - 10 min ) , resistance training ( 15 - 30 min ) , and a cool-down ( approximately 8 min ) . Significant changes in TCI were observed among groups ( F1,18 = 8.582 ; P = 0.009 ) , at treatments 2 and 3 , and at the end of the study [ experimental ( 1973 + /- 419 ) , control ( 1488 + /- 418 ) ; experimental ( 1946 + /- 437 ) , control ( 1436 + /- 429 ) ; experimental ( 2315 + /- 455 ) , control ( 1474 + /- 294 ) , respectively ] . A significant negative correlation was found ( Spearman rho(18 ) = -0.759 ; P TCI and % BF and between TCI and fatigue levels ( Spearman rho(18 ) = -0.541 ; P = 0.014 ) at the end of the study . In conclusion , the results of this study suggest that an exercise intervention administered to breast cancer patients undergoing medical treatment may assist in the mitigation of some treatment side effects , including decreased TCI , increased fatigue , and negative changes in body composition",
"Cancer-related fatigue is the most disabling symptom experienced by breast cancer patients following the cancer treatment . The positive effects of physical activity in the rehabilitation of breast cancer patients are documented in several studies . In a r and omized controlled study the effects of a structured physical training program on fatigue and health-related quality of life were evaluated . Patients and Methods : 63 breast cancer patients with cancer-related chronic fatigue were r and omized at the beginning of the inpatient rehabilitation . The control group received the st and ard complex rehabilitation program , the intervention group a structured physical training program and additional muscle strength and aerobic exercises . The effects of the treatment were evaluated by question naires at the start of rehabilitation ( t1 ) , end of rehabilitation ( t2 ) , and 3 months after t2 ( t3 ) . Isometric muscle strength and aerobic capacity were evaluated at t1 and t2 . Results : There was an improvement of muscle strength at the end of rehabilitation for both groups . The increase from t1 to t2 was significantly higher for the training group . The scores for global quality of life , physical well-being , and functionality increased from t1 to t2 , but further improvement in the follow-up ( t3 ) was only observed in the training group . The cancer-related fatigue was significantly reduced in the training group from t1 to t3 , however , not in the control group . Conclusions : Structured physical training programs initiated during inpatient rehabilitation and continuously practice d in the time thereafter can improve symptoms of chronic fatigue and quality of life in breast cancer patients",
"Exercise for Health was a r and omized , controlled trial design ed to evaluate two modes of delivering ( face-to-face [ FtF ] and over-the-telephone [ Tel ] ) an 8-month translational exercise intervention , commencing 6-weeks post-breast cancer surgery ( PS ) . Outcomes included quality of life ( QoL ) , function ( fitness and upper body ) and treatment-related side effects ( fatigue , lymphoedema , body mass index , menopausal symptoms , anxiety , depression and pain ) . Generalised estimating equation modelling determined time ( baseline [ 5 weeks PS ] , mid-intervention [ 6 months PS ] , post-intervention [ 12 months PS ] ) , group ( FtF , Tel , Usual Care [ UC ] ) and time-by-group effects . 194 women representative of the breast cancer population were r and omised to the FtF ( n = 67 ) , Tel ( n = 67 ) and UC ( n = 60 ) groups . There were significant ( p QoL , fitness and fatigue with differences being observed between the treatment groups and the UC group . Trends observed for the treatment groups were similar . The treatment groups reported improved QoL , fitness and fatigue over time and changes observed between baseline and post-intervention were clinical ly relevant . In contrast , the UC group experienced no change , or worsening QoL , fitness and fatigue , mid-intervention . Although improvements in the UC group occurred by 12-months post-surgery , the change did not meet the clinical ly relevant threshold . There were no differences in other treatment-related side effects between groups . This translational intervention trial , delivered either FtF or Tel , supports exercise as a form of adjuvant breast cancer therapy that can prevent declines in fitness and function during treatment and optimise recovery post-treatment",
"Purpose Few r and omized controlled trials in exercise oncology have examined survival outcomes . Here , we report an exploratory follow-up of progression-free survival ( PFS ) from the Healthy Exercise for Lymphoma Patients ( HELP ) Trial . Methods The HELP Trial r and omized 122 lymphoma patients between 2005 and 2008 to either control ( n = 62 ) or 12 weeks of supervised aerobic exercise ( n = 60 ) . PFS events were abstract ed from medical records in 2013 . In addition to the r and omized comparison , we explored the effects of exercise adherence ( control group crossover ( no vs. yes ) . Results After a median follow-up of 61 months ( interquartile range 36–67 ) , the adjusted 5-year PFS was 64.8 % for the exercise group compared with 65.0 % for the control group ( Hazard ratio [ HR ] 1.01 , 95 % CI 0.51–2.01 , p = 0.98 ) . In the secondary analysis , the adjusted 5-year PFS was 59.0 % in the control group without crossover compared with 69.2 % for the control group with crossover ( HR 0.68 , 95 % CI 0.22–2.06 , p = 0.49 ) , 67.7 % for the exercise group with supervised exercise , the adjusted 5-year PFS for the supervised exercise groups was 68.5 % compared with 59.0 % for the group that received no supervised exercise ( HR 0.70 , 95 % CI 0.35–1.39 , p = 0.31 ) . Conclusions This exploratory follow-up of the HELP Trial suggests that supervised aerobic exercise may be associated with improved PFS in lymphoma patients . Larger trials design ed to answer this question are needed",
"OBJECTIVE To determine the effect of exercise on quality of life in ( a ) a r and omized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and ( b ) a similar trial among post-treatment survivors . METHODS Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and r and omized to a 6-month , home-based exercise program ( n=25 ) or a usual care group ( n=25 ) . In a separate trial , 75 post-treatment survivors were r and omized to a 6-month , supervised exercise intervention ( n=37 ) or to usual care ( n=38 ) . Participants in both studies completed measures of happiness , depressive symptoms , anxiety , stress , self-esteem , and quality of life at baseline and 6 months . RESULTS Forty-five participants completed the trial for newly diagnosed survivors and 67 completed the trial for post-treatment survivors . Good adherence was observed in both studies . Baseline quality of life was similar for both studies on most measures . Exercise was not associated with quality of life benefits in the full sample of either study ; however exercise was associated with improved social functioning among post-treatment survivors who reported low social functioning at baseline ( p Exercise did not affect quality of life in either recently diagnosed or post-treatment breast cancer survivors ; however this may be due in part to relatively high baseline functioning among participants in both studies . Strategies for future research include limiting enrollment to survivors who report reduced quality of life on screening question naires and targeting survivor subgroups known to be at particular risk for quality of life impairment",
"Objective This study examined how free-text comments from cancer survivors could complement formal patient-reported outcome measures ( PROMs ) , as part of the Engl and PROMs survey programme for cancer . Design A qualitative content analysis was conducted of responses to a single open-ended free-text question placed at the end of the cross-sectional population -based postal question naire . Setting Individuals were identified through three UK Cancer Registries and question naires were posted to their home addresses . Participants A r and om sample of individuals ( n=4992 ) diagnosed with breast , colorectal , non-Hodgkins lymphoma or prostate cancer at 1 , 2 , 3 and 5 years earlier . Results 3300 participants completed the survey ( 68 % response rate ) . Of these 1056 ( 32 % ) completed the free-text comments box , indicating a high level of commitment to provide written feedback on patient experience . Almost a fifth ( 19 % ) related experiences of excellent care during the treatment phase , with only 8 % reporting negative experiences . This contrasted with experiences of care after primary cancer treatment where the majority were negative . Factors impacting negatively upon patient-reported outcomes included the emotional impact of cancer ; poor experiences of treatment and care ; comorbidities , treatment side effects , social difficulties and inadequate preparation for a wide range of sometimes long-lasting on-going physical and psychological problems . Mediating factors assisting recovery incorporated both professional-led factors , such as quality of preparation for anticipated problems and aftercare services , and participant-led factors , such as learning from other cancer survivors and self-learning through trial and error . The support of friends and family was also a factor in participants ' outcomes . Conclusions This analysis of free-text comments complements quantitative analysis of PROMs measure 's by illuminating relationships between factors that impact on quality of life ( QoL ) and indicate why cancer patients may experience significantly worse QoL than the general population . The data suggest more systematic preparation and aftercare for individuals to self-manage post-treatment problems might improve QoL outcomes among cancer survivors",
"Background : High insulin and insulin-like growth factor-I ( IGF-I ) levels may be associated with an increased breast cancer risk and /or death . Given the need to identify modifiable factors that decrease insulin , IGF-I , and breast cancer risk and death , we investigated the effects of a 6-month r and omized controlled aerobic exercise intervention versus usual care on fasting insulin , IGF-I , and its binding protein ( IGFBP-3 ) in postmenopausal breast cancer survivors . Methods : Seventy-five postmenopausal breast cancer survivors were identified from the Yale-New Haven Hospital Tumor Registry and r and omly assigned to an exercise ( n = 37 ) or usual care ( n = 38 ) group . The exercise group participated in 150 minutes per week of moderate-intensity aerobic exercise . The usual care group was instructed to maintain their current physical activity level . A fasting blood sample was collected on each study participant at baseline and 6 months . Blood levels of insulin and IGF were measured with ELISA . Results : On average , exercisers increased aerobic exercise by 129 minutes per week compared with 45 minutes per week among usual care participants ( P exercise experienced decreases in insulin , IGF-I , and IGFBP-3 , whereas women r and omized to usual care had increases in these hormones . Between-group differences in insulin , IGF-I , and IGFBP-3 were 20.7 % ( P = 0.089 ) , 8.9 % ( P = 0.026 ) , and 7.9 % ( P = 0.006 ) , respectively . Conclusions : Moderate-intensity aerobic exercise , such as brisk walking , decreases IGF-I and IGFBP-3 . The exercise-induced decreases in IGF may mediate the observed association between higher levels of physical activity and improved survival in women diagnosed with breast cancer . ( Cancer Epidemiol Biomarkers Prev 2009;18(1):306–13",
"Background Despite being a critical survivorship care issue , there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer . There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer . Furthermore , despite the multidimensional aetiology of sexual dysfunction , there is a paucity of research investigating the efficacy of integrated treatment models . Therefore , the purpose of this study is to : 1 ) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer ; 2 ) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health ; and 3 ) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term . Methods / Design A three-arm , multi-site r and omised controlled trial involving 240 prostate cancer survivors will be implemented . Participants will be r and omised to : 1 ) ‘ Exercise ’ intervention ; 2 ) ‘ Exercise + Psychosexual ’ intervention ; or 3 ) ‘ Usual Care ’ . The Exercise group will receive a 6-month , group based , supervised resistance and aerobic exercise intervention . The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being . The Usual Care group will maintain st and ard care for 6 months . Measurements for primary and secondary endpoints will take place at baseline , 6 months ( post-intervention ) and 1 year follow-up . The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer . Discussion Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer . Despite this , very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors . This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best- practice management approach by integrating pharmacological , physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12613001179729",
"BACKGROUND / AIM Regular physical activity and exercise improves quality of life and possibly reduces risk of disease relapse and prolongs survival in breast cancer survivors . The aim of this study was to evaluate the impact of a 3-week moderate intensity aerobic training , on aerobic capacity ( VO2max ) in breast cancer survivors . METHODS A prospect i ve , r and omized clinical study included 18 female breast cancer survivors in stage I-IIIA , in which the primary treatment was accomplished at least 3 months before the study inclusion . In all the patients VO2max was estimated using the Astr and 's protocol on a bicycle-ergometer ( before and after 3 weeks of training ) , while subjective assessment of exertion during training were estimated by the Category-Ratio RPE Scale . Each workout lasted 21 minutes : 3 minutes for warm-up and cool-down each and 15 min of full training , 2 times a week . The workload in the group E1 was predefined at the level of 45 % to 65 % of individual VO2max , and in the group E2 it was based on subjective evaluation of exertion , at the level marked 4 - 6 . Data on the subjective feeling of exertion were collected after each training course in both groups . RESULTS We recorded a statistically significant improvement in VO2max in both groups ( E1 - -11.86 % ; E2 - -17.72 % ) , with no significant differences between the groups . The workload level , determined by the percent of VO2max , was different between the groups E1 and E2 ( 50.47 + /- 7.02 % vs 55.58 + /- 9.58 % ) , as well as subjective perception of exertion ( in the groups E1 and E2 , 11.6 % and 41.6 % of training , respectively , was grade d in the mark 6 ) . CONCLUSION In our group of breast cancer survivors , a 3-week moderate intensity aerobic training significantly improved the level of VO2max",
"BACKGROUND Participation in physical activity can improve the health outcomes of breast cancer survivors . To impact public health , broad-reaching sustainable interventions that promote physical activity are needed . PURPOSE To evaluate the efficacy of two distance-based interventions for promoting physical activity among breast cancer survivors compared with a st and ard recommendation control . METHODS Breast cancer survivors who had finished ' active ' cancer treatment were eligible to participate . Participants ( n = 330 ) were r and omly assigned to receive one of the following mail-delivered interventions : three computer-tailored newsletters , a previously developed breast cancer-specific physical activity booklet or a pamphlet detailing the public health recommendations for physical activity ( control ) . Primary outcomes were self-reported moderate to vigorous aerobic activity and participant 's self-reported resistance training activity at 4 months post-baseline . Secondary outcomes were pedometer step counts , whether or not participants were meeting the physical activity guidelines , time spent in sedentary behaviour , fatigue and health-related quality of life . RESULTS Participants r and omised into the tailored-print intervention group were three times more likely to commence resistance training and meet the resistance-training guidelines immediately after the intervention than participants allocated to the control group . There were no other significant intervention effects . CONCLUSION Computer-tailored newsletters may be an effective strategy for enhancing resistance-based physical activity among breast cancer survivors . The None findings relating to other outcomes may be due to ceiling effects ( in the case of aerobic activity , fatigue and health-related quality of life ) or the sensitivity of the measure used ( in the case of sitting time ) . These issues require further exploration",
"PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment",
"PURPOSE Interventions to increase physical activity among breast cancer survivors are needed to improve health and quality of life and possibly to reduce the risk of disease recurrence and early mortality . Therefore , we report the feasibility and preliminary outcomes of a pilot r and omized trial design ed to increase physical activity in sedentary breast cancer survivors receiving hormone therapy . METHODS Forty-one sedentary women on estrogen receptor modulators or aromatase inhibitors for stage I , II , or IIIA breast cancer were r and omly assigned to receive a 12-wk multidisciplinary physical activity behavior change intervention or usual care . RESULTS Recruitment was 34 % , intervention adherence was 99 % , and complete follow-up data were obtained on 93 % . Most participants ( 93 % ) were white with mean age of 53 + /- 9 yr . Differences favoring the intervention group were noted for accelerometer physical activity counts ( mean difference = 72,103 ; 95 % confidence interval ( CI ) = 25,383 - 119,000 ; effect size ( d ) = 1.02 ; P = 0.004 ) , aerobic fitness ( mean difference = 2.9 ; 95 % CI = -0.1 to 5.8 ; d = 0.64 ; P = 0.058 ) , back/leg muscle strength ( mean difference = 12.3 ; 95 % CI = 0.4 - 15.9 ; d = 0.81 ; P = 0.017 ) , waist-to-hip ratio ( mean difference = -0.05 ; 95 % CI = -0.01 to -0.08 ; d = -0.77 ; P = 0.018 ) , and social well-being ( mean difference = 2.0 ; 95 % CI = 0.3 - 3.8 ; d = 0.76 ; P = 0.03 ) . However , the intervention group also reported a greater increase in joint stiffness ( mean difference = 1.1 ; 95 % CI = 0.1 - 2.2 ; d = 0.70 ; P = 0.04 ) . CONCLUSIONS A behavior change intervention for breast cancer survivors based on the social cognitive theory is feasible and results in potentially meaningful improvements in physical activity and selected health outcomes . Confirmation in a larger study is warranted",
"OBJECTIVE Evidence of the benefits of exercise for those treated for cancer has led to exercise interventions for this population . Some have question ed whether cancer patients offered a home-based intervention adhere to the exercise prescribed . METHOD We examined exercise adherence in a r and omized controlled trial of a 12-week , home-based exercise trial for breast cancer patients . Three adherence outcomes were examined : minutes of exercise participation/week , number of steps taken during planned exercise/week , and whether the participant met her weekly exercise goal . Predictors of adherence ( e.g. demographic and medical variables , Transtheoretical Model variables , history of exercise ) were examined . RESULTS Findings indicate that participants significantly increased their minutes of exercise and steps taken during planned exercise from Week 1 to 12 . The percentage of participants achieving exercise goals was highest in the first few weeks . Exercise self-efficacy significantly predicted each adherence outcome . Baseline PA predicted mean exercise session steps over the 12 weeks . CONCLUSION Adherence to a home-based exercise intervention for breast cancer patients changes over time and may be related to baseline levels of exercise self-efficacy",
"UNLABELLED Erectile dysfunction ( ED ) is a major adverse effect of radical prostatectomy ( RP ) . We conducted a r and omized controlled trial to examine the efficacy of aerobic training ( AT ) compared with usual care ( UC ) on ED prevalence in 50 men ( n=25 per group ) after RP . AT consisted of five walking sessions per week at 55 - 100 % of peak oxygen uptake ( VO2peak ) for 30 - 60 min per session following a nonlinear prescription . The primary outcome was change in the prevalence of ED , as measured by the International Index of Erectile Function ( IIEF ) , from baseline to 6 mo . Secondary outcomes were brachial artery flow-mediated dilation ( FMD ) , VO2peak , cardiovascular ( CV ) risk profile ( eg , lipid profile , body composition ) , and patient-reported outcomes ( PROs ) . The prevalence of ED ( IIEF score ≤ 21 ) decreased by 20 % in the AT group and by 24 % in the UC group ( difference : p=0.406 ) . There were no significant between-group differences in any erectile function subscale ( p>0.05 ) . Significant between-group differences were observed for changes in FMD and VO2peak , favoring AT . There were no group differences in other markers of CV risk profile or PROs . In summary , nonlinear AT does not improve ED in men with localized prostate cancer in the acute period following RP . TRIAL REGISTRATION Clinical trials.gov identifier NCT00620932",
"Purpose Peak oxygen consumption ( VO2peak ) is an important predictive factor for long-term prognosis in patients with non-small cell lung cancer ( NSCLC ) . The purpose of this study was to investigate whether 8 weeks of exercise training improves exercise capacity , as assessed by VO2peak , and other related factors in patients with NSCLC receiving targeted therapy . Methods A total of 24 participants with adenocarcinoma were r and omly assigned to either the control group ( n = 11 ) or the exercise group ( n = 13 ) . Subjects in the exercise group participated in individualized , high-intensity aerobic interval training of exercise . The outcome measures assessed at baseline and after 8 weeks were as follows : VO2peak and the percentage of predicted VO2peak ( % predVO2peak ) , muscle strength and endurance of the right quadriceps , muscle oxygenation during exercise , insulin resistance as calculated by the homeostasis model , high-sensitivity C-reactive protein , and quality of life ( QoL ) question naire inventory . Results No exercise-related adverse events were reported . After exercise training , VO2peak and % predVO2peak increased by 1.6 mL kg−1 min−1 and 5.3 % ( p improvements in circulatory , respiratory , and muscular functions at peak exercise ( all p = 0.001 ) . The exercise group also had less dyspnea ( p = 0.01 ) and favorably lower fatigue ( p = 0.05 ) than baseline . Conclusions Patients with NSCLC receiving targeted therapy have quite a low exercise capacity , even with a relatively high QoL. Exercise training appears to improve exercise capacity and alleviate some cancer-related symptoms",
"Background : Patients with lymphoma experience sleep problems that may be managed with aerobic exercise but no previous study has examined this issue . Methods : We r and omized 122 patients with lymphoma to usual care ( n = 62 ) or 12 weeks of supervised aerobic exercise training ( AET ; n = 60 ) . Our primary sleep endpoint was global sleep quality assessed by the Pittsburgh Sleep Quality Index ( PSQI ) . Secondary endpoints were the PSQI component scores . Planned subgroup analyses were also conducted . Results : Intention-to-treat analyses indicated that AET result ed in a nonsignificant ( P = 0.16 ) improvement in global sleep quality compared with usual care [ mean group difference = −0.64 ; 95 % confidence interval ( CI ) , −1.56 to + 0.27 ] . In planned subgroup analyses , statistically significant or borderline significant interactions were identified for type of lymphoma ( Pinteraction = 0.006 ) , current treatment status ( Pinteraction = 0.036 ) , time since diagnosis ( Pinteraction = 0.010 ) , body mass index ( Pinteraction = 0.075 ) , and baseline sleep quality ( Pinteraction = 0.041 ) . Specifically , AET improved global sleep quality in patients with lymphoma who had indolent non – Hodgkin lymphoma ( P = 0.001 ) , were receiving chemotherapy ( P = 0.013 ) , were AET did not significantly improve sleep quality in this heterogeneous sample of patients with lymphoma ; however , clinical ly identifiable subgroups appeared to benefit . Future exercise trials targeting these responsive subgroups are needed to confirm these findings . Impact : If replicated in larger and more focused trials , aerobic exercise may be an attractive option to manage sleep dysfunction in patients with cancer because of its favorable safety profile and other documented health benefits . Cancer Epidemiol Biomarkers Prev ; 21(6 ) ; 887–94 . © 2012 AACR",
"Objectives To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer , with six month follow-up . Design Pragmatic r and omised controlled prospect i ve open trial . Setting Three National Health Service oncology clinics in Scotl and and community exercise facilities . Participants 203 women entered the study ; 177 completed the six month follow-up . Interventions Supervised 12 week group exercise programme in addition to usual care , compared with usual care . Main outcome measures Functional assessment of cancer therapy ( FACT ) question naire , Beck depression inventory , positive and negative affect scale , body mass index , seven day recall of physical activity , 12 minute walk test , and assessment of shoulder mobility . Results Mixed effects models with adjustment for baseline values , study site , treatment at baseline , and age gave intervention effect estimates ( intervention minus control ) at 12 weeks of 129 ( 95 % confidence interval 83 to 176 ) for metres walked in 12 minutes , 182 ( 75 to 289 ) for minutes of moderate intensity activity reported in a week , 2.6 ( 1.6 to 3.7 ) for shoulder mobility , 2.5 ( 1.0 to 3.9 ) for breast cancer specific subscale of quality of life , and 4.0 ( 1.8 to 6.3 ) for positive mood . No significant effect was seen for general quality of life ( FACT-G ) , which was the primary outcome . At the six month follow-up , most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged . No adverse effects were noted . Conclusion Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later . Clinicians should encourage activity for their patients . Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services . Trial registration Current controlled trials IS RCT N12587864",
"CONTEXT Physical activity has been shown to decrease the incidence of breast cancer , but the effect on recurrence or survival after a breast cancer diagnosis is not known . OBJECTIVE To determine whether physical activity among women with breast cancer decreases their risk of death from breast cancer compared with more sedentary women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study based on responses from 2987 female registered nurses in the Nurses ' Health Study who were diagnosed with stage I , II , or III breast cancer between 1984 and 1998 and who were followed up until death or June 2002 , whichever came first . MAIN OUTCOME MEASURE Breast cancer mortality risk according to physical activity category ( or = 24 metabolic equivalent task [ MET ] hours per week ) . RESULTS Compared with women who engaged in less than 3 MET-hours per week of physical activity , the adjusted relative risk ( RR ) of death from breast cancer was 0.80 ( 95 % confidence interval [ CI ] , 0.60 - 1.06 ) for 3 to 8.9 MET-hours per week ; 0.50 ( 95 % CI , 0.31 - 0.82 ) for 9 to 14.9 MET-hours per week ; 0.56 ( 95 % CI , 0.38 - 0.84 ) for 15 to 23.9 MET-hours per week ; and 0.60 ( 95 % CI , 0.40 - 0.89 ) for 24 or more MET-hours per week ( P for trend = .004 ) . Three MET-hours is equivalent to walking at average pace of 2 to 2.9 mph for 1 hour . The benefit of physical activity was particularly apparent among women with hormone-responsive tumors . The RR of breast cancer death for women with hormone-responsive tumors who engaged in 9 or more MET-hours per week of activity compared with women with hormone-responsive tumors who engaged in less than 9 MET-hours per week was 0.50 ( 95 % CI , 0.34 - 0.74 ) . Compared with women who engaged in less than 3 MET-hours per week of activity , the absolute unadjusted mortality risk reduction was 6 % at 10 years for women who engaged in 9 or more MET-hours per week . CONCLUSIONS Physical activity after a breast cancer diagnosis may reduce the risk of death from this disease . The greatest benefit occurred in women who performed the equivalent of walking 3 to 5 hours per week at an average pace , with little evidence of a correlation between increased benefit and greater energy expenditure . Women with breast cancer who follow US physical activity recommendations may improve their survival",
"OBJECTIVE To investigate the effectiveness of an 8-week aquatic program on cancer-related fatigue , as well as physical and psychological outcomes in breast cancer survivors . DESIGN A r and omized controlled trial . SETTING Outpatient clinic , urban , academic medical center , and a sport university swimming pool . PARTICIPANTS Breast cancer survivors ( N=68 ) were r and omly assigned to either an experimental ( aquatic exercise group in deep water pool ) group or a control ( usual care ) group . INTERVENTIONS The intervention group attended aquatic exercise sessions 3 times per week for 8 weeks in a heated deep swimming pool . Sessions lasted 60 minutes in duration : 10 minutes of warm-up , 40 minutes of aerobic and endurance exercises , and 10 minutes of cool-down exercises . Patients allocated to the usual care group followed the oncologist 's recommendations in relation to a healthy lifestyle . MAIN OUTCOME MEASURES Values for fatigue ( Piper Fatigue Scale ) , mood state ( Profile of Mood States ) , and abdominal ( trunk curl static endurance test ) and leg ( multiple sit-to-st and test ) strength were collected at baseline , after the last treatment session , and at a 6-month follow-up . RESULTS Immediately after discharge , the aquatic exercise group showed a large effect size in total fatigue score ( d=.87 ; 95 % confidence interval , .48 - 1.26 ) , trunk curl endurance ( d=.92 ; 95 % confidence interval , 1.97 - 3.83 ) , and leg strength ( d=1.10 ; .55 - 2.76 ) , but negligible effects in vigor , confusion , and disturbance of mood ( d aquatic exercise group maintained large to small effect sizes in fatigue scores , multiple sit-to-st and test , and trunk curl static endurance ( .25>d>.90 ) and negligible effects for the fatigue-severity dimension and different scales of the Profile of Mood States ( d aquatic exercise program conducted in deep water was effective for improving cancer-related fatigue and strength in breast cancer survivors",
"Background : Bleomycin – etoposid – cisplatin ( BEP ) chemotherapy is curative in most patients with disseminated germ cell cancer ( GCC ) but also associated with toxic actions and dysfunction in non-targeted tissues . We investigated changes in muscle function during BEP and the safety and efficacy of resistance training to modulate these changes . Methods : Thirty GCC patients were r and omly assigned to resistance training ( resistance training group ( INT ) , n=15 ) or usual care ( CON , n=15 ) during 9 weeks of BEP therapy . Resistance training consisted of thrice weekly sessions of four exercises , 3–4 sets/exercise of 10–15 repetitions at 12–15 repetition maximum load . The primary endpoint was muscle fibre size , assessed in muscle biopsies from musculus vastus lateralis . Secondary endpoints were fibre phenotype composition , body composition , strength , blood biochemistry and patient-reported endpoints . Healthy age-matched subjects ( REF , n=19 ) performed the same RT-programme for comparison purpose s. Results : Muscle fibre size decreased by −322 μm2 ( 95 % confidence interval ( CI ) : −899 to 255 ; P=0.473 ) in the CON-group and increased by + 206 μm2 ( 95 % CI : −384 to 796 ; P=0.257 ) in the INT-group ( adjusted mean difference ( AMD ) , + 625 μm2 , 95 % CI : −253 to 1503 , P=0.149 ) . Mean differences in type II fibre size ( AMD , + 823 μm2 , P=0.09 ) and lean mass ( AMD , + 1.49 kg , P=0.07 ) in favour of the INT-group approached significance . The REF-group improved all muscular endpoints and had significantly superior changes compared with the INT-group ( P in lean mass and strength and trends toward unfavourable changes in muscle fibre size and phenotype composition . Resistance training was safe and attenuated dysfunction in selected endpoints , but BEP blunted several positive adaptations observed in healthy controls . Thus , our study does not support the general application of resistance training in this setting but larger-scaled trials are required to confirm this finding",
"BACKGROUND The efficacy of a home-based physical activity ( PA ) intervention for colorectal cancer patients versus contact control was evaluated in a r and omized controlled trial . METHODS Forty-six patients ( mean age = 57.3 years [ SD = 9.7 ] , 57 % female , mean = 2.99 years post-diagnosis [ SD = 1.64 ] ) who had completed treatment for stages 1 - 3 colorectal cancer were r and omized to telephone counseling to support PA ( PA group , n = 20 ) or contact control ( control group , n = 26 ) . PA group participants received 3 months of PA counseling ( based on the transtheoretical model and the social cognitive theory ) delivered via telephone , as well as weekly PA tip sheets . Assessment s of PA ( Seven-day Physical Activity Recall [ 7-day PAR ] and Community Healthy Activities Model Program for Seniors [ CHAMPS ] ) , submaximal aerobic fitness ( Treadwalk test ) , motivational readiness for PA , and psychosocial outcomes were conducted at baseline , 3 , 6 , and 12 months post-baseline . Objective accelerometer data were collected at the same time points . RESULTS The PA group reported significant increases in minutes of PA at 3 months ( 7-day PAR ) and caloric expenditure ( CHAMPS ) compared with the control group , but the group differences were attenuated over time . The PA group showed significant improvements in fitness at 3 , 6 , and 12 months versus the control group . Improvements in motivational readiness for PA were reported in the PA group only at 3 months . No significant group differences were found for fatigue , self-reported physical functioning , and quality of life at 3 , 6 , and 12 months . CONCLUSION A home-based intervention improved survivors ' PA and motivational readiness at 3 months and increased submaximal aerobic fitness at 3 , 6 , and 12 months",
"PURPOSE To examine the effects of aerobic exercise therapy on quality of life ( QoL ) and associated outcomes in women treated for breast cancer . Evidence suggests that exercise may be beneficial , but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients . PATIENTS AND METHODS A total of 108 women who had been treated for breast cancer 12 to 36 months previously were r and omly assigned to supervised aerobic exercise therapy ( n = 34 ) , exercise-placebo ( body conditioning ; n = 36 ) , or usual care ( n = 38 ) . Exercise therapy and exercise-placebo sessions took place three times per week for 8 weeks . Outcomes included QoL , depression , exercise behavior , aerobic fitness ; outcomes were assessed at baseline and at the 8- and 24-week follow-up . RESULTS Analyses of covariance revealed a significant mean difference of 9.8 units in Functional Assessment of Cancer Therapy-General ( primary outcome ) favoring aerobic exercise therapy at 8 weeks , relative to usual care . Significant differences that favored aerobic exercise therapy relative to usual care were recorded for Functional Assessment of Cancer Therapy-Breast , social/family well-being , functional well-being , and breast cancer subscale scores at 8-week follow-up . Psychological health outcomes improved modestly for both intervention groups ; these improvements were sustained for several end points . CONCLUSION Exercise therapy had large , clinical ly meaningful , short-term beneficial effects on QoL in women treated for breast cancer ; this finding can not be attributable to attention , given that the exercise-placebo group did not report similar effects relative to usual care",
"PURPOSE / OBJECTIVES To examine the effects of a comprehensive rehabilitation program on facilitating physical and psychosocial adaptation of women with breast cancer who are receiving adjuvant chemotherapy . DESIGN Experimental . SETTING Breast evaluation clinics of two New Engl and medical centers with comprehensive cancer treatment programs . SAMPLE 14 women ( mean age = 44 years ) receiving adjuvant chemotherapy for breast cancer ( 86 % stage II ) following surgical treatment . METHODS Subjects were assigned r and omly to the experimental group or the usual care group . Experimental group members began a structured exercise program of walking and attended support group meetings . All subjects were tested before beginning chemotherapy , during the course of chemotherapy , and one month following chemotherapy completion . MAIN RESEARCH VARIABLES Performance status , physical functioning , psychosocial adjustment , self-concept and body image , and 12 symptoms ( e.g. , fatigue , nausea , anxiety ) . FINDINGS Measures of physical performance , psychosocial adjustment , and symptom intensity revealed improved adaptation in subjects who completed the walking/support group program . CONCLUSIONS Physical and psychosocial benefits from a modest walking exercise program and a support group are possible for patients receiving adjuvant chemotherapy . IMPLICATION S FOR NURSING PRACTICE Although more detailed research is necessary to answer some of the questions raised by this study , implementing the walking program and forming a support group are achievable in an outpatient setting",
"Purpose Although physical activity ( PA ) adoption improves fitness and psychological well-being among cancer survivors , PA maintenance has not been examined . This paper presents follow-up of a home-based PA program for women treated for early-stage breast cancer . Material s and methods Eighty-six sedentary women ( mean age = 53.14 years , SD = 9.70 ) were r and omly assigned to a PA or contact control group . The PA group received a 12-week telephone counseling program to adopt PA . Assessment s were conducted at baseline , end-of-intervention ( 12 weeks ) , 6 , and 9 months post-baseline . Results When comparing change from end-of-intervention ( 12 weeks ) between groups , a significant reduction was observed in minutes of PA at 6 months ( t = −2.10 , p reductions in fatigue were lost at 6 months ( t = 3.27 , p ’s fitness improvements were maintained at both follow-ups ( t = 1.04 , p = 0.30 and t = 0.05 , p = 0.96 ) . The previously significant intervention effect on vigor was maintained at 6 months ( t = 1.32 , p = 0.19 ) but was significantly reduced at 9 months ( t = −2.15 , p 0.05 ) . PA participants were more likely to progress in motivational readiness at 6 ( OR = 5.95 , 95 % CI = 2.30 , 15.36 ) and 9 months ( OR = 4.09 , 95 % CI = 1.69 , 9.87 ) ; however , group differences in meeting PA guidelines were not maintained . ConclusionS ome positive effects of a home-based PA intervention for breast cancer patients were maintained at 6 and 9 months",
"AIM This paper is a report of a study analysing the effect of a home-based walking exercise program on symptoms and mood distress among breast cancer women receiving chemotherapy postoperatively . BACKGROUND Treatment-related symptoms , mood distress and decline in physical activity have been identified as major complaints among cancer patients . Studies on the efficacy of home-based walking exercise for symptoms and mood did not fully describe the exercise prescriptions that could be safe and beneficial for women with breast cancer , especially these receiving adjuvant chemotherapy . METHOD This is a prospect i ve , r and omized clinical trial . In 2008 - 2009 , participants were recruited from the oncology outpatient clinic of a medical center in Taiwan , and were assigned to either the exercise group ( n=19 ) or the control group ( n=21 ) . Women in the exercise group participated in a moderate-intensity home-based walking program for 12 weeks during their chemotherapy treatments . Symptoms , mood status and physical activity level were measured at baseline , 6- and 12-week follow-up . Data were analysed by two-way repeated- measures analysis of variance . RESULTS Women in the exercise group reported significantly lower symptom severity scores and mood disturbance compared with those in the control group throughout the study period . CONCLUSION Regular moderate-intensity exercise can play an important role in improving treatment-related symptoms and mood in women with breast cancer . A home-based walking exercise program can be easily incorporated into care for women with breast cancer undergoing chemotherapy",
"PURPOSE Cancer survivors are at increased risk for cardiovascular disease , diabetes , osteoporosis , and second primary tumors . Healthful lifestyle practice s may improve the health and well-being of survivors . The FRESH START trial tested the efficacy of sequentially tailored versus st and ardized mailed material s on improving cancer survivors ' diet and exercise behaviors . METHODS Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America . Participants were r and omly assigned either to a 10-month program of tailored mailed print material s promoting fruit and vegetable ( F&V ) consumption , reducing total/saturated fat intake , and /or increasing exercise or to a 10-month program of nontailored mailed material s on diet and exercise available in the public domain . Telephone surveys conducted at baseline and 1 year assessed body mass index ( BMI ) , dietary consumption , physical activity , and other psychosocial/behavioral indices . Clinical assessment s were conducted on a 23 % sub sample ; information was used to vali date self-reports . RESULTS Five hundred nineteen participants completed the 1-year follow-up ( 4.4 % attrition ; sample characteristics : 57 + /- 10.8 years old , 83 % white , 56 % female , 64 % overweight/obese , and 0 % underweight ) . Although both arms significantly improved their lifestyle behaviors ( P Mailed material interventions , especially those that are tailored , are effective in promoting healthful lifestyle changes among cancer survivors . Further study is needed to determine sustainability , cost to benefit , and generalizability to other cancer population",
"In this 12-month RCT , we examined whether aerobic impact exercise training ( 3x/week ) could facilitate breast cancer survivors ' recovery by enhancing their bone structural strength , physical performance and body composition . After the adjuvant chemo- and / or radiotherapy , 86 patients were r and omly assigned into the training or control group . Structural bone traits were assessed with pQCT at the tibia and with DXA at the femoral neck . Agility ( figure-8 running ) , jump force and power ( force platform ) , grip strength and cardiovascular fitness ( 2-km walk test ) were also assessed . Training effects on outcome variables were estimated by two-way factorial ANCOVA using the study group and menopausal status as fixed factors . Bone structural strength was better maintained among the trainees . At the femoral neck , there was a small but significant 2 % training effect in the bone mass distribution ( p=0.05 ) . At the tibial diaphysis , slight 1 % to 2 % training effects ( p=0.03 ) in total cross-sectional area and bone structural strength were observed ( p=0.03 ) among the postmenopausal trainees . Also , 3 % to 4 % training effects were observed in the figure-8 running time ( p=0.03 ) and grip strength ( p=0.01 ) . In conclusion , vigorous aerobic impact exercise training has potential to maintain bone structural strength and improve physical performance among breast cancer survivors",
"Abstract Introduction . Radical cystectomy with lymph-node dissection is a complex procedure and often followed by high postoperative morbidity and physical impairments leading to prolonged length of stay ( LOS ) . Fast-track principles are st and ard procedure in radical cystectomy . Additional preoperative and postoperative physical exercises and enhanced mobilization may reduce LOS and early complications . Material s and methods . In total , 107 patients were included in a prospect i ve r and omized controlled design , 50 in the intervention group ( nI = 50 ) and 57 in the st and ard group ( ns = 57 ) . The st and ard regimen comprised regular fast-track principles . The intervention included st and ardized preoperative and postoperative strength and endurance exercises and progressive postoperative mobilization . The programme was initiated 2 weeks before surgery . Efficacy was expressed as a reduction in postoperative LOS . Early complications were defined as events occurring at most 90 days postoperatively and grade d using the Clavien – Dindo classification system . Results . Adherence to prehabilitation , i.e. patients who accomplished at least 75 % of the programme , was 59 % . Postoperative mobilization was significantly improved by walking distance ( p ≤ 0.001 ) . The ability to perform personal activities of daily living was improved by 1 day ( p ≤ 0.05 ) . The median LOS was 8 days in both treatment groups ( p = 0.68 ) . There was no significant difference between treatment groups in severity of complications ( p = 0.64 ) . Conclusions . There was no reduction in LOS due to the preoperative and postoperative rehabilitation programme , although enhanced mobilization was achieved . The optimized minimal surgical procedure may have affected the ability to reduce LOS further with available techniques and procedures . Alternative parameters for recovery may offer more precise and relevant information",
"Background International evidence -based guidelines recommend physical exercise to form part of st and ard care for all cancer survivors . However , at present , the optimum exercise intensity is unclear . Therefore , we aim ed to evaluate the effectiveness of a high intensity ( HI ) and low-to-moderate intensity ( LMI ) resistance and endurance exercise program compared with a wait list control ( WLC ) group on physical fitness and fatigue in a mixed group of cancer survivors who completed primary cancer treatment , including chemotherapy . Methods Overall , 277 cancer survivors were r and omized to 12 weeks of HI exercise ( n = 91 ) , LMI exercise ( n = 95 ) , or WLC ( n = 91 ) . Both interventions were identical with respect to exercise type , duration and frequency , and only differed in intensity . Measurements were performed at baseline ( 4–6 weeks after primary treatment ) and post-intervention . The primary outcomes were cardiorespiratory fitness ( peakVO2 ) , muscle strength ( grip strength and 30-second chair-st and test ) , and self-reported fatigue ( Multidimensional Fatigue Inventory ; MFI ) . Secondary outcomes included health-related quality of life , physical activity , daily functioning , body composition , mood , and sleep disturbances . Multilevel linear regression analyses were performed to estimate intervention effects using an intention-to-treat principle . Results In the HI and LMI groups , 74 % and 70 % of the participants attended more than 80 % of the prescribed exercise sessions , respectively ( P = 0.53 ) . HI ( β = 2.2 ; 95 % CI , 1.2–3.1 ) and LMI ( β = 1.3 ; 95 % CI , 0.3–2.3 ) exercise showed significantly larger improvements in peakVO2 compared to WLC . Improvements in peakVO2 were larger for HI than LMI exercise ( β = 0.9 ; 95 % CI , −0.1 to 1.9 ) , but the difference was not statistically significant ( P = 0.08 ) . No intervention effects were found for grip strength and the 30-second chair-st and test . HI and LMI exercise significantly reduced general and physical fatigue and reduced activity ( MFI subscales ) compared to WLC , with no significant differences between both interventions . Finally , compared to WLC , we found benefits in global quality of life and anxiety after HI exercise , improved physical functioning after HI and LMI exercise , and less problems at work after LMI exercise . Conclusions Shortly after completion of cancer treatment , both HI and LMI exercise were safe and effective . There may be a dose – response relationship between exercise intensity and peakVO2 , favoring HI exercise . HI and LMI exercise were equally effective in reducing general and physical fatigue . Trial registration This study was registered at the Netherl and s Trial Register [ NTR2153 ] on the 5th of January 2010",
"The purpose of the present paper was to evaluate the effects of an 8-week multimodal program focused on core stability exercises and recovery massage with DVD support for a 6-month period in physical and psychological outcomes in breast cancer survivors . A r and omized controlled clinical trial was performed . Seventy-eight ( n = 78 ) breast cancer survivors were assigned to experimental ( core stability exercises plus massage-myofascial release ) and control ( usual health care ) groups . The intervention period was 8 weeks . Mood state , fatigue , trunk curl endurance , and leg strength were determined at baseline , after the last treatment session , and at 6 months of followup . Immediately after treatment and at 6 months , fatigue , mood state , trunk curl endurance , and leg strength exhibited greater improvement within the experimental group compared to placebo group . This paper showed that a multimodal program focused on core stability exercises and massage reduced fatigue , tension , depression , and improved vigor and muscle strength after intervention and 6 months after discharge",
"Previous studies suggest that increased physical activity may lower the risk of breast cancer incidence , but less is known about whether levels of physical activity after breast cancer diagnosis can influence survival . We prospect ively examined the relation between postdiagnosis recreational physical activity and risk of breast cancer death in women who had a previous invasive breast cancer diagnosed between 1988 and 2001 ( at ages 20 - 79 years ) . All women completed a question naire on recent postdiagnosis physical activity and other lifestyle factors . Among 4,482 women without history of recurrence at the time of completing the question naire , 109 died from breast cancer within 6 years of enrollment . Physical activity was expressed as metabolic equivalent task-hours per week ( MET-h/wk ) ; hazard ratios ( HR ) and 95 % confidence intervals ( 95 % CI ) were estimated using Cox proportional hazards regression . After adjusting for age at diagnosis , stage of disease , state of residence , interval between diagnosis and physical activity assessment , body mass index , menopausal status , hormone therapy use , energy intake , education , family history of breast cancer , and treatment modality compared with women expending lower risk of dying from breast cancer ( HR , 0.65 ; 95 % CI , 0.39 - 1.08 for 2.8 - 7.9 MET-h/wk ; HR , 0.59 ; 95 % CI , 0.35 - 1.01 for 8.0 - 20.9 MET-h/wk ; and HR , 0.51 ; 95 % CI , 0.29 - 0.89 for ≥21.0 MET-h/wk ; P for trend = 0.05 ) . Results were similar for overall survival ( HR , 0.44 ; 95 % CI , 0.32 - 0.60 for ≥21.0 versus reduced overall mortality and mortality from breast cancer among women who engage in physical activity after breast cancer diagnosis . ( Cancer Epidemiol Biomarkers Prev 2008;17(2):379–86",
"Background Prostate cancer is the most commonly diagnosed non-melanoma cancer among men . And rogen deprivation therapy ( ADT ) has been the core therapy for men with advanced prostate cancer . It is only in recent years that clinicians began to recognize the cognitive-psychosocial side effects from ADT , which significantly compromise the quality of life of prostate cancer survivors . The objectives of the study are to determine the efficacy of a simple and accessible home-based , walking exercise program in promoting cognitive and psychosocial functions of men with prostate cancer receiving ADT . Methods A 6-month prospect i ve , single-blinded , r and omized controlled trial will be conducted to compare the Exercise Group with the Control Group . Twenty men with prostate cancer starting ADT will be recruited and r and omly assigned to one of the two groups : the Exercise Group will receive instructions in setting up an individualized 6-month home-based , walking exercise program , while the Control Group will receive st and ard medical advice from the attending physician . The primary outcomes will be psychosocial and cognitive functions . Cognitive functions including memory , attention , working memory , and executive function will be assessed using a battery of neurocognitive tests at baseline and 6 months . Psychosocial functions including depression , anxiety and self-esteem will be assessed at baseline , 3 and 6 months using the Center for Epidemiological Studies Depression Scale , Spielberger State-Trait Anxiety Inventory , and Rosenberg Self-Esteem Scale . Discussion The significance of the cognitive-psychosocial side effects of ADT in men with prostate cancer has only been recently recognized , and the management remains unclear . This study addresses this issue by design ing a simple and accessible home-based , exercise program that may potentially have significant impact on reducing the cognitive and psychosocial side effects of ADT , and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.Trial registration",
"PURPOSE To examine the effect of a progressive upper-body exercise program on lymphedema secondary to breast cancer treatment . METHODS Fourteen breast cancer survivors with unilateral upper extremity lymphedema were r and omly assigned to an exercise ( n = 7 ) or control group ( n = 7 ) . The exercise group followed a progressive , 8-week upper-body exercise program consisting of resistance training plus aerobic exercise using a Monark Rehab Trainer arm ergometer . Lymphedema was assessed by arm circumference and measurement of arm volume by water displacement . Patients were evaluated on five occasions over the experimental period . The Medical Outcomes Trust Short-Form 36 Survey was used to measure quality of life before and after the intervention . Significance was set at alpha arm circumference or arm volume as a result of the exercise program . Three of the quality -of-life domains showed trends toward increases in the exercise group : physical functioning ( P = .050 ) , general health ( P = .048 ) , and vitality ( P = .023 ) . Mental health increased , although not significantly , for all subjects ( P = .019 ) . Arm volume measured by water displacement was correlated with calculated arm volume ( r = .973 , P upper-body exercise program caused no changes in arm circumference or arm volume in women with lymphedema after breast cancer , and they may have experienced an increase in quality of life . Additional studies should be done in this area to determine the optimum training program",
"BACKGROUND To determine whether the Health Partner Program is effective in training long-term cancer survivors to be health coaches . MATERIAL S AND METHODS We r and omly assigned cancer survivors who were selected through a rigorous screening process to either the Health Partner Program or the waiting-list control group . The program consisted of 8 weeks of training in health management , leadership , and coaching . At baseline , 8 , and 16 weeks , we measured primary outcomes using the Seven Habit Profile ( SHP ) , the Korean Leadership Coaching Competency Inventory ( KCCI ) , Ed Diner 's Satisfaction with Life Scale ( SWLS ) , and the Posttraumatic Growth inventory ( PTGI ) and secondary outcomes using the Hospital Anxiety and Depression Scale ( HADS ) , the Impact of Event Scale-Revised ( IES-R ) , and the Medical Outcomes Study ( MOS ) short form 36-item question naire ( SF- 36 ) . RESULTS We recruited 70 subjects and r and omly assigned 34 to the intervention group . The Sharpen the Saw habit of the SHP increased significantly more in intervention group than in the control group ( p = 0.049 ) , as did most PTGI factors . The intervention group also showed a significantly greater enhancement of vitality ( p = 0.015 ) and mental health ( p = 0.049 ) SF-36 scores but no improvement in KCCI , SWLS , HADS , or IES-R scores . The intervention group also showed a greater clinical ly meaningful improvement in the \" Think Win-Win \" of SHP ( p = 0.043 ) and in the personal strength score ( p = 0.025 ) and total score ( p = 0.015 ) of the PTGI . CONCLUSIONS Long-term cancer survivors can benefit from the Health Partner Program to become health coaches",
"OBJECTIVE Physical activity ( PA ) has been shown to provide health benefits for breast cancer patients . The effects of augmenting oncology health care provider ( HCP ) advice for PA with 3 months of telephone counseling versus contact control were evaluated in a r and omized trial . METHODS After receiving brief HCP advice to become physically active , 192 women ( age in years : M = 60.0 , SD = 9.9 ) who had completed treatment for Stage 0-IV breast cancer were r and omized to telephone counseling to support PA ( n = 106 ) or contact control ( n = 86 ) . Their PA , motivational readiness , fatigue , and physical functioning were assessed at baseline ( before receiving HCP advice ) , 3 , 6 , and 12 months . RESULTS Telephone counseling produced significant effects on the primary outcome of moderate-intensity PA of about 30 min/week at both 3 months ( 95 % CI = 0.44 , 57.32 ) and 6 months ( 95 % CI = 3.06 , 61.26 ) . Intervention participants were also more than twice as likely as control participants to report improvements in achieving PA guidelines of at least 150 min/week at 3 ( OR = 2.43 , 95 % CI = 1.18 , 4.98 ) and 6 months ( OR = 2.11 , 95 % CI = 1.00 - 4.48 ) . Telephone counseling was significantly more effective than contact control in increasing motivational readiness for PA at all follow-ups ( ORs = 3.93 - 6.28 , all ps fatigue , while differential improvements in physical functioning did not remain significant past 3 months ( p = .01 ) . CONCLUSION HCP advice plus telephone counseling improved PA among breast cancer patients at 3 and 6 months and also differentially improved patients ' motivational readiness at all follow-ups , suggesting the potential for exercise promotion in cancer follow-up care",
"A pilot research study was conducted at 2 cancer centers in Connecticut to determine the effect of a dance and movement program on quality of life and shoulder function in breast cancer survivors treated within the prior 5 years . Thirty-five women completed the trial that included a 12-week intervention , using The Lebed Method , Focus on Healing Through Movement and Dance . The study design was a r and omized control trial with a wait list control group crossover to active treatment in weeks 13 to 25 , with the treatment group receiving the program in weeks 1 to 12 , and no program in weeks 13 to 25 . Outcome measures were the Breast Cancer Quality of Life ( FACT-B ) , Shoulder range of motion ( ROM ) , and Body Image Scale . FACT-B significantly improved in the intervention group at 13 weeks from 102.0 ± 15.8 to 116.7 ± 16.9 , compared to the wait list group 108.1 ± 16.4 to 107.1 ± 21.3 ( time × group effect , P = .008 ) . During the crossover phase , the FACT-B score increased in the wait list group and was stable in the treatment group . The overall effect of the training at 26 weeks was significant ( time effect , P = .03 ) , and the order of training was also significant ( P = .015 ) . Shoulder ROM increased in both groups at 13 weeks —15 ° and 8 ° in the intervention and wait list groups ( Time effect , P = .03 ; time × group , P = .58 ) . Body Image improved similarly in both groups at 13 weeks ( time effect , P = .001 ; time × group , P = .25 ) , and at 26 weeks . There was no significant effect of the order of training for these outcome measures . A dance movement program that addressed the physical and emotional needs of women following treatment for breast cancer substantially improved a breast cancer – specific quality -of-life measure . Larger studies are justified to determine the acceptability of this therapy as part of the continuum of care for breast cancer survivors",
"OBJECTIVE This pilot project evaluated the acceptability and estimated the effect size of a tailored multidisciplinary quality of life ( MQOL ) intervention for men who have biochemical recurrence of prostate cancer . METHODS Participants included 57 men with localized prostate cancer with biochemical recurrence ( Median=76 years ; 89 % White ) . Participants were r and omized to wait list control which offered the intervention upon conclusion of the study ( n=27 ) or to an eight-session group-based , MQOL ( n=30 ) intervention . Assessment s were completed at baseline , end of treatment , and 6 months post-treatment . RESULTS MQOL was acceptable as indicated by favorable participant retention ( 100 % retained ) , treatment compliance ( 97 % attended > 6 treatment sessions ) , and high ratings of helpfulness ( 80 % rated helpfulness > 4 on 5-point scale ) . MQOL had a favorable impact on the mental health composite score of the Short Form-36 at the end of treatment but not at 6 months ( effect size=0.52 and -0.04 ) ; health-related QOL as measured by the Functional Assessment of Cancer Therapy-Prostate at the end of treatment and 6 months ( effect size=0.14 and 0.10 ) ; and prostate cancer specific anxiety as measured by the Memorial Anxiety Scale for Prostate Cancer at the end of treatment and 6 months ( effect size=0.45 and 0.23 ) . CONCLUSIONS This pilot project provides preliminary data supporting the premise that a tailored behaviorally based MQOL intervention for men with biochemical recurrence of prostate cancer is acceptable to men and might reduce prostate cancer specific anxiety and enhance QOL . Further research examining the efficacy of this intervention in a larger r and omized trial is warranted",
"PURPOSE / OBJECTIVES To compare the effectiveness of a prescribed home-based walking exercise intervention with usual care in older women receiving hormonal treatment for breast cancer , and to examine relationships among levels of the cortisol , serotonin , interleukin-6 , and bilirubin biomarkers and fatigue , sleep disturbances , and depressive symptoms . DESIGN Longitudinal r and omized clinical trial . SETTING A National Cancer Institute- design ated cancer center in the southeastern United States . SAMPLE 20 women ( aged 55 years or older ) with breast cancer receiving hormonal treatment . METHODS Participants were r and omized to a walking exercise intervention or usual care . Laboratory sample s and the Pittsburgh Sleep Quality Index ( PSQI ) , the Piper Revised Fatigue Scale , and the Center for Epidemiological Studies -Depression Scale were collected at the initial clinic visit and at 12 weeks from the groups . Question naires also were collected at weeks 2 and 14 . MAIN RESEARCH VARIABLES Fatigue , sleep disturbances , depressive symptoms , biomarkers , and exercise . FINDINGS Effect of the exercise intervention on sleep scores was highly significant between groups . Exercise group scores on the PSQI decreased significantly over time ( indicating improved sleep quality ) , although scores did not change significantly within the control group . Sleep actigraphy also showed significantly shorter actual wake time and less movement in the exercise group . Serotonin levels also were significantly affected by the intervention . CONCLUSIONS Data suggest that a walking exercise intervention improves sleep in older women receiving hormonal treatment for their breast cancer . Serotonin levels may be a useful biomarker when assessing sleep disturbances in this group . IMPLICATION S FOR NURSING Clinicians need to be aware that older women receiving hormonal treatment for their breast cancer may experience fatigue , sleep disturbances , and depressive symptoms . Homebased walking activity may reduce symptom severity in this group",
"Objective To evaluate the effects of an 8-week multidimensional physical therapy program , including strengthening exercises and recovery massage , on neck and shoulder pain , pressure hypersensitivity , and the presence of active trigger points ( TrPs ) in breast cancer survivors . Methods In this r and omized controlled clinical trial , 44 breast cancer survivors were r and omly assigned into 2 groups : CUI DATE group who received a multidimensional physical therapy program ; or CONTROL group who received usual care treatment for breast cancer . CUI DATE program consisted of 24 hours of individual physical training ( aerobic , mobility , stretching , and strengthening exercises ) and 12 hours of physical therapy recovery ( stretching , massage ) interventions ( 3 times/wk , 90 min ) . Outcomes included neck and shoulder pain ( visual analog scale , 0 to 100 ) , pressure pain thresholds over the C5-C6 zygapophyseal joints , deltoid muscles , second metacarpal and tibialis anterior muscles , and the presence of active TrPs in shoulder muscles . Outcomes were assessed at baseline and after the 8-week program by a blinded assessor . Results The CUI DATE group showed an estimated improvement for neck pain of –56 mm [ 95 % confidence interval ( CI ) , −71-–40 , P for shoulder/axillary of –56 mm ( 95 % CI , –74-–38 , P for pressure pain thresholds levels : C5-C6 zygapophyseal joints ( between-group differences 101 kPa , 95 % CI , 60 - 143 ; effect size 1.68 , 1.00 to 2.35 ; 92 kPa 55 to 129 ; d : 1.98 , 1.18 to 2.77 ) , deltoid muscles ( 98 kPa , 45 to 149 ; d : 1.34 , 0.62 to 2.04 ; 75 kPa 18 to 132 ; d : 1.12 , 0.27 to 1.96 ) , second metacarpal ( 93 kPa , 45 to 134 ; d : 1.30 , 0.63 to 1.86 ; 99 kPa 59 to 139 ; d : 1.60 , 0.96 to 2.24 ) , and tibialis anterior muscles ( 71 kPa , 40 to 144 ; d : 1.16 , 0.65 to 2.34 ; 118 kPa 57 to 178 ; d : 1.17 , 0.56 to 1.77 ) . Finally , patients within the CUI DATE program showed a greater reduction of active muscle TrPs compared with the CONTROL group ( P multidimensional program including strengthening exercises , and massage as major components was effective for improving neck and shoulder pain and reducing widespread pressure hyperalgesia in breast cancer survivors compared with usual care treatment",
"Deterioration in exercise tolerance and impairment in quality of life ( QoL ) are common consequences of lobectomy . This study evaluates additional exercise and strength training after lung resection on QoL , exercise tolerance and muscle strength . Fifty-three ( 28 male ) patients attending thoracotomy for lung cancer , mean age , range 64 ( 32 - 82 ) years ; mean pack years ( SD ) 31.9 ( 26.8 ) ; BMI 25.6 ( 4.2 ) ; FEV1 2.0 ( 0.7 ) l were r and omised to control ( usual care ) or intervention ( twice daily training plus usual care ) . After discharge the intervention group received monthly home visits and weekly telephone calls , the control group received monthly telephone calls up to 12 weeks . Assessment pre-operatively , 5 day and 12 weeks post-operatively consisted of quadriceps strength using magnetic stimulation , 6 Minute Walking Distance ( 6MWD ) and QoL-EORTC-QLQ-LC13 . QoL was unchanged over 12 weeks ; 6MWD showed significant deterioration at 5 days post-operatively compared with pre-operatively , mean difference (SD)-131.6 ( 101.8 ) m and -128.0 ( 90.7 ) m in active and control groups respectively ( p=0.89 between groups ) which returned to pre-operative levels by 12 weeks in both groups . Quadriceps strength over the 5 day in-patient period showed a decrease of -8.3 ( 11.3 ) kg in the control group compared to increase of 4.0 ( 21.2 ) kg in the intervention group ( p=0.04 between groups ) . Strength training after thoracotomy successfully prevented the fall in quadriceps strength seen in controls , however , there was no effect on 6MWD or QoL. 6MWD returned to pre-operative levels by 12 weeks regardless of additional support offered",
"Background Fatigue is the most common and disabling symptom affecting quality of life ( QOL ) and daily function in patients who have completed treatment for acute myeloid leukemia ( AML ) . Although trials in patients with various solid tumors have reported improved fatigue and QOL following exercise interventions , there have been no studies in AML patients post treatment . Methods Forty patients aged ≥40 years who had completed treatment for AML were enrolled in a 12-week r and omized phase II exercise intervention to determine feasibility ( recruitment , retention , and adherence ) , efficacy , and safety of the intervention . Patients assigned to the exercise group received an individualized , moderate-intensity , 12-week home-based exercise program with weekly telephone support from a certified exercise physiologist . QOL , fatigue , and fitness outcomes were measured at baseline , 6 weeks , and 12 weeks . Between-group differences in 12-week change scores were calculated using linear regression adjusting for age and baseline function . Results Recruitment and retention rates were 38 % and 91 % , respectively . Adherence was low at 28 % . Analyses did not suggest statistically significant or clinical ly important benefits in QOL , fatigue , or physical fitness with the intervention . The level of adherence did not appear to impact outcomes . There were no adverse events . Conclusion A home-based exercise program for post-treatment AML patients age 40 years or older can be safely delivered with reasonable recruitment and high retention . However , feasibility was hampered by low adherence . Further research and program modification are needed to better underst and and overcome barriers to exercise delivery and adherence in AML survivors",
"OBJECTIVE To show fatigue prevention and quality of life ( QOL ) improvement from cardiovascular exercise during radiotherapy . DESIGN Prospect i ve enrollment ( n=21 ) , r and omized to exercise ( n=11 ) and control groups ( n=10 ) , with pre- and post-radiotherapy between- and within-group comparisons . SETTING Academic medical center . PARTICIPANTS Localized prostate cancer patients undergoing radiotherapy . INTERVENTIONS The interventional group received radiotherapy plus aerobic exercise 3 times a week for 8 weeks whereas the control group received radiotherapy without exercise . MAIN OUTCOME MEASURES Pre- and post-radiotherapy differences in cardiac fitness , fatigue , depression , functional status , physical , social , and functional well-being , leg strength , and flexibility were examined within and between 2 groups . RESULTS No significant differences existed between 2 groups at pre-radiotherapy assessment . At post-radiotherapy assessment , the exercise group showed significant within group improvements in : cardiac fitness ( P fatigue ( P=.02 ) , Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) ( P=.04 ) , physical well-being ( P=.002 ) , social well-being ( P=.02 ) , flexibility ( P=.006 ) , and leg strength ( P=.000 ) . Within the control group , there was a significant increase in fatigue score ( P=.004 ) and a decline in social well-being ( P cardiac fitness ( P=.006 ) , strength ( P=.000 ) , flexibility ( P fatigue ( P FACT-P ( P=.006 ) , physical well-being ( P social well-being ( P=.002 ) , and functional well-being ( P=.04 ) . CONCLUSIONS An 8-week cardiovascular exercise program in patients with localized prostate cancer undergoing radiotherapy improved cardiovascular fitness , flexibility , muscle strength , and overall QOL and prevented fatigue",
"OBJECTIVE To investigate the differences between the effects of complex decongestive physiotherapy with and without active resistive exercise for the treatment of patients with breast cancer-related lymphedema ( BCRL ) . DESIGN R and omized control-group study . SETTING An outpatient rehabilitation clinic . PARTICIPANTS Patients ( N=40 ) with diagnosed BCRL . INTERVENTIONS Patients were r and omly assigned to either the active resistive exercise group or the nonactive resistive exercise group . In the active resistive exercise group , after complex decongestive physiotherapy , active resistive exercise was performed for 15min/d , 5 days a week for 8 weeks . The nonactive resistive exercise group performed only complex decongestive physiotherapy . MAIN OUTCOME MEASURES The circumferences of the upper limbs ( proximal , distal , and total ) for the volume changes , and the Short Form-36 version 2 question naire for the quality of life ( QOL ) at pretreatment and 8 weeks posttreatment for each patient . RESULTS The volume of the proximal part of the arm was significantly more reduced in the active resistive exercise group than that of the nonactive resistive exercise group ( P active resistive exercise group , there was significantly more improvement in physical health and general health , as compared with that of the nonactive resistive exercise group ( P patients with BCRL , active resistive exercise with complex decongestive physiotherapy did not cause additional swelling , and it significantly reduced proximal arm volume and helped improve QOL",
"Smoking , caffeine , and alcohol intake are all potentially modifiable factors that have an unclear association with ovarian cancer risk . Therefore , the associations between these exposures and ovarian cancer risk were prospect ively examined among 110,454 women in the Nurses ' Health Study ( NHS ) for the smoking analyses and 80,253 women for the dietary analyses",
"The purpose of this r and omized controlled trial was to determine the effects of an 8-week ( aerobic+strength ) exercise training program ( 3 sessions/week ) on the circulating cytokine levels of breast cancer survivors . We r and omly allocated 16 female survivors of breast cancer ( mean±SD age : 50±5 years ) to an intervention or usual care ( control ) group ( N=8 in each group ) . The intervention group followed an 8-week exercise program consisting of 3 sessions/week ( session duration : 90 min ) . We measured the levels of the following cytokines before and after the intervention : beta-NGF , CTACK , eotaxin , FGF basic , G-CSF , gmCSFα , HGF , ICAM1 , IFNα2 , IFNγ , IL1α , IL1ß , IL1ra , IL2 , IL2ra , IL3 , IL4 , IL6 , IL7 , IL8 , IL9 , IL10 , IL12 , IL13 , IL15 , IL16 , IL17 , IL18 , IP10 , LIF , MCS-F , MIP1α , MIP1β , MIF , MCP1 , MCP3 , MIG , PDGF bb , SCF , SCGFβ , SDF1α , TRAIL , TNFα , TNFβ , VCAM1 , and VEGF . We only observed a significant interaction ( group*time ) effect for CTACK ( P=0.016 ) , with mean values remaining stable in the intervention group but increasing over time in controls . The intervention program did not induce a significant decrease in the main breast cancer-related cytokines such as IL6 and IL8 . A combined ( aerobic+strength ) 8-week exercise training intervention did not induce major changes in the basal cytokine levels of breast cancer survivors",
"Background Many patients with lung cancer are deconditioned with poor physical fitness . Lung resection reduces physical fitness further , impairing the patient 's ability to function in daily life . Methods We conducted a single-blind r and omised controlled trial of high-intensity endurance and strength training ( 60 min , three times a week , 20 weeks ) , starting 5–7 weeks after surgery . The control group received st and ard postoperative care . The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion . Other outcomes included changes in pulmonary function , muscular strength by one-repetition maximum ( 1RM ) , total muscle mass measured by dual energy X-ray absorptiometry , daily physical functioning and quality of life ( QoL ) . Results The intention-to-treat analysis of the 61 r and omised patients showed that the exercise group had a greater increase in peak oxygen uptake ( 3.4 mL/kg/min between-group difference , p=0.002 ) , carbon monoxide transfer factor ( Tlco ) ( 5.2 % predicted , p=0.007 ) , 1RM leg press ( 29.5 kg , p chair st and ( 2.1 times p stair run ( 4.3 steps , p=0.002 ) and total muscle mass ( 1.36 kg , p=0.012 ) compared with the controls . The mean±SD QoL ( SF-36 ) physical component summary score was 51.8±5.5 and 43.3±11.3 ( p=0.006 ) , and the mental component summary score was 55.5±5.3 and 46.6±14.0 ( p=0.015 ) in the exercise and control groups , respectively . Conclusions In patients recently operated for lung cancer , high-intensity endurance and strength training was well tolerated and induced clinical ly significant improvements in peak oxygen uptake , Tlco , muscular strength , total muscle mass , functional fitness and QoL. This study may provide a basis for exercise therapy after lung cancer surgery . Trial registration number NCT01748981",
"This pilot study examined whether exercise as an adjunctive rehabilitation therapy could benefit women who have early stage breast cancer and are currently receiving chemotherapy/radiotherapy . The study was design ed as a r and omised controlled trial ( RCT ) . Physical functioning , fatigue and Quality of Life ( QoL ) outcomes were evaluated pre and post a 12-week intervention . The results showed that after 12 weeks the women who participated in the exercise programme ( n = 12 ) displayed significantly higher levels of physical functioning and reported higher QoL scores than the controls ( n = 10 ) . Changes in fatigue and satisfaction with life favoured the intervention group but did not reach significance . These results are encouraging and suggest that a structured group exercise programme during adjuvant treatment is a safe , well tolerated and effective way of providing physical and psychological health benefits to women during treatment for early stage breast cancer . Since this was a pilot study the numbers did not allow appropriately powered analyses of some variables of interest and favoured relatively young and socio-economically advantaged women . Future studies need to address these issues and determine if these short-term benefits can be sustained",
"Background . The goal of this pilot study was to determine the magnitude and direction of intervention effect sizes for inflammatory-related serum markers and relevant health outcomes among breast cancer survivors ( BCSs ) receiving a physical activity behavior change intervention compared with usual care . Methods . This r and omized controlled trial enrolled 28 stage I , II , or IIIA BCSs who were post– primary treatment and not regular exercisers . Participants were assigned to either a 3-month physical activity behavior change intervention group ( ING ) or usual care group ( UCG ) . Intervention included supervised aerobic ( 150 weekly minutes , moderate-intensity ) and resistance ( 2 sessions per week ) exercise that gradually shifted to home-based exercise . Outcomes were assessed at baseline and 3 months . Results . Cardiorespiratory fitness significantly improved in the ING versus the UCG ( between-group difference = 3.8 mL/kg/min ; d = 1.1 ; P = .015 ) . Self-reported sleep latency was significantly reduced in the ING versus the UCG ( between group difference = −0.5 ; d = −1.2 ; P = .02 ) as was serum leptin ( between-group difference = −9.0 ng/mL ; d = −1.0 ; P = .031 ) . Small to medium nonsignificant negative effect sizes were noted for interleukin (IL)-10 and tumor necrosis factor (TNF)-α and ratios of IL-6 to IL-10 , IL-8 to IL-10 , and TNF-α to IL-10 , whereas nonsignificant positive effect sizes were noted for IL-6 and high-molecular-weight adiponectin . Conclusions . Physical activity behavior change interventions in BCSs can achieve large effect size changes for several health outcomes . Although effect sizes for inflammatory markers were often small and not significant , changes were in the hypothesized direction for all except IL-6 and IL-10",
"And rogen deprivation therapy ( ADT ) remains a cornerstone in the management of patients with prostate cancer ( PCa ) despite adverse effects on body composition and functional parameters . We compared the effects of football training with st and ard care in PCa patients managed with ADT ( > 6 months ) . Fifty-seven men aged 67 ( range : 43 - 74 ) were r and omly assigned to a football group ( FG , n = 29 ) or a usual care control group ( CON , n = 28 ) . The primary outcome was change in lean body mass ( LBM ) assessed by dual-energy X-ray absorptiometry scanning . Secondary outcomes included changes in knee-extensor muscle strength ( one repetition maximum ) , fat percentage , and maximal oxygen uptake ( VO2max ) . Mean heart rate during training was 137.7 ( st and ard deviation 13.7 ) bpm or 84.6 (3.9)% HRmax . In FG , LBM increased by 0.5 kg [ 95 % confidence interval ( CI ) 0.1 - 0.9 ; P = 0.02 ] with no change in CON ( mean group difference 0.7 kg ; 95 % CI 0.1 - 1.2 ; P = 0.02 ) . Also , muscle strength increased in FG ( 8.9 kg ; 95 % CI 6.0 - 11.8 ; P FG , VO2max increased ( 1.0 mL/kg/min ; 95 % CI 0.2 - 1.9 ; P = 0.02 ) and fat percentage tended to decrease ( 0.7 % ; 95%CI 1.3 - 0.0 ; P = 0.06 ) , but these changes were not significantly different from CON . In conclusion , football training over 12 weeks improved LBM and muscle strength compared with usual care in men with prostate cancer receiving ADT",
"PURPOSE / OBJECTIVES To compare a 12-week nontraditional exercise Nia program practice d at home to usual care on fatigue , quality of life ( QOL ) , aerobic capacity , and shoulder flexibility in women with breast cancer undergoing radiation therapy . DESIGN R and omized clinical trial . SETTING Large community-based hospital in the midwestern United States . SAMPLE 41 women with stage I , II , or III breast cancer starting radiation therapy . METHODS 22 women were r and omized to the Nia group and 19 to the usual care group . Those in the Nia group were instructed to practice Nia 20 - 60 minutes three times per week for 12 weeks . Those in the usual care group were instructed to continue normal activities . MAIN RESEARCH VARIABLES Fatigue , QOL , aerobic capacity , and shoulder flexibility . FINDINGS Controlling for baseline scores , change over time between groups was significantly different for the women who practice d Nia at least 13 times during the 12-week period ; those in the Nia intervention reported significantly less fatigue between weeks 6 and 12 , as compared to control group ( p = 0.05 ) . No statistical differences in QOL , aerobic capacity , or shoulder flexibility were found , but trends favoring Nia were identified . CONCLUSIONS For women undergoing radiation therapy for breast cancer , Nia can help relieve fatigue . Additional research in arm and shoulder mobility and preservation also may be beneficial . IMPLICATION S FOR NURSING Oncology nurses are in a unique position to offer suggestions to help manage fatigue , and Nia could be considered as part of a cancer survivorship program . KNOWLEDGE TRANSLATION Exercise is beneficial for women with breast cancer , and interest is growing in nontraditional exercise options . Nia can benefit women with breast cancer undergoing radiation therapy",
"Exercise participation has been shown to improve cardiovascular fitness and reduce psychological distress among women receiving chemotherapy and /or radiation . The purpose of this pilot study was to examine the changes in distress and body image , and fitness following exercise participation among 24 women who had been diagnosed with breast cancer within the previous 3 years . The women were r and omly assigned to participate in a 12-week supervised aerobic exercise program in a hospital setting or a wait-list control group . Assessment s of distress and body image were conducted at pre- and post-treatment . Data showed that the women in the exercise group improved significantly in body image ( Physical Condition and Weight Concerns subscales ) vs control group participants at post-treatment . Reductions in distress were also noted in the exercise group , but these were nonsignificant . At post-treatment , there were modest improvements in fitness in the exercise group",
"BACKGROUND Active for Life After Cancer is a r and omized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program ( Lifestyle ) for prostate cancer patients to improve quality of life ( QOL ) including physical and emotional functioning compared to a group-based Educational Support Program and a St and ard Care Program ( no group ) . METHOD A total of 134 prostate cancer patients receiving continuous and rogen-ablation were r and omly assigned to one of the three study conditions . RESULTS Results indicated no significant improvements in QOL at 6 or 12 months . Both group-based programs were positively received and yielded good attendance and retention . Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity . Despite these improvements , no significant changes were found for most physical activity measures . CONCLUSIONS Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients",
"Purpose To examine predictors of exercise adherence in breast cancer survivors . Methods Seventy-five breast cancer survivors were r and omly assigned to exercise ( n = 37 ) or usual care ( n = 38 ) . Demographic , prognostic , physiologic , and psychosocial information was collected at baseline and 6 months . The exercise goal was 30 min of exercise 5 days/week for 6 months . Results Women r and omized to exercise participated in moderate-intensity recreational exercise for 123 ± 52 min/week ( 81 % of the prescribed 150 min/week ) over 6 months . Baseline variables associated with better adherence were lower body mass index ( BMI ) , smaller waist circumference , higher amounts of physical activity 6 months prior to enrollment , being in the preparation vs. contemplation Stage of Change and higher FACT-B breast cancer subscale score . After adjusting for these variables , lower BMI and higher Stage of Change continued to be associated with better adherence ( p of exercise and breast cancer prognosis should target obese women for participation , as well as women just beginning to contemplate participation and its benefits after a cancer diagnosis",
"OBJECTIVES Restorative yoga ( RY ) is a gentle type of yoga that may be beneficial for cancer patients and post-treatment survivors . Study goals were : to determine the feasibility of implementing a RY intervention for women with breast cancer ; and to examine group differences in self-reported emotional , health-related quality of life , and symptom outcomes . METHODS Women with breast cancer ( n=44 ; mean age 55.8 years ) enrolled in this study ; 34 % were actively undergoing cancer treatment . Study participants were r and omized to the intervention ( 10 weekly 75-minute RY classes ) or a waitlist control group . Participants completed question naires at Week 0 ( baseline ) and Week 10 ( immediately post-intervention for the yoga group ) . RESULTS Group differences favoring the yoga group were seen for mental health , depression , positive affect , and spirituality ( peace/meaning ) . Significant baseline*group interactions were observed for negative affect and emotional well-being . Women with higher negative affect and lower emotional well-being at baseline derived greater benefit from the yoga intervention compared to those with similar values at baseline in the control group . The yoga group demonstrated a significant within-group improvement in fatigue ; no significant difference was noted for the control group . CONCLUSIONS Although limited by sample size , these pilot data suggest potential benefit of RY on emotional outcomes and fatigue in cancer patients . This study demonstrates that a RY intervention is feasible for women with breast cancer ; implication s for study design and implementation are noted with an emphasis on program adoption and participant adherence",
"BACKGROUND / AIMS Treatment for breast cancer produces side effects that diminish functional capacity and quality of life ( QOL ) among survivors . Tai Chi Chuan ( TCC ) is a moderate form of exercise that may improve functional capacity and QOL in these individuals . Women who completed treatment for breast cancer were r and omized to receive TCC or psychosocial support therapy for 12 weeks ( 60 min ; three times weekly ) . RESULTS The TCC group demonstrated significant improvements in functional capacity , including aerobic capacity , muscular strength , and flexibility , as well as QOL ; the psychosocial support therapy group showed significant improvements only in flexibility , with declines in aerobic capacity , muscular strength , and QOL . CONCLUSIONS The TCC group exhibited significant improvements in functional capacity and QOL . These data suggest that TCC may enhance functional capacity and QOL among breast cancer survivors",
"Purpose . Following surgical lung resection , patients frequently suffer functional decline and reduced activity levels . Despite this exercise interventions are not routinely provided . This study aim ed to establish the safety and feasibility of exercise administered following lung resection in an Australian setting . Method . Pilot r and omized controlled trial . Fifteen individuals ( 53 % male ) , mean ± st and ard deviation age 65.5 ± 16.1 years , undergoing surgery for suspected lung cancer . R and omization occurred postoperatively . Control arm received protocol ized inpatient respiratory physiotherapy . Intervention arm additionally received twice daily exercise until discharge home and twice weekly as outpatient for 8 weeks . Outcome measures ( safety , feasibility , functional capacity , functional mobility , and health-related quality of life [ HRQoL ] ) were assessed preoperatively and 2 and 12 weeks postoperatively . Results . Fifteen participants ( lung cancer n = 10 ) were assigned to control ( n = 8) and intervention ( n = 7 ) groups . Inpatient exercise was delivered on 71 % of occasions ( 35 out of 49 planned sessions ) . Four participants attended outpatient exercise sessions and these participants attended sessions on 81 % of occasions ( 52 out of 64 planned sessions ) . No adverse events occurred . There was a significant between group difference in 6-Minute Walk Test ( 6MWT ; P = .024 ) . In both groups the 6MWT declined from baseline to 2 weeks postoperative and then improved up to 12 weeks ; improvements were greater in the intervention group . Intervention was associated with positive trends of improvement in some HRQoL domains . Conclusions . Exercise intervention performed in the inpatient and outpatient setting s for individuals following lung resection was safe and feasible . The uptake rate for outpatient exercise was 57 % , similar to previous trials ; however , adherence was excellent within the subgroup of participants who attended . Further research is required to investigate the best setting of exercise delivery and explore ways to improve the uptake rate",
"PURPOSE Lymphedema is a common condition that breast cancer survivors face . Despite a lack of supporting evidence from prospect i ve observational studies , occupational and leisure time physical activity are feared to be possible risk factors for lymphedema onset or exacerbation . We examined effects of supervised upper- and lower-body weight training on the incidence and symptoms of lymphedema in 45 breast cancer survivors who participated in the Weight Training for Breast Cancer Survivors study . METHODS Participants were on average 52 years old , 4 to 36 months post-treatment , and had axillary dissection as part of their treatment . Thirteen women had prevalent lymphedema at baseline . The intervention was twice-a-week weight training over a period of 6 months . Lymphedema was monitored at baseline and 6 months by measuring the circumference of each arm , and by self-report of symptoms and clinical diagnosis . RESULTS None of the intervention-group participants experienced a change in arm circumferences > or = 2.0 cm after a 6-month exercise intervention . Self-reported incidence of a clinical diagnosis of lymphedema or symptom changes over 6 months did not vary by intervention status ( P = .40 and P = .22 , respectively ) . CONCLUSION This is the largest r and omized controlled trial to examine associations between exercise and lymphedema in breast cancer survivors . The results of this study support the hypotheses that a 6-month intervention of resistance exercise did not increase the risk for or exacerbate symptoms of lymphedema . These results herald the need to start reevaluating common clinical guidelines that breast cancer survivors avoid upper body resistance activity for fear of increasing risk of lymphedema",
"PURPOSE The purpose of this study was to investigate the effect of a comprehensive rehabilitation program on physical function , immune response , fatigue and quality of life in mastectomy patients . METHOD The subjects included fifty-five patients with breast cancer ( 27 in the control group and 28 in the experimental group ) . The subjects in the experimental group participated in a comprehensive rehabilitation program for 10 weeks , which was composed of 1 session of education , 2 sessions of stress management , 2 sessions of exercise , and 1 session of peer support group activity per week . RESULT The results revealed an increase in shoulder extension , abduction , external rotation , and internal rotation of the affected upper extremity , and in shoulder extension and abduction of the healthy upper extremity . Also an increase in quality of life and a decrease in fatigue were significantly higher in the experimental group than the control group . However , the results revealed that the natural killer cell ratio of the experimental group increased but there was no significant difference from that of the control group . CONCLUSION The 10-week comprehensive rehabilitation program showed a large affirmative effect on physical function , fatigue and quality of life of breast cancer patients after a mastectomy",
"OBJECTIVE To compare the effects of resistance and cardiovascular exercise on functional mobility in individuals with advanced cancer . DESIGN Prospect i ve , 2-group pretest-posttest pilot study with r and omization to either resistance or cardiovascular exercise mode . SETTING Comprehensive community cancer center and a hospital-based fitness facility . PARTICIPANTS Volunteer sample of individuals ( N=66 ; 30 men ; 36 women ; mean age , 62y ) with advanced cancer recruited through the cancer center , palliative care service , rehabilitation department , and a local hospice . INTERVENTIONS Ten weeks of individualized resistance or cardiovascular exercise , prescribed and monitored by oncology-trained exercise personnel . MAIN OUTCOME MEASURES Functional mobility was assessed using the Short Physical Performance Battery ( SPPB ) ; self-reported pain and fatigue were assessed secondarily using visual analog scales . Data were analyzed using a split plot 2 × 2 analysis of variance ( α=.05 ) . RESULTS Fifty-two patients ( 78.8 % ) completed the study : 23 ( 67.7 % ) of 34 patients in the resistance arm and 29 ( 90.6 % ) of 32 patients in the cardiovascular arm . No participant withdrew because of study adverse events . Ten-week outcomes ( n=52 ) included a significant increase in SPPB total score ( P , increase in gait speed ( P=.001 ) , and reduction in fatigue ( P=.05 ) . Although cardiovascular exercise participants had a modestly greater improvement in SPPB total score than resistance training participants ( F1,49=4.21 , P=.045 ) , the difference was not confirmed in a subsequent intention-to-treat analysis ( N=66 ) . CONCLUSIONS Individuals with advanced cancer appear to benefit from exercise for improving functional mobility . Neither resistance nor cardiovascular exercise appeared to have a strong differential effect on outcome",
"BACKGROUND The purpose of this study was to determine the feasibility of a r and omized trial of resistance exercise in patients with head and neck cancer receiving radiation . METHODS Fifteen patients with head and neck cancer receiving radiation were r and omized to resistance exercise ( using resistance b and s ) or control group . Resistance exercise occurred at the radiation therapy site ( weeks 1 - 6 ) and home ( weeks 7 - 12 ) . RESULTS No serious adverse events occurred related to resistance exercise . Medium to large effect size differences favoring resistance exercise versus control group were noted for perceived fatigue at 6 weeks ( smaller increase in fatigue for resistance exercise group ; 7.4 vs 15.4 , effect size [ d ] = -0.64 ) , quality of life at 6 weeks ( -7.0 vs -14.4 , d = 0.52 ) , and chair rise time ( seconds ) at 6 and 12 weeks ( -1.6 vs 0.4 , d = -.63 and -1.9 vs 0.1 , d = -0.60 , respectively ) . CONCLUSIONS Resistance exercise is safe and feasible in patients with head and neck cancer receiving radiation ; a definitive trial is warranted",
"OBJECTIVE The majority of endometrial cancer survivors ( ECS ) are obese and at risk for premature death . The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss , change in eating behaviors , and increased physical activity in obese ECS . STUDY DESIGN Early stage ECS ( n=45 ) were r and omized to a 6-month lifestyle intervention ( LI ; n=23 ) or usual care ( UC ; n=22 ) . The LI group received group and individual counseling for 6 months . The primary endpoint was weight change . Secondary endpoints were physical activity , [ Leisure score index ( LSI ) ] and nutrient intake ( 3-day food records ) . Quantitative vitamin C and folate intake were used to assess fruit/vegetable intake . RESULTS Recruitment was 29 % , adherence ( LI group ) was 73 % and 84 % of participants completed follow-up assessment s. At 12 months , the intervention group lost 3.5 kg compared to a 1.4 kg gain in the control group [ mean difference=-4.9 kg ; 95 % CI : -9.0 to -0.9 kg ; p=.018 ] and had an increased LSI score of 16.4 versus -1.3 in the control group from baseline [ mean group difference=17.8 ; 95 % CI=7.1 to 28.4 ; p=.002 ] . There were no differences in vitamin C and folate intake . The LI group had lower intake of kilocalories , although differences were not significant . CONCLUSION ( S ) A lifestyle intervention program in obese ECS is feasible and can result in sustained behavior change and weight loss over a 1-year period",
"The purpose of this secondary analysis was to examine the nutritional symptoms and body composition outcomes of aerobic exercise in women with breast cancer . A single-blind clinical trial , r and omized to tailored Pro-Self © exercise during and after chemotherapy , after chemotherapy only , or no Pro-Self ( usual care ) . One hundred women , average age 49.9 years ( SD = 9.6 ) , participated . Mild taste changes , nausea , constipation , and anorexia were experienced by 47 % to 55 % at baseline and end of treatment but diminished post treatment . No group differences were found in total nutritional symptoms or symptom severity . Intervention group participants maintained lean body mass ; control group participants had nonsignificant lean body mass loss . Issues related to self-report , protocol adherence , and generalizability limit findings . Aerobic exercise is useful in achieving healthy weight and body composition , but the intensity and duration achieved during cancer treatment and recovery did not produce significant changes",
"Objectives Breathlessness in patients with lung cancer is a common and distressing symptom affecting 50–70 % of patients , rising to some 90 % for those with advanced lung cancer . The aim of the current study was to assess how feasible inspiratory muscle training ( IMT ) is in the lung cancer population and explore changes in outcome variables . Material s and methods A pilot feasibility r and omised trial was conducted in patients with clinical ly stable lung cancer . The experimental group received training using a pressure threshold device . Patients were instructed to carry out five IMT sessions weekly for 12 weeks for a total of 30 mins/day . Patients in the control group received st and ard care . Outcome measures were completed at baseline and monthly for 3 months , and included : physiological parameters ( FEV1 , FVC ) ; perceived severity of breathlessness using six 10-point NRS ; modified Borg Scale ; quality of life using the short form Chronic Respiratory Disease Question naire ; Hospital Anxiety and Depression Scale , and safety . Results Forty-six patients ( M = 37 , F = 9 ) at a mean age of 69.5 years old and a mean of 16 months post-diagnosis who were not currently receiving chemotherapy and /or radiotherapy were recruited . Seventy-percent had NSCLC and advanced disease . Statistical ( area under the curve-AUC ) and clinical ly important differences were seen with regard to distress from breathlessness ( p = 0.03 ) , ability to cope with breathlessness ( p = 0.01 ) , satisfaction with breathlessness management ( p = 0.001 ) , fatigue ( p = 0.005 ) , emotional function ( p = 0.011 ) , breathlessness mastery ( p = 0.015 ) and depression ( p = 0.028 ) . The m-Borg difference between the two groups at 3 months was 0.80 , which is borderline clinical ly significant . Changes were more evident in the 3-month assessment where the effect of the intervention came to its peak . Conclusion This trial shows the IMT is feasible and potentially effective in patients with lung cancer . These findings warrant a fully powered larger r and omised controlled trial",
"Background : Previous research has shown exercise to be an effective method to mitigate many adverse treatment-related effects of and rogen suppression therapy ( AST ) but the potential impact of exercise on sexual activity remains unknown . The purpose of this investigation was to report the effect of a 12-week exercise program on sexual activity in prostate cancer patients undergoing AST . Methods : Fifty-seven prostate cancer patients undergoing AST were r and omly assigned to an exercise program ( resistance and aerobic modes ; n=29 ) or usual care control ( n=28 ) . Sexual activity was assessed by the European Organization for Research and Treatment of Cancer prostate cancer-specific quality of life question naire ( QLQ-PR25 ) . Results : QLQ-PR25 data were log transformed and analysis of covariance was used to compare sexual activity between groups following the intervention adjusted for baseline activity . No differences in sexual activity were observed between the exercise and control groups before the intervention . There was a significant ( P=0.045 ) adjusted group difference in sexual activity following the 12-week intervention . Patients undergoing usual care decreased sexual activity while patients in the exercise program maintained their level of sexual activity . At baseline , 20.6 and 22.2 % of participants in the exercise and control groups reported a major interest in sex ( that is , high libido ) . Following the intervention , the exercise group had a significantly higher percentage of participants reporting a major interest in sex ( exercise=17.2 % vs control=0 % ; P=0.024 ) . Conclusions : Participation in a short-term exercise program result ed in the maintenance of sexual activity in prostate cancer patients undergoing AST",
"OBJECTIVE To investigate the feasibility of a pragmatic lifestyle intervention in patients who had recently completed surgery and chemotherapy for colon cancer and to obtain preliminary data of its impact on important health outcomes . DESIGN A prospect i ve , r and omized , controlled pilot trial . SETTING University rehabilitation facility . PARTICIPANTS Eighteen ( N=18 ) colon cancer survivors ( mean age=69y ; range , 52 - 80y ) , Dukes stage A to C. INTERVENTIONS Participants were r and omized 6 to 24 months postoperatively to either a 12-week program of combined exercise and dietary advice or st and ard treatment . MAIN OUTCOME MEASURES Exercise and dietary behavior , fatigue , health-related quality of life ( QOL ) , aerobic exercise tolerance , functional capacity , muscle strength , and anthropometery were assessed at baseline and immediately after the intervention . RESULTS Adherences to supervised and independent exercise during the intervention were 90 % and 94 % , respectively , and there was low attrition ( 6 % ) . The lifestyle intervention elicited improvements in exercise behavior ( P=.068 ) , fatigue ( P=.005 ) , aerobic exercise tolerance ( P=.010 ) , chair sit-to-st and performance ( P=.003 ) , and waist-to-hip ratio ( P=.002 ) . A positive change in dietary fiber intake ( P=.044 ) was also observed in the intervention group . No change in QOL was observed ( P=.795 ) . CONCLUSIONS These preliminary results suggest that a pragmatic lifestyle intervention implemented 6 to 24 months after primary treatment for colon cancer was feasible . We observed a significant impact on dietary behavior , fatigue , aerobic exercise tolerance , functional capacity , and waist-to-hip ratio . These findings need to be confirmed with a larger-scale definitive r and omized controlled trial",
"Objectives This study aim ed to determine the effect of a moderate , tailored exercise program on health-related quality of life , physical function , and arm volume in women receiving treatment for nonmetastatic breast cancer . Methods Women who were within 4–12 weeks of surgery for stage I – III breast cancer were r and omized to center-based exercise and lymphedema education intervention or patient education . Functional Assessment of Cancer Therapy – Breast Cancer ( FACT-B ) , 6-min walk , and arm volume were performed at 3-month intervals through 18 months . Repeated measures analysis of covariance was used to model the total meters walked over time , FACT-B scores , and arm volume . Models were adjusted for baseline measurement , baseline affected arm volume , number of nodes removed , age , self-reported symptoms , baseline SF-12 mental and physical component scores , visit , and treatment group . Results Of the recruited 104 women , 82 completed all 18 months . Mean age ( range ) was 53.6 ( 32–82 ) years ; 88 % were Caucasian ; 45 % were employed full time ; 44 % were overweight ; and 28 % obese . Approximately , 46 % had breast-conserving surgery ; 79 % had axillary node dissection ; 59 % received chemotherapy ; and 64 % received radiation . The intervention result ed in an average increase of 34.3 ml ( SD = 12.8 ) versus patient education ( p = 0.01 ) . Changes in FACT-B scores and arm volumes were not significantly different . Conclusions With this early exercise intervention after breast cancer diagnosis , a significant improvement was achieved in physical function , with no decline in health-related quality of life or detrimental effect on arm volume . Implication s for cancer survivorsStarting a supervised exercise regimen that is tailored to an individual 's strength and stamina within 3 months following breast cancer surgery appears safe and may hasten improvements in physical functioning",
"CONTEXT AND OBJECTIVE Changes in metabolism have been reported in the majority of patients undergoing cancer treatment , and these are usually characterized by progressive change in body composition . The effects of aerobic exercise programs to combat the cancer and cancer treatment-related side effects , which include the negative changes in body composition , have been extensively reported in the literature . However , few resistance exercise intervention studies have hypothesized that breast cancer patients might benefit from this type of exercise . The purpose of this study was to determine whether exercise protocol s that emphasize resistance training would change body composition and strength in breast cancer patients undergoing treatment . DESIGN AND SETTING R and omized controlled trial , at the Campus Recreation Center and Rocky Mountain Cancer Rehabilitation Institute of the University of Northern Colorado , and the North Colorado Medical Center . METHODS Twenty inactive breast cancer patients were r and omly assigned to a 21-week exercise group ( n = 10 ) or a control group ( n = 10 ) . The exercise group trained at low to moderate intensity for 60 minutes on two days/week . The primary outcome measurements included body composition ( skinfold method ) and muscle strength ( one repetition maximum ) . RESULTS Significant differences in lean body mass , body fat and strength ( p = 0.004 , p = 0.004 , p = 0.025 , respectively ) were observed between the groups at the end of the study . CONCLUSION The results suggest that exercise emphasizing resistance training promotes positive changes in body composition and strength in breast cancer patients undergoing treatment",
"OBJECTIVE To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments . METHODS A two arm , single blind , r and omised controlled trial was conducted within the Northern Irel and regional Cancer Centre . Thirty three sedentary gynaecological cancer survivors ( stage I-III ; ≤3 years post diagnosis ) , experiencing cancer-related fatigue ( mild-severe ) took part . Participants were r and omly assigned to a behavioural change , moderate intensity physical activity intervention ( n=16 ) or a Contact Control group ( n=17 ) . The primary outcome was fatigue ( Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale ) . Secondary outcomes included quality of life , physical functioning , positive and negative affect , depression , body composition , sleep dysfunction and self-reported physical activity . Feasibility was assessed based on the recruitment rate , programme and physical activity adherence and participants ' programme evaluation , including optional focus groups ( n=16 ) . RESULTS Twenty five percent of eligible women took part ( 33/134 ) . Participants were 8.7 ( SD=9.1 ) months post diagnosis , with a mean age of 53 ( SD=10.3 ) years . The majority of the sample had a diagnosis of ovarian ( n=12 ) or endometrial cancer ( n=11 ) . Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up ( 12 week : mean difference=-11.06 ; 95 % confidence interval (CI)=-21.89 to -0.23 ; effect size (d)=0.13 ; p=0.046 ; 6 month : mean difference=-19.48 ; 95 % CI=-19.67 to -19.15 ; effect size (d)=0.20 ; p=0.01 ) . A mean of 10 calls ( SD=1.2 calls ) were delivered to the Physical Activity Group , and 10 ( SD=1.6 calls ) to the CC group . The intervention was positively perceived based on exit question naire and focus group findings . CONCLUSIONS A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants ' programme adherence and evaluation , and the intervention demonstrates improvements in fatigue . However , confirmation in the form of a larger fully powered RCT is warranted",
"BACKGROUND Adjuvant treatment for breast cancer may result in long-lasting , adverse emotional and physical side effects , and reduce quality of life ( QOL ) . This pilot study examined the effects of a home-based walking program on QOL and fatigue in early stage breast cancer survivors and whether changes in walking behavior were associated with changes in outcomes . METHODS Participants ( n = 32 ) were r and omized to a 12-week home-based walking intervention plus brief telephone counseling ( n = 20 ) or a wait-list control group ( n = 12 ) . Self-reported fatigue , QOL , and walking were assessed at baseline and 12-weeks . Results are presented as effect sizes . RESULTS Participants in the intervention had improvements in a majority of fatigue and QOL outcomes , whereas the control group had no change or worsened in many ; effect sizes were generally in the small to medium range . Changes in fatigue/QOL outcomes were associated with changes in walking behavior , with effects generally in the small to medium range . CONCLUSION Home-based physical activity ( walking ) programs may be an appropriate avenue for alleviating the adverse side effects that often accompany adjuvant treatment for breast cancer . These programs have potential for widespread dissemination , which may have considerable impact on the quality of life of women recently completing breast cancer treatment",
"Most breast cancer survivors ( BCS ) are not meeting recommended physical activity guidelines . Here , we report the effects of the Better Exercise Adherence after Treatment for Cancer ( BEAT Cancer ) behavior change intervention on physical activity , aerobic fitness , and quality of life ( QoL ) . We r and omized 222 post- primary treatment BCS to the 3-month intervention ( BEAT Cancer ) or usual care ( UC ) . BEAT Cancer combined supervised exercise , face-to-face counseling , and group discussion s with tapering to home-based exercise . Assessment s at baseline , immediately post-intervention ( month 3 ; M3 ) , and 3 months post-intervention ( month 6 ; M6 ) included accelerometer and self-reported physical activity , submaximal treadmill test , and QoL [ Functional Assessment of Cancer Therapy (FACT)-Breast scale ] . Adjusted linear mixed-model analyses demonstrated significant effects of BEAT Cancer compared to UC on weekly minutes of ≥moderate intensity physical activity at M3 by accelerometer [ mean between group difference ( M ) = + 41 ; 95 % confidence interval ( CI ) = 10–73 ; p = 0.010 ] and self-report ( M = + 93 ; CI = 62–123 ; p self-reported physical activity ( M = + 74 ; CI = 43–105 ; p BEAT Cancer participants were significantly more likely to meet physical activity recommendations at both time points [ accelerometer M3 adjusted odds ratio ( OR ) = 2.2 ; CI = 1.0–4.8 and M6 adjusted OR = 2.4 ; CI = 1.1–5.3 ; self-report M3 adjusted OR = 5.2 ; CI = 2.6–10.4 and M6 adjusted OR = 4.8 ; CI = 2.3–10.0 ] . BEAT Cancer significantly improved fitness at M6 ( M = + 1.8 ml/kg/min ; CI = 0.8–2.8 ; p = 0.001 ) and QoL at M3 and M6 ( M = + 6.4 ; CI = 3.1–9.7 ; p ) . The BEAT Cancer intervention significantly improved physical activity , fitness , and QoL with benefits continuing 3 months post-intervention",
"Background : Breast cancer is one of the most common cancers amongst women in developed and developing countries . It is associated with the highest mortality rate in low to average-income countries . Breast cancer investigation amongst Iranian women reveals that the number of its incidence is yet the highest in all cancer types . Despite recent longer survival time of women with breast cancer , most of the patients suffer from long term physical and mental distress due to combined treatments . Exercise interventions are among new approaches to promote the better quality of life of the patients , which has only recently been considered by research ers . This study aim ed to investigate the effect of exercise intervention on the quality of life of breast cancer survivors . Material s and Methods : This is a clinical trial conducted on 80 women with I-III breast cancer , at 18 - 55 years of age mostly two years after the completion of their treatment in Seyed al Shohada hospital in Isfahan . They were r and omly divided into two groups of study and control . Exercise intervention went on for 8 weeks in the study group ( three sessions a week , 60 minutes ) . Quality of life in both groups was measured a day before , and at the end of the eight weeks period by the instrument of the National Medical Center and Beckman Research Institute . The data were analyzed by descriptive and inferential statistical tests of X2 , t-test and Mac Hammer test . Findings : Results showed that there was no significant difference in the mean score of the physical dimension of quality of life in the study group before and after intervention while the score of physical health was significantly better in the control group ( p mean score of mental dimension had increased in the study group , while it had decreased in the control group . The mean score of social health showed no significant difference before and after intervention . The mean score of spiritual health had significantly decreased in the control group , while it had significantly increased in the study group ( p = 0.004 ) . Generally , the total mean score of the quality of life showed no significant difference before and after intervention . However , the percentage of the quality of life score increased in the study group , but decreased in the control group . Conclusions : The results of this study showed that exercise interventions can promote a better quality of life for the patients , and increase the total score of quality of life . Although , the total score of quality of life was not significantly different , it was concluded that exercise can promote the quality of life amongst patients with breast cancer",
"Summary This study examined whether 24 months of weight training exercises enhanced the effectiveness of risedronate , calcium , and vitamin D in maintaining or improving bone mineral density ( BMD ) in 223 postmenopausal breast cancer survivors . Subjects who were ≥50 % adherent to exercise had no improvement in BMD but were less likely to lose BMD . Introduction This study examined whether ( 1 ) postmenopausal breast cancer survivors ( BCS ) with bone loss taking 24 months of risedronate , calcium , and vitamin D had increased bone mineral density ( BMD ) at the total hip , femoral neck , L1-L4 spine , total radius and 33 % radius , and decreased bone turnover ; ( 2 ) subjects who also participated in strength/weight training ( ST ) exercises had greater increases in BMD and greater decreases in bone turnover ; and ( 3 ) subjects who also exercised were more likely to preserve ( at least maintain ) BMD . Methods Postmenopausal BCS ( 223 ) were r and omly assigned to exercise plus medication or medication only groups . Both groups received 24 months of 1,200 mg of calcium and 400 IU of vitamin D daily and 35 mg of risedronate weekly , and the exercise group additionally had ST exercises twice weekly . Results After 24 months , women who took medications without exercising had significant improvements in BMD at the total hip ( + 1.81 % ) and spine ( + 2.85 % ) and significant decreases in Alkphase B ( −8.7 % ) and serum NTx ( −16.7 % ) . Women who also exercised had additional increases in BMD at the femoral neck ( + 0.29 % ) , total hip ( + 0.34 % ) , spine ( + 0.23 % ) , total radius ( + 0.30 % ) , and additional decreases in Alkphase B ( −2.4 % ) and Serum NTx ( −6.5 % ) . Additional changes in BMD and bone turnover with exercise were not significant . Subjects who were ≥50 % adherent to exercise were less likely to lose BMD at the total hip ( chi-square [ 1 ] = 4.66 , p = 0.03 ) and femoral neck ( chi-square [ 1 ] = 4.63 , p = 0.03 ) . ConclusionS trength/weight training exercises may prevent loss of BMD in postmenopausal BCS at risk for bone loss",
"OBJECTIVE Although studies have shown that physical activity ( PA ) can reduce some treatment-related side effects of breast cancer , there is a need to offer PA programs outside of research setting s to reach more cancer survivors . We partnered with the American Cancer Society 's Reach to Recovery ( RTR ) program to train their volunteers ( breast cancer survivors ) to deliver a 12-week PA intervention to other breast cancer survivors . METHOD We conducted a r and omized controlled trial to compare the PA intervention delivered by RTR volunteers ( PA plus RTR ) with contact control ( RTR control ) . Eighteen RTR volunteers/coaches ( Mage = 54.9 years ; Mtime since diagnosis = 7.0 years ) delivered the contact control condition or the PA intervention . Seventy-six breast cancer survivors in New Engl and ( Mage = 55.6 years ; Mtime since diagnosis = 1.1 years ) were r and omized to 1 of the 2 groups . At baseline , 12 weeks ( postintervention ) , and at 24 weeks , participants wore an accelerometer for 7 days , were interviewed about their PA , and reported their motivational readiness for PA . RESULTS Adjusted , mixed-effects longitudinal regression models showed significant group differences favoring the PA plus RTR group in minutes of moderate to vigorous PA at 12 weeks ( Mdifference = 103 min/week , p differences in accelerometer data favoring the PA plus RTR group at both time points . CONCLUSION Peer volunteers were able to significantly increase PA among cancer survivors relative to contact control . Partnerships with existing volunteer programs can help to widen the reach of behavioral interventions among cancer survivors . ( PsycINFO Data base",
"PURPOSE / OBJECTIVES To examine the effects of a seated exercise program on fatigue and quality of life ( QOL ) in women with metastatic breast cancer . DESIGN R and omized , controlled , longitudinal trial . SETTING Outpatient clinic of a comprehensive cancer center . SAMPLE Convenience sample of 38 women who were beginning outpatient chemotherapy . METHODS Subjects were r and omized to a control or intervention group ; the intervention was performance of a seated exercise program using home videotape three times per week for four cycles of chemotherapy . All subjects completed the Functional Assessment of Chronic Illness Therapy Fatigue Version IV ( FACIT F ) at baseline and at the time of the next three cycles . Subjects were asked to document the frequency , duration , and intensity of all exercise participation on monthly calendars . MAIN RESEARCH VARIABLES Exercise , fatigue , and QOL . FINDINGS 32 subjects , 16 per group , completed the study follow-up . With a mixed modeling approach , total FACIT F scores for the entire sample declined at a significant rate ( p = 0.003 ) beginning with cycle 3 but at a slower rate for the experimental group ( p = 0.02 ) . Fatigue scores indicated less increase and physical well-being subscale scores showed less decline for the experimental group ( p = 0.008 and p = 0.02 , respectively ) . CONCLUSIONS Women with advanced breast cancer r and omized to the seated exercise intervention had a slower decline in total and physical well-being and less increase in fatigue scores starting with the third cycle of chemotherapy . IMPLICATION S FOR NURSING Seated exercise may be a feasible exercise program for women with advanced cancer for controlling fatigue and improving physical well-being",
"Background Participation in an exercise trial is a major commitment for cancer survivors , but few exercise trials have evaluated patient satisfaction with trial participation . Purpose To examine patient satisfaction with participation in the Healthy Exercise for Lymphoma Patients ( HELP ) Trial and to explore possible determinants . Methods The HELP Trial r and omized 122 lymphoma patients to 12 weeks of supervised aerobic exercise training ( AET ; n = 60 ) or to usual care ( UC ; n = 62 ) , with the option of participating in a 4-week posttrial exercise program . At the 6-month follow-up assessment , participants evaluated their overall trial satisfaction . Results Personal satisfaction with trial participation was strongly influenced by group assignment with participants r and omized to AET reporting participation to be more rewarding ( p personally useful ( p program reported participation to be more rewarding ( p = 0.008 ) and personally useful ( p participant satisfaction , and the fact that the offer of participation in the posttrial exercise program to the UC group was not r and omized . Conclusions Lymphoma patients r and omized to UC viewed it as less rewarding and personally useful despite being offered a 4-week posttrial exercise program . UC participants who completed the 4-week program reported personal satisfaction levels similar to the AET group ; however , the causal direction of this association is unknown . Research ers should continue to evaluate participant satisfaction in exercise trials",
"We conducted a r and omized controlled trial to determine the effects of a home-based exercise intervention on change in quality of life ( QOL ) in recently resected colorectal cancer survivors , most of whom were receiving adjuvant therapy . Participants were r and omly assigned in a 2:1 ratio to either an exercise ( n = 69 ) or control ( n = 33 ) group . The exercise group was asked to perform moderate intensity exercise 3 - 5 times per week for 20 - 30 min each time . The primary outcome was change in QOL as measured by the Functional Assessment of Cancer Therapy-Colorectal ( FACT-C ) scale . Adherence in the exercise group was good ( 75.8 % ) but contamination in the control group was problematic ( 51.6 % ) . Intention-to-treat analysis revealed no significant differences between groups for change in the FACT-C ( mean difference , -1.3 ; 95 % CI , -7.8 to 5.1 ; P = 0.679 ) . In an ' on-treatment ' ancillary analysis , we compared participants who decreased versus increased their cardiovascular fitness over the course of the intervention . This analysis revealed significant differences in favour of the increased fitness group for the FACT-C ( mean difference , 6.5 ; 95 % CI , 0.4 - 12.6 ; P = 0.038 ) . These data suggest that increased cardiovascular fitness is associated with improvements in QOL in colorectal cancer survivors but better controlled trials are needed",
"Goal of workBreast cancer survivors have limited options for the treatment of hot flashes and related symptoms . Further , therapies widely used to prevent recurrence in survivors , such as tamoxifen , tend to induce or exacerbate menopausal symptoms . The aim of this preliminary , r and omized controlled trial was to evaluate the effects of a yoga intervention on menopausal symptoms in a sample of survivors of early-stage breast cancer ( stages IA – IIB ) . Material s and methods Thirty-seven disease-free women experiencing hot flashes were r and omized to the 8-week Yoga of Awareness program ( gentle yoga poses , meditation , and breathing exercises ) or to wait-list control . The primary outcome was daily reports of hot flashes collected at baseline , posttreatment , and 3 months after treatment via an interactive telephone system . Data were analyzed by intention to treat . Main results At posttreatment , women who received the yoga program showed significantly greater improvements relative to the control condition in hot-flash frequency , severity , and total scores and in levels of joint pain , fatigue , sleep disturbance , symptom-related bother , and vigor . At 3 months follow-up , patients maintained their treatment gains in hot flashes , joint pain , fatigue , symptom-related bother , and vigor and showed additional significant gains in negative mood , relaxation , and acceptance . Conclusions This pilot study provides promising support for the beneficial effects of a comprehensive yoga program for hot flashes and other menopausal symptoms in early-stage breast cancer survivors",
"Objective : Assessment of feasibility and effects of an exercise training programme in patients following cystectomy due to urinary bladder cancer . Design : Single-blind , pilot , r and omized controlled trial . Setting : University hospital , Sweden . Subjects : Eighteen patients ( 64–78 years ) , of 89 suitable , cystectomized due to urinary bladder cancer , were r and omized after hospital discharge to intervention or control . Interventions : The 12-week exercise programme included group exercise training twice a week and daily walks . The control group received only st and ardized information at discharge . Main outcome measures : Trial eligibility and compliance to inclusion were registered . Assessment s of functional capacity , balance , lower body strength and health-related quality of life ( HRQoL ) with SF-36 . Results : Out of 122 patients 89 were eligible , but 64 did not want to participate/were not invited . Twenty-five patients were included , but 7 dropped out before r and omization . Eighteen patients were r and omized to intervention or control . Thirteen patients completed the training period . The intervention group increased walking distance more than the control group , 109 m ( 75–177 ) compared to 62 m ( 36–119 ) ( P = 0.013 ) , and role physical domain in SF-36 more than the control group ( P = 0.031 ) . Ten patients were evaluated one year postoperatively . The intervention group had continued increasing walking distance , 20 m ( 19–36 ) , whereas the control group had shortened the distance −15.5 m ( −43 to −5 ) ( P = 0.010 ) . Conclusions : A 12-week group exercise training programme was not feasible for most cystectomy patients . However , functional capacity and the role-physical domain in HRQoL increased in the short and long term for patients in the intervention group compared with controls",
"Cardiopulmonary responses to an 8-week moderate-intensity aerobic exercise intervention and adherence to exercise during and after intervention were assessed in 41 women newly diagnosed with breast cancer undergoing adjuvant therapy . The intervention was primarily aim ed at minimizing deconditioning . Women were r and omly assigned to the intervention or control group , completed grade d exercise tests before and after intervention , and encouraged to continue their exercise postintervention . Over time , only the intervention group showed significant decreases in resting heart rate , resting systolic blood pressure ( SBP ) , P maximum SBP , P increase in VO2 peak , P resting SBP was higher in the intervention group at both timepoints , P exercise intervention was 78.3 % with average weekly attendance of 2.4 sessions and 42.7 minutes ( 27.8 minutes within target heart rate ) exercise per session . Overall physical activity levels over 16 weeks postintervention did not differ between 2 groups . However , the within-group analysis indicated that only the intervention group showed a significant increase in voluntary activity , P .02 , and energy expenditure , P sedentary activity , P deconditioning of cardiopulmonary responses in newly diagnosed breast cancer women undergoing adjuvant therapy",
"INTRODUCTION It has been noted that only 14 % of all clinical trials are translated into practice . The objective of this paper is to promote translation of an efficacious rehabilitative exercise program for breast cancer survivors by clarifying for clinicians the safety profile of participants ( e.g. , rates of musculoskeletal injury and referral to medical professionals ) , and to use this evidence to make recommendations on the appropriate training of health and fitness staff who would be capable of safely , effectively , and sustainably delivering the program . METHODS Breast cancer survivors with and at risk for lymphedema were r and omized to twice-weekly weightlifting or st and ard care for 1 year . An injury survey and health care evaluation were administered after 1 year and in 3-month intervals , respectively . RESULTS The cumulative incidence and rate of injury were higher in the weightlifting than in the control group . The injury rates were 2.3 and 0.3 per 1,000 bouts of weightlifting among breast cancer survivors with and at risk for lymphedema , respectively . Among breast cancer survivors with or at risk for lymphedema , 20.9 % in the weightlifting group had an encounter with a health care provider that required cessation or dose modification of weightlifting . CONCLUSION Despite the demonstrated efficacy of weightlifting , musculoskeletal injuries and other health problems did occur . Therefore , for the successful translation of this rehabilitative intervention into clinical practice , health and fitness professionals working with breast cancer survivors need the knowledge , skills , and abilities that clarify their scope of practice to address these health care needs",
"Sixteen female breast cancer patients who had been diagnosed ( 3.0 + /- 1.2 years previous to the study ) and undergone surgery , chemotherapy , and /or radiation treatment were r and omly assigned to exercise and nonexercise groups . Pre- and post- study measurements were taken for aerobic performance , leg strength , and concentrations of circulating lymphocyte subsets and natural killer cell cytotoxic activity ( NKCA ) . Exercise training consisted of 60 minutes of supervised weight training and aerobic activity three times each week for eight weeks . Although subjects in the exercise groups demonstrated some modest improvement in the various aerobic and strength tests , NKCA and concentrations of circulating T and NK cells were not significantly altered relative to the nonexercise group . This study suggests that moderate exercise over an eight-week period has no significant effect on the function of in vitro natural killer cells in breast cancer patients",
"BACKGROUND Regular exercise and dietary practice s have been shown to affect the health-related quality of life ( HRQOL ) and survival of breast cancer patients . OBJECTIVE The current study aim ed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients . DESIGN A 12-week r and omized , controlled trial . SETTING Oncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea . PARTICIPANTS Fifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0-III cancers within 2 years prior to the study were recruited . METHODS Participants were r and omly assigned to either the intervention group , which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model (TTM)-based strategies ( n=29 ) , or to the control group , which used a 50-page educational booklet on exercise and diet ( n=28 ) . The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables ( F&V ) per day , dietary quality , HRQOL , anxiety , depression , fatigue , motivational readiness , and self-efficacy . RESULTS The proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week ; ate 5 servings of F&V per day ; and had overall improvements in dietary quality , physical functioning and appetite loss ( HRQOL ) , fatigue , and motivational readiness was greater in the intervention group than in the control group . The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group . A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy , although further research with a larger sample size is required to enable definitive conclusions",
"Background & objectives : Patients with head and neck cancer ( HNC ) undergoing chemoradiotherapy ( CRT ) suffer from fatigue causing a decrease in functional capacity and quality of life ( QoL ) . Limited research in the field of exercise training among these patients dem and ed the need for this study to assess the effects of exercise training on functional capacity and quality of life . Methods : A r and omized controlled trial was conducted on 48 patients with HNC undergoing CRT . The exercise group received an individually tailored , supervised , exercise programme for six weeks , while the control group did not receive any form of exercise . Functional capacity and QoL were assessed at baseline and at the end of the intervention using the six minute walk distance ( 6MWD ) and medical outcomes survey short form 36 ( SF 36 ) . Results : The mean age of patients was 52 yr with 42 males . After six weeks , the 6MWD improved by 42 metres ( P mental component score ( MCS ) of SF36 for the exercise group ( 4.8 ; P physical component score ( PCS ) remained almost the same , while a decrease in PCS and MCS was seen in the control group ( -5.9 ; P=0.064 and -17.3 ; P 6MWD and SF36 were compared between the groups , there was a statistically significant difference ( P functional capacity and QoL decreased among those not receiving a supervised exercise program , while exercise training improved functional capacity and QoL in HNC patients undergoing CRT",
"Summary The ability of combined step aerobic- and circuit-training to prevent bone loss after breast cancer treatments was related to skeletal site and patients ’ menopausal status . Among premenopausal breast cancer survivors , a 12-month exercise intervention completely prevented bone loss at the femoral neck , whereas no exercise effect was seen at lumbar spine or at neither site in postmenopausal women . Introduction The primary objective of this r and omised clinical trial was to determine the preventive effect of supervised weight-bearing jumping exercises and circuit training on bone loss among breast cancer patients . Methods Of 573 breast cancer survivors aged 35–68 years r and omly allocated into exercise or control group after adjuvant treatments , 498 ( 87 % ) were included in the final analysis . The 12-month exercise intervention comprised weekly supervised step aerobic- and circuit-exercises and similar home training . Bone mineral density ( BMD ) at lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry . Physical performance was assessed by 2-km walking and figure-8 running tests , and the amount of physical activity was estimated in metabolic equivalent-hours/week . Results In premenopausal women , bone loss at the femoral neck was prevented by exercise , the mean BMD changes being −0.2 % among the trainees vs. −1.4 % among the controls ( p = 0.01 ) . Lumbar bone loss could not be prevented ( −1.9 % vs. −2.2 % ) . In postmenopausal women , no significant exercise-effect on BMD was found either at the lumbar spine ( −1.6 % vs. −2.1 % ) or femoral neck ( −1.1 % vs. −1.1 % ) . Conclusions This 12-month aerobic jumping and circuit training intervention completely prevented femoral neck bone loss in premenopausal breast cancer patients , whereas no effect on BMD was seen in postmenopausal women",
"PURPOSE And rogen deprivation therapy is a common treatment in men with prostate cancer that may cause fatigue , functional decline , increased body fatness , and loss of lean body tissue . These physical changes can negatively affect health-related quality of life . Resistance exercise may help to counter some of these side effects by reducing fatigue , elevating mood , building muscle mass , and reducing body fat . METHODS In a two-site study , 155 men with prostate cancer who were scheduled to receive and rogen deprivation therapy for at least 3 months after recruitment were r and omly assigned to an intervention group that participated in a resistance exercise program three times per week for 12 weeks ( 82 men ) or to a waiting list control group ( 73 men ) . The primary outcomes were fatigue and disease-specific quality of life as assessed by self-reported question naires after 12 weeks . Secondary outcomes were muscular fitness and body composition . RESULTS Men assigned to resistance exercise had less interference from fatigue on activities of daily living ( P = .002 ) and higher quality of life ( P = .001 ) than men in the control group . Men in the intervention group demonstrated higher levels of upper body ( P = .009 ) and lower body ( P muscular fitness than men in the control group . The 12-week resistance exercise intervention did not improve body composition as measured by changes in body weight , body mass index , waist circumference , or subcutaneous skinfolds . CONCLUSION Resistance exercise reduces fatigue and improves quality of life and muscular fitness in men with prostate cancer receiving and rogen deprivation therapy . This form of exercise can be an important component of supportive care for these patients",
"PURPOSE The efficacy of a home-based physical activity ( PA ) intervention for early-stage breast cancer patients was evaluated in a r and omized controlled trial . PATIENTS AND METHODS Eighty-six sedentary women ( mean age , 53.14 years ; st and ard deviation , 9.70 years ) who had completed treatment for stage 0 to II breast cancer were r and omly assigned to a PA or contact control group . Participants in the PA group received 12 weeks of PA counseling ( based on the Transtheoretical Model ) delivered via telephone , as well as weekly exercise tip sheets . Assessment s were conducted at baseline , after treatment ( 12 weeks ) , and 6 and 9 month after baseline follow-ups . The post-treatment outcomes are reported here . RESULTS Analyses showed that , after treatment , the PA group reported significantly more total minutes of PA , more minutes of moderate-intensity PA , and higher energy expenditure per week than controls . The PA group also out-performed controls on a field test of fitness . Changes in PA were not reflected in objective activity monitoring . The PA group was more likely than controls to progress in motivational readiness for PA and to meet PA guidelines . No significant group differences were found in body mass index and percent body fat . Post-treatment group comparisons revealed significant improvements in vigor and a reduction in fatigue in the PA group . There was a positive trend in intervention effects on overall mood and body esteem . CONCLUSION The intervention successfully increased PA and improved fitness and specific aspects of psychological well-being among early-stage breast cancer patients . The success of a home-based PA intervention has important implication s for promoting recovery in this population",
"Purpose Adherence to prescribed exercise is a challenge for cancer patients undergoing treatment . The changing pattern of exercise adherence over time can not be fully understood by an overall measure of adherence . This study was aim ed to identify the trajectory of exercise adherence and its predictors for women with breast cancer during their chemotherapy . Methods Participants were 78 women with breast cancer assigned to the exercise arm of a r and omized control trial . Based on the weekly adherence rates in time and intensity , patients were classified as good ( > 100 % ) , acceptable ( 80–100 % ) , and poor ( both time and intensity adherence declined significantly . The decline in exercise-time adherence was significantly slower in women who reported higher interest in exercise . Women with higher perceived importance of exercise , early disease stage , and employed were more likely to be classified as good intensity adherents . Poorer weekly adherence for both exercise time and intensity was associated with higher fatigue level for that week . Conclusions Adherence to exercise adherence in breast cancer patients declined as the dose of exercise prescription increased . Factors influencing overall adherence and adherence trend were identified",
"PURPOSE Accumulating data suggest that exercise may affect breast cancer risk and outcomes . Studies have demonstrated that high levels of insulin , often seen in sedentary individuals , are associated with increased risk of breast cancer recurrence and death . We sought to analyze whether exercise lowered insulin concentrations in breast cancer survivors . METHODS One hundred one sedentary , overweight breast cancer survivors were r and omly assigned either to a 16-week cardiovascular and strength training exercise intervention or to a usual care control group . Fasting insulin and glucose levels , weight , body composition , and circumference at the waist and hip were collected at baseline and 16 weeks . RESULTS Baseline and 16-week measurements were available for 82 patients . Fasting insulin concentrations decreased by an average of 2.86 microU/mL in the exercise group ( P = .03 ) , with no significant change in the control group ( decrease of 0.27 microU/mL , P = .65 ) . The change in insulin levels in the exercise group seemed greater than the change in controls , but the comparison did not reach statistical significance ( P = .07 ) . There was a trend toward improvement in insulin resistance in the exercise group ( P = .09 ) but no change in fasting glucose levels . The exercise group also experienced a significant decrease in hip measurements , with no change in weight or body composition . CONCLUSION Participation in an exercise intervention was associated with a significant decrease in insulin levels and hip circumference in breast cancer survivors . The relationship between physical activity and breast cancer prognosis may be mediated , in part , through changes in insulin levels and /or changes in body fat or fat deposition",
"AIMS In this prospect i ve controlled r and omized trial we assessed the effects of early , intensive , prolonged pelvic floor exercises ( PFE ) on urinary incontinence following bladder neck ( BN ) sparing RRP . METHODS A sample of 152 patients with localized prostate cancer underwent RRP with BN preservation . Out of this group we r and omized 107 incontinent patients into 2 groups . We considered incontinent patients with 24 hr Pad test > 2 g. The T group received instructions regarding an intensive program of PFE , from 7 days after catheter removal for as long as any degree of incontinence persisted , within a period of 1 year . The control ( C ) group did not receive instructions . The outcome was assessed using the 24 hr Pad test , a visual analogue scale ( VAS ) and a single question of QoL. Results at baseline and at 1 , 3 , 6 , and 12 months were available for 54 and 40 patients , respectively . RESULTS The overall spontaneous continence rate after catheter removal was 23.6 % . The proportion of men still incontinent was significantly higher in the C group than treatment ( T ) group at 1 ( 97.5 % vs. 83.3 % ; P = 0.04 ) , 3 ( 77.5 % vs. 53.7 % ; P = 0.03 ) , 6 ( 60 % vs. 33.3 % ; P = 0.01 ) , and 12 months ( 52.5 % vs. 16.6 % ; P VAS and the response to the QoL question at 12 months significantly differed between the two groups ( P = 0.01 and 0.03 , respectively ) . CONCLUSIONS Our study suggests that early intensive prolonged PFE can further increase the number of continent patients and this improvement persists in the first 12 months . The second 6 months following surgery are still useful to recovery",
"Cancer treatment is associated with decreased hemoglobin ( Hb ) concentration and aerobic fitness ( VO2 max ) , which may contribute to cancer-related fatigue ( CRF ) and decreased quality of life ( QoL ) . Endurance exercise may attenuate CRF and improve QoL , but the mechanisms have not been thoroughly investigated . Objectives . To ( a ) determine the feasibility of conducting an exercise intervention among women receiving treatment for breast cancer ; ( b ) examine the effects of exercise on Hb and VO2 max and determine their association with changes in CRF and QoL ; and ( c ) investigate changes in selected inflammatory markers . Methods . Fourteen women receiving chemotherapy for Stages I – II breast cancer were r and omly assigned to exercise ( n = 7 ) or usual care ( n = 7 ) . Women in the exercise group performed supervised , individualized treadmill exercise 2–3 times/week for the duration of chemotherapy ( 9–12 weeks ) . Data were collected 4 times over 15–16 weeks . Results . Recruitment rate was 45.7 % . Sixteen women consented and 14 completed the trial , for a retention rate of 87.5 % . Adherence to exercise protocol was 95–97 % , and completion of data collection was 87.5–100 % . Exercise was well tolerated . VO2 max was maintained at prechemotherapy levels in exercisers but declined in the usual-care group ( p .05 ) . Hb decreased ( p Exercise did not have significant effects on CRF or QoL. Changes in inflammatory markers favored the exercise group . Conclusions . Exercise during chemotherapy may protect against chemotherapy-induced decline in VO2 max but not Hb concentration",
"PURPOSE Participating in regular physical activity is encouraged after treatment for breast cancer , with exception of those who have subsequently developed lymphedema . The purpose of this project was to investigate , in a r and omized controlled trial , the effect of participating in a supervised , mixed-type exercise program on lymphedema status among women with lymphedema after breast cancer . METHODS Women younger than 76 yr , who completed breast cancer treatment at least 6 months prior and had subsequently developed unilateral , upper-limb lymphedema , were r and omly allocated to an intervention ( n = 16 ) or control ( n = 16 ) group . The intervention group ( IG ) participated in 20 supervised , group , aerobic and resistance exercise sessions over 12 wk , whereas the control group ( CG ) was instructed to continue habitual activities . Lymphedema status was assessed by bioimpedance spectroscopy ( impedance ratio between limbs ) and perometry ( volume difference between limbs ) , and independent t-tests ( two-tailed P Mean ratio and volume measures at baseline were similar for the IG ( 1.13 + /- 0.15 and 337 + /- 307 mL , respectively ) and the CG ( 1.13 + /- 0.19 and 377 + /- 416 mL , respectively ) , and no changes were observed over time for either group . Although no group change was observed between preintervention and 3-month follow-up for the IG ( ratio and volume change = 0.02 + /- 0.07 and 2 + /- 71 mL , respectively ) , two women in this group no longer had evidence of lymphedema by study end . Average attendance was more than 70 % of supervised sessions , there were no withdrawals , and several qualitative comments from participants support the program acceptability . CONCLUSIONS The results from this pilot study indicate that , at minimum , exercise does not exacerbate secondary lymphedema . Women with secondary lymphedema should be encouraged to be physically active , optimizing their physical and psychosocial recovery",
"OBJECTIVES To assess the impact of lifestyle on health-related quality of life ( HR-QOL ) , perceived stress , and self-reported sexual function in men with early-stage prostate cancer electing active surveillance . METHODS A total of 44 intervention and 49 usual-care control participants were enrolled in a r and omized clinical trial examining the effects of lifestyle changes on prostate cancer progression . The intervention consisted of a low-fat , vegan diet , exercise , and stress management . Participants completed the Medical Outcomes Study Short Form-36 Health Status Survey ( a measure of mental and physical HR-QOL ) , the Perceived Stress Scale , the Sexual Function subscale of the University of California , Los Angeles , Prostate Cancer Index , and measures of lifestyle behaviors ( to yield an overall lifestyle index ) at baseline and 12 months . The data were analyzed using analysis of variance for repeated measures . The relationship between lifestyle and QOL was also analyzed using multiple linear regression analyses . RESULTS Intervention participants had significantly improved their lifestyle compared with controls at 12 months . The quality -of-life scores were high across groups and time points . However , a healthier lifestyle was related to better QOL at baseline . Participants in both groups who reported a healthier lifestyle also reported better mental and physical HR-QOL and sexual function . Furthermore , participants whose lifestyle improved over time showed enhanced physical HR-QOL and decreased perceived stress . CONCLUSIONS Men who choose active surveillance for early-stage prostate cancer are able to make comprehensive lifestyle changes . Although the average QOL was already high in this sample , individuals who improved their lifestyle enhanced their QOL further",
"BACKGROUND And rogen deprivation therapy ( ADT ) has significant deleterious effects on body composition that may be accompanied by unfavourable changes in adipokine levels . While exercise has been shown to improve a number of side effects associated with ADT for prostate cancer , no studies have assessed the effect of exercise on adiponectin and leptin levels , which have been shown to alter the mitogenic environment . METHODS Twenty-six men with prostate cancer treated with ADT were r and omized to home-based aerobic exercise training or resistance exercise training for 24 weeks . Adiponectin , leptin , insulin-like growth factor 1 ( IGF-1 ) , insulin-like growth factor binding protein 3 ( IGFBP-3 ) were analyzed by ELISA ( enzyme-linked immunosorbent assay ) , in addition to physical activity volume , peak aerobic capacity , and anthropometric measurements , at baseline , 3 months and 6 months . RESULTS Resistance exercise significantly reduced IGF-1 after 3 months ( p = 0.019 ) ; however , this change was not maintained at 6 months . At 6 months , IGFBP-3 was significantly increased compared to baseline for the resistance training group ( p = 0.044 ) . In an exploratory analysis of all exercisers , favourable changes in body composition and aerobic fitness were correlated with favourable levels of leptin , and favourable leptin : adiponectin and IGF-1:IGFBP-3 ratios at 3 and 6 months . CONCLUSIONS Home-based exercise is correlated with positive changes in adipokine levels and the IGF-axis that may be related to healthy changes in physical fitness and body composition . While the improvements of adipokine markers appear to be more apparent with resistance training compared to aerobic exercise , these findings must be considered cautiously and require replication from larger r and omized controlled trials to clarify the role of exercise on adipokines and IGF-axis proteins for men with prostate cancer",
"Evidence suggests that exercise affects breast cancer risk and outcomes , but little is known about the mechanisms through which this effect may be mediated . This study examines the impact of exercise upon levels of adiponectin , high molecular weight adiponectin ( HMWA ) , and leptin in breast cancer survivors . Methods One hundred and one sedentary , overweight breast cancer survivors were r and omized to a 16-week exercise intervention or usual care control group . Anthropometric measurements were taken and fasting levels of adiponectin , HMWA and leptin were collected at baseline and 16 weeks . Results Baseline and week-16 measurements were available for 81 patients . The exercise group experienced a significant decrease in hip measurements , with no change in weight or body composition . There were no significant changes in adiponectin , HMWA , or leptin in either group . Modeling analyses demonstrated a significant inverse relationship between changes in leptin and adiponectin , but no relationship between changes in BMI , waist or hip circumference , or body fat percentage and change in leptin or adiponectin . Conclusions This study did not demonstrate a significant change in adipocytokine levels in breast cancer survivors participating in an exercise intervention , suggesting that further work is needed to explore the mechanisms through which exercise may impact breast cancer",
"PURPOSE This study , theoretically based on the Exercise Self-Esteem Model , EXSEM , examined effects of exercise modality on physical and global self-esteem ( PSE , GSE ) in breast cancer survivors . The EXSEM posits GSE at the apex with PSE feeding into GSE . PSE has three subdomains : physical condition ( PC ) , attractive body ( AB ) , and physical strength ( PS ) . The goals were to compare the effect of combination modality versus single-modality exercise on PSE and GSE and to explore the relationship between exercise modality and the subdomains of PSE . METHODS Survivors were r and omly allocated to flexibility ( F ) , aerobic ( A ) , resistance ( R ) , or aerobic plus resistance ( AR ) , 12-wk , individualized , home-based exercise program . Pre/posttesting included submaximal treadmill test , six-repetition maximum chest press and leg press , YMCA bench press , shoulder/hip flexibility , and bioelectric impedance analysis body composition . Esteem measures were the Physical Self-Perception Profile and the Rosenberg Self-Esteem Scale . RESULTS Forty-two women completed the study ( F = 12 , A = 10 , R = 9 , and AR = 11 ) . Fitness improvements congruent with exercise modality were seen in all groups . PSE and GSE outcomes did not reveal a greater effect from the combination modality program , AR , compared with the single-modality programs A and R. The relationships between the single-modality groups and the subdomains of PC , PS , and AB were supported in the R group ( PS and AB increased ) and were partially supported in the A group ( PC , not AB , increased ) . CONCLUSIONS A single-modality R program significantly improved all domains of PSE , and participation in the A program improved the PC subdomain . The combination exercise program did not enhance PSE greater than the single-modality programs . EXSEM was a useful framework for exploring esteem in breast cancer survivors",
"Objective : Mechanisms for cancer related fatigue suggest that exercise but “ not too much and not too little ” could be effective . This study aim ed to investigate feasibility and estimate the potential effects of a walking exercise program in people with advanced cancer and fatigue . Design : A pilot r and omized trial . Setting : McGill University Health Centre ( MUHC ) , Montreal , Canada . Subjects : People with advanced cancer undergoing interdisciplinary assessment and rehabilitation with a fatigue level of 4 to 10 on a visual analogue scale . Interventions : An 8-week fatigue-adapted , walking intervention , facilitated using a pedometer ( STEPS ) , and offered at the same time as or after rehabilitation . Measures : Measures of fatigue , physical function and well-being were administered at entry , and 8 , 16 and 24 weeks . Generalized estimating equations ( GEE ) estimated the odds of response for people receiving the STEPS program in comparison to the odds of response in the controls ( odds ratio , OR ) . Results : Twenty-six persons were r and omized to three groups : during rehabilitation , after rehabilitation , and usual care . For the fatigue measures the OR for STEPS offered at any time using an intention-to-treat approach was 3.68 ( 95%CI : 1.05 - 12.88 ) ; for the physical function measures , the OR was 1.40 ( 95%CI : 0.41- 4.79 ) and 2.36 ( 95%CI : 0.66 - 8.51 ) for the well-being measures . Conclusion : Fifty percent of eligible people were able to participate . This small trial suggests that a personalized exercise program reduces fatigue and that 100 people are needed in a full strength trial",
"Prostate cancer patients receiving and rogen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment . Because physical activity improves physical and psychological well-being , a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life ( QOL ) . No studies have evaluated an intervention to improve multiple QOL domains in patients receiving and rogen ablation therapy . Active for Life After Cancer is a three-group r and omized controlled trial design ed to evaluate the effectiveness of a lifestyle physical activity intervention ( Lifestyle Program ) in improving QOL . The Lifestyle Program , a 6-month behavioral skills training group , is compared to an Educational Support Program and St and ard Care . The purpose of this paper is to describe the design of the r and omized trial and present baseline data that will characterize the QOL of the sample . Challenges to recruitment for the trial also will be presented and discussed",
"PURPOSE Physically active individuals have a lower risk of developing colorectal cancer but the influence of exercise on cancer survival is unknown . PATIENTS AND METHODS By a prospect i ve , observational study of 573 women with stage I to III colorectal cancer , we studied colorectal cancer-specific and overall mortality according to predefined physical activity categories before and after diagnosis and by change in activity after diagnosis . To minimize bias by occult recurrences , we excluded women who died within 6 months of their postdiagnosis physical activity assessment . RESULTS Increasing levels of exercise after diagnosis of nonmetastatic colorectal cancer reduced cancer-specific mortality ( P for trend = .008 ) and overall mortality ( P for trend = .003 ) . Compared with women who engaged in less than 3 metabolic equivalent task [ MET ] -hours per week of physical activity , those engaging in at least 18 MET-hours per week had an adjusted hazard ratio for colorectal cancer-specific mortality of 0.39 ( 95 % CI , 0.18 to 0.82 ) and an adjusted hazard ratio for overall mortality of 0.43 ( 95 % CI , 0.25 to 0.74 ) . These results remained unchanged even after excluding women who died within 12 and 24 months of activity assessment . Prediagnosis physical activity was not predictive of mortality . Women who increased their activity ( when comparing prediagnosis to postdiagnosis values ) had a hazard ratio of 0.48 ( 95 % CI , 0.24 to 0.97 ) for colorectal cancer deaths and a hazard ratio of 0.51 ( 95 % CI , 0.30 to 0.85 ) for any-cause death , compared with those with no change in activity . CONCLUSION Recreational physical activity after the diagnosis of stages I to III colorectal cancer may reduce the risk of colorectal cancer-specific and overall mortality",
"Numerous studies have reported that exercise is safe and beneficial for breast cancer survivors ; however , long-term adherence to exercise programs is not easy to accomplish . This secondary analysis examined the demographic and clinical characteristics , adherence to exercise , and cognitive — behavioral intervention components data collected on 120 postmenopausal women with a history of breast cancer and bone loss who had been r and omized to the exercise group in a 24-month study . Hierarchical regression was used to identify variables that predicted adherence to exercise . Mean adherence to exercises was 61.89 % . Feedback and support were the most frequently used cognitive — behavioral intervention components . In hierarchical regression , predictors for adherence to exercise were feedback ( β = .40 , p and adherence to exercise in the previous time period ( β = .31 , p < .001 ) . Participants receiving more frequent feedback had higher adherence to exercise",
"The purpose of this pilot study was to examine the effects of a combined cardiorespiratory and resistance exercise training program of short duration on the cardiorespiratory fitness , strength endurance , task specific functional muscle capacity , body composition and quality of life ( QOL ) in women breast cancer survivors . Sixteen subjects were r and omly assigned to either a training ( n = 8 ; age : 50 + /- 5 yrs ) or control non-exercising group ( n = 8 ; age : 51 + /- 10 yrs ) . The training group followed an 8-week exercise program consisting of 3 weekly sessions of 90-min duration , supervised by an experienced investigator and divided into resistance exercises and aerobic training . Before and after the intervention period , all of the subjects performed a cardiorespiratory test to measure peak oxygen uptake ( VO2peak ) , a dynamic strength endurance test ( maximum number of repetitions for chest and leg press exercise at 30 - 35 % and 100 - 110 % of body mass , respectively ) and a sit-st and test . Quality of life was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 ( EORTC-C30 ) question naire . In response to training , QOL , VO2peak ( mean 3.9 ml/kg/min ; 95 % CI , 0.93 , 6.90 ) performance in leg press ( 17.9 kg ; 95 % CI , 12.8 , 22.4 ) and sit-st and test ( - 0.67 s ; 95 % CI , - 0.52 , - 1.2 ) improved ( p control group . Combined cardiorespiratory and resistance training , even of very brief duration , improves the QOL and the overall physical fitness of women breast cancer survivors",
"BACKGROUND Shoulder dysfunction remains a frequent complication after neck dissection procedures for head and neck cancer . METHODS We conducted a pilot study to evaluate the effects of progressive resistance exercise training ( PRET ) on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in patients with head and neck cancer . Twenty patients ( mean age , 61 + /- 7.7 years ) were r and omly assigned to PRET or st and ard care intervention . Subjects assigned to the PRET group exercised three times per week for 12 weeks . The goal of the exercise program was to enhance scapular stability and strength of the upper extremity . The resistance-training program was progressive in terms of number of sets and repetitions performed , as well as the amount of weight lifted , depending on performance status . RESULTS The completion rate for the trial was 85 % ( 17 of 20 ) . The exercise group completed 93 % of scheduled exercise sessions . Significant improvements were found in favor of the PRET group in active shoulder external rotation ( p = .001 ) , shoulder pain ( p = .038 ) , and overall score for shoulder pain and disability ( p = .045 ) . CONCLUSIONS The study results demonstrate a high rate of completion and adherence with our PRET program among patients with head and neck cancer . The preliminary findings , although limited , also suggest a potential therapeutic role for resistance exercise as an adjunct to st and ard physical therapy treatment",
"BACKGROUND Exercise for Health was a pragmatic , r and omised , controlled trial comparing the effect of an eight-month exercise intervention on function , treatment-related side effects and quality of life following breast cancer , compared with usual care . The intervention commenced six weeks post-surgery , and two modes of delivering the same intervention was compared with usual care . The purpose of this paper is to describe the study design , along with outcomes related to recruitment , retention and representativeness , and intervention participation . METHODS Women newly diagnosed with breast cancer and residing in a major metropolitan city of Queensl and , Australia , were eligible to participate . Consenting women were r and omised to a face-to-face-delivered exercise group ( FtF , n = 67 ) , telephone-delivered exercise group ( Tel , n = 67 ) or usual care group ( UC , n = 60 ) and were assessed pre-intervention ( 5-weeks post-surgery ) , mid-intervention ( 6 months post-surgery ) and 10 weeks post-intervention ( 12 months post-surgery ) . Each intervention arm entailed 16 sessions with an Exercise Physiologist . RESULTS Of 318 potentially eligible women , 63 % ( n = 200 ) agreed to participate , with a 12-month retention rate of 93 % . Participants were similar to the Queensl and breast cancer population with respect to disease characteristics , and the r and omisation procedure was mostly successful at attaining group balance , with the few minor imbalances observed unlikely to influence intervention effects given balance in other related characteristics . Median participation was 14 ( min and max : 0 and 16 ) and 13 ( min and max : 3 and 16 ) intervention sessions for the FtF and Tel , respectively , with 68 % of those in Tel and 82 % in FtF participating in at least 75 % of sessions . DISCUSSION Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women . Future work , design ed to inform translation into practice , will evaluate the quality of life , clinical , psychosocial and behavioural outcomes associated with each mode of delivery",
"This r and omized , controlled pilot trial was carried out to assess the feasibility and efficacy of an aerobic exercise in enhancing physical performance of breast cancer patients after adjuvant treatments . The potential of the training regimen to prevent accompanying bone loss was also assessed . Thirty patients , 41–65 years of age , were r and omly assigned into training or control groups shortly after adjuvant chemo- or radiotherapy . The 12-week training included a guided aerobic exercise session once a week ( the effective part being either step aerobic- or circuit-training in alternate weeks ) and similar home exercise sessions twice a week . Adherence to the guided sessions was 78 % , while home training was performed an average 2.1 times per week . Agility assessed with figure-8 running test and peak jumping power showed significant between-group treatment-effects ( ∼5 % and ∼10 % , respectively ) . Judged from the accelerometer data , reaction forces up to six times body weight occurred during the training , which implies that the training could also have potential to affect bone mass . The present exercise regimen turned out to be feasible and effective among breast cancer patients in terms of physical performance . Large controlled trials are necessary to confirm these findings",
"Given the negative effects of a breast cancer diagnosis and its treatments on body weight and bone mass , we investigated the effects of a 6-month r and omized controlled aerobic exercise intervention vs. usual care on body composition in breast cancer survivors . Secondary aims were to examine the effects stratified by important prognostic and physiologic variables . Seventy-five physically inactive postmenopausal breast cancer survivors were recruited through the Yale-New Haven Hospital Tumor Registry and r and omly assigned to an exercise ( n = 37 ) or usual care ( n = 38 ) group . The exercise group participated in 150 min/week of supervised gym- and home-based moderate-intensity aerobic exercise . The usual care group was instructed to maintain their current physical activity level . Body composition was assessed at baseline and 6-months through dual-energy X-ray absorptiometry ( DXA ) by one radiologist blinded to the intervention group of the participants . On an average , exercisers increased moderate-intensity aerobic exercise by 129 min/week over and above baseline levels compared with 45 min/week among usual care participants ( P percent body fat ( P = 0.0022 ) and increases in lean mass ( P = 0.047 ) compared with increases in body fat and decreases in lean mass in usual care participants . Bone mineral density ( BMD ) was also maintained among exercisers compared with a loss among usual care participants ( P = 0.043 ) . In summary , moderate-intensity aerobic exercise , such as brisk walking , produces favorable changes in body composition that may improve breast cancer prognosis",
"Although exercise may be used by some to decrease distress , little is known about how it may contribute to stress management ( SM ) among patients receiving chemotherapy . We evaluated whether exercise separately or in combination with SM training is effective at increasing perceived ability to manage stress . Patients receiving chemotherapy ( N = 391 ) were r and omized to receive usual care only ( UCO ) , SM , exercise ( EX ) , or stress management and exercise ( SMEX ) . They completed the Measure of Current Status prior to receiving chemotherapy and 12 weeks after the first infusion . We hypothesized that participants r and omized to an intervention condition would report improvements in relaxation , awareness of tension , getting needs met and coping confidence compared with those receiving UCO . Results indicated significant group-by-time interactions for the following : relaxation ( UCO versus SM , p = 0.008 ) , awareness of tension ( UCO versus SMEX , p = 0.029 and UCO versus EX , p getting needs met ( UCO versus SMEX , p = 0.020 ) and Measure of Current Status total score ( UCO versus SMEX , p = 0.007 and UCO versus EX , p = 0.016 ) . There were no group-by-time interactions for coping confidence ( p-values > 0.05 ) . This study provides support for including an exercise component in SM interventions for cancer patients receiving chemotherapy ( clinical trials.gov identifier : NCT00740038 )",
"82 Background : A common physical sequel after adjuvant therapy is a decrease in shoulder movement of the upper-limb of the affected side and the development of LE . Resistance exercise is known to be safe and does not increase the risk of LE . The objective of this study is to evaluate the effect of a VEP on shoulder range of motion and upper-limb LE after adjuvant therapy in BCs . METHODS 22 BCs treated with surgery and adjuvant therapy were r and omly assigned to the VEP ( n=12 ) or the control ( n=10 ) . The VEP aim ed at improving aerobic endurance , joint mobility and muscle strength . The frequency of the VEP was 2 times a week , during 3 months , with a total of 30 sessions . Primary endpoints included the range shoulder motion and arm volumes of both arms . The secondary outcome was quality of life ( QoL ) as measured by the EORTC QLQ-C30 . All outcome measures were assessed at baseline and after 3 months . RESULTS After ending the VEP , in the exercise group , the movements such as abduction ( p=0.04 ) , external rotation ( p=0.02 ) , extension ( p=0.03 ) and flexion ( p=0.01 ) of the affected arm increased significantly but there was no change for internal rotation ( 0.27 ) . No significant changes in arm volume ( p=0.06 ) were found after 3 months compared to baseline , whereas the quality of life did improve significantly ( p=0.01 ) . After 3 months the range of motion of the shoulder of the affected arm ( sum of abduction , external rotation , extension and flexion ) in the exercise group tended to be better although this was not significant ( p=0.50 ) . The arm volume difference between the two groups was not significant ( p=0.10 ) but it was for the QoL ( p=0.02 ) . CONCLUSIONS A VEP lead to significant specific improvements in arm mobility compared to baseline . These BCs also compared favourably to the control cohort , but this was not significant . The study confirms that exercising the ipsilateral arm and shoulder has no detrimental effect on LE and has a positive impact on the QoL. St and ard guidelines concerning physical therapy to ameliorate shoulder function and LE are not available . Additional patients will be enrolled to develop st and ard recommendations for physical therapy to improve shoulder and limb function in BCs",
"Background : Aerobic exercise training ( AET ) is known to increase RBC production ; however , this has not been evaluated in breast cancer patients undergoing adjuvant chemotherapy . The purpose of this study was to examine the changes in hemoglobin ( Hb ) levels in the Supervised Trial of Aerobic versus Resistance Training ( START ) and to determine its association with changes in VO2peak . Methods : Two hundred and forty-two breast cancer patients initiating chemotherapy were r and omized to usual care ( n = 82 ) , resistance exercise ( RET , n = 82 ) , or AET ( n = 78 ) groups for the duration of their chemotherapy ( median , 17 weeks ) . Supervised exercise was thrice weekly based on st and ard AET and RET prescriptions . Aerobic fitness ( VO2peak ) and Hb concentration were measured at baseline and end of chemotherapy . Results : Regardless of the exercise group , Hb declined over the course of chemotherapy ( 13.4 ± 10.0 to 11.8 ± 11.5 g/dL , P change in VO2peak and Hb ( AET : r = 0.49 , P regular exercise does not protect against the decline in Hb associated with chemotherapy in breast cancer patients , but result ed in a stronger association between Hb and VO2peak . Impact : Even with the chemotherapy-induced decline in Hb , breast cancer patients can maintain their aerobic capacity by participating in regular aerobic exercise . Further studies are required to determine safe intensity levels that may stimulate the maintenance of Hb levels in breast cancer patients . Cancer Epidemiol Biomarkers Prev ; 19(11 ) ; 2826–32 . © 2010 AACR",
"OBJECTIVE To evaluate the effect of a combined hospital plus home exercise programme following curative surgery for non-small cell lung cancer ( NSCLC ) . DESIGN R and omised controlled trial . SETTING Teaching hospital . PARTICIPANTS One hundred and thirty-one subjects with NSCLC admitted for curative surgery . INTERVENTIONS Participants were r and omised to usual care or a hospital plus home exercise programme . OUTCOMES The primary outcome was the between-group difference in physical activity 4 weeks after surgery . Secondary outcomes were the difference in quadriceps strength , exercise tolerance and quality of life [ Short Form-36 ( SF-36 ) and European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-LC13 ] from pre-operatively ( baseline ) to 4 weeks after surgery . RESULTS The participants ( n=131 ) had a mean age of 68 [ st and ard deviation ( SD ) 11 ] years and mean forced expiratory volume in 1 second of 2.4 ( SD 1.1)l . There were no significant differences in physical activity between the groups 4 weeks after surgery [ mean difference adjusted for baseline 12minutes/day , 95 % confidence interval ( CI ) -20.2 to 44.1 ] . In addition , there were no significant differences in total SF-36 or EORTC QLQ-LC13 scores from baseline to 4 weeks after surgery . Both groups had recovered their pre-operative walking distance 4 weeks after surgery , and there were no differences between the groups ( mean difference in Incremental Shuttle Walk Test from baseline to 4 weeks after surgery ( -26 m , 95 % CI -94.2 to 42.3 ) . CONCLUSIONS A hospital plus home exercise programme showed little benefit in unselected patients with NSCLC following surgery . Regardless of group allocation , the patients had recovered their pre-operative exercise tolerance levels by 4 weeks after surgery",
"Background : Physical activity can confer many benefits on cancer survivors , including relief of persistent symptoms related to cancer treatment . Objectives : To evaluate the effect of a motivational interviewing ( MI ) intervention on increasing physical activity ( Community Healthy Activities Model Program for Seniors question naire ) and improving aerobic fitness ( 6-minute walk ) , health ( Medical Outcomes Study Short-Form 36 ) , and fatigue ( Schwartz Cancer Fatigue Scale ) in cancer survivors . A secondary purpose was to evaluate whether the effect of MI on physical activities depended on self-efficacy . Methods : Fifty-six physically inactive adult cancer survivors ( mean = 42 months since completion of treatment ) were assigned r and omly to intervention and control groups . The MI intervention consisted of one in-person counseling session followed by two MI telephone calls over 6 months . Control group participants received two telephone calls without MI content . Outcomes were measured at baseline , 3 months , and 6 months , and were analyzed using multilevel modeling . Results : The results of the MI intervention explained significant group differences in regular physical activities ( measured in caloric expenditure per week ) , controlling for time since completion of cancer treatment ( p Aerobic fitness , physical and mental health , and fatigue were not different between groups . In the intervention group , individuals with high self-efficacy for exercise at baseline increased their physical activity more than those with low self-efficacy ( p physical activity did not depend on self-efficacy . Discussion : Use of MI may increase physical activity in long-term cancer survivors , especially in persons with high self-efficacy for exercise . Multilevel modeling analysis revealed individual changes that would not have been shown by analysis of group means . Future studies with larger sample s or more intense MI interventions may show changes in aerobic fitness , physical and mental health , and fatigue",
"BACKGROUND We evaluated the effect of Emotionally Focused Therapy ( EFT ) [ intervention ( INT ) ] , modified for the advanced cancer population versus st and ard care [ control ( CTL ) ] , on marital functioning and psychosocial outcomes among distressed couples . EFT examines the ways couples process patterns of interaction , facilitating change . METHODS Forty-two patients with metastatic cancer and their caregivers were assigned r and omly to receive eight sessions of EFT delivered by one EFT-trained psychologist or st and ard care provided by multidisciplinary clinicians . Partners completed measures of marital functioning , depression , hopelessness , empathic caregiving ( patient ) , and caregiver burden ( caregiver ) before r and omization at baseline ( T0 ) , post-intervention ( T1 ) , and 3-month post-intervention ( T2 ) . Data were analyzed using three-way analyses of covariance ; main effects were treatment , patient status , and sex . Multilevel modeling was also employed . RESULTS At T1 , INT group led to significant improvement in marital functioning ( p ≤ 0.0001 ) and patients ' experience of caregiver empathic care ( p = 0.02 ) versus CTL group . Effect sizes for these differences were in the large range ( d = 1.00 ) . In both groups , patients showed a marginally higher mean score for marital functioning compared with caregivers [ INT : M = 56.3 , st and ard deviation ( SD ) = 4.6 vs M = 54.3 , SD = 4.5 ; CTL group : M = 43.4 , SD = 10.3 vs M = 42.4 , SD = 6.8 , respectively ] . At T2 , results were maintained . CONCLUSIONS The effectiveness of and adherence to the EFT couple intervention for patients facing advanced cancer were demonstrated in this study . Larger r and omized control trials are needed to confirm these findings . Qualitative studies may help to further underst and the mechanism by which such an intervention may act",
"ABSTRACT The primary objective of this pilot study was to explore the feasibility of implementing two exercise programs for female patients who are breast cancer survivors and residents of the metropolitan area of San Juan , Puerto Rico . Potential benefits and complications of participating in a gym‐exercise program or a home‐exercise program , as opposed to st and ard care , were identified . Participants were r and omly assigned to 1 of 3 groups : a gym‐exercise group , a home‐exercise group , or a non‐exercise group . Interventions consisted of exercise programs with both aerobic and strengthening components , offered for a 26‐week period . Outcome measures consisted of functional evaluation , shoulder range of motion , 12‐minute walk test , h and grip strength , body mass index , and quality of life . The results of this study showed that it is feasible for Puerto Rican women to participate in a moderate intensity exercise program without developing complications . Participation in the exercise programs studied here minimized the side effects after cancer treatment , such as reduced physical functional ability and restricted shoulder mobility . Improvements were found in the measures of shoulder range of motion , upper extremity related physical function , and distance walked",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"Physical exercise is becoming an accepted part of therapy for many patients with cancer . Exercise may alleviate patients ' fatigue and improve physical performance and psychological outlook . Much of the research is limited to women with breast cancer and excludes patients with bone metastases . This article reports on the authors ' work in facilitating exercise adherence for patients with multiple myeloma ( MM ) and bone lesions while they were enrolled in a feasibility/pilot exercise study as they were receiving treatment for their disease in an outpatient treatment program . The exercise program for these patients receiving high-dose chemotherapy and stem cell transplantation consisted of aerobic and strength-building components . The program was home based , and patients performed exercises without direct supervision . On average , the patients completed the six-month exercise prescription 75 % of the time . Overall trends showed that all 14 patients in the exercise group improved in several areas of testing , and the test results of all 10 patients in the usual-care group declined . Flexibility and simplicity are essential when design ing exercise programs for patients , and encouragement and support also are needed to help patients adhere to prescribed exercise",
"AIM The study aim ed at determining whether physical exercise training improves the quality of life ( QoL ) and physical fitness of breast cancer survivors . PATIENTS AND METHODS A total of 573 breast cancer survivors were r and omized into an exercise or a control group , 12-months after adjuvant treatments . EORTC QLQ-C30 and BR-23 question naires were used for evaluation of QoL , FACIT-F for fatigue and the Finnish modified version of Beck 's 13-item depression scale ( RBDI ) for depression . Physical fitness was assessed by a 2-km walking test , and a figure-8 running test and physical activity ( PA ) by metabolic equivalent ( MET ) hours per week ( MET-h/wk ) . RESULTS Figure-8 running time improved significantly among the patients of the intervention group compared with the controls ( p 2-km walking time , in PA , EORTC-QLQ-C30 , BR-23 , FACIT-F or BDI . However , there was a linear relationship between increased PA and improved QoL ( p=0.006 ) , irrespective of the intervention . CONCLUSION Increase in physical activity was associated with improved QoL , but no effect of the exercise intervention was observed",
"BACKGROUND Nearly 35 % of men treated for prostate cancer ( PrCA ) will experience biochemically defined recurrence , noted by a rise in PSA , within 10 years of definitive therapy . Diet , physical activity , and stress reduction may affect tumor promotion and disease progression . METHODS A r and omized trial of an intensive diet , physical activity , and meditation intervention was conducted in men with rising post-treatment PSA after definitive treatment for PrCA . Intention-to-treat methods were used to compare usual care to the intervention in 47 men with complete data . Signal detection methods were used to identify dietary factors associated with PSA change . RESULTS The intervention and control groups did not differ statistically on any demographic or disease-related factor . Although the intervention group experienced decreases of 39 % in intakes of saturated fatty acid ( SFA as percent of total calories ) ( p total energy intake ( 218 kcal/day , p PSA change was observed by intervention status . Signal detection methods indicated that in men increasing their consumption of fruit , 56 % experienced no rise in PSA ( vs. 29 % in men who did not increase their fruit intake ) . Among men who increased fruit and fiber intakes , PSA increased in 83 % of participants who also increased saturated fatty acid intake ( vs. 44 % in participants who decreased or maintained saturated fatty acid intake ) . CONCLUSION Results are discussed in the context of conventional treatment strategies that were more aggressive when this study was being conducted in the mid-2000s . Positive health changes in a number of lifestyle parameters were observed with the intervention , and both increased fruit and reduced saturated fat intakes were associated with maintaining PSA levels in men with biochemically recurrent disease",
"PURPOSE This study aim ed to examine mediators of fatigue response to an exercise intervention for breast cancer survivors in a pilot r and omized controlled trial . METHODS Postmenopausal breast cancer survivors ( n = 46 ; ≤stage 2 ) , off primary treatment , and reporting fatigue and /or sleep dysfunction were r and omized to a 3-month exercise intervention ( 160 min·wk of moderate-intensity aerobic walking , twice weekly resistance training with resistance b and s ) or control group . Six discussion group sessions provided behavioral support to improve adherence . Fatigue , serum cytokines , accelerometer physical activity , cardiorespiratory fitness , sleep dysfunction , and psychosocial factors were assessed at baseline and 3 months . RESULTS The exercise intervention effect sizes for fatigue were as follows : fatigue intensity d = 0.30 ( P = 0.34 ) , interference d = -0.38 ( P = 0.22 ) , and general fatigue d = -0.49 ( P = 0.13 ) . Using the Freedman-Schatzkin difference-in-coefficients tests , increase in fatigue intensity was significantly mediated by interleukin 6 ( IL-6 ) ( 82 % ) , IL-10 ( 94 % ) , IL-6/IL-10 ( 49 % ) , and tumor necrosis factor-α (TNF-α):IL-10 ( 78 % ) with reduced sleep dysfunction increasing the relationship between intervention and fatigue intensity rather than mediating intervention effects ( -88 % ) . Decrease in fatigue interference was mediated by sleep dysfunction ( 35 % ) , whereas IL-10 and pro-anti-inflammatory cytokine ratios increased the relationship between intervention and interference ( -25 % to -40 % ) . The reduction in general fatigue was significantly mediated by minutes of physical activity ( 76 % ) , sleep dysfunction ( 45 % ) , and physical activity enjoyment ( 40 % ) , with IL-10 ( -40 % ) and IL-6/IL-10 ( -11 % ) increasing the intervention-fatigue relationship . In the intervention group , higher baseline fatigue , anxiety , depression , and perceived exercise barrier interference predicted a greater decline in fatigue interference and /or general fatigue during the intervention . CONCLUSIONS Biobehavioral factors mediated and enhanced intervention effects on fatigue , whereas psychosocial factors predicted fatigue response . Further study is warranted to confirm our results and to improve underst and ing of relationships that mediate and strengthen the intervention-fatigue association",
"OBJECTIVES To assess the feasibility and efficacy of delivering Pilates exercises for resistance training to breast cancer survivors using the MVe Fitness Chair ™ . DESIGN Pilot r and omized controlled trial . METHODS Twenty-six female breast cancer survivors were r and omized to use the MVe Fitness Chair ™ ( n=8 ) , traditional resistance training ( n=8 ) , or a control group ( no exercise ) ( CO ) ( n=10 ) . The MVe Fitness Chair ™ and traditional resistance training groups completed 8 weeks of exercise . Muscular endurance was assessed pre and post-test for comparisons within and between groups using push ups , curl ups , and the Dynamic Muscular Endurance Test Battery for Cancer Patients of Various Ages . RESULTS Feasibility of the MVe Fitness Chair ™ was good , evidence d by over 80 % adherence for both exercise groups and positive narrative feedback . Significant improvements in muscular endurance were observed in the MVe Fitness Chair ™ ( p that Pilates and traditional resistance training may be equally effective at improving muscular endurance in this population . CONCLUSIONS The MVe Fitness Chair ™ is feasible for use in breast cancer survivors . It appears to promote similar improvements in muscular endurance when compared to traditional resistance training , but has several advantages over traditional resistance training , including cost , logistics , enjoyment , and ease of learning",
"Background : Depression , anxiety , and fatigue are among the most significant problems that influence the quality of life of patients with breast cancer who receive adjuvant chemotherapy . Although evidence has shown yoga to decrease anxiety , depression , and fatigue in patients with cancer , few studies on the effects of yoga have targeted patients with breast cancer . Yoga interventions should be tested to promote the psychological and physical health of women with breast cancer . Purpose : This study examines the effectiveness of an 8-week yoga exercise program in promoting the psychological and physical health of women with breast cancer undergoing adjuvant chemotherapy in terms of depression , anxiety , and fatigue . Methods : A sample of 60 women with nonmetastatic breast cancer was recruited . Participants were r and omly assigned into either the experimental group ( n = 30 ) or the control group ( n = 30 ) . A 60-minute , twice-per-week yoga exercise was implemented for 8 weeks as the intervention for the participants in the experimental group . The control group received st and ard care only . Results : Analysis using the Johnson – Neyman procedure found that the yoga exercise reduced overall fatigue and the interference of fatigue in everyday life for the experimental group participants . Significant reductions were obtained after 4 weeks of intervention participation for those experimental group patients with relatively low starting baseline values ( baseline item mean value levels of depression ( F = 1.29 , p > .05 ) or anxiety ( F = 2.7 , p > .05 ) . Conclusions / Implication s for Practice : The 8-week yoga exercise program developed in this study effectively reduced fatigue in patients with breast cancer but did not reduce depression or anxiety . Oncology nurses should strengthen their clinical health education and apply yoga to reduce the fatigue experienced by patients with breast cancer who undergo adjuvant chemotherapy",
"Background . Chronic fatigue is one of the most restricting symptoms following primary breast cancer treatment , but clinical studies on symptom management are rare . The objective was to evaluate the impact of a multimodal mind – body program ( MMMT ) , including moderate physical activity as compared with a walking intervention alone , on chronic fatigue symptoms of women with stage I to IIIA breast cancer . Patients and Methods . Sixty-four women ( mean age = 56.7 years ) suffering from chronic fatigue after active tumor treatment were r and omly assigned to either an experimental or a control ( n = 32 each ) intervention ( 10 weeks ) . Fatigue , quality of life ( QoL ) , functional well-being , anxiety , and depression were measured with st and ard question naires at baseline , after 10 weeks , and after 3 months . Results . Compared with baseline , both groups had reduced fatigue scores after treatment without any significant difference between groups ( posttreatment , Δ = −0.3 , confidence interval = −1.6 to 1.0 , P = .678 ; follow-up , Δ = −0.4 , confidence interval = −1.8 to 0.9 , P = .510 ) . All patients also improved regarding QoL and general functional well-being . Conclusion . Since both interventions reduced fatigue symptoms and enhanced QoL to a similar extent , we observed no verifiable add-on effect of the MMMT regarding fatigue symptoms . Considering the higher costs with additional expenditure related to MMMT , home-based walking intervention is recommended",
"OBJECTIVES Previous research has demonstrated that patients with prostate cancer participating in the Prostate Cancer Lifestyle Trial had a reduction in prostate-specific antigen ( PSA ) levels , inhibition of LNCaP cell growth , and fewer prostate cancer-related clinical events at the end of 1 year compared with controls . The aim of this study was to examine the clinical events in this trial during a 2-year period . METHODS The Prostate Cancer Lifestyle Trial was a 1-year r and omized controlled clinical trial of 93 patients with early-stage prostate cancer ( Gleason score The patients in the experimental arm were encouraged to adopt a low-fat , plant-based diet , to exercise and practice stress management , and to attend group support sessions . The control patients received the usual care . RESULTS By 2 years of follow-up , 13 of 49 ( 27 % ) control patients and 2 of 43 ( 5 % ) experimental patients had undergone conventional prostate cancer treatment ( radical prostatectomy , radiotherapy , or and rogen deprivation , P clinical events ( eg , cardiac ) , and no deaths occurred . Three of the treated control patients but none of the treated experimental patients had a PSA level of > or=10 ng/mL , and 1 treated control patient but no treated experimental patients had a PSA velocity of > 2 ng/mL/y before treatment . No significant differences were found between the untreated experimental and untreated control patients in PSA change or velocity at the end of 2 years . CONCLUSIONS Patients with early-stage prostate cancer choosing active surveillance might be able to avoid or delay conventional treatment for at least 2 years by making changes in their diet and lifestyle",
"We compared the effect of a group-based 12-week supervised exercise programme , i.e. aerobic and resistance exercise , and group sports , with that of the same programme combined with cognitive-behavioural training on physical fitness and activity of cancer survivors . One hundred and forty seven cancer survivors ( all cancer types , medical treatment ≥3 months ago ) were r and omly assigned to physical training ( PT , n=71 ) or PT plus cognitive-behavioural training ( PT+CBT , n=76 ) . Maximal aerobic capacity , muscle strength and physical activity were assessed at baseline and post-intervention . Analyses using multilevel linear mixed-effects models showed that cancer survivors ’ physical fitness increased significantly in PT and PT+CBT from baseline to post-intervention . Changes did not differ between PT and PT+CBT . Physical fitness of cancer survivors was improved following an intensive physical training programme . Adding a structured cognitive-behavioural intervention did not enhance the effect",
"The effect of a 10-week aerobic interval-training cycle ergometer protocol on the functional capacity ( VO2Lmax ) of 45 women receiving chemotherapy for treatment of Stage II breast cancer was studied . Subjects were stratified by baseline functional capacity ( ± 1 MET ) and r and omized to experimental ( EX ) , placebo ( PL ) , and control ( CO ) groups . EX subjects completed a 10-week , 3 times/week exercise training program ; PL subjects participated in 10 weeks of nonaerobic stretching and flexibility exercises ; the CO group maintained normal activities . The EX group showed significant , p on pre- to posttest VO2Lmax as well as workload and test time compared to the PL and CO groups . The interval-training exercise intervention was effective in improving the functional capacity of Stage II breast cancer patients on adjuvant chemotherapy",
"BACKGROUND As patients with pancreas and periampullary cancer ( PPC ) experience improved survival rates and longevity , the focus shifts toward living life while surviving cancer . Fatigue is the most commonly reported symptom in all cancer patients . Exercise has been found to effectively decrease fatigue levels and improve physical functioning in cancer patients . STUDY DESIGN One hundred two patients with resected PPC consented to participate in this study and were r and omized to either an intervention group ( IG ) or a usual care group ( UCG ) . Subjects completed visual analog scales , the FACIT-Fatigue Scale and the Short Form-36v2 after surgery and again 3 to 6 months after hospital discharge . RESULTS Patients in the IG and UCG were comparable with regard to demographics , comorbidities , cancer type and staging , type of resection , preoperative fatigue and pain levels , adjuvant therapy , and baseline walking distance . Patients in the IG had significantly improved scores on the FACIT-Fatigue Scale at study completion , improved fatigue and pain scores , as well as overall physical functioning and mental health composite scores . At study completion , participants in the IG were walking twice as far and were significantly more likely to have continued walking or another form of exercise as compared with the UCG . Using hierarchical cluster analysis , 3 mutually exclusive symptom groupings were identified in the cohort . Kaplan-Meier survival analysis did not indicate an overall survival benefit for the IG . CONCLUSIONS This is the first prospect i ve , r and omized controlled trial to report that participation in a home walking program confers a significant benefit in resected PPC patients with regard to fatigue levels , physical functioning , and health-related quality of life",
"Evidence -based exercise and relaxation recommendations for people with breast cancer-related lymphedema ( BCRL ) are needed . We report a r and omized controlled study of one program , design ed to achieve synergistic improvements in physical and emotional BCRL symptoms . People in the treatment group received an exercise and relaxation program , The Breast Cancer Recovery Program ( N=16 ) . The control participants ( N=16 ) continued with health professionals ' recommendations . Participants were tested at entry , 2.5 weeks , 5 weeks , and 3 months . Treatment group participants , compared with control participants , demonstrated significant treatment effects for improved bioimpedance z , arm flexibility , quality of life , mood at 3 months , and weight loss . Adherence was high for this safe and effective program , which improved lymphedema physical and emotional symptoms",
"Fatigue is the most prevalent and debilitating symptom experienced by breast cancer patients receiving adjuvant chemotherapy or radiation therapy and few evidence -based treatments are available to manage this distressing side-effect . The purpose of this multi-institutional r and omized controlled trial was to determine the effects of exercise on fatigue levels during treatment for breast cancer . Sedentary women ( N=119 ) with Stage 0-III breast cancer receiving outpatient adjuvant chemotherapy or radiation therapy were r and omized to a home-based moderate-intensity walking exercise program or to usual care for the duration of their cancer treatment . Of participants r and omized to exercise , 72 % adhered to the exercise prescription ; 61 % of the usual care group adhered . The intention-to-treat analysis revealed no group differences in part because of a dilution of treatment effect as 39 % of the usual care group exercised and 28 % of the exercise group did not . When exercise participation was considered using the data analysis method of instrumental variables with principal stratification , a clinical ly important and statistically significant ( p=0.03 ) effect of exercise on pretest-to-posttest change in fatigue levels was demonstrated . Adherence to a home-based moderate-intensity walking exercise program may effectively mitigate the high levels of fatigue prevalent during cancer treatment",
"CONTEXT Clinical guidelines for breast cancer survivors without lymphedema advise against upper body exercise , preventing them from obtaining established health benefits of weight lifting . OBJECTIVE To evaluate lymphedema onset after a 1-year weight lifting intervention vs no exercise ( control ) among survivors at risk for breast cancer-related lymphedema ( BCRL ) . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled equivalence trial ( Physical Activity and Lymphedema trial ) in the Philadelphia metropolitan area of 154 breast cancer survivors 1 to 5 years postunilateral breast cancer , with at least 2 lymph nodes removed and without clinical signs of BCRL at study entry . Participants were recruited between October 1 , 2005 , and February 2007 , with data collection ending in August 2008 . INTERVENTION Weight lifting intervention included a gym membership and 13 weeks of supervised instruction , with the remaining 9 months unsupervised , vs no exercise . MAIN OUTCOME MEASURES Incident BCRL determined by increased arm swelling during 12 months ( ≥5 % increase in interlimb difference ) . Clinician-defined BCRL onset was also evaluated . Equivalence margin was defined as doubling of lymphedema incidence . RESULTS A total of 134 participants completed follow-up measures at 1 year . The proportion of women who experienced incident BCRL onset was 11 % ( 8 of 72 ) in the weight lifting intervention group and 17 % ( 13 of 75 ) in the control group ( cumulative incidence difference [ CID ] , -6.0 % ; 95 % confidence interval [ CI ] , -17.2 % to 5.2 % ; P for equivalence = .04 ) . Among women with 5 or more lymph nodes removed , the proportion who experienced incident BCRL onset was 7 % ( 3 of 45 ) in the weight lifting intervention group and 22 % ( 11 of 49 ) in the control group ( CID , -15.0 % ; 95 % CI , -18.6 % to -11.4 % ; P for equivalence = .003 ) . Clinician-defined BCRL onset occurred in 1 woman in the weight lifting intervention group and 3 women in the control group ( 1.5 % vs 4.4 % , P for equivalence = .12 ) . CONCLUSION In breast cancer survivors at risk for lymphedema , a program of slowly progressive weight lifting compared with no exercise did not result in increased incidence of lymphedema . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00194363",
"Given observational findings that physical activity reduces breast cancer risk , improves survival , and improves quality of life in breast cancer survivors , a need has been identified for r and omized controlled trials that testthe efficacy of exercise on biological mechanisms associated with breast cancer survival . The primary aims of the Yale Exercise and Survivorship Study were to 1 ) determine the feasibility of recruiting breast cancer survivors into a r and omized controlled trial of the effects of exercise on biological markers and /or mechanisms associated with survival , 2 ) compare the effectiveness of various recruitment strategies on accrual rates and baseline characteristics , and 3 ) report adherence to the exercise trial",
"Background : Physical inactivity and obesity increase the risk of colorectal cancer but little is known about whether they influence prognosis after diagnosis . Methods : Incident cases of colorectal cancer were identified among participants of the Melbourne Collaborative Cohort Study , a prospect i ve cohort study of 41 528 Australians recruited from 1990 to 1994 . Participants diagnosed with their first colorectal cancer between recruitment and 1 August 2002 were eligible . At the time of study entry , body measurements were taken and participants were interviewed about their physical activity . Information on tumour site and stage , treatments given , recurrences , and deaths were obtained from systematic review of the medical records . Results : A total of 526 cases of colorectal cancer were identified . Median follow up among survivors was 5.5 years , and 208 deaths had occurred , including 181 from colorectal cancer . After adjusting for age , sex , and tumour stage , exercisers had an improved disease specific survival ( hazard ratio 0.73 ( 95 % confidence interval ( CI ) 0.54–1.00 ) ) . The benefit of exercise was largely confined to stage II – III tumours ( hazard ratio 0.49 ( 95 % CI 0.30–0.79 ) ) . Increasing per cent body fat result ed in an increase in disease specific deaths ( hazard ratio 1.33 per 10 kg ( 95 % CI 1.04–1.71 ) ) . Similarly , increasing waist circumference reduced disease specific survival ( hazard ratio 1.20 per 10 cm ( 95 % CI 1.05–1.37 ) ) . Conclusions : Increased central adiposity and a lack of regular physical activity prior to the diagnosis of colorectal cancer is associated with poorer overall and disease specific survival ",
"PURPOSE Radiotherapy for prostate cancer ( PCa ) may cause unfavorable changes in fatigue , quality of life ( QOL ) , and physical fitness . We report results from the Prostate Cancer Radiotherapy and Exercise Versus Normal Treatment study examining the effects of 24 weeks of resistance or aerobic training versus usual care on fatigue , QOL , physical fitness , body composition , prostate-specific antigen , testosterone , hemoglobin , and lipid levels in men with PCa receiving radiotherapy . PATIENTS AND METHODS Between 2003 and 2006 , we conducted a r and omized controlled trial in Ottawa , Canada , where 121 PCa patients initiating radiotherapy with or without and rogen deprivation therapy were r and omly assigned to usual care ( n = 41 ) , resistance ( n = 40 ) , or aerobic exercise ( n = 40 ) for 24 weeks . Our primary end point was fatigue assessed by the Functional Assessment of Cancer Therapy-Fatigue scale . RESULTS The follow-up assessment rate for our primary end point of fatigue was 92.6 % . Median adherence to prescribed exercise was 85.5 % . Mixed-model repeated measures analyses indicated both resistance ( P = .010 ) and aerobic exercise ( P = .004 ) mitigated fatigue over the short term . Resistance exercise also produced longer-term improvements ( P = .002 ) . Compared with usual care , resistance training improved QOL ( P = .015 ) , aerobic fitness ( P = .041 ) , upper- ( P lower-body ( P ( P = .036 ) , while preventing an increase in body fat ( P = .049 ) . Aerobic training also improved fitness ( P = .052 ) . One serious adverse event occurred in the group that performed aerobic exercise . CONCLUSION In the short term , both resistance and aerobic exercise mitigated fatigue in men with PCa receiving radiotherapy . Resistance exercise generated longer-term improvements and additional benefits for QOL , strength , triglycerides , and body fat",
"PURPOSE To investigate the efficacy and safety of aerobic training ( AT ) in patients with cancer with medically stable heart failure ( HF ) . PATIENTS AND METHODS A retrospective analysis of 90 patients with cancer who have HF and who were r and omly assigned to AT ( n = 47 ) or guideline -based usual care ( UC ; n = 43 ) was performed . AT consisted of three supervised sessions per week at 20 to 45 minutes per session at 60 % to 70 % of heart rate reserve for 12 weeks followed by home-based sessions for 4 to 12 months . The primary end point was all-cause mortality and hospitalization . Secondary end points were other clinical events , safety , and change in exercise capacity ( VO(2peak ) ) and health-related quality of life ( HRQOL ) . RESULTS Median follow-up was 35 months . In intention-to-treat ( ITT ) analyses , all-cause mortality or hospitalization at 2 years was 74 % in the AT group compared with 67 % in the UC group ( adjusted hazard ratio [ HR ] , 1.11 ; 95 % CI , 0.69 to 1.77 ; P = .676 ) . The incidence of cardiovascular mortality or cardiovascular hospitalization was significantly higher in the AT group compared with the UC group ( 41 % v 67 % ; adjusted HR , 1.94 ; 95 % CI , 1.12 to 3.16 ; P = .017 ) . There were no differences in any VO(2peak ) or HRQOL end points . In post hoc analyses based on adherence to AT , all-cause mortality and hospitalization was 66 % in adherent patients ( ≥ 90 minutes per week ) compared with 84 % in nonadherent patients ( patients with cancer who had HF . Post hoc analyses suggested that patients not capable of adhering to the planned AT prescription may be at increased risk of clinical events",
"PURPOSE Arthralgia occurs in up to 50 % of breast cancer survivors treated with aromatase inhibitors ( AIs ) and is the most common reason for poor AI adherence . We conducted , in 121 breast cancer survivors receiving an AI and reporting arthralgia , a yearlong r and omized trial of the impact of exercise versus usual care on arthralgia severity . PATIENTS AND METHODS Eligibility criteria included receiving an AI for at least 6 months , reporting ≥ 3 of 10 for worst joint pain on the Brief Pain Inventory ( BPI ) , and reporting aerobic exercise and no strength training . Participants were r and omly assigned to exercise ( 150 minutes per week of aerobic exercise and supervised strength training twice per week ) or usual care . The BPI , Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index , and Disabilities of the Arm , Shoulder and H and ( DASH ) question naire were completed at baseline and at 3 , 6 , 9 , and 12 months . Intervention effects were evaluated using mixed-model repeated measures analysis , with change at 12 months as the primary end point . RESULTS Over 12 months , women r and omly assigned to exercise ( n = 61 ) attended 70 % ( ± st and ard deviation [ SD ] , 28 % ) of resistance training sessions and increased their exercise by 159 ( ± SD , 136 ) minutes per week . Worst joint pain scores decreased by 1.6 points ( 29 % ) at 12 months among women r and omly assigned to exercise versus a 0.2-point increase ( 3 % ) among those receiving usual care ( n = 60 ; P .001 ) . Pain severity and interference , as well as DASH and WOMAC pain scores , also decreased significantly at 12 months in women r and omly assigned to exercise , compared with increases for those receiving usual care ( all P CONCLUSION Exercise led to improvement in AI-induced arthralgia in previously inactive breast cancer survivors",
"UNLABELLED Observational studies suggest that physical activity after a breast cancer diagnosis is associated with improved cancer outcomes ; however , no r and omized data are available . Here , we report an exploratory follow-up of cancer outcomes from the Supervised Trial of Aerobic versus Resistance Training ( START ) . METHODS The START was a Canadian multicenter trial that r and omized 242 breast cancer patients between 2003 and 2005 to usual care ( n = 82 ) , supervised aerobic ( n = 78 ) , or resistance ( n = 82 ) exercise during chemotherapy . The primary end point for this exploratory analysis was disease-free survival ( DFS ) . Secondary end points were overall survival , distant DFS , and recurrence-free interval . The two exercise arms were combined for analysis ( n = 160 ) , and selected subgroups were explored . RESULTS After a median follow-up of 89 months , there were 25/160 ( 15.6 % ) DFS events in the exercise groups and 18/82 ( 22.0 % ) in the control group . Eight-year DFS was 82.7 % for the exercise groups compared with 75.6 % for the control group ( HR , 0.68 ; 95 % confidence interval ( CI ) , 0.37 - 1.24 ; log-rank , P = 0.21 ) . Slightly stronger effects were observed for overall survival ( HR , 0.60 ; 95 % CI , 0.27 - 1.33 ; log-rank , P = 0.21 ) , distant DFS ( HR , 0.62 ; 95 % CI , 0.32 - 1.19 ; log-rank , P = 0.15 ) , and recurrence-free interval ( HR , 0.58 ; 95 % CI , 0.30 - 1.11 ; Gray test , P = 0.095 ) . Subgroup analyses suggested potentially stronger exercise effects on DFS for women who were overweight/obese ( HR , 0.59 ; 95 % CI , 0.27 - 1.27 ) , had stage II/III cancer ( HR , 0.61 ; 95 % CI , 0.31 - 1.20 ) , estrogen receptor-positive tumors ( HR , 0.58 ; 95 % CI , 0.26 - 1.29 ) , human epidermal growth factor receptor 2-positive tumors ( HR , 0.21 ; 95 % CI , 0.04 - 1.02 ) , received taxane-based chemotherapies ( HR , 0.46 ; 95 % CI , 0.19 - 1.15 ) , and ≥85 % of their planned chemotherapy ( HR , 0.50 ; 95 % CI , 0.25 - 1.01 ) . CONCLUSIONS This exploratory follow-up of the START provides the first r and omized data to suggest that adding exercise to st and ard chemotherapy may improve breast cancer outcomes . A definitive phase III trial is warranted",
"PURPOSE Cancer related fatigue ( CRF ) is a common problem for cancer patients across diagnoses during chemotherapy and is associated with physical inactivity , lower functional level and lack of energy . Few RCT exercise intervention studies have included cancer patients undergoing chemotherapy . The objective of this study is to evaluate whether a six-week supervised multimodal exercise intervention , adjunct to chemotherapy and st and ard care , can reduce the patient 's CRF level . METHODS Data is based on analyses of a prospect i ve r and omised controlled trial ' The Body & Cancer Trial ' . 213 cancer patients with different diagnoses were r and omised into an intervention group or wait-list control group . The primary outcome , Fatigue score ( CRF ) , was evaluated by the Functional Assessment of Cancer Therapy-Anaemia Question naire ( FACT-An- ) ( FACT-G score & FACT-An Anemia subscale ) . INTERVENTION Supervised exercise , comprising high-intensity cardiovascular and heavy resistance training , relaxation- and body awareness training and massage , 9 h weekly for 6 weeks . RESULTS CRF was significantly reduced in the intervention group , corresponding to a Fatigue score reduction of 3.04 ( effect size of 0.44 , 95 % CI 0.17 - 0.72 ) ( P = .002 ) , the FACT-An score by 5.40 ( P = .015 ) , the FACT-An Toi score by 5.22 ( P = .009 ) and the Anaemia-ANS by 3.76 ( P = .002 ) . There was no statistically significant effect on the General Quality of Life score ( FACT-G ) or on any of the individual wellbeing scores ; Physical ( P = .13 ) , Emotional ( P = .87 ) , Social ( P = .83 ) and Functional ( P = .26 ) . CONCLUSION In summary , this six-week supervised multimodal exercise intervention can lead to significant reduction in self-reported CRF in cancer patients undergoing chemotherapy",
"BACKGROUND Prostate cancer is a key driver of cancer-related global disability-adjusted life-years . And rogen-deprivation therapy ( ADT ) for advanced disease is linked to fatigue , reduced physical function , and quality of life ( QoL ) . OBJECTIVE To evaluate the effect of a lifestyle intervention on disease-specific QoL , diastolic blood pressure , and cancer-related fatigue in sedentary men receiving long-term ADT for advanced prostate cancer . DESIGN , SETTING , AND PARTICIPANTS A total of 100 hundred sedentary men with locally advanced or metastatic prostate cancer on long-term ADT were r and omised to an intervention or usual care group . INTERVENTION A 12-wk lifestyle intervention consisting of aerobic and resistance exercise with parallel dietary advice . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Disease-specific QoL was measured using the Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and Functional Assessment of Cancer Therapy-Fatigue ( FACT-F ) question naires at 12 wk postintervention and at 6 mo following withdrawal of support . Analysis of covariance and mixed regression were conducted . RESULTS AND LIMITATIONS Clinical ly relevant improvements in FACT-P were seen at 12 wk in the intervention group compared with controls ( mean difference : 8.9 points ; 95 % confidence interval [ CI ] , 3.7 - 14.2 ; adjusted p=0.001 ) . No difference was apparent at 6 mo ( mean difference : 3.3 points ; 95 % CI , -2.6 to 9.3 ; adjusted p=0.27 ) . No difference in diastolic blood pressure was seen at either follow-up ( all p > 0.05 ) . Clinical ly relevant improvements in FACT-F were seen at 12 wk ( mean difference : 5.3 points ; 95 % CI , 2.7 - 7.9 ; adjusted p in exercise tolerance and behaviour were maintained at 6 mo ( adjusted p disease-specific QoL that was not maintained postintervention . No effect on blood pressure occurred . Durability of response was seen in fatigue and exercise behaviour . Further evaluation of support structures is essential . TRIAL REGISTRATION IS RCT N88605738"
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BACKGROUND Hyperlipidemia increases the risk of cardiovascular diseases , and control is pivotal for preventing disease complications . Multidisciplinary interventions , including those performed by pharmacists , are important for improving patients ' outcomes . OBJECTIVE To quantify the impact of pharmacist interventions in enhancing patients ' outcomes . METHODS Two review ers search ed International Pharmaceutical Abstract s , MEDLINE , EMBASE , The Cochrane Central Register of Controlled Trials , 3rd Quarter , and Cumulative Index to Nursing and Allied Health Literature ( all from inception to July 2007 ) for pharmacist interventions in hyperlipidemia . Quality was assessed using the Downs-Black scale . Data extracted included the number of patients enrolled ; study characteristics ; intervention type ; and pre- and postintervention measures for low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides , total cholesterol , adherence , and quality of life . A r and om effects meta- analysis combined data . Heterogeneity of effects was tested using chi(2 ) analysis . Publication bias was assessed using funnel plots and the Begg-Mazumdar statistic . RESULTS Forty-eight studies were found ; 23 met inclusion criteria . Study setting s included medical clinic/center ( n = 12 ) , community pharmacy ( n = 8) , hospital ( n = 2 ) , and patient homes ( n = 1 ) . Article quality was good ( 71 % + /- 7.0 % ) . Patient education ( 78 % ) and medication management ( 74 % ) were the most common interventions . Total cholesterol was significantly reduced from baseline ( mean + /- SD ; 34.3 + /- 10.3 mg/dL ; p LDL-C was reduced significantly from baseline ( 32.6 + /- 11.3 mg/dL ; p = 0.004 ) , but not significantly more than controls ( 17.5 + /- 10.9 mg/dL ; p = 0.109 ) . A clinical ly relevant but not statistically significant reduction in triglycerides was found . No impact on HDL-C levels was found . Patients ' adherence to pharmacotherapeutic regimens and quality of life were considered possibly not sensitive and possibly sensitive to pharmacist interventions , respectively . CONCLUSIONS Total cholesterol is sensitive to pharmacist interventions , while LDL-C and triglyceride levels are possibly sensitive to those interventions . Further research is required for these outcomes
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"The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life",
"BACKGROUND Pharmacists have been shown to positively impact the outcomes of care for treatment of many different kinds of disease states . In particular , pharmacist-run lipid clinics have enjoyed varying degrees of success , depending on the outcome assessed . At our hospital , when a patient is transferred to the pharmacist-coordinated lipid clinic , the primary care pharmacist is responsible for ordering and interpreting labs and prescribing and monitoring lipid-altering therapy . OBJECTIVE This study was design ed to assess if there is a statistically significant difference between the magnitude of serum cholesterol reduction for patients receiving lipid-altering pharmacotherapy when clinical ly trained pharmacists are actively prescribing and adjusting the drug therapy compared to other health care practitioners ( usual care ) . METHODS Patient records from the hospital computer data bases were retrospectively and r and omly selected for analysis . Following evaluation for inclusion s and exclusions , 41 patient records remained for statistical analysis for the cohort group , and 47 records remained from the group of patients managed by a clinical pharmacist . RESULTS Management of dyslipidemia by a clinical pharmacist was associated with a significant reduction in overall mean low-density lipoprotein ( LDL , 18.5 % ) compared to the cohort that did not have a clinical pharmacist as the primary manager of dyslipidemia ( 6.5 % , P=0.049 ) . This suggests improved clinical outcomes , defined as greater LDL reduction , when clinical pharmacists participate in lipid management , including drug prescribing . The magnitude reduction in LDL was found to be related to the number of clinical pharmacy visits ( 11.4 % for 1 visit , 23.2 % for 2 visits , and 23.7 % for > 3 visits ) , compared to the usual care group ( -11.0 % , 18.0 % , and 7.4 % ; statistically significant , P=0.038 , for > 3 visits only ) . These results occurred even though the group of dyslipidemic patients managed primarily by a clinical pharmacist contained a statistically greater number of patients with 2 or more risk factors and high-density lipoprotein ( HDL ) levels less than 40 mg/dL. CONCLUSION Interdisciplinary medical teams that include clinical pharmacists who are actively prescribing and adjusting lipid drug therapy may achieve greater reductions in LDL for patients who have been assessed with multiple risk factors compared to patients managed without clinical pharmacists . Active participation by clinical pharmacists in lipid management for patients with elevated LDL result ed in improved treatment success as measured by the magnitude reduction in LDL . The reduction in LDL was between 5 % and 22 % per visit greater for patients being treated by clinical pharmacists versus usual care , even in a patient population with more risk factors . These intermediate outcomes may translate into long-term outcomes in fewer cardiovascular events , improved quality of life for patients with dyslipidemia , and lower costs associated with sequelae of dyslipidemias",
"OBJECTIVES To identify patients at risk for coronary artery disease ( CAD ) through a search of a community pharmacy 's prescription data base , to screen and identify patients with elevated cholesterol and at risk for CAD , to enroll patients in a pharmacist-directed lipid management program , and to evaluate selected clinical and humanistic outcomes . DESIGN R and omized , pretest-posttest control groups . SETTING Independent community pharmacy in a suburban metropolitan area . PATIENTS 51 patients who were not at National Cholesterol Education Program low-density lipoprotein cholesterol ( LDL-C ) or defined triglyceride goals and who met inclusion criteria . INTERVENTION Pharmacist-directed lipid management program . MAIN OUTCOME MEASURES Clinical outcome measures included total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , and triglyceride levels ; achievement of LDL-C goal ; and risk factor prediction scores . Humanistic outcome measures included patient satisfaction with pharmaceutical care and patient knowledge of hyperlipidemia . RESULTS LDL-C was decreased in the pharmacist intervention group ( n = 25 ) , compared with an increase in the control group at study end . HDL-C levels increased and triglyceride levels decreased in both groups . Of treatment group patients , 32 % achieved their cholesterol goals , compared with 15 % of control group patients . Risk factor prediction scores improved in the treatment group and worsened in the control group . The treatment group 's hyperlipidemia knowledge scores improved significantly from pretest to posttest . Both treatment and control group patient satisfaction scores for the pharmacist investigator were favorable at study end . CONCLUSION Both treatment and control patients benefited from participating in this study . Patients enrolled in the lipid management program made greater improvements in their knowledge of hyperlipidemia , risk factor scores , and cholesterol levels",
"CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier :",
"OBJECTIVE : To implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting , to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz , and to measure patient outcomes result ing from provision of pharmaceutical care to patients with hyperlipidemia . DESIGN : A prospect i ve study was conducted over a 1 -year period . Patients served as their own controls . SETTING : Two independent community pharmacies in Richmond , Virginia . PARTICIPANTS : Twenty-five adult patients with confirmed dyslipidemias completed the study . INTERVENTIONS : Study pharmacists assessed each patient and assisted in setting therapeutic goals ; patients also completed a visit with a registered dietitian . Drug therapy recommendations were made to physicians by the pharmacist when appropriate . Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects . MAIN OUTCOME MEASURES : Fasting lipoprotein profiles were measured initially and at 6 and 12 months . The SF-36 survey , the MacKeigan-Larson satisfaction survey , and a patient opinion survey were administered initially and at the conclusion of the study . RESULTS : Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values ( p quality of life , patient satisfaction with pharmacy services , and patient opinions on the role of the pharmacist improved after the intervention . CONCLUSIONS : Pharmaceutical care may positively affect lipid values , quality of life , and patient satisfaction",
"BACKGROUND Despite clear evidence for the efficacy of lowering cholesterol levels , there is a deficiency in its real-world application . There is a need to explore alternative strategies to address this important public health problem . This study aim ed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events . METHODS A r and omized controlled trial conducted in 54 community pharmacies ( 1998 - 2000 ) included patients at high risk for cardiovascular events ( with atherosclerotic disease or diabetes mellitus with another risk factor ) . Patients r and omized to pharmacist intervention received education and a brochure on risk factors , point-of-care cholesterol measurement , referral to their physician , and regular follow-up for 16 weeks . Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions . Usual care patients received the same brochure and general advice only , with minimal follow-up . The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication . RESULTS The external monitoring committee recommended early study termination owing to benefit . Of the 675 patients enrolled , approximately 40 % were women , and the average age was 64 years . The primary end point was reached in 57 % of intervention patients vs 31 % in usual care ( odds ratio , 3.0 ; 95 % confidence interval , 2.2 - 4.1 ; P community-based intervention program improved the process of cholesterol management in high-risk patients . This program demonstrates the value of community pharmacists working in collaboration with patients and physicians",
"We conducted a prospect i ve trial to determine whether a formal , integrated pharmaceutical care plan can enhance patient acceptance and compliance with colestipol therapy and improve outcomes . Forty patients with hypercholesterolemia were equally divided and assigned to either a usual care or pharmaceutical care group . In the pharmaceutical care group compared with the usual care group , after 52 weeks , colestipol therapy result ed in a greater reduction in total cholesterol ( 12.5 % vs 7.3 % ) , low-density lipoprotein cholesterol ( LDL-C ; 16 % vs 9.4 % ) , and LDL-C : high-density lipoprotein cholesterol ( HDL-C ) ratio ( 24.4 % vs 12.2 % , p achieved their LDL-C goal at week 52 was much greater in the pharmaceutical care group ( 29.4 % ) than in the usual care group ( 5.0 % , p hypercholesterolemic veterans treated with colestipol can enhance patient acceptance of the drug , LDL-C reduction , and achievement of therapeutic goals",
"BACKGROUND Dyslipidemias are a modifiable risk factor for coronary heart disease . The benefits of cholesterol reduction drug therapies are limited by poor patient compliance with drug regimens . OBJECTIVES To determine the impact of a community pharmacist pilot disease-management program on patient compliance with lipid-lowering drug therapy and on serum cholesterol levels . METHODS One hundred forty-nine patients who were nonadherent to prescribed hypolipidemic drug regimens were recruited for this six-month prospect i ve study . Each subject served as their own control . Pharmacists educated these patients on lipid disorders , the benefit of medication compliance and lifestyle modifications that reduce the risk for coronary heart disease . Pharmacists followed up participants by telephone at two-month intervals . Drug renewal rates were monitored throughout the study and plasma lipid levels were measured at study outset and study end . RESULTS Pharmacist intervention and patient-education programs significantly increased medication compliance , as shown by a 15.3 % increase ( P compliant patients and an 11 day ( P number of days to prescription renewal . Concurrently , levels of total cholesterol , triglycerides and low-density lipoprotein ( LDL ) cholesterol , were reduced by 6 % , 16.2 % , and 8.5 % ( P High density lipoprotein ( HDL ) cholesterol remained relatively unchanged ( + 0.7 % ) so that the LDL to HDL ratio was improved by 17.2 % overall ( P<0.01 ) . Almost all of the patients ( 99.2 % ) were satisfied with the program and expressed a willingness to pay an average $ 34.50 per 30 min consultation for the pharmacist services offered . CONCLUSION Pharmacists can contribute significantly to disease management of dyslipidemic individuals",
"OBJECTIVE The objective of this study was to assess the effectiveness of pharmacist- managed dyslipidemia clinics at 2 Veterans Affairs medical centers since the release of the 2001 National Cholesterol Education Panel Adult Treatment Panel III ( NCEP ATP III ) guideline compared with the usual care ( UC ) provided by other health care professionals in the same setting . METHODS Analysis was performed through retrospective chart review of patients with a diagnosis of dyslipidemia who received care in either the Amarillo or Lubbock , Texas , pharmacist-managed lipid clinics ( LCs ) or UC from a primary care physician . Data from medical charts were abstract ed for date s of service from July 2001 to December 2003 for 115 patients selected r and omly from LC rolls matched with 115 patients with a diagnosis of dyslipidemia selected r and omly from UC . All patients had to have had at least 3 visits with the LC or 3 visits in UC with a billing code of dyslipidemia ; they were followed for at least 6 months after an initial visit in July 2001 or thereafter and were enrolled in the VA health care system for at least 1 year . Baseline lipid values were available for LC but not UC patients . Cholesterol target goals were determined according to NCEP ATP III guideline . RESULTS After an average of 21.6 months of follow-up , the proportion of patients in the LC group that attained goal level increased from 45.2 % at baseline to 82.6 % for total cholesterol ( TC ) and from 36.5 % at baseline to 64.3 % for lowdensity lipoprotein cholesterol ( LDL-C [ P LDL-C along with significant improvements in the other lipid levels ( P TC and LDL-C , P = 0.007 for triglycerides [ TGs ] ) with the exception of highdensity lipoprotein cholesterol ( HDL-C ) , which declined from 40.0 mg/dL to 36.3 mg/dL ( P goal LDL-C ( 64.3 % vs. 15.7 % for UC , P TC ( 82.6 % vs. 40.9 % , P proportion of patients at TG goal for LC ( 65.2 % ) compared with UC ( 52.2 % , P = 0.061 ) or at HDL-C goal ( 23.5 % for LC vs. 33.0 % for UC , P = 0.143 ) . A higher proportion of LC patients ( 93.9 % ) used lipid-lowering agents compared with UC patients ( 24.3 % , P total cholesterol compared with 60.7 % for UC ( P = 0.012 ) and at goal LDL-C ( 66.7 % for LC vs. 39.3 % for UC , P = 0.016 ) . However , a lower proportion were at goal HDL-C for LC ( 21.3 % ) versus 42.9 % for UC ( P = 0.043 ) . Overall , only 11 LC patients ( 9.6 % ) attained goal levels for all 4 serum lipid values by the end of follow-up versus 2 UC patients ( 1.7 % , P = 0.019 ) . CONCLUSIONS Nearly two thirds of patients diagnosed with dyslipidemia and enrolled in a pharmacist-managed LC had LDL-C levels at or below NCEP ATP III target goal compared with 16 % of dyslipidemia patients who received UC from their primary care provider . The pharmacist-managed LC patients were also twice as likely ( 83 vs. 41 % ) to have attained the TC target goal , but there was no difference between the 2 groups in the proportion of patients who attained either TG or HDL-C target goals . Only 9.6 % of LC patients were at goal for all 4 individual lipid measures at the end of follow-up",
"BACKGROUND : Inappropriate use of medications is a significant problem in health care today . A possible solution to this problem may be achieved through better control of patients ' drug therapy . OBJECTIVE : To design a pharmaceutical care program for dyslipidemic patients within a community pharmacy setting that provides education in the areas of medication compliance and lifestyle modifications , while emphasizing the importance of achieving cholesterol goals to ensure improvement in quality of life . METHODS : Patients at an outpatient pharmacy volunteered to be surveyed for 16 weeks . Although both the intervention and control groups were surveyed , the r and omly selected intervention group was interviewed more frequently and more comprehensively . Cholesterol , triglycerides , glucose , weight , risk factors , drug-related problems ( DRPs ) , and quality of life were measured via a survey at the onset of the study and continually measured until the study 's conclusion . RESULTS : In the intervention group , 26 DRPs were detected , of which 24 were resolved ; in the control group , 26 DRPs were detected , of which 5 were resolved . When comparing initial and final blood cholesterol levels in the intervention group , the mean decrease was 27.0 ± 41.1 mg/dL ( p = 0.0266 ) ; in the control group , the average blood cholesterol level decreased by a mean of 1.4 ± 37.2 mg/dL ( p = 0.6624 ) . In the intervention group , the triglyceride level decreased an average of 50.5 ± 80.3 mg/dL ( p = 0.0169 ) , while the control group experienced a mean triglyceride level increase of 29.6 ± 118.5 mg/dL ( p = 0.1435 ) . As a result of the intervention , the quality of life in the intervention group was improved . CONCLUSIONS : Short-term pharmaceutical care plans developed in a retail pharmacy within the proper setting may contribute to improved blood lipid values , cardiovascular disease risk factors , and patients ' quality of life",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"STUDY OBJECTIVE To determine the effect of a community pharmacist intervention in patients at high risk for coronary heart disease on low-density lipoprotein cholesterol ( LDL ) levels 1 year after completion of the Second Study of Cardiovascular Risk Intervention by Pharmacists ( SCRIP- plus ) . METHODS Patients who completed the original study were invited to make a single return visit to their community pharmacy so that the pharmacist could measure their fasting LDL level using a point-of-care device . The primary outcome was change in LDL level from the 6-month ( final ) visit to the extended follow-up evaluation . RESULTS Of the 359 patients who completed the original 6-month visit , data were collected for 162 ( 45 % ) patients . The mean + /- SD LDL level at completion of the original study was 107.9 + /- 33.6 mg/dl ( 2.79 + /- 0.96 mmol/L ) ( an increase of 2.7 mg/dl [ 0.07 mmol/L ] , 95 % confidence interval -19.3 - 7.3 [ -0.5 - 0.19 ] ) . Sixty-one ( 38 % ) patients were at the target LDL level ( LDL reduction was maintained 1 year after completion of the extended follow-up . Since most patients were still not at the target LDL level , this finding suggests that continuing intervention is necessary to help patients reach this target",
"AIMS Correct execution of prescribed dosing regimen(s ) is essential for patients to benefit from lipid lowering treatments . The objective of this study was to estimate the effect of a pharmaceutical care program on the adherence of once-daily atorvastatin treatment in patients with elevated cholesterol levels . METHODS In both linguistic regions of Belgium , two districts were r and omized between usual care and a supportive intervention program . Eligible patients included hyperlipemic subjects taking atorvastatin for at least 3 months . ' Adherence ' was defined as the proportion of days during which the electronic device record showed that the patient had taken the daily dose . ' Persistence ' quantifies how long the treatment is executed . RESULTS A total of 392 patients from 35 pharmacies were included in the intent-to-treat ( ITT ) analysis of the data ( 194 patients received intervention and 198 in the control group ) . The intervention result ed in a 6.5 % increase in post-baseline adherence ( p persistence at 1 year ( p = 0.002 ) . CONCLUSION A supportive pharmaceutical care program consisting of review by patient and pharmacist of each patient 's electronically compiled dosing history , plus educational reminders , improves patient adherence to the once-daily atorvastatin dosing regimen , mainly by extending persistence",
"STUDY OBJECTIVES To objective ly compare the results of a collaborative approach using pharmacists with the results of usual care for achieving a low-density lipoprotein cholesterol ( LDL ) goal of 100 mg/dl or less in out patients with documented coronary heart disease ( CHD ) who are not at goal , and to document the effect on LDL after removal of such a collaborative model from the study population . DESIGN Prospect i ve , multiclinic , controlled study . SETTING Four clinics of a 19-clinic staff model health maintenance organization in Minneapolis and St. Paul , Minnesota . Two clinics treated the intervention patients , two the controls ; one clinic for each group was suburban , and one for each was urban . PATIENTS Four hundred eighty-one patients aged 18 years or older with CHD and whose LDL levels were not at goal . INTERVENTION Clinical pharmacists implemented the physician-approved care plan for each intervention patient ; activities included managing lipid-lowering drug therapy and educating patients on cardiovascular risk reduction . MEASUREMENTS AND MAIN RESULTS Primary outcomes were changes in LDL level and the proportion of patients achieving goal LDL in the intervention versus the usual care ( control ) group . Secondary outcomes were the sustainability of the impact observed up to 18 months after discontinuation of the intervention . Mean+/-SD baseline LDL levels were 131+/-28 and 131+/-26 mg/dl ( p = NS ) for the intervention and control groups , respectively . After a mean of 6.5 months follow-up , 107 ( 72 % ) patients in the intervention group and 61 ( 18 % ) patients in the control group had attained their LDL goal ( p Mean LDL levels were reduced by 35.6 mg/dl ( 27.5 % ) and 6.7 mg/dl ( 4.6 % ) in the intervention and control groups , respectively ( p approach as an intervention to optimize management of patients with CHD whose LDL levels are not at goal ; this approach is specifically called for in the executive summary of the National Cholesterol Education Program Adult Treatment Panel III . Furthermore , this study documents both the magnitude and sustainability of the impact collaborative care models can have in managed care environments",
"A prospect i ve controlled study on the benefits of pharmacists ' individualized counseling on drug compliance , cholesterol concentration reduction , attainment of National Cholesterol Education Program ( NCEP ) Adult Treatment Panel III ( ATP III ) low-density lipoprotein cholesterol ( LDL-C ) goals , and patient satisfaction was carried out in a private community hospital in Hong Kong . All patients who were newly prescribed with lipid-lowering drugs for primary prevention were included . The patients in the individualized counseling group received \" intense \" counseling and follow-up of cholesterol concentration by a pharmacist for 3 months . The control group received routine counseling . Fifty patients completed the study ( 26 in the individualized group , 24 in the control group ) . Compliance was assessed , and those patients who achieved 75 % compliance were defined as compliers . In the individualized group , 76.9 % were compliers compared with 41.7 % in the control group ( p total cholesterol , LDL-C , and triglycerides , respectively , compared with 15.3 % , 16.3 % , and 10.6 % in the control group ( p ATP III LDL-C goals compared to 58.3 % in the control group ( p pharmacist counseling service could improve their disease management . The study demonstrated that pharmacists ' individualized counseling , together with the assessment of cholesterol concentrations , had positive impacts on the management of hyperlipidemia , including improved drug compliance , better treatment endpoints , and patient satisfaction",
"The objective was to study the effect of \" academic group detailing \" on the prescribing of lipid-lowering drugs in Swedish primary care . A r and omized controlled trial was conducted , r and omization being by group . Groups of doctors at 134 community health centres were r and omly allocated to an intervention and a control group . The 67 intervention health centres were offered four sessions , conducted by a pharmacist , with group information on guidelines for the management of hyperlipidaemia . The number of prescriptions of lipid-lowering drugs per month increased in the intervention health centres and the increase was statistically different from the corresponding change in the control health centres among women in the age group 30 - 65 years ( p = 0.03 ) . The prescription of first-line lipid-lowering drugs increased by 20 % in the intervention health centres ( p = 0.03 ) . \" Academic group detailing \" by pharmacists to primary care doctors can be an effective method for influencing prescribing practice",
"OBJECTIVE To evaluate a pharmacist-conducted educational and monitoring programme , design ed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy , for patients with dyslipidaemia . METHODS This was a prospect i ve , r and omized , controlled study . The participants were 94 adults , with 81 completing the study ( intervention group : 39 ; control group : 42 ) , with a cardiovascular-related diagnosis and discharged from hospital , between April and October 2001 , on lipid-lowering drug therapy . Patients in the intervention group were visited at home monthly by a pharmacist , who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy , assessed patients for drug-related problems , and measured total blood cholesterol levels using point-of-care testing . Patients in the control group received st and ard medical care . The main outcome measure was total blood cholesterol levels after 6 months , and an evaluation of patient and general practitioner satisfaction with the programme . RESULTS There was no significant difference in baseline total blood cholesterol levels between the two groups . The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant ( 4.9 + /- 0.7 to 4.4 + /- 0.6 , P cholesterol levels below 4.0 mmol/L ( P=0.06 ) . The reduction in total cholesterol in the intervention group should translate to an expected 21 % reduction in cardiovascular mortality risk and a 16 % reduction in total mortality risk -- more than twice the risk reduction achieved in the control group . In addition , the programme was very well received by the patients and their general practitioners , by satisfaction question naire . CONCLUSION A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy",
"OBJECTIVE To evaluate apparent discontinuation rates in patients newly prescribed lipid-lowering drugs . DESIGN AND SETTING A prospect i ve survey of 12 months ' dispensing data in 138 community pharmacies across metropolitan Sydney . PATIENTS 610 adults ( 49 % men ) with a mean age of 58 years ; 91 % of prescriptions were from general practitioners ; prescribed drugs were simvastatin ( 54 % ) , pravastatin ( 31 % ) and gemfibrozil ( 15 % ) . MAIN OUTCOME MEASURE The number of patients failing to collect prescription refills . RESULTS 60 % of patients ( 95 % confidence interval [ CI ] , 56%-64 % ) apparently discontinued their medication over 12 months . Half of the apparent discontinuations occurred within three months and a quarter within one month of starting treatment . The predominant reasons for discontinuation were : patient unconvinced about need for treatment ( 32 % ) , poor efficacy ( 32 % ) and adverse events ( 7 % ) . Only half of those experiencing poor efficacy were switched to another drug . The relative risk ( RR ) of discontinuation was lower in older patients ( age 65 + v. : RR 0.66 ; 95 % CI 0.47 - 0.93 ) and in those using other cardiovascular drugs ( RR 0.69 ; CI 0.56 - 0.86 ) , but was increased in those showing early evidence of poor compliance ( RR 1.77 ; CI 1.33 - 2.35 ) . Discontinuation appeared to be unrelated to sex , the source of the prescription ( general practitioner or specialist ) , past use of lipid-lowering drugs or the cost of medication . CONCLUSIONS High apparent discontinuation rates with lipid-lowering drugs suggest significant wastage of re sources in treatments that are initiated but not continued and a lost opportunity for heart disease prevention . Many patients appear to discontinue therapy for illogical reasons and this may be amenable to intervention"
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The aim of this review was to recommend training strategies that improve the functional capacity in physically frail older adults based on scientific literature , focusing specially in supervised exercise programs that improved muscle strength , fall risk , balance , and gait ability . Scielo , Science Citation Index , MEDLINE , Scopus , Sport Discus , and ScienceDirect data bases were search ed from 1990 to 2012 . Studies must have mentioned the effects of exercise training on at least one of the following four parameters : Incidence of falls , gait , balance , and lower-body strength . Twenty studies that investigated the effects of multi-component exercise training ( 10 ) , resistance training ( 6 ) , endurance training ( 1 ) , and balance training ( 3 ) were included in the present revision . Ten trials investigated the effects of exercise on the incidence of falls in elderly with physical frailty . Seven of them have found a fewer falls incidence after physical training when compared with the control group . Eleven trials investigated the effects of exercise intervention on the gait ability . Six of them showed enhancements in the gait ability . Ten trials investigated the effects of exercise intervention on the balance performance and seven of them demonstrated enhanced balance . Thirteen trials investigated the effects of exercise intervention on the muscle strength and nine of them showed increases in the muscle strength . The multi-component exercise intervention composed by strength , endurance and balance training seems to be the best strategy to improve rate of falls , gait ability , balance , and strength performance in physically frail older adults
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"OBJECTIVES To determine the independent and combined effects of progressive resistance muscle strength training ( PRMST ) and megestrol acetate ( MA ) on strength , muscle mass , and function in older recuperative care patients . DESIGN Double-blind , r and omized , controlled intervention using a two-by-two factorial design and conducted between 1999 and 2001 . SETTING University-affiliated Department of Veterans Affairs hospital . PARTICIPANTS Twenty-nine patients ( mean age 79.4 + /- 7.4 , 90 % white ) aged 65 and older and had recent functional decline . INTERVENTIONS After r and omization to one of four treatment groups ( low-resistance exercises plus 800 mg per day of MA or a placebo or high-intensity PRMST plus 800 mg/d of MA or placebo ) , subjects received training and the drug or placebo for 12 weeks . MEASUREMENTS Change in muscle strength , mid-thigh muscle area , and aggregate functional performance score as assessed using analysis of covariance . RESULTS Five subjects withdrew from the study before its completion . Based on intent-to-treat analyses , subjects who received high-intensity PRMST and placebo experienced the greatest strength gains . The addition of MA was associated with worse outcomes than with high-intensity exercise training alone , especially with regard to the leg exercises . Post hoc analysis demonstrated that subjects who received high-intensity PRMST and placebo experienced significantly greater percentage increases in leg strength than subjects in either of the MA treatment groups ( P MA on physical function . In general , subjects who received MA experienced a deterioration in aggregate physical function scores , whereas the remaining subjects improved ( -0.80+/-0.40 vs 0.48+/-0.41 , P=.04 ) . There was not a significant interaction between exercise and MA for any outcome . CONCLUSION High-intensity PRMST is a safe and well-tolerated exercise regimen for frail elderly patients . The addition of MA appears to blunt the beneficial effects of PRMST , result ing in less muscle strength and functional performance gains",
"OBJECTIVE To evaluate the effects of two exercise approaches , Tai Chi ( TC ) and computerized balance training ( BT ) , on specified primary outcomes ( biomedical , functional , and psychosocial indicators of frailty ) and secondary outcomes ( occurrence of falls ) . DESIGN The Atlanta FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) , a prospect i ve , r and omized , controlled clinical trial with three arms ( TC , BT , and education [ ED ] . Intervention length was 15 weeks , with primary outcomes measured before and after intervention and at 4-month follow-up . Falls were monitored continuously throughout the study . SETTING Persons aged 70 and older living in the community . PARTICIPANTS A total of 200 participants , 162 women and 38 men ; mean age was 76.2 . MEASUREMENTS Biomedical ( strength , flexibility , cardiovascular endurance , body composition ) , functional ( IADL ) , and psychosocial well-being ( CES-D scale , fear of falling question naire , self-perception of present and future health , mastery index , perceived quality of sleep , and intrusiveness ) variables . RESULTS Grip strength declined in all groups , and lower extremity range of motion showed limited but statistically significant changes . Lowered blood pressure before and after a 12-minute walk was seen following TC participation . Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group ( P = .046 and P = .058 , respectively ) . After adjusting for fall risk factors , TC was found to reduce the risk of multiple falls by 47.5 % . CONCLUSIONS A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty . This intervention can also have favorable effects upon the occurrence of falls . Tai Chi warrants further study as an exercise treatment to improve the health of older people",
"OBJECTIVE To determine the safety and efficacy of an exercise protocol design ed to improve strength , mobility , and balance and to reduce subsequent falls in geriatric patients with a history of injurious falls . DESIGN A r and omized controlled 3-month intervention trial , with an additional 3-month follow-up . SETTING Out-patient geriatric rehabilitation unit . PARTICIPANTS Fifty-seven female geriatric patients ( mean age 82 + /- 4.8 years ; range 75 - 90 ) admitted to acute care or inpatient rehabilitation with a history of recurrent or injurious falls including patients with acute fall-related fracture . INTERVENTION Ambulatory training of strength , functional performance , and balance 3 times per week for 3 months . Patients of the control group attended a placebo group 3 times a week for 3 months . Both groups received an identical physiotherapeutic treatment 2 times a week , in which strengthening and balance training were excluded . MEASUREMENTS Strength , functional ability , motor function , psychological parameters , and fall rates were assessed by st and ardized protocol s at the beginning ( T1 ) and the end ( T2 ) of intervention . Patients were followed up for 3 months after the intervention ( T3 ) . RESULTS No training-related medical problems occurred in the study group . Forty-five patients ( 79 % ) completed all assessment s after the intervention and follow-up period . Adherence was excellent in both groups ( intervention 85.4 + /- 27.8 % vs control 84.2 + /- 29.3 % ) . The patients in the intervention group increased strength , functional motor performance , and balance significantly . Fall-related behavioral and emotional restrictions were reduced significantly . Improvements persisted during the 3-month follow-up with only moderate losses . For patients of the control group , no change in strength , functional performance , or emotional status could be documented during intervention and follow-up . Fall incidence was reduced nonsignificantly by 25 % in the intervention group compared with the control group ( RR:0.753 CI:0.455 - 1.245 ) . CONCLUSIONS Progressive resistance training and progressive functional training are safe and effective methods of increasing strength and functional performance and reducing fall-related behavioral and emotional restrictions during ambulant rehabilitation in frail , high-risk geriatric patients with a history of injurious falls",
"This study investigated the effects of different intra-session exercise sequences in the cardiovascular and neuromuscular adaptations induced by concurrent training in elderly . Twenty-six healthy elderly men ( 64.7±4.1years ) , were r and omly placed into two concurrent training groups : strength training prior to ( SE , n=13 ) or after ( ES , n=13 ) endurance training . Subjects trained strength and endurance training 3 times per week performing both exercise types in the same training session . The peak oxygen uptake ( VO(2peak ) ) , maximum aerobic workload ( W(máx ) ) , absolute ( VT(1 ) and VT(2 ) ) and relative ( VT(1)% and VT(2)% ) ventilatory thresholds , as well as workloads at VT(1 ) and VT(2 ) ( W(VT1 ) and W(VT2 ) ) were evaluated during a maximal incremental test on a cycle ergometer before and after the training . In addition , muscle quality ( MQ ) was evaluated by the quotient between maximal dynamic strength ( one repetition maximum test ) of the knee extensors and the quadriceps femoris muscle thickness determined by ultrasonography . There were no modifications after training in the VT(1 ) , VT(2 ) , VT(1)% , and VT(2)% . There was significant increase in the W(VT1 ) only in SE ( P the W(VT2 ) in both groups ( P the VO(2peak ) , with both groups showing increases ( P in the W(máx ) ( P The force per unit of muscle mass of knee extensors increased in both groups ( P maximal endurance power adaptations to concurrent training , but had influence in the magnitude of the muscle quality enhancements",
"Objective To assess the prevalence of the frailty syndrome and its associated variables among the older adult population in the province of Toledo ( Spain ) . Methods Data were taken from the Toledo Study for Healthy Aging , a population -based study conducted on 2,488 individuals aged 65 years and older . Study participants were selected by a two-stage r and om sampling from the municipal census of Toledo , covering both institutionalized and community dwelling persons from rural and urban setting s. Data were collected from 2006 to 2009 , and included information on social support , activities of daily living , comorbidity , physical activity , quality of life , depressive symptoms , and cognitive function . In addition , a nurse collected anthropometric data , conducted tests of physical performance ( walk speed , upper and lower extremities strength , and the st and - and -sit from a chair test ) and obtained a blood sample . The diagnosis of the frailty syndrome was based on the Fried criteria ( weakness , low speed , low physical activity , exhaustion , and weight loss ) . Results In total , 41.8 % ( 95 % confidence interval [ CI ] 39.4–44.2 % ) of the study participants were prefrail , and 8.4 % ( 95 % CI 7.1–9.8 % ) were frail . There were no differences in the prevalence of frailty by sex , level of education , occupation , marital status , or place of residence . The frequency of the frailty syndrome increased with age , and was higher in those with disability , depression , hip fracture and other comorbidity , such as cardiovascular disease and disorders of the central nervous system . Conclusions The prevalence of the frailty syndrome in older Spanish adults is high and similar to that reported in other population s in the Mediterranean basin",
"BACKGROUND recent studies have found that moderate intensity exercise is an effective intervention strategy for preventing falls in older people . However , research is required to determine whether supervised group exercise programmes , conducted in community setting s with at-risk older people referred by their health care practitioner are also effective in improving physical functioning and preventing falls in this group . OBJECTIVES to determine whether participation in a weekly group exercise programme with ancillary home exercises over one year improves balance , muscle strength , reaction time , physical functioning , health status and prevents falls in at-risk community-dwelling older people . METHODS the sample comprised 163 people aged over 65 years identified as at risk of falling using a st and ardised assessment screen by their general practitioner or hospital-based physiotherapist , residing in South Western Sydney , Australia . Subjects were r and omised into either an exercise intervention group or a control group . Physical performance and general health measures were assessed at baseline and repeated 6-months into the trial . Falls were measured over a 12-month follow-up period using monthly postal surveys . RESULTS at baseline both groups were well matched in their physical performance , health and activity levels . The intervention subjects attended a median of 23 exercise classes over the year , and most undertook the home exercise sessions at least weekly . At retest , the exercise group performed significantly better than the controls in three of six balance measures ; postural sway on the floor with eyes open and eyes closed and coordinated stability . The groups did not differ at retest in measures of strength , reaction time and walking speed or on Short-Form 36 , Physical Activity Scale for the Elderly or fear of falling scales . Within the 12-month trial period , the rate of falls in the intervention group was 40 % lower than that of the control group ( IRR=0.60 , 95 % CI 0.36 - 0.99 ) . CONCLUSIONS these findings indicate that participation in a weekly group exercise programme with ancillary home exercises can improve balance and reduce the rate of falling in at-risk community dwelling older people",
"The purpose of the study was to examine the effects of 12 weeks high-speed power training on isometric contraction ( h and grip strength ) , maximal strength ( 1RM ) , muscle power ( walking velocity , counter movement jump and ball throwing ) and functional tasks of the arm and leg muscles ( sit-to-st and and get-up and go ) . Fifty-six older women were divided into an experimental group and a control group [ EG , n=28 , 62.5 ( 5.4 ) years ; CG : n=28 , 62.5 ( 4.3 ) years ] . The EG was su bmi tted to a high-speed power training that consisted of 40 % of one repetition maximum ( 1 ) to 75 % of 1RM ) ; 3 sets 4 - 12 reps , countermovement jump and medicine ball ( 1.5 kg ) throwing . Over the 12-week training period , the EG significantly increased dynamic and isometric strength performance ( 57 % to 61 % ) , muscle power ( range from 14 % to 40 % ) ( P function ( P high-speed power training is an effective exercise approach leading to large gains in upper and lower extremity muscle performance and function capacity",
"Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older , high risk people living at home . Design Three arm , r and omised parallel trial ; assessment s at baseline and after six and 12 months . R and omisation done by computer generated r and om blocks , stratified by sex and fall history and concealed by an independent secure website . Setting Residents in metropolitan Sydney , Australia . Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months , recruited from Veteran ’s Affairs data bases and general practice data bases . Exclusion criteria were moderate to severe cognitive problems , inability to ambulate independently , neurological conditions that severely influenced gait and mobility , resident in a nursing home or hostel , or any unstable or terminal illness that would affect ability to do exercises . Interventions Three home based interventions : Lifestyle integrated Functional Exercise ( LiFE ) approach ( n=107 ; taught principles of balance and strength training and integrated selected activities into everyday routines ) , structured programme ( n=105 ; exercises for balance and lower limb strength , done three times a week ) , sham control programme ( n=105 ; gentle exercise ) . LiFE and structured groups received five sessions with two booster visits and two phone calls ; controls received three home visits and six phone calls . Assessment s made at baseline and after six and 12 months . Main outcome measures Primary measure : rate of falls over 12 months , collected by self report . Secondary measures : static and dynamic balance ; ankle , knee and hip strength ; balance self efficacy ; daily living activities ; participation ; habitual physical activity ; quality of life ; energy expenditure ; body mass index ; and fat free mass . Results After 12 months ’ follow-up , we recorded 172 , 193 , and 224 falls in the LiFE , structured exercise , and control groups , respectively . The overall incidence of falls in the LiFE programme was 1.66 per person years , compared with 1.90 in the structured programme and 2.28 in the control group . We saw a significant reduction of 31 % in the rate of falls for the LiFE programme compared with controls ( incidence rate ratio 0.69 ( 95 % confidence interval 0.48 to 0.99 ) ) ; the corresponding difference between the structured group and controls was non-significant ( 0.81 ( 0.56 to 1.17 ) ) . Static balance on an eight level hierarchy scale , ankle strength , function , and participation were significantly better in the LiFE group than in controls . LiFE and structured groups had a significant and moderate improvement in dynamic balance , compared with controls . Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention . Functional based exercise should be a focus for interventions to protect older , high risk people from falling and to improve and maintain functional capacity . Trial registration Australia and New Zeal and Clinical Trials Registry 12606000025538",
"OBJECTIVES To compare the effectiveness of tai chi and low-level exercise in reducing falls in older adults ; to determine whether mobility , balance , and lower limb strength improved and whether higher doses of tai chi result ed in greater effect . DESIGN R and omized controlled trial . SETTING Eleven sites throughout New Zeal and . PARTICIPANTS Six hundred eighty-four community-residing older adults ( mean age 74.5 ; 73 % female ) with at least one falls risk factor . INTERVENTION Tai chi once a week ( TC1 ) ( n = 233 ) ; tai chi twice a week ( TC2 ) ( n = 220 ) , or a low-level exercise program control group ( LLE ) ( n = 231 ) for 20 wks . MEASUREMENTS Number of falls was ascertained according to monthly falls calendars . Mobility ( Timed-Up- and -Go Test ) , balance ( step test ) , and lower limb strength ( chair st and test ) were assessed . RESULTS The adjusted incident rate ratio ( IRR ) for falls was not significantly different between the TC1 and LLE groups ( IRR = 1.05 , 95 % confidence interval ( CI ) = 0.83 - 1.33 , P = .70 ) or between the TC2 and LLE groups ( IRR = 0.88 , 95 % CI = 0.68 - 1.16 , P = .37 ) . Adjusted multilevel mixed-effects Poisson regression showed a significant reduction in logarithmic mean fall rate of -0.050 ( 95 % CI = -0.064 to -0.037 , P improvements in balance ( P lower limb strength ( P mobility ( P = .54 ) in all groups over time , with no differences between the groups ( P = .37 ( right leg ) , P = .66 ( left leg ) , P = .21 , and P = .44 , respectively ) . CONCLUSION There was no difference in falls rates between the groups , with falls reducing similarly ( mean falls rate reduction of 58 % ) over the 17-month follow-up period . Strength and balance improved similarly in all groups over time",
"To determine the mechanisms underlying increased aerobic power in response to exercise training in octogenarians , we studied mildly frail elderly men and women r and omly assigned to an exercise group ( n = 22 ) who participated in a training program of 6 mo of physical therapy , strength training , and walking followed by 3 mo of more intense endurance exercise at 78 % of peak heart rate or a control sedentary group ( n = 24 ) . Peak O2 consumption ( V(O2 peak ) ) increased 14 % in the exercise group ( P peak exercise cardiac output ( Q ) , determined via acetylene re-breathing , and no change in arteriovenous O2 content difference . The increase in Q was mediated by increases in heart rate ( P = 0.009 ) and probably stroke volume ( P = 0.096 ) . Left ventricular stroke work also increased significantly . In the men , the increase in V(O2 peak ) was exclusively due to a large increase in peak Q ( 22 % ) . In the women , the gain in V(O2 peak ) was due to small increases in Q and O2 extraction from skeletal muscles . Pulse pressure normalized for stroke volume and arterial elastance during peak effort did not change with training . Controls showed no changes . The results suggest that , although frail octogenarians have a diminished capacity for improvement in aerobic power in response to exercise training , this adaptation is mediated mostly by an increase in Q during peak effort . Furthermore , Q likely plays a greater role in the adaptive increase in V(O2 peak ) in old men than old women",
"PURPOSE To compare the effects of the 16-wk training period ( 2 d.wk(-1 ) ) of resistance training alone ( S ) , endurance training alone ( E ) , or combined resistance ( once weekly ) and endurance ( once weekly ) training ( SE ) on muscle mass , maximal strength and power of the leg and arm extensor muscles , and maximal workload ( Wmax ) by using a incremental cycling test in older men . METHODS Thirty-one healthy men ( 65 - 74 yr ) were divided into three treatment groups to train 2x wk(-1 ) for 16 wk : S ( N = 10 ) , E ( N = 11 ) , or SE ( N = 10 ; 1x wk(-1 ) S + 1x wk(-1 ) E ) . The subjects were tested at 8-wk intervals ( i.e. , weeks 8 and 16 ) . RESULTS There were no significant differences between S- and SE-induced muscle hypertrophy ( 11 % and 11 % ) and maximal strength ( 41 % and 38 % ) gains of the legs as well as between E- and SE-induced Wmax ( 28 % and 23 % ) gains . The increase in arm strength in S ( 36 % ) was greater than that recorded in SE ( 22 % ) and greater than that recorded in E ( 0 % ) . CONCLUSIONS Prolonged combined resistance and endurance training in older men seemed to lead to similar gains in muscle mass , maximal strength , and power of the legs as resistance training alone and to similar gains in maximal peak power output measured in an incremental cycling test as endurance training alone . These findings may have an effect on how resistance exercise is prescribed to older adults ",
"BACKGROUND In Japan , older adults are assessed by frailty checklist for care prevention . However , the effect of care prevention programs in community-dwelling frail older adults is still unclear . OBJECTIVES The purpose of this study was to investigate whether the care prevention program would reduce care and disability and to measure its cost-effectiveness in frail older adults . DESIGN This is a prospect i ve study using propensity score matching . SETTING AND SUBJECTS A total of 610 community-dwelling older adults were recruited in 2 cities of Japan . INTERVENTION Subjects in the exercise group ( n = 305 ) attended physical exercise sessions once a week for 16 consecutive weeks . The exercise sessions were in a st and ardized format consisting of moderate-intensity aerobic exercise , progressive strength training , flexibility and balance exercises , and cool-down activities . The control group ( n = 305 ) received only screening evaluation . MEASUREMENTS Primary outcome was long term care insurance requirement certification during the 1-year follow-up period . Secondary outcome measurements were changes of frailty checklist , and care and medical cost . RESULTS Twenty-five subjects ( 8.1 % ) in the exercise group and 55 ( 18 % ) in the control group were newly certified for long-term care insurance service requirement in 1 year after the intervention ( RR = 2.16 , 95 % CI = 1.46 - 3.20 ) . Consequently , the health care cost for the subjects in the exercise group was significantly lower than in the control group ( P improvements in total scores of the frailty checklist compared with the control group that worsened after 1 year ( exercise group : from 7.41 ± 3.98 to 7.11 ± 4.00 , control group : from 7.34 ± 4.27 to 8.02 ± 4.81 , F = 12.84 , P that physical exercise is effective in preventing the progression of frailty and further disability in older adults living in the community . We could save heath care costs by our care prevention program",
"OBJECTIVES To determine the long-term effects of three strength and balance exercise interventions on physical performance , fall-related psychological outcomes , and falls in older people . DESIGN A single-blinded , four-group , r and omized controlled trial . SETTING Community , Germany . PARTICIPANTS Community-dwelling adults aged 70 to 90 who had fallen in the past 6 months or reported fear of falling . INTERVENTION After baseline assessment , 280 participants were r and omly assigned to the control group ( CG ; no intervention ; n = 80 ) or one of three strength and balance exercise interventions ( the strength and balance group ( SBG ; strength and balance only ; n = 63 ) , the fitness group ( FG ; strength and balance plus endurance training ; n = 64 ) , or the multifaceted group ( MG ; strength and balance plus fall risk education ; n = 73 ) . The interventions consisted of 32 one-hour group sessions in 16 weeks . MEASUREMENTS Data on physical performance , fall-related psychological outcomes , and falls were collected for 24 months . RESULTS Mixed-effects regression analyses showed improved short- and long-term ( 12 and 24 months , respectively ) physical performance for the SBG and FG , particularly regarding mobility , balance , and walking speed ( P physical performance outcomes were most prominent in the FG . Fall-related psychological outcomes , number of falls , and injurious falls were not significantly different from in the control group . CONCLUSION Training focusing on strength , balance , and endurance can enhance physical performance for up to 24 months in community-dwelling older adults . These findings did not translate to improved fall-related psychological outcomes or reduced incidence of falls . This demonstrates the need for a different approach ( e.g. , regarding intervention dose and components ) to gain intervention benefits in the multiple domains that contribute to independence and well-being in older adults",
"OBJECTIVE To study the long-term outcome of a physical training regimen of ambulant postward rehabilitation in community-dwelling geriatric patients with a history of injurious falls . DESIGN Prospect i ve 2-year follow-up of a r and omized placebo-controlled intervention trial . SETTING Postward rehabilitation in a geriatric hospital in Germany . PARTICIPANTS Fifty-seven geriatric patients ( mean age , 84.3+/-4.4 y ) with a history of severe falls . INTERVENTION Ambulatory training of strength , functional performance , and balance 3 times a week for 3 months for 31 patients versus placebo activities for 26 patients . MAIN OUTCOME MEASURES Strength , functional performance , fall-related psychologic parameters , and physical activity assessed by st and ardized protocol s 2 years after the training intervention , compared with baseline results . RESULTS Motor performance decreased substantially in both groups . As patients in the intervention group declined from significantly improved motor performance levels achieved in the initial training intervention , differences between the groups were still significant in most functional performances 2 years later . Functional decline was greater in persons who were institutionalized or being cared for by family members . Physical activity , which increased during the exercise intervention , returned to low baseline levels . CONCLUSIONS Improved functional performance in the training group did not lead to an increased level of physical activity after training , which might have preserved the functional improvements . In mobility-restricted , frail , geriatric patients such as our study population , training programs should continue to keep patients active and to prevent the decline in strength and functional performance that precedes loss of autonomy",
"OBJECTIVES Although deficits in skeletal muscle strength , gait , balance , and oxygen uptake are potentially reversible causes of frailty , the efficacy of exercise in reversing frailty in community-dwelling older adults has not been proven . The aim of this study was to determine the effects of intensive exercise training ( ET ) on measures of physical frailty in older community-dwelling men and women . DESIGN R and omized controlled trial . SETTING Medical school research center . PARTICIPANTS One hundred fifteen sedentary men and women ( mean age + /- st and ard deviation = 83 + /- 4 ) with mild to moderate physical frailty , as defined by two of the following three criteria : Modified Physical Performance Test ( modified PPT ) score between 18 and 32 , peak oxygen uptake ( VO2 peak ) between 10 and 18 mL/kg/min , and self-report of difficulty or assistance with one basic activity of daily living ( ADL ) , or two instrumental ADLs . INTERVENTION Participants were r and omly assigned to a control group that performed a 9-month low-intensity home exercise program ( control ) or an exercise-training program ( ET ) . The control intervention primarily consisted of flexibility exercises . ET began with 3 months of flexibility , light-resistance , and balance training . During the next 3 months , resistance training was added , and , during the next 3 months , endurance training was added . MEASUREMENTS Modified PPT score , VO2 peak , performance of ADLs as measured by the Older Americans Re sources and Services instrument , and the Functional Status Question naire ( FSQ ) . RESULTS ET result ed in significantly greater improvements than home exercise in three of the four primary outcome measures . Adjusted 95 % confidence bounds on the magnitude of improvement in the ET group compared with the control group were 1.0 to 5.2 points for the modified PPT score , 0.9 to 3.6 mL/kg/min for VO2 peak , and 1.6 to 4.9 points for the FSQ score . CONCLUSIONS Our results show that intensive ET can improve measures of physical function and pre clinical disability in older adults who have impairments in physical performance and oxygen uptake and are not taking hormone replacement therapy better than a low-intensity home exercise program",
"OBJECTIVE To determine the effects of center-based exercise on physical performance in older persons at risk for decline in physical functioning . DESIGN R and omized controlled trial . SETTING Senior centers . PARTICIPANTS A total of 155 community-dwelling persons , 78.7 % women , ages 70 years and older ( mean + /- st and ard deviation , 77.0+/-4.5y ) , with mobility impairments . INTERVENTION Intervention volunteers ( n=80 ) exercised at a center ( endurance , strength , balance , flexibility ) 3 times weekly , for months 1 to 6 ; once weekly , for months 7 to 12 with home exercise 2 sessions a week ; and at home only , for months 13 to 18 . Home control volunteers ( n=75 ) were instructed in home endurance exercise . MAIN OUTCOME MEASURES MacArthur battery , Physical Performance Test ( PPT-8 ) , and 6-Minute Walk Test ( 6MWT ) at baseline and 3 , 6 , 12 , and 18 months . RESULTS MacArthur battery scores improved in intervention compared with home control at 3 , 6 , and 12 months ( repeated- measures analysis of variance : group x time , P PPT-8 and 6MWT did not improve . Intervention group assignment , younger age , and better baseline physical function and self-perceived health were independent predictors of long-term MacArthur battery score improvement . CONCLUSIONS Compared with home control , center-based exercise improved gait , chair rise time , and balance over 1 year . Improvements were not sustained with transition to home exercise for months 13 to 18 . Classes may be necessary to maintain improvements in older persons attending center-based exercise",
"This study determined the effects of endurance or resistance exercise training on maximal O2 consumption ( VO2max ) and the cardiovascular responses to exercise of 70- to 79-yr-old men and women . Healthy untrained subjects were r and omly assigned to a control group ( n = 12 ) or to an endurance ( n = 16 ) or resistance training group ( n = 19 ) . Training consisted of three sessions per week for 26 wk . Resistance training consisted of one set of 8 - 12 repetitions on 10 Nautilus machines . Endurance training consisted of 40 min at 50 - 70 % VO2max and at 75 - 85 % VO2max for the first and last 13 wk of training , respectively . The endurance training group increased its VO2max by 16 % during the first 13 wk of training and by a total of 22 % after 26 wk of training ; this group also increased its maximal O2 pulse , systolic blood pressure , and ventilation , and decreased its heart rate and perceived exertion during submaximal exercise . The resistance training group did not elicit significant changes in VO2max or in other maximal or submaximal cardiovascular responses despite eliciting 9 and 18 % increases in lower and upper body strength , respectively . Thus healthy men and women in their 70s can respond to prolonged endurance exercise training with adaptations similar to those of younger individuals . Resistance training in older individuals has no effect on cardiovascular responses to submaximal or maximal treadmill exercise",
"OBJECTIVES To determine whether an intense tai chi ( TC ) exercise program could reduce the risk of falls more than a wellness education ( WE ) program in older adults meeting criteria for transitioning to frailty . DESIGN R and omized , controlled trial of 48 weeks duration . SETTING Twenty congregate living facilities in the greater Atlanta area . PARTICIPANTS Sample of 291 women and 20 men aged 70 to 97 . MEASUREMENTS Demographics , time to first fall and all subsequent falls , functional measures , Sickness Impact Profile , Centers for Epidemiologic Studies -Depression Scale , Activities-specific Balance Confidence Scale , Falls Efficacy Scales , and adherence to interventions . RESULTS The risk ratio ( RR ) of falling was not statistically different in the TC group and the WE group ( RR=0.75 , 95 % confidence interval (CI)=0.52 - 1.08 ) , P=.13 ) . Over the 48 weeks of intervention , 46 % ( n=132 ) of the participants did not fall ; the percentage of participants that fell at least once was 47.6 % for the TC group and 60.3 % for the WE group . CONCLUSION TC did not reduce the RR of falling in transitionally frail , older adults , but the direction of effect observed in this study , together with positive findings seen previously in more-robust older adults , suggests that TC may be clinical ly important and should be evaluated further in this high-risk population",
"OBJECTIVES To determine whether a 12-month program of group exercise can improve physical functioning and reduce the rate of falling in frail older people . DESIGN Cluster r and omized , controlled trial of 12 months duration . SETTING Retirement villages in Sydney and Wollongong , Australia . PARTICIPANTS Five hundred fifty-one people aged 62 to 95 ( mean+/-st and ard deviation=79.5+/-6.4 ) who were living in self- and intermediate-care retirement villages . MEASUREMENTS Accidental falls , choice stepping reaction time , 6-minute walk distance postural sway , leaning balance , simple reaction time , and lower-limb muscle strength . RESULTS Two hundred eighty subjects were r and omized to the weight-bearing group exercise ( GE ) intervention that was design ed to improve the ability of subjects to undertake activities for daily living . Subjects r and omized to the control arm ( n=271 ) attended flexibility and relaxation ( FR ) classes ( n=90 ) or did not participate in a group activity ( n=181 ) . In spite of the reduced precision of cluster r and omization , there were few differences in the baseline characteristics of the GE and combined control ( CC ) subjects , although the mean age of the GE group was higher than that of the CC group , and there were fewer men in the GE group . The mean number of classes attended was 39.4+/-28.7 for the GE subjects and 31.5+/-25.2 for the FR subjects . After adjusting for age and sex , there were 22 % fewer falls during the trial in the GE group than in the CC group ( incident rate ratio=0.78 , 95 % confidence interval (CI)=0.62 - 0.99 ) , and 31 % fewer falls in the 173 subjects who had fallen in the past year ( incident rate ratio=0.69 , 95 % CI=0.48 - 0.99 ) . At 6-month retest , the GE group performed significantly better than the CC group in tests of choice stepping reaction time , 6-minute walking distance , and simple reaction time requiring a h and press . The groups did not differ at retest in tests of strength , sway , or leaning balance . CONCLUSION These findings show that group exercise can prevent falls and maintain physical functioning in frail older people",
"The objective of the present study was to evaluate and compare the neuromuscular , morphological and functional adaptations of older women subjected to 3 different types of strength training . 58 , healthy women ( 67 ± 5 year ) were r and omized to experimental ( EG , n=41 ) and control groups ( CG , n=17 ) during the first 6 weeks when the EG group performed traditional resistance exercise for the lower extremity . Afterwards , EG was divided into three specific strength training groups ; a traditional group ( TG , n=14 ) , a power group ( PG , n=13 ) that performed the concentric phase of contraction at high speed and a rapid strength group ( RG , n=14 ) that performed a lateral box jump exercise emphasizing the stretch-shortening-cycle ( SSC ) . Subjects trained 2 days per week through the entire 12 weeks . Following 6 weeks of generalized strength training , significant improvements occurred in EG for knee extension one-repetition ( 1RM ) maximum strength ( + 19 % ) , knee extensor muscle thickness ( MT , + 15 % ) , maximal muscle activation ( + 44 % average ) and onset latency ( -31 % average ) for vastus lateralis ( VL ) , vastus medialis ( VM ) and rectus femoris ( RF ) compared to CG ( p specific strength training , the 1RM increased significantly and similarly between groups ( average of + 21 % ) , as did muscle thickness of the VL ( + 25 % ) , and activation of VL ( + 44 % ) and VM ( + 26 % ) . The onset latency of RF ( TG=285 ± 109 ms , PG=252 ± 76 ms , RG=203 ± 43 ms ) , reaction time ( TG=366 ± 99 ms , PG=274 ± 76 ms , RG=201 ± 41 ms ) , 30-s chair st and ( TG=18 ± 3 , PG=18 ± 1 , RG=21 ± 2 ) and counter movement jump ( TG=8 ± 2 cm , PG=10 ± 3 cm , RG=13 ± 2 cm ) was significantly improved only in RG ( p training , the rate of force development ( RFD ) over 150 ms ( TG=2.3 ± 9.8 N·s(-1 ) , PG=3.3 ± 3.2 N·s(-1 ) , RG=3.8 ± 6.8 N·s(-1 ) , CG=2.3 ± 7.0 N·s(-1 ) ) was significantly greater in RG and PG than in TG and CG ( p conclusion , rapid strength training is more effective for the development of rapid force production of muscle than other specific types of strength training and by consequence , better develops the functional capabilities of older women",
"OBJECTIVE Reduced muscle mass and strength are characteristic findings of growth hormone deficiency ( GHD ) and aging . We evaluated measures of muscle strength , muscle fiber type , and cross sectional area in response to treatment with recombinant human growth hormone ( rhGH ) with or without a structured resistance exercise program in frail older subjects . DESIGN Placebo-controlled , r and omized , double blind trial . SETTING Outpatient clinical research center at an urban university-affiliated teaching hospital . PARTICIPANTS Thirty-one consenting older subjects ( mean age 71.3 + /- 4.5 years ) recruited as a subset of a larger project evaluating rhGH and exercise in older people , who underwent 62 quadricep-muscle biopsies . INTERVENTION R and om assignment to a 6-month course of one of four protocol s : rhGH administered subcutaneously daily at bedtime , rhGH and a structured resistance exercise program , structured resistance exercise with placebo injections , or placebo injections only . MEASUREMENTS Muscle biopsy specimens were obtained from the vastus lateralis muscle . Isokinetic dynamometry strength tests were used to monitor individual progress and to adjust the weights used in the exercise program . Serum insulin-like growth factor-I ( IGF-I ) was measured and body composition was measured using a Hologic QDR 1000W dual X-ray densitometer . RESULTS The administration of rhGH result ed in significant increase in circulating IGF-I levels in the individuals receiving rhGH treatment . Muscle strength increased significantly in both the rhGH/exercise ( + 55.6 % , P = .0004 ) as well as the exercise alone ( + 47.8 % , P = .0005 ) groups . There was a significant increase in the proportion of type 2 fibers between baseline and six months in the combined rhGH treated subjects versus those not receiving rhGH ( P = .027 ) . CONCLUSIONS Our results are encouraging in that they suggest an effect of growth hormone on a specific aging-correlated deficit . IGF-I was increased by administrating rhGH and muscle strength was increased by exercise . The administration of rhGH to frail older individuals in this study result ed in significant changes in the proportions of fiber types . Whether changes in fiber cross-sectional area or absolute number occur with long-term growth hormone administration requires further study",
"OBJECTIVES To investigate the effects of dehydroepi and rosterone ( DHEA ) combined with exercise on bone mass , strength , and physical function in older , frail women . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING A major medical institution . PARTICIPANTS Ninety-nine women ( mean age 76.6 ± 6.0 ) with low sulfated DHEA ( DHEAS ) levels , low bone mass , and frailty . INTERVENTION Participants received 50 mg/d DHEA or placebo for 6 months ; all received calcium and cholecalciferol . Women participated in 90-minute twice-weekly exercise regimens . MEASUREMENTS Hormone levels , bone mineral density ( BMD ) , bone turnover markers , body composition , upper and lower extremity strength , physical performance . RESULTS Eighty-seven women ( 88 % ) completed 6 months . There were no significant changes in BMD or bone turnover markers . DHEA supplementation result ed in gains in lower extremity strength ( from 459 ± 121 N to 484 ± 147 N ; P=.01 ) . There was also improvement in Short Physical Performance Battery score , a composite score that focuses on lower extremity function , in those taking DHEA ( from 10.1 ± 1.8 to 10.7 ± 1.9 ; P=.02 ) . There were significant changes in all hormone levels , including DHEAS , estradiol , estrone , and testosterone , and a decline in sex hormone-binding globulin levels in those taking DHEA . CONCLUSION DHEA supplementation improved lower extremity strength and function in older , frail women involved in a gentle exercise program of chair aerobics or yoga . No changes were found in BMD either due to small sample size , short duration of study or no effect . The physical function findings are promising and require further evaluation as frail women are at high risk for falls and fracture",
"OBJECTIVES To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge . DESIGN Multicenter , r and omized , controlled trial with a factorial design . SETTING Five hospitals in Auckl and , New Zeal and , and Sydney , Australia . PARTICIPANTS Two hundred forty-three frail older people . INTERVENTIONS Patients were r and omized to receive a single dose of vitamin D ( calciferol , 300,000 IU ) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits . MEASUREMENTS The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months . Physical performance and self-rated function were secondary endpoints . Assessment s took place in the participants ' homes at 3 and 6 months after r and omization and were performed by blinded assessors . RESULTS There was no effect of either intervention on physical health or falls , but patients in the exercise group were at increased risk of musculoskeletal injury ( risk ratio = 3.6 , 95 % confidence interval = 1.5 - 8.0 ) . Vitamin D supplementation did not improve physical performance , even in those who were vitamin D deficient ( vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization . There was no effect of vitamin D on physical performance , and the exercises increased the risk of musculoskeletal injury . These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people",
"OBJECTIVES To evaluate the effectiveness of exercise and amino acid supplementation in enhancing muscle mass and strength in community-dwelling elderly sarcopenic women . DESIGN R and omized controlled trial . SETTING Urban community in Tokyo , Japan . PARTICIPANTS One hundred fifty-five women aged 75 and older were defined as sarcopenic and r and omly assigned to one of four groups : exercise and amino acid supplementation ( exercise + AAS ; n = 38 ) , exercise ( n = 39 ) , amino acid supplementation ( AAS ; n = 39 ) , or health education ( HE ; n = 39 ) . INTERVENTION The exercise group attended a 60-minute comprehensive training program twice a week , and the AAS group ingested 3 g of a leucine-rich essential amino acid mixture twice a day for 3 months . MEASUREMENTS Body composition was determined using bioelectrical impedance analysis . Data from interviews and functional fitness parameters such as muscle strength and walking ability were collected at baseline and after the 3-month intervention . RESULTS A significant group × time interaction was seen in leg muscle mass ( P = .007 ) , usual walking speed ( P = .007 ) , and knee extension strength ( P = .017 ) . The within-group analysis showed that walking speed significantly increased in all three intervention groups , leg muscle mass in the exercise + AAS and exercise groups , and knee extension strength only in the exercise + AAS group ( 9.3 % increase , P = .01 ) . The odds ratio for leg muscle mass and knee extension strength improvement was more than four times as great in the exercise + AAS group ( odds ratio = 4.89 , 95 % confidence interval = 1.89 - 11.27 ) as in the HE group . CONCLUSION The data suggest that exercise and AAS together may be effective in enhancing not only muscle strength , but also combined variables of muscle mass and walking speed and of muscle mass and strength in sarcopenic women",
"BACKGROUND Physical training to increase muscle strength and balance is considered useful for prevention of falls in older people . AIM This study compares conventional balance training with visual computer feedback training . DESIGN This was a r and omized controlled 12-week intervention trial with pre- and post-training evaluations . SETTING Out- patients referred to a geriatric falls and balance clinic . POPULATION Thirty-five patients were r and omized into two training groups . METHODS Both groups received progressive resistance muscle strength training and physical fitness training . Additionally , one group received traditional balance training and the other group received computer feedback balance training . Strength , physical endurance , balance and falls efficacy scale scoring were assessed before and after end of training . RESULTS Twenty-seven patients ( 77 % ) were available for the evaluation ; mean compliance was 71 % . In the combined group , significant mean improvement was observed in knee extension ( 19 % ) , ankle dorsiflexion ( 16 % ) , sitting to st and ing ( 16 % ) , and in the six-minute walk test ( 8 % ) . In the traditional balance training group , the static balance in the Modified Clinical Test of Sensory Interaction and Balance st and ing on a foam mat with closed eyes showed a significant increase ( 80 % ) . No increase occurred in the computer balance training group . However , the computer feed-back training group showed a marked improvement that was up to 400 % in the training specific performance . CONCLUSION Elderly frail patients were able to increase muscle strength and physical endurance . A limited improvement was seen in the static balance tests . The computer feedback group showed a remarkable increase in training specific performance . Clinical Rehabilitation Impact",
"OBJECTIVES To assess the effects of an 8-week exercise training program with a special focus on light- to moderate-intensity resistance exercises ( 30 - 70 % of one repetition maximum , 1RM ) and a subsequent 4-week training cessation period ( detraining ) on muscle strength and functional capacity in participants aged 90 and older . DESIGN R and omized controlled trial performed during March to September 2009 . SETTING Geriatric nursing home . PARTICIPANTS Forty nonagenarians ( 90 - 97 ) were r and omly assigned to an intervention or control group ( 16 women and 4 men per group ) . INTERVENTION Eight-week muscle strength exercise intervention focused on lower limb strength exercises of light to moderate intensity . MEASUREMENTS PRIMARY OUTCOME 1RM leg press . SECONDARY OUTCOMES h and grip strength , 8-m walk test , 4-step stairs test , Timed Up and Go test , and number of falls . RESULTS A significant group by time interaction effect ( P=.02 ) was observed only for the 1RM leg press . In the intervention group , 1RM leg press increased significantly with training by 10.6 kg [ 95 % confidence interval (CI)=4.1 - 17.1 kg ; P=.01 ] . Except for the mean group number of falls , which were 1.2 falls fewer per participant in the intervention group ( 95 % CI=0.0 - 3.0 ; P=.03 ) , no significant training effect on the secondary outcome measures was found . CONCLUSION Exercise training , even of short duration and light to moderate intensity , can increase muscle strength while decreasing fall risk in nonagenarians",
"BACKGROUND Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people , the efficacy of interventions targeted specifically at these deficits has not been carefully studied . METHODS We conducted a r and omized , placebo-controlled trial comparing progressive resistance exercise training , multinutrient supplementation , both interventions , and neither in 100 frail nursing home residents over a 10-week period . RESULTS The mean ( + /- SE ) age of the 63 women and 37 men enrolled in the study was 87.1 + /- 0.6 years ( range , 72 to 98 ) ; 94 percent of the subjects completed the study . Muscle strength increased by 113 + /- 8 percent in the subjects who underwent exercise training , as compared with 3 + /- 9 percent in the nonexercising subjects ( P Gait velocity increased by 11.8 + /- 3.8 percent in the exercisers but declined by 1.0 + /- 3.8 percent in the nonexercisers ( P = 0.02 ) . Stair-climbing power also improved in the exercisers as compared with the nonexercisers ( by 28.4 + /- 6.6 percent vs. 3.6 + /- 6.7 percent , P = 0.01 ) , as did the level of spontaneous physical activity . Cross-sectional thigh-muscle area increased by 2.7 + /- 1.8 percent in the exercisers but declined by 1.8 + /- 2.0 percent in the nonexercisers ( P = 0.11 ) . The nutritional supplement had no effect on any primary outcome measure . Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation . CONCLUSIONS High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people . In contrast , multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty"
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41165402-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To investigate the efficacy and safety of drug interventions to promote motor recovery post-stroke . DATA SOURCES CENTRAL , CINAHL , Embase , MEDLINE , SCOPUS and Web of Science . STUDY SELECTION Published human r and omized controlled trials in which the primary intervention was a drug administered to promote motor recovery post-stroke , vs placebo . DATA EXTRACTION St and ardized pro forma used to extract safety and efficacy data ; Cochrane Collaboration risk of bias assessment tool performed to assess risk of bias . DATA SYNTHESIS Fifty r and omized controlled trials from 4,779 citations were included . An overall trend of high risk of attrition ( n = 27 ) and reporting bias ( n = 36 ) was observed . Twenty-eight different drug interventions were investigated , 18 of which demonstrated statistically significant results favouring increased motor recovery compared with control intervention . Forty-four studies measured safety ; no major safety concerns were reported . CONCLUSION C and i date drug interventions promoting motor recovery post-stroke were identified , specifically selective serotonin reuptake inhibitors and levodopa ; however , the high risk of bias in many trials is concerning . Drugs to improve motor function remain an important area of enquiry . Future research must focus on establishing the right drug intervention to be administered at an optimal dose and time , combined with the most effective adjuvant physical therapy to drive stroke recovery
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"Background and Purpose — Evidence suggests the potential to improve motor status in patients with stroke by modifying brain catecholaminergic tone . The current study hypothesized that increased dopaminergic tone via the dopamine agonist ropinirole , when combined with physiotherapy ( PT ) , would significantly and safely increase gait velocity . Methods — Patients with moderate motor deficits due to stroke 1 to 12 months prior were r and omized ( double blinded ) to 9 weeks of immediate-release ropinirole or placebo , each with PT , and followed up for 3 additional weeks . Drug dose ( 0.25 to 4 mg once daily ) was titrated weekly , as tolerated . The primary end point was gait velocity during the 12 weeks of study participation . Results — Patients in the ropinirole+PT group averaged 2.4 mg/d by end of week 9 , although the target dose was at least 3 mg/d . Ropinirole+PT was generally safe and well tolerated , including no drug-related serious adverse events . Across all 33 enrollees , significant gains were found over time for gait velocity and for most secondary end points . However , gains did not differ by treatment assignment . PT and occupational therapy were commonly prescribed outside of the trial , although the extent of these was not correlated with study outcomes . Conclusions — At doses achieved in this trial , increased dopaminergic tone via ropinirole+PT was generally well tolerated but did not show any improvement over and above the effects of PT alone",
"Background Several small trials have suggested that fluoxetine improves neurological recovery from stroke . FOCUS , AFFINITY and EFFECTS are a family of investigator-led , multicentre , parallel group , r and omised , placebo-controlled trials that aim to determine whether routine administration of fluoxetine ( 20 mg daily ) for 6 months after acute stroke improves patients ’ functional outcome . Methods / Design The three trial investigator teams have collaboratively developed a core protocol . Minor variations have been tailored to the national setting in the UK ( FOCUS ) , Australia and New Zeal and ( AFFINITY ) and Sweden ( EFFECTS ) . Each trial is run and funded independently and will report its own results . A prospect ively planned individual patient data meta- analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients .The trials include patients ≥18 years old with a clinical diagnosis of stroke , persisting focal neurological deficits at r and omisation between 2 and 15 days after stroke onset . Patients are r and omised central ly via web-based r and omisation systems using a common minimisation algorithm . Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months . Our primary outcome measure is the modified Rankin scale ( mRS ) at 6 months . Secondary outcomes include the Stroke Impact Scale , EuroQol ( EQ5D-5 L ) , the vitality subscale of the Short-Form 36 , diagnosis of depression , adherence to medication , adverse events and re source use . Outcomes are collected at 6 and 12 months . The methods of collecting these data are tailored to the national setting . If FOCUS , AFFINITY and EFFECTS combined enrol 6000 participants as planned , they would have 90 % power ( alpha 5 % ) to detect a common odds ratio of 1.16 , equivalent to a 3.7 % absolute difference in percentage with mRS 0–2 ( 44.0 % to 47.7 % ) . This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm . Discussion If fluoxetine is safe and effective in promoting functional recovery , it could be rapidly , widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke . Trial registration FOCUS : IS RCT N83290762 ( 23/05/2012 ) , AFFINITY : ACTRN12611000774921 ( 22/07/2011 ) . EFFECTS : IS RCT N13020412 ( 19/12/2014 )",
"OBJECTIVE To examine rehabilitation interventions and result ing physical activity patterns of patients managed in acute stroke units to help inform development of a r and omized controlled trial of very early rehabilitation . DESIGN An open observational study of patient activity and therapist report of patient interventions . A survey of stroke unit re sources . METHODS Patients less than 14 days post-stroke from 5 metropolitan stroke units were observed over 2 consecutive weekdays at 10-minute intervals between 08.00 h and 17.00 h. Physical activity , location and person(s ) present were ascertained at each observation . Therapists completed treatment records . Senior staff completed stroke unit surveys . RESULTS Patients after stroke ( n=58 ) were with therapists 5.2 % of the observed day . Few patients ( 17.1 % ) received daily therapy by more than one therapist . When patients received therapy , average session times were 24 minutes of physiotherapy , 23 minutes of occupational therapy and 33 minutes of speech pathology . The more time that family members were present , the longer the treatment time . Four to 11 min of upper-limb therapy was provided . Muscle weakness and left hemiparesis were associated with less upper-limb activity . CONCLUSION These acute stroke care units were re source d according to recommended staff-patient ratios . Patients received little therapy and had low levels of physical activity",
"Background and Purpose — One class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein . The purpose of the current study was to extend pre clinical and clinical findings of GSK249320 , a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region , to explore effects on motor outcomes poststroke . Methods — In this phase IIb double-blind , r and omized , placebo-controlled study , patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were r and omized to 2 IV infusions of GSK249320 or placebo . Primary outcome measure was change in gait velocity from baseline to day 90 . Results — A total of 134 subjects were r and omized between May 2013 and July 2014 . The 2 groups were overall well matched at baseline . The study was stopped at the prespecified interim analysis because the treatment difference met the predefined futility criteria cutoff ; change in gait velocity to day 90 was 0.55±0.46 ( mean±SD ) in the GSK249320 group and 0.56±0.50 for placebo . Secondary end points including upper extremity function were concordant . The 2 IV infusions of GSK249320 were well tolerated . No neutralizing antibodies to GSK249320 were detected . Conclusions — GSK249320 , within 72 hours of stroke , demonstrated no improvement on gait velocity compared with placebo . Possible reasons include challenges translating findings into humans and no direct evidence that the therapy reached the biological target . The antibody was well tolerated and showed low immunogenicity , findings potentially useful to future studies aim ing to use a monoclonal antibody to modify activity in specific biological pathways to improve recovery from stroke . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01808261",
"Background and Purpose — The aim of this trial was to investigate whether stroke patients who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with patients who receive a placebo . Methods — This study was a prospect i ve , r and omized , double-blind , placebo-controlled , multicenter , parallel-group study . Patients were treated with Cerebrolysin ( 30 mL/d ) or a placebo ( saline ) once daily for 21 days , beginning at 24 to 72 hours after stroke onset . The patients also participated in a st and ardized rehabilitation program for 21 days that was initiated within 72 hours after stroke onset . The primary end point was the Action Research Arm Test score on day 90 . Results — The nonparametric effect size on the Action Research Arm Test score on day 90 indicated a large superiority of Cerebrolysin compared with the placebo ( Mann – Whitney estimator , 0.71 ; 95 % confidence interval , 0.63–0.79 ; P multivariate effect size on global status , as assessed using 12 different outcome scales , indicated a small-to-medium superiority of Cerebrolysin ( Mann – Whitney estimator , 0.62 ; 95 % confidence interval , 0.58–0.65 ; P rate of premature discontinuation was Cerebrolysin was safe and well tolerated . Conclusions — Cerebrolysin had a beneficial effect on function and global outcome in early rehabilitation patients after stroke . Its safety was comparable with that of the placebo , suggesting a favorable benefit/risk ratio . Because this study was exploratory and had a relatively small sample size , the results should be confirmed in a large-scale , r and omized clinical trial . Clinical Trial Registration — URL : http://www . clinical trialsregister.eu . Unique identifier : 2007 - 000870 - 21",
"Background : Intensive , task-oriented motor training has been associated with neuroplastic reorganization and improved upper extremity movement function after stroke . However , to optimize such training for people with moderate-to-severe movement impairment , pharmacological modulation of neuroplasticity may be needed as an adjuvant intervention . Objective : Evaluate safety , as well as improvement in movement function , associated with motor training paired with a drug to upregulate neuroplasticity after stroke . Methods : In this double-blind , r and omized , placebo-controlled study , 12 subjects with chronic stroke received either atomoxetine or placebo paired with motor training . Safety was assessed using vital signs . Upper extremity movement function was assessed using Fugl-Meyer Assessment , Wolf Motor Function Test , and Action Research Arm Test at baseline , post-intervention , and 1-month follow-up . Results : No significant between-groups differences were found in mean heart rate ( 95 % CI , –12.4–22.6 ; p = 0.23 ) , mean systolic blood pressure ( 95 % CI , –1.7–29.6 ; p = 0.21 ) , or mean diastolic blood pressure ( 95 % CI , –10.4–13.3 ; p = 0.08 ) . A statistically significant between-groups difference on Fugl-Meyer at post-intervention favored the atomoxetine group ( 95 % CI , 1.6–12.7 ; p = 0.016 ) . Conclusion : Atomoxetine combined with motor training appears safe and may optimize motor training outcomes after stroke",
"OBJECTIVE To investigate the effects of single doses of a selective serotonin reuptake inhibitor ( SSRI ) on lower limb voluntary and reflex function in individuals with chronic stroke . DESIGN Double-blind , r and omized , placebo-controlled crossover trial . SETTING Outpatient research setting . PARTICIPANTS Individuals ( N=10 ; 7 men ; mean age ± SD , 57±10y ) with poststroke hemiplegia of > 1 year duration who completed all assessment s. INTERVENTIONS Patients were assessed before and 5 hours after single-dose , overencapsulated 10-mg doses of escitalopram ( SSRI ) or placebo , with 1 week between conditions . MAIN OUTCOME MEASURES Primary assessment s included maximal ankle and knee isometric strength , and velocity-dependent ( 30 ° /s-120 ° /s ) plantarflexor stretch reflexes under passive conditions , and separately during and after 3 superimposed maximal volitional drive to simulate conditions of increased serotonin release . Secondary measures included clinical measures of lower limb coordination and locomotion . RESULTS SSRI administration significantly increased stretch reflex torques at higher stretch velocities ( eg , 90 ° /s ; P=.03 ) , with reflexes at lower velocities enhanced by superimposed voluntary drive ( P=.02 ) . No significant improvements were seen in volitional peak torques or in clinical measures of lower limb function ( lowest P=.10 ) . CONCLUSIONS Increases in spasticity but not strength or lower limb function were observed with single-dose SSRI administration in individuals with chronic stroke . Further studies should evaluate whether repeated dosing of SSRIs , or as combined with specific interventions , is required to elicit significant benefit of these agents on lower limb function poststroke",
"Background and Purpose — Hemiparesis is the commonest disabling deficit caused by stroke . In animals , dextroamphetamine ( AMPH ) paired with training enhances motor recovery , but its clinical efficacy is uncertain . Methods — In a r and omized , double-blind , placebo-controlled trial , 71 stroke patients were stratified by hemiparesis severity and r and omly assigned to 10 sessions of physiotherapy coupled with either 10 mg AMPH or placebo . Study treatments were administered by 1 physiotherapist , beginning 5 to 10 days after stroke and continuing twice per week for 5 weeks . Outcomes were assessed by 1 physiotherapist at baseline , after each treatment session , at 6 weeks , and at 3 months . The primary outcome was motor recovery ( impairment level ) on the Fugl-Meyer ( FM ) scale . Secondary outcomes assessed mobility , ambulation , arm/h and function , and independence in activities of daily living . Results — Baseline hemiparesis was severe overall ( mean FM score 27.7±20.0 ) . Motor scores improved during treatment in both groups ( mean change , baseline to 3 months 29.5±16.6 ) . Repeated- measures ANOVA revealed no significant differences in recovery between the treatment groups for the entire cohort ( n=67 ) or for subgroups with a severe hemiparesis ( n=43 ) , moderate hemiparesis ( n=24 ) , or cortically based stroke ( n=26 ) . In the moderate subgroup , there was a significant drug × time interaction for upper extremity motor recovery ( F=5.14 ; P baseline imbalance in motor scores in this subgroup . Conclusion — In stroke patients with a severe motor deficit , 10 mg AMPH coupled with physiotherapy twice per week for 5 weeks in the early poststroke period provided no additional benefit in motor or functional recovery compared with physiotherapy alone . Patients with moderate severity hemiparesis deserve further investigation . Increased intensity and longer duration drug/therapy dosing regimens should be explored , targeting the upper and lower limbs separately",
"OBJECTIVE To test the hypothesis that administration of dopamine precursor levodopa improves procedural motor learning ( defined as the ability to acquire novel movement patterns gradually through practice ) in patients with residual motor deficits in the chronic phase after stroke ( > or = 1 y after stroke ) . DESIGN A double-blind , placebo-controlled , r and omized crossover design . SETTING Neurology department in a German university . PARTICIPANTS Eighteen patients with chronic motor dysfunction because of stroke ( 13 men , 5 women ; age range , 53 - 78 y ; mean time poststroke + /- SD , 3.3+/-2.1 y ) . INTERVENTION Patients received 3 doses of levodopa ( 100 mg of levodopa plus 25 mg of carbidopa ) or placebo before 1 session of procedural motor learning . MAIN OUTCOME MEASURES Procedural motor learning performed by using the paretic h and assessed by using a modified version of the serial reaction time task with a probabilistic sequence . The primary outcome measure was the difference in reaction times between r and om and sequential elements . RESULTS Levodopa significantly improved our primary outcome measure , procedural motor learning , compared with placebo ( P Reaction times to r and om elements , analysis of error rates , psychophysical assessment s , and performance in a simple motor task were comparable between conditions , indicating that better learning under levodopa was not caused by differences in response styles , arousal , mood , or motor reaction times but that levodopa modulated learning . CONCLUSIONS Our results show that levodopa may improve procedural motor learning in patients with chronic stroke , in line with our hypothesis . These findings suggest that this interventional strategy in combination with customary rehabilitative treatments could significantly improve the outcome of neurorehabilitation in the chronic stage after stroke . ( Clinical trials.gov identifier NCT00126087 .",
"Background The neurotrophic drug Cerebrolysin accelerated recovery and prevented acute neuronal damage in pre clinical models of ischaemia . Previous clinical trials support therapeutic effects in stroke patients . The study investigated whether the combination with alteplase and Cerebrolysin is safe and can further reduce disability after acute ischaemic stroke . Methods This placebo-controlled , double-blind trial involved 119 patients with acute ischaemic hemispheric stroke , r and omly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo ( administered 1 h after thrombolytic treatment ) starting within three-hours after onset of symptoms . A daily i.v . infusion of 30 ml Cerebrolysin or placebo was given for 10 consecutive days . Primary outcome was the modified Rankin Scale at day 90 . A sequential design with interim analyses was applied . Results The third interim analysis did not show a benefit in the modified Rankin Scale for Cerebrolysin on day 90 compared to placebo and the study was stopped . The National Institutes of Health Stroke Scale responder analysis ( secondary outcome measure ) showed significantly more patients with an improvement of 6 or more points ( or a total score of 0 or 1 ) after two- , five- , 10 , and 30 days in the Cerebrolysin group . Similar trends were observed for the modified Rankin Scale responder analysis without achieving statistical significance . There was no difference between treatment groups regarding adverse events . Conclusions The combination of Cerebrolysin with recombinant tissue-Plasminogen Activator is safe for treatment of acute ischaemic stroke but did not improve outcome at day 90 . During the treatment period with Cerebrolysin ( 10 days ) , significantly more patients had a favourable response in neurological outcome measures ( National Institutes of Health Stroke Scale ) as compared to the placebo group",
"Background Cerebrolysin , a brain-derived neuropeptide , has been shown to improve the neurological outcomes of stroke , but no study has demonstrated its effect on cerebral blood flow . This study aim ed to determine the cerebrolysin impact on the neurological outcomes and cerebral blood flow . Methods In a r and omized , double-blinded , placebo-controlled trial , 46 patients who had acute focal ischemic stroke were r and omly assigned into two groups to receive intravenously either 30 mL of cerebrolysin diluted in normal saline daily for 10 days ( n=23 ) or normal saline alone ( n=23 ) adjunct to 100 mg of aspirin daily . All patients were examined using the National Institutes of Health Stroke Scale and transcranial Doppler to measure the mean flow velocity and pulsatility index ( PI ) of their cerebral arteries at baseline as well as on days 30 , 60 , and 90 . Results The patients ’ mean age was 60±9.7 years , and 51.2 % of patients were male . The National Institutes of Health Stroke Scale was significantly lower in the cerebrolysin group compared with the placebo group on day 60 ( median 10 , interquartile range 9–11 , P=0.008 ) and day 90 ( median 11 , interquartile range 10–13.5 , P=0.001 ) . The median of PI in the right middle cerebral artery was significantly lower in the cerebrolysin group compared with the placebo group on days 30 , 60 , and 90 ( P died before day 30 ( 4.3 % versus 8.7 % ) . Conclusion Cerebrolysin can be useful to improve the neurological outcomes and the PI of middle cerebral artery in patients with acute focal ischemic stroke",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE We hypothesized that a single dose of methylpheni date ( MP ) would modulate cerebral motor activation and behavior in patients having suffered a subcortical stroke . METHODS Eight men with a single stroke on the corticospinal tract result ing in a pure motor hemiparesia were included in a r and omized , cross-over , double-blind , placebo-controlled study . Patients were first evaluated 17 days after stroke onset by vali date d neurological scales , motor tests and fMRI ( flexion/extension of the digits ) after 20 mg MP or placebo . Seven days later , the patients underwent the same protocol and received the drug they had not taken at the first evaluation . Each patient was his own control . RESULTS Placebo intake did not change performance . MP compared to placebo elicited a significant improvement in motor performance of the affected h and at the finger tapping test . MP induced : ( 1 ) a hyperactivation of the ipsilesional primary sensorimotor cortex including the motor h and and face areas and of the contralesional premotor cortex ; ( 2 ) a hypoactivation of the ipsilesional anterior cingulum . Hyperactivation in the face motor area correlated positively with the improvement in performance . CONCLUSION We demonstrated that the reorganized network may efficiently be targeted by the drug and that the effect of MP might partly rely on an improvement in attention/effort through cingulum modulation",
"PURPOSE To assess the effects of d-amphetamine on motor facilitation and recovery in stroke patients with mild arm paresis receiving the Arm Ability training . METHODS Thirty-one stroke patients with mild arm paresis were r and omly assigned to either ( a. ) receiving placebo or ( b. ) d-amphetamine twice a week 2 hours before Arm Ability training sessions for three weeks . MAIN OUTCOME MEASURE time needed to perform TEMPA tasks , a measure of upper extremity performance reflecting everyday life tasks . Secondary measures : aim ed movements , tapping , and a 10 m walkway as well as motor performance during training sessions . RESULTS The interim efficacy analysis of 26 stroke patients who completed the study intervention showed overall arm motor recovery both from pre to post test after 3 weeks of training and from pre test to follow-up 1 year later . No superior effect of d-amphetamine over placebo could be substantiated for either motor facilitation during training or motor recovery ( post training or long-term ) . D-amphetamine exerted mild effects on blood pressure . Serious adverse events were not observed . CONCLUSIONS d-Amphetamine failed to facilitate motor performance during training sessions , to promote skill acquisition with training tasks , and most importantly to enhance motor recovery among patients with mild arm paresis after stroke",
"BACKGROUND Hemiplegia and hemiparesis are the most common deficits caused by stroke . A few small clinical trials suggest that fluoxetine enhances motor recovery but its clinical efficacy is unknown . We therefore aim ed to investigate whether fluoxetine would enhance motor recovery if given soon after an ischaemic stroke to patients who have motor deficits . METHODS In this double-blind , placebo-controlled trial , patients from nine stroke centres in France who had ischaemic stroke and hemiplegia or hemiparesis , had Fugl-Meyer motor scale ( FMMS ) scores of 55 or less , and were aged between 18 years and 85 years were eligible for inclusion . Patients were r and omly assigned , using a computer r and om-number generator , in a 1:1 ratio to fluoxetine ( 20 mg once per day , orally ) or placebo for 3 months starting 5 - 10 days after the onset of stroke . All patients had physiotherapy . The primary outcome measure was the change on the FMMS between day 0 and day 90 after the start of the study drug . Participants , carers , and physicians assessing the outcome were masked to group assignment . Analysis was of all patients for whom data were available ( full analysis set ) . This trial is registered with Clinical Trials.gov , number NCT00657163 . FINDINGS 118 patients were r and omly assigned to fluoxetine ( n=59 ) or placebo ( n=59 ) , and 113 were included in the analysis ( 57 in the fluoxetine group and 56 in the placebo group ) . Two patients died before day 90 and three withdrew from the study . FMMS improvement at day 90 was significantly greater in the fluoxetine group ( adjusted mean 34·0 points [ 95 % CI 29·7 - 38·4 ] ) than in the placebo group ( 24·3 points [ 19·9 - 28·7 ] ; p=0·003 ) . The main adverse events in the fluoxetine and placebo groups were hyponatraemia ( two [ 4 % ] vs two [ 4 % ] ) , transient digestive disorders including nausea , diarrhoea , and abdominal pain ( 14 [ 25 % ] vs six [ 11 % ] ) , hepatic enzyme disorders ( five [ 9 % ] vs ten [ 18 % ] ) , psychiatric disorders ( three [ 5 % ] vs four [ 7 % ] ) , insomnia ( 19 [ 33 % ] vs 20 [ 36 % ] ) , and partial seizure ( one [ patients with ischaemic stroke and moderate to severe motor deficit , the early prescription of fluoxetine with physiotherapy enhanced motor recovery after 3 months . Modulation of spontaneous brain plasticity by drugs is a promising pathway for treatment of patients with ischaemic stroke and moderate to severe motor deficit . FUNDING Public French National Programme for Clinical Research",
"Background and Purpose — Previous clinical studies suggested benefit for poststroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset . The Chinese Medicine Neuroaid Efficacy on Stroke recovery ( CHIMES ) study tested the hypothesis that MLC601 is superior to placebo in acute , moderately severe ischemic stroke within a 72-hour time window . Methods — This multicenter , double-blind , placebo-controlled trial r and omized 1100 patients with a National Institutes of Health Stroke Scale score 6 to 14 , within 72 hours of onset , to trial medications for 3 months . The primary outcome was a shift in the modified Rankin Scale . Secondary outcomes were modified Rankin Scale dichotomy , National Institutes of Health Stroke Scale improvement , difference in National Institutes of Health Stroke Scale total and motor scores , Barthel index , and mini-mental state examination . Planned subgroup analyses were performed according to age , sex , time to first dose , baseline National Institutes of Health Stroke Scale , presence of cortical signs , and antiplatelet use . Results — The modified Rankin Scale shift analysis –adjusted odds ratio was 1.09 ( 95 % confidence interval , 0.86–1.32 ) . Statistical difference was not detected between the treatment groups for any of the secondary outcomes . Subgroup analyses showed no statistical heterogeneity for the primary outcome ; however , a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted . Serious and nonserious adverse events rates were similar between the 2 groups . Conclusions — MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity . Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00554723",
"BACKGROUND Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke , but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established . We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke . METHODS After exclusion of patients with a brain hemorrhage or major infa rct ion , as detected on a computed tomographic scan , we r and omly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase ( 0.9 mg per kilogram of body weight ) or placebo . The primary end point was disability at 90 days , dichotomized as a favorable outcome ( a score of 0 or 1 on the modified Rankin scale , which has a range of 0 to 6 , with 0 indicating no symptoms at all and 6 indicating death ) or an unfavorable outcome ( a score of 2 to 6 on the modified Rankin scale ) . The secondary end point was a global outcome analysis of four neurologic and disability scores combined . Safety end points included death , symptomatic intracranial hemorrhage , and other serious adverse events . RESULTS We enrolled a total of 821 patients in the study and r and omly assigned 418 to the alteplase group and 403 to the placebo group . The median time for the administration of alteplase was 3 hours 59 minutes . More patients had a favorable outcome with alteplase than with placebo ( 52.4 % vs. 45.2 % ; odds ratio , 1.34 ; 95 % confidence interval [ CI ] , 1.02 to 1.76 ; P=0.04 ) . In the global analysis , the outcome was also improved with alteplase as compared with placebo ( odds ratio , 1.28 ; 95 % CI , 1.00 to 1.65 ; P incidence of intracranial hemorrhage was higher with alteplase than with placebo ( for any intracranial hemorrhage , 27.0 % vs. 17.6 % ; P=0.001 ; for symptomatic intracranial hemorrhage , 2.4 % vs. 0.2 % ; P=0.008 ) . Mortality did not differ significantly between the alteplase and placebo groups ( 7.7 % and 8.4 % , respectively ; P=0.68 ) . There was no significant difference in the rate of other serious adverse events . CONCLUSIONS As compared with placebo , intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke ; alteplase was more frequently associated with symptomatic intracranial hemorrhage . ( Clinical Trials.gov number , NCT00153036 .",
"Background and objectives : Stroke is a major cause of disability . Certain experimental studies have suggested that a combination of almitrine + raubasine ( Duxil * ) increases the supply of oxygen to cerebral tissues and may be beneficial in post-stroke rehabilitation . This multicentre clinical study was carried out in order to assess the efficacy of this combination on post-stroke rehabilitation . * Duxil is a registered trade name of Les Laboratoires Servier , Neuilly-sur-Seine , France Methods : The trial was a r and omised , double-blind , placebo-controlled study . Patients that had experienced an ischaemic cerebrovascular accident ( confirmed by CT scan ) were included 4 - 6 weeks after the acute onset and received r and omised treatment of either almitrine + raubasine or placebo 2 tablets daily for 3 months . Before treatment , there was a 2-week washout period for stopping all other drugs , except for antihypertensive and antidiabetic drugs . We assessed the patients by Barthel Index ( BI ) , Neurological Functional Deficit Scores ( NFDS ) , and Hasagawa Dementia Scales ( HDS ) each month after treatment . Results : A total of 83 patients were entered into the study and data were available for 74 . Of these , 38 patients received almitrine + raubasine and 36 received placebo . The baseline characteristics were comparable between both groups . Almitrine + raubasine was significantly more effective than placebo at increasing BI at 1 , 2 or 3 months ( 14.6 ± 13.8 versus 3.3 ± 13.2 , p = 0.01 ; 19.3 ± 13.6 versus 8.8 ± 14.0 , p = 0.02 ; 22.6 ± 14.7 versus 10.7 ± 17.0 , p = 0.02 respectively ) and reducing NFDS at 1 month ( 3.6 ± 3.2 versus 1.9 ± 3.5 , p = 0.034 ) after treatment . More almitrine + raubasine-treated patients ' NFDS had improved compared with placebo-treated patients at 2 and 3 months ( 97 versus 78 % , p = 0.013 ; 100 versus 86 % , p = 0.023 respectively ) . Compared with pre-treatment , there was a strong tendency towards an improvement of HDS with almitrine + raubasine . The number of adverse events reported was low for the almitrine + raubasine-treated group and the placebo group and all events were mild , of short duration and resolved without treatment . Almitrine + raubasine had no clinical ly significant effect on blood pressure , heart rate or other laboratory tests . Conclusion : The results indicate that almitrine + raubasine can accelerate neurological function recovery after stroke to some degree and is well tolerated",
"INTRODUCTION Selegiline ( l-deprenyl ) is a selective monoamine oxidase type B inhibitor that has been shown to have neurotrophic and anti-apoptotic properties and to protect neurons in different experimental models of cerebral ischaemia . The aim of this explorative study was to investigate whether selegiline could enhance cognitive and functional recovery in stroke survivors . METHODS This was a r and omized controlled study in which patients enrolled within two weeks of stroke underwent a clinical and functional evaluation and a neuropsychological assessment . The patients were given selegiline ( 10mg/day ) or matched placebo once a day for six weeks in addition to st and ard rehabilitation care . RESULTS Of 137 stroke survivors , 47 patients met the inclusion criteria and were r and omly assigned to the Study Group ( n=23 ) or the Control Group ( n=24 ) . The statistical analysis showed a significant improvement in most neuropsychological tests after two and six weeks in the study group ; these improvements were not replicated in the control group . The between-group analysis revealed that the domains of attention and executive functions benefited most from the drug treatment . With regard to functional status , comparison of clinical scores at admission and discharge showed a statistically significant enhancement in both groups without statistically significant differences between the groups . CONCLUSIONS These preliminary results suggest that selegiline administered in the subacute phase can promote cognitive functioning in stroke patients . Further studies will eluci date whether and how this enhancement can impact on functional recovery in the short and in the long term",
"Neurological rehabilitation involving motor training has result ed in clinical ly meaningful improvements in function but is unable to eliminate many of the impairments associated with neurological injury . Thus there is a growing need for interventions that facilitate motor learning during rehabilitation therapy , to optimize recovery . d-Cycloserine ( DCS ) , a partial N-methyl-d-aspartate ( NMDA ) receptor agonist that enhances neurotransmission throughout the central nervous system ( Ressler KJ , Rothbaum BO , Tannenbaum L , And erson P , Graap K , Zim and E , Hodges L , Davis M. Arch Gen Psychiatry 61 : 1136 - 1144 , 2004 ) , has been shown to facilitate declarative and emotional learning . We therefore tested whether combining DCS with motor training facilitates motor learning after stroke in a series of two experiments . Forty-one healthy adults participated in experiment I , and twenty adults with stroke participated in experiment II of this two-session , double-blind study . Session one consisted of baseline assessment , subject r and omization , and oral administration of DCS or placebo ( 250 mg ) . Subjects then participated in training on a balancing task , a simulated feeding task , and a cognitive task . Subjects returned 1 - 3 days later for posttest assessment . We found that all subjects had improved performance from pretest to posttest on the balancing task , the simulated feeding task , and the cognitive task . Subjects who were given DCS before motor training , however , did not show enhanced learning on the balancing task , the simulated feeding task , or the associative recognition task compared with subjects given placebo . Moreover , training on the balancing task did not generalize to a similar , untrained balance task . Our findings suggest that DCS does not enhance motor learning or motor skill generalization in neurologically intact adults or in adults with stroke",
"Background : The CHInese Medicine NeuroAiD Efficacy on Stroke recovery ( CHIMES ) study was an international r and omized double-blind placebo-controlled trial of MLC601 ( NeuroAiD ) in subjects with cerebral infa rct ion of intermediate severity within 72 h. CHIMES-E ( Extension ) aim ed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years . Methods : All subjects r and omized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18 , baseline National Institute of Health Stroke Scale of 6 - 14 , and pre-stroke modified Rankin Scale ( mRS ) ≤1 . Initial CHIMES treatment allocation blinding was maintained , although no further study treatment was provided in CHIMES-E. Subjects received st and ard care and rehabilitation as prescribed by the treating physician . mRS , Barthel Index ( BI ) , and occurrence of medical events were ascertained at months 6 , 12 , 18 , and 24 . The primary outcome was mRS at 24 months . Secondary outcomes were mRS and BI at other time points . Results : CHIMES-E included 880 subjects ( mean age 61.8 ± 11.3 ; 36 % women ) . Adjusted OR for mRS ordinal analysis was 1.08 ( 95 % CI 0.85 - 1.37 , p = 0.543 ) and mRS dichotomy ≤1 was 1.29 ( 95 % CI 0.96 - 1.74 , p = 0.093 ) at 24 months . However , the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months ( OR 1.49 , 95 % CI 1.11 - 2.01 , p = 0.008 ) , 12 months ( OR 1.41 , 95 % CI 1.05 - 1.90 , p = 0.023 ) , and 18 months ( OR 1.36 , 95 % CI 1.01 - 1.83 , p = 0.045 ) , and for BI dichotomy ≥95 at 6 months ( OR 1.55 , 95 % CI 1.14 - 2.10 , p = 0.005 ) but not at other time points . Subgroup analyses showed no treatment heterogeneity . Rates of death and occurrence of vascular and other medical events were similar between groups . Conclusions : While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years , the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke",
"Background Erythropoietin ( EPO ) and its receptor play a major role in embryonic brain , are weakly expressed in normal postnatal/adult brain and up-regulated upon metabolic stress . EPO protects neurons from hypoxic/ischemic injury . The objective of this trial is to study the safety and efficacy of recombinant human EPO ( rhEPO ) for treatment of ischemic stroke in man . Material s and Methods The trial consisted of a safety part and an efficacy part . In the safety study , 13 patients received rhEPO intravenously ( 3.3 × 104 IU/50 ml/30 min ) once daily for the first 3 days after stroke . In the double-blind r and omized proof-of-concept trial , 40 patients received either rhEPO or saline . Inclusion criteria were age The study endpoints were functional outcome at day 30 ( Barthel Index , modified Rankin scale ) , NIH and Sc and inavian stroke scales , evolution of infa rct size ( sequential MRI evaluation using diffusion-weighted [ DWI ] and fluid-attenuated inversion recovery sequences [ FLAIR ] ) and the damage marker S100ß . Results No safety concerns were identified . Cerebrospinal fluid EPO increased to 60–100 times that of nontreated patients , proving that intravenously administered rhEPO reaches the brain . In the efficacy trial , patients received rhEPO within 5 hr of onset of symptoms ( median , range 2:40–7:55 ) . Admission neurologic scores and serum S100β concentrations were strong predictors of outcome . Analysis of covariance controlled for these two variables indicated that rhEPO treatment was associated with an improvement in follow-up and outcome scales . A strong trend for reduction in infa rct size in rhEPO patients as compared to controls was observed by MRI . Conclusion Intravenous high-dose rhEPO is well tolerated in acute ischemic stroke and associated with an improvement in clinical outcome at 1 month . A larger scale clinical trial is warranted",
"Amphetamine enhances recovery after experimental ischaemia and has shown promise in small clinical trials when combined with motor or sensory stimulation . Amphetamine , a sympathomimetic , might have haemodynamic effects in stroke patients , although limited data have been published . Subjects were recruited 3–30 days post-ischaemic stroke into a phase II r and omized ( 1:1 ) , double-blind , placebo-controlled trial . Subjects received dexamphetamine ( 5 mg initially , then 10 mg for 10 subsequent doses with 3- or 4-day separations ) or placebo in addition to inpatient physiotherapy . Recovery was assessed by motor scales ( Fugl – Meyer ( FM ) ) , and functional scales ( Barthel index ( BI ) and modified Rankin score ( mRS ) ) . Peripheral blood pressure ( BP ) , central haemodynamics and middle cerebral artery blood flow velocity were assessed before , and 90 min after , the first two doses . Thirty-three subjects were recruited , aged 33–88 ( mean 71 ) years , males 52 % , 4–30 ( median 15 ) days post stroke to inclusion . Sixteen patients were r and omized to placebo and seventeen to amphetamine . Amphetamine did not improve motor function at 90 days ; mean ( s.d . ) FM 37.6 ( 27.6 ) vs control 35.2 ( 27.8 ) ( P=0.81 ) . Functional outcome ( BI , mRS ) did not differ between treatment groups . Peripheral and central systolic BP , and heart rate ( HR ) , were 11.2 mm Hg ( P=0.03 ) , 9.5 mm Hg ( P=0.04 ) and 7 beats per minute ( P=0.02 ) higher , respectively , with amphetamine , compared with control . A nonsignificant reduction in myocardial perfusion ( BUI ) was seen with amphetamine . Other cardiac and cerebral haemodynamics were unaffected . Amphetamine did not improve motor impairment or function after ischaemic stroke but did significantly increase BP and HR without altering cerebral haemodynamics ",
"Background and Purpose : Published reports of intervention in r and omized controlled trials are often poorly described . The Template for Intervention Description and Replication ( TIDieR ) checklist has been recently developed to improve the reporting of interventions . The aim of this article is to describe a therapy intervention used in the stroke rehabilitation trial , “ Clinical Efficacy of Functional Strength Training for Upper Limb Motor Recovery Early After Stroke : Neural Correlates and Prognostic Indicators ” ( FAST-INdICATE ) , using TIDieR. Methods : The functional strength training intervention used in the FAST-INdICATE trial was described using TIDieR so that intervention can be replicated by both clinicians , who may implement it in practice , and research ers , who may deliver it in future research . The usefulness of TIDieR in the context of a complex stroke rehabilitation intervention was then discussed . Results and Discussion : The TIDieR checklist provided a systematic way of describing a treatment intervention used in a clinical trial of stroke rehabilitation . Clarification is needed regarding several aspects of the TIDieR checklist , including in which section to report about the development of the intervention in pilot studies , results of feasibility studies ; overlap between training and procedures for assessing fidelity ; and where to publish supplementary material so that it remains in the public domain . Conclusions : TIDieR is a systematic way of reporting the intervention delivered in a clinical trial of a complex intervention such as stroke rehabilitation . This approach may also have value for st and ardizing intervention in clinical practice . Video abstract available for more insights from the authors ( see Supplemental Digital Content 1 , http://links.lww.com/JNPT/A131 )",
"Background and Purpose — Granulocyte colony – stimulating factor ( G-CSF ; AX200 ; Filgrastim ) is a stroke drug c and i date with excellent pre clinical evidence for efficacy . A previous phase IIa dose – escalation study suggested potential efficacy in humans . The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients . Methods — G-CSF ( 135 µg/kg body weight intravenous over 72 hours ) was tested against placebo in 328 patients in a multinational , multicenter , r and omized , and placebo-controlled trial ( NCT00927836 ; www . clinical trial.gov ) . Main inclusion criteria were ⩽9-hour time window after stroke onset , infa rct localization in the middle cerebral artery territory , baseline National Institutes of Health Stroke Scale score range of 6 to 22 , and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90 , respectively . Data were analyzed using a prespecified model that adjusted for age , National Institutes of Health Stroke Scale score at baseline , and initial infa rct volume ( diffusion-weighted imaging ) . Results — G-CSF treatment failed to meet the primary and secondary end points of the trial . For additional end points such as mortality , Barthel index , or infa rct size at day 30 , G-CSF did not show efficacy either . There was , however , a trend for reduced infa rct growth in the G-CSF group . G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles , with a strong increase in leukocytes and monocytes . In parallel , the cytokine profile showed a significant decrease of interleukin-1 . Conclusions — G-CSF , a novel and promising drug c and i date with a comprehensive pre clinical and clinical package , did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00927836",
"OBJECTIVE Stroke often produces marked physical and cognitive impairments leading to functional dependence , caregiver burden , and poor quality of life . We examined the course of disability during a 1-year follow-up period after stroke among patients who were administered antidepressants for 3 months compared to patients given placebo for 3 months . METHODS A total of 83 patients entered a double-blind r and omized study of the efficacy of antidepressants to treat depressive disorders and reduce disability after stroke . Patients were assigned to either fluoxetine ( N = 32 ) , nortriptyline ( N = 22 ) or placebo ( N = 29 ) . Psychiatric assessment included administration of the Present State Examination modified to identify DSM-IV symptoms of depression . The severity of depression was measured using the 17-item Hamilton Depression Rating Scale . The modified Rankin Scale was used to evaluate the disability of patients at initial evaluation and at quarterly follow-up visits for 1 year . Impairment in activities of daily living was assessed by Functional Independence Measure at the same time . RESULTS During the 1-year follow-up period , and after adjusting for critical confounders including age , intensity of rehabilitation therapy , baseline stroke severity , and baseline Hamilton Depression Rating Scale , patients who received fluoxetine or nortriptyline had significantly greater improvement in modified Rankin Scale scores compared to patients who received placebo ( t [ 156 ] = -3.17 , p = 0.002 ) . CONCLUSIONS Patients treated with antidepressants had better recovery from disability by 1-year post stroke ( i.e. , 9 months after antidepressants were stopped ) than patients who did not receive antidepressant therapy . This effect was independent of depression suggesting that antidepressants may facilitate the neural mechanisms of recovery in patients with stroke",
"BACKGROUND Functional disability is generally caused by hemiplegia after stroke . Physiotherapy used to be the only way of improving motor function in such patients . However , administration of amphetamines in addition to exercise improves motor recovery in animals , probably by increasing the concentration of norepinephrine in the central nervous system . Our aim was to ascertain whether levodopa could enhance the efficacy of physiotherapy after hemiplegia . METHODS We did a prospect i ve , r and omised , placebo-controlled , double-blind study in which we enrolled 53 primary stroke patients . For the first 3 weeks patients received single doses of levodopa 100 mg or placebo daily in combination with physiotherapy . For the second 3 weeks patients had only physiotherapy . We quantitatively assessed motor function every week with Rivermead motor assessment ( RMA ) . FINDINGS Six patients were excluded from analyses because of non-neurological complications . Motor recovery was significantly improved after 3 weeks of drug intervention in those on levodopa ( RMA improved by 6.4 points ) compared with placebo ( 4.1 ) , and the result was independent of initial degree of impairment ( p total RMA score gain for the levodopa group was 8.2 points compared with 5.7 in the placebo group ( p=0.020 ) . INTERPRETATION A single dose of levodopa is well tolerated and , when given in combination with physiotherapy , enhances motor recovery in patients with hemiplegia . In view of its minimal side-effects , levodopa will be a possible add- on during stroke rehabilitation",
"Introduction Pre clinical studies suggest that growth factors in the early days after stroke improve final outcome . A prior study found three doses of human choriogonadotropin alfa followed by three doses of erythropoietin to be safe after stroke in humans . A proof of concept trial ( REGENESIS ) was initiated but placed on regulatory hold during review of an erythropoietin neuroprotective trial . Due to financial constraints , the trial was largely moved to India , using lower erythropoietin doses , as the REGENESIS-LED trial . Methods Entry criteria included National Institutes of Health Stroke Scale 8–20 , supratentorial ischemic stroke , and 24–48 h poststroke at start of therapy . Patients were r and omized to three QOD doses of subcutaneous human choriogonadotropin alfa followed by three QD doses of intravenous erythropoietin ( three escalating dose cohorts , 4000–20 000 IU/dose ) vs. placebo . Primary outcomes were safety and neurological recovery . Results The study was halted early by the sponsor after 96 enrollees . There was no significant difference across treatment groups in the proportion of patients experiencing death , serious adverse events , or any adverse event . There was no significant difference in National Institutes of Health Stroke Scale score change from baseline to Day 90 between placebo and active treatment , whether active cohorts were analyzed together or separately , and no exploratory secondary measure of neurological recovery showed a significant difference between groups . Discussion Administration of human choriogonadotropin alfa followed by erythropoietin is safe after a new ischemic stroke . At the doses studied , placebo and active groups did not differ significantly in neurological recovery . Study limitations , such as the use of multiple assessors , differences in rehabilitation care , and being underpowered to show efficacy , are discussed",
"Background . For early inpatient stroke rehabilitation , the effectiveness of amphetamine combined with physiotherapy varies across studies . Objective . To investigate whether the recovery of activities of daily living ( ADL , primary outcome ) and motor function ( secondary outcome ) can be improved by dexamphetamine added to physiotherapy . Methods . In a double-blind , placebo-controlled trial , 16 patients , from 918 who were screened , were r and omized to the experimental group ( EG , dexamphetamine + physiotherapy ) or control group ( CG , placebo + physiotherapy ) . Both groups received multidisciplinary inpatient rehabilitation . Dexamphetamine ( 10 mg oral ) or placebo was administered 2 days per week before physiotherapy . ADL and motor function were measured using the Chedoke – McMaster Stroke Assessment ( CMSA ) twice during baseline , every week during the 5-week treatment period , and at follow-up 1 week , 6 months , and 12 months after intervention . Results . The majority of ineligible patients had too little paresis , were on anticoagulants , or had a stroke > 60 days prior to entry . Participants ( EG , n = 7 , age 70.3 ± 10 years , 5 women , 37.9 ± 9 days after stroke ; CG , n = 9 , age 65.2 ± 17 years , 3 women , 40.3 ± 9 days after stroke ) did not differ at baseline except for the leg subscale . Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL ( P = .023 ) and arm function ( P = .020 ) at end of treatment . No adverse events were detected . Conclusion . In this small trial that was based on prior positive trials , significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy . Effect size calculation suggests inclusion of at least 25 patients per group in future studies ( Clinical Trials.gov number : NCT00572767 )",
"Motor excitability is increased in both hemispheres in stroke patients during motor recovery . Pharmacologically controlled changes of cortical excitability might be beneficial for synaptic plasticity and therefore facilitate functional recovery after a brain lesion . In particular , it has been suggested that antidepressant drugs can modulate motor excitability . Several recent reports suggest the possibility of monitoring pharmacological effects on brain excitability through transcranial magnetic stimulation ( TMS ) . The aim of this study was to investigate motor area excitability in patients with stroke after oral administration of citalopram . We conducted a prospect i ve r and omised placebo controlled study . Twenty patients with unilateral stroke were included in the study : ten patients treated by antidepressive drug and ten patients with placebo . A selective serotonergic drug ( citalopram ) or a placebo was administered using a mean dosage of 10 mg/day in combination with physiotherapy . Motor cortex excitability was studied by single and paired transcranial magnetic stimulation . TMS recording was tested before ( T1 ) and 1 month after ( T2 ) beginning drug treatment . Patients treated by the serotonergic drug , compared to patients that received a placebo , showed a significant improvement in neurological status as measured by NIHSS and a decrease of motor excitability over the unaffected hemisphere , while no differences were observed over the affected hemisphere . Our findings suggest that treatment with serotonergic drugs can bring about a significant decrease of the motor cortex excitability in stroke patients with effects on both the affected and unaffected hemispheres associated with a better motor recovery",
"In order to determine the influence of a single dose of fluoxetine on the cerebral motor activation of lacunar stroke patients in the early phase of recovery , we conducted a prospect i ve , double‐blind , crossover , placebo‐controlled study on 8 patients with pure motor hemiparesia . Each patient underwent two functional magnetic resonance imaging ( fMRI ) examinations : one under fluoxetine and one under placebo . The first was performed 2 weeks after stroke onset and the second a week later . During the two fMRI examinations , patients performed an active controlled motor task with the affected h and and a passive one conducted by the examiner with the same h and . Motor performance was evaluated by motor tests under placebo and under fluoxetine immediately before the examinations to investigate the effect of fluoxetine on motor function . Under fluoxetine , during the active motor task , hyperactivation in the ipsilesional primary motor cortex was found . Moreover , fluoxetine significantly improved motor skills of the affected side . We found that a single dose of fluoxetine was enough to modulate cerebral sensory‐motor activation in patients . This redistribution of activation toward the motor cortex output activation was associated with an enhancement of motor performance",
"Background and Objective : Previous clinical studies have shown that Neuroaid ( MLC 601 ) may be beneficial in post-stroke rehabilitation . Our aim was to investigate the efficacy of Neuroaid on motor recovery in ischemic stroke patients using rehabilitation endpoints in accordance with the International Conference on Harmonization/Good Clinical Practice guidelines , in order to provide predictive information for further larger trials . Methods : This is a phase II double-blind , placebo-controlled pilot study of 40 subjects admitted with a recent ( less than 1 month ) ischemic stroke . All subjects were given either Neuroaid or placebo , 4 capsules 3 times a day for 4 weeks . Fugl-Meyer Assessment ( FMA ) , National Institutes of Health Stroke Scale and Functional Independence Measure scores were measured at initiation of the treatment , and at 4 and 8 weeks . Results : None of the outcomes was statistically significant between the two groups . However , FMA scores showed a positive trend for improvement with Neuroaid treatment over time . Subgroup analysis of subjects with posterior circulation infa rct ion and severe stroke both showed a tendency for better recovery . Conclusion : Some positive trends were observed in the Neuroaid group . A larger multicenter trial focusing on severe stroke patients is needed to better evaluate the role of Neuroaid in aiding stroke recovery in rehabilitation",
"Background and Purpose — The & sgr;-1 receptor ( Sig-1R ) agonist cutamesine ( SA4503 ) enhanced functional recovery after experimental stroke with a treatment initiation window of 48 hours and chronic treatment for 28 days . We conducted a phase 2 clinical trial exploring the safety , tolerability , dose range , and functional effects of cutamesine in patients with ischemic stroke . Methods — Subjects were r and omized between 48 and 72 hours after stroke to receive cutamesine 1 mg/d , 3 mg/d , or placebo for 28 days . Effects on safety and function were assessed at baseline , at end of treatment ( day 28 ) , and at end of follow-up ( day 56 ) . Results — In 60 patients , treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbers of treatment emergent or serious adverse events . No significant effect was observed on the primary efficacy measure ( change in National Institutes of Health Stroke Scale from baseline to day 56 ) or modified Rankin Scale and Barthel Index scores . Post hoc analysis of moderately and severely affected patients ( baseline National Institutes of Health Stroke Scale , ≥7 and ≥10 ) showed greater National Institutes of Health Stroke Scale improvements in the 3 mg/d cutamesine group when compared with placebo ( P=0.034 and P=0.038 , respectively ) . A trend toward a higher proportion being able to complete a 10 m timed walk was observed for cutamesine-treated subjects . Conclusions — Cutamesine was safe and well tolerated at both dosage levels . Although no significant effects on functional end points were seen in the population as a whole , greater improvement in National Institutes of Health Stroke Scale scores among patients with greater pretreatment deficits seen in post hoc analysis warrants further investigation . Additional studies should focus on the patient population with moderate-to-severe stroke . Clinical Trial Registration — URL : http://www . clinical trials.gov/show/NCT00639249 . Unique identifier : NCT00639249 . The EudraCT number is 2007 - 004840 - 60 ( https://www . clinical trialsregister.eu/ctr- search /trial/2007 - 004840 - 60/GB )",
"Background and Purpose — Cerebrolysin showed neuroprotective and neurotrophic properties in various pre clinical models of ischemia and small clinical trials . The aim of this large double-blind , placebo-controlled r and omized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke . Methods — Patients with acute ischemic hemispheric stroke were r and omized within 12 hours of symptoms onset to active treatment ( 30 mL Cerebrolysin daily ) or placebo ( saline solution ) given as intravenous infusion for 10 days in addition to aspirin ( 100 mg daily ) . The patients were followed up to 90 days . The primary end point was the result of a combined global directional test of modified Rankin Scale , Barthel Index , and National Institutes of Health Stroke Scale . Adverse events were documented to assess safety . Results — A total of 1070 patients were enrolled in this study . Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo . The confirmatory end point showed no significant difference between the treatment groups . When stratified by severity however , a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale > 12 ( National Institutes of Health Stroke Scale : OR , 1.27 ; CI lower bound , 0.97 ; modified Rankin Scale : OR , 1.27 ; CI lower bound , 0.90 ) . In this subgroup , the cumulative mortality by 90 days was 20.2 % in the placebo and 10.5 % in the Cerebrolysin group ( hazard ratio , 1.9661 ; CI lower bound , 1.0013 ) . Conclusions — In this study , the confirmatory end point showed neutral results between the treatment groups . However , a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin . This observation should be confirmed by a further clinical trial . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00868283",
"Abstract s Background Cerebrolysin is a neuropeptide preparation with neuroprotective and neurorestorative effects . Combining Cerebrolysin treatment with a st and ardized rehabilitation program may have a potential synergistic effect in the subacute stage of stroke . This study aims to evaluate whether Cerebrolysin provides additional motor recovery on top of rehabilitation therapy in the subacute stroke patients with moderate to severe motor impairment . Methods This phase IV trial was design ed as a prospect i ve , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study . A total of 70 patients ( Cerebrolysin n = 35 , placebo n = 35 ) with moderate to severe motor function impairment were included within 7 days after stroke onset and were r and omized to receive a 21-day treatment course of either Cerebrolysin or placebo , given in addition to st and ardized rehabilitation therapy . Assessment s were performed at baseline , immediately after treatment as well as 2 and 3 months after stroke onset . The plasticity of motor system was assessed by diffusion tensor imaging and with resting state functional magnetic resonance imaging . Results Both groups demonstrated significant improvement in motor function ( p no significant difference was found between the two groups . In the stroke patients with severe motor impairment , the Cerebrolysin group exhibited significantly more improvement in motor function compared with the placebo group ( p Cerebrolysin were demonstrated as restricted increments of corticospinal diffusivity and as recovery of the sensorimotor connectivity . Conclusion The combination of st and ard rehabilitation therapy with Cerebrolysin treatment in the subacute stroke has shown additional benefit on motor recovery and plastic changes of the corticospinal tract in patients with severe motor impairment . Trial registration NCT01996761 ( November 5 , 2013",
"BACKGROUND AND PURPOSE In animal models of brain injury , administration of numerous pharmaceuticals is reported to facilitate functional recovery . However , only drugs that increase the release of norepinephrine have been shown to promote recovery when administered late ( days to weeks ) after injury . To determine whether these findings were applicable to humans , we administered the norepinephrine stimulant dextroamphetamine , paired with physical therapy , to hemiplegic stroke patients . METHODS Ten hemiplegic patients who suffered an acute ischemic infa rct ion were entered between days 16 and 30 after onset and r and omly assigned to receive either 10 mg of dextroamphetamine or a placebo orally every fourth day for 10 sessions paired with physical therapy . The Fugl-Meyer Motor Scale was used at baseline , within each session , and for 12 months after onset as the dependent measure . Confounding medications such as alpha-adrenergic antagonists or agonists were excluded in all subjects . RESULTS Although there were no differences between the groups at baseline ( P = .599 ) , there was a significant ( P = .047 ) difference between the groups when the drug had been discontinued for 1 week and at the 12-month follow-up visit ( P = .047 ) . CONCLUSIONS Administration of dextroamphetamine paired with physical therapy increased the rate and extent of motor recovery in a small group of hemiplegic stroke patients . These data support and extend previous findings of the facilitatory aspects of certain types of drugs on recovery from brain injury . The use of neuromodulation may allow the nervous system to adapt previously unused or alternative pathways to relevant external input",
"Background and Purpose — Granulocyte colony-stimulating factor ( G-CSF ) is a promising stroke drug c and i date . The present phase IIa study assessed safety and tolerability over a broad dose range of G-CSF doses in acute ischemic stroke patients and explored outcome data . Methods — Four intravenous dose regimens ( total cumulative doses of 30–180 & mgr;g/kg over the course of 3 days ) of G-CSF were tested in 44 patients in a national , multicenter , r and omized , placebo-controlled dose escalation study ( NCT00132470 ; www . clinical trial.gov ) . Main inclusion criteria were a 12-hour time window after stroke onset , infa rct localization to the middle cerebral artery territory , a baseline National Institutes of Health Stroke Scale range of 4 to 22 , and presence of diffusion-weighted imaging/perfusion-weighted imaging mismatch . Results — Concerning the primary safety end points , we observed no increase of thromboembolic events in the active treatment groups , and no increase in related serious adverse events . G-CSF led to expected increases in neutrophils and monocytes that resolved rapidly after end of treatment . We observed a clinical ly insignificant drug-related decrease of platelets . As expected from the low number of patients , we did not observe significant differences in clinical outcome in treatment vs. placebo . In exploratory analyses , we observed an interesting dose-dependent beneficial effect of treatment in patients with DWI lesions > 14–17 cm3 . Conclusions — We conclude that G-CSF was well-tolerated even at high dosages in patients with acute ischemic stroke , and that a substantial increase in leukocytes appears not problematic in stroke patients . In addition , exploratory analyses suggest treatment effects in patients with larger baseline diffusion-weighted imaging lesions . The obtained data provide the basis for a second trial aim ed to demonstrate safety and efficacy of G-CSF on clinical end points",
"The effects of a single oral dose of levodopa administered in a r and omized , double-blind , placebo-controlled cross-over design on formation of a motor memory were studied by a training protocol in patients with chronic stroke . Levodopa enhanced the ability of motor training to encode an elementary motor memory relative to placebo . Up-regulation of dopaminergic function may enhance motor memory formation , crucial for successful rehabilitative treatments in patients with chronic stroke",
"PURPOSE Drugs that modulate neuronal transmission can influence motor recovery after stroke . Here , we tested if a single dose of levodopa could improve motor functions and change motor excitability in a group of chronic stroke patients . METHODS Ten patients > 6 months after their stroke participated in a placebo-controlled double-blind trial . On two different occasions , they received either 100 mg levodopa or placebo in a r and omized order . After drug intake , they participated in one hour of physiotherapy aim ed at an improvement of dexterity . Motor functions were tested by application of the Nine-Hole-Peg Test , a dynamometer measuring grip strength and the Action Research Arm Test . In addition , transcranial magnetic stimulation ( TMS ) was applied to study intracortical excitability , stimulus response curves and silent periods . TMS studies and motor function measurements were performed before drug intake , 45 minutes after drug ingestion and after the physiotherapy . RESULTS Compared to placebo , levodopa neither improved motor functions nor changed motor excitability as tested by TMS . CONCLUSION These findings suggests that a single levodopa dose is not sufficient to improve motor function in chronic stroke . However , it can not be excluded that the lack of a beneficial effect is related to the small study sample",
"BACKGROUND AND PURPOSE In animals , drugs that increase brain amine concentrations influence the rate and degree of recovery from cortical lesions . It is therefore conceivable that antidepressants may influence outcome after ischemic brain injury in humans . We evaluated the effects of the norepinephrine reuptake blocker maprotiline and the serotonin reuptake blocker fluoxetine on the motor/functional capacities of poststroke patients undergoing physical therapy . METHODS Fifty-two severely disabled hemiplegic subjects were r and omly assigned to three treatment groups ; during 3 months of physical therapy , patients were treated with placebo , maprotiline ( 150 mg/d ) , or fluoxetine ( 20 mg/d ) . Before and at the end of the observation period , we assessed activities of daily living by the Barthel Index , degree of neurological deficit by a neurological scale for hemiplegic subjects , and depressive symptomatology by the Hamilton Depression Rating Scale . RESULTS The diverse treatments ameliorated walking and activities of daily living capacities to different extents . The greatest improvements were observed in the fluoxetine-treated group and the lowest in the maprotiline-treated group . Furthermore , fluoxetine yielded a significantly larger number of patients with good recovery compared with maprotiline or placebo . These effects of the drugs were not related to their efficacy in treating depressive symptoms . CONCLUSIONS Fluoxetine may facilitate or , alternatively , maprotiline may hinder recovery in poststroke patients undergoing rehabilitation . The effects of fluoxetine as an adjunct to physical therapy warrant further investigation , since treatment with fluoxetine may result in a better functional outcome from stroke than physical therapy alone",
"Objective Evidence s from cultured cells and animal models of ischemia suggest that lithium has neuroprotective and neurotrophic effects and may play a desirable role in reducing infa rct volume and even improving the brain insults from stroke . The aim of this study was to evaluate the efficacy of lithium in early motor recovery of patients after ischemic stroke . Methods Eighty patients with first ever stroke , allocated r and omly in lithium , 300 mg twice daily , or placebo . Treatment was initiated 48 hours after stroke and continued for 30 days . Modified National Institute of Health Stroke Scale ( mNIHSS ) and h and subsection of Fugl-Meyer Assessment ( hFMA ) were used to evaluate impairment on the fifth and 30th day of treatment . Results Sixty-six subjects ( 32 subjects in the lithium group and 34 subjects in the placebo group ) completed the study . There were no significant differences in the improvement in mNIHSS ( P=0.40 ) and hFMA ( P=0.07 ) after 30 days . However , a subgroup analysis showed that patients with cortical strokes in the lithium group had significantly better improvement in both mNIHSS and hFMA in comparison to the placebo group ( P=0.003 ) . Approximately 44 % ( n=14 ) of patients in the lithium group , mainly from the cortical stroke subgroup , regained more than 25 % of full function based on hFMA , whereas this rate in the placebo group was 14.7 % ( n=5 ; P=0.009 ) . Conclusion The observed discrete difference between the lithium group and the placebo group in the cortical stroke subgroup may suggest an enhanced motor recovery after stroke by using an early treatment with a low dose of lithium carbonate . However , a larger trial with more patients with cortical stroke is needed to investigate this effect better",
"Objective : Selegiline ( L-deprenyl ) is a selective monoamine oxidase B ( MAO- B ) inhibitor used in the treatment of Parkinson 's disease . In addition , it is thought to rescue neurons with a loss of target-derived trophic support . Several mechanisms have been proposed to explain these phenomena , such as the production of neurotrophic actions through astrocyte activation , reduction of free radical production , or the pres ence of antiapoptotic properties . The aim of this study was to investigate whether the systemic administration of selegiline facilitates recovery after a cerebral infa rct ion in humans . Methods : This phase II study was r and omized , double-blind , and placebo con trolled . Selegiline , 5 mg , or matched placebo was given twice a day for 3 months . The drug therapy was started within 48 h after a hemispheric infa rct ion in the territory of middle cerebral artery . There were 24 patients recruited . Twenty patients were followed up to 3 months or until their death , and they represent the efficacy analysis group . The primary efficacy parameters were Sc and inavian Stroke Scale ( SSS ) , Barthel Index ( BI ) , and Fugl-Meyer Scale ( FMS ) . Secondary parameters were Zung Self-Rating Depres sion Scale ( ZDS ) and 15-Dimensional Measure of Health Related Quality of Life test ( 15-D ) . Results : SSS improved statistically significantly from the baseline when com pared with placebo ( p = 0.019 ) . The results were parallel among the other two pri mary efficacy variables ( BI and FMS ) , showing a positive trend for selegiline , although they did not reach statistical significance . Similarly , in the analysis of the secondary efficacy variables , both the 15-D test and ZDS supported this positive trend in favor of selegiline , although no statistically significant differences between groups were found ( p = 0.06 in 15-D test ) . Conclusions : Selegiline seems to be beneficial after a cere bral infa rct ion . This benefit may be due to the enhancement of the recovery process . Key Words : Cerebrovascular disorders — Stroke — Selegiline — L-deprenyl — Recovery of function",
"R and omised controlled trials , when appropriately design ed , conducted , and reported , represent the gold st and ard in evaluating healthcare interventions . However , r and omised trials can yield biased results if they lack method ological rigour [ 1 ] . To assess a trial accurately , readers of a published report need complete , clear , and transparent information on its methodology and findings . Unfortunately , attempted assessment s frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [ 2,3,4 ] . That lack of adequate reporting fuelled the development of the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement in 1996 [ 5 ] and its revision five years later [ 6,7,8 ] . While those statements improved the reporting quality for some r and omised controlled trials [ 9,10 ] , many trial reports still remain inadequate [ 2 ] . Furthermore , new method ological evidence and additional experience has accumulated since the last revision in 2001 . Consequently , we organised a CONSORT Group meeting to up date the 2001 statement [ 6,7,8 ] . We introduce here the result of that process , CONSORT 2010 .",
"We conducted a double‐blind pilot study of 8 patients with established cerebral infa rct ion to evaluate the effect of a single dose of amphetamine on recovery of motor function using the Fugl‐Meyer scale . Four patients received amphetamine ; the rest were given placebo . All underwent a session of physical therapy . Patients treated with amphetamine obtained greater increments in motor scores than the controls . Along with animal studies , these findings may allow the development of a pharmacological approach to stroke rehabilitation",
"OBJECTIVE To determine the efficacy and safety of methylpheni date in acute stroke rehabilitation . DESIGN A prospect i ve , r and omized , double-blind , placebo-controlled study . PATIENTS AND SETTING Twenty-one stroke patients consecutively admitted to a community-based rehabilitation unit . INTERVENTION Three-week treatment of methylpheni date ( or placebo ) in conjunction with physical therapy . Methylpheni date was started at 5 mg and increased gradually to 30 mg ( 15 mg at 8:00AM and 15 mg at 12:00 noon ) , and discontinued before discharge . MAIN OUTCOME MEASURES Mood measures included the Hamilton Depression Rating Scale ( HAM-D ) and Zung Self-Rating Depression Scale ( ZDS ) . Cognitive status was evaluated using the Mini-Mental State Exam ( MMSE ) . Motor functioning was assessed using the Fugl-Meyer Scale ( FMS ) and a modified version of the Functional Independence Measure ( M-FIM ) . All measures were administered pretreatment and weekly thereafter . Side effects were measured after each increase in dosage and weekly . RESULTS Patients receiving methylpheni date treatment scored lower on the HAM-D ( F(1,18)=5.714 , p=.028 ) , lower on the ZDS ( F(1,18)=4.206 , p=.055 ) , higher on the M-FIM ( F(1,18)=5.374 , p=.032 ) , and higher on the FMS ( F(1,9)=4.060 , p=.075 ) than patients receiving placebo . CONCLUSION Methylpheni date appears to be a safe and effective intervention in early poststroke rehabilitation that may expedite recovery",
"Background . A majority of stroke patients have persisting motor deficits despite ongoing physiotherapy . Therefore , additional treatment options are desirable . Objective . We investigated if the serotonin reuptake inhibitor , citalopram , would improve motor functions in chronic stroke patients . Methods . In all , 8 patients > 6 months after their stroke participated in a double-blind , placebo-controlled , single-dose crossover experiment . The order ( first drug then placebo or vice versa ) was r and omized . Sessions were separated by at least 2 weeks . Motor function was assessed by nine-hole peg test , and measurements of h and grip-strength before drug intake , 2 hours after drug intake , and after 1 hour of training aim ed at improving the function of the paretic h and . Results . Compared with placebo , citalopram intake significantly improved performance of the nine-hole peg test for the paretic h and but not for the unaffected h and . H and grip-strength remained unchanged . Conclusions . A single dose of citalopram can enhance dexterity in chronic stroke patients . This pilot study justifies a test of efficacy of citalopram in a larger group of stroke patients",
"OBJECTIVES This study aim ed to investigate the safety and therapeutic efficacy of herbal drug , Di Huang Yin Zi ( DHYZ ) , in patients affected by ischemic stroke . METHODS In this double blind , placebo-controlled study , a total of 100 patients with recent ( less than 30 days ) ischemic stroke were r and omized to receive DHYZ or placebo for 12 weeks . Both groups also received rehabilitation therapy during the study period . As there were 13 dropouts , a total of 45 patients on DHYZ and 42 on placebo were available for analysis . The Fugl-Meyer Assessment ( FMA ) and Barthel index ( BI ) were assessed before treatment and at 4-week intervals . RESULTS We observed that the FMA score and BI were increased , in both groups at week 4 , 8 and 12 compared with the baseline . Furthermore , significantly better FMA score was observed in patients treated with DHYZ at week 8 and 12 ( both P ) . BI was significantly higher in DHYZ group than in placebo group at weeks 12 ( P ( CI ) of mean difference of FMA and BI also indicated that the differences between two groups were statistically significant . Compared to placebo , DHYZ produced significantly greater improvement in FMA grade at week 12 ( 44.4 % versus 23.8 % , χ(2)=4.09 , P . CONCLUSIONS DHYZ showed good efficacy , safety and tolerability in patients affected by ischemic stroke . We conclude that DHYZ may be a useful therapeutic option in patients with ischemic stroke",
"Major therapeutic advances in the rehabilitation of subacute stroke are lacking . One promising approach is treatment with amphetamine in combination with physiotherapy so as to promote motor function . In a r and omized , double-blind , placebo-controlled clinical trial , the effect of 10 sessions with 10 mg of amphetamine combined with physiotherapy during a 5-week period was investigated in 39 geriatric patients who had been admitted to a stroke rehabilitation unit . Motor function ( Fugl-Meyer motor performance score ) and activities of daily living ( ADL ; Barthel ’s index ) were assessed at baseline and at the end of treatment . All patients improved significantly over the intervention period . Amphetamine-treated patients did not show any increase in motor function or ADL as compared to the control group . Rehabilitation with amphetamine at this dosage and interval , combined with physiotherapy , did not promote motor recovery or functional capacity in patients suffering from stroke",
": Hydergine ( 1 mg three times daily ) or placebo was administered orally to geriatric patients who were convalescing from stroke . Twenty-one patients were studied in a 12-week double-blind trial , and 15 in a 12-week double-blind cross-over study . Regular assessment s were made of symptomatology , physical , mental and psychological status and recovery from paralysis . Statistical analyses of the results of both studies showed that there was no significant difference between the effects of Hydergine and of placebo . The possible relationship between cerebral function , cerebral arteriosclerosis and cerebral blood flow is discussed",
"BACKGROUND Reducing inhibitory neurotransmission with pharmacological agents is a potential approach for augmenting plasticity after stroke . Previous work in healthy subjects showed diminished intracortical inhibition after administration of theophylline . OBJECTIVE We assessed the effect of single-dose theophylline on intracortical and interhemispheric inhibition in patients with chronic stroke , in a double-blind , placebo-controlled , cross-over study . METHODS Eighteen subjects were r and omly administered 300 mg of extended-release theophylline or placebo . Immediately and 5 hours following administration , transcranial magnetic stimulation was used to assess bihemispheric resting motor threshold , short-interval intracortical inhibition , long-interval intracortical inhibition , and interhemispheric inhibition . Adverse effects on cardiovascular , neurological , and motor performance outcomes were also surveilled . Change between morning and afternoon sessions were compared across conditions . One week later , patients underwent the same assessment s after crossing over to the opposite experimental condition . Subjects and investigators were blinded to the experimental condition during data acquisition and analysis . RESULTS For both hemispheres , changes in intracortical or interhemispheric neurophysiology were comparable under theophylline and placebo conditions . Theophylline induced no adverse neurological , cardiovascular , or motor performance effects . For both conditions and hemipsheres , the baseline level of inhibition inversely correlated with its change between sessions : less baseline inhibition ( i.e. disinhibition ) was associated with a strengthening in inhibition over the day , and vice versa . CONCLUSION A single dose of theophylline is well-tolerated by patients with chronic stroke , but does not alter cortical excitability . The inverse relationship between baseline inhibition and its change suggests the existence of a homeostatic process . The lack of effect on cortical inhibition may be related to an insufficiently long exposure to theophylline , or to differential responsiveness of disinhibited neural circuitry in patients with stroke",
"BACKGROUND Results of small trials indicate that fluoxetine might improve functional outcomes after stroke . The FOCUS trial aim ed to provide a precise estimate of these effects . METHODS FOCUS was a pragmatic , multicentre , parallel group , double-blind , r and omised , placebo-controlled trial done at 103 hospitals in the UK . Patients were eligible if they were aged 18 years or older , had a clinical stroke diagnosis , were enrolled and r and omly assigned between 2 days and 15 days after onset , and had focal neurological deficits . Patients were r and omly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm . The primary outcome was functional status , measured with the modified Rankin Scale ( mRS ) , at 6 months . Patients , carers , health-care staff , and the trial team were masked to treatment allocation . Functional status was assessed at 6 months and 12 months after r and omisation . Patients were analysed according to their treatment allocation . This trial is registered with the IS RCT N registry , number IS RCT N83290762 . FINDINGS Between Sept 10 , 2012 , and March 31 , 2017 , 3127 patients were recruited . 1564 patients were allocated fluoxetine and 1563 allocated placebo . mRS data at 6 months were available for 1553 ( 99·3 % ) patients in each treatment group . The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups ( common odds ratio adjusted for minimisation variables 0·951 [ 95 % CI 0·839 - 1·079 ] ; p=0·439 ) . Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months ( 210 [ 13·43 % ] patients vs 269 [ 17·21 % ] ; difference 3·78 % [ 95 % CI 1·26 - 6·30 ] ; p=0·0033 ) , but they had more bone fractures ( 45 [ 2·88 % ] vs 23 [ 1·47 % ] ; difference 1·41 % [ 95 % CI 0·38 - 2·43 ] ; p=0·0070 ) . There were no significant differences in any other event at 6 or 12 months . INTERPRETATION Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes . Although the treatment reduced the occurrence of depression , it increased the frequency of bone fractures . These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function . FUNDING UK Stroke Association and NIHR Health Technology Assessment Programme",
"BACKGROUND Stroke is the third common cause of mortality and the most common cause of morbidity in adults . MLC601 ( NeuroAiD ™ ) is a treatment indicated for post stroke recovery . An increase of impaired cerebral blood flow may be an important parameter for recovery processes . The aim of this study was to investigate the effect of MLC601 on cerebral blood flow velocity as an indirect evidence of cerebral blood flow increase in post stroke subjects . METHODS This is a double-blinded , placebo controlled , r and omized study of 80 subjects included within a week of stroke onset . All subjects were given either MLC601 or placebo , 4 capsules , 3 times a day for 3 months . Cerebral blood flow within the middle cerebral artery , with blood flow velocity measured by transcranial Doppler ( TCD ) , and Barthel index was assessed at baseline and at 3 months . RESULTS The mean change in cerebral blood flow velocity in the MLC601 treatment group ( 15.9 ) was significantly increased ( p=0.009 ) compared to the placebo group ( 9.6 ) . Subjects in the treatment group also showed a significant difference in the mean rank of modified ranking scale ( p change of the Barthel Index : 36 vs. 29 in the placebo group ( p treatment with MLC601 may increase cerebral blood flow in stroke subjects . This may be mediated by an effect on stimulating microcirculation , an important process contributing to neuroplasticity in the central nervous system . This effect on cerebral blood flow may be associated with improvement in measures of functional recovery"
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R and omized controlled trials , being published in English and investigating the associations of at least 4 weeks intervention of citrus and /or its extracts on weight loss among adults , were search ed from PubMed , Web of Science , Scopus , and Cochrane by June 2019 to conduct a meta- analysis . Thirteen articles , including 921 participants , were selected and evaluated by modified Jadad scale . Pooled results by the r and om-effects model showed that citrus and /or its extracts administration significantly reduced 1.280 kg body weight ( 95 % CI : -1.818 to -0.741 , p = 0.000 , I2 = 81.4 % ) , 0.322 kg/m2 BMI ( 95 % CI : -0.599 to -0.046 , p = 0.022 , I2 = 87.0 % ) , 2.185 cm WC ( 95 % CI : -3.804 to -0.566 , p = 0.008 , I2 = 98.3 % ) , and 2.137 cm HC ( 95 % CI : -3.775 to -0.500 , p = 0.011 , I2 = 96.2 % ) , respectively , but no significantly decreased effects on WHR and body fat were observed . Subgroup analysis deduced the different effects of study location , intervention duration on body weight associated indices . No publication bias was observed . Our meta- analysis supported the beneficial effects of citrus and /or its extracts supplement on body weight control , and future well- design ed studies are required to firmly establish the clinical efficacy of citrus and /or its extracts intervention on body weight
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"Folklore has suggested that consuming grapefruit may promote weight control . Sparse data exist to support this hypothesis , although there is some evidence of health promotion effects with regard to blood pressure control and modulation of circulating lipids . The aim of this r and omized controlled trial was to prospect ively evaluate the role of grapefruit in reducing body weight and blood pressure and in promoting improvements in the lipid profile in overweight adults ( N = 74 ) . Following a 3-week washout diet low in bioactive-rich fruits and vegetables , participants were r and omized to either the control diet ( n = 32 ) or daily grapefruit ( n = 42 ) in the amount of one half of a fresh Rio-Red grapefruit with each meal ( 3 × daily ) for 6 weeks . No differences between group in weight , blood pressure , or lipids were demonstrated . Grapefruit consumption was associated with modest weight loss ( -0.61 ± 2.23 kg , P = .097 ) , a significant reduction in waist circumference ( -2.45 ± 0.60 cm , P = .0002 ) , and a significant reduction in systolic blood pressure ( -3.21 ± 10.13 mm Hg , P = .03 ) compared with baseline values . Improvements were observed in circulating lipids of those consuming grapefruit , with total cholesterol and low-density lipoprotein significantly decreasing by -11.7 mg/dL ( P = .002 ) and -18.7 mg/dL ( P of grapefruit daily for 6 weeks does not significantly decrease body weight , lipids , or blood pressure as compared with the control condition . However , the improvements in blood pressure and lipids demonstrated in the intervention group suggest that grapefruit should be further evaluated in the context of obesity and cardiovascular disease prevention",
"Elevated levels of reactive oxygen species under diabetic condition lead to vascular complications and inflammation . This study aim ed to examine the effects of hesperidin supplement on blood pressure and inflammatory markers in type 2 diabetes . In this research , 64 patients were r and omly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks . Data on systolic blood pressure ( SBP ) , diastolic blood pressure , serum total antioxidant capacity ( TAC ) , tumor necrosis factor alpha , interleukin 6 ( IL-6 ) , and high-sensitivity C-reactive protein ( hs-CRP ) were collected at the baseline and at the end of the study . In the hesperidin group , SBP ( 122.7 ± 8.5 vs. 119.0 ± 7.4 ; p = .005 ) , mean arterial blood pressure ( 94.2 ± 5.5 vs. 91.8 ± 5.5 ; p = .009 ) , IL-6 ( 8.3 ± 2.1 vs. 7.4 ± 1.8 ; p = .001 ) , and hs-CRP ( 1.9 ± 1.2 vs. 1.1 ± 0.9 ; p .000 ) decreased whereas TAC increased ( 0.74 ± 0.1 vs. 0.82 ± 0.1 ; p change of SBP , diastolic blood pressure , mean arterial blood pressure , serum TAC , and inflammatory markers ( tumor necrosis factor alpha , IL-6 , and hs-CRP ) between hesperidin and control groups following intervention in adjusted models ( p that hesperidin may have antihypertensive and anti-inflammatory effects in type 2 diabetes",
"OBJECTIVE Assumptions have linked orange juice ( OJ ) consumption with weight gain and adverse effects on health due to its sugar content ; however , epidemiologic studies have not shown increased risk for overweight or obesity with the consumption of 100 % OJ . The aim of this study was to verify whether the combination of a reduced-calorie diet ( RCD ) and 100 % OJ contribute to weight loss , promote changes in glucose and lipid metabolism , and improve diet quality in obese individuals . METHODS A r and omized controlled trial with 78 obese patients ( age 36 ± 1 y , body mass index [ BMI ] 33 ± 3 kg/m2 ) were enrolled in two groups : Individuals in the OJ group su bmi tted to an RCD that included OJ ( 500 mL/d ) , and individuals in the control group su bmi tted to an RCD without OJ . Body composition , biochemical biomarkers , and dietary intake were analyzed over a 12-wk period . RESULTS Both treatments had similar outcomes regarding body weight ( -6.5 kg ; P = 0.363 ) , BMI ( -2.5 kg/m2 ; P = 0.34 ) , lean mass ( -1 kg ; P = 0.29 ) , fat mass ( -5 kg ; P = 0.58 ) , body fat ( -3 % ; P = 0.15 ) , and waist-to-hip ratio ( -0.1 ; P = 0.79 ) . Insulin levels in the OJ group decreased by 18 % ( P = 0.05 ) , homeostasis model assessment -insulin resistance by 33 % ( P = 0.04 ) , total cholesterol by 24 % ( P = 0.004 ) , low-density lipoprotein cholesterol by 24 % ( P ≤ 0.001 ) , and high-sensitivity C-reactive protein levels by 33 % ( P = 0.001 ) compared with the control group . Consumption of energy and nutrients was similar between the two groups , but vitamin C and folate increased by 62 % ( P ≤ 0.015 ) and 39 % ( P = 0.033 ) , respectively , after OJ intervention . CONCLUSION When consumed concomitantly with an RCD , OJ does not inhibit weight loss ; ameliorate the insulin sensitivity , lipid profile , or inflammatory status , or contribute nutritionally to the quality of the diet",
"The association between drinking 100 % fruit juice and long-term weight gain is controversial and has been investigated in few studies . We examined whether 100 % fruit juice consumption was associated with weight change in a large prospect i ve cohort of postmenopausal women . We analyzed data from 49,106 postmenopausal women in the United States enrolled in the Women 's Health Initiative between 1993 and 1998 . Food frequency question naires at baseline and year 3 assessed food and beverage intake . Body weight was measured at in-person clinic visits . We used linear mixed effects modeling to determine the association between change in 100 % fruit juice consumption and 3-year weight change over the same time period . Covariates of interest included age , demographic factors , smoking , body mass index , hormone replacement therapy , lifestyle factors , change in whole fruit intake , and change in sugar-sweetened beverage intake . The mean weight change was 3.2 lbs . over 3 years . In multivariable adjusted analyses , each 1 serving/day increase in 100 % fruit juice intake was associated with a 3-year weight gain of 0.39 lbs . ( 95 % confidence interval : 0.10 , 0.69 ) . In conclusion , an increase in 100 % fruit juice consumption was associated with a small amount of long-term weight gain in postmenopausal women",
"BACKGROUND The consumption of citrus fruits is associated with health benefits . However , clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking . OBJECTIVE The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice ( GFJ ) consumption on vascular function in healthy postmenopausal women . DESIGN Forty-eight healthy postmenopausal women aged 50 - 65 y within 3 - 10 y since menopause , a body mass index ( in kg/m(2 ) ) of 19 - 30 , and a waist size > 88 cm completed this double-blind , r and omized , controlled , crossover trial . These volunteers were r and omly assigned to consume 340 mL GFJ/d , providing 210 mg naringenin glycosides , or a matched control drink without flavanones for 6 mo each , with a 2-mo washout between beverages . The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation . Blood pressure , arterial stiffness , and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function . These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the 6-mo treatment periods . RESULTS The mean ± SD carotid-femoral pulse wave velocity , which reflects central aortic stiffness , was statistically significantly lower after consumption of GFJ ( 7.36 ± 1.15 m/s ) than after consumption of the matched control drink without flavanones ( 7.70 ± 1.36 m/s ) , with a P value of 0.019 for the treatment effect . Endothelial function in macro- and microcirculation , blood pressure , anthropometric measures , glucose metabolism , and biomarkers of inflammation and oxidative stress were not affected by the intervention . CONCLUSIONS Regular GFJ consumption by middle-aged , healthy postmenopausal women is beneficial for arterial stiffness . This effect may be related to flavanones present in grapefruit . This trial was registered at clinical trials.gov as NCT01272167",
"Background YY-312 is a herbal extract powder from Imperata cylindrica Beauvois , Citrus unshiu Markovich , and Evodia officinalis Dode , which have health promoting effects , including body fat reduction . We aim ed to evaluate the efficacy and safety of YY-312 for body fat reduction in overweight adults . Methods This was a 12-week , r and omized , double-blind , placebo-controlled , parallel-group clinical trial performed in overweight Korean adults aged 19–60 years with a body mass index of 25.0–29.9 kg/m2 . The daily dose of YY-312 was 2400 mg ( containing 1800 mg of active herbal extract and 600 mg of cyclodextrin ) . Primary outcomes were reductions in body fat mass ( BFM ) and body fat percentage ( BF% ) after 12 weeks . Secondary outcomes included reductions in body weight and waist circumference ( WC ) after 12 weeks . Results After 12 weeks , BFM ( 1.6 kg vs. 0.1 kg ; P = 0.023 ) and BF% ( 1.5 % vs. -0.2 % ; P = 0.018 ) decreased significantly more in the YY-312 group than in the placebo group , as did body weight ( 2.7 kg vs. 1.0 kg ; P = 0.014 ) and WC ( 2.2 cm vs. 0.8 cm ; P = 0.049 ) . All safety parameters were within normal limits ; no serious adverse events occurred in either group . Conclusions In a 12-week clinical trial in overweight adults , YY-312 result ed in significantly greater reduction in body fat vs. placebo , while being safe and well tolerated . Trial registration cris.nih.go.kr : ( KCT0001225 )",
"BACKGROUND The consumption of orange juice may lead to reduced oxidative stress and may enhance the antioxidant defense system . OBJECTIVE The aim was to evaluate the effects of the intake of orange juice containing either normal ( NPJ ) or high ( HPJ ) concentrations of polyphenols ( 299 and 745 mg/d , respectively ) on the antioxidant defense system , oxidative stress biomarkers , and clinical signs of metabolic syndrome in 100 nonsmoking subjects who were either overweight or obese . METHODS A r and omized , double-blind crossover study was conducted over two 12-wk periods with a 7-wk washout period . The effects on enzymatic and nonenzymatic blood antioxidant defense systems , urinary and plasma oxidative stress biomarkers , and clinical signs of metabolic syndrome were evaluated before and after an intervention with both of the orange juices . Paired t tests and linear mixed-effects models were used to evaluate the effects of juice , time , and interactions . RESULTS The intake of either NPJ or HPJ led to a decrease in urinary 8-hydroxy-2'-deoxyguanosine ( NPJ : 935 ± 134 to 298 ± 19 ng/mg creatinine ; HPJ : 749 ± 84 to 285 ± 17 ng/mg creatinine ) , 8-iso-prostagl and in F2α ( NPJ : 437 ± 68 to 156 ± 14 ng/mg creatinine ; HPJ : 347 ± 43 to 154 ± 13 ng/mg creatinine ) , erythrocyte catalase , and glutathione reductase activities . A decrease was also observed in body mass index , waist circumference , and leptin ( all P ) . The NPJ intervention decreased systolic and diastolic blood pressures ( systolic blood pressure : 128 ± 1 to 124 ± 2 mm Hg ; diastolic blood pressure : 79 ± 1 to 76 ± 1 mm Hg ) , whereas the HPJ intervention increased erythrocyte superoxide dismutase ( SOD ) activity ( 17.7 ± 1.5 to 23.1 ± 1.7 U/mg hemoglobin ) . CONCLUSIONS Our results show that the consumption of either NPJ or HPJ protected against DNA damage and lipid peroxidation , modified several antioxidant enzymes , and reduced body weight in overweight or obese nonsmoking adults . Only blood pressure and SOD activity were influenced differently by the different flavanone supplementations . This trial was registered at clinical trials.gov as NCT01290250"
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The effects of ruminant ( R ) trans-fatty acids ( TFA ) on the risk of CVD are still under debate . It could be argued that the lack of the effect of R-TFA may be the result of the small amount of their intake . Taking into consideration the growing available data from intervention studies , we carried out a systematic review and meta-regression to assess the impact of R-TFA intake levels on changes in the total cholesterol : HDL-cholesterol ( TC : HDL-C ) ratio . A systematic review of the literature was conducted and thirteen r and omised clinical trials were included , yielding a total of twenty-three independent experimental groups of subjects . A univariate r and om-effects meta-regression approach was used to quantify the relationship between the dose of R-TFA and changes in the TC : HDL-C ratio . To consider several potential modifiers such as subject and dietary characteristics , a multivariate regression analysis was performed . We found no relationship between R-TFA intake levels of up to 4.19 % of daily energy intake ( EI ) and changes in cardiovascular risk factors such as TC : HDL-C and LDL-cholesterol (LDL-C):HDL-C ratios . In addition , a multivariate regression analysis that included other dietary variables , as well as subject baseline characteristics , confirmed that doses of R-TFA did not significantly influence the changes in the lipid ratio . Our findings showed that doses of R-TFA did not influence the changes in the ratios of plasma TC : HDL-C and LDL-C : HDL-C. These data suggest that TFA from natural sources , at least at the current levels of intake and up to 4.19 % EI , have no adverse effects on these key CVD risk markers in healthy people
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"We have compared the effects of partially hydrogenated fish oil ( PHFO-diet ) , partially hydrogenated soybean oil ( PHSO-diet ) , and butterfat ( butter-diet ) on serum lipids and lipoprotein[a ] in 31 young men . The three test margarines , which contributed 78 % of total fat in the diets , were produced from 70 % of butterfat , PHSO , or PHFO , each with 30 % of soybean oil . Fat provided about 35 % of energy , and trans fatty acids 0.9 % , 8.5 % , and 8.0 % of energy in the butter- , the PHSO- , and the PHFO-diet , respectively . Dietary cholesterol was balanced by the addition of dried egg powder to the PHSO- and the butter-diet ; thus all diets contained 420 mg dietary cholesterol per 10 MJ per day . The subjects consumed all three test diets for 19 - 21 days in a r and om order ( crossover design ) . The serum levels of total and LDL-cholesterol were significantly elevated on the PHFO-diet ( mean values 5.42 and 3.94 mmol/L , respectively ) compared to the PHSO-diet ( 5.11 and 3.58 mmol/L , respectively ) but not different from those on the butter-diet ( 5.32 and 3.81 mmol/L , respectively ) . LDL-cholesterol was significantly reduced on the PHSO-diet compared to the butter-diet . The level of HDL-cholesterol was significantly lower on the PHFO-diet ( 0.98 mmol/L ) when compared to the butter-diet ( 1.05 mmol/L ) and with border-line significance compared to the PHSO-diet ( 1.05 mmol/L ) . The ratio of LDL- to HDL-cholesterol was significantly higher on the PHFO-diet ( 4.20 ) when compared to both other test diets ( 3.85 and 3.65 , respectively ) . No significant differences in triglyceride values were observed . Lp[a ] increased and apoA-I decreased significantly after consumption of both the PHSO-diet and the PHFO-diet , compared to the butter-diet . In conclusion , our results indicate that consumption of PHFO may unfavorably affect lipid risk indicators for coronary heart disease at least to the same extent as butterfat . To what extent the observed effects are due to the content of monoene trans , diene trans , or to the long chain saturated fatty acids in PHFO remains to be eluci date",
"Background / Objectives : The objective of this study was to evaluate the impact of three specific ruminant ( R ) milk fats result ing from modification of the cow 's diet on cardiovascular risk factors in healthy volunteers . R-milk fats were characterized by increased content in total trans fatty acids ( R-TFAs ) and parallel decrease in saturated fatty acids (SFAs).Subjects/ Methods : A total of 111 healthy , normolipemic men and women have been recruited for a monocentric , r and omized , double-blind and parallel intervention , 4-week controlled study . Volunteers consumed three experimental products ( butter , dessert cream and cookies ) made with one of the three specific milk fats ( 55 g fat per day ) . During the first week ( run-in period ) , the subjects consumed on a daily basis dairy products containing 72 % SFA/2.85 % R-TFA ( called ‘ L0 ’ ) . For the next 3 weeks of the study ( intervention period ) , the first group continued to consume L0 products . The second group received dairy products containing 63.3 % SFA/4.06 % R-TFA ( called ‘ L4 ’ ) , and the third group received dairy products containing 56.6 % SFA/12.16 % R-TFA ( called ‘ L9 ’ ) . Results : Plasma concentrations of high-density lipoprotein (HDL)-cholesterol were not significantly altered by either diet ( P=0.38 ) . Compared to L0 diet , L4 diet contributed to reduce low-density lipoprotein (LDL)-cholesterol ( −0.14±0.38 mmol/l , P=0.04 ) , total cholesterol ( −0.13±0.50 mmol/l , P=0.04 ) , LDL-cholesterol/HDL-cholesterol ( −0.14±0.36 , P=0.03 ) and total cholesterol/HDL-cholesterol ( −0.18±0.44 , P=0.02 ) . Conclusions : Different milk fat profiles can change cardiovascular plasma parameters in human healthy volunteers . A limited increase of the R-TFA/SFA ratio in dairy products is associated with an improvement in some cardiovascular risk factors . However , a further increase in R-TFA/SFA ratio has no additional benefit",
"Fatty acid profile of milk fat can be modified by cow feeding strategies . Our aim was postpr and ially and after 4 wk to compare the effect of a modified milk fat ( M diet ) [ with 16 % of the cholesterolemic saturated fatty acid ( C12–16 ) replaced by mainly oleic and stearic acids ] with the effect of D diet , including a conventional Danish milk fat on plasma lipids and lipoproteins . A side effect of the cow feeding regime was a 5 % ( w/w ) increase in trans fatty acid in M diet . Eighteen subjects were fed for two periods of 4 wk strictly controlled isoenergetic test diets with 40 % of energy from total fat and the same content of dietary cholesterol in a r and omized study with cross-over design . Contrary to expectations , fasting low density lipoprotein ( LDL ) cholesterol concentration did not differ after the experimental periods . However , M diet result ed in a higher fasting total triacylglycerol concentration compared to D diet ( P=0.009 ) . Postpr and ial sample s were taken at two different occasions ( i ) at day 21 , after breakfast and lunch and ( ii ) on the last day of the study 2 , 4 , 6 , and 8 h after a fat load . Postpr and ial plasma triacylglycerol and chylomicron triacylglycerol showed higher peak values after D diet than M diet ( interaction effect , diet × times P did not lower LDL cholesterol compared to D diet . Thus any cholesterol-lowering effect of oleic and stearic acids may have been obscured by the high content of cholesterol-raising saturated fatty acids in milk fat . A higher content of the trans fatty acids in M diet might have counteracted the cholesterol neutral/decreasing effect and increased plasma triacylglycerol",
"BACKGROUND Dietary trans fatty acids ( FAs ) , which are formed during the process of hydrogenating vegetable oil , are known to increase plasma LDL-cholesterol concentrations . However , their effect on LDL particle size has yet to be investigated . OBJECTIVE We investigated the effect of trans FA consumption on the electrophoretic characteristics of LDL particles . DESIGN Eighteen women and 18 men each consumed 5 experimental diets in r and om order for 35-d periods . Fat represented 30 % of total energy intake in each diet , with two-thirds of the fat in the form of semiliquid margarine ( 0.6 g trans FAs/100 g fat ) , soft margarine ( 9.4 g trans FAs/100 g fat ) , shortening ( 13.6 g trans FAs/100 g fat ) , stick margarine ( 26.1 g trans FAs/100 g fat ) , or butter , which was low in trans FAs ( 2.6 g trans FAs/100 g fat ) but rich in saturated fat . LDL particle size and distribution were characterized by nondenaturing , 2 - 16 % polyacrylamide gradient gel electrophoresis . RESULTS Relative to the LDL particle size observed after consumption of the butter-enriched diet , LDL particle size decreased significantly and in a dose-dependent fashion with increasing amounts of dietary trans FAs ( P Cholesterol concentrations in large ( > 260 A ) and medium-sized ( 255 - 260 A ) LDL particles also increased proportionately to the amount of trans FAs in the diet . CONCLUSION Consumption of dietary trans FAs is associated with a deleterious increase in small , dense LDL , which further reinforces the importance of promoting diets low in trans FAs to favorably affect the lipoprotein profile",
"BACKGROUND The intake of trans fatty acids ( TFA ) from industrially hydrogenated vegetable oils ( iTFA ) is known to have a deleterious effect on cardiovascular health , the effects of TFA from ruminants ( rTFA ) are virtually unknown . OBJECTIVE The purpose of the present study was to compare the effects of rTFA and iTFA on plasma LDL concentrations and other cardiovascular disease risk factors in healthy subjects . DESIGN In a double-blind , r and omized crossover controlled study , 38 healthy men were fed each of 4 experimental isoenergetic diets lasting 4 wk each . The 4 diets were high in rTFA ( 10.2 g/2500 kcal ) , moderate in rTFA ( 4.2 g/2500 kcal ) , high in iTFA ( 10.2 g/2500 kcal ) , and low in TFA from any source ( 2.2 g/2500 kcal ) ( control diet ) . RESULTS Plasma LDL-cholesterol concentrations were significantly higher after the high- rTFA diet than after the control ( P = 0.03 ) or the moderate- rTFA ( P = 0.002 ) diet . Plasma LDL-cholesterol concentrations also were significantly ( P = 0.02 ) higher after the iTFA diet than after the moderate-rTFA diet . Plasma HDL-cholesterol concentrations were significantly ( P = 0.02 ) lower after the high-rTFA diet than after the moderate-rTFA diet . Finally , all risk factors were comparable between the control and the moderate-rTFA diets . CONCLUSIONS These results suggest that , whereas a high dietary intake of TFA from ruminants may adversely affect cholesterol homeostasis , moderate intakes of rTFA that are well above the upper limit of current human consumption have neutral effects on plasma lipids and other cardiovascular disease risk factors",
"BACKGROUND The effect of individual dietary fatty acids on emerging risk factors for cardiovascular disease that are associated with sub clinical inflammation is unknown . OBJECTIVE The goal was to evaluate the role of dietary fat and specific fatty acids , especially trans fatty acids , in altering concentrations of markers of inflammation in humans fed controlled diets . DESIGN In a r and omized crossover design , 50 men consumed controlled diets for 5 wk that provided 15 % of energy from protein , 39 % of energy from fat , and 46 % of energy from carbohydrate . Eight percent of fat or fatty acids was replaced across diets with the following : cholesterol , oleic acid , trans fatty acids ( TFAs ) , stearic acid ( STE ) , TFA+STE ( 4 % of energy each ) , and 12:0 - 16:0 saturated fatty acids ( LMP ) . RESULTS Fibrinogen concentrations were higher after consumption of the diet enriched in stearic acid than after consumption of the carbohydrate diet . C-reactive protein concentrations were higher after consumption of the TFA diet than after consumption of the carbohydrate diet , but were not significantly different after consumption of the TFA and TFA+STE diets than after consumption of the LMP diet . Interleukin 6 concentrations were lower after consumption of the oleic acid diet than after consumption of the LMP , TFA , and STE diets . E-selectin concentrations were higher after consumption of the TFA diet than after consumption of the carbohydrate diet . Consumption of the TFA but not the TFA+STE diet result ed in higher E-selectin concentrations than did the LMP diet . CONCLUSIONS These data provide evidence that dietary fatty acids can modulate markers of inflammation . Although stearic acid minimally affects LDL cholesterol , it does appear to increase fibrinogen concentrations",
"BACKGROUND The consumption of monounsaturated trans fatty acids ( TFAs ) increases the risk of cardiovascular disease ( CVD ) . Putative differences between the effects of TFAs from industrially produced and natural sources on CVD risk markers were not previously investigated in healthy subjects . OBJECTIVE We aim ed to compare the effects of TFAs from industrially produced and natural sources on HDL and LDL cholesterol , lipoprotein particle size and distribution , apolipoproteins , and other lipids in healthy subjects . DESIGN In a r and omized , double-blind , controlled , crossover design , 46 healthy subjects ( 22 men and 24 women ) consumed food items containing TFAs ( 11 - 12 g/d , representing approximately 5 % of daily energy ) from the 2 sources . RESULTS Forty subjects ( 19 men and 21 women ) completed the study . Compared with TFAs from industrially produced sources , TFAs from natural sources significantly ( P = 0.012 ) increased HDL cholesterol in women but not in men . Significant ( P = 0.001 ) increases in LDL-cholesterol concentrations were observed in women , but not in men , after the consumption of TFAs from natural sources . Apolipoprotein (apo)B and apoA1 concentrations confirmed the changes observed in LDL and HDL cholesterol . Analysis of lipoprotein subclass showed that only large HDL and LDL concentrations were modified by TFAs from natural sources but not by those from industrially produced sources . CONCLUSIONS This study shows that TFAs from industrially produced and from natural sources have different effects on CVD risk factors in women . The HDL cholesterol-lowering property of TFAs seems to be specific to industrial sources . However , it is difficult in the present study to draw a conclusion about the effect of TFAs from either source on absolute CVD risk in these normolipidemic subjects . The mechanism underlying the observed sex- and isomer-specific effects warrants further investigation",
"BACKGROUND Evidence suggests that ruminant trans fatty acids ( FAs ) , such as vaccenic acid , do not increase the risk of ischemic heart disease ( IHD ) . However , the effects of ruminant trans FAs on risk markers of IHD have been poorly investigated . OBJECTIVE The objective was to investigate the effect of butter with a naturally high content of vaccenic acid and a concomitantly higher content of monounsaturated FAs on classic and novel risk markers of IHD . DESIGN In a double-blind , r and omized , 5-wk , parallel intervention study , 42 healthy young men were given 115 g fat/d from test butter that was high in vaccenic acid ( 3.6 g vaccenic acid/d ) or a control butter with a low content of vaccenic acid . Blood and urine sample s were collected before and after the intervention . RESULTS The intake of the vaccenic acid-rich diet result ed in 6 % and 9 % lower total cholesterol and plasma HDL-cholesterol concentrations , respectively , than did the intake of the control diet ( P = 0.05 and 0.002 , respectively ) , whereas the ratio of total to HDL cholesterol did not differ significantly between the groups . The FA composition of lipid classes reflected the FAs ' proportion of the test butter . No other differences were observed . CONCLUSIONS Butter high in ruminant trans and monounsaturated FAs result ed in significantly lower total and HDL cholesterol than did the control butter with higher amounts of saturated FAs . It may be that the differences were due to the greater content of monounsaturated FAs and the lesser content of saturated FAs in the butter rich in ruminant trans FAs , rather than to the content of vaccenic acid per se",
"BACKGROUND Metabolic studies suggest that fatty acids containing at least one double bond in the trans configuration , which are found in hydrogenated fat , have a detrimental effect on serum lipoprotein cholesterol levels as compared with unsaturated fatty acids containing double bonds only in the cis configuration . We compared the effects of diets with a broad range of trans fatty acids on serum lipoprotein cholesterol levels . METHODS Eighteen women and 18 men consumed each of six diets in r and om order for 35-day periods . The foods were identical in each diet , and each diet provided 30 percent of calories as fat , with two thirds of the fat contributed as soybean oil ( semiliquid margarine ( soft margarine ( 7.4 g per 100 g ) , shortening ( 9.9 g per 100 g ) , or stick margarine ( 20.1 g per 100 g ) . The effects of those diets on serum lipoprotein cholesterol , triglyceride , and apolipoprotein levels were compared with those of a diet enriched with butter , which has a high content of saturated fat . RESULTS The mean ( + /-SD ) serum low-density lipoprotein ( LDL ) cholesterol level was 177+/-32 mg per deciliter ( 4.58+/-0.85 mmol per liter ) and the mean high-density lipoprotein ( HDL ) cholesterol level was 45+/-10 mg per deciliter ( 1.2+/-0.26 mmol per liter ) after subjects consumed the butter-enriched diet . The LDL cholesterol level was reduced on average by 12 percent , 11 percent , 9 percent , 7 percent , and 5 percent , respectively , after subjects consumed the diets enriched with soybean oil , semiliquid margarine , soft margarine , shortening , and stick margarine ; the HDL cholesterol level was reduced by 3 percent , 4 percent , 4 percent , 4 percent , and 6 percent , respectively . Ratios of total cholesterol to HDL cholesterol were lowest after the consumption of the soybean-oil diet and semiliquid-margarine diet and highest after the stick-margarine diet . CONCLUSIONS Our findings indicate that the consumption of products that are low in trans fatty acids and saturated fat has beneficial effects on serum lipoprotein cholesterol levels",
"Objective : To estimate the intake of ruminant trans fatty acids ( TFA ) in the Danish population aged 1–80 years . Design : Descriptive study .Subjects : A sex- and age-stratified r and om sample drawn from the Danish Civil Registration System . A total of 3098 participants ( 51 % female ) aged 1–80 years were included . The participation was 66%.Dietary information : A 7-day dietary record . Results : The estimated median intake of ruminant TFA was 1.4 g/day with the 80 % central range being from 0.9 to 2.1 among children aged 1–6 years and 1.6 g/day ( 1.0–2.4 ) among children aged 7–14 years . The median TFA intake was 1.8 g/day ( 0.9–2.9 ) among adults aged 15–29 years and among adults aged 30–80 years . The intake expressed as percentage of energy intake was 0.8 , 0.6 , 0.7 , and 0.7 , respectively . Dairy products were the main source of ruminant TFA . Conclusions : The median intake of ruminant TFA in the Danish population aged 1–80 years is estimated to be 1.7 g/day ( 0.9–2.7 ) , corresponding to 0.7 % of energy intake ( 0.5–1.0 ) , with dairy products being the main source of ruminant TFA.Sponsorship : The Danish Heart Foundation ( Grants 02 - 2 - 9 - 8 - 22010 and 03 - 2 - 9 - 4 - 22087 ) and the Female Research ers in Joint Action ( FREJA ) programme from the Danish Medical Research Council",
"Milk fat contains considerable amounts of saturated fatty acids , known to increase serum cholesterol . Little is known , however , about the relative effect of different milk products on risk factors for CHD . The aim of the present study was to compare the effects of Jarlsberg cheese ( a Norwegian variety of Swiss cheese ) with butter on serum lipoproteins , haemostatic variables and homocysteine . A controlled dietary study was performed with twenty-two test individuals ( nine men and thirteen women ) aged 23 - 54 years . The subjects consumed three isoenergetic test diets , with equal amounts of fat and protein , and containing either cheese ( CH diet ) , butter + calcium caseinate ( BC diet ) or butter + egg-white protein ( BE diet ) . The study was a r and omised cross-over study and the subjects consumed each diet for 3 weeks , with 1 week when they consumed their habitual diet in between . Fasting blood sample s were drawn at baseline and at the end of each period . Serum was analysed for lipids and plasma for haemostatic variables and homocysteine . Total cholesterol was significantly lower after the CH diet than after the BC diet ( -0.27 mmol/l ; P=0.03 ) , while the difference in LDL-cholesterol was found to be below significance level ( -0.22 mmol/l ; P=0.06 ) . There were no significant differences in HDL-cholesterol , triacylglycerols , apo A-I , apo B or lipoprotein ( a ) , haemostatic variables and homocysteine between the diets . The results indicate that , at equal fat content , cheese may be less cholesterol increasing than butter",
"Dietary trans fatty acids/partially-hydrogenated fat has been associated with increased risk of developing cardiovascular disease ( CVD ) , possibly greater than predicted from changes in lipoprotein levels . To explore this issue further potential risk factors were assessed in subjects provided with each of six diets in r and omized order containing as the major source of fat : soybean oil , semi-liquid margarine , soft margarine , shortening , traditional stick margarine or butter . Plasma fatty acid profiles reflected diet , with triglyceride and phospholipid subfractions affected to a greater extent than cholesteryl ester . Non-fasting LDL-cholesterol levels were 144+/-27 , 141+/-27 , 146+/-26 , 148+/-30 , 151+/-29 and 165+/-31 mg/dl ( P total cholesterol/HDL-cholesterol ratios were 5.50+/-1.25 , 5.54+/-1.50 , 5.69+/-1.29 , 5.82+/-1.40 , 6.11+/-1.30 and 5.94+/-1.43 ( P=0.011 ) , respectively , whereas other lipoprotein levels were not significantly different . Remnant-like particles levels were unaffected by dietary fat , either in the fasting or non-fasting state . Differences in fasting insulin and glucose levels were small and would not be predicted to have a large impact on glucose homeostasis . There was no significant effect of dietary fat type on C-reactive protein levels or blood pressure . These data suggest that , as previously demonstrated , the major CVD risk factor adversely affected by dietary trans fatty acids/partially-hydrogenated fat is LDL-cholesterol levels and total cholesterol/HDL-cholesterol ratios",
"BACKGROUND Fatty acids that contain a trans double bond are consumed in large amounts as hydrogenated oils , but their effects on serum lipoprotein levels are unknown . METHODS We placed 34 women ( mean age , 26 years ) and 25 men ( mean age , 25 years ) on three mixed natural diets of identical nutrient composition , except that 10 percent of the daily energy intake was provided as oleic acid ( which contains one cis double bond ) , trans isomers of oleic acid , or saturated fatty acids . The three diets were consumed for three weeks each , in r and om order . RESULTS On the oleic acid diet , the mean ( + /- SD ) serum values for the entire group for total , low-density lipoprotein ( LDL ) , and high-density lipoprotein ( HDL ) cholesterol were 4.46 + /- 0.66 . 2.67 + /- 0.54 , and 1.42 + /- 0.32 mmol per liter ( 172 + /- 26 , 103 + /- 21 , and 55 + /- 12 mg per deciliter ) , respectively . On the trans-fatty-acid diet , the subjects ' mean HDL cholesterol level was 0.17 mmol per liter ( 7 mg per deciliter ) lower than the mean value on the diet high in oleic acid ( P less than 0.0001 ; 95 percent confidence interval , 0.13 to 0.20 mmol per liter ) . The HDL cholesterol level on the saturated-fat diet was the same as on the oleic acid diet . The LDL cholesterol level was 0.37 mmol per liter ( 14 mg per deciliter ) higher on the trans-fatty-acid diet than on the oleic acid diet ( P less than 0.0001 ; 95 percent confidence interval , 0.28 to 0.45 mmol per liter ) and 0.47 mmol per liter ( 18 mg per deciliter ) higher on the saturated-fat diet ( P less than 0.001 ; 95 percent confidence interval , 0.39 to 0.55 mmol per liter ) than on the oleic acid diet . The effects on lipoprotein levels did not differ between women and men . CONCLUSIONS The effect of trans fatty acids on the serum lipoprotein profile is at least as unfavorable as that of the cholesterol-raising saturated fatty acids , because they not only raise LDL cholesterol levels but also lower HDL cholesterol levels",
"BACKGROUND Studies have suggested that replacing saturated fatty acids ( SFAs ) with carbohydrates is modestly associated with a higher risk of ischemic heart disease , whereas replacing SFAs with polyunsaturated fatty acids is associated with a lower risk of ischemic heart disease . The effect of carbohydrates , however , may depend on the type consumed . OBJECTIVES By using substitution models , we aim ed to investigate the risk of myocardial infa rct ion ( MI ) associated with a higher energy intake from carbohydrates and a concomitant lower energy intake from SFAs . Carbohydrates with different glycemic index ( GI ) values were also investigated . DESIGN Our prospect i ve cohort study included 53,644 women and men free of MI at baseline . RESULTS During a median of 12 y of follow-up , 1943 incident MI cases occurred . There was a nonsignificant inverse association between substitution of carbohydrates with low-GI values for SFAs and risk of MI [ hazard ratio ( HR ) for MI per 5 % increment of energy intake from carbohydrates : 0.88 ; 95 % CI : 0.72 , 1.07 ) . In contrast , there was a statistically significant positive association between substitution of carbohydrates with high-GI values for SFAs and risk of MI ( HR : 1.33 ; 95 % CI : 1.08 , 1.64 ) . There was no association for carbohydrates with medium-GI values ( HR : 0.98 ; 95 % CI : 0.80 , 1.21 ) . No effect modification by sex was observed . CONCLUSION This study suggests that replacing SFAs with carbohydrates with low-GI values is associated with a lower risk of MI , whereas replacing SFAs with carbohydrates with high-GI values is associated with a higher risk of MI"
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411654b6-06ff-11f0-808a-c43d1ab1c353
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Structured lifestyle interventions can reduce diabetes incidence and cardiovascular disease ( CVD ) risk among persons with impaired glucose tolerance ( IGT ) , but it is unclear whether they should be implemented among persons without IGT . We conducted a systematic review and meta-analyses to assess the effectiveness of lifestyle interventions on CVD risk among adults without IGT or diabetes . We systematic ally search ed MEDLINE , EMBASE , CINAHL , Web of Science , the Cochrane Library , and PsychInfo data bases , from inception to May 4 , 2016 . We selected r and omized controlled trials of lifestyle interventions , involving physical activity ( PA ) , dietary ( D ) , or combined strategies ( PA+D ) with follow-up duration ≥12 months . We excluded all studies that included individuals with IGT , confirmed by 2-hours oral glucose tolerance test ( 75 g ) , but included all other studies recruiting population s with different glycemic levels . We stratified studies by baseline glycemic levels : ( 1 ) low-range group with mean fasting plasma glucose ( FPG ) 5.5mmol/L or glycated hemoglobin ( A1C ) 5.5 % , and ( 2 ) high-range group with FPG ≥5.5mmol/L or A1C ≥5.5 % , and synthesized data using r and om-effects models . Primary outcomes in this review included systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , and triglycerides ( TG ) . Totally 79 studies met inclusion criteria . Compared to usual care ( UC ) , lifestyle interventions achieved significant improvements in SBP ( -2.16mmHg[95%CI , -2.93 , -1.39 ] ) , DBP ( -1.83mmHg[-2.34 , -1.31 ] ) , TC ( -0.10mmol/L[-0.15 , -0.05 ] ) , LDL-C ( -0.09mmol/L[-0.13 , -0.04 ] ) , HDL-C ( 0.03mmol/L[0.01 , 0.04 ] ) , and TG ( -0.08mmol/L[-0.14 , -0.03 ] ) . Similar effects were observed among both low- and high-range study groups except for TC and TG . Similar effects also appeared in SBP and DBP categories regardless of follow-up duration . PA+D interventions had larger improvement effects on CVD risk factors than PA alone interventions . In adults without IGT or diabetes , lifestyle interventions result ed in significant improvements in SBP , DBP , TC , LDL-C , HDL-C , and TG , and might further reduce CVD risk
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"Background Colorectal cancer ( CRC ) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK . Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity , type 2 diabetes mellitus ( T2DM ) and cardiovascular disease ( CVD ) . These diseases share risk factors related to the metabolic syndrome including large body size , abnormal lipids and markers of insulin resistance indicating common aetiological pathways . Methods / Design This 3 year study will be a two-arm , multicentre , r and omised controlled trial comparing the BeWEL lifestyle ( diet , physical activity and behaviour change ) programme against usual care . The pre-trial development will take 6 months and participants will be recruited over a 12 month period and undertake the intervention and follow up for 12 months ( total 24 months recruitment and intervention implementation ) with a further 6 months for data collection , analysis and interpretation . Four hundred and fifty two participants who have had a colorectal adenoma detected and removed ( through the national colorectal screening programme ) will provide 80 % power to detect a weight loss of 7 % over 12 months . Primary outcomes are changes in body weight and waist circumference . Secondary outcomes will include cardiovascular risk factors , psycho-social measures and intervention costs . Discussion The results from this study will enhance the evidence base for lifestyle change in patients at higher risk of chronic disease including obesity related cancers . International St and ard R and omised Controlled Trials No : IS RCT",
"BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values reductions in metabolic indicators and adiposity ",
"Aims /hypothesis . The World Health Organisation Consultation recommended new diagnostic criteria for diabetes mellitus including : lowering of the diagnostic fasting plasma glucose to 7.0 mmol/l and introduction of a new category : impaired fasting glycaemia . The diagnostic 2-h glucose concentrations for diabetes and for impaired glucose tolerance were unchanged . This study identifies fasting plasma glucose concentrations predicting a diabetic 2-h plasma glucose of 11.1 mmol/l or more , analyses the sensitivity and specificity of different screening strategies for diabetes and describes the cardiovascular risk profile in people with impaired fasting glycaemia . Methods . European population based studies ( n = 17 ) or large , representative sample s of employees ( n = 3 ) with both fasting and 2-h post load glucose concentrations following 75-g oral glucose tolerance tests were included ( 18 918 men and 10 190 women ) . The Icel and study ( 8881 men and 9407 women ) is presented separately as a 50-g glucose load was used . Results . The fasting plasma glucose predicting a 2-h plasma glucose of 11.1 mmol/l or more with optimal sensitivity and specificity was a ) 5.8 mmol/l in women and 6.4 mmol/l in men ; b ) independent of age ; c ) increased with obesity . Fasting plasma glucose of 7.0/7.8 mmol/l or more predicted a diabetic 2-h plasma glucose with sensitivities of 49.0/29.8 % and specificities of 98.2/99.7 % , respectively . Conclusion /interpretation . If fasting glucose is used alone , the 31 % of diabetic subjects with a non-diabetic fasting glucose but a diabetic 2-h glucose , will not be diagnosed ; impaired fasting glycaemia and impaired glucose tolerance do not identify the same people ; the risk profile of people with impaired fasting glycaemia depends on 2-h glucose concentrations . Obesity is the main confounder in the association between fasting and 2-h glucose . [ Diabetologia ( 1999 ) 42 : 647–654",
"OBJECTIVE To evaluate the effectiveness of a lifestyle intervention for male workers in the construction industry at risk of cardiovascular disease ( CVD ) . METHODS In a r and omized controlled trial performed in the Netherl and s between 2007 and 2009 , usual care was compared to 6 months of individual counseling using motivational interviewing techniques , delivered face to face and by telephone . Participants aim ed at improving energy balance-related behavior or smoking cessation . Linear regression analyses were performed to determine the effects . RESULTS Body weight had significantly decreased at 6 ( β=-1.9 , 95 % CI -2.6 ; -1.2 ) and 12 months ( β=-1.8 , 95%CI -2.8 ; -1.1 ) . The intervention effects were also significant for diastolic blood pressure at 6 months ( β=-1.7 , 95 % CI -3.3 ; -0.1 ) . Among participants who had aim ed at energy balance , the intervention had a significant favorable effect on body weight at 6 ( β=-2.1 , 95 % CI -2.9 ; -1.3 ) and 12 months ( β=-2.2 , 95 % CI -3.1 ; -1.3 ) and at HDL cholesterol ( β=0.05 , 95 % CI 0.01 ; 0.10 ) and HbA1c ( β=-0.06 , 95%CI -0.12 ; -0.001 ) at 12 months , although there was no intervention effect on these variables over time . CONCLUSION Individual-based counseling result ed in significant beneficial long-term effects on body weight . This is an important finding for occupational health , considering the rising prevalence of obesity and CVD",
"BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P Lean body mass and bone mineral density at the hip decreased less in the diet-exercise group than in the diet group ( reductions of 3 % and 1 % , respectively , in the diet-exercise group vs. reductions of 5 % and 3 % , respectively , in the diet group ; P Strength , balance , and gait improved consistently in the diet-exercise group ( P musculoskeletal injuries . CONCLUSIONS These findings suggest that a combination of weight loss and exercise provides greater improvement in physical function than either intervention alone . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00146107 . )",
"BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention",
"Background / Objectives : Direct evidence for the effects of vegetable intake on weight loss is qualified . The study aim ed to assess the effect of higher vegetable consumption on weight loss . Subjects/ Methods : A single blind parallel controlled trial was conducted with 120 overweight adults ( mean body mass index=29.98 kg/m2 ) r and omised to two energy deficit healthy diet advice groups differing only by doubling the serving ( portion ) sizes of vegetables in the comparator group . Data were analysed as intention-to-treat using a linear mixed model . Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss . Results : After 12 months , the study sample lost 6.5±5.2 kg ( P0.05 interaction ) . Both groups increased vegetable intake and lost weight in the first 3 months , and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables ( rho=–0.217 , P=0.024 ) . Fasting glucose , insulin and triglyceride levels decreased ( P and high-density lipoprotein cholesterol levels increased ( P groups . Weight loss was sustained for 12 months by both groups , but the comparator group reported greater hunger satisfaction ( P=0.005 ) . Conclusions : Advice to consume a healthy low-energy diet leads to sustained weight loss , with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables . In the short term , consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable",
"Background Of all workers in Dutch construction industry , 20 % has an elevated risk of cardiovascular disease ( CVD ) . A major risk factor for CVD risk is an unhealthy lifestyle . The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk , and to evaluate its ( cost- ) effectiveness . Methods / Design In a RCT , 692 participants will be r and omised to either the control or the intervention group . The control group will receive usual care . For the intervention group , a lifestyle intervention has been design ed based on interviews and current literature . The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts , consisting of individual counselling aim ed at increasing daily physical activity ( PA ) and improving dietary behaviour , and /or smoking cessation . Counselling will take place at the Occupational Health Service ( OHS ) , and will be done according to motivational interviewing ( MI ) . Additional written information about healthy lifestyle will also be provided to those in the intervention group . At baseline , after 6 and after 12 months , measurements will take place . Primary outcome variables will be the lifestyle behaviours of concern , i.e. daily PA , dietary intake , and smoking status . Secondary outcome variables will be body mass index ( BMI ) , systolic and diastolic blood pressure , total and HDL blood cholesterol , Hba1c and cardio-respiratory fitness ( CRF ) . Sickness absenteeism and cost-effectiveness will be assessed as well . Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group . Discussion By improving lifestyle , CVD risk may be lowered , yielding benefits for both employee and employer . If proven effective , this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry . Trial registration Current Controlled Trials IS RCT",
"Aims /hypothesisA diet low in saturated fatty acids and rich in wholegrains , vegetables and fruit is recommended in order to reduce the risk of obesity , cardiovascular disease and type 2 diabetes mellitus . However there is widespread interest in high-fat ( “ Atkins Diet ” ) and high-protein ( “ Zone Diet ” ) alternatives to the conventional high-carbohydrate , high-fibre approach . We report on a r and omised trial that compared these two alternative approaches with a conventional diet in overweight insulin-resistant women . Methods Ninety-six normoglycaemic , insulin-resistant women ( BMI > 27 kg/m2 ) were r and omised to one of three dietary interventions : a high-carbohydrate , high-fibre ( HC ) diet , the high-fat ( HF ) Atkins Diet , or the high-protein ( HP ) Zone Diet . The experimental approach was design ed to mimic what might be achieved in clinical practice : the recommendations involved advice concerning food choices and were not prescriptive in terms of total energy . There were supervised weight loss and weight maintenance phases ( 8 weeks each ) , but there was no contact between the research team and the participants during the final 8 weeks of the study . Outcome was assessed in terms of body composition and indicators of cardiovascular and diabetes risk . Results Body weight , waist circumference , triglycerides and insulin levels decreased with all three diets but , apart from insulin , the reductions were significantly greater in the HF and HP groups than in the HC group . These observations suggest that the popular diets reduced insulin resistance to a greater extent than the st and ard dietary advice did . When compared with the HC diet , the HF and HP diets were shown to produce significantly ( p including weight loss ( HF −2.8 kg , HF −2.7 kg ) , waist circumference ( HF −3.5 cm , HF −2.7 cm ) and triglycerides ( HF −0.30 mmol/l , HF −0.22 mmol/l ) . LDL cholesterol decreased in individuals on the HC and HP diets , but tended to fluctuate in those on the HF diet to the extent that overall levels were significantly lower in the HP group than in the HF group ( −0.28 mmol/l , 95 % CI 0.04–0.52 , p=0.02 ) . Of those on the HF diet , 25 % showed a > 10 % increase in LDL cholesterol , whereas this occurred in only 13 % of subjects on the HC diet and 3 % of those on the HP diet . Conclusions /interpretationIn routine practice a reduced-carbohydrate , higher protein diet may be the most appropriate overall approach to reducing the risk of cardiovascular disease and type 2 diabetes . To achieve similar benefits on a HC diet , it may be necessary to increase fibre-rich wholegrains , legumes , vegetables and fruits , and to reduce saturated fatty acids to a greater extent than appears to be achieved by implementing current guidelines . The HF approach appears successful for weight loss in the short term , but lipid levels should be monitored . The potential deleterious effects of the diet in the long term remain a concern",
"Purpose Translating strategies and approaches from the successful clinical ly based Diabetes Prevention Program ’s lifestyle intervention to community setting s is a key next step . This article describes a lifestyle program developed in partnership by research ers at a major university and public health professionals at a local health department . Methods The Live Well , Be Well ( LWBW ) program was design ed to meet the needs of lower income , minority , and low-literacy adults at risk for diabetes . It was adapted from interventions with demonstrated efficacy and delivered in Spanish and English by health department staff . The program consisted of a 6-month active phase and a 6-month maintenance phase and was primarily telephone based , with one in-person planning session and several group workshops . In-person and group sessions were held in convenient community-based setting s. Counselors provided education and skills training to modify diet and increase physical activity . Self-selected and attainable goal - setting and action plans were emphasized to enhance self-efficacy . LWBW is the intervention component of a r and omized trial with primary outcomes of fasting glucose , weight , and other clinical measures . Conclusions The program provides a unique translational model for implementing diabetes risk reduction programs for underserved population s. Individually tailored and non-prescriptive , it utilized existing health department infrastructure , focused on telephone counseling , used culturally appropriate , low-literacy material s , and was delivered in local , community-based facilities",
"Context : Menopausal-related weight gain and increased waist circumference have major cardiovascular health implication s for older women . The efficacy of a dietary and physical activity lifestyle intervention to prevent weight gain and elevations in cardiovascular disease ( CVD ) risk factors from the peri- to postmenopause is unknown . Objective : To report the 54-month results of a lifestyle dietary and physical activity program on weight , body composition , physical activity , diet , and other CVD risk factors . Design : Data are from a 5-year r and omized clinical trial known as the Women ’s Healthy Lifestyle Project , conducted from 1992 to 1999 . Participants : 535 healthy , premenopausal women ages 44 to 50 at study entry enrolled into the trial . Intervention : Participants were r and omly assigned to either a lifestyle intervention group receiving a 5-year behavioral dietary and physical activity program or to an assessment -only control group . The lifestyle intervention group was given modest weight loss goals ( 5–15 lb , or approximately 2.3–6.8 kg ) to prevent subsequent gain above baseline weight by the end of the trial . To achieve weight loss and lower low-density lipoprotein cholesterol levels , intervention participants followed an eating pattern consisting of 1,300 kcal/day ( 25 % total fat , 7 % saturated fat , 100 mg of dietary cholesterol ) and increased their physical activity expenditure ( 1,000–1,500 kcal/week).Main Outcome Measures : Regarding weight gain prevention , 55 % ( 136/246 ) of intervention participants were at or below baseline weight compared with 26 % ( 68/261 ) of controls after 4.5 years , χ(2 , N = 507 ) = 45.0 , p . The mean weight change in the intervention group was 0.1 kg below baseline ( SD = 5.2 kg ) compared with an average gain of 2.4 kg ( SD = 4.9 kg ) observed in the control group . Waist circumference also significantly decreased more in the intervention group compared with controls ( M = −2.9 cm , SD = 5.3 vs. M = −0.5 cm , SD = 5.6 , p physically active and reported eating fewer calories and less fat than controls . Long-term adherence to physical activity and a low-fat eating pattern was associated with better weight maintenance . Conclusions : In healthy women , weight gain and increased waist circumference during the peri- to postmenopause can be prevented with a long-term lifestyle dietary and physical activity intervention",
"The Oslo Diet and Exercise Study ( ODES ) is an unmasked r and omized 2 x 2 factorial trial of 1-year duration for each participant . During 1990 - 1991 219 participants ( 198 males and 21 females ) aged 41 - 50 were r and omized into one of four treatment groups ; no treatment ( control ) , dietary changes alone , exercise alone , or a combination of the two treatments . At inclusion , the participants had no overt heart disease , but they had increased body weight ; slightly increased blood pressure , serum triglycerides , and total cholesterol , and they had decreased HDL cholesterol . Further , they were all inactive at leisure time . The primary aim of the trial is to compare the isolated and combined effects of the four treatments on the variables fibrinogen , fibrinolytic capacity , coagulation factor VII , and platelet volume . A series of secondary hypotheses will also be tested , such as the effects on other coagulation and fibrinolytic components and activities ; lipids and lipoproteins ; fatty acids ; glucose and insulin response to a glucose load ; clinical , physiological , and anthropometric variables ; and quality of life . The dietary treatments are adapted according to each participant 's risk profile ( level of total cholesterol , HDL cholesterol , triglycerides , blood pressure , and body weight ) . Fish and fish products are recommended . Special emphasis is put on caloric restriction in those who are overweight and those with elevated blood pressure . Exercise sessions take place three times a week under the guidance of highly qualified instructors . The aim is to increase peak oxygen uptake through aerobic endurance training . Adherence to the exercise program is monitored closely",
"BACKGROUND Weight loss , through calorie restriction or increases in energy expenditure via exercise , improves glucose tolerance and insulin action . However , exercise-induced energy expenditure may further improve glucoregulation through mechanisms independent of weight loss . OBJECTIVE The objective was to assess the hypothesis that weight loss through exercise-induced energy expenditure improves glucoregulation and circulating factors involved in insulin action to a greater extent than does similar weight loss through calorie restriction . DESIGN Sedentary men and women aged 50 - 60 y with a body mass index ( kg/m(2 ) ) of 23.5 - 29.9 were r and omly assigned to 1 of 2 weight-loss interventions [ 12 mo of exercise training ( EX group ; n = 18 ) or calorie restriction ( CR group ; n = 18 ) ] or to a healthy lifestyle ( HL ) control group ( n = 10 ) . The insulin sensitivity index and areas under the curve for glucose and insulin were assessed with an oral-glucose-tolerance test . Adiponectin and tumor necrosis factor alpha concentrations were measured in fasting serum . Fat mass was measured by dual-energy X-ray absorptiometry . RESULTS Yearlong energy deficits were not significantly different between the EX and CR groups , as evidence d by body weight and fat mass changes . The insulin sensitivity index increased and the glucose and insulin areas under the curve decreased in the EX and CR groups , remained unchanged in the HL group , and did not differ significantly between the EX and CR groups . Marginally significant increases in adiponectin and decreases in the ratio of tumor necrosis factor alpha to adiponectin occurred in the EX and CR groups but not in the HL group . CONCLUSIONS Weight loss induced by exercise training or calorie restriction improves glucose tolerance and insulin action in nonobese , healthy , middle-aged men and women . However , it does not appear that exercise training-induced weight loss results in greater improvements than those that result from calorie restriction alone",
"We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels . We r and omized 194 obese individuals ( M age = 47.0 ± 12.7 years ; BMI = 35.5 ± 3.6 ; 78 % women ) to a 5.5-month diet-exercise program with or without mindfulness training . The mindfulness group , relative to the active control group , evidence d increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment . Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants , but this association was not statistically significant among active control group participants . Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment . Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels",
"OBJECTIVES To determine if a widely available weight-management program ( Weight Watchers ) could achieve sufficient weight loss in persons with prediabetes compared with a Diabetes Prevention Program-based individual counseling program supported by National Diabetes Education Program material s. METHODS We conducted an individual , r and omized intervention trial in Indianapolis , Indiana , in 2013 to 2014 , in 225 persons with prediabetes . We compared the Weight Watchers weight-management program ( n = 112 ) with Your Game Plan to Prevent Type 2 Diabetes , a program developed by the National Diabetes Education Program . Outcomes were weight and metabolic markers measured at baseline , 6 months , and 12 months . RESULTS Intervention participants lost significantly more weight than controls at 6 months ( 5.5 % vs 0.8 % ) and 12 months ( 5.5 % vs 0.2 % ; both P greater improvements in hemoglobin A1c and high-density lipoprotein cholesterol level than did controls . CONCLUSIONS A large weight-management program is effective for achieving lifestyle changes associated with diabetes prevention . Such programs could significantly increase the availability of diabetes prevention programs worldwide making an immediate and significant public health impact",
"The Women on the Move through Activity and Nutrition ( WOMAN ) study was design ed to test whether a nonpharmacological intervention including qualitative and quantitative dietary changes to induce weight loss and increased physical activity levels would reduce blood triglyceride levels and number of low-density lipoprotein particles ( LDL-P ) . Such decreases in lipoproteins and other risk factors could reduce or slow progression of sub clinical cardiovascular disease ( CVD ) . Study participants were r and omized to either the intervention ( Lifestyle Change ) or assessment ( Health Education ) group . Most of the intervention ended at the 30-month visit . The last 48-month examination was completed in 9/2008 . There was very substantial weight loss and increased exercise during the first 30 months of the trial result ing in significant decreases in CV risk factors . Most of the intervention effect was lost through 48 months . Weight loss was 3.4 kg in Lifestyle Intervention and 0.2 kg in the Health Education at 48 months ( P = 0.000 ) . There were no significant changes at 48 months in lipid levels , blood pressure ( BP ) , glucose , insulin , or in the sub clinical measures of coronary calcium , carotid intima media thickness , or plaque . There was a significant decrease in long-distance corridor walk time in the Lifestyle vs. Health Education groups . Significant lifestyle changes can be achieved that result in decreases in CV risk factors . Whether such changes reduce CV outcomes is still untested in clinical trials of weight loss or exercise . Long-term maintenance of successful lifestyle changes , weight loss and reduced risk factors is the hurdle for lifestyle interventions attempting to prevent CV and other chronic diseases",
"BACKGROUND Low-carbohydrate diets are popular for weight loss , but their cardiovascular effects have not been well-studied , particularly in diverse population s. OBJECTIVE To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors . DESIGN A r and omized , parallel-group trial . ( Clinical Trials.gov : NCT00609271 ) . SETTING A large academic medical center . PARTICIPANTS 148 men and women without clinical cardiovascular disease and diabetes . INTERVENTION A low-carbohydrate ( Both groups received dietary counseling at regular intervals throughout the trial . MEASUREMENTS Data on weight , cardiovascular risk factors , and dietary composition were collected at 0 , 3 , 6 , and 12 months . RESULTS Sixty participants ( 82 % ) in the low-fat group and 59 ( 79 % ) in the low-carbohydrate group completed the intervention . At 12 months , participants on the low-carbohydrate diet had greater decreases in weight ( mean difference in change , -3.5 kg [ 95 % CI , -5.6 to -1.4 kg ] ; P = 0.002 ) , fat mass ( mean difference in change , -1.5 % [ CI , -2.6 % to -0.4 % ] ; P = 0.011 ) , ratio of total-high-density lipoprotein ( HDL ) cholesterol ( mean difference in change , -0.44 [ CI , -0.71 to -0.16 ] ; P = 0.002 ) , and triglyceride level ( mean difference in change , -0.16 mmol/L [ -14.1 mg/dL ] [ CI , -0.31 to -0.01 mmol/L { -27.4 to -0.8 mg/dL } ] ; P = 0.038 ) and greater increases in HDL cholesterol level ( mean difference in change , 0.18 mmol/L [ 7.0 mg/dL ] [ CI , 0.08 to 0.28 mmol/L { 3.0 to 11.0 mg/dL } ] ; P low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet . Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors . PRIMARY FUNDING SOURCE National Institutes of Health",
"Background People with Familial Hypercholesterolemia ( FH ) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia . This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids ( low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , total cholesterol ( TC ) and triglycerides ) , systolic blood pressure , glucose , body mass index ( BMI ) and waist circumference in people with FH . Methods Adults with FH ( n = 340 ) , recruited from a Dutch cascade screening program , were r and omly assigned to either a control group or an intervention group . The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling . The control group received care as usual . Lipids , systolic blood pressure , glucose , BMI , and waist circumference were measured at baseline and after 12 months . Regression analyses were conducted to examine differences between both groups . Results After 12 months , no significant between-group differences of cardiovascular disease ( CVD ) risk indicators were observed . LDL-C levels had decreased in both the intervention and control group . This difference between intervention and control group was not statistically significant . Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH . The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies .Trial registration NTR1899 at",
"The objectives of this study were to 1 ) identify the independent effects of exercise ( aerobic or resistance training ) and weight loss on whole body insulin sensitivity and 2 ) determine if aerobic or resistance training would be more successful for maintaining improved whole body insulin sensitivity 1 yr following weight loss . Subjects were 97 healthy , premenopausal women , body mass index ( BMI ) 27 - 30 kg/m(2 ) . Following r and omized assignment to one of three groups , diet only , diet + aerobic , or diet + resistance training until a BMI whole body insulin sensitivity index ( S(I ) ) was determined using a frequently sample d intravenous glucose tolerance test . Results of repeated- measures ANOVA indicated a significant improvement in S(I ) following weight loss . However , there were no group or group × time interactions . At 1-yr follow up , there were no significant time or group interactions for S(I ; ) however , there was a significant group × time interaction for S(I ) . Post hoc analysis revealed that women in the aerobic training group showed a significant increased S(I ) from weight reduced to 1-yr follow up ( P S(I ) from weight reduced to 1-yr follow up were observed for diet only or diet + resistance groups . Additionally , multiple linear regression analysis revealed that change in whole body insulin sensitivity from baseline to 1-yr follow up was independently associated with the change in Vo(2max ) from baseline to 1-yr follow up ( P long-term aerobic exercise training may conserve improvements in S(I ) following weight loss and that maintaining cardiovascular fitness following weight loss may be important for maintaining improvements in S(I )",
"Background Latinos comprise the largest racial/ethnic group in the United States and have 2–3 times the prevalence of type 2 diabetes mellitus as Caucasians . Methods and design The Lawrence Latino Diabetes Prevention Project ( LLDPP ) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a ≥ 30 % probability of developing diabetes in the next 7.5 years per a predictive equation . The project was conducted in Lawrence , Massachusetts , a predominantly Caribbean-origin urban Latino community . Individuals were identified primarily from a community health center 's patient panel , screened for study eligibility , r and omized to either a usual care or a lifestyle intervention condition , and followed for one year . Like the efficacious Diabetes Prevention Program ( DPP ) , the LLDPP intervention targeted weight loss through dietary change and increased physical activity . However , unlike the DPP , the LLDPP intervention was less intensive , tailored to literacy needs and cultural preferences , and delivered in Spanish . The group format of the intervention ( 13 group sessions over 1 year ) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist . Study measures included demographics , Stern predictive equation components ( age , gender , ethnicity , fasting glucose , systolic blood pressure , HDL-cholesterol , body mass index , and family history of diabetes ) , glycosylated hemoglobin , dietary intake , physical activity , depressive symptoms , social support , quality of life , and medication use . Body weight was measured at baseline , 6-months , and one-year ; all other measures were assessed at baseline and one-year . All surveys were orally administered in Spanish . Results A community-academic partnership enabled the successful recruitment , intervention , and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%.Trial registration",
"CONTEXT Adiponectin and leptin are closely related to weight control and energy balance , whereas exercise affects elderly metabolic regulation and functional capacity . OBJECTIVE The objective of this study was to investigate leptin and adiponectin responses in elderly males after exercise training and detraining . DESIGN The study design was a 1-yr r and omized controlled trial . SETTING The study was performed at the Laboratory of Physical Education and Sport Science Department . PARTICIPANTS Fifty inactive men [ age , 65 - 78 yr ; body mass index ( BMI ) , 28.7 - 30.2 kg/m2 ] were recruited from a volunteer data base by word of mouth and fliers sent to medical practitioners , physiotherapists , and nursing homes in the local community . INTERVENTION(S ) Participants were r and omly assigned to a control ( n = 10 ) , low-intensity ( n = 14 ) , moderate-intensity ( n = 12 ) , or high-intensity training ( HI ; n = 14 ) group . Resistance training ( 6 months , 3 d/wk , 10 exercises/three sets ) was followed by 6 months of detraining . MAIN OUTCOME MEASURE(S ) Strength , exercise energy cost , skinfold sum , body weight , maximal oxygen consumption , resting metabolic rate ( RMR ) , and plasma leptin and adiponectin were determined at baseline and after training and detraining . RESULTS Strength , maximal oxygen consumption , RMR , and exercise energy cost increased ( P Skinfold sum and BMI were reduced by resistance training ( P Leptin was diminished ( P adiponectin increased ( P percent leptin decrease was associated ( P percent BMI decrease and the percent RMR increase , whereas the percent adiponectin increase was associated ( P BMI decrease . CONCLUSIONS Resistance training and detraining may alter leptin and adiponectin responses in an intensity-dependent manner . Leptin and adiponectin changes were strongly associated with RMR and anthropometric changes",
"OBJECTIVE The Diabetes Prevention Program demonstrated the ability to delay or prevent type 2 diabetes in participants with impaired glucose tolerance ( IGT ) . Participants with IGT are at high risk for cardiovascular disease ( CVD ) , with a marked increase in the number and severity of CVD risk factors . We prospect ively assessed the impact of our interventions on hypertension , dyslipidemia , and CVD events . RESEARCH DESIGN AND METHODS The study group consisted of 3,234 individuals with IGT r and omly assigned to receive intensive lifestyle intervention , metformin , or placebo . Annual assessment of blood pressure , lipids , electrocardiogram , and CVD events was undertaken . RESULTS Hypertension was present in 30 % of participants at study entry and then increased in the placebo and metformin groups , although it significantly decreased with intensive lifestyle intervention . Triglyceride levels fell in all treatment groups , but fell significantly more with intensive lifestyle intervention . Total cholesterol and LDL cholesterol levels were similar among treatment groups . Intensive lifestyle intervention significantly increased the HDL cholesterol level and reduced the cumulative incidence of the proatherogenic LDL phenotype B. At 3 years of follow-up , the use for pharmacologic therapy to achieve established goals in the intensive lifestyle group was 27 - 28 % less for hypertension and 25 % less for hyperlipidemia compared with placebo and metformin groups . Over an average of 3 years , 89 CVD events from 64 participants were positively adjudicated study wide , with no differences among treatment groups . CONCLUSIONS Lifestyle intervention improves CVD risk factor status compared with placebo and metformin therapy . Although no differences in CVD events were noted after 3 years , achieved risk factor modifications suggest that longer intervention may reduce CVD event rates",
"Aims /hypothesis . The aim of the Diabetes Prevention Study is to assess the efficacy of an intensive diet-exercise programme in preventing or delaying Type II ( non-insulin-dependent ) diabetes mellitus in subjects with impaired glucose tolerance , to evaluate the effects of the intervention programme on cardiovascular risk factors and to assess the determinants for the progression to diabetes in persons with impaired glucose tolerance . Methods . A total of 523 overweight subjects with impaired glucose tolerance ascertained by two oral glucose tolerance tests were r and omised to either a control or intervention group . The control subjects received general information at the start of the trial about the lifestyle changes necessary to prevent diabetes and about annual follow-up visits . The intervention subjects had seven sessions with a nutritionist during the first year and a visit every 3 months thereafter aim ed at reducing weight , the intake of saturated fat and increasing the intake of dietary fibre . Intervention subjects were also guided individually to increase their physical activity . Results . During the first year , weight loss in the first 212 study subjects was 4.7 ± 5.5 vs 0.9 ± 4.1 kg in the intervention and control group , respectively ( p The plasma glucose concentrations ( fasting : 5.9 ± 0.7 vs 6.4 ± 0.8 mmol/l , p in blood pressure , serum lipids and anthropometric indices in the intervention group . Conclusion /interpretation . The interim results show the efficacy and feasibility of the lifestyle intervention programme . [ Diabetologia ( 1999 ) 42 : 793–801",
"OBJECTIVES This study tested a feasible method for screening for cardiovascular risk at the worksite and investigated the effects of a long-term comprehensive program of life-style intervention to prevent cardiovascular disease . METHODS Employees in the public sector filled out a self-administered question naire with questions on social , medical , and work-related factors . The respondents numbered 454 ( 80 % ) . A score sum for cardiovascular risk was calculated ( range 1 - 20 , median 7.0 ) , and the 128 subjects with a sum above 8 were invited to a health examination including blood sampling . Thereafter the subjects were invited to participate , following r and omization , in a comprehensive , 18-month , life-style intervention program to improve cardiovascular risk or in a control group . RESULTS The intervention group significantly decreased body mass index , diastolic blood pressure , heart rate , low-density lipoprotein ( LDL ) cholesterol , and smoking habits during the intervention . The initially elevated serum cortisol , as a marker of stress reaction , normalized in the intervention group . In the control group LDL cholesterol also decreased , but the glucose and triglyceride levels increased , and smoking habits were unchanged . Sick days for a given period decreased after 1 year in the intervention group but not in the control group . CONCLUSIONS Several cardiovascular risk factors can be improved and morning serum cortisol normalized during a long-term life-style intervention program with a r and omized design using a worksite population of middle-aged subjects . The use of a 2-step screening program , with an initial question naire followed by a health check of subjects with elevated risk , is feasible for worksite setting",
"OBJECTIVE The aim of this study was to assess the effectiveness of a new dietary education ( NDE ) program in reducing plasma glucose ( PG ) levels in Japanese male workers at high risk for type 2 diabetes through a r and omized controlled trial . RESEARCH DESIGN AND METHODS We r and omly assigned 173 high-risk men ( mean age , 55 years ) to either the NDE or the control ( conventional dietary education ) group . Each subject in the NDE group received two individualized interventions especially aim ed at reducing total energy intake at dinner by modifying dietary intake . The control group received conventional group counseling . An \" overintake/underintake fraction \" for total energy intake was used to measure the status of dietary intake . Our hypothesis was that the NDE group would have a 10 % decrease in 2-h PG 1 year after the start of the education . Outcome measures were compared with ANCOVA by adjusting for baseline values . RESULTS The NDE group had a significantly lower total energy intake at dinner and daily than the control group . The adjusted differences in changes from baseline in the absolute value of the ' overintake/underintake fraction ' were -15.3 % ( 95 % CI -24.6 to -6.0 % , P = 0.002 ) for dinner and -6.0 % ( -9.8 to -2.2 % , P = 0.002 ) for daily [ corrected ] . The NDE group had a decreased 2-h PG after 1 year , whereas that value was increased in the control group . The adjusted difference in the percent change of 2-h PG was significant ( -15.2 % , -22.0 to -8.4 % , P glucose levels in high-risk subjects for type 2 diabetes ",
"BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426",
"OBJECTIVE Studies suggest that high-dairy and high-fiber/low-glycemic index diets may facilitate weight loss , but data are conflicting . The effects on weight loss and body fat of a high-dairy diet and a diet high in dairy and fiber and low in glycemic index were compared with a st and ard diet . RESEARCH METHODS AND PROCEDURES Ninety obese subjects were recruited into a r and omized trial of three diets design ed to provide a calorie deficit of 500 calories/d over a 48-week period . The study compared a moderate ( not low)-calcium diet with a high-calcium diet . RESULTS Seventy-two subjects completed the study . Significant weight and fat loss occurred with all three diets . A diet with 1400 mg of calcium did not result in greater weight ( 11.8 + /- 6.1 kg ) or fat ( 9.0 + /- 6.0 kg ) loss than a diet with 800 mg of calcium ( 10.0 + /- 6.8 and 7.5 + /- 6.6 kg , respectively ) . A diet with 1400 mg of calcium , increased fiber content , and fewer high-glycemic index foods did not result in greater weight ( 10.6 + /- 6.8 kg ) or fat ( 8.5 + /- 7.8 kg ) loss than the st and ard diet with 800 mg of calcium . Lipid profile , high-sensitivity C-reactive protein , leptin , fasting glucose , and insulin improved significantly , but there were no significant differences between the experimental diets and the control diet . DISCUSSION We found no evidence that diets higher than 800 mg of calcium in dairy products or higher in fiber and lower in glycemic index enhance weight reduction beyond what is seen with calorie restriction alone",
"OBJECTIVE : To compare the long-term compliance and effects of two low-fat diets differing in carbohydrate to protein ratio on body composition and biomarkers of cardiovascular disease risk in obese subjects with hyperinsulinemia . DESIGN : Outpatient , parallel , clinical intervention study of two groups of subjects r and omly assigned to either a st and ard protein ( SP ; 15 % protein , 55 % carbohydrate ) or high-protein ( HP ; 30 % protein , 40 % carbohydrate ) diet , during 12 weeks of energy restriction ( ∼6.5 MJ/day ) and 4 weeks of energy balance ( ∼8.3 MJ/day ) . Subsequently , subjects were asked to maintain the same dietary pattern for the succeeding 52 weeks with minimal professional support . SUBJECTS : A total of 58 obese , nondietetic subjects with hyperinsulinemia ( 13 males/45 females , mean age 50.2 y , mean body mass index ( BMI ) 34.0 kg/m2 , mean fasting insulin 17.8 mU/l ) participated in the study . MEASUREMENTS : Body composition , blood pressure , blood lipids , fasting glucose , insulin , CRP and sICAM-1 were measured at baseline and at weeks 16 and 68 . Urinary urea/creatinine ratio was measured at baseline , week 16 and at 3 monthly intervals thereafter . RESULTS : In total , 43 subjects completed the study with similar dropouts in each group ( P=0.76 ) . At week 68 , there was net weight loss ( SP −2.9±3.6 % , HP −4.1±5.8 % ; P fat loss ( P significantly increased HDL cholesterol concentrations ( P and decreased fasting insulin , insulin resistance , sICAM-1 and CRP levels ( P ) . Protein intake was significantly greater in HP during the initial 16 weeks ( P achieved net weight loss and improvements in cardiovascular risk factors ",
"Objective : High-carbohydrate (HC)–high-fibre diets are recommended for weight loss and for treating and preventing diseases such as diabetes and cardiovascular disease . We report a r and omised trial comparing high-fat ( HF ) and high-protein ( HP ) diets with the conventional approach . Research design and methods : A total of 93 overweight insulin-resistant women received advice following r and omisation to HF , HP or HC dietary regimes , to achieve weight loss followed by weight maintenance over 12 months . Weight , body composition and measures of carbohydrate and lipid metabolism were investigated . Results : Retention rates were 93 % for HP and 75 % for HC and HF . Features of the metabolic syndrome improved in all groups during the first 6 months , to a greater extent on HF and HP than an HC . During the second 6 months the HF group had increases in waist circumference ( mean difference 4.4 cm ( 95 % CI 3.0 , 5.8 ) ) , fat mass ( 2.3 kg ( 1.5 , 3.1 ) ) , triglycerides ( 0.28 mmol/l ( 0.09 , 0.46 ) ) and 2 h glucose ( 0.70 mmol/l ( 0.22 , 1.18 ) ) . Overall there was substantial sustained improvement in waist circumference , triglycerides and insulin in the HP group and sustained but more modest changes on HC . Dietary compliance at 12 months was poor in all groups . Conclusions : HP and HC approaches appear to be appropriate options for insulin-resistant individuals . When recommending HP diets appropriate composition of dietary fat must be ensured . HC diet recommendations must include advice regarding appropriate high-fibre , low glycaemic index foods",
"CONTEXT Although commercial weight loss programs provide treatment to millions of clients , their efficacy has not been evaluated in rigorous long-term trials . OBJECTIVE To compare weight loss and health benefits achieved and maintained through self-help weight loss vs with a structured commercial program . DESIGN AND SETTING A 2-year , multicenter r and omized clinical trial with clinic visits at 12 , 26 , 52 , 78 , and 104 weeks conducted at 6 academic research centers in the United States between January 1998 and January 2001 . PARTICIPANTS Overweight and obese men ( n = 65 ) and women ( n = 358 ) ( body mass index , 27 - 40 ) aged 18 to 65 years . INTERVENTION R and om assignment to either a self-help program ( n = 212 ) consisting of two 20-minute counseling sessions with a nutritionist and provision of self-help re sources or to a commercial weight loss program ( n = 211 ) consisting of a food plan , an activity plan , and a cognitive restructuring behavior modification plan , delivered at weekly meetings . MAIN OUTCOME MEASURES Weight change was the primary outcome measure . Secondary outcomes included waist circumference , body mass index , blood pressure , serum lipids , glucose , and insulin levels . RESULTS At 2 years , 150 participants ( 71 % ) in the commercial group and 159 ( 75 % ) in the self-help group completed the study . In the intent-to-treat analysis , mean ( SD ) weight loss of participants in the commercial group was greater than in the self-help group at 1 year ( -4.3 [ 6.1 ] kg vs -1.3 [ 6.1 ] kg , respectively ; P Waist circumference ( P = .003 ) and body mass index ( P Changes in blood pressure , lipids , glucose , and insulin levels were related to changes in weight in both groups , but between-group differences in biological parameters were mainly nonsignificant by year 2 . CONCLUSION The structured commercial weight loss program provided modest weight loss but more than self-help over a 2-year period",
"Objective Swimming is often recommended in the prevention and treatment of hypertension . Few studies have investigated the effect of swimming training on blood pressure ( BP ) . Our objective was to evaluate 6 months of supervised moderate swimming or walking on BP in previously sedentary , normotensive , older women . Design Women aged 50–70 years ( n = 116 ) were r and omly assigned to a supervised 6-month swimming or walking programme . They were further r and omized to receive usual care or a behavioural intervention package . Methods Exercise comprised 3 sessions/week with a warm-up , cool down , and 30-min of moderate intensity walking or swimming . BP was recorded for 20 min supine , and 5 min st and ing . Assessment s were made at 0 and 6 months . Results At baseline , mean supine BP ( ± SD ) was 115.7 ± 1.3/66.8 ± 0.7 mmHg . Swimming improved swim distance by 78.1 m ( 29.3 % ) [ 95 % confidence interval ( CI ) ; 66.7 , 89.4 ] and walk time by 0.58 min ( 3.8 % ) ( 0.41 , 0.74 ) . Walking decreased walk time by 1.0 min ( 6.5 % ) ( 0.81 , 1.19 ) . After adjustment for initial BP , age , hypertension treatment status and change in weight , swimming increased supine and st and ing systolic BP relative to walking by 4.4 mmHg ( 1.2 , 7.5 ) ( P = 0.008 ) and 6.0 mmHg ( 2.6 , 9.5 ) ( P = 0.001 ) , respectively . Supine and st and ing diastolic BP increased by 1.4 mmHg ( −0.14 , 3.0 ) ( P = 0.07 ) and 1.8 mmHg ( −0.02 , 3.5 ) ( P = 0.05 ) , respectively . Conclusion Relative to moderately paced walking , regular swimming significantly elevates BP in previously sedentary , normotensive , older women . This finding may have important implication s for exercise prescription in older subjects",
"OBJECTIVE : To compare the long-term effects of three different programs including initial 6 weeks (V)LCD diets 420 kcal/d , 530 kcal/d , 880 kcal/d ) on sustained weight loss , attrition and obesity associated conventional cardio-vascular risk factors . DESIGN : Prospect i ve , r and omized clinical 52 weeks trial . Two weeks of a booster (V)LCD period after week 26 . SETTING : University outpatient obesity clinic . SUBJECTS : Ninety-three middle-aged obese patients ( 30 men ) , initial mean BMI 38.7 kg/m2 , age 20–65 y , from the waiting list . MAIN OUTCOME MEASURES : Weight loss pattern , attrition , reported side effects , blood pressure , blood glucose and serum lipid levels . Repeated frequent measurements up to week 26 , intermittently up to final measurements at week 52 . RESULTS : One year attrition ( 30–45 % ) , sustained weight loss ( 8–15 % of initial body weight ) and changes in obesity associated risk parameters were similar in all three group . Fewer adverse events were reported in the LCD group . CONCLUSION : The results compare favorably with most previous reports of similar design . VLCD ( 420 kcal or 530 kcal/d and LCD 880 kcal/d ) were equally effective in long term treatment of obesity . The tendency to less side effects with LCD suggests that such preparations deserve further attention",
"OBJECTIVE To assess effects of a cognitively based program on health-related behaviors and cardiovascular risk factors in overweight drug-treated hypertensives . STUDY DESIGN AND SETTING In a clinical trials center , volunteers , recruited by advertisement , were r and omized to usual care ( N=118 ) or to a 4-month program ( N=123 ) incorporating weight loss ; a low-sodium diet , high in fruit , vegetables , and fish ; and increased physical activity . Diet , physical activity , weight , blood lipids , glucose , and insulin were measured at 4 and 16 months . RESULTS Ninety-eight usual care and 106 program participants completed the 4-month assessment ; 90 and 102 , respectively , completed follow-up . Using intention-to-treat analysis , relative to usual care , net changes with the program at 4 months were as follows : dietary fat ( -2.6 % energy ; P sodium ( -290mg/d ; P=0.004 ) ; energy ( -313mJ/d ; P=0.005 ) ; fish ( + 2.1 serves/wk ; P vegetables ( + 3.0 serves/wk ; P physical activity ( + 37min/wk ; P=0.004 ) ; weight ( -2.8 kg ; P waist girth ( -3.1 cm ; P total cholesterol ( -0.2mmol/L ; P=0.017 ) ; and triacylglycerols ( -0.12mmol/L ; P=0.002 ) . One year later , net changes included dietary fat ( -2.2 % energy ; P vegetables ( + 4.3 serves/wk ; P weight ( -2.5 kg ; P=0.001 ) ; waist girth ( -3.1 cm ; P high-density lipoprotein cholesterol ( + 0.03mmol/L ; P=0.031 ) . CONCLUSION Improvements in behaviors and risk factors , several maintained long term , suggest the potential for long-term benefits in hypertensives",
"Abstract About 75 % of African-Americans ( AAs ) ages 20 or older are overweight and nearly 50 % are obese , but community-based programs to reduce diabetes risk in AAs are rare . Our objective was to reduce weight and fasting plasma glucose ( FPG ) and increase physical activity ( PA ) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul ( FBAS ) . We conducted a single-blinded , cluster r and omized , community trial in 20 AA churches enrolling 604 AAs , aged 20–64 years with BMI ≥ 25 kg/m2 and without diabetes . The church ( and their parishioners ) was r and omized to FBAS or health education ( HE ) . FBAS participants had a significant difference in adjusted weight loss compared with those in HE ( 2.62 vs. 0.50 kg , p = 0.001 ) at 12-weeks and ( 2.39 vs. −0.465 kg , p = 0.005 ) at 12-months and were more likely ( 13 % ) than HE participants ( 3 % ) to achieve a 7 % weight loss ( p a 7 % weight loss ( 19 vs. 8 % , p differences in FPG and PA between arms . Of the 15.2 % of participants with baseline pre-diabetes , those in FBAS had , however , a significant decline in FPG ( 10.93 mg/dl ) at 12-weeks compared with the 4.22 mg/dl increase in HE ( p = 0.017 ) , and these differences became larger at 12-months ( FBAS , 12.38 mg/dl decrease ; HE , 4.44 mg/dl increase ) ( p = 0.021 ) . Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants . Clinical Trials.gov Identifier NCT01730196",
"OBJECTIVE : We examined three methods for calculating the area under the curve ( AUC ) following an oral glucose tolerance test ( OGTT ) in overweight adults prior to and after 9 months of exercise . METHOD : Subjects ( n=27 ) were r and omly assigned to a control ( CON , n=9 ) or intervention ( INT , n=18 ) group . INT performed supervised exercise 5 days per week , 45 min per session , at 65 % of heart rate reserve . OGTTs were administered pre- and post-training . Blood was collected during a 75 g OGTT and analyzed for glucose ( GLU ) and insulin ( INS ) concentrations . AUCs were calculated using the incremental , positive incremental , and total AUC methods and the difference scores for pre- and post-training were determined . RESULTS : No differences were observed among the methods for glucose AUC for either group . Significant differences were observed for INT insulin AUC with total AUC ( 1525±3291 µU/1/180 min ) significantly greater than incremental AUC ( 1112±3229 µU/1/180 min ) or positive incremental AUC ( 1085±3195 µU/I/180 min ) . Total insulin AUC was significantly reduced following training for INT , while incremental and positive incremental insulin AUCs showed no change . CONCLUSION : These data suggest that the method of used to calculate AUC may affect the interpretation of whether or not an intervention was effective",
"BACKGROUND It is known that obesity , sodium intake , and alcohol consumption factors influence blood pressure . In this clinical trial , Dietary Approaches to Stop Hypertension , we assessed the effects of dietary patterns on blood pressure . METHODS We enrolled 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg . For three weeks , the subjects were fed a control diet that was low in fruits , vegetables , and dairy products , with a fat content typical of the average diet in the United States . They were then r and omly assigned to receive for eight weeks the control diet , a diet rich in fruits and vegetables , or a \" combination \" diet rich in fruits , vegetables , and low-fat dairy products and with reduced saturated and total fat . Sodium intake and body weight were maintained at constant levels . RESULTS At base line , the mean ( + /-SD ) systolic and diastolic blood pressures were 131.3+/-10.8 mm Hg and 84.7+/-4.7 mm Hg , respectively . The combination diet reduced systolic and diastolic blood pressure by 5.5 and 3.0 mm Hg more , respectively , than the control diet ( P systolic blood pressure by 2.8 mm Hg more ( P diastolic blood pressure by 1.1 mm Hg more than the control diet ( P=0.07 ) . Among the 133 subjects with hypertension ( systolic pressure , > or = 140 mm Hg ; diastolic pressure , > or = 90 mm Hg ; or both ) , the combination diet reduced systolic and diastolic blood pressure by 11.4 and 5.5 mm Hg more , respectively , than the control diet ( P 326 subjects without hypertension , the corresponding reductions were 3.5 mm Hg ( P blood pressure . This diet offers an additional nutritional approach to preventing and treating hypertension",
"Objective To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period . Design R and omised controlled trial . Setting 17 primary care practice s in Wellington , New Zeal and Participants 1089 women aged 40 - 74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week Intervention Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months . Main outcome measure Physical activity assessed at baseline and 12 and 24 months . Secondary outcomes were quality of life ( SF-36 ) , weight , waist circumference , blood pressure , concentrations of fasting serum lipids , glycated haemoglobin ( HbA1c ) , glucose , insulin , and physical fitness . Results Mean age was 58.9 ( SD 7 ) years . Trial retention rates were 93 % and 89 % at 12 and 24 months , respectively . At baseline , 10 % of intervention participants and 11 % of control participants were achieving 150 minutes of at least moderate intensity physical activity a week . At 12 months rates increased to 43 % and 30 % and at 24 months to 39.3 % and 32.8 % ( P SF-36 physical functioning ( P=0.03 ) and mental health ( P role physical scores were significantly lower ( P falls ( P injuries ( P=0.03 ) were recorded in the intervention group . Conclusions This programme of exercise on prescription increased physical activity and quality of life over two years , although falls and injuries also increased . This finding supports the use of exercise on prescription programmes as part of population strategies to reduce physical inactivity . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ANZCTRN012605000490673",
"Objective Investigate the effects of 12 months of dietary weight loss and /or aerobic exercise on leukocyte telomere length in postmenopausal women . Design and Methods 439 overweight or obese women ( 50–75 y ) were r and omized to : i ) dietary weight loss ( N=118 ) ; ii ) aerobic exercise ( N=117 ) , iii ) diet + exercise ( N=117 ) , or iv ) control ( N=87 ) . The diet intervention was a group-based program with a 10 % weight loss goal . The exercise intervention was 45 mins/day , 5 days/week of moderate-to-vigorous aerobic activity . Fasting blood sample s were taken at baseline and 12 months . DNA was extracted from isolated leukocytes and telomere length was measured by quantitative-polymerase chain reaction ( qPCR ) . Mean changes were compared between groups ( intent-to-treat ) using generalized estimating equations . Results Baseline telomere length was inversely associated with age ( r=−0.12 p maximal oxygen uptake ( r=0.11 , p=0.03 ) , but not with BMI or % body fat . Change in telomere length was inversely correlated with baseline telomere length ( r=−0.47 , p significant difference in leukocyte telomere length was detected in any intervention group compared to controls , nor was the magnitude of weight loss associated with telomere length at 12 months . Conclusions Twelve-months of dietary weight loss and exercise did not change telomere length in postmenopausal women",
"Our aim was to determine whether short-term weight loss on a low-carbohydrate/low-saturated fat diet improved endothelial function compared with a conventional high-carbohydrate diet , as this diet is expected to lower both blood glucose and LDL-cholesterol . In a r and omised parallel design of two energy-restricted diets in an outpatient setting , thirty-six subjects ( BMI 33 ( sem 4 ) kg/m2 ) were r and omised to a low- or high-carbohydrate diet both low in saturated fat . Flow-mediated dilatation ( FMD ) , fasting glucose , insulin , lipids , adiponectin and adhesion molecules were measured at baseline , during weight loss and at 52 weeks . FMD did not change with either diet ( 5.2 ( sem 0.6 ) to 5.5 ( sem 0.6 ) % ) despite weight loss of 5 % and significant reductions in glucose and insulin and LDL-cholesterol and was not different after sustained weight loss of 5 % at 52 weeks . Adiponectin fell by 6 % at 12 weeks ( P = 0.1 ) with weight loss but rose by 17 % at 12 months ( P weight loss . There were no effects of diet . In contradistinction , adhesion molecules fell at 12 weeks , vascular cell adhesion molecule-1 by 14 % and intracellular adhesion molecule-1 by 13 % ( both P in HDL ( r 0.778 , P glucose ( r - 0.563 , P = 0.057 ) . In summary , weight loss does not improve FMD . Novel cardiovascular risk factors improved at 12 weeks but the improvement in adiponectin was delayed",
"Objective To evaluate the impact of a diet and physical activity intervention ( BeWEL ) on weight change in people with a body mass index > 25 weight (kg)/height (m)2 at increased risk of colorectal cancer and other obesity related comorbidities . Design Multicentre , parallel group , r and omised controlled trial . Setting Four Scottish National Health Service health boards . Participants 329 overweight or obese adults ( aged 50 to 74 years ) who had undergone colonoscopy after a positive faecal occult blood test result , as part of the national bowel screening programme , and had a diagnosis of adenoma confirmed by histopathology . 163 were r and omised to intervention and 166 to control . Intervention Participants were r and omised to a control group ( weight loss booklet only ) or 12 month intervention group ( three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls ) . A goal of 7 % reduction in body weight was set and participants received a personalised energy prescription ( 2508 kJ ( 600 kcal ) below that required for weight maintenance ) and bodyweight scales . Motivational interviewing techniques explored self assessed confidence , ambivalence , and personal values concerning weight . Behavioural strategies included goal setting , identifying intentions of implementation , self monitoring of body weight , and counsellor feedback about reported diet , physical activity , and weight change . Main outcome measures The primary outcome was weight change over 12 months . Secondary outcomes included changes in waist circumference , blood pressure , fasting cardiovascular biomarkers , and glucose metabolism variables , physical activity , diet , and alcohol consumption . Results At 12 months , data on the primary outcome were available for 148 ( 91 % ) participants in the intervention group and 157 ( 95 % ) in the control group . Mean weight loss was 3.50 kg ( SD 4.91 ) ( 95 % confidence interval 2.70 to 4.30 ) in the intervention group compared with 0.78 kg ( SD 3.77 ) ( 0.19 to 1.38 ) in the control group . The group difference was 2.69 kg ( 95 % confidence interval 1.70 to 3.67 ) . Differences between groups were significant for waist circumference , body mass index , blood pressure , blood glucose level , diet , and physical activity . No reported adverse events were considered to be related to trial participation . Conclusions Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme , offering considerable potential for risk reduction of disease in older adults . Trial registration Current Controlled Trials IS RCT N53033856",
"OBJECTIVES In this paper , we present the results of changes in risk factors by use of hormone therapy ( HT ) at 18 months in the Women On the Move through Activity and Nutrition ( WOMAN ) r and omized trial . METHODS The trial was design ed to test the hypothesis that aggressive dietary changes and increased physical activity to reduce weight , waist circumference ( WC ) , glucose , insulin , and lipoproteins would reduce progression of sub clinical atherosclerosis , carotid intimal media thickness and plaque , coronary artery calcification , and pulse wave velocity ( PWV ) . The study focused on postmenopausal women ( n = 508 ) , mean age of 57 , who were r and omized to the Lifestyle Change ( LC ) or Health Education ( HE ) group . RESULTS At 18 months of follow-up , there was significant , 17 lb , weight loss and 10 cm WC decrease in the LC group . There were significant differences in changes in low-density lipoprotein cholesterol ( LDL-C ) , insulin , glucose , large LDL , and LDL particles between the LC and HE groups . Risk factor changes were greater for women in the LC who lost a significant amount of weight ( > or=18.8 lb ) . Participants at 18 months were subdivided into women who had stayed on HT , 125 ( 28 % ) ; stopped HT after r and omization , 145 ( 33 % ) ; and not on HT at baseline but stopped an average of 7 months prior to r and omization , 173 ( 39 % ) . Weight loss in the LC was similar for all three groups , but LDL lipoprotein response was better for women who stopped HT after r and omization or were not on HT at baseline . CONCLUSIONS The trial has been successful in increasing exercise and diet changes and reduction in weight and WC and variables related to metabolic syndrome",
"Objective : To compare the effects of counseling alone with that of additional participation in supervised training courses on exercise capacity in patients with impaired fasting glucose . Design : R and omized , controlled intervention trial using a nested cohort approach . Setting : Primary care centers in western Austria . Patients : Thirty-six patients with impaired fasting glucose ( 16 males , 20 females ; mean age , 57.5 ± 6.9 years ) . Interventions : Participants of both groups were instructed about the preventive effectiveness of changing their lifestyle , especially losing weight and increasing physical activity . One group had additionally been offered supervised , progressive , individually tailored aerobic exercise programs for 1 hour twice a week . Main Outcome Measures : Changes in the levels of exercise capacity , body mass , and fasting blood glucose . Results : The subjects with supervised exercise participated in this program for 1.8 hours ( ± 0.3 ) per week over 12 months . Supervised exercise was sufficient to maintain exercise capacity , whereas counseling alone was not ( + 4.4 % versus -6.9 % ; P = 0.01 ) . After the 12-month intervention period , body mass was reduced in the supervised exercise group ( -3.0 % ) compared with the counseling alone group ( + 1.0 % ) ( P = 0.03 ) and fasting plasma glucose levels had similarly improved by counseling for adequate lifestyle changes alone ( -8.2 % ) and in combination with supervised exercise ( -6.0 % ) . Conclusion : In contrast to counseling alone , 2 sessions of supervised training per week , besides the self-chosen physical activity and nutritional measures , are sufficient to maintain exercise capacity in patients with impaired fasting glucose",
"OBJECTIVE --To assess the validity of the 1990 US weight guidelines for women that support a substantial gain in weight at approximately 35 years of age and recommend a range of body mass index ( BMI ) ( defined as weight in kilograms divided by the square of height in meters ) from 21 to 27 kg/m2 , in terms of coronary heart disease ( CHD ) risk in women . DESIGN -- Prospect i ve cohort study . SETTING --Female registered nurses in the United States . PARTICIPANTS --A total of 115,818 women aged 30 to 55 years in 1976 and without a history of previous CHD . MAIN OUTCOME MEASURE -- Incidence of CHD defined as nonfatal myocardial infa rct ion or fatal CHD . RESULTS --During 14 years of follow-up , 1292 cases of CHD were ascertained . After controlling for age , smoking , menopausal status , postmenopausal hormone use , and parental history of CHD and using as a reference women with a BMI of less than 21 kg/m2 , relative risks ( RRs ) and 95 % confidence intervals ( CIs ) for CHD were 1.19 ( 0.97 to 1.44 ) for a BMI of 21 to 22.9 kg/m2 , 1.46 ( 1.20 to 1.77 ) for a BMI of 23 to 24.9 kg/m2 , 2.06 ( 1.72 to 2.48 ) for a BMI of 25 to 28.9 kg/m2 , and 3.56 ( 2.96 to 4.29 ) for a BMI of 29 kg/m2 or more . Women who gained weight from 18 years of age were compared with those with stable weight ( + /- 5 kg ) in analyses that controlled for the same variables as well as BMI at 18 years of age . The RRs and CIs were 1.25 ( 1.01 to 1.55 ) for a 5- to 7.9-kg gain , 1.64 ( 1.33 to 2.04 ) for an 8- to 10.9-kg gain , 1.92 ( 1.61 to 2.29 ) for an 11- to 19-kg gain , and 2.65 ( 2.17 to 3.22 ) for a gain of 20 kg or more . Among women with the BMI range of 18 to 25 kg/m2 , weight gain after 18 years of age remained a strong predictor of CHD risk . CONCLUSIONS --Higher levels of body weight within the \" normal \" range , as well as modest weight gains after 18 years of age , appear to increase risks of CHD in middle-aged women . These data provide evidence that current US weight guidelines may be falsely reassuring to the large proportion of women older than 35 years who are within the current guidelines but have potentially avoidable risks of CHD",
"OBJECTIVES . To compare weight loss on a balanced hypocaloric diet to that of a Very Low Calorie Diet ( VLCD ) after two months of treatment and to further compare 26 months of weight maintenance and safety with or without VLCD assistance in obese patients . DESIGN . Prospect i ve , r and omized , controlled intervention trial , initially with two and later with three parallel groups . SETTING . Swedish University out-patient obesity clinic . SUBJECTS . Eighty-one obese patients of both gender with a BMI ≥30 kg/m2 from the waiting list participated in a structured weight reduction+weight maintenance programme . INTERVENTION . Twenty-seven patients ( group A ) were r and omized to a balanced diet of 6720 kJ/d ( 1600 kcal/d ) during the whole treatment period . The other patients ( n=54 ) were r and omized to VLCD ( Nutrilett ® ) 1764 kJ/d ( 420 kcal/d ) diet during the first two months . The VLCD treated patients were rer and omized after the initial treatment to the well balanced hypocaloric diet ( 6720 kJ/d ) with ( group C ) or without ( group B ) 1 MJ of VLCD to be taken during the evening . MAIN OUTCOME MEASURES . During the first two-month period , the mean body weight loss in the VLCD group was 18.9±7.1 kg compared to 7.2±4.8 kg in the diet treated group , with a similar relative fat loss assessed by bioimpedance of 68 % and 76 % respectively . The maintained weight loss in all groups after 28 months of treatment was 10.9±10.2 kg in the 52 % who completed the programme . Weight losses and drop-out rates were similar in all three groups . CONCLUSIONS . Twenty-four months weight maintenance and drop out rates are independent of whether the initial treatment commences with VLCD or a hypocaloric diet . One MJ nutrition powder taken freely does not affect 24 months weight maintenance on a hypocaloric ( 6.7 MJ/d ) diet",
"OBJECTIVE The main goal of the present study was to evaluate the effect of a commercially available milk containing small amounts of eicosapentaenoic acid and docosahexaenoic acid , oleic acid , and vitamins A , B6 , D , E , and folic acid compared with semi-skimmed and skimmed milk in volunteers with moderate cardiovascular risk . METHODS Two hundred ninety-seven subjects 25 to 65 y of age with moderate cardiovascular risk were r and omly allocated into three groups . In addition to their diets , one group consumed 500 mL/d of the enriched milk , another group consumed 500 mL/d of skimmed milk , and a control group consumed 500 mL/d of semi-skimmed milk . All groups consumed the dairy drinks for 1 y and blood sample s were taken at 0 and 12 mo . RESULTS Consumption of enriched milk for 1 y produced significant ( P serum folate ( 58 % ) and high-density lipoprotein cholesterol ( 4 % ) . Plasma triacylglycerols ( 10 % ) , total cholesterol ( 4 % ) , and low-density lipoprotein cholesterol ( 6 % ) were reduced significantly only in the supplemented group . Serum glucose , homocysteine , and C-reactive protein remained unchanged . In the skimmed milk and semi-skimmed milk groups , the only significant decreases were in serum folate ( 17 % and 11 % , respectively ) . CONCLUSION Daily intake of a milk enriched with fish oil , oleic acid , and vitamins improved the nutritional status and cardiovascular risk markers of volunteers , whereas skimmed milk and semi-skimmed milk did not",
"INTRODUCTION Impact exercise is known to be beneficial for bones , but information regarding its effects on other health aspects is scarce . The aim of this study was to assess the effects of high-impact exercise on physical performance and glucose and lipid profiles . METHODS We performed a 12-month , population -based , r and omized controlled trial with 120 women ( 60 in the exercise group and 60 in the control group ; ages 35 - 40 yr ) . The exercise regimen comprised supervised , progressive , high-impact exercises two to three times per week and an additional home program . Physical activity was continuously recorded using an accelerometer-based method and was analyzed as the daily number of impacts within five acceleration ranges between 0.3 and 9.2 g ( g = acceleration of gravity : 9.81 m x s(-2 ) ) . The changes in physical performance and in glucose and lipid profiles were determined . RESULTS Thirty-nine women in the exercise group and 41 women in the control group completed the study . Maximal oxygen uptake ( 6.2 vs 3.1 mL x kg(-1 ) x min(-1 ) ; P = 0.008 ) and countermovement ( 2.3 vs -0.3 cm ; P static ( 1.4 vs -0.3 cm ; P = 0.004 ) jump heights increased significantly more in the exercise group than in the control group . Exercise training also decreased waist ( -1.1 vs 0.9 cm ; P = 0.048 ) and hip circumference ( -1.0 vs 1.1 cm ; P = 0.037 ) . Total cholesterol and LDL cholesterol decreased significantly more in women , with the highest number of impacts compared with the lowest quartile at intensities exceeding 1.1 g , with differences being up to -0.5 mM ( P = 0.005 ) . Additionally , poor baseline values predicted greater exercise effects . CONCLUSION The moderate-intensity exercise regimen , initially targeted at weight-bearing bones , improved cardiorespiratory fitness , speed-strength , and lipid profiles . In addition to bone health , impact exercise may be recommended for prevention of cardiovascular diseases",
"BACKGROUND Maintenance of weight loss is a core problem in the treatment of obesity . Physical activity may improve maintenance and metabolic risk factors associated with obesity . HYPOTHESES ( 1 ) A walking training program of moderate intensity , started after weight reduction by a very-low-energy diet , improves maintenance of weight loss and obesity-related metabolic disorders ; and ( 2 ) the effect of the training program is related to the prescribed amount of physical activity , ie , a higher amount ( energy expenditure ) leads to more favorable results . METHODS The participants were premenopausal women with a mean body mass index of 34.0 kg/m(2 ) . Eighty-two participants were r and omized to this study ; 74 participated in the follow-up assessment . A 12-week weight reduction by mostly a very-low-energy diet was followed by a 40-week maintenance program r and omized in 3 groups : a control group with no increase in habitual exercise and with counseling on diet and relapse prevention ; a walk-1 group , with a walking program targeted to expend 4.2 MJ/wk and diet counseling ; and a walk-2 group , with a walking program of 8 . 4 MJ/wk and diet counseling . R and om permuted blocks within strata were used , with weight loss ( in 3 classes ) as the stratifying factor . After the intervention , the subjects were followed up for 2 years . MAIN OUTCOME MEASURES Primary outcomes were body weight , fat mass , and waist circumference at the 2-year follow-up . Secondary outcomes were the levels of serum lipoproteins and lipids , plasma glucose , insulin , and blood pressure . RESULTS The mean weight loss after weight reduction was 13.1 kg . The main outcome variables remained stable during the maintenance program , but increased during the follow-up period . Compared with the end of weight reduction , weight regain at the 2-year follow-up was 3.5 kg less ( 95 % confidence interval , 0.2 - 6.8 ) and waist circumference regain 3.8 cm less ( 95 % confidence interval , 0.3 - 7.3 ) in the walk-1 group vs controls . The secondary outcomes showed a partial relapse during the maintenance program , and a further regain during the follow-up period . CONCLUSIONS Inclusion of a walking program of moderate training regimen into a weight maintenance program improved maintenance of losses in weight and waist circumference",
"Most primary care providers ( PCPs ) , constrained by time and re sources , can not provide intensive behavioral counseling for obesity . This study evaluated the effect of using medical assistants ( MAs ) as weight loss counselors . The study was a r and omized controlled trial conducted in two primary care offices at an academic medical center . Patients ( n = 50 ) had a BMI of 27 - 50 kg/m(2 ) and no contraindications to weight loss . They were r and omized to quarterly PCP visits and weight loss material s ( Control group ) or to the same approach combined with eight visits with a MA over 6 months ( Brief Counseling ) . Outcomes included change in weight and cardiovascular risk factors ( glucose , lipids , blood pressure , and waist circumference ) . Patients in the Brief Counseling and Control groups lost 4.4 + /- 0.6 kg ( 5.1 + /- 0.7 % of initial weight ) and 0.9 + /- 0.6 kg ( 1.0 + /- 0.7 % ) , respectively , at month 6 ( P cardiovascular risk factors . Brief Counseling patients regained weight between month 6 and month 12 , when MA visits were discontinued . Attrition was 10 % after 6 months and 6 % after 12 months . Brief Counseling by MAs induced significant weight loss during 6 months . Office-based obesity treatment should be tested in larger trials and should include weight loss maintenance counseling",
"Lifestyle interventions for weight loss are the cornerstone of obesity therapy , yet their optimal design is debated . This is particularly true for postmenopausal women ; a population with a high prevalence of obesity yet toward whom fewer studies are targeted . We conducted a year-long , 4-arm r and omized trial among 439 overweight-to-obese postmenopausal sedentary women to determine the effects of a calorie-reduced , low-fat diet ( D ) , a moderate-intensity , facility-based aerobic exercise program ( E ) , or the combination of both interventions ( D+E ) , vs. a no-lifestyle-change control ( C ) on change in body weight and composition . The group-based dietary intervention had a weight-reduction goal of ≥10 % , and the exercise intervention consisted of a gradual escalation to 45-min aerobic exercise 5 day/week . Participants were predominantly non-Hispanic whites ( 85 % ) with a mean age of 58.0 ± 5.0 years , a mean BMI of 30.9 ± 4.0 kg/m(2 ) and an average of 47.8 ± 4.4 % body fat . Baseline and 12-month weight and adiposity measures were obtained by staff blinded to participants ' intervention assignment . Three hundred and ninety nine women completed the trial ( 91 % retention ) . Using an intention-to-treat analysis , average weight loss at 12 months was -8.5 % for the D group ( P decrease . BMI , waist circumference , and % body fat were also similarly reduced . Among postmenopausal women , lifestyle-change involving diet , exercise , or both combined over 1 year improves body weight and adiposity , with the greatest change arising from the combined intervention",
"The Women 's Healthy Lifestyle Project is a 5-year r and omized clinical testing whether a behavioral intervention aim ed at lifestyle changes in diet and physical activity can prevent the rise in weight and low-density lipoprotein cholesterol ( LDL-c ) observed during menopause . Cardiovascular risk factor and behavioral data from 489 participants ( intervention group n = 236 ; control group n = 253 ) who attended baseline , 6-month , and 18-month clinical assessment s were analyzed to determine how well initial improvements achieved at 6 months were maintained over the subsequent year of follow-up . Results indicated that the treatment effect persisted at 18 months for weight , body mass index , total cholesterol , LDL-c , systolic blood pressure ( SBP ) , and glucose levels . Intervention participants maintained improvements in physical activity , caloric intake , dietary cholesterol , SBP , and glucose levels between 6 and 18 months , although weight , total cholesterol , and LDL-c began to rise during this period . Eighty percent of intervention participants compared to 45 % of controls were at or under baseline weight at 18 months , suggesting that promoting modest weight loss may be an effective approach to preventing weight gain in these women",
"BACKGROUND The maintenance of weight loss may be influenced by the distribution of macronutrients in the diet and insulin sensitivity . OBJECTIVE The objective of the study was to evaluate the longterm effect of two hypocaloric diets with different protein/carbohydrate ratios in overweight and obese individuals either with insulin resistance ( IR ) or without insulin resistance ( IS ) . DESIGN Prospect i ve , r and omized , clinical intervention study . Forty patients were classified as IR/IS after a 75 g oral glucose tolerance test and then r and omized to a diet with either 40 % carbohydrate/30 % protein/30 % fat ( diet A ) or 55 % carbohydrate/15 % protein/30 % fat ( diet B ) . RESULTS After one year of follow-up there was no difference in weight loss between diets A and B in each group , but the IS group maintained weight loss better than the IR group [ -5.7 ( 3.9 ) vs. -0.6 ( 4.1 ) ; P = 0.04 ] . No differences were found in either Homeostasis Model Assessment ( HOMA ) or other metabolic glucose parameters except lower insulin at 120 minutes with diet A [ 21.40 ( 8.30 ) vs. 71.40 ( 17.11 ) ; P = 0.02 ] . CONCLUSIONS The hypocaloric diets with different protein/carbohydrate ratios produced similar changes in weight . Insulin resistance may play a negative role in maintaining weight loss",
"The relationships of age , body composition , and physical conditioning status to glucose tolerance , insulin , and lipoprotein levels were examined in 77 healthy , nonsmoking white male volunteers , aged 46 to 73 years with no evidence of coronary artery or endocrine-metabolic disease . The men had a wide range of body fat ( 13 % to 39 % ) , indexed as waist-to-hip ratio ( WHR , 0.84 to 1.08 ) , and maximal aerobic capacity ( VO2max , 17 to 48 mL/kg.min ) . Multiple regression analysis with age , VO2max , WHR , and percent body fat as independent variables demonstrated that fasting plasma insulin , triglyceride ( TG ) , and high density lipoprotein cholesterol ( HDL-C ) levels were independently related to both percent body fat and WHR . In contrast , fasting plasma glucose levels and insulin responses during oral glucose tolerance tests ( OGTT ) correlated independently with percent body fat , and glucose responses to OGTT correlated only with WHR . Although fasting plasma TG and HDL-C correlated with glucose and insulin levels , in multiple regression analyses only percent body fat and WHR were the significant independent variables . Fasting total and low density lipoprotein cholesterol values were not related to these variables . To test the effects of weight loss and exercise training on these relationships , 20 obese men of comparable age , percent body fat , WHR , and VO2max were r and omly assigned to weight loss or aerobic exercise training programs . A 12 % + /- 3 % loss in body weight ( P less than .01 , mean + /- SD ) result ed in a 19 % + /- 9 % decline in body fat ( P less than .01 ) with no change in fat free mass , WHR , or VO2max . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE There is a significant need for an obesity treatment model suitable for the primary care environment . We examined the effectiveness of a brief counselling intervention alone , in combination with orlistat , and drug-alone in a 12-month r and omized- clinical trial at a medical school obesity centre . METHODS Participants ( N = 250 ) with body mass index ( BMI ) > or=27 were r and omized . Changes in body weight , lipids , blood pressure and serum glucose were examined . Drug adherence and attendance were also evaluated . RESULTS Completers analysis was conducted on 136 participants with data at baseline , 6 and 12 months and intention-to-treat analyses ( ITT ) for the total sample . Amongst completers , participants in the drug only ( P = 0.012 ) and drug + brief counselling ( P = 0.001 ) groups lost more weight ( mean + /- SD : -3.8 + /- 5.8 kg and -4.8 + /- 4.4 kg , respectively ) than participants in the brief counselling only group at 6 months ( -1.7 + /- 3.3 kg ) , but there were no significant group differences at 12 months . ITT model results were similar to completers at 6 months and remained significant at 12 months , but the weight losses were more modest ( orlistat . For brief counselling alone , participants gained weight ( 1.7 + /- 4.2 kg ) . Cardiovascular disease ( CVD ) parameter changes were negligible . CONCLUSIONS Pharmacotherapy alone or combined with brief counselling result ed in modest weight losses that had minimal impact on cardiovascular parameters , but were greater than brief counselling alone . Whilst brief interventions and primary pharmacotherapy have been suggested as viable treatments for implementation in primary care setting s , our study suggests that such minimal interventions provide minimal benefits",
"BACKGROUND The long-term effectiveness of multicomponent worksite health promotion programs targeting cardiovascular disease risk factors remains unclear in Japan . This study was conducted to evaluate the effectiveness of such a health promotion program consisting of a main program provided over 4 days and a follow-up program provided over 1 year . METHODS The subjects of this r and omized controlled trial were male employees working for a building maintenance company in Japan . The intervention group ( n = 152 ) and the control group ( n = 150 ) consisted of employees having abnormal findings in at least one of the following items at baseline health examination : body mass index ( BMI ) , systolic ( SBP ) or diastolic blood pressure , total cholesterol , HDL cholesterol , triglycerides , and fasting blood glucose . Evaluation was conducted at 18 months after the main program . RESULTS BMI , SBP , total cholesterol , and triglycerides improved significantly in the intervention group compared with the control group ( P BMI , total cholesterol , and triglycerides improved significantly in the intervention group ( P multicomponent health promotion program provided to employees was shown to be effective in improving obesity , high blood pressure , and hyperlipidemia when evaluated 18 months after the main intervention program",
"OBJECTIVE To assess the effect of lifestyle intervention over 2 years on changes in weight , coronary heart disease ( CHD ) risk factors , and incidence of diabetes in overweight individuals with a parental history of diabetes . RESEARCH DESIGN AND METHODS Participants ( n = 154 ) , who were 30–100 % over ideal body weight , had one or both parents with diabetes , and were currently nondiabetic , were r and omly assigned to 2-year treatments focused on diet ( decreasing calories and fat intake ) , exercise ( goal of 1,500 kcal/week of moderate activity ) , or the combination of diet plus exercise or to a no-treatment control group . Subjects were reassessed at 6 months , 1 year , and 2 years . RESULTS At 6 months , the groups differed significantly on measures of eating , exercise , and fitness ; weight losses in the diet and diet-plus-exercise groups were significantly > in the exercise and control conditions . Weight losses were associated with positive changes in CHD risk factors . After 6 months , there was gradual deterioration of behavioral and physiological changes , so that at 2 years , almost no between-group differences were maintained . Differences between groups in risk of developing diabetes were of borderline significance ( P = 0.08 ) . Strongest predictors were impaired glucose tolerance at baseline , which was positively related to risk of developing diabetes , and weight loss from baseline to 2 years , which was negatively related ; in all treatment groups , a modest weight loss of 4.5 kg reduced the risk of type 2 diabetes by ∼ 30 % compared with no weight loss . CONCLUSIONS Although initially successful , the interventions studied here were not effective in producing long-term changes in behavior , weight , or physiological parameters . However , weight loss from 0 to 2 years reduced the risk of developing type 2 diabetes . Since modest weight loss significantly reduced risk of type 2 diabetes , further research is needed to determine how best to increase the percentage of subjects achieving at least a modest weight loss ",
"OBJECTIVE To examine in previously sedentary older women the effects of exercise mode and a behavioural intervention on short and long-term retention and adherence . METHODS Healthy , sedentary women aged 50 - 70 years ( N=116 ) were r and omly assigned to a supervised 6-month swimming or walking program 3 sessions a week . They were further r and omised to usual care or a behavioural intervention . The same program was further continued unsupervised for 6 months . We assessed retention , adherence , stage of exercise behaviour and changes in fitness . RESULTS One hundred women ( 86 % ) completed 6 months and 86 ( 74 % ) continued for 12 months . Retention rates were similar for both exercise modes at 6 and 12 months . Adherence to swimming or walking was similar after 6 months ( 76.3 ( 95 % CI : 69.5 , 83.1)% vs. 74.3 ( 67.7 , 80.9)% ) and 12 months ( 65.8 ( 57.9 , 73.8)% vs. 62.2 ( 54.6 , 70.0)% ) . The behavioural intervention did not enhance retention or adherence . Fitness improved for both exercise modes after 6 months and was maintained at 12 months . CONCLUSIONS Either swimming or walking programs initiated with careful supervision over 6 months result ed in similar high retention and adherence rates by highly motivated older women over 12 months . Behavioural intervention in this setting did not improve these rates further",
"OBJECTIVE Insulin resistance and hyperinsulinaemia are , in some prospect i ve studies , linked to an increased cardiovascular risk , at least in men . We tested the hypothesis that hyperinsulinaemia may be reduced by non-pharmacological methods independently of other cardiovascular risk factors . DESIGN In a non-pharmacological intervention study for 1 year three groups of subjects ( hypertensives as well as normotensives ) were selected after stratification for insulin level at baseline . Half of the hyperinsulinaemic subjects were r and omly assigned to active intervention with physical exercise and dietary regulation ( HI-A group ) , the other half were followed passively during the study period ( HI-P group ) . Normo-insulinaemics and hypo(low)-insulinaemics also underwent active intervention ( NI-A and LI-A groups , respectively ) . SETTING Primary health care in Sweden . RESULTS During the 1-year follow-up subjects in the HI-A group reduced their weight , waist : hip ratio and systolic and diastolic blood pressure , as well as their low : high-density lipoprotein (LDL : HDL)-cholesterol ratio . Glucose levels before and during an oral glucose tolerance test did not change . However , plasma insulin and plasma-C-peptide decreased both in the fasting state and after 1 and 2 h of oral glucose tolerance testing . This decrease was independent of the previously mentioned reduction in weight , waist : hip ratio , blood pressure and LDL : HDL-cholesterol ratio . No reduction in insulin levels was seen in the HI-P , NI-A or LI-A groups , but in the HI-P group there was a slight decrease in fasting plasma-C-peptide levels . In the HI-A group dietary improvements were observed during the study period , with a reduction in energy intake , fat consumption and cholesterol intake . Fibre intake was increased . No major changes were seen in the HI-P group . CONCLUSIONS We conclude that in hypertensive and normotensive subjects with hyperinsulinaemia insulin levels can be reduced by active non-pharmacological treatment for 1 year without altering glucose tolerance . This shows that insulin resistance may be lowered by non-pharmacological treatment , which may be of considerable importance , and not only for hypertensives",
"Background —The Women ’s Healthy Lifestyle Project Clinical Trial tested the hypothesis that reducing saturated fat and cholesterol consumption and preventing weight gain by decreased caloric and fat intake and increased physical activity would prevent the rise in LDL cholesterol and weight gain in women during perimenopause to postmenopause . Methods and Results —There were 275 premenopausal women r and omized into the assessment only group and 260 women into the intervention group . The mean age of participants at baseline was 47 years , and 92 % of the women were white . The mean LDL cholesterol was 115 mg/dL at baseline , and mean body mass index was 25 kg/m2 . The follow-up through 54 months was excellent . By 54 months , 35 % of the women had become postmenopausal . At the 54-month examination , there was a 3.5-mg/dL increase in LDL cholesterol in the intervention group and an 8.9-mg/dL increase in the assessment -only group ( P = 0.009 ) . Weight decreased 0.2 lb in the intervention and increased 5.2 lb in the assessment -only group ( P = 0.000 ) . Triglycerides and glucose also increased significantly more in the assessment -only group than in the intervention group . Waist circumference decreased 2.9 cm in the intervention compared with 0.5 cm in the assessment -only group ( P = 0.000 ) . Conclusions —The trial was successful in reducing the rise in LDL cholesterol during perimenopause to postmenopause but could not completely eliminate the rise in LDL cholesterol . The trial was also successful in preventing the increase in weight from premenopause to perimenopause to postmenopause . The difference in LDL cholesterol between the assessment and intervention groups was most pronounced among postmenopausal women and occurred among hormone users and nonusers",
"BACKGROUND In short-term studies , diet and exercise both improve insulin sensitivity . OBJECTIVE To determine the effects of a 48-week supervised diet and exercise program on weight and insulin sensitivity after initial weight loss and weight maintenance , and then subsequent weight regain over 96 weeks . METHODS Forty-five obese women were r and omly assigned to 1 of 3 treatment groups : ( 1 ) diet alone , ( 2 ) diet and aerobic training , and ( 3 ) diet and strength training . All subjects received the same 48-week group behavior modification program and diet ( approximately 3879 kJ/d [ approximately 925 kcal/d ] for the first 16 weeks ; approximately 6276 kJ/d [ approximately 1500 kca/d ] thereafter ) . Exercising subjects were provided 3 supervised exercise sessions per week for the first 28 weeks and 2 sessions weekly until week 48 . During weeks 48 to 96 , subjects were unsupervised . Oral glucose tolerance tests were performed at baseline and weeks 16 , 24 , 44 , and 96 . RESULTS Subjects across the 3 conditions achieved a mean weight loss of 13.8 kg by week 16 , which was associated with decreased insulin levels ( 61.8 % of baseline ) There were no significant differences among groups in changes in body mass index , which is a measure of weight in kilograms divided by the square of the height in meters , weight , glucose tolerance , or insulin levels at weeks 16 , 24 , and 44 . No additional beneficial effect of aerobic or strength exercise on insulin resistance , as reflected by serum insulin levels before and after a glucose load , was demonstrated . The 22 subjects who were studied at week 96 maintained a loss of approximately 10 % of initial weight . Insulin levels , however , had returned to pretreatment levels . CONCLUSIONS This study confirms the beneficial effect of weight reduction on hyperinsulinemia in obese individuals . Participation in supervised exercise did not result in additional improvement in weight loss or insulin sensitivity . We also observed a marked increase in insulin levels with only partial weight regain . Determining the amount of sustained weight loss necessary for continued improvement in insulin sensitivity will require further study",
"OBJECTIVE To examine changes in biomarkers of disease risk after 51 months of reduced energy intake and sustained weight loss . RESEARCH METHODS AND PROCEDURES This study was conducted as a prospect i ve , r and omized , two-arm , parallel intervention for 12 weeks followed by a prospect i ve , single-arm , 4-year trial in a university-based hospital clinic . One hundred patients were r and omly assigned to one of two dietary interventions for 3 months . Group A was prescribed an energy-restricted diet of 1200 to 1500 kcal/d , and group B was prescribed an isocaloric diet , whereby two of three meals were replaced with nutrient-fortified liquid meal replacements . After 3 months , the patients were prescribed the same caloric reduction and used once-daily replacements for the succeeding 4 years . Body weight and blood pressure were checked monthly . Biomarkers of disease risk were measured after 3 , 9 , 15 , 27 , and 51 months . RESULTS During the 3-month weight-loss period , body weight was reduced by 1.5 + /- 0.4 % and 7.8 + /- 0.5 % ( mean + /- SEM ) for groups A and B , respectively . After 4 years , 75 % of the patients were evaluated . Total mean weight loss was 3.3 + /- 0.8 % and 8.4 + /- 0.8 % for groups A and B , respectively . Both groups of patients showed significant improvement in glucose , insulin , triacylglycerol , and systolic blood pressure . Cholesterol concentrations were reduced in patients with high initial cholesterol levels and maintenance of a 7 % weight loss . DISCUSSION Providing a structured meal plan with liquid meal replacements is an effective treatment for obese subjects . Long-term maintenance of weight loss with meal replacements improves biomarkers of disease risk",
"INTRODUCTION Limited data are available supporting the notion that treatment of lifestyle risk factors may improve erectile dysfunction ( ED ) . AIM In the present study , we analyzed the effect of a program of changing in lifestyle design ed to improve erectile function in subjects with ED or at increasing risk for ED . METHODS Men were identified in our data base of subjects participating in r and omized controlled trials evaluating the effect of lifestyle changes . A total of 209 subjects were r and omly assigned to one of the two treatment groups . The 104 men r and omly assigned to the intervention program received detailed advice about how to reduce body weight , improve quality of diet , and increase physical activity . The 105 subjects in the control group were given general information about healthy food choices and general guidance on increasing their level of physical activity . MAIN OUTCOME MEASURES Changes in erectile function score ( International Index of Erectile Function-5 [ IIEF-5 ] ; items 5 , 15 , 4 , 2 , and 7 from the full-scale IIEF-15 ) and dependence of the restoration of erectile function on the changes in lifestyle that were achieved . RESULTS Erectile function score improved in the intervention group . At baseline , 35 subjects in the intervention group and 38 subjects in the control group had normal erectile function ( 34 % and 36 % , respectively ) . After 2 years , these figures were 58 subjects in the intervention group and 40 subjects in the control group , respectively ( 56 % and 38 % , P = 0.015 ) . There was a strong correlation between the success score and restoration of erectile function . CONCLUSIONS It is possible to achieve an improvement of erectile function in men at risk by means of nonpharmacological intervention aim ing at weight loss and increasing physical activity",
"BACKGROUND Guidelines established by the National Cholesterol Education Program ( NCEP ) promote exercise and weight loss for the treatment of abnormal lipoprotein levels . Little is known , however , about the effects of exercise or the NCEP diet , which is moderately low in fat and cholesterol , in persons with lipoprotein levels that place them at high risk for coronary heart disease . METHODS We studied plasma lipoprotein levels in 180 postmenopausal women , 45 through 64 years of age , and 197 men , 30 through 64 years of age , who had low high-density lipoprotein ( HDL ) cholesterol levels ( lipoprotein ( LDL ) cholesterol ( > 125 mg per deciliter but 125 mg per deciliter but The subjects were r and omly assigned to aerobic exercise , the NCEP Step 2 diet , or diet plus exercise , or to a control group , which received no intervention . RESULTS Dietary intake of fat and cholesterol decreased during the one-year study ( P body weight , in women and men in either the diet group or the diet-plus-exercise group , as compared with the controls ( P dietary intake and body weight were unchanged . Changes in HDL cholesterol and triglyceride levels and the ratio of total to HDL cholesterol did not differ significantly among the treatment groups , for subjects of either sex . The serum level of LDL cholesterol was significantly reduced among women ( a decrease of 14.5+/-22.2 mg per deciliter ) and men ( a decrease of 20.0+/-17.3 mg per deciliter ) in the diet-plus-exercise group , as compared with the control group ( women had a decrease of 2.5+/-16.6 mg per deciliter , P reduction in LDL cholesterol in men in the diet-plus-exercise group was also significant as compared with that among the men in the exercise group ( 3.6+/-18.8 mg per deciliter , P LDL cholesterol levels were not significant among the women ( a decrease of 7.3+/-18.9 mg per deciliter ) or the men ( 10.8+/-18.8 mg per deciliter ) in the diet group , as compared with the controls . CONCLUSIONS The NCEP Step 2 diet failed to lower LDL cholesterol levels in men or women with high-risk lipoprotein levels who did not engage in aerobic exercise . This finding highlights the importance of physical activity in the treatment of elevated LDL cholesterol levels",
"AIM To study the effects of a supervised exercise program on serum gamma-glutamyl transferase ( GGT ) , glycemic control and cardiovascular risk factors in pre-diabetic patients with isolated impaired fasting glucose ( IFG ) and those with IFG plus impaired glucose tolerance ( IGT ) . METHODS Out of 60 pre-diabetic patients ( 30 with isolated IFG and 30 with IFG + IGT ) 24 were r and omly assigned to the supervised exercise program ( 1 h twice a week ) and 36 only obtained counselling on the risk of diabetes and its prevention . Patients have been followed over a 12-month period . RESULTS The main findings were that patients with IFG + IGT had increased GGT levels at baseline ( 49.2±27.4 U/L ) compared to subjects with isolated IFG ( 28.1±21.9 U/L ) ( p GGT levels improved only after the supervised exercise intervention within the IFG + IGT subjects ( - 17.7±19.6 U/L ) . Similarly , baseline triglyceride levels were also higher in IFG + IGT patients ( p exercise intervention in these patients only ( p GGT is an unspecific marker of oxidative stress and both high plasma glucose and triglycerides levels may produce oxidative stress . Thus , patients with IFG + IGT seem to have higher levels of oxidative stress than those with isolated IFG . Based on the known association between GGT levels and cardiovascular risk factors , IFG + IGT patients may be at higher risk for the development of cardiovascular diseases . The specific effect of regular exercise on GGT in pre-diabetic patients may contribute to the underst and ing of the preventive effects related to exercise ",
"All types of aerobic exercise are assumed to affect cardiovascular risk similarly . There are few studies of swimming , but complex responses to water-based exercise suggest its potential for differential effects . The aim of the study was to compare the effects of swimming and walking on fitness , body weight , lipids , glucose , and insulin in older women . Sedentary women aged 50 to 70 years ( N = 116 ) , r and omly assigned to swimming or walking plus usual care or a behavioral intervention , completed 3 sessions per week of moderate-intensity exercise , supervised for 6 months then unsupervised for 6 months . After 6 months , 1.6-km walk time decreased in walkers and swimmers , with greater improvement in walkers ( 1.0 vs 0.6 minute , P = .001 ) . In swimmers , but not walkers , distance swum in 12 minutes increased ( 78.1 vs -2.2 m , P = .021 ) . Waist and hip circumferences ( 80.8 vs 83.1 cm and 101.8 vs 102.4 cm ; P = .023 and P = .042 , respectively ) and insulin area under the curve ( oral glucose tolerance test ) ( 5128 vs 5623 μU/[L 120 min ] , P with swimming . Lipids did not differ between groups . At 12 months , fitness was maintained . Relative to walking , swimming reduced body weight by ( 1.1 kg , P = .039 ) and result ed in lower total and low-density lipoprotein cholesterol ( 0.3 and 0.2 mmol/L ; P = .040 and P = .049 , respectively ) . The magnitude of the difference in the reduction of insulin area under the curve between swimming and walking was greater at 12 months ; however , the significance was attenuated ( 4677 vs 5240 μU/[L 120 min ] , P = .052 ) . Compared with walking , swimming improved body weight , body fat distribution , and insulin in the short term and , in the longer term , body weight and lipid measures . These findings suggest that the type of exercise can influence health benefits",
"The current study examined the insulin and glucose response during an oral glucose tolerance test ( OGTT ) in overweight young adults prior to and following exercise training in the Midwest Exercise Trial ( MET ) . Subjects ( N = 66 ) were r and omly assigned to non-exercise control ( CON ; 16 females , 13 males ) or exercise ( EX ; 22 females , 15 males ) groups . EX performed supervised and verified exercise on 3 to 5 days per week in 20- to 45-minute sessions at 60 % to 75 % of heart rate reserve . OGTTs and assessment s for body mass , body composition , and maximal oxygen consumption ( Vo(2 ) max ) were performed at baseline , and after 9 and 16 months of training . Blood was collected during a 75-g OGTT and analyzed for glucose and insulin concentrations with the total area under the glucose and insulin curves used in the analysis . The EX males had significant decreases from baseline to 9 months in body mass ( 94.8 + /- 12.5 to 89.2 + /- 9.8 kg ) and percent fat ( 28.3 + /- 4.8 to 24.2 + /- 3.9 ) with no further changes at 16 months . CON females had significant increases in body mass ( 78.2 + /- 6.4 to 81.1 + /- 8.1 kg ) and percent fat ( 36.6 + /- 4.2 to 37.8 + /- 4.7 ) from baseline to 16 months . Vo(2 ) max increased significantly from baseline to 9 months in the EX males ( 3.67 + /- 0.62 to 4.36 + /- 0.55 L/min ) and EX females ( 2.53 + /- 0.32 to 2.99 + /- 0.42 L/min ) . For glucose area under the curve , there were no significant differences between EX or CON across the 16 months of the study . For insulin area under the curve , there was a significant decrease for male EX from baseline to 9 months ( 12,535 + /- 6,114 to 8,390 + /- 4,231 microU/L/180 min ) . We conclude that regular exercise in healthy , previously sedentary overweight adult males leads to improvements in Vo(2 ) max and weight loss and a reduction in the insulin concentration required to dispose of a set glucose load . In females , improvement in Vo(2 ) max without weight loss does not lead to improvement in insulin sensitivity",
"A pilot trial was conducted to test adherence to specific lifestyle interventions among Pima Indians of Arizona , and to compare them for changes in risk factors for diabetes mellitus . Ninety-five obese , normoglycaemic men and women , aged 25 - 54 years , were r and omized to treatments named ' Pima Action ' ( Action ) and ' Pima Pride ' ( Pride ) , which were tested for 12 months . Action involved structured activity and nutrition interventions , and Pride included unstructured activities emphasizing Pima history and culture . Adherence to interventions , changes in self-reported activity and diet , and changes in weight , glucose concentrations , and other risk factors were assessed regularly . Thirty-five eligible subjects who had declined r and omization were also followed as an ' observational ' group and 22 members of this group were examined once at a median of 25 months for changes in weight and glucose concentration . After 12 months of intervention , members of both intervention groups reported increased levels of physical activity ( median : Action 7.3 h month(-1 ) , Pride 6.3 h month(-1 ) , p decreased starch intake ( 28 g , p = 0.008 ) . Body mass index , systolic and diastolic blood pressures , weight , 2-h glucose and 2-h insulin had all increased in Action members ( p waist circumference had decreased in Pride members ( p = 0.05 ) . Action members gained more weight than Pride members ( 2.5 kg vs 0.8 kg , p = 0.06 ) , and had a greater increase in 2-h glucose than Pride members ( 1.33 mM vs 0.03 mM , p = 0.007 ) . Members of the observational group gained an average of 1.9 kg year(-1 ) in weight and had an increase of 0.36 mM year(-1 ) in 2-h glucose . Sustaining adherence in behavioural interventions over a long term was challenging . Pimas may find a less direct , less structured , and more participative intervention more acceptable than a direct and highly structured approach",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"CONTEXT Healthy lifestyle factors are associated with maintenance of erectile function in men . OBJECTIVE To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men . DESIGN , SETTING , AND PATIENTS R and omized , single-blind trial of 110 obese men ( body mass index > or = 30 ) aged 35 to 55 years , without diabetes , hypertension , or hyperlipidemia , who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function ( IIEF ) . The study was conducted from October 2000 to October 2003 at a university hospital in Italy . INTERVENTIONS The 55 men r and omly assigned to the intervention group received detailed advice about how to achieve a loss of 10 % or more in their total body weight by reducing caloric intake and increasing their level of physical activity . Men in the control group ( n = 55 ) were given general information about healthy food choices and exercise . MAIN OUTCOMES MEASURES Erectile function score , levels of cholesterol and triglycerides , circulating levels of interleukin 6 , interleukin 8 , and C-reactive protein , and endothelial function as assessed by vascular responses to l-arginine . RESULTS After 2 years , body mass index decreased more in the intervention group ( from a mean [ SD ] of 36.9 [ 2.5 ] to 31.2 [ 2.1 ] ) than in the control group ( from 36.4 [ 2.3 ] to 35.7 [ 2.5 ] ) ( P serum concentrations of interleukin 6 ( P = .03 ) , and C-reactive protein ( P = .02 ) . The mean ( SD ) level of physical activity increased more in the intervention group ( from 48 [ 10 ] to 195 [ 36 ] min/wk ; P mean ( SD ) IIEF score improved in the intervention group ( from 13.9 [ 4.0 ] to 17 [ 5 ] ; P IIEF score of 22 or higher . In multivariate analyses , changes in body mass index ( P = .02 ) , physical activity ( P = .02 ) , and C-reactive protein ( P = .03 ) were independently associated with changes in IIEF score . CONCLUSION Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"AIMS To evaluate the effectiveness and feasibility of implementing a linguistically and culturally tailored Diabetes Prevention Program among Chinese immigrants with prediabetes living in New York City . METHODS A total of 60 Chinese immigrants with prediabetes were r and omized into either a Diabetes Prevention Program lifestyle intervention ( n = 30 ) consisting of 12 bi-weekly core sessions and six monthly post-core sessions or the control intervention ( n = 30 ) , consisting of quarterly mailing of diabetes prevention information . Each Diabetes Prevention Program intervention session lasted 1.5 - 2 h and covered topics such as healthy eating , physical activity , stress reduction and problem-solving skills . Outcomes such as percent change in weight , BMI , and HbA1c concentration were assessed at baseline , 6 and 12 months . A mixed-effects linear regression was applied to test the intervention effect at months 6 and 12 . Data were collected in the period 2012 - 2013 and analysed in 2014 . RESULTS The participant attrition rate was greater percent weight loss in the intervention group ( -3.5 vs. -0.1 % ; P = 0.0001 ) at 6 months , which was largely maintained at 12 months ( -3.3 vs. 0.3 % ; P = 0.0003 ) . CONCLUSIONS Participants in a Diabetes Prevention Program-based intervention achieved greater weight loss and improvements in HbA1c concentration than control participants . Evaluation of the Chinese Diabetes Prevention Program curriculum in a larger trial is warranted",
"OBJECTIVE To compare and assess the single and joint effect of diet and exercise intervention for 1 year on insulin resistance and the development leading toward the insulin resistance syndrome . RESEARCH DESIGN AND METHODS An unmasked , r and omized 2 × 2 factorial intervention trial was applied with a duration of 1 year for each participant . The trial comprised 219 men and women with diastolic blood pressure of 86–99 mmHg , HDL cholesterol 1.4 mmol/l , total cholesterol of 5.20–7.74 mmol/l , and BMI > 24 kg/m2 . Participants were r and omly allocated to diet group ( n = 35 ) , diet and exercise group ( n = 67 ) , exercise group ( n = 54 ) , and control group ( n = 43 ) . The diet included increased intake of fish and reduced total fat intake . The exercise program entailed supervised endurance exercise three times a week . Baseline cross-sectional changes and 1-year changes in insulin resistance , fasting serum levels of insulin , C-peptide , proinsulin , glucose , and lipids as well as weight , mean blood pressure , and plasminogen activator inhibitor 1 ( PAI-1 ) values were recorded . RESULTS The cross-sectional results at baseline showed significant correlations between the calculated insulin resistance and BMI ( r = 0.54 ) and correlations between the mean blood pressure ( mBP ) ( r = 0.26 ) and PAI-1 ( r = 0.40 ) . The 1-year diet intervention gave a significant decrease in the calculated insulin resistance from 4.6 to 4.2 and a positive correlation between the changes in insulin resistance and changes in BMI ( r = 0.40 ) . The diet and exercise intervention also led to significantly decreased insulin resistance ( from 5.0 to 4.0 ) . The exercise intervention did not significantly change insulin resistance . CONCLUSIONS The cross-sectional and 1-year intervention results supported each other and underscored the important connection between increased BMI and the development leading toward the insulin resistance syndrome",
"BACKGROUND We hypothesized that favorable changes in dietary patterns would lead to a reduction in body size and an improvement in metabolic status . OBJECTIVE The objective was to study changes in diet patterns relative to changes in body size , blood pressure , and circulating concentrations of lipids , glucose , insulin , adiponectin , and other cytokines in the context of a 1-y r and omized intervention study . DESIGN For 1 y , 187 men aged 45 + /- 2 y , approximately 50 % of whom met the criteria of the metabolic syndrome , were r and omly assigned to a diet protocol ( n = 45 ) , an exercise protocol ( n = 48 ) , a protocol of diet plus exercise ( n = 58 ) , or a control protocol ( n = 36 ) . A previously defined a priori diet score was created by summing tertile rankings of 35 food group variables ; a higher score generally reflected recommended dietary changes in the trial ( mean + /- SD at baseline : 31 + /- 6.5 ; range : 15 - 47 ) . RESULTS Over the study year , the diet score increased by approximately 2 + /- 5.5 in both diet groups , with a decrease of an equivalent amount in the exercise and control groups . The weight change was -3.5 + /- 0.6 kg/10-point change in diet score ( P Weight change was attenuated but remained significant after adjustment for intervention group and percentage body fat . Subjects with an increased diet score had more favorable changes in other body size variables , systolic blood pressure , and blood lipid , glucose , insulin , and adiponectin concentrations . Change in diet score was unrelated to resistin and several cytokines . CONCLUSION The change toward a more favorable diet pattern was associated with improved body size and metabolic profile",
"AIM To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes . METHODS A r and omised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose : 6.1 - 6.9 mmol/l and /or HbA1c : 6.0- Participants were r and omised to a control group or to receive the intervention delivered over four 2h group sessions during five weeks , and two further sessions after one and six months . Question naire data and clinical measures were collected at baseline , three months and one year after intervention . Primary outcomes ; total-fat intake 5 % ; changes in physical activity . RESULTS 85 % attended one-year follow-up . After adjusting for gender , age and education , Odds ratio ( OR ) ( 95 % CI ) intervention vs control : total-fat intake saturated-fat intake fibre intake ≥ 15 g/1000 kcal : 1.18 ( 0.48;2.92 ) , weight reduction > 5 % : 2.47 ( 0.95 ; 6.39 ) . β ( 95 % CI ) between intervention vs control in changes from baseline : IPAQ , MET min/week : -236 ( -2760 ; 2288 ) , waist circumference , cm : -2.5 ( -4.5 ; -0.5 ) ; systolic blood pressure , mmHg : -4.6 ( -8.8 ; -0.3 ) . CONCLUSION A brief theory-based health promotion intervention delivered in the community indicated effect on weight , waist circumference and systolic blood pressure at one year among Danish adults at high risk of diabetes . No effect was shown on diets or physical activity ",
"BACKGROUND AND AIM Very low carbohydrate ad libitum diets have been shown to enhance weight loss without increasing cardiometabolic risk factors but no kilojoule-controlled trials have been conducted relative to no intervention . The aim of this study was to compare the changes in weight and other cardiovascular risk factors in 3 isocaloric energy-restricted diets to no-intervention control after 1 year . METHODS AND RESULTS One hundred and thirteen subjects ( age 47 ± 10 years , BMI 32 ± 6 kg/m(2 ) with one additional cardiovascular risk factor ) were r and omly allocated to one of three isocaloric diets ( VLC-very low carbohydrate , 60 % fat , 4 % carbohydrate , n=30 ; VLF-very low fat , 10 % fat , n = 30 ; HUF-high unsaturated fat , 30 % fat , n = 30 ) with intensive support for 3 months followed by minimal support for 12 months compared to a control group ( no intervention , n = 23 ) . The estimated weight change was -3.0 ± 0.2 kg for VLC , -2.0 ± 0.1 kg for VLF , -3.7 ± 0.01 kg for HUF and 0.8 ± 0.5 kg for controls ( P=0.065 ) . After correcting for baseline values , decreases in body weight and diastolic blood pressure in the diet groups ( -2.9 ± 5.2 ) were significantly different to the increase in the control group ( 0.8 ± 5.0 ) ( P differences in cardiovascular risk factors were observed between the diet groups . CONCLUSION Significant cardiometabolic risk factor reduction was observed equally with VLC , VLF and HUF diets after 15 months , compared to an exacerbation of risk factors in the control group . At a modest level of adherence , 3 months of intensive support on these dietary patterns confer an improvement in cardiometabolic profile compared to no dietary intervention after 15 months",
"CONTEXT Prior risk stratification schemes for atrial fibrillation ( AF ) have been based on r and omized trial cohorts or Medicare administrative data bases , have included patients with established AF , and have focused on stroke as the principal outcome . OBJECTIVE To derive risk scores for stroke alone and stroke or death in community-based individuals with new-onset AF . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , community-based , observational cohort in Framingham , Mass. We identified 868 participants with new-onset AF , 705 of whom were not treated with warfarin at baseline . Risk scores for stroke ( ischemic or hemorrhagic ) and stroke or death were developed with censoring when warfarin initiation occurred during follow-up . Event rates were examined in low-risk individuals , as defined by the risk score and 4 previously published risk schemes . MAIN OUTCOME MEASURES Stroke and the combination of stroke or death . RESULTS During a mean follow-up of 4.0 years free of warfarin use , stroke alone occurred in 83 participants and stroke or death occurred in 382 participants . A risk score for stroke was derived that included the following risk predictors : advancing age , female sex , increasing systolic blood pressure , prior stroke or transient ischemic attack , and diabetes . With the risk score , 14.3 % of the cohort had a predicted 5-year stroke rate stroke rate Actual stroke rates in these low-risk groups were 1.1 and 1.5 per 100 person-years , respectively . Previous risk schemes classified 6.4 % to 17.3 % of subjects as low risk , with actual stroke rates of 0.9 to 2.3 per 100 person-years . A risk score for stroke or death is also presented . CONCLUSION These risk scores can be used to estimate the absolute risk of an adverse event in individuals with AF , which may be helpful in counseling patients and making treatment decisions",
"BACKGROUND TCF7L2 is the strongest locus linked to type 2 diabetes that has been identified thus far , and rs7903146 is the most significantly associated variant . Few intervention studies have shown that it has negative effects on metabolic improvement after lifestyle programs . OBJECTIVE Our objective was to assess the effects of this variant on lifestyle intervention-induced changes in glucose values and metabolic variables at 1- and 4-y follow-ups . DESIGN The rs7903146 variant was genotyped in 335 nondiabetic , dysmetabolic participants in a r and omized lifestyle intervention trial . RESULTS Subjects with the unfavorable TT genotype showed higher values of fasting glucose and lower homeostasis model assessment of beta cell function at baseline . Lifestyle modifications were successful in the amelioration of metabolic traits in all genetic subgroups after 1 y. At 4-y follow-up most of the metabolic benefits had disappeared . In a multiple regression model , values for glucose and homeostasis model assessment of beta cell function at 4 y were significantly associated with the T allele ( for glucose and homeostasis model assessment s , respectively : beta = 6.6 ; 95 % CI : 2.5 , 10.7 ; P = 0.001 ; and beta = -0.37 ; 95 % CI : -0.54 , -0.20 ; P impaired fasting glucose and diabetes incidence were inversely associated with intervention . After 4 y , the presence of a T allele was associated with impaired fasting glucose ( odds ratio : 3.04 ; 95 % CI : 1.53 , 6.04 ; P = 0.001 ) and diabetes ( odds ratio : 2.63 ; 95 % CI : 1.00 , 6.96 ; P = 0.05 ) but not with intervention . CONCLUSIONS Lifestyle modifications improved the metabolic pattern in all genetic subgroups . At the end of the trial , however , weight gain occurred , and carriers of the T allele developed first hyperglycemia and decreased insulin secretion , which suggests the need for different \" after-care \" preventive approaches tailored to each genotype 's metabolic risk",
"CONTEXT Obesity is an independent risk factor for cardiovascular disease , which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue . OBJECTIVE To determine the effect of a program of changes in lifestyle design ed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance . DESIGN AND SETTING R and omized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy . PATIENTS One hundred twenty premenopausal obese women ( body mass index > or = 30 ) aged 20 to 46 years without diabetes , hypertension , or hyperlipidemia . INTERVENTIONS The 60 women r and omly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10 % or more through a low-energy Mediterranean-style diet and increased physical activity . The control group ( n = 60 ) was given general information about healthy food choices and exercise . MAIN OUTCOME MEASURES Lipid and glucose intake ; blood pressure ; homeostatic model assessment of insulin sensitivity ; and circulating levels of interleukin 6 ( IL-6 ) , interleukin 18 ( IL-18 ) , C-reactive protein ( CRP ) , and adiponectin . RESULTS After 2 years , women in the intervention group consumed more foods rich in complex carbohydrates ( 9 % corrected difference ; P energy ( -310 kcal/d ; P saturated fat ( -3.5 % ; P = .007 ) , and cholesterol intake ( -92 mg/d ; P Body mass index decreased more in the intervention group than in controls ( -4.2 ; P serum concentrations of IL-6 ( -1.1 pg/mL ; P = .009 ) , IL-18 ( -57 pg/mL ; P = .02 ) , and CRP ( -1.6 mg/L ; P = .008 ) , while adiponectin levels increased significantly ( 2.2 microg/mL ; P = .01 ) . In multivariate analyses , changes in free fatty acids ( P = .008 ) , IL-6 ( P = .02 ) , and adiponectin ( P = .007 ) levels were independently associated with changes in insulin sensitivity . CONCLUSION In this study , a multidisciplinary program aim ed to reduce body weight in obese women through lifestyle changes was associated with a reduction in markers of vascular inflammation and insulin resistance",
"OBJECTIVE To investigate the correlation between lifestyle improvements , in particular increased cardio-respiratory fitness and changes in the blood lipid profile . METHODS The participants were 217 residents of Fuji and Yamato Towns , Saga City , with mildly abnormal blood pressure , serum lipids or blood glucose detected at health check-ups in 2003 . Participants were r and omly allocated to an Intervention ( 108 subjects ) or Control group ( 109 subjects ) , matched for age and various conditions . The Intervention group was given exercise advice and prescription and dietary instructions . Cardio-respiratory fitness was evaluated using the work rate at double product breaking point . Changes of lipid parameters were compared before and after intervention , and examined the relationship with cardio-respiratory fitness . RESULTS Seventy nine subjects in each group could be followed up for 17 months without requiring pharmacotherapy . Body mass index , waist circumference , systolic blood pressure , homeostasis model assessment insulin resistance , and triglycerides were decreased in the Intervention group . Furthermore , apolipoprotein B levels were lower ( p ratio of LDL cholesterol to apolipoprotein B ( LDL/ApoB ) was higher ( p cardio-respiratory fitness , LDL/ApoB increased and apolipoprotein B decreased as the degree of improvement increased ( p<0.05 ) . CONCLUSION Improvement was seen in atherosclerotic risk factors through lifestyle modification . In particular , improved cardiorespiratory fitness was associated with qualitative and quantitative changes in LDLs",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"The aim of this work was to determine whether the effects of weight loss on coronary heart disease ( CHD ) risk factors are comparable in men and women and whether the long term impact of modest weight loss is as great as the initial response . Changes in CHD risk factors were examined at 6 month intervals in 159 moderately overweight subjects who were participating in an 18 month behavioral weight loss program . Men experienced greater decreases in blood pressure , triglycerides , and waist-to-hip ratio ( WHR ) and greater increases in HDL-cholesterol with weight loss than women . Most of these gender differences were removed by adjusting for baseline values and changes in BMI . After these adjustments , improvements in WHR at 18 months were shown to be greater in women than in men . Participants ( n = 39 ) who lost 4.5 kg or more from baseline to 6 months ( mean weight loss of 11.8 kg or 13 % of initial body weight ) and maintained this weight loss within + /- 2.3 kg had significant long term improvements ( through 18 months ) in triglycerides , HDL and LDL-cholesterol , WHR , systolic and diastolic blood pressure , and fasting and 2 h insulin . Changes in HDL-cholesterol , the HDL : Total cholesterol ratio , and WHR actually increased between 6 and 18 months and improvements in all other parameters were maintained over time . Men have greater improvements in CHD risk factors with weight loss than women , but this gender difference appears to derive from differences in CHD risk factors at baseline and differences in weight loss . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population",
"OBJECTIVE To evaluate the impact of a low-cost nutritional intervention in changing the lifestyle of adults . DESIGN R and omised clinical trial . SETTING Primary health-care centre in São José do Rio Preto , São Paulo State , Brazil . SUBJECTS We r and omly assigned 104 adults ( 83 women and 21 men aged 30 - 65 years , body mass index 24 - 35 kg m(-2 ) , non-diabetic ) into two groups : nutrition counselling and control . Each subject in the intervention group received three individualised nutritional counselling sessions during the first 6 months aim ed at increasing intakes of fruits , vegetables and olive oil , reducing saturated fat and improving physical activity . Body composition , biochemical indicators and lifestyle were assessed at baseline and at 6 months and 1 year in both groups . RESULTS After 6 months of follow-up , body weight , waist circumference , diastolic blood pressure , fasting blood glucose , total and low-density lipoprotein cholesterol , total and saturated fat , and dietary energy and cholesterol levels showed a more significant decrease among subjects in the intervention group than in the control group ( P reduced intake of saturated fat and increased intakes of fruits , vegetables , fibre and olive oil ( P low-cost nutritional intervention programme improved serum lipids profile and weight control , and appeared to be feasible for use at a primary health-care centre in a developing country ",
"Objective To develop and evaluate the effectiveness of a community behavioural intervention to prevent weight gain and improve health related behaviours in women with young children . Design Cluster r and omised controlled trial . Setting A community setting in urban Australia . Participants 250 adult women with a mean age of 40.39 years ( SD 4.77 , range 25 - 51 ) and a mean body mass index of 27.82 kg/m2 ( SD 5.42 , range 18 - 47 ) were recruited as clusters through 12 primary ( elementary ) schools . Intervention Schools were r and omly assigned to the intervention or the control . Mothers whose schools fell in the intervention group ( n=127 ) attended four interactive group sessions that involved simple health messages , behaviour change strategies , and group discussion , and received monthly support using mobile telephone text messages for 12 months . The control group ( n=123 ) attended one non-interactive information session based on population dietary and physical activity guidelines . Main outcome measures The main outcome measures were weight change and difference in weight change between the intervention group and the control group at 12 months . Secondary outcomes were changes in serum concentrations of fasting lipids and glucose , and changes in dietary behaviours , physical activity , and self management behaviours . Results All analyses were adjusted for baseline values and the possible clustering effect . Women in the control group gained weight over the 12 month study period ( 0.83 kg , 95 % confidence interval ( CI ) 0.12 to 1.54 ) , whereas those in the intervention group lost weight ( −0.20 kg , −0.90 to 0.49 ) . The difference in weight change between the intervention group and the control group at 12 months was −1.13 kg ( −2.03 to −0.24 kg ; P for total cholesterol concentration ( −0.35 mmol/l , −0.70 to −0.001 ) , self management behaviours ( diet score 0.18 , 0.13 to 0.33 ; physical activity score 0.24 , 0.05 to 0.43 ) , and confidence to control weight ( 0.40 , 0.11 to 0.69 ) . Regular self weighing was associated with weight loss in the intervention group only ( −1.98 kg , −3.75 to −0.23 ) . Conclusions Weight gain in women with young children could be prevented using a low intensity self management intervention delivered in a community setting . Self management of health behaviours improved with the intervention . The response rate of 12 % , although comparable with that in other community studies , might limit the ability to generalise to other population s. Trial registration Australian New Zeal and Clinical Trials Registry number ACTRN12608000110381",
"OBJECTIVES We evaluated a community-based , translational lifestyle program to reduce diabetes risk in lower-socioeconomic status ( SES ) and ethnic minority adults . METHODS Through an academic-public health department partnership , community-dwelling adults at risk for diabetes were r and omly assigned to individualized lifestyle counseling delivered primarily via telephone by health department counselors or a wait-list control group . Primary outcomes ( 6 and 12 months ) were fasting glucose level , triglycerides , high- and low-density lipoprotein cholesterol , weight , waist circumference , and systolic blood pressure . Secondary outcomes included diet , physical activity , and health-related quality of life . RESULTS Of the 230 participants , study retention was 92 % . The 6-month group differences for weight and triglycerides were significant . The intervention group lost 2 pounds more than did the control group ( P=.03 ) and had decreased triglyceride levels ( difference in change , 23 mg/dL ; P=.02 ) . At 6 months , the intervention group consumed 7.7 fewer grams per day of fat ( P=.05 ) and more fruits and vegetables ( P=.02 ) than did control participants . CONCLUSIONS Despite challenges design ing effective translational interventions for lower-SES and minority communities , this program modestly improved some diabetes risk factors . Thus , individualized , telephone-based models may be a promising alternative to group-based interventions",
"OBJECTIVE Although the benefits of in-person Diabetes Prevention Program ( DPP ) classes for diabetes prevention have been demonstrated in trials , effectiveness in clinical practice is limited by low participation rates . This study explores whether text message support enhances weight loss in patients offered DPP classes . RESEARCH DESIGN AND METHODS English- and Spanish-speaking patients with prediabetes ( n = 163 ) were r and omized to the control group , which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention , or to the text message – augmented intervention group , which also received text messages adapted from the DPP curriculum for 12 months . RESULTS Mean weight decreased 0.6 pounds ( 95 % CI −2.7 to 1.6 ) in the control group and 2.6 pounds ( 95 % CI −5.5 to 0.2 ) in the intervention group ( P value 0.05 ) . Three percent weight loss was achieved by 21.5 % of participants in the control group ( 95 % CI 12.5–30.6 ) , compared with 38.5 % in the intervention group ( 95 % CI 27.7–49.3 ) ( absolute difference 17.0 % ; P value 0.02 ) . Mean glycated hemoglobin ( HbA1c ) increased by 0.19 % or 2.1 mmol/mol ( 95 % CI −0.1 to 0.5 % ) and decreased by 0.09 % or 1.0 mmol/mol ( 95 % CI −0.2 to 0.0 % ) in the control group and intervention participants , respectively ( absolute difference 0.28 % ; P value 0.07 ) . Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers . CONCLUSIONS Text message support can lead to clinical ly significant weight loss in patients with prediabetes . Further study assessing effect by primary language and in an operational setting is warranted",
"BACKGROUND The Arizona Well-Integrated Screening and Evaluation for Women Across the Nation ( WISEWOMAN ) project used provider counseling , health education , and community health workers ( CHWs ) to target chronic disease risk factors in uninsured , primarily Hispanic women over age 50 . METHODS Participants were recruited from two Tucson clinics participating in the National Breast and Cervical Cancer Early Detection Program ( NBCCEDP ) . Women were r and omly assigned into one of three intervention groups : ( 1 ) provider counseling , ( 2 ) provider counseling and health education , or ( 3 ) provider counseling , health education , and CHW support . At baseline and 12 months ( 1998 - 2000 ) , participants were measured for height , weight , waist and hip circumference , and blood pressure . Blood tests were conducted to check blood glucose , cholesterol , and triglyceride levels . At each time point , participants also completed 24-hour dietary recalls and question naires focusing on their physical activity levels . RESULTS A total of 217 women participated in baseline and 12-month follow-up . Three fourths were Hispanic . All three intervention groups showed an increase in self-reported weekly minutes of moderate-to-vigorous physical activity , with no significant differences between the groups . Significantly more women who received the comprehensive intervention of provider counseling , health education , and CHW support progressed to eating five fruits and vegetables per day , compared with participants who received only provider counseling or provider counseling plus health education . CONCLUSIONS All three interventions increased moderate-to-vigorous physical activity but not fruit and vegetable consumption . The intervention group with provider counseling , health education , and CHW support significantly increased the number of women meeting national recommendations for fruit and vegetable consumption",
"BACKGROUND A number of factors contribute to increased risk of coronary heart disease ( CHD ) among postmenopausal women , including atherogenic changes in serum cholesterol profiles , weight gain , and decreases in physical activity during the menopause . To date , no study has attempted to prevent elevations in primary CHD risk factors as women experience menopause . METHODS A sample of 535 healthy premenopausal women , ages 44 - 50 , were recruited for an ongoing 5-year r and omized prevention trial testing whether increases in low-density lipoprotein cholesterol ( LDL-C ) and body weight can be prevented during the menopause with a dietary and behavioral intervention . The aim was to reduce total dietary and saturated fat and cholesterol , prevent weight gain , and increase physical activity levels . Changes in CHD risk factors after the first 6 months of treatment were analyzed comparing 253 intervention and 267 assessment -only control participants . RESULTS The intervention group showed significant reductions in total cholesterol ( -0.34 mmol/liter ) , LDL-C ( -0.28 mmol/liter ) , triglycerides ( -0.04 mmol/liter ) , weight ( -4.8 kg ) , waist-hip ratio ( -0.008 ) , systolic blood pressure ( -3.5 mm Hg ) , diastolic blood pressure ( -2.2 mm Hg ) , serum glucose levels ( -0.06 mmol/liter ) , and HDL-C ( -0.06 mmol/liter ) and significant increases in physical activity ( + 383 kcal ) . No significant changes were observed in the control group . CONCLUSION Six-month results suggested that participants were receptive to the preventive approach to CHD risk reduction and were successful in making initial positive lifestyle changes . Follow-up data will evaluate long-term adherence to the intervention and the interaction between adherence and physiological changes during menopause",
"OBJECTIVES This study examined the health-related effects of two worksite interventions , physical exercise and reduced workhours , on women employed in dentistry . METHODS Six workplaces were r and omized to one of the following three conditions : ( i ) 2.5 hours of weekly , m and atory physical exercise of middle-to-high intensity to be performed during workhours ( N=62 ) , ( ii ) a reduction of full-time weekly workhours from 40 to 37.5 hours ( N=50 ) , and ( iii ) reference . In all , 177 women participated . Biomarkers and self-ratings in question naires were obtained before the intervention ( T ( 1 ) ) , and six ( T ( 2 ) ) and 12 months ( T ( 3 ) ) after the intervention . RESULTS The results showed increased levels of physical activity and exercise in all of the groups , the level of physical exercise being significantly greater in the physical exercise group . Repeated- measures analyses of variance using data from T ( 1 ) and T (3)for biological measures and all three time points for self-ratings produced significant interaction effects for glucose , waist-to-hip ratio , and work ability and clear trends for general symptoms and upper-extremity disorders . Posthoc analyses showed that the results of the health-related measures differed between the interventions , decreased glucose and upper-extremity disorders in the exercise group , and increased high-density lipoprotein and waist-to-hip ratio among those working reduced hours . CONCLUSIONS These results show that the two interventions had small and varied effects on biomarkers and self-reports of different aspects of health among women . It is suggested that interventions involving a modest reduction in workhours seem to be more effective if these hours are used for physical exercise",
"BACKGROUND AND AIMS Improvements in a lifestyle modification program for hypertensives were maintained 1 year later . Longer follow-up in such studies is limited ; we therefore re-assessed participants after an additional 2 years in which there was no contact with program facilitators . METHODS AND RESULTS Participants r and omised to usual care ( N=118 ) or a 4-month lifestyle program ( N=123 ) were previously assessed after 4 months and 1 year . After a further 2 years , diet , alcohol intake , physical activity , weight , waist girth , ambulatory blood pressure ( BP ) , blood lipids , glucose and insulin were measured ( usual care N=64 ; program N=76 ) . Statistically significant net changes , relative to usual care , included blood cholesterol ( -0.2 mmol/L , 95 % CI 0.1 - 0.4 ) ; physical activity ( 53 min/week , 95 % CI 15 - 91 ) ; dietary saturated fat ( -1.9 % energy , 95 % CI -0.1 to -3.8 ) ; fish ( 3.2 serves/month , 95 % CI 0.7 - 5.7 ) ; vegetables ( 9.1 serves/month , 95 % CI 3.2 - 15.1 ) ; and sweet foods ( -6.2 serves/month , 95 % CI -1.1 to -11.3 ) . Between-group changes in weight ( -0.7 kg , 95 % CI -1.8 - 0.4 ) , BP ( systolic 1.4 mmHg , 95 % CI -0.7 - 3.5)/diastolic 1.0 mmHg , 95 % CI -0.3 - 2.4 ) and Framingham risk ( usual care : men 12.1 % , women 3.7 % ; program : men 12.2 % ; women 3.5 % ) did not differ significantly . CONCLUSION Continued reinforcement with long-term follow-up is needed in lifestyle modification programs",
"BACKGROUND Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear . We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study . METHODS The study was a cluster r and omised trial in which 33 clinics in Da Qing , China-serving 577 adults with impaired glucose tolerance-were r and omised ( 1:1:1:1 ) to a control group or lifestyle intervention groups ( diet or exercise or both ) . Patients were enrolled in 1986 and the intervention phase lasted for 6 years . In 2009 , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population . FINDINGS Of the 577 patients , 439 were assigned to the intervention group and 138 were assigned to the control group ( one refused baseline examination ) . 542 ( 94 % ) of 576 participants had complete data for mortality and 568 ( 99 % ) contributed data to the analysis . 174 participants died during the 23 years of follow-up ( 121 in the intervention group vs 53 in the control group ) . Cumulative incidence of cardiovascular disease mortality was 11.9 % ( 95 % CI 8.8 - 15.0 ) in the intervention group versus 19.6 % ( 12.9 - 26.3 ) in the control group ( hazard ratio [ HR ] 0.59 , 95 % CI 0.36 - 0.96 ; p=0.033 ) . All-cause mortality was 28.1 % ( 95 % CI 23.9 - 32.4 ) versus 38.4 % ( 30.3 - 46.5 ; HR 0.71 , 95 % CI 0.51 - 0.99 ; p=0.049 ) . Incidence of diabetes was 72.6 % ( 68.4 - 76.8 ) versus 89.9 % ( 84.9 - 94.9 ; HR 0.55 , 95 % CI 0.40 - 0.76 ; p=0.001 ) . INTERPRETATION A 6-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes . These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes . FUNDING Centers for Disease Control and Prevention , WHO , the China-Japan Friendship Hospital , Da Qing First Hospital ",
"Although the Diabetes Prevention Program ( DPP ) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals , it has yet to be widely adopted at the community level . The Healthy Living Partnership to Prevent Diabetes study ( HELP PD ) was design ed to translate the DPP approach for use in community setting s as a cost-effective intervention led by Community Health Workers ( CHW 's ) and administered through a Diabetes Care Center ( DCC ) . Approximately 300 overweight and obese ( BMI 25 - 40 kg/m(2 ) ) individuals with prediabetes ( fasting blood glucose 95 - 124 mg/dl ) were r and omly assigned to either a lifestyle weight loss intervention ( LW ) or an enhanced usual care comparison condition ( UC ) . The goal of LW is > or=7 % weight loss achieved through increases in physical activity ( 180 min/wk ) and decreases in caloric intake ( approximately 1500 kcal/day ) . The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months . UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter . The primary outcome is change in fasting blood glucose . Secondary outcomes include cardiovascular risk factors , health-related quality of life , and social cognitive variables . Outcomes are masked and are collected every 6 months . The cost-effectiveness of the program will also be assessed . A community-based program that is administered through local DCC 's and that harnesses the experience of community members ( CHW 's ) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals",
"The authors investigated the efficacy of a lifestyle educational program , organized in small group meetings , in improving the outcome of a nonpharmacologic intervention . One hundred and eighty-eight hypertensive patients with stable blood pressure ( BP ) levels and drug therapy in the previous 6 months were r and omly divided into educational care ( EC ) and usual care ( UC ) groups . They were followed at 3-month intervals up to 2 years . In addition to the visits in an outpatient clinic , patients in the EC program participated in small group meetings in order to improve their knowledge of the disease and reinforce their motivation for treatment . At baseline , EC and UC groups were similar for age , sex , body mass index ( BMI ) , blood pressure ( BP ) levels , and pharmacologic treatment . Patients in the EC group had significantly reduced total energy , total and saturated fats , and sodium intake . Physical activity was significantly increased in the EC group as well . At the end of the 1-year follow-up , BMI ( P visceral fat ( P and BP ( P<.001 ) were significantly lower in the EC group compared with the UC group . Pharmacologic treatment during the study was similar for all classes of drugs apart from diuretics whose dose was higher in the UC group at the end of the study",
"Purpose The purpose of this study is to evaluate the effectiveness of a nutrition-based shared medical appointment ( SMA ) intervention in the treatment of prediabetes compared to the individualized counseling st and ard of care . Methods A r and omized controlled trial design comparing health outcomes in patients with prediabetes attending either an individualized counseling ( control group ) or three 90-minute nutrition SMA ( intervention group ) sessions . Demographic , anthropometric ( weight and body mass index ) , clinical ( blood pressure ) , and biochemical ( lipid profile , fasting blood sugar , glycated hemoglobin , albumin-to-creatinine ratio ) measures were obtained from all participants at baseline , at 3 months , and at 1 year . Results Ninety-four participants were r and omized into the 2 study groups with a 69 % completion rate at 1 year ( n = 34 SMA , n = 31 control ) . The average participant was Caucasian ( 64 % ) , male ( 54 % ) , 58.3 ± 9.6 years , had a BMI of 30.8 ± 4.9 kg/m2 ( obese ) , and fasting blood glucose of 109 ± 9.5 mg/dL. The SMA and control participants lost a mean of 6.6 pounds and 3.6 pound , respectively ; neither group met the 5 % modest weight loss expected . The SMA and control group experienced a mean drop in fasting blood glucose of 6 mg/dL. Conclusions As dem and s on health care providers continue to rise , finding innovative ways to manage the patient load while providing quality health care is increasingly important . SMA health outcomes were equivalent to individual counseling outcomes , while increasing the provider ’s productivity by treating 6 to 8 people with prediabetes in 90 minutes compared to 1 patient in 60 minutes"
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OBJECTIVE To develop a guidance document concerning the use of systemic therapy for women with recurrent ovarian cancer that would be applicable for the Canadian health care system . This will be done using a st and ardized systematic review process , guideline evaluation instruments , multi-disciplinary expert consensus opinion and evidence -rating systems . DATA SELECTION The primary data sources were MEDLINE , National Guideline Clearinghouse and Cochrane Library . METHODS Clinical practice guidelines , technology assessment s , systematic review s and r and omized controlled trials addressing systemic therapy for women with recurrent ovarian cancer were eligible . DATA EXTRACTION Data was identified and extracted by the methodology team and review ed by the authors . Results were review ed and discussed by members of an expert working group comprised of a multidisciplinary and geographic divergent group of practitioners . DATA SYNTHESIS The existing 7 practice guidelines underwent formal evaluation for quality , currency and content using the AGREE tool . Recommendations with evidence -ratings were developed . This data was used by a pan-Canadian panel in an informal consensus process , which result ed in the initial draft of a guideline . The guideline team review ed the draft and made further edits to ensure the guideline 's appropriateness for a national context . Practitioner feedback was requested from 165 health care providers who treat ovarian cancer from across Canada . Overall response rate was 37 % and was very positive . Comments were review ed and the guideline was edited appropriately . CONCLUSION The development of a national practice guideline on the use of systemic therapy for recurrent ovarian cancer was feasible using systematic literature review , expert consensus , guideline evaluation instruments , evidence -rating systems , independent internal and external review measures and final approval by a national discipline specific society ( GOC ) . Recommendations for practice are offered
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"PURPOSE We wished to critically examine the level of activity of weekly paclitaxel in a patient population with well-characterized platinum/paclitaxel-resistant ( 3-week schedule ) ovarian cancer . PATIENTS AND METHODS Eligibility criteria for this phase II trial included the following : ovarian and fallopian tube cancers or primary carcinoma of the peritoneum ; prior initial therapy with platinum/paclitaxel ; and failure to respond to treatment ( progression or stable disease as best response ) , or a response duration of less than 3 months , or if the response was more than 3 months , retreatment with both agents required and failure to respond a second time or the response duration was less than 3 months . Measurable or assessable disease ( CA-125 response criteria ) was required . Patients received weekly paclitaxel ( 80 mg/m(2 ) ) until disease progression , unacceptable toxicity developed , or they elected to discontinue treatment . RESULTS Fifty-three patients ( 52 assessable for toxicity and 51 for response ) were entered onto this multi-institution trial . Of 248 total cycles ( 887 doses ) , only 13 ( 1 % ) were modified ( dose reduction or treatment delay ) because of side effects . Therapy was discontinued in five patients because of toxicity ( four because of peripheral neuropathy , and one because of painful fingernail beds ) . Thirteen patients ( 25 % ; 95 % confidence interval , 13.5 % to 37.5 % ) achieved an objective response ( four by CA-125 criteria , and nine by > or = 50 % reduction of measurable disease ) . CONCLUSION Weekly paclitaxel ( 80 mg/m(2 ) ) is generally well tolerated and is an active second-line regimen against ovarian cancer that has demonstrated resistance to platinum/paclitaxel delivered on an every-3-week schedule",
"PURPOSE A phase II trial was conducted to determine the activity of prolonged oral etoposide in platinum-resistant and platinum-sensitive ovarian carcinoma . PATIENTS AND METHODS Platinum-resistant disease was defined as progression on platinum-based chemotherapy or recurrence within 6 months of completing therapy . The starting dose was 50 mg/m2/d ( 30 mg/m2/d for prior radiotherapy ) for 21 days , every 28 days . A dose escalation to a maximum dose of 60 mg/m2/d was prescribed . RESULTS Of 99 patients entered , 97 were assessable for toxicity and 82 were assessable for response . Among 41 platinum-resistant patients a 26.8 % response rate ( 7.3 % complete response [ CR ] and 19.5 % partial response [ PR ] rate ) occurred . The median response duration was 4.3 months ( range , 1.3 to 8.7 ) , median progression-free interval ( PFI ) was 5.7 months ( range , 0.8 to 30.8 + ) , and median survival time was 10.8 months ( range , 1.9 to 45.8 ) . Twenty-five of 41 platinum-resistant patients had also previously received paclitaxel ; of which eight ( 32 % ) responded . Among 41 platinum-sensitive patients , a 34.1 % response rate ( 14.6 % CR and 19.5 % PR rate ) occurred . The median response duration was 7.5 months ( range , 1.9 to 15.2 + ) , median PFI was 6.3 + months ( range , 0.9 to 20.4 ) , and median survival time was 16.5 + months ( range , 0.9 to 34.8 ) . Of 97 patients assessable for toxicity , grade 3 or 4 hematologic toxicity was common , with leukopenia occurring in 41.2 % ( grade 3 , 29 % ; grade 4 , 12 % ) , neutropenia in 45.4 % ( grade 3 , 20 % ; grade 4 , 25 % ) , thrombocytopenia in 9 % ( grade 3 , 5 % ; grade 4 , 4 % ) , and anemia in 13.4 % . Three treatment-related deaths occurred : two from neutropenic sepsis and one from thrombocytopenic bleeding after an overdose . One patient developed leukemia . CONCLUSION This regimen is active in platinum-resistant and platinum-sensitive ovarian carcinoma . Additionally , the regimen is active in paclitaxel-resistant ovarian carcinoma",
"This phase II study evaluated the response rate and toxicity of single-agent gemcitabine in 40 women with epithelial ovarian cancer , previously treated with platinum-based chemotherapy . Patients had stage III or IV disease and progressive disease 1 - 12 months after the last treatment . Gemcitabine 1250 mg/m2 was administered on days 1 , 8 and 15 of each 28-day cycle as a 30-minute infusion . The overall response rate to gemcitabine was 22 % ( 95 % confidence intervals : 10 - 39 % ) . Responses to gemcitabine were observed in patients with platinum-refractory disease , which suggests no cross resistance to platinum . Gemcitabine was well tolerated and no grade 4 toxicity was seen . This study confirms that gemcitabine is active and well tolerated in pre-treated women with ovarian cancer",
"PURPOSE Topotecan is a topoisomerase I inhibitor with pre clinical activity against various tumor types . We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who had failed to respond to one prior cisplatin-based chemotherapeutic regimen . PATIENTS AND METHODS Topotecan 1.5 mg/m2/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks . As the cisplatin-free interval relates to response in subsequent treatment , patients were stratified in subgroups , ie , cisplatin-refractory , cisplatin-resistant , and cisplatin-sensitive . RESULTS One-hundred eleven patients entered the study . Nineteen patients were considered to be ineligible ; 92 patients were assessable for response . A total of 552 courses were given ( median , four per patient ; range , one to 17 ) . The major toxicities were leukocytopenia and neutropenia , which were grade 3 to 4 in 54.2 % and 69.1 % of courses , respectively , but with only 4.3 % of these being grade 4 neutropenia plus fever or infectious complications . Prophylactic granulocyte colony-stimulating factor ( G-CSF ) was given in 20.5 % of courses to maintain dose-intensity . Other relatively frequent side effects were alopecia ( 82 % ) , nausea ( 36.4 % ) , and vomiting ( 17.5 % ) . The overall response rate was 16.3 % , with one complete response ( CR ) and 14 partial responses ( PRs ) . In the cisplatin-refractory , cisplatin-resistant , and cisplatin-sensitive strata , the response rates were 5.9 % , 17.8 % , and 26.7 % , respectively . The median duration of time of documented response was 21.7 weeks ( range , 4.6 to 41.9 ) . CONCLUSION Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer . Further investigations of topotecan in ovarian cancer , including first-line use and combination with other active agents , are indicated",
"PURPOSE The aim of the study was to evaluate the activity of vinorelbine ( VNLB ) in a population of advanced ovarian cancer patients , with particular attention to defining its role in platinum-resistant disease . PATIENTS AND METHODS Thirty-three patients were recruited and treated with VNLB 25 mg/m2 intravenously ( IV ) weekly . the median age was 53 years , performance status 0 to 2 , and number of previous chemotherapy regimens two ( range , one to five ) . Twenty-four patients were platinum-resistant ; the remaining nine either were platinum-sensitive ( four cases ) or had undetermined sensitivity ( five cases ) . RESULTS The mean delivered dose-intensity of VNLB was 67 % of the planned level , because 60 % of the cycles were delayed due to neutropenia or anemia . Four partial responses ( PRs ) and one complete response ( CR ) were observed , for an overall response rate of 15 % ( 95 % exact confidence interval , 5.1 % to 31.9 % ) . All the responses occurred in the subgroup of 24 platinum-resistant cases , in whom the response rate was 21 % ( 95 % exact confidence interval , 7.1 % to 42.1 % ) . Seven patients became stabilized on VNLB , and 27 % of the cases showed a reduction in serum cancer antigen 125 ( CA 125 ) levels . G3/G4 side effects consisted of neutropenia , anemia , and worsening of preexisting peripheral neuropathy . No treatment-related deaths occurred . CONCLUSION VNLB led to a 21 % response rate in the population of heavily pretreated and platinum-resistant ovarian cancer patients . Further studies of VNLB alone or in combination with taxanes are warranted in patients with less pretreatment",
"BACKGROUND The aim of this study was to evaluate the efficacy of a more convenient topotecan administration schedule in the second-line treatment of advanced platinum-refractory ovarian cancer . METHODS AND MATERIAL S The Gynecologic Oncology Group conducted a Phase II trial of 24-h infusional topotecan ( 8.5 mg/m(2 ) ) , repeated every 3 weeks in 26 patients with platinum-refractory ovarian cancer ( failure to respond to initial platinum-based treatment or development of recurrent disease within 6 months of completion of chemotherapy ) . RESULTS Grade 4 neutropenia ( 85 % of patients ) and thrombocytopenia ( 12 % ) were the major toxicities encountered . Of the 25 patients evaluable for response , only a single patient experienced an objective response ( 4 % ) . CONCLUSIONS When employed at this dose and schedule ( 24-h infusion every 3 weeks ) , topotecan has minimal second-line activity in platinum-refractory ovarian cancer",
"PURPOSE Stealth liposomal doxorubicin ( Alzal Corp , Palo Alto , CA ) has a slower clearance rate than free doxorubicin , result ing in sustained serum levels . Liposomal encapsulation also leads to increased concentration of drug in tumor tissue . Meta- analysis of previous studies has shown that doxorubicin has activity in epithelial ovarian cancer . The current study was developed to examine the activity of Stealth liposomal doxorubicin in platinum- and paclitaxel-refractory ovarian cancer . PATIENTS AND METHODS Patients had epithelial ovarian cancer that either progressed on or recurred within 6 months of completion of platinum and paclitaxel chemotherapy . All patients had measurable disease . Stealth liposomal doxorubicin was administered at 50 mg/m(2 ) every 4 weeks as a 1-hour infusion . RESULTS Eighty-nine patients were treated and included in an intent-to-treat analysis . There were 82 patients who were platinum and paclitaxel refractory and met all study criteria . There was one complete response and 14 partial responses , for a total response rate of 16.9 % ( 95 % confidence interval [ CI ] , 9.1 % to 24.6 % ) . For platinum- and paclitaxel-refractory patients , the response rate was 18.3 % ( 95 % CI , 9.9 % to 26.7 % ) . Median time to progression was 19 . 3 weeks for the entire population . Ten patients ( 11.2 % ) withdrew because of adverse events related to the drug ( palmar-plantar erythrodysesthesia [ PPE ] , n = 3 ; asthenia , n = 2 ; cardiac , n = 2 ; neutropenia , n = 1 ; stomatitis , n = 1 ; and edema , n = 1 ) . There were no drug-related fatal events . There were only eight grade 4 adverse events attributable to the drug . Stomatitis , PPE , and skin lesions were managed with dose reductions and delays in most cases . CONCLUSION Stealth liposomal doxorubicin has activity in refractory epithelial ovarian cancer . PPE and stomatitis can usually be managed by dose adjustment . The ease of administration makes this an attractive agent",
"PURPOSE A phase II study of liposomal doxorubicin was conducted in patients with ovarian cancer who failed to respond to platinum- and paclitaxel-based regimens . Liposomal doxorubicin was selected as a result of its superior activity against ovarian cancer xenografts relative to free doxorubicin and activity in refractory ovarian cancer patients that was noted during the phase I study . PATIENTS AND METHODS Thirty-five consecutive patients were accrued in two institutions ( 22 in one and 13 in the other ) . All had progressive disease after either cisplatin or carboplatin and paclitaxel , or at least one platinum-based and one paclitaxel-based regimen . Patients received intravenous ( I.V. ) liposomal doxorubicin 50 mg/m2 every 3 weeks with a dose reduction to 40 mg/m2 in the event of grade 3 or 4 toxicities , or a lengthening of the interval to 4 weeks ( and occasionally to 5 weeks ) with persistence of grade 1 or 2 toxicities beyond 3 weeks . RESULTS Nine clinical responses ( one complete response [ CR ] , eight partial responses [ PRs ] ) were observed in 35 patients ( 25.7 % ) , with seven of these having been confirmed by two consecutive computed tomographic ( CT ) measurements . The median progression-free survival was 5.7 months with an overall survival of 1.5 to 24 + months ( median , 11 months ) . Although 13 patients experienced grade 3 or 4 nonhematologic skin and mucosal toxicities ( either h and -foot syndrome or stomatitis ) , with dose modifications , the treatment was very well tolerated . Nausea that was clearly attributable to the drug , hair loss , extravasation necrosis , or decreases in ejection fraction did not occur . CONCLUSION Liposomal doxorubicin has substantial activity against ovarian cancer refractory to platinum and paclitaxel . The responses achieved with liposomal doxorubicin were durable and maintained with minimal toxicity . This liposomal formulation should be evaluated further in combination with other drugs in less refractory patients",
"PURPOSE Topotecan , a topoisomerase I inhibitor , was evaluated in a multicenter , phase II study of women with epithelial ovarian carcinoma who relapsed after one or two prior regimens that included platinum and paclitaxel . PATIENTS AND METHODS Topotecan 1.5 mg/m2 daily was administered as a 30-minute infusion for 5 consecutive days on a 21-day cycle . Eligibility criteria included bidimensionally measurable disease , Eastern Cooperative Oncology Group performance status of 2 or less , and adequate bone marrow , liver , and renal function . Efficacy was assessed by independent radiologic review . RESULTS One hundred thirty-nine patients were treated ; 81 % were platinum resistant . Sixty-two patients had received one prior regimen and 77 patients had received two prior regimens . Nine patients were not assessable for response ; however , all patients were included in the response analysis . The overall response rate was 13.7 % ; 12.4 % in platinum-resistant and 19.2 % in platinum-sensitive patients . Stable disease lasted at least 8 weeks in 27.3 % of the patients . The median duration of response and time to progression were 18.1 and 12.1 weeks , respectively . The median survival was 47.0 weeks . Grade 4 neutropenia occurred in 82 % of the patients ( 34 % of the courses ) and thrombocytopenia in 30 % of the patients ( 9 % of the courses ) . Infectious complications occurred in 6 % of the courses . Nonhematologic toxicities were mild . There were no drug-related toxic deaths . CONCLUSION As a single agent , topotecan has modest activity in women with advanced epithelial ovarian carcinoma who have progressed or not responded after one or two prior regimens with platinum and paclitaxel . Further investigation of combination regimens is indicated in the primary therapy for ovarian cancer based on the mechanism of action and tolerability",
" Thirty-eight women with epithelial ovarian cancer were treated with gemcitabine , a new antimetabolite . All had previously received platinum , and 27 had also received paclitaxel . Four patients had a partial response giving a response rate of 13 % in assessable patients ( n = 31 ) and 11 % for all patients entered . Additionally , 6 patients had stable disease with > 50 % reduction in CA-125 for at least 3 months . Activity was seen in patients resistant to both platinum and paclitaxel . Gemcitabine was well tolerated , with uncomplicated neutropenia the main hematological toxicity . Nonhematological toxicities were generally mild and included fatigue , myalgias , and skin rash . Gemcitabine has some activity in heavily pretreated ovarian cancer patients and deserves further investigation in this malignancy",
"PURPOSE Twenty-one-day topotecan infusion was administered as second-line therapy in patients with previously treated ovarian cancer ( based on our prior favorable phase I experience ) to determine its activity , time to progression , and pharmacodynamics . PATIENTS AND METHODS Ovarian cancer patients with measurable lesions and one prior platinum-containing regimen were eligible . Topotecan 0.4 mg/m(2)/d 21-day continuous ambulatory intravenous infusion , with appropriate dose modifications for toxicity , was administered every 28 days . Weekly blood levels of topotecan and topoisomerase-1 ( topo-1 ) levels in peripheral-blood mononuclear cells ( P BMC s ) were determined for pharmacodynamic correlation . RESULTS Twenty-four patients were entered onto the study ( six cisplatin-refractory , five relapsing within 6 months after platinum-based therapy ) . A total of 128 cycles of topotecan ( median , four cycles per patient ; range , one to 12 cycles ) were administered . The major toxicity was neutropenia ( 29 % grade 3 in all cycles and 4 % grade 4 ) . One episode of grade 4 thrombocytopenia ( 4 % ) occurred . Fifty-two percent of the patients had anemia that required transfusions . Eight of 23 patients with measurable disease ( 35 % ; 95 % confidence interval [ CI ] , 15 % to 54 % ) had partial responses ( PRs ) lasting longer than 1 month . Two of these patients had minor residual computed tomographic changes but had clinical complete remissions that lasted up to 53 weeks while they were not undergoing further therapy . One patient with nonmeasurable disease had a PR ( by CA-125 criteria ) that lasted 6 months , for an overall response rate of 38 % in nine of 24 patients ( 95 % CI , 18 % to 57 % ) . The median time to progression was 26 weeks . Pharmacodynamic analysis demonstrated a statistically significant decrease in free P BMC topo-1 level at weeks 2 and 3 of drug administration . There was a strong statistical correlation between the decrease in free topo-1 levels and increasing area under the curve ( AUC ) for topotecan . This was confirmed in a pharmacodynamic model . CONCLUSION Twenty-one-day infusion is a well-tolerated method of administering topotecan . Pharmacodynamic studies demonstrate correlations between ( 1 ) the week of infusion and the P BMC topo-1 level , ( 2 ) the AUC of topotecan and the decrease in topo-1 levels , and ( 3 ) the change in topo-1 level and the neutrophil nadir . The objective response rate of 35 % to 38 % ( 95 % CI , 15 % to 57 % ) in this small multicenter study is at the upper level for topotecan therapy in previously treated ovarian cancer . Prolonged topotecan administration therefore warrants further investigation in larger , r and omized studies comparing this 21-day schedule with the once-daily-for-5-days schedule",
"OBJECTIVE The purpose of this study was to define the response rate and toxicity of topotecan in patients with ovarian cancer resistant to first-line therapy . METHODS Twenty patients with advanced or recurrent ovarian cancer were enrolled in a phase I/II protocol , and an additional 16 patients were treated following protocol closure at Washington University Medical Center . The starting dose of topotecan was 1.25 mg/m2/day given intravenously over 30 min for 5 consecutive days . Patients were eligible for response evaluation if they completed more than one cycle of topotecan . All patients were evaluated for toxicity . RESULTS Of 28 patients eligible for response evaluation , 26 were resistant to both platinum and paclitaxel prior to treatment with topotecan . There were four partial responders and no complete responders for a total response rate of 14 % ( 95 % confidence interval : 4 to 33 % ) . All responders had exhibited primary resistance to both platinum and paclitaxel . Myelotoxicity was the major toxicity , with 92 % of patients experiencing Gynecologic Oncology Group ( GOG ) grade 3 or 4 neutropenia and 67 % experiencing GOG grade 3 or 4 thrombocytopenia . Other toxicity was minimal and easily managed . Fifty percent of patients receiving more than one cycle of topotecan tolerated a dose equal or greater to the starting dose . CONCLUSIONS Topotecan exhibits activity in patients with ovarian cancer resistant to both platinum and paclitaxel . Further study is warranted in less heavily pretreated patients and in combination with other chemotherapeutic agents"
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4116552e-06ff-11f0-808a-c43d1ab1c353
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INTRODUCTION Low carbohydrate diets ( LCD ) have shown beneficial effects on short-term weight reduction programs for obese individuals without diabetes , but the long-term evidence of efficacy on individuals with type 2 diabetes is not conclusive . OBJECTIVE To evaluate , the effectiveness of 12 or more weeks of LCD compared to Low Fat Diet ( LFD ) , Usual Care Diet ( UCD ) or Low Glycemic Index Diet ( LGID ) on weight reduction and AIC on type 2 diabetes individuals . METHODS A systematic review was conducted on r and omized trials registered in PubMed , Cochrane and EBSCOhost from January 1st 2000 to January 1st 2010 including those with an intervention program with LCD in type 2 diabetes subjects and a follow-up ≥ 12 weeks . Available data on study design ; carbohydrate composition of diet ; duration of diet ; and the outcomes of weight , lipid levels ( total , low density lipoprotein and high-density lipoprotein cholesterol , and triglycerides ) , hemoglobin A1C percent and /or fasting glucose were extracted . RESULTS Five studies showed greater weight reduction with LCD , of which four demonstrated no significant difference . The longest trial intervention studies did not show a difference in weight change . Only two studies showed greater reduction of A1C with LCD , including the longest intervention trial with a low carbohydrate Mediterranean diet . CONCLUSIONS This review shows that there are no consistent differences in weight and A1C changes over the long-term treatment with LCD and LFD , UCD or LGID
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"BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed",
"UNLABELLED Weight loss and resolution of comorbidities is well established after modern bariatric procedures , however chronology of glyco-lipidic biochemical response is still debated . OBJECTIVE Aim ing to analyze this variable as well as its correlation with food amount and composition , a prospect i ve study was design ed . METHODOLOGY Eighty consecutive patients undergoing Roux-en-Y gastric bypass were investigated every three months until one year after surgery . Females only were accepted and variables included general and nutritional course as well as glucose and lipid measurements . Energy intake was documented including percentage of macronutrients in the diet . RESULTS Surgery was successful with about 71 % excess body weight loss at the end of the first year . Mean energy intake on the 4 postoperative quarters was respectively 519.6 + /- 306.6 , 836.0 + /- 407.9 , 702.1 + /- 313.1 and 868.8 + /- 342.8 kcal/day ( mean + /- SD ) . Fat intake was initially low but reached 34.1 + /- 7.9 % of total calories at final measurement . Blood glucose and lipid fractions tended to be borderline or abnormal preoperatively , and favorably changed by 12 months . Consumption of glucose- and lipid-lowering medication significantly diminished , but each of these was still necessary in 6.3 % of the group . Correlation between body mass index and also calorie intake versus glucose and lipid measurements was highly significant ( P = 0.000 ) . CONCLUSIONS 1 ) Energy intake after operation was very low ; 2 ) Weight loss proceeded rapidly and correlated with meal pattern ; 3 ) Improvement of glucose and lipid tests was adequate but took several quarters to normalize ; 4 ) Decreased requirements for glucose- and lipid-lowering medication was significant but not absolute ; 4 ) Fat percentage of total calories exceeded 30 % at the end of the observation period , despite recommendations to the contrary",
"Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes",
"OBJECTIVE To compare the effects of a 1-year intervention with a low-carbohydrate and a low-fat diet on weight loss and glycemic control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This study is a r and omized clinical trial of 105 overweight adults with type 2 diabetes . Primary outcomes were weight and A1C . Secondary outcomes included blood pressure and lipids . Outcome measures were obtained at 3 , 6 , and 12 months . RESULTS The greatest reduction in weight and A1C occurred within the first 3 months . Weight loss occurred faster in the low-carbohydrate group than in the low-fat group ( P = 0.005 ) , but at 1 year a similar 3.4 % weight reduction was seen in both dietary groups . There was no significant change in A1C in either group at 1 year . There was no change in blood pressure , but a greater increase in HDL was observed in the low-carbohydrate group ( P = 0.002 ) . CONCLUSIONS Among patients with type 2 diabetes , after 1 year a low-carbohydrate diet had effects on weight and A1C similar to those seen with a low-fat diet . There was no significant effect on blood pressure , but the low-carbohydrate diet produced a greater increase in HDL cholesterol",
"OBJECTIVE This study sought to examine the effects of a 3-month programme of dietary advice to restrict carbohydrate intake compared with reduced-portion , low-fat advice in obese subjects with poorly controlled Type 2 diabetes . RESEARCH DESIGN AND METHODS One hundred and two patients with Type 2 diabetes were recruited across three centres and r and omly allocated to receive group education and individual dietary advice . Weight , glycaemic control , lipids and blood pressure were assessed at baseline and 3 months . Dietary quality was assessed at the end of study . RESULTS Weight loss was greater in the low-carbohydrate ( LC ) group ( -3.55 + /- 0.63 , mean + /- sem ) vs. -0.92 + /- 0.40 kg , P = 0.001 ) and cholesterol : high-density lipoprotein ( HDL ) ratio improved ( -0.48 + /- 0.11 vs. -0.10 + /- 0.10 , P = 0.01 ) . However , relative saturated fat intake was greater ( 13.9 + /- 0.71 vs. 11.0 + /- 0.47 % of dietary intake , P short-term weight loss compared with st and ard advice , but this was at the expense of an increase in relative saturated fat intake",
"Approximately 80 % of patients with type 2 diabetes are overweight/obese ( 1 ) , and weight loss is the mainstay of treatment for these individuals . However , there is growing controversy as to whether reduced-fat or reduced-carbohydrate diets are best suited for this purpose , and results ( 2–8 ) in nondiabetic subjects suggest that lower carbohydrate diets are similarly or more efficacious in improving weight , triglycerides , and HDL cholesterol . There are no published r and omized studies evaluating the role of dietary macronutrients with respect to weight loss and cardiovascular risk improvement in patients with type 2 diabetes . Thus , we r and omized diet-treated patients with type 2 diabetes to hypocaloric diets , moderately restricted in either carbohydrate or fat , to determine whether weight loss or metabolic improvement differed as a function of macronutrient composition . A total of 29 patients with diet-treated type 2 diabetes were recruited from the San Francisco Bay area . All subjects gave written informed consent . Inclusion criteria included BMI 27–36 kg/m2 , fasting plasma glucose concentration 7.2–8.3 mmol/l , no use of antihyperglycemic medications , and stable weight for 3 months . Subjects on anti-hypertensive or cholesterol-lowering drugs or aspirin were allowed to continue their medications . Insulin-mediated glucose uptake was quantified by a modification ( 9 ) of the insulin suppression test as originally described ( 10 ) and vali date d ( 11 ) . In this test , a 180-min infusion of somatostatin ( 0.27 μg/m2 per min ) , insulin ( 25 mU/m2 per min ) ,",
" In two groups of obese patients with type 2 diabetes the effects of 2 different diet compositions were tested with regard to glycaemic control and bodyweight . A group of 16 obese patients with type 2 diabetes was advised on a low-carbohydrate diet , 1800 kcal for men and 1600 kcal for women , distributed as 20 % carbohydrates , 30 % protein and 50 % fat . Fifteen obese diabetes patients on a high-carbohydrate diet were control group . Their diet , 1600 - 1800 kcal for men and 1400 - 1600 kcal for women , consisted of approximately 60 % carbohydrates , 15 % protein and 25 % fat . Positive effects on the glucose levels were seen very soon . After 6 months a marked reduction in bodyweight of patients in the low-carbohydrate diet group was observed , and this remained one year later . After 6 months the mean changes in the low-carbohydrate group and the control group respectively were ( + /-SD ) : fasting blood glucose ( f-BG ) : -3.4 + /- 2.9 and -0.6 + /- 2.9 mmol/l ; HBA1c : -1.4 + /- 1.1 % and -0.6 + /- 1.4 % ; Body Weight : -11.4 + /- 4 kg and -1.8 + /- 3.8 kg ; BMI : -4.1 + /- 1.3 kg/m _ and -0.7 + /- 1.3 kg/m_. Large changes in blood glucose levels were seen immediately . A low-carbohydrate diet is an effective tool in the treatment of obese patients with type 2 diabetes",
"BACKGROUND Low-carbohydrate diets are effective for weight reduction in people without diabetes , but there is limited evidence for people with Type 2 diabetes . Aims To assess the impact of a low-carbohydrate diet on body weight , glycated haemoglobin ( HbA(1c ) ) , ketone and lipid levels in diabetic and non-diabetic subjects . METHODS Thirteen Type 2 diabetic subjects ( on diet or metformin ) and 13 non-diabetic subjects were r and omly allocated to either a low-carbohydrate diet ( or = 40 g carbohydrate/day ) or a healthy-eating diet following Diabetes UK nutritional recommendations and were seen monthly for 3 months . Subjects ( 25 % male ) were ( mean + /- sd ) age 52 + /- 9 years , weight 96.3 + /- 16.6 kg , body mass index 35.1 kg/m(2 ) , HbA(1c ) 6.6 + /- 1.1 % , total cholesterol 5.1 + /- 1.1 mmol/l , high-density lipoprotein cholesterol 1.3 + /- 0.4 mmol/l , low-density lipoprotein cholesterol 3.1 + /- 0.9 mmol/l , triglycerides ( geometric mean ) 1.55 ( 1.10 , 2.35 ) mmol/l and ketones range 0.0 - 0.2 mmol/l . RESULTS Analysis was by intention to treat with last observation carried forward . Twenty-two of the participants ( 85 % ) completed the study . Weight loss was greater ( 6.9 vs. 2.1 kg , P = 0.003 ) in the low-carbohydrate group , with no difference in changes in HbA(1c ) , ketone or lipid levels . CONCLUSIONS The diet was equally effective in those with and without diabetes"
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41165574-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Research on Internet-based interventions typically use digital versions of pen and paper self-report symptom scales . However , adaptation into the digital format could affect the psychometric properties of established self-report scales . Several studies have investigated differences between digital and pen and paper versions of instruments , but no systematic review of the results has yet been done . OBJECTIVE This review aims to assess the interformat reliability of self-report symptom scales used in digital or online psychotherapy research . METHODS Three data bases ( MEDLINE , Embase , and PsycINFO ) were systematic ally review ed for studies investigating the reliability between digital and pen and paper versions of psychiatric symptom scales . RESULTS From a total of 1504 publications , 33 were included in the review , and interformat reliability of 40 different symptom scales was assessed . Significant differences in mean total scores between formats were found in 10 of 62 analyses . These differences were found in just a few studies , which indicates that the results were due to study effects and sample effects rather than unreliable instruments . The interformat reliability ranged from r=.35 to r=.99 ; however , the majority of instruments showed a strong correlation between format scores . The quality of the included studies varied , and several studies had insufficient power to detect small differences between formats . CONCLUSIONS When digital versions of self-report symptom scales are compared to pen and paper versions , most scales show high interformat reliability . This supports the reliability of results obtained in psychotherapy research on the Internet and the comparability of the results to traditional psychotherapy research . There are , however , some instruments that consistently show low interformat reliability , suggesting that these conclusions can not be generalized to all question naires . Most studies had at least some method ological issues with insufficient statistical power being the most common issue . Future studies should preferably provide information about the transformation of the instrument into digital format and the procedure for data collection in more detail
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"Although the Insomnia Severity Index ( ISI ) is already administered online , this frequently used instrument has not been vali date d for Web delivery . This study compares online and paper- and -pencil ISI versions completed by participants in a r and omized controlled trial testing an Internet-delivered intervention for insomnia . Forty-three adults with insomnia completed both ISI versions during pre- ( Assessment 1 ) and post-intervention ( Assessment 2 ) . Correlations between total scores of both versions were significant ( rs ≥ .98 , ps both ISI versions , internal consistency was acceptable ( Assessment 1 , α = .61 ; Assessment 2 , α ≥ .88 ) . Among participants not receiving the parent study intervention , correlations between 1 format at Assessment 1 and the alternative format at Assessment 2 were generally significant ( rs = .26–.82 ) . Together , findings suggest the ISI can be delivered online",
"Background Low response rates among surgeons can threaten the validity of surveys . Internet technologies may reduce the time , effort , and financial re sources needed to conduct surveys . Objective We investigated whether using Web-based technology could increase the response rates to an international survey . Methods We solicited opinions from the 442 surgeon – members of the Orthopaedic Trauma Association regarding the treatment of femoral neck fractures . We developed a self-administered question naire after conducting a literature review , focus groups , and key informant interviews , for which we used sampling to redundancy techniques . We administered an Internet version of the question naire on a Web site , as well as a paper version , which looked similar to the Internet version and which had identical content . Only those in our sample could access the Web site . We alternately assigned the participants to receive the survey by mail ( n=221 ) or an email invitation to participate on the Internet ( n=221 ) . Non-respondents in the mail arm received up to three additional copies of the survey , while non-respondents in the Internet arm received up to three additional requests , including a final mailed copy . All participants in the Internet arm had an opportunity to request an emailed Portable Document Format ( PDF ) version . Results The Internet arm demonstrated a lower response rate ( 99/221 , 45 % ) than the mail question naire arm ( 128/221 , 58 % ) ( absolute difference 13 % , 95 % confidence interval 4%-22 % , P surgeons result ed in a significantly lower response rate than a traditional mailed survey . Research ers should not assume that the widespread availability and potential ease of Internet-based surveys will translate into higher response rates",
"Background When evaluating hearing rehabilitation , it is reasonable to use self-report question naires as outcome measure . Question naires used in audiological research are developed and vali date d for the paper- and -pencil format . As computer and Internet use is increasing , st and ardized question naires used in the audiological context should be evaluated to determine the viability of the online administration format . The aim of this study was to compare administration of question naires online versus paper- and pencil of four st and ardised question naires used in hearing research and clinic . We included the Hearing H and icap Inventory for the Elderly ( HHIE ) , the International Outcome Inventory for Hearing Aids ( IOI-HA ) , Satisfaction with Amplification in Daily Life ( SADL ) , and the Hospital Anxiety and Depression Scale ( HADS ) . Methods A cross-over design was used by r and omly letting the participants complete the question naires either online or on paper . After 3 weeks the participants filled out the same question naires again but in the other format . A total of 65 hearing-aid users were recruited from a hearing clinic to participate on a voluntary basis and of these 53 completed both versions of the question naires . Results A significant main effect of format was found on the HHIE ( p interaction effect . For the other question naires were no significant main or interaction effects of format . Significant correlations between the two ways of presenting the measures was found for all question naires ( p showed Cronbachs α ’s above .70 for all four question naires and differences in Cronbachs α between administration formats were negligible . Conclusions For three of the four included question naires the participants ’ scores remained consistent across administrations and formats . For the fourth included question naire ( HHIE ) a significant difference of format with a small effect size was found . The relevance of the difference in scores between the formats depends on which context the question naire is used in . On balance , it is recommended that the administration format remain stable across assessment points",
"It has been argued that behavior on the Internet differs from similar behavior in the “ real world ” ( Joinson , 1998a ) . In the present study , participants completed measures of self-consciousness , social anxiety , self-esteem , and social desirability , using either the World-Wide Web ( WWW ) or pen and paper , and were assigned to either an anonymous or a nonanonymous condition . It was found that people reported lower social anxiety and social desirability and higher self-esteem when they were anonymous than when they were nonanonymous . Furthermore , participants also reported lower social anxiety and social desirability when they were using the Internet than when they were using paper-based methods . Contrast analyses supported the prediction that participants using the WWW anonymously would show the lowest levels of social desirability , whereas participants answering with pen and paper nonanonymously would score highest on the same measure . Implication s for the use of the Internet for the collection of psychological data are discussed",
"This study examines whether the Internet-based question naire is psychometrically equivalent to the paper-based question naire . A r and om sample of 2,400 teachers in Taiwan was divided into experimental and control groups . The experimental group was invited to complete the electronic form of the Chinese version of Center for Epidemiologic Studies Depression Scale ( CES-D ) placed on the Internet , whereas the control group was invited to complete the paper-based CES-D , which they received by mail . The multi sample invariance approach , derived from structural equation modeling ( SEM ) , was applied to analyze the collected data . The analytical results show that the two groups have equivalent factor structures in the CES-D. That is , the items in CES-D function equivalently in the two groups . Then the e quality of latent mean test was performed . The latent means of \" depressed mood , \" \" positive affect , \" and \" interpersonal problems \" in CES-D are not significantly different between these two groups . However , the difference in the \" somatic symptoms \" latent means between these two groups is statistically significant at alpha = 0.01 . But the Cohen 's d statistics indicates that such differences in latent means do not apparently lead to a meaningful effect size in practice . Both CES-D question naires exhibit equal validity , reliability , and factor structures and exhibit a little difference in latent means . Therefore , the Internet-based question naire represents a promising alternative to the paper-based question naire",
"Background The majority of Internet-mediated studies use measures developed as paper- and -pencil measures or face-to-face-delivered material . Previous research suggests that the equivalence between online and offline measures must be demonstrated rather than assumed . Objective The objective of this study was to explore the equivalence 4 measures completed in an online or offline setting . Methods A sample of students ( n = 1969 ) was r and omly assigned to complete 4 popular scales ( the SF-12v2 , the Hospital Anxiety and Depression Scale ( HADS ) , the Fatigue Symptom Inventory , and a single-item fatigue measure ) either online or by mail survey ( pencil and paper ) . The response rate was 52.51 % ( n = 1034 ) and comparable between the online and offline groups . Results Significant differences were noted in fatigue levels between the online and offline group ( P = .01 ) as measured by the Fatigue Symptom Inventory , with the online sample demonstrating higher levels of fatigue . Equivalency was noted for the SF-12v2 , the Hospital Anxiety and Depression Scale , and the single-item fatigue measure . Internal consistency was high except for the SF-12v2 . The SF-12v2 may not be an ideal measure to use for remote administration . Conclusions Equivalency of the Hospital Anxiety and Depression Scale ( HADS ) and the Physical Component Score and Mental Component Score of the SF-12v2 for online and offline data were demonstrated . Equivalency was not demonstrated for the Fatigue Symptom Inventory . Explanations for the difference in fatigue score between the online and offline sample s are unclear . Research that seeks to match sample s and control for extraneous online and offline variables is called for , along with exploration of factors that may mediate the completion of question naires or alter the respondents ’ relationship with the same , to enhance progress in this area",
"Background Self-report measures can guide clinical decisions and are useful when evaluating treatment outcomes . However , many clinicians do not use self-report measures systematic ally in their clinical practice . Internet-based question naires could facilitate administration , but the psychometric properties of the online version of an instrument should be explored before implementation . The recommendation from the International Test Commission is to test the psychometric properties of each question naire separately . Objective Our objective was to compare the psychometric properties of paper- and -pencil versions and Internet versions of two question naires measuring depressive symptoms . Methods The 87 participating patients were recruited from primary care and psychiatric care within the public health care system in Sweden . Participants completed the Beck Depression Inventory ( BDI-II ) and the Montgomery-Åsberg Depression Rating Scale — Self-rated ( MADRS-S ) , both on paper and on the Internet . The order was r and omized to control for order effects . Symptom severity in the sample ranged from mild to severe depressive symptoms . Results Psychometric properties of the two administration formats were mostly equivalent . The internal consistency was similar for the Internet and paper versions , and significant correlations were found between the formats for both MADRS-S ( r = .84 ) and the BDI-II ( r = .89 ) . Differences between paper and Internet total scores were not statistically significant for either question naire nor for the MADRS-S question dealing with suicidality ( item 9 ) when analyzed separately . The score on the BDI-II question about suicidality ( item 9 ) was significantly lower when administered via the Internet compared with the paper score , but the difference was small ( effect size , Cohen ’s [ d ] = 0.14 ) . There were significant main effects for order of administration on both question naires and significant interaction effects between format and order . This should not , however , pose a problem in clinical use as long as the administration format is not changed when repeated measurements are made . Conclusions The MADRS-S can be transferred to online use without affecting the psychometric properties in a clinical ly meaningful way . The full BDI-II also seems to retain its properties when transferred ; however , the item measuring suicidality in the Internet version needs further investigation since it was associated with a lower score in this study . The use of online question naires offers clinicians a more practical way of measuring depressive symptoms and has the potential to save re sources",
"This study compared Web-based assessment techniques with traditional paper-based methods of commonly used measures of alcohol use . Test-retest reliabilities were obtained , and tests of validity were conducted . A total of 255 participants were r and omly assigned to 1 of 3 conditions : paper-based ( P&P ) , Web-based ( Web ) , or Web-based with interruption ( Web-I ) . Follow-up assessment s 1 week later indicated reliabilities ranging from .59 to .93 within all measures and across all assessment methods . Significantly high test-retest reliability coefficients support the use of these measures for research and clinical applications . Furthermore , no significant differences were found between assessment techniques , suggesting that Web-based methods are a suitable alternative to more traditional methods . This cost-efficient alternative has the advantage of minimizing data collection and entry errors while increasing survey accessibility",
"Objective : The purpose of this study was to examine whether computer administration of the Symptom Check List ( SCL‐90‐R ) is equivalent to paper‐ and ‐pencil originals"
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BACKGROUND AND PURPOSE This systematic review and meta- analysis aim ed to assess the effects of vitamin D supplements on indices of glycemic control [ homeostatic model assessment -insulin resistance ( HOMA-IR ) , hemoglobin A1C ( HbA1C ) , fasting blood glucose ( FBG ) , and quantitative insulin-sensitivity check index ( QUICKI ) and lipid profile in diabetic patients . METHODS Eight data bases were search ed , for r and omized controlled trials ( RCTs ) or cross-sectional and cohort studies that have been published up to December 2017 . We used the comprehensive meta- analysis ( CMA ) software for all statistical analysis and used the I2 index for assessing heterogeneity . A p value of 621 articles , and after the exclusion of ineligible publications , 82 studies remained to be assessed of which 37 were used for meta- analysis . Vitamin D supplementation was associated with a significant improvement in FBG ( p = 0.001 and 95 % CI : -0.526 to -0.136 ) and HbA1C ( p = 0.003 and 95 % CI : 1.719 to -0.361 ) in individuals with type 2 diabetes mellitus ( T2DM ) ; while in women with gestational diabetes mellitus ( GDM ) the reduction in FBG ( p = 0.071 and 95 % CI : -0.873 to -0.035 ) and HbA1C ( p = 0.199 and 95 % CI : 3.270 to 0.681 ) failed to reach statistical significance . Treatment with vitamin D supplements was associated with an improvement in HOMA-IR in pregnant diabetic women ( p = 0.028 and 95 % CI : 0.924 to -0.053 ) and for individuals with diabetes mellitus ( p = 0.005 and 95 % CI : 1.772 to -0.319 ) . The pooled result of the cross-sectional meta- analysis indicated that serum vitamin D concentrations were significantly lower in diabetic patients than in healthy controls ( p = 0.018 and 95 % CI : 0.587 to -0.054 ) . CONCLUSION This meta- analysis suggests that vitamin D supplementation improves indices of glycemic control ( FBG , HOMA-IR , and HbA1C ) in patients with diabetes mellitus . Hence , vitamin D supplements may be of potential therapeutic value in diabetic patients , as an adjuvant therapy along with other treatments
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"BACKGROUND Low serum concentrations of 25-hydroxyvitamin D [ 25(OH)D ] have been associated with impaired glucose tolerance and diabetes . OBJECTIVE This study aim ed to compare the effects of daily intake of vitamin D- or vitamin D(3 ) + calcium-fortified yogurt drink on glycemic status in subjects with type 2 diabetes ( T2D ) . DESIGN Ninety diabetic subjects were r and omly allocated to 3 groups to consume plain yogurt drink ( PY ; containing no vitamin D and 150 mg Ca/250 mL ) , vitamin D-fortified yogurt drink ( DY ; containing 500 IU vitamin D(3 ) and 150 mg Ca/250 mL ) , or vitamin D + calcium-fortified yogurt drink ( DCY ; containing 500 IU vitamin D(3 ) and 250 mg Ca/250 mL ) twice per day for 12 wk . Fasting serum glucose ( FSG ) , glycated hemoglobin ( Hb A(1c ) ) , homeostasis model assessment of insulin resistance ( HOMA-IR ) , serum lipid profile , and percentage fat mass ( FM ) were assessed before ( baseline ) and after the intervention . RESULTS In both the DY and DCY groups , mean serum 25(OH)D(3 ) improved ( + 32.8 ± 28.4 and + 28.8 ± 16.1 nmol/L , respectively ; P but FSG [ -12.9 ± 33.7 mg/dL ( P = 0.015 ) and -9.6 ± 46.9 mg/dL ( P = 0.035 ) ] , Hb A(1c ) [ -0.4 ± 1.2 % ( P [ -0.6 ± 1.4 ( P = 0.001 ) and -0.6 ± 3.2 ( P 0.001 ) ] , waist circumference ( -3.6 ± 2.7 and -2.9 ± 3.3 ; P both ) , and body mass index [ in kg/m(2 ) ; -0.9 ± 0.6 ( P between changes in serum 25(OH)D(3 ) and FSG ( r = -0.208 , P = 0.049 ) , FM ( r = -0.219 , P = 0.038 ) , and HOMA-IR ( r = -0.219 , P = 0.005 ) . CONCLUSION Daily intake of a vitamin D-fortified yogurt drink , either with or without added calcium , improved glycemic status in T2D patients . This trial was registered at clinical trials.gov as NCT01229891",
"This study aim ed to investigate the effects of daily intake of vitamin D-fortified yogurt drink ( doogh ) on central obesity indicators in subjects with type 2 diabetes ( T2D ) and the possible modulation of this effect by vitamin D receptor ( VDR ) Cdx-2 genotypes . A total of sixty T2D subjects were r and omly allocated to two groups to receive either plain doogh ( PD ; n 29 , containing 170 mg Ca and no vitamin D/250 ml ) or vitamin D3-fortified doogh ( FD ; n 31 , containing 170 mg Ca and 12·5 μg/250 ml ) twice a day for 12 weeks . 25-hydroxyvitamin D ( 25(OH)D ) , glycaemic as well as adiposity indicators were evaluated before and after the intervention . VDR-Cdx-2 genotypes in extended number of T2D subjects in the FD group ( n 60 ) were determined as AA , GA and GG . After 12 weeks , in FD compared with PD , serum 25(OH)D increased ( + 35·4 v. -4·8 nmol/l ; P ( WC ; -1·3 v. + 1·6 cm ; P=0·02 ) , body fat mass ( FM ; -1·9 v. + 0·60 % ; P=0·008 ) , truncal fat ( TF ; -1·1 v. 0·13 % ; P=0·003 ) and visceral adipose tissue ( -0·80 v. + 0·37 AU ; P significantly . Circulating 25(OH)D was raised only in the AA group ( 34·8 nmo/l in AA group v. -6·4 nmol/l in AG and -1·6 nmol/l in GG groups ; P accompanied by a significant decrease in changes of WC ( P=0·004 ) , FM% ( P=0·01 ) and TF% ( P the AA genotype . Daily intake of vitamin D-FD for 12 weeks improved the central obesity indices in T2D subjects , and the improvement was more pronounced in the carriers of the AA genotype of VDR-Cdx-2",
"Background : Peripheral neuropathy is a common complaint of diabetes . This study aim ed to determine the effects of 12 weeks combined training with Vitamin D supplement on improvement of sensory-motor neuropathy in women with diabetic neuropathy . Material s and Methods : This clinical trial study conducted on 90 patients were selected and r and omly divided into two groups . Finally , 81 adult females with diabetes type II ( 20–55 years old ) were interred in this study . The control group had no training , but received Vitamin D. The experimental group received Vitamin D and 12 weeks training program ( 3 days a week , 60 min/session ) including aerobic exercises , strength , and flexibility . Aerobic exercise intensity was set at 60–70 % maximum heart rate and resistance training intensity was determined by 10 R.M. Michigan neuropathy question naire , reflex hammer and tuning fork 128 Hz used to screening tense of neuropathy ( Michigan Neuropathy Screening Instrument ) that were used for pretest and posttest . Results : Following 3 months combined training and supplementation with Vitamin D , had observed a significant reduction in numbness ( P = 0.001 ) , pain ( 0.002 ) , tingling ( P = 0.001 ) , and weakness ( P = 0.002 ) in the lower limb and also increases in sense of touch intervention ( P = 0.005 ) , detects the position of the fingers ( P = 0.001 ) and vibration perception ( P = 0.001 ) in tissues . Knee reflexes ( P = 0.77 ) and ankles reflexes ( P = 0.47 ) did not significantly change after interventions . Conclusion : It seems that taking part in combined training and supplementation with Vitamin D can improve the symptoms of sensory-motor neuropathy",
"Abstract Limited data are available assessing the effects of vitamin D and evening primrose oil ( EPO ) administration on markers of insulin resistance and lipid concentrations in gestational diabetes mellitus ( GDM ) . This study was design ed to evaluate the effects of vitamin D and EPO administration on insulin resistance and lipid concentrations among women with GDM . In this prospect i ve r and omized , double-blind , placebo-controlled clinical trial , 60 participants with GDM were divided into 2 groups of either 1000 IU vitamin D3 and 1000 mg EPO or placebo for 6 weeks . At the beginning and end of the study , fasting blood sample s were obtained from the participants to measure related variables . After 6 weeks of intervention , changes in fasting plasma glucose ( −3.6 ± 7.5 vs. + 1.5 ± 11.4 mg/dL , P = 0.04 ) , serum insulin concentrations ( −2.0 ± 5.3 vs. + 4.6 ± 10.7 µIU/mL , P = 0.004 ) , homeostasis model of assessment ( HOMA ) insulin resistance ( −0.5 ± 1.1 vs. + 1.1 ± 2.5 , P = 0.003 ) , HOMA-B cell function ( −7.7 ± 23.3 vs. + 17.4 ± 42.9 , P = 0.007 ) and the quantitative insulin sensitivity check index ( + 0.01 ± 0.02 vs. −0.01 ± 0.02 , P = 0.007 ) in the vitamin D plus EPO group were significantly different from the placebo group . In addition , compared with the placebo , vitamin D and EPO supplementation result ed in significant reductions in serum TAG ( −20.0 ± 54.3 vs. + 34.3 ± 38.2 mg/dL , P ( −4.0 ± 10.9 vs. + 6.9 ± 7.6 mg/dL , P TC ( −22.1 ± 32.6 vs. + 5.3 ± 20.1 mg/dL , P concentrations ( −18.0 ± 25.5 vs. + 1.8 ± 15.7 mg/dL , P = 0.001 ) and TC/HDL ( −0.3 ± 0.4 vs. + 0.3 ± 0.5 mg/dL , P 0.001 ) . We did not observe any significant effect of vitamin D and EPO supplementation on serum HDL concentrations . Clinical trial registration number : http://www.i rct .ir : I RCT 201509115623N52",
"BACKGROUND & AIMS Low levels of serum 25-hydroxy vitamin D ( 25(OH)D ) are common in type 2 diabetic patients and cause several complications particularly , in postmenopausal women due to their senile and physiological conditions . This study aim ed to assess the effects of vitamin D-fortified low fat yogurt on glycemic status , anthropometric indexes , inflammation , and bone turnover in diabetic postmenopausal women . METHODS In a r and omized , placebo-controlled , double-blind parallel-group clinical trial , 59 postmenopausal women with type 2 diabetes received fortified yogurt ( FY ; 2000 IU vitamin D in 100 g/day ) or plain yogurt ( PY ) for 12 weeks . Glycemic markers , anthropometric indexes , inflammatory , and bone turnover markers were assessed at baseline and after 12 weeks . RESULTS After intervention , in FY group ( vs PY group ) , were observed : significant increase in serum 25(OH)D and decrease of PTH ( stable values in PY ) ; significant improvement in serum fasting insulin , HOMA-IR , HOMA-B , QUICKI , and no changes in serum fasting glucose and HbA1c ( significant worsening of all indexes in PY ) ; significant improvement in WC , WHR , FM , and no change in weight and BMI ( stable values in PY ) ; significant increase of omentin ( stable in PY ) and decrease of sNTX ( significant increase in PY ) . Final values of glycemic markers ( except HbA1c ) , omentin , and bone turnover markers significantly improved in FY group compared to PY group . Regarding final values of serum 25(OH)D in FY group , subjects were classified in insufficient and sufficient categories . Glycemic status improved more significantly in the insufficient rather than sufficient category ; whereas the other parameters had more amelioration in the sufficient category . CONCLUSIONS Daily consumption of 2000 IU vitamin D-fortified yogurt for 12 weeks improved glycemic markers ( except HbA1c ) , anthropometric indexes , inflammation , and bone turnover markers in postmenopausal women with type 2 diabetes . TRIAL REGISTRATION www.i rct .ir ( I RCT 2013110515294N1 )",
"Background : Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes . Objective : This r and omized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes ( GDM ) , gestational hypertension , preeclampsia and preterm labor , vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily . Material s and Methods : 500 women with gestational age 12 - 16 weeks and serum 25 hydroxy vitamin D ( 25 ( OH ) D ) less than 30 ng/ml r and omly categorized in two groups . Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery . Maternal and Neonatal outcomes were assessed in two groups . Results : The incidence of GDM in group B was significantly lower than group A ( 6.7 % versus 13.4 % ) and odds ratio ( 95 % Confidence interval ) was 0.46 ( 0.24 - 0.87 ) ( P=0.01 ) . The mean ± SD level of 25 ( OH ) D at the time of delivery in mothers in group B was significantly higher than A ( 37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml , respectively ) ( P=0.001 ) . There were no differences in the incidence of preeclampsia , gestational hypertension , preterm labor , and low birth weight between two groups . The mean level of 25 ( OH ) D in cord blood of group B was significantly higher than group A ( 37.9 ± 18 versus 29.7 ± 19ng/ml , respectively ) . Anthropometric measures between neonates were not significantly different . Conclusion : Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM ",
"Background Despite the certain role of both vitamin D and adiponectin in the regulation of insulin sensitivity , the interaction between these two agents has remained uncertain . Objective The present study aim ed to determine whether vitamin D is able to change plasma adiponectin and affect glucose homeostasis and insulin sensitivity in first-degree relatives of subjects with type 2 diabetes . Methods This r and omized clinical trial was conducted at Clinic of Shahid Sadoughi Hospital in Yazd , Iran , from January 25 , 2012 to December 25 , 2014 . In this r and omized , double-blinded controlled trial , 64 first-degree relatives of type 2 diabetic patients were assigned r and omly to receive either vitamin D supplement ( 50000 IU vitamin D tablet weekly ) plus lifestyle change as the intervention group ( n = 32 ) or placebo plus lifestyle change as the control group ( n = 32 ) for twelve weeks ( three months ) . Results Fifty-three patients ( 28 in the intervention group and 25 in the control group ) completed the study . Serum levels of vitamin D increased while insulin level and consequently insulin resistance ( calculated by HOMA formula ) significantly decreased in the case group ( p-value markers including adiponectin , Fasting Blood Sugar ( FBS ) , triglyceride , and total cholesterol remained insignificant in both study groups after completing interventions compared with before interventions . Conclusion This study showed that decreased insulin resistance is expected by administrating vitamin D supplement in first-degree relatives of the patients with diabetes mellitus . Trial Registration The trial was registered at the Iranian Registry of Clinical Trials ( http://www.i rct .ir ) with the I RCT ID : 201105176430N1 . Funding The authors received no financial support for the research or publication of this article",
"Background : The purpose of this study was to investigate the effects of an 8-week aerobic exercise and supplementation of 25(OH)D3 on GLP1 and DDP4 levels in men with type II diabetes . Methods : In this semiexperimental research , among 40–60-year-old men with type II diabetes who were referred to the diabetic center of Isabn-E Maryam hospital in Isfahan ; of whom , 48 patients were voluntarily accepted and then were r and omly divided into 4 groups : aerobic exercise group , aerobic exercise with 25(OH ) D supplement group , 25(OH ) D supplement group , and the control group . An aerobic exercise program was conducted for 8 weeks ( 3 sessions/week , each session 60 to75 min with 60–80 % HRmax ) . The supplement user group received 50,000 units of oral Vitamin D once weekly for 8 weeks . The GLP1 , DPP4 , and 25(OH ) D levels were measured before and after the intervention . At last , the data were statistically analyzed using the ANCOVA and post hoc test of least significant difference . Results : The results of ANCOVA showed a significant difference between the GLP1 and DPP4 levels in aerobic exercise with control group while these changes were not statistically significant between the 25(OH ) D supplement group with control group ( P Conclusions : Aerobic exercises have result ed an increase in GLP1 level and a decrease in DPP4 level . However , consumption of Vitamin D supplement alone did not cause any changes in GLP1 and DPP4 levels but led to an increase in 25-hydroxy Vitamin D level ",
"Abstract Aims To assess whether a single parental dose of 25-hydroxy vitamin D [ 25(OH)Vit D ] could improve glucose control and inflammation in type 2 diabetic patients ( T2D ) with ischemic heart disease ( IHD ) . Methods A r and omized , placebo-controlled , double-blind trial was performed on 95 patients ( 47—placebo and 48—vitamin D groups ) . Participants were r and omized using a r and omization table to a single dose of either vitamin D ( 300,000 IU , IM ) or a matching placebo . Fasting blood sugar ( FBS ) , glycosylated hemoglobin ( HbA1c ) , 25(OH)Vit D and high-sensitivity C-reactive protein ( hs-CRP ) were measured at baseline and at 8 weeks . Results No significant differences in baseline values were noted between groups , except in HbA1c , which was lower in the placebo group . In the supplemented group , the level of serum 25(OH)Vit D increased ( 29.6 ± 20.8 vs. 44.5 ± 19.2 ng/mL ) and those of FBS and HbA1c decreased significantly [ 186.5 ± 64.1 vs. 165.1 ± 58.5 mg/dL and 8.2 ± 2.0 % ( 66.3 ± 21.8 mmol/mol ) vs. 7.7 ± 1.8 % ( 61.7 ± 20.0 mmol/mol ) , respectively ] ( all p of outcome variables ( HbA1c , FBS , 25(OH)Vit D and hs-CRP ) from baseline between the vitamin D versus placebo group , using ANCOVA , adjusted for the baseline of each variable itself , season at study entry , age and body mass index . During trial , only HbA1c level decreased significantly [ 0.48 % ( st and ard error : 0.17 ) , p = 0.04 ] . No any adverse effect was seen . Conclusions A single parenteral dose of vitamin D in T2D patients with IHD improved glycemic control , but not inflammatory status . Clinical trial registryAustralian New Zeal and Clinical Trial Registry . Clinical trial numberACTRN12614000529640",
"Background : Vitamin D deficiency is prevalent in diabetes type 2 and this vitamin may be related to insulin action . This r and omized controlled trial study was done to evaluate the effect of vitamin D supplementation on glucose control and insulin resistance in patients with diabetes type 2 . Methods : Participants of this r and omized clinical trial study consisted of 28 patients with type 2 diabetes who received 100 microgram ( 4000 IU ) vitamin D and 30 diabetic patients who received placebo for 2 months between September 2012 and February 2013 . The effect of vitamin D on glucose control was assessed by measuring HbA1c and insulin resistance as HOMA-IR at the baseline and the end of the intervention . Results : The results showed a significant decrease in HbA1c ( from 7.29 ± 0.22 % to 6.76 ± 0.18 % , P ) and insulin concentration ( from 8.24 ± 0.97 μIU/mL to 6.55 ± 0.28 μIU/mL , P=0.048 ) , but a non-significant decrease in HOMA-IR in vitamin D group . Also , HDL-C level increased significantly in both of vitamin D ( P=0.046 ) and placebo groups ( P=0.028 ) . Conclusion : It seems that vitamin D supplementation has beneficial effects on glucose homeostasis and can increases insulin sensitivity in diabetic 2 patients",
"Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease , the major cause of death in diabetes . We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes ( T2D ) . In this study , the effects of improvement of vitamin D status on glycemic status , lipid profile and endothelial biomarkers in T2D subjects were investigated . Methods Subjects with T2D were r and omly allocated to one of the two groups to receive either plain yogurt drink ( PYD ; containing 170 mg calcium and no vitamin D/250 mL , n1 = 50 ) or vitamin D3-fortified yogurt drink ( FYD ; containing 170 mg calcium and 500 IU/250 mL , n2 = 50 ) twice a day for 12 weeks . Anthropometric measures , glycemic status , lipid profile , body fat mass ( FM ) and endothelial biomarkers including serum endothelin-1 , E-selectin and matrix metalloproteinase (MMP)-9 were evaluated at the beginning and after the 12-week intervention period . Results The intervention result ed in a significant improvement in fasting glucose , the Quantitative Insulin Check Index ( QUICKI ) , glycated hemoglobin ( HbA1c ) , triacylglycerols , high-density lipoprotein cholesterol ( HDL-C ) , endothelin-1 , E-selectin and MMP-9 in FYD compared to PYD ( P of endothelin-1 , E-selectin and MMP-9 concentrations in FYD compared to PYD ( -0.35 ± 0.63 versus -0.03 ± 0.55 , P = 0.028 ; -3.8 ± 7.3 versus 0.95 ± 8.3 , P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL , respectively , P significant for endothelin-1 and MMP-9 ( P = 0.009 and P = 0.005 , respectively ) but disappeared for E-selectin ( P = 0.092 ) . On the contrary , after controlling for serum 25(OH)D , the differences disappeared for endothelin-1(P = 0.066 ) and MMP-9 ( P = 0.277 ) but still remained significant for E-selectin ( P = 0.011 ) . Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status , lipid profile and endothelial biomarkers in T2D subjects . Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers . Trial registration Clinical Trials.gov :",
"Background It is suggested that vitamin D deficiency is associated with cardiovascular disease ( CVD ) via its effect on lipid profiles . The objective of this study was to determine the association between fasting serum levels of 25(OH ) D and lipid profiles in patients with type 2 diabetes . Methods This cross-sectional study was conducted on 108 type 2 diabetics . Patients were selected r and omly among members of the Iranian Diabetes Association according to study criteria . Fasting concentration of 25(OH ) D , calcium , phosphorus , parathyroid hormone ( PTH ) and lipid profiles ( including triglyceride ( TG ) , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and total cholesterol ) were measured . Results The mean serum levels of 25-hydroxyvitamin D ( 25(OH ) D ) and PTH were 53.41 ± 33.25 nmol/l and 40.24 ± 18.24 pmol/l , respectively , in type 2 diabetic patients . Prevalence of vitamin D deficiency was 58.34 % and vitamin D sufficiency and insufficiency combined was 41.66 % . Although in diabetic patients with vitamin D deficiency , serum levels of total cholesterol , TG , and LDL were higher and HDL was lower compared to patients with vitamin D sufficiency , this association was statistically significant only for serum level of TG ( 145.91 ± 79.00 vs. 122.95 ± 55.82 mg/dl ) . Conclusions The results of present study show that serum concentrations of 25(OH ) D were inversely associated with TG . More interventional studies are needed to confirm the relationship between serum concentration of vitamin D and lipid profile in patients with type 2 diabetes",
"Background : Some epidemiological and interventional studies have shown the role of vitamin D on insulin secretion and resistance . A previous study in our center showed that intramuscular vitamin D decreases insulin sensitivity in pre-diabetic patients . We investigated the role of oral vitamin D on the insulin sensitivity index and insulin resistance in pre-diabetic patients . Material s and Methods : In a r and omized clinical trial , we divided 45 people with pre-diabetes aged 47.4 ± 6.6 ( range 33 - 61 ) years into three groups : group A subjects treated with 50,000 IU oral vitamin D and 500 mg calcium carbonate ( n = 21 ) , group B subjects treated with a single 300,000 IU intramuscular vitamin D and 500 mg calcium carbonate ( n = 9 ) , and group C subjects treated with 500 mg calcium carbonate alone ( n = 15 ) . Serum 25-hydroxyvitamin D [ 25(OH ) D ] was measured at baseline . If it was less than 75 nmol/l , 50,000 IU vitamin D was given weekly , and if serum 25(OH ) D was more than that , vitamin D was administered every 2 weeks . Before and after 12 weeks of treatment , a 75-g glucose tolerance test was performed . We used paired t-test and analysis of variance ( ANOVA ) to analyze the data . P values less than 0.05 were considered significant . Results : Mean ( SD ) of serum vitamin D increased from 77.5 ± 39.2 to 118.8 ± 56.3 nmol/l ( P = 0.009 ) in group A and from 80 ± 36 to 102.8 ± 43.3 nmol/l ( P = 0.053 ) in group B , and decreased from 44.8 ± 18.3 to 34.6 ± 13.9 nmol/l ( P = 0.06 ) in group C. Insulin sensitivity index ( Matsuda ) decreased from 11.4 ± 3 to 9.9 ± 3.2 ( P = 0.046 ) in group A , but in comparison with other groups , it was not significant . Conclusion : Oral vitamin D had no effect on insulin sensitivity in pre-diabetes patients in 12 weeks treatment . A r and omized double-blind study with a longer duration of treatment is suggested to investigate the effect of vitamin D on insulin resistance",
"Background : Vitamin D deficiency is common in pregnancy , leading to increase in the frequency of preeclampsia , cesarean delivery , neonatal bacterial vaginosis , and gestational diabetes . The current study was design ed and implemented to investigate the effect of vitamin D during the first and second trimesters of pregnancy in reducing the risk of gestational diabetes mellitus ( GDM ) in women who are at high risk [ history of GDM , birth macrosomia , family history , and high body mass index ( BMI ) ] . Material s and Methods : In a r and omized , double-blind , and placebo-controlled trial , 90 pregnant women who had at least one risk factor for GDM were r and omized into intervention ( 46 participants ) and control ( 44 participants ) groups . Participants in the intervention group took 5000 units of vitamin D daily and the control group took placebo until the 26th week of pregnancy . Then the glucose challenge test ( GCT ) and the glucose tolerance test ( GTT ) were performed to evaluate GDM . Results : Mean ± st and ard deviation ( SD ) age was 31.28 ± 6.38 years and 29 ± 6.24 years for the intervention group and the placebo group , respectively , ( P > 0.05 ) . In addition , there were no significant differences between two groups in terms of vitamin D levels and GCT ( P > 0.05 ) , and the difference was not significant . The incidence of diabetes in the intervention groups was statistically lower than in control group ( 11.4 % vs 34.8 ; P showed that abnormal GCT in the placebo group was statistically higher than in intervention group ( 35.9 % vs 10.9 P of vitamin D supplementation in the first and second trimesters of pregnancy was effective in reducing GDM and controlling GTT and GTC",
"CONTEXT Systemic inflammation is thought to have a central role in diabetic long-term complications . OBJECTIVE The aim of this study was to investigate the effects of vitamin D either with or without extra calcium on certain inflammatory biomarkers in the subjects with type 2 diabetes ( T2D ) . DESIGN , SETTING , AND PARTICIPANTS This was a double-blind , r and omized , controlled trial conducted over 12 wk in 90 T2D subjects aged 30 - 60 yr from both sexes . INTERVENTION Subjects were r and omly allocated to one of three groups to receive two 250-ml bottles a day of plain Persian yogurt drink or doogh ( PD , containing 150 mg calcium and no detectable vitamin D(3)/250 ml ) , vitamin D-fortified doogh ( DD , containing 500 IU vitamin D(3 ) and 150 mg calcium/250 ml ) , or calcium + vitamin D(3)-fortified doogh ( CDD , containing 500 IU vitamin D(3 ) and 250 mg calcium/250 ml ) . OUTCOME MEASURES The changes in inflammatory markers were evaluated . RESULTS Compared to the baseline values , highly sensitive C-reactive protein , IL-1β , IL-6 , fibrinogen , and retinol binding protein-4 concentrations significantly decreased in both the DD and CDD groups . Although the decrement in highly sensitive C-reactive protein and fibrinogen was more in CDD compared to DD ( -4.0 ± 8.5 vs. -1.3 ± 2.8 mg/liter , and -0.40 ± 0.74 and -0.20 ± 0.52 mg/liter , respectively ) , the differences were not significant . There was a significant increase in serum adiponectin in both the DD and CDD groups ( 51.3 ± 65.3 vs. 57.1 ± 33.8 μg/liter ; P adiponectin changes in CDD were significantly higher than in PD ( P = 0.021 ) . CONCLUSIONS Daily intake of vitamin D-fortified doogh improved inflammatory markers in T2D subjects , and extra calcium conferred additional benefit only for the antiinflammatory adipokine , i.e. adiponectin",
"BACKGROUND Cardiovascular mortality is high among diabetic patients due to abnormalities in the plasma lipid and lipoprotein metabolism , and increased oxidative stress . This study aim ed to investigate the effects of active vitamin D on serum lipids and oxidative stress markers in type 2 diabetic patients . METHODS A double-blind r and omized placebo-controlled trial was carried out in 70 participants with type 2 diabetes , aged 30 - 75 years of age . The participants were r and omly assigned to two groups . One group received two capsules of calcitriol ( 0.25 µg 1,25-dihydroxycholecalciferol per capsule ) per day . The second group received placebo tablets . All participants received their oral hypoglycemic drugs as prescribed by the endocrinologist . At the beginning , after 6 weeks , and at the end of the 12-week supplementation trial , serum total cholesterol , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , triglyceride ( TG ) , and serum malondialdehyde ( MDA ) levels were measured . RESULTS There was a significant reduction in total cholesterol , LDL-cholesterol , TG , and MDA levels in both treatment and placebo groups ( P 0.05 ) . Serum HDL-cholesterol level decreased significantly in the placebo group ( P CONCLUSION Active vitamin D reduced lipid profile and oxidative stress markers in diabetic patients compared to the control group , but these alterations were not statistically",
"Background & the purpose of the study Prevalence of type 2 diabetes mellitus ( T2DM ) is increasing worldwide . To reduce its risk and progression , preventive strategies are needed . Vitamin supplementation such as vitamin D is one of the strategies . This study was design ed to investigate the effect of injection of vitamin D on insulin resistance and anthropometric parameters in T2DM . Methods This r and omized double-blind clinical trial was conducted with 42 diabetic patients in two groups ; intervention group with single intramuscular injection of 300,000 International Unit ( IU ) of vitamin D3 and the placebo group . After recording demographic and anthropometric factors ( waist circumference , blood pressure and body mass index ) , fasting blood sample s was taken for measurement of blood glucose , 25-hydroxyvitamin D3 ( 25-OHD3 ) , insulin , glycosylated hemoglobin A1c ( HbA1c ) and estimation of Homeostasis Model Assessment Index ( HOMA ) in two times ; before study and after three months . Results Two groups had similar baseline characteristics ( each group = 21 subjects ) . Three months after vitamin D injection , HbA1c , anthropometric factors and HOMA index in intervention group stayed constant , however , serum 25- OHD3 was significantly increased ( p = 0.007 ) . Conclusion The present data is not convincing and further studies with large sample sizes are needed to show the definite effect of injection of vitamin D on control of diabetes and its risk",
"OBJECTIVE The present study was design ed to assess the effects of Ca+vitamin D supplementation on pregnancy outcomes in women with gestational diabetes mellitus ( GDM ) . DESIGN A r and omized , double-blind , placebo-controlled trial was conducted among sixty women with GDM . Participants were divided into two groups to receive Ca+vitamin D supplements or placebo . Individuals in the Ca+vitamin D group ( n 30 ) received 1000 mg Ca/d and two pearls containing 1250 µg ( 50 000 IU ) of cholecalciferol ( vitamin D(3 ) ) during the intervention ( one at study baseline and another at day 21 of the intervention ) ; those in the placebo group ( n 30 ) received two placebos of vitamin D at the mentioned times and placebos of Ca every day for 6 weeks . Pregnancy outcomes were determined . SETTING A urban community setting in Arak , Iran . SUBJECTS Sixty women with GDM and their newborns , living in Arak , Iran were enrolled . RESULTS Women treated with Ca+vitamin D had a significant decrease in caesarean section rate ( 23·3 % v. 63·3 % , P=0·002 ) and maternal hospitalization ( 0 v. 13·3 % , P=0·03 ) compared with those receiving placebo . In addition , newborns of GDM women r and omized to Ca+vitamin D had no case of macrosomia , while the prevalence of macrosomia among those r and omized to placebo was 13·3 % ( P=0·03 ) . Lower rates of hyperbilirubinaemia ( 20·0 % v. 56·7 % , P=0·03 ) and hospitalization ( 20·0 % v. 56·7 % , P=0·03 ) were also seen in the supplemented group of newborns than in the placebo group . CONCLUSIONS Ca+vitamin D supplementation for 6 weeks among pregnant women with GDM led to decreased caesarean section rate and maternal hospitalization , and decreased macrosomia , hyperbilirubinaemia and hospitalization in newborns",
"OBJECTIVE Inter population as well as interindividual variations in response to vitamin D intake commonly observed in subjects with type 2 diabetes may be related to genetic makeup . One of the c and i date genes potentially responsible for this diversity is vitamin D receptor ( VDR ) . This study aim ed to investigate the interactive effect of VDR Fok-I polymorphism and vitamin D intake on diverse aspects of diabetic host response . RESEARCH DESIGN AND METHODS Glycemic status , lipid profiles , inflammatory biomarkers , and VDR Fok-I genotypes were determined in diabetic subjects ( n = 140 ) who participated in a r and omized controlled trial . Participants consumed two 250-mL bottles per day of yogurt drink ( doogh ) fortified with 500 IU vitamin D/250 mL for 12 weeks . RESULTS Mean serum 25(OH)D increased by ~30 nmol/L ( P for 25(OH)D ( P = 0.030 ) , HDL ( P = 0.011 ) , high-sensitivity C-reactive protein ( hsCRP ) ( P 0.001 ) , interleukin (IL)-4 ( P = 0.008 ) , and IL-6 ( P = 0.017 ) among the genotypic groups . The alleles were defined as ‘ ‘ F ’ ’ or ‘ ‘ f ’ ’ depending on the absence or presence of the restriction site , respectively . The least increment in 25(OH)D was in ff ( 23.0 ± 3.8 nmol/L ) compared with Ff ( 31.2 ± 3.4 nmol/L ) and FF ( 35.6 ± 2.7 nmol/L ) ( P for trend = 0.009 ) , but only the difference between ff and FF was significant ( P = 0.023 ) . FF group had the largest decrement of both hsCRP and IL-6 compared with Ff ( P vitamin D intake in terms of response of circulating 25(OH)D and certain inflammatory biomarkers . A nutrigenetic approach may , therefore , be needed to protect diabetic patients from vitamin D deficiency ",
"Background Hypovitaminosis D has been associated with the development of gestational diabetes mellitus ( GDM ) in many observational studies . Objectives We report the first study of the impact of prenatal vitamin D supplementation on postpartum dysglycemia in GDM patients in a r and omized clinical trial . Patients and Methods Women with GDM at 12 - 32 weeks of gestation were assigned r and omly to either the intervention group ( in which serum 25-hydroxy vitamin D [ 25OHD ] levels were measured immediately , n = 48 ) or the control group ( in which the serum was stored and assayed at 6 - 12 weeks post-partum , n = 48 ) . Participants with initial serum 25OHD in the intervention group were instructed to take a total of 700,000 IU vitamin D3 during pregnancy . The primary outcomes were fasting plasma glucose ( FPG ) , insulin , 2-h post 75 g glucose load plasma glucose ( 2-hPLG ) , homeostasis model assessment of insulin resistance ( HOMA-IR ) , HbA1C , and 25 OHD at 6 - 12 weeks after delivery . Results The mean ± SD of serum 25OHD in the intervention group raised dramatically from 14.6 ± 6.3 to 32.4 ± 14.4 ng/mL , whereas no significant change occurred in the control group ( from 17.7 ± 6.1 to 19.3 ± 9.6 ng/mL , P Thirteen participants developed dysglycemia in each group . Mean FPG , 2-hPLG , and HOMA-IR were not significantly different between the groups . There was no significant difference between the groups for maternal and neonatal outcomes . Conclusions Although the high vitamin D supplementation dose in the present study ( compared to the 400 IU/day dose usually recommended for pregnancy ) safely increases the serum 25OHD , in GDM cases , the higher dose does not affect the plasma glucose level or insulin resistance at short term follow-up after delivery",
"Background : During pregnancy and lactation outst and ing changes occur in mother ’s vitamin D metabolism . This study was carried out to evaluate the efficacy of 300,000 IU vitamin D given intramuscularly on body status in new cases of gestational diabetes mellitus ( GDM ) . Methods : This is a r and omized clinical trial with the follow-up period of 3 months . Totally 45 participants were r and omly divided into intervention group ( IG ) and control group ( CG ) . The IG received an IM injection of 300,000 IU of vitamin D , whereas CG did not . The glycosylated hemoglobin A1C ( HBA1C ) , serum 25-OH-D , parathyroid hormone ( PTH ) , serum calcium and phosphorus were measured . Results : Forty five patients including 24 with the mean age of 30.7±6.2 years in the IG and 21 with the mean age of 29.5±4.0 years in the CG participated in the study . The median concentration of serum 25(OH)D3 in the IG was to 62.10 nmol/l after the intervention , showing an increase of around 158 % , compared to before intervention ( 24.25 nmol/l ) whereas the CG showed a decrease of around 4.5 % . Of the patients , 79.2 % of IG and 81.9 % of CG suffered to some degree from vitamin D deficiency . These figures were 4.2 % and 71.4 % for the IG and CG , respectively after the intervention . For the IG , the PTH was significantly lower and Ca was significantly higher after the intervention . The serum Phosphorus before and after the intervention in each group or between the two groups was not significant . Conclusions : The single 300,000 IM dose of vitamin D is regarded as an effective and safe to promptly improve vitamin D status in GDM . Trial Registration Number : I RCT",
"Background Vitamin D ( Vit D ) deficiency is a common disorder in diabetic patients and may be a risk factor for ischemic heart disease and exacerbation of diabetic nephropathy(DN ) . Objectives The aim of this study was to evaluate the effect of Vit D3 therapy on protein uriain type 2 diabetic patients with deficient or insufficient serum Vit D. Patients and Methods In a double blind clinical trial , 60 type 2 diabetic patients with proteinuria greater than 150 mg/day who had Vit D deficiency or insufficiency were r and omly enrolled in two equal groups . Pearl of Vit D as 50 000 IU/week and placebo ( 1 tablet per week ) were prescribed in patients of case and control groups respectively for 8 weeks . At the beginning and 2 months later , 24 hours urine protein was checked in all patients . Results There is no difference between serums Vit D level in case and control group at the beginning of the study , however at the end of the study serum Vit D level was significantly higher in the case group . There is no difference in proteinuria between case and control group at the beginning and the end of the study , while a significant difference between the changes of proteinuria before and after the study was seen in two groups ( P = 0.028 ) . Conclusions Vit D deficiency may exacerbate protein uric and DN , hence correction of Vit D deficiency may decrease proteinuria in diabetic patients with nephropathy",
"Background : During pregnancy , Low serum 25-hydroxyvitamin-D [ 25(OH)D ] concentration is even more critical . This deficiency leads to higher incidences of preeclampsia , gestational diabetes , preterm birth , bacterial vaginosis , and also affects the health of the infants . The aim of this study was to evaluate the relationships between serum levels of 25-hydroxyvitamin D ( 25[OH]D ) and gestational diabetes mellitus ( GDM ) and differences in high-risk pregnant women and women without risk factors for GDM . Methods : This cross sectional study including 155 pregnant women , who are still in the first trimester of pregnancy ( less than 12 weeks gestation ) , were r and omized to two groups of high and low risk for GDM . For these people , once at the gestational age less than 12 times a week and once at for 24 to 28 weeks of pregnancy , tests of FBS / BS / HbA1C / 25OHD / insulin / Ca / Albumin was requested . Besides , the OGTT test was performed with 75 g glucose at 24 and 28 weeks of pregnancy to diagnose GDM . Results : Serum levels of 25(OH)D in the second trimester of pregnancy ng / ml ( 24.1 ± 39.5 ) was significantly lower than that of the first trimester ng / ml ( 25.9 ± 45.6 ) ( p ) . But serum 25(OH)D levels in the first and second trimester of pregnancy was significantly different in women at high risk for GDM than women who had no risk factors ( p = 0.584 and p = 0.99 ) . Serum levels of 25(OH)D has an inverse and significant relationship with HbA1C at the beginning of pregnancy ( p=0.007 ) . In addition , a significant and inverse relationship was shown between serum levels of 25(OH)D in the second trimester with insulin ( p=0.047 ) and blood sugar 2 hours after ingestion of 75 g glucose ( p=0.045 ) at 24 - 28 weeks of gestation . Conclusion : Regarding to the relationship between serum levels of 25(OH)D and blood sugar and insulin at the second trimester of pregnancy , it is recommended for pregnant women to take vitamin D supplementation",
"Background : Lower vitamin D status has been reported in diabetic patients . Serum 25-hydroxyvitamin D and adiponectin were inversely associated with type 2 diabetes and insulin resistance . Vitamin D may involve in regulation of the adiponectin levels , which is directly related to insulin sensitivity . Objectives : The aim of this study was to investigate the effect of therapeutic dose of vitamin D on serum adiponectin and insulin resistance in vitamin D-insufficient or deficient type 2 diabetic patients . Material s and Methods : This double-blind , r and omized , clinical trial was conducted on 81 type 2 diabetic patients with vitamin D level of 10 - 30 ng/mL. Intervention was 50000 IU vitamin D or placebo once a week for 8 weeks . At the beginning and end of the study , blood sample s were collected after 12 hours of fasting and serum glucose , insulin , 25-hydroxyvitamin D , and adiponectin were measured . Insulin resistance was calculated by homeostasis model assessment ( HOMA-IR ) . Results : After 8-week intervention , serum 25-hydroxyvitamin D significantly increased and reached the normal levels in patients receiving vitamin D ( P of fasting serum glucose , insulin , and HOMA-IR were significantly decreased ( P = 0.04 , 0.02 and 0.007 , respectively ) . No significant changes were observed in these levels in the placebo group . Significant differences were observed in mean changes in the above-mentioned variables between the two groups ( P = 0.01 , 0.04 and 0.006 , respectively ) . No significant changes were found in serum adiponectin in the vitamin D and placebo groups ( P = 0.83 ) . Conclusions : Therapeutic dose of vitamin D can improve vitamin D status and glycemic indicators . But it seems that an 8-week intervention period was not sufficient to reveal the possible effects of vitamin D on serum adiponectin levels",
"Background : Nowadays Vitamin D deficiency is a notable medical condition world-wide and also in Iran . Since , vitamin D can have renoprotective effect by inhibiting the renin-angiotensin system ; it appears that low vitamin D level can worsen the renal injury in diabetic patients . This study demonstrates the effect of vitamin D3 therapy on reducing proteinuria in diabetic patients with concomitant diabetic nephropathy and vitamin D deficiency after controlling hypertension and use of angiotensin converting enzyme inhibitors ( ACEIs ) or angiotensin II type receptor blockers ( ARBs ) . Material s and Methods : In this r and omized double blinded parallel groups clinical trial , 51 diabetic patients with proven nephropathy and vitamin D deficiency/insufficiency and stable hypertension , dyslipidemia , and hyperglycemic treatment were enrolled . The patients were divided r and omly into two groups ( treatment and placebo group ) . Patients received oral vitamin D3 ( pearl 50000 IU ) or placebo one pearl every week for 12 weeks . Patients were assessed at baseline and 12 weeks after intervention from the point of 25(OH ) D level , and urine albumin/creatinine ration ( UACR ) . Results : Mean serum 25(OH ) D concentrations were 14.06 ng/ml and 16.05 ng/ml before treatment . Furthermore , after intervention , its levels were risen to 71.23 and 17.63 in drug and placebo groups , respectively . Whereas , UACR as the main variable did not change significantly after intervention in both groups ( P = 0.919 ) . Conclusion : According to our finding , there was not a decrease in proteinuria in diabetic patients who received vitamin D for a period of 3 months",
"Background : The aim of this study was survey of the effect of Vitamin D supplementation on the incidence of gestational diabetes ( GDM ) in pregnant women . Material s and Methods : This r and omized clinical trial was conducted at Alzahra and Shahid Beheshti Hospital in Isfahan , Iran , from January , 2013 to January , 2014 on 210 pregnant women referred to gynecology clinics . Serum levels of Vitamin D were measured , and those with lower serum levels of 10 nmol/L r and omly divided into two groups of A and B. Pregnant women with normal Vitamin D level assigned as Group C. Group A was given 50,000 IU Vitamin D supplement every 2 weeks for 10 weeks , and Group B were given the omega-3 pearl as placebo . Then , the incidence of GDM was measured in 24–26 weeks of pregnancy with glucose tolerance test and compared in three groups . Data were analyzed using SPSS version 20 by descriptive statistics , Chi-square and Logistic regression . Results : The mean age of participants was 24.76 years ( 8.02 st and ard deviation , range 16–36 years ) . The incidence of GDM at 24–26 weeks gestational age were 8.57 % in normal Vitamin D group , 10.00 % in Vitamin D deficiency with treatment group , and 11.43 % in Vitamin D deficiency without treatment group . The difference between groups in terms of incidence of GDM was not statistically significant ( P = 0.112 ) . Conclusion : Vitamin D supplementation had not effect on incidence of GDM during pregnancy",
"Purpose This study aim ed to evaluate the effect of daily consumption of vitamin D-fortified yogurt drink ( doogh ) in comparison with plain doogh on appetite-regulating hormones including leptin and ghrelin in type 2 diabetes ( T2D ) patients . Methods In a single blind r and omized clinical trial , subjects with T2D were r and omly allocated to one of the two groups and received either vitamin D3-fortified doogh ( FD ; containing 170 mg calcium and 500 IU/250 mL , n2 = 50 ) or plain doogh ( PD ; containing 170 mg calcium and no vitamin D/250 mL , n1 = 50 ) twice a day for 12 weeks . Leptin and ghrelin were evaluated at the beginning and after 12 weeks of intervention . Results The intervention result ed in a significant improvement of circulating 25(OH)D , fasting glucose , Quantitative Insulin Check Index ( QUICKI ) , hs-CRP , in FD compared with PD group . A significant rise in both serum leptin ( + 1.3 ± 7.2 mg/L ; p = 0.013 ) and ghrelin ( 10.1 ± 26.1 ng/L ; p = 0.012 ) was observed in FD group . A between-group difference for ghrelin changes ( p = 0.029 ) remained significant after adjusting for changes QUICKI ( p = 0.039 ) , body mass index ( p = 0.034 ) and hs-CRP ( p = 0.022 ) . Despite an increase in both leptin and ghrelin , leptin to ghrelin ( L/G ) ratio actually decreased in FD . Changes of L/G ratio showed a significant between-group difference ( p = 0.036 ) , which remained significant even after adjusting for changes of hs-CRP ( p = 0.028 ) and fat mass ( p = 0.047 ) but disappeared after adjusting for changes of QUICKI ( p = 0.42 ) . Conclusions Daily intake of vitamin D-fortified doogh may increase circulating leptin and ghrelin but L/G ratio may actually decrease . Our results suggest that improving vitamin D may result in an improvement in insulin sensitivity which may finally regulate beneficially appetite hormones . Further studies with adequate power are needed to confirm the results",
"BACKGROUND Both poor vitamin D status and oxidative stress ( OS ) have been independently associated with late diabetic complications , including cardiovascular disease ( CVD ) . The present study aim ed to examine the effect of daily intake of vitamin D alone or in combination with calcium as a fortified Persian yogurt drink ( doogh ) on OS over 12 weeks . METHODS Ninety patients with type 2 diabetes aged 30 - 50 years from both sexes were r and omly allocated to one of the three groups to receive two 250-mL bottles of doogh a day , which was either plain ( PD ; containing 150 mg per 250 mL of calcium and no detectable vitamin D ) , vitamin D-fortified ( DD ; containing 150 mg of calcium + 500 IU vitamin D per 250 mL ) or calcium-vitamin D-fortified ( CDD ; 250 mg od calcium + 500 IU vitamin D per 250 mL ) . RESULTS Although mean ( SD ) serum concentrations of protein carbonyl significantly decreased in both DD and CDD groups [ -2.07 ( 4.39 ) nm , P = 0.015 and -4.4 ( 7.64 ) nm , P = 0.003 , respectively ] , the change in PD group was not significant [ -0.54 ( 6.96 ) nm , P = 0.674 ] . A similar pattern was observed for cardiac myeloperoxidase [ PD : -19.4 ( 75.9 ) μg L(-1 ) , P = 0.173 ; DD : -21.8 ( 54.2 ) μg L(-1 ) , P = 0.035 , CDD : -48.5 ( 76.9 ) μg L(-1 ) , P = 0.002 ] . Superoxide dismutase increased significantly only in DD and CDD [ 56.9 ( 74.0 ) U L(-1 ) , P respectively ] . Changes of serum advanced glycation end-products showed a significant between-group difference among PD , DD and CDD [ 239.4 ( 388.4 ) U L(-1 ) , -58.1 ( 147.6 ) U L(-1 ) and -143.7 ( 475.9 ) U L(-1 ) × 10(3 ) , respectively , P = 0.003 ] , which remained significant after controlling for changes of fasting serum glucose ( P = 0.013 ) and glycated haemoglobin ( P = 0.015 ) . CONCLUSIONS The findings of the present study demonstrated an OS attenuating effect of vitamin D. However , extra calcium did not convey additional benefit",
"The renin-angiotensin system has a major role in the development of diabetic nephropathy ( DN ) . It is reported that vitamin D analogues are able to suppress renin excretion . Thus , this study was conducted to determine whether there is any correlation between albuminuria as a marker of DN with vitamin D levels in diabetic patients . Also , an assessment was made on the effects of vitamin D therapy on albuminuria in this group of patients . We conducted this cross-sectional study on 119 out patients with type-2 diabetes . The serum levels of 25-hydroxy vitamin D [ 25 ( OH ) D ] and the albumin to creatinine ratio were assessed in all the study patients . Patients with vitamin D deficiency/insufficiency received calcitriol therapy for eight weeks , following which the laboratory tests were repeated . The mean age of the study patients was 55.3 ± 11.2 years , 43 ( 36.13 % ) had vitamin D insufficiency [ 25 ( OH ) D . We found a significant correlation between 25 ( OH ) D levels and presence of microalbuminuria ( P = 0.04 ) in patients with vitamin D deficiency . Therapy with calcitriol had a beneficial effect on the albumin excretion rate , although this change was not significant ( P = 0.22 ) . However , the effects of calcitriol on reduction of diastolic blood pressure ( P = 0.004 ) , glycosylated hemoglobin ( P = 0.014 ) and levels of total cholesterol ( P = 0.019 ) , low-density lipoprotein ( 0.04 ) and high-density lipoprotein ( P = 0.001 ) was significant . Our study suggests that vitamin D deficiency has a negative effect on albuminuria in diabetic patients , and its replacement may be associated with a beneficial effect on the risk factors of DN , such as hyperlipidemia and hypertension",
"Aims /hypothesisThis study was design ed to assess the effects of calcium and vitamin D supplementation on the metabolic status of pregnant women with gestational diabetes mellitus ( GDM ) . Methods This r and omised placebo-controlled trial was performed at maternity clinics affiliated to Kashan University of Medical Sciences , Kashan , Iran . Participants were 56 women with GDM at 24–28 weeks ’ gestation ( 18 to 40 years of age ) . Subjects were r and omly assigned to receive calcium plus vitamin D supplements or placebo . All study participants were blinded to group assignment . Individuals in the calcium – vitamin D group ( n = 28 ) received 1,000 mg calcium per day and a 50,000 U vitamin D3 pearl twice during the study ( at study baseline and on day 21 of the intervention ) , and those in the placebo group ( n = 28 ) received two placebos at the mentioned times . Fasting blood sample s were taken at study baseline and after 6 weeks of intervention . Results The study was completed by 51 participants ( calcium – vitamin D n = 25 , placebo n = 26 ) . However , as the analysis was based on an intention-to-treat approach , all 56 women with GDM ( 28 in each group ) were included in the final analysis . After the administration of calcium plus vitamin D supplements , we observed a significant reduction in fasting plasma glucose ( −0.89 ± 0.69 vs + 0.26 ± 0.92 mmol/l , p ( −13.55 ± 35.25 vs + 9.17 ± 38.50 pmol/l , p = 0.02 ) and HOMA-IR ( −0.91 ± 1.18 vs + 0.63 ± 2.01 , p = 0.001 ) and a significant increase in QUICKI ( + 0.02 ± 0.03 vs −0.002 ± 0.02 , p = 0.003 ) compared with placebo . In addition , a significant reduction in serum LDL-cholesterol ( −0.23 ± 0.79 vs + 0.26 ± 0.74 mmol/l , p = 0.02 ) and total cholesterol : HDL-cholesterol ratio ( −0.49 ± 1.09 vs + 0.18 ± 0.37 , p = 0.003 ) and a significant elevation in HDL-cholesterol levels ( + 0.15 ± 0.25 vs −0.02 ± 0.24 mmol/l , p = 0.01 ) was seen after intervention in the calcium – vitamin D group compared with placebo . In addition , calcium plus vitamin D supplementation result ed in a significant increase in GSH ( + 51.14 ± 131.64 vs −47.27 ± 203.63 μmol/l , p = 0.03 ) and prevented a rise in MDA levels ( + 0.06 ± 0.66 vs + 0.93 ± 2.00 μmol/l , p = 0.03 ) compared with placebo . Conclusions /interpretationCalcium plus vitamin D supplementation in women with GDM had beneficial effects on their metabolic profile . Trial registration www.i rct .ir I RCT 201311205623N11 Funding The study was supported by a grant ( no. 92110 ) from Kashan University of Medical Sciences",
"CONTEXT To the best of our knowledge , no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics . OBJECTIVE This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes . METHODS Totally , 118 diabetic patients were enrolled in this r and omized , placebo-controlled clinical trial . After matching for age , sex , body mass index , type and dose of hypoglycemic agents , and duration of diabetes , subjects were r and omly assigned into 4 groups receiving the following : 1 ) 50000 IU/wk vitamin D + calcium placebo ; 2 ) 1000 mg/d calcium + vitamin D placebo ; 3 ) 50 000 IU/wk vitamin D + 1000 mg/d calcium ; or 4 ) vitamin D placebo + calcium placebo for 8 weeks . Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention . RESULTS Calcium ( changes from baseline : -75 ± 19 ng/ml , P = .01 ) and vitamin D alone ( -56 ± 19 ng/mL , P = .01 ) and joint calcium-vitamin D supplementation ( -92 ± 19 ng/mL , P = .01 ) result ed in a significant reduction in serum leptin levels compared with placebo ( -9 ± 18 ng/mL ) . This was also the case for serum IL-6 , such that calcium ( -2 ± 1 pg/mL , P and vitamin D alone ( -4 ± 1 pg/mL , P the calcium ( -3.1 ± 1.3 , P , vitamin D ( -3.1 ± 1.3 , P joint calcium-vitamin D groups ( -3.4 ± 1.3 , P reductions in serum TNF-α concentrations compared with placebo ( 0.1 ± 1.2 ) . Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels ( -1.14 ± 0.25 vs 0.02 ± 0.24 ng/mL , P = .09 ) . CONCLUSION Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF-α concentrations in vitamin D-insufficient people with type 2 diabetes",
"BACKGROUND Observational data suggest that low 25-hyroxyvitamin D is associated with cardiovascular disease ( CVD ) and its risk factors include diabetes , metabolic syndrome , insulin resistance , hypertension , microalbuminuria and inflammation . We examined the differences between risk factors of CVD before and after treatment with calcitriol in type 2 diabetic patients with vitamin D deficiency . METHODS This study was a clinical trial consisting of 119 type 2 diabetic patients . Forty three patients had vitamin D insufficiency ( 25 OH D less than 30 ng/dl ) who underwent calcitriol treatment with 0.5 microgram per day for 8 weeks . Blood pressure , fasting blood sugar ( FBS ) , glycosylated hemoglobin ( HbA1C ) , lipid profile , high sensitive C-reactive protein ( HsCRP ) , Homocysteine and albumin to creatinine ratio were measured , before and after the treatment period . Then the two sets of results were compared with each other . RESULTS Following treatment with calcitriol HbA1C , total cholesterol , low density lipoprotein(LDL ) , high density lipoprotein(HDL ) and diastolic blood pressure decreased significantly ( p = 0.01 , 0.01 , 0.04 , 0.001 and 0.04 respectively ) but the changes in other parameters were not significant . CONCLUSION Replacement of vitamin D may have a beneficial effect on some of the risk factors of CVD in diabetic patients",
"Objective : Cardiovascular disease ( CVD ) is the major morbidity and cause of death in diabetic subjects . Observational studies have shown the association of low vitamin D status with poor glycemic control , atherogenic lipid profile , and CVD . However , the possible link between circulating 25-hydroxycholecalciferol and apoproteins ( Apo A1 and B ) and the atherogenic lipoprotein ( a ) [ Lp(a ) ] has not been documented to date . Methods : Ninety subjects with type 2 diabetes ( T2D ) aged 30–60 years from both sexes were r and omly allocated to one of the 3 groups to receive 2 bottles a day of either ( 1 ) plain doogh ( PD ; containing 150 mg calcium and no detectable vitamin D/250 mL ) ; ( 2 ) vitamin D – fortified doogh ( DD ; containing 150 mg calcium and 500 IU vitamin D/250 mL ) ; or ( 3 ) calcium- and vitamin D – fortified doogh ( CDD ; containing 250 mg calcium and 500 IU vitamin D/250 mL ) for 12 weeks . Anthropometric , dietary , and laboratory assessment s , including Apo A1 , Apo B , and Lp(a ) , were done . Results : Improvement of vitamin D status in DD and CDD groups , compared to PD , result ed in a significant increase in Apo A1 ( mean changes 0.22 ± 0.38 , 0.20 ± 0.27 and 0.01 ± 0.35 g/L , respectively , p = 0.047 ) and a significant decrease in serum Lp(a ) ( mean changes −0.08 ± 0.30 , −0.08 ± 0.31 , and 0.14 ± 0.25 μmol/L , respectively , p = 0.011 ) . There was no significant difference between DD and CDD groups . Serum Apo B did not change significantly in any of the groups . Conclusions : Significant amelioration of serum Apo A1 and Lp(a ) following improvement of vitamin D status in T2D subjects may have preventive implication s against long-term diabetic complications , notably CVD . This trial was registered at Clinical Trials.gov as NTC01229891",
"Background : Since tumor necrosis factor-α ( TNF-α ) could be one of the risk factors at the development of diabetes complications ; as well as serum leptin deficiency is related to increased susceptibility to infections in diabetic patients , they are potential indices from the preventive medicine viewpoint . This study was conducted to represent the effect of supplemental vitamin D3 on serum leptin , TNF-α and adiposity in type 2 diabetic patients . Methods : In this r and omized double-blind placebo-controlled trial , study sample was selected through type 2 diabetic patients ( n = 51 ) . A total of 26 patients were orally supplemented by vitamin D3 ( 400 IU/d ) ( vitamin D group ) and 25 patients by placebo ( placebo group ) for 14 weeks . The blood glycated hemoglobin ( HbA1c ) and the serum ionized Ca , leptin , TNF-α , and serum 25-hydroxyvitamin D ( 25[OH ] D ) were measured at the two groups in the baseline and postintervention stages . Results : It was shown that despite of theplacebo group , serum 25(OH ) D and serum leptin was significantly increased ( P = 0.001 and P = 0.002 , respectively ) , while serum TNF-α was decreased significantly ( P = 0.001 ) in vitamin D group . The remaining parameters , including body fat mass and HbA1c had no alterations between baseline and postintervention stages in vitamin D group . Conclusions : This study may advocate vitamin D supplementation among type 2 diabetic patients due to its beneficial effects on prevention of diabetes complications",
"AIM This study was performed to determine the effect of a single , large , intramuscular injection of vitamin D post-partum on glucose tolerance and insulin resistance in women with gestational diabetes . METHODS Forty-five participants in a r and omized controlled trial on gestational diabetes mellitus were divided into an intervention group and a control group . Only subjects in the intervention group received one intramuscular injection of 300,000 IU of vitamin D3 . HbA(1c ) , serum 25-hydroxyvitamin D3 , fasting insulin and blood glucose , C-peptide , homeostasis model assessment insulin resistance index ( HOMA-IR ) , β-cell function , insulin sensitivity and the Quantitative Insulin Sensitivity Check Index ( QUICKI ) were measured at baseline and after 3 months of intervention . RESULTS Approximately 80 % of the mothers had a degree of vitamin D deficiency . Post-intervention , this was found in 4.2 and 71.4 % in the intervention and control groups , respectively . The medians of HOMA-IR indices before and after intervention were 0.6 and 0.5 ( P = 0.7 ) , respectively , in subjects in the intervention group , and 0.5 and 0.9 ( P = 0.01 ) in subjects in the control group . The mean of the QUICKI fell only in the control group ( P = 0.008 ) . In the control group , β-cell function increased by ~8 % ( P = 0.01 ) and insulin sensitivity decreased after 3 months ( P = 0.002 ) . Post-intervention , the median C-peptide decreased in the intervention group and increased in the control group , but the change was significant only in the control group ( P = 0.03 ) . CONCLUSIONS A single injection of 300,000 IU of vitamin D3 achieves a 3-month serum 25-hydroxyvitamin D range of 50 - 80 nmol/l and is an efficient , effective and safe procedure for improving the vitamin status and indices of insulin resistance in mothers with gestational diabetes after delivery",
"INTRODUCTION Type 2 diabetes is a major public health problem . Recent epidemiological evidence also points to a potential association of vitamin D insufficiency with adverse metabolic risks , including that for type 2 diabetes . SUBJECTS AND METHOD A double-blind r and omized placebo-controlled trial was carried out . Seventy subjects with type 2 diabetes , age 30 - 75 years old , were r and omly assigned in a double-blind fashion to two groups . One group received two capsules of calcitriol ( 0.25 μg 1,25-dihydroxy cholecalciferol per each capsule ) per day . The second group received placebo tablets . At the beginning , middle and the end of the 12 week supplementation trial , serum glucose , insulin , calcium and phosphorous , HbA1c and 25(OH ) vitamin D were measured . RESULTS There was no significant difference between two groups at baseline . At the end of the study , fasting plasma glucose increased in the control group ( p=0.038 ) , while it remained unchanged in calcitriol group . Level of insulin and HbA1c increased significantly in both groups ( p=0.013 and 0.0004 in treatment and control group ) . Regarding insulin resistance indices , there was a significant change in HOMA-IR and QUICKI in both groups ( p=0.023 and 0.002 in treatment and 0.001 and respectively ) . Insulin secretion as assessed by HOMA-%β , remained relatively unchanged in the control group , while it increased significantly in the treatment group at the end of study ( p=0.009 ) . CONCLUSION Vitamin D supplementation attenuated the increase in glycemia , and increased insulin secretion , but had no effect on insulin resistance",
"OBJECTIVE This study was performed to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on glucose metabolism and lipid concentrations in gestational diabetes ( GDM ) patients . METHODS This r and omized double-blind placebo-controlled clinical trial was done among 140 GDM patients . Participants were r and omly divided into 4 groups to receive : ( 1 ) 1000 mg omega-3 fatty acids containing 360 mg eicosapentaenoic acid and 240 mg docosahexaenoic acid ( DHA ) twice a day + vitamin D placebo ( n = 35 ) ; ( 2 ) 50,000 IU vitamin D every 2 weeks + omega-3 fatty acids placebo ( n = 35 ) ; ( 3 ) 50,000 IU vitamin D every 2 weeks + 1000 mg omega-3 fatty acids twice a day ( n = 35 ) , and ( 4 ) vitamin D placebo + omega-3 fatty acids placebo ( n = 35 ) for 6 weeks . RESULTS After 6 weeks of intervention , patients who received combined vitamin D and omega-3 fatty acids supplements compared with vitamin D , omega-3 fatty acids , and placebo had significantly decreased fasting plasma glucose ( -7.3 ± 7.8 , -6.9 ± 6.6 , -4.0 ± 2.5 , and + 1.0 ± 11.4 mg/dL , respectively , P ( -1.9 ± 1.9 , -1.3 ± 6.3 , -0.4 ± 6.3 , and + 2.6 ± 6.5 μIU/mL , respectively , P = .005 ) , homeostatic model of assessment for insulin resistance ( -0.7 ± 0.6 , -0.5 ± 1.4 , -0.2 ± 1.5 , and + 0.6 ± 1.5 , respectively , P index ( + 0.01 ± 0.01 , + 0.008 ± 0.02 , + 0.002 ± 0.02 , and -0.005 ± 0.02 , respectively , P = .001 ) . In addition , changes in serum triglycerides ( -8.2 ± 41.0 , + 7.6 ± 31.5 , + 3.6 ± 29.9 , and + 20.1 ± 29.6 mg/dL , respectively , P = .006 ) and very low-density lipoprotein cholesterol ( -1.6 ± 8.2 , + 1.5 ± 6.3 , + 0.8 ± 6.0 , and + 4.0 ± 5.9 mg/dL , respectively , P = .006 ) in the vitamin D plus omega-3 fatty acids group were significantly different from the changes in these indicators in the vitamin D , omega-3 fatty acids , and placebo groups . CONCLUSION Overall , vitamin D and omega-3 fatty acids co-supplementation for 6 weeks among GDM patients had beneficial effects on fasting plasma glucose , serum insulin levels , homeostatic model of assessment for insulin resistance , quantitative insulin sensitivity check index , serum triglycerides , and very low-density lipoprotein cholesterol levels ",
"Gestational diabetes mellitus ( GDM ) has been recognized as a significant risk factor for unfavorable pregnancy outcomes . Prevalence of vitamin D deficiency is highly prevalent among women with GDM . This study was design ed to assess the effect of vitamin D supplementation on pregnancy outcomes of pregnant women with GDM who were not on oral hypoglycemic agents . This r and omized controlled clinical trial was performed among 45 pregnant women diagnosed with GDM at 24 - 28 weeks ' gestation . Subjects were r and omly assigned to consume either vitamin D supplements ( cholecalciferol ) or placebo . Individuals in the vitamin D group ( n=22 ) received 50 000 IU vitamin D3 pearl 2 times during the study : at study baseline and day 21 of intervention and those in placebo group ( n=23 ) received 2 placebos at the mentioned times . Fasting blood sample s were taken at baseline to measure fasting plasma glucose . Participants underwent a 3-h oral glucose tolerance tests ( OGTT ) and the blood sample s were collected at time 60 , 120 , and 180 min to measure plasma glucose levels . Newborn 's weight , height , head circumference , Apgar score , and hyperbilirubinemia were determined . Taking vitamin D supplements , compared with placebo , result ed in improved pregnancy outcomes ; such that those in the vitamin D group had no case of polyhydramnios , while 17.4 % of subjects in placebo group had this condition ( p=0.04 ) . In addition , newborn 's hyperbilirubinemia was significantly lower in vitamin D group than that in placebo group ( 27.3 % vs. 60.9 % , p=0.02 ) . In conclusion , vitamin D supplementation for 6 weeks among pregnant women with GDM result ed in decreased maternal polyhydramnios and infant hyperbilirubinemia compared with placebo . Clinical trial registration number www.i rct .ir : I RCT 201305115623N7",
"Background : Up to 75 % of the risk of type 2 diabetes is attributable to obesity . Therefore , finding a way to control obesity can be useful for management of diabetes . Objective : This study was performed to assess the effects of vitamin D3 and calcium supplementation on anthropometric measurements and blood pressure in vitamin D insufficient people with type 2 diabetes . Methods : One hundred eighteen patients with diabetes were enrolled in this r and omized placebo-controlled clinical trial . All subjects were r and omly assigned into 4 groups receiving ( 1 ) 50,000 IU/wk vitamin D3 plus ( equal to 7143 IU/d ) calcium placebo ; ( 2 ) 1000 mg/d calcium plus vitamin D3 placebo ; ( 3 ) 50,000 IU/wk vitamin D3 ( equal to 7143 IU/d ) plus 1000 mg/d calcium ; or ( 4 ) vitamin D3 placebo plus calcium placebo for 8 weeks . Anthropometric measurements and blood pressure were assessed at study baseline and after 8 weeks of intervention . Results : A greater reduction in body mass index was observed in calcium plus vitamin D group than other groups ( p = 0.03 ) . Comparison of changes in waist circumference among 4 groups revealed no significant difference in crude model ( p = 0.21 ) and when the effect of confounders was taken into account ( p = 0.08 ) . Calcium supplementation result ed in a significant reduction in hip circumference compared to other groups ( p significantly decreased in the calcium plus vitamin D group compared to placebo ( −7.3 ± 8.7 mmHg vs 0.5 ± 8.2 mmHg ; p = 0.001 ) . However , calcium and vitamin D supplementation had no significant effects on diastolic blood pressure . Conclusion : Calcium – vitamin D3 cosupplementation can have beneficial effect on body mass index ( BMI ) , hip circumference , and systolic blood pressure in vitamin D – insufficient type 2 diabetics",
"We estimated proportions of different types of diabetes , comorbidities , treatment ( the use of oral glucose-lowering agents and insulin ) , control ( hyperglycemia , dyslipidemia and hypertension ) and chronic microvascular and macrovascular complications among people with diabetes presenting to the tertiary-care academic diabetes outpatient clinics in Iran . This study is the prospect i ve analysis of data ( n = 30,202 ) from the registry of university-affiliated adult outpatient diabetes clinics in the country during 2015–2016 . The proportions of type 1 diabetes , types 2 diabetes , and other types of diabetes were 11.4 % , 85.5 % , and 1.3 % , respectively . The frequencies of drug-naivety , use of oral agents , insulin monotherapy and insulin combination therapy were 2.9 % , 60.5 % , 11.5 % , and 25.1 % , respectively . Around 13.2 % , 11.9 % and 43.3 % of patients with diabetes had controlled hyperglycemia , hyperlipidemia and hypertension , respectively . The proportions of retinopathy , nephropathy , peripheral neuropathy , diabetic foot , and ischemic heart disease were 21.9 % , 17.6 % , 28.0 % , 6.2 % , and 23.9 % , respectively . Despite the wide availability of medications and insulin coverage in Iran , the estimated national control of hyperglycemia , hyperlipidemia and hypertension ( especially for young men and old women ) remains subpar . The present study further suggests that the frequencies of chronic vascular complications among patients with diabetes are relatively high in Iran"
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411655ec-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Stemless anatomic total shoulder arthroplasty ( TSA ) is used in the treatment of osteoarthritis of the shoulder joint and other degenerative shoulder diseases . It has several proposed advantages over stemmed TSA including increased bone preservation , decreased operative time , and easier removal at revision . METHODS A systematic search was conducted using MEDLINE , Embase , PubMed , and CENTRAL ( Cochrane Central Register of Controlled Trials ) to retrieve all relevant studies . RESULTS The literature search yielded 1417 studies , of which 22 were included in this review , with 962 patients undergoing stemless TSA . Stemless TSA led to significant improvements in range of motion and functional scores in all included studies . Meta- analysis of comparative studies between stemless and stemmed TSA identified no significant differences in postoperative Constant scores ( mean difference [ MD ] , 1.26 ; 95 % confidence interval [ CI ] , -3.29 to 5.81 points ; P = .59 ) or complication rates ( odds ratio , 1.79 ; 95 % CI , 0.71 - 4.54 ; P = .22 ) . Stemless TSA result ed in a significantly shorter operative time compared with stemmed TSA ( MD , -15.03 minutes ; 95 % CI , -23.79 to -6.26 minutes ; P = .0008 ) . Stemless TSA also result ed in significantly decreased intraoperative blood loss compared with stemmed TSA ( MD , -96.95 mL ; 95 % CI , -148.53 to -45.36 mL ; P = .0002 ) . CONCLUSION Stemless anatomic TSA result ed in similar functional outcomes and complication rates to stemmed TSA with decreased operative time and lower blood loss . Further research is required to investigate the long-term durability of the stemless implant
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"Background The aim of this study is to compare the functional midterm outcome of stemless shoulder prostheses with st and ard anatomical stemmed shoulder prostheses and to show that the STEMLESS results are comparable to the STEMMED with respect to active maximum range of shoulder motion ( ROM ) and Constant score ( CS ) . Methods Seventeen patients underwent total shoulder arthroplasty ( TSA ) in 25 shoulder joints . Stemless TSA was performed in 12 shoulder joints ( group STEMLESS ) , third-generation stemmed TSA in 13 shoulder joints ( group STEMMED ) . Functional results were documented using the CS . 3D-motion- analysis using the Heidelberg upper extremity model ( HUX ) was conducted to measure active maximum ( ROM ) . Results The group STEMLESS achieved a CS of 67.9 ( SD 12.0 ) points and the group STEMMED of 70.2 ( SD 5.8 points ) without significant difference between the groups ( p = 0.925 ) . The maximum ROM of the group STEMLESS , ascertained by 3-D-motion- analysis , was in forward flexion 125.5 ° ( SD 17.2 ° ) , in extension 49.4 ° ( SD 13.8 ° ) , in abduction 126.2 ° ( SD 28.5 ° ) and in external rotation 40.3 ° ( SD 13.9 ° ) . The maximum ROM of the group STEMMED , also ascertained by 3-D-motion analysis , was in forward flexion 135.0 ° ( SD 16.8 ° ) , in extension 47.2 ° ( SD 11.5 ° ) , in abduction 136.3 ° ( SD 24.2 ° ) and in external rotation 40.1 ° ( SD 12.2 ° ) . The maximum ROM of the STEMLESS group was lower in forward flexion and abduction , higher in extension and almost identical in external rotation . But there was no significant difference ( forward flexion p = 0.174 , extension p = 0.470 , abduction p = 0.345 , external rotation p = 0.978 ) . Conclusion Both types of shoulder prostheses achieve a similar and good active ROM and similar results in CS.Trial registration DRKS00013166 , retrospectively registered ,",
"Background Stemless shoulder arthroplasty is a fairly new concept . Clinical and radiological follow-up is essential to prove implant safety and concept . This prospect i ve single-centre study was performed to evaluate the influence of radiological changes on clinical mid-term outcome following stemless humeral head replacement with hollow screw fixation . Methods Short- and mid-term radiological and clinical evaluations were performed in 73 consecutive shoulders treated mainly for idiopathic and posttraumatic osteoarthritis with stemless humeral head arthroplasty including 40 hemi- ( HSA ) and 33 total shoulder arthroplasties ( TSA ) . Operating times of stemless implantations were compared to 110 stemmed anatomical shoulder prostheses . Appearances of humeral radiolucencies or radiological signs of osteolysis or stress shielding were assessed on st and ardized radiographs . Patients ’ clinical outcome was evaluated using the Constant score and patients ’ satisfaction was documented . Results Radiological changes , detected in 37.0 % , did not affect clinical outcome . Constant scores significantly improved from baseline to short and mid-term follow-up ( p satisfied with the procedure . No loosening of the humeral head component was detected during a mean follow-up of 58 months . Operating times were significantly shorter with stemless compared to stemmed implants ( p stemless humeral head replacement was not affected by radiological changes . Trial registration The institutional review board ( St. Vincent Hospital Vienna ; 201212_EK01 ; date of issue : 11.12.2012 ) approved the study . The trial was registered at Clinical Trials.gov ( NCT02754024 ) . Retrospective registration",
"BACKGROUND Several stemless shoulder implants are available on the market , but only a few studies have presented results with sufficient mid- to long-term follow-up . The present study evaluated clinical and radiologic outcomes 9 years after anatomic stemless shoulder replacement . METHODS This is a prospect i ve cohort study evaluating the stemless shoulder prosthesis since 2005 . Anatomic stemless shoulder replacement using a single prosthesis was performed in 49 shoulders ; 17 underwent total shoulder replacement , and 32 underwent hemiarthroplasty . Forty-three patients were clinical ly and radiologically monitored after a mean of 9 years ( range , 90 - 127 months ; follow-up rate , 88 % ) . The indications for shoulder replacement were primary osteoarthritis in 7 shoulders , post-traumatic in 24 , instability in 7 , cuff tear arthropathy in 2 , postinfectious arthritis in 1 , and revision arthroplasty in 2 . RESULTS The Constant-Murley Score improved significantly from 52 % to 79 % ( P The active range of motion also increased significantly for flexion from 101 ° to 118 ° ( P = .022 ) , for abduction from 79 ° to 105 ° ( P = .02 ) , and for external rotation from 21 ° to 43 ° ( P Radiologic evaluation revealed incomplete radiolucency in 1 patient without clinical significance or further intervention . No revision caused by loosening or countersinking of the humeral implant was observed . CONCLUSIONS The 9-year outcome after stemless shoulder replacement is comparable to that of third- and fourth-generation st and ard shoulder arthroplasty",
"BACKGROUND The aim of this prospect i ve multicenter study was to evaluate clinical and radiologic results of a new metaphyseal anchored system . This system features a different anchor geometry that potentially leads to better bony integration and less loosening . METHODS From November 2012 until December 2015 , 148 patients ( 151 shoulders ) were treated with the Sidus Stem-Free Shoulder System at 9 centers in Europe . The main indication was primary osteoarthritis ( 80.1 % ) . This analysis only includes patients diagnosed with primary osteoarthritis ( n = 121 ) . A clinical evaluation was performed using the Constant-Murley score , Subjective Shoulder Value , American Shoulder and Elbow Surgeons St and ardized Shoulder Assessment Form , and range of motion . Radiologic assessment was based on the occurrence of radiolucent lines and signs of implant migration , osteolysis , loosening , and heterotopic ossification . RESULTS We evaluated 105 patients after a follow-up period of 2 years . There were 53 women and 52 men . The average age was 64 years . Total shoulder arthroplasty was performed in 73 cases and hemiarthroplasty in 32 . The Constant-Murley score improved from 26 points preoperatively to 70 points at 2 years ' follow-up ( P Subjective Shoulder Value increased from 34 % to 84 % ( P American Shoulder and Elbow Surgeons St and ardized Shoulder Assessment Form increased from 34 points to 86 points ( P migration nor loosening was found . However , radiolucent lines of 2 mm or greater could be detected around the glenoid in 2 cases , but none of them have had clinical relevance yet . The overall complication rate was 6.7 % , and the revision rate was 0 % . CONCLUSION Patients with the Sidus Stem-Free Shoulder System achieve good clinical and radiologic short-term results that are comparable with the results of other stem-free shoulder implants",
"Aims The aims of this study were to investigate any possible relationship between a preoperative sensitivity to pain and the degree of pain at rest and on exertion with postoperative function in patients who underwent stemless total shoulder arthroplasty ( TSA ) . Patients and Methods In this prospect i ve study , we included 63 patients who underwent stemless TSA and were available for evaluation one year postoperatively . There were 31 women and 32 men ; their mean age was 71 years ( 53 to 89 ) . The pain threshold , which was measured using a Pain Matcher ( PM ) unit , the degree of pain ( visual analogue scale at rest and on exertion , and function using the short version of the Disabilities of the Arm , Shoulder and H and question naire ( QuickDASH ) , were recorded preoperatively , as well as three and 12 months postoperatively . Results We found an inverse relationship between both the preoperative PM threshold and pain ( VAS ) at rest and the 12‐month postoperative QuickDASH score ( Pearson correlation coefficient ( r ) ≥ 0.4 , p the preoperative PM threshold on the affected side and preoperative pain ( VAS ) at rest were the only factors associated with the QuickDASH score at 12 months . Conclusion These findings indicate the importance of central sensitization in the restoration of function after TSA . Further studies are required to investigate whether extra analgesia and rehabilitation could influence the outcome in at risk patients",
"BACKGROUND Anatomic total shoulder arthroplasty ( TSA ) and reverse total shoulder arthroplasty ( RTSA ) are increasingly common procedures employed to treat arthritic conditions . Although TSA is a widely accepted procedure for glenohumeral arthritis with intact rotator cuff , concerns about RTSA persist because of variable complication rates and outcomes . METHODS This is a prospect i ve , case-control study comparing outcomes and complications after TSA and RTSA . The study included 47 patients undergoing TSA for glenohumeral arthritis and 53 patients undergoing RTSA for rotator cuff tear arthropathy . Average clinical follow-up was more than 2 years in both groups . Major complications included infection , periprosthetic fracture , instability , glenoid loosening , and need for revision surgery . Patient outcome measures included the American Shoulder and Elbow Surgeons score , pain visual analog scale score , and goniometer-measured range of motion . Plain radiographs were review ed to assess for degree of glenoid lucency in TSA and scapular notching in RTSA . RESULTS At 2 years , there were no differences in rate of major complications ( TSA , 15 % ; RTSA , 13 % ; P = .808 ) or revision surgeries ( TSA , 11 % ; RTSA , 9 % ) . Outcomes assessed by the American Shoulder and Elbow Surgeons score and visual analog scale were also similar between the 2 groups . TSA patients had greater external rotation than RTSA patients did ( 53 ° vs 38 ° ; P = .001 ) . Otherwise , forward flexion , abduction , and internal rotation were comparable in range of motion . CONCLUSIONS TSA and RTSA have similar complication rates , need for revision , patient-reported outcomes , and range of motion at 2 years of follow-up . The use of side-by-side cohorts in this study allows st and ardized comparison between these 2 shoulder arthroplasty procedures",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"BACKGROUND This prospect i ve longitudinal study compared clinical and radiologic outcomes of total shoulder arthroplasty ( TSA ) using 3 different prosthetic design s , the Neer II system , the Bigliani-Flatow ( BF ) , and a stemless prosthesis , the Total Evolutive Shoulder System ( TESS ) . MATERIAL S AND METHODS Patients with advanced osteoarthritis of the glenohumeral joint who underwent TSA were followed up for 2 years . Four patient-oriented disability outcomes were used . The clinical data collected before surgery and at follow-up assessment s during a 2-year period included active range of motion ( ROM ) in 6 directions and strength . Radiographic signs of glenoid and humeral component loosening were recorded . The incidence of humeral head subluxation was documented . RESULTS Seventy-four patients completed the study . There was a significant improvement in the 4 disability measures , ROM , and strength at 2 years in all 3 groups ( P Active external rotation at 90 ° abduction was statistically significantly lower in the Neer II group ( P = .001 ) . The incidence of lucent lines around the glenoid component was higher in the Neer II group ( P = .0002 ) . No statistically significant relationship was seen between type of prosthesis and patient satisfaction ( P > 0.05 ) . CONCLUSIONS The 3 types of TSA prostheses used in this study all provided significant improvement in pain and function and were associated with high patient satisfaction . The Neer II was associated with less active external rotation and more lucent lines",
"BACKGROUND Stemmed humeral components have been used since the 1950s ; canal-sparing ( also known as stemless ) humeral components became commercially available in Europe in 2004 . The Simpliciti total shoulder system ( Wright Medical , formerly Tornier ) is a press-fit , porous-coated , canal-sparing humeral implant that relies on metaphyseal fixation only . This prospect i ve , single-arm , multicenter study was performed to evaluate the two-year clinical and radiographic results of the Simpliciti prosthesis in the U.S. METHODS One hundred and fifty-seven patients with glenohumeral arthritis were enrolled at fourteen U.S. sites between July 2011 and November 2012 in a U.S. Food and Drug Administration ( FDA ) Investigational Device Exemption (IDE)-approved protocol . Their range of motion , strength , pain level , Constant score , Simple Shoulder Test ( SST ) score , and American Shoulder and Elbow Surgeons ( ASES ) score were compared between the preoperative and two-year postoperative evaluations . Statistical analyses were performed with the Student t test with 95 % confidence intervals . Radiographic evaluation was performed at two weeks and one and two years postoperatively . RESULTS One hundred and forty-nine of the 157 patients were followed for a minimum of two years . The mean age and sex-adjusted Constant , SST , and ASES scores improved from 56 % preoperatively to 104 % at two years ( p The mean forward elevation improved from 103 ° ± 27 ° to 147 ° ± 24 ° ( p mean external rotation , from 31 ° ± 20 ° to 56 ° ± 15 ° ( p The mean strength in elevation , as recorded with a dynamometer , improved from 12.5 to 15.7 lb ( 5.7 to 7.1 kg ) ( p and the mean pain level , as measured with a visual analog scale , decreased from 5.9 to 0.5 ( p : infection , glenoid component loosening , and failure of a subscapularis repair . There was no evidence of migration , subsidence , osteolysis , or loosening of the humeral components or surviving glenoid components . CONCLUSIONS The study demonstrated good results at a minimum of two years following use of the Simpliciti canal-sparing humeral component . Clinical results including the range of motion and the Constant , SST , and ASES scores improved significantly , and radiographic analysis showed no signs of loosening , osteolysis , or subsidence of the humeral components or surviving glenoid components . LEVEL OF EVIDENCE Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence",
"Abstract Background Although several studies have been performed on the use of various devices in total shoulder arthroplasty ( TSA ) , no data are available in order to establish whether to prefer stemmed or stemless humeral components . Thus , the purpose of our study was to evaluate the short-term functional outcome in a cohort of subjects treated with TSA r and omized to treatment with stemmed or stemless prosthesis . Methods In this prospect i ve longitudinal study , we r and omized to treatment with stemmed ( group 1 ) or with stemless ( group 2 ) humeral component in nineteen subjects ( 2 M and 17 F ) diagnosed with humeral primary osteoarthritis with indication to TSA . We evaluated the range of movement of all the participants and the functional outcome using Constant score and simple shoulder test ( SST ) before and after 2 years from surgery . Results No differences were detected after 2 years from surgery in the two groups in terms of functional scores and range of motion ( p > 0.05 ) . ConclusionS temmed and stemless prostheses are comparable in terms of functional outcome . These data might be useful for the surgeon in order to choose more tissues-paring method ologies and less invasive procedures , such as stemless humeral implants",
"Aims The purpose of the present study was to evaluate the impact of intravenous tranexamic acid on the reduction of blood loss , transfusion rate , and early post‐operative clinical outcome in total shoulder arthroplasty . Patients and Methods A r and omised , placebo‐controlled trial which included 54 patients undergoing unilateral primary stemless anatomical or stemmed reverse total shoulder arthroplasty was undertaken . Patients received either 100 ml saline ( placebo , n = 27 ) , or 100 ml saline together with 1000 mg of tranexamic acid ( TXA , n = 27 ) intravenously prior to skin incision and during wound closure . Peri‐operative blood loss via an intra‐articular drain was recorded and total blood loss was calculated . The post‐operative transfusion rate was documented . Assessment of early clinical parameters included the visual analogue scale for pain ( VAS ) , documentation of haematoma formation and adverse events . Results Mean peri‐operative blood drainage ( placebo : 170 ml versus TXA : 50 ml , p = 0.001 ) and calculated mean total blood loss ( placebo : 1248.2 ml versus TXA : 871.0 ml , p = 0.009 ) were significantly lower in the TXA group . No transfusions were necessary during the study period in either group . Mean VAS for pain significantly decreased from pre‐operative ( VAS 7 ) to the early post‐operative period ( VAS 1.7 , p regarding mean post‐operative pain between placebo ( VAS 2.0 ) and TXA ( VAS 1.3 ) were detected ( p = 0.05 ) . The occurrence of haematomas was significantly more frequent in the placebo ( 59.3 % , n = 16 ) than in the TXA group ( 25.9 % , n = 6 , p = 0.027 ) . Whereas only mild haematomas developed in the TXA group , in the placebo group a total of 22.2 % ( n = 6 ) developed either moderate or severe haematomas . No adverse events associated with administration of TXA occurred . Conclusion Intravenous administration of TXA successfully reduced mean peri‐operative blood drainage , total estimated blood loss , pain during the first post‐operative days , and haematoma formation in total shoulder arthroplasty",
"BACKGROUND This study evaluated the functional and radiologic results of shoulder arthroplasty using a single type of stemless humeral head implant with a minimum follow-up of 5 years . METHODS Stemless shoulder arthroplasties in 78 patients at a mean age of 58 years were prospect ively evaluated at a mean clinical and radiologic follow-up of 72 months . Functional results were documented using the age- and sex-adjusted Constant score with st and ardized radiographic examination . RESULTS The Constant score improved significantly from 38.1 % to 75.3 % ( P ) . Active range of motion improved significantly for flexion ( from 114 ° to 141 ° ) , abduction ( from 74 ° to 130 ° ) , and external rotation ( from 25 ° to 44 ° ; P ) . Bone mineral density was reduced in 34.9 % of the older population , without an influence on shoulder function ( Constant score without lowering of bone density ; 73 % ; Constant score with lowering of bone density 80 % ; P = .404 ) . The overall complication rate was 12.8 % , with an overall revision rate of 9 % . None of the stemless implants were revised for loosening . CONCLUSION The functional and radiologic results of the stemless shoulder arthroplasty are comparable to the third and fourth generation of st and ard stem arthroplasty",
"Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument",
"Context : It is agreed that it is important to anatomically reproduce the proximal humeral anatomy when performing a prosthetic shoulder replacement . This can be difficult with a long stemmed prosthesis , in particular if there is little relationship of the metaphysis to the humeral shaft . The ‘ short stem ’ prosthesis can deal with this problem . Aims : A prospect i ve study assessed the results of total shoulder arthroplasty using a short stem humeral prosthesis , a ceramic humeral head , and a pegged cemented polyethylene glenoid . Material s and methods : Patients with primary shoulder osteoarthritis were recruited into this prospect i ve trial and pre-operatively had the ASES , Constant , SPADI , and DASH scores recorded . The patients were clinical ly review ed at the two weeks , eight weeks , one year , and two year mark with completion of a data form . Radiological evaluation was at the eight week , one year and two year follow-up . At the one and two year follow-up the satisfaction rating , the range of passive and active motion , Constant , ASES , SPADI , DASH and pain results were recorded and analysed with SPPS 20 . Results : During the study period 97 short stem , ceramic head total shoulder replacements were carried out . At the time of follow-up 12 were two years from operation and 38 one year from operation . Active elevation was overall mean 160 degrees . Constant scores were 76 at 1 year , and 86 at 2 years , ASES 88 and 93 , and satisfaction 96 % and 98 % respectively at one and 2 year follow up . There were no problems during insertion of the humeral prosthesis , or any radiolucent lines or movement of the prosthesis on later radiographs . Conclusion : The short stem prosthesis had no complications , and on follow up radiographs good bone fixation . These fairly short term clinical results were overall good",
"BACKGROUND The influence of preoperative rotator cuff fatty infiltration ( FI ) and muscle atrophy ( MA ) on the postoperative outcome of total shoulder arthroplasty ( TSA ) has only rarely been investigated and reported in the literature . We hypothesized that more FI and MA would be associated with a worse postoperative functional outcome . METHODS This prospect i ve cohort study included 63 patients ( 31 female and 32 male patients ; mean age , 71 years [ range , 53 - 89 years ; st and ard deviation , 7 years ] ) with primary osteoarthritis of the shoulder operated on with anatomic stemless TSA . Preoperatively and at 3 months and 1 year after the operation , the functional outcome ( QuickDASH [ short version of Disabilities of the Arm , Shoulder and H and question naire ] score ) and range of motion ( ROM ) ( goniometer ) and strength ( dynamometer ) for abduction at the scapular plane and for external rotation were measured . The degree of preoperative FI and MA was evaluated using computed tomography scans according to the Goutallier classification and Warner classification , respectively , for the supraspinatus and infraspinatus . RESULTS We found clinical ly and statistically significant improvements in functional outcome , strength , and ROM at both 3 months and 1 year of follow-up compared with those preoperatively . The Pearson correlation coefficient ( r ) showed significant correlations between preoperative supraspinatus and infraspinatus FI and MA and preoperative and 1-year postoperative shoulder abduction and external rotation strength but not ROM . However , we found no influence of the rotator cuff FI and MA on the functional outcome after TSA . CONCLUSION We demonstrated a significant correlation between rotator cuff FI and MA and strength but not ROM of the shoulder joint"
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BACKGROUND The Diabetes Prevention Program ( DPP ) study showed that weight loss in high-risk adults lowered diabetes incidence and cardiovascular disease risk . No prior analyses have aggregated weight and cardiometabolic risk factor changes observed in studies implementing DPP interventions in non research setting s in the United States . METHODS AND FINDINGS In this systematic review and meta- analysis , we pooled data from studies in the United States implementing DPP lifestyle modification programs ( focused on modest [ 5%-7 % ] weight loss through ≥150 min of moderate physical activity per week and restriction of fat intake ) in clinical , community , and online setting s. We reported aggregated pre- and post-intervention weight and cardiometabolic risk factor changes ( fasting blood glucose [ FBG ] , glycosylated hemoglobin [ HbA1c ] , systolic or diastolic blood pressure [ SBP/DBP ] , total [ TC ] or HDL-cholesterol ) . We search ed the MEDLINE , EMBASE , Cochrane Library , and Clinical trials.gov data bases from January 1 , 2003 , to May 1 , 2016 . Two review ers independently evaluated article eligibility and extracted data on study design s , population s enrolled , intervention program characteristics ( duration , number of core and maintenance sessions ) , and outcomes . We used a r and om effects model to calculate summary estimates for each outcome and associated 95 % confidence intervals ( CI ) . To examine sources of heterogeneity , results were stratified according to the presence of maintenance sessions , risk level of participants ( prediabetes or other ) , and intervention delivery personnel ( lay or professional ) . Forty-four studies that enrolled 8,995 participants met eligibility criteria . Participants had an average age of 50.8 years and body mass index ( BMI ) of 34.8 kg/m2 , and 25.2 % were male . On average , study follow-up was 9.3 mo ( median 12.0 ) with a range of 1.5 to 36 months ; programs offered a mean of 12.6 sessions , with mean participant attendance of 11.0 core sessions . Sixty percent of programs offered some form of post-core maintenance ( either email or in person ) . Mean absolute changes observed were : weight -3.77 kg ( 95 % CI : -4.55 ; -2.99 ) , HbA1c -0.21 % ( -0.29 ; -0.13 ) , FBG -2.40 mg/dL ( -3.59 ; -1.21 ) , SBP -4.29 mmHg ( -5.73 , -2.84 ) , DBP -2.56 mmHg ( -3.40 , 1.71 ) , HDL + 0.85 mg/dL ( -0.10 , 1.60 ) , and TC -5.34 mg/dL ( -9.72 , -0.97 ) . Programs with a maintenance component achieved greater reductions in weight ( additional -1.66 kg ) and FBG ( additional -3.14 mg/dl ) . Findings are subject to incomplete reporting and heterogeneity of studies included , and confounding because most included studies used pre-post study design s. CONCLUSIONS DPP lifestyle modification programs achieved clinical ly meaningful weight and cardiometabolic health improvements . Together , these data suggest that additional value is gained from these programs , reinforcing that they are likely very cost-effective
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"BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention",
"Purpose The objective was to take prevention from the clinic to the community by including a high-risk group and working with the community to tailor , enhance , deliver , and evaluate a community-based version of the Diabetes Prevention Program ’s ( DPP ) clinic-based lifestyle intervention . Methods This was a nonr and omized prospect i ve study using a single-group design . Study eligibility included a screening glucose value in the normal to prediabetes range with no current diagnosis of diabetes , overweight , not pregnant nor planning to become pregnant during study period , aged 18 to 65 , Latino , living in the study target communities , and no reported medical restrictions related to the program goals . A total of 69 individuals participated . The Healthy Living Program ( HLP ) was based on the DPP ’s 1-year intensive lifestyle program , was tailored and enhanced for a Latino community , and was delivered by community health workers . Anthropometric and paper and pencil measures were administered to examine program outcome at 6 months and 12 months . Results In general , results indicate statistically significant improvements in anthropometrics and many behavioral outcomes , particularly at 6 months . Participants demonstrated forward movement through the stages of change during the program . Conclusions Results support the effectiveness of the intervention and show that delivery of the translated version of the DPP ’s lifestyle intervention in the community by community residents holds promise as one strategy to reach people at increased risk of developing diabetes . Use of this translation model , including collaboration with community health workers , offers diabetes educators an opportunity to extend their reach into underserved communities",
"Asian Americans experience diabetes at a higher rate than non-Hispanic whites . Diabetes prevention programs using lifestyle interventions have been shown to produce beneficial results , yet there have been no culturally-tailored programs for diabetes prevention in the Korean community . We explore the impact and feasibility of a pilot Community Health Worker ( CHW ) intervention to improve health behaviors and promote diabetes prevention among Korean Americans using a r and omized controlled trial . Between 2011 and 2012 , a total of 48 Korean Americans at risk for diabetes living in New York City ( NYC ) participated in the intervention . Participants were allocated to treatment or control groups . A community-based participatory research approach guided development of the intervention , which consisted of 6 workshops held by CHWs on diabetes prevention , nutrition , physical activity , diabetes complications , stress and family support , and access to health care . Changes over 6 months were examined for clinical measurements ( weight , BMI , waist circumference , blood pressure , glucose , and cholesterol ) ; health behaviors ( physical activity , nutrition , food behaviors , diabetes knowledge , self-efficacy , and mental health ) ; and health access ( insurance and self-reported health ) . In this small pilot study , changes were seen in weight , waist circumference , diastolic blood pressure , physical activity nutrition , diabetes knowledge , and mental health . Qualitative findings provide additional context ual information that inform ways in which CHWs may influence health outcomes . These findings demonstrate that a diabetes prevention program can be successful among a Korean American population in NYC , and important insight is provided for ways that programs can be tailored to meet the needs of vulnerable population ",
"Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of 24.0 kg/m2 and of , respectively , by diet and exercise . In the intervention group , detailed instructions on lifestyle were repeated every 3 - 4 months during hospital visits . Diabetes was judged to have developed when two or more consecutive fasting plasma glucose ( FPG ) values exceeded 140 mg/dl . A 100 g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance . The subjects were seen in an ordinary outpatient clinic . The cumulative 4-year incidence of diabetes was 9.3 % in the control group , versus 3.0 % in the intervention group , and the reduction in risk of diabetes was 67.4 % ( P Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group ( P decrease in body weight . The incidence of diabetes was positively correlated with the changes in body weight , and the improvement in glucose tolerance was negatively correlated . Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG . Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes , but the differences were not significant . Subjects with a low insulinogenic index ( DeltaIRI/DeltaPG 30 min after an oral glucose load ) developed diabetes at a significantly higher rate than those with a normal insulinogenic index . Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values , with the exception of the DaQing Study . However , the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI , suggesting that the effect of lifestyle intervention can not be solely ascribed to the body weight reduction . We conclude that lifestyle intervention aim ed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting",
"BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426",
"Background : Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical setting s is needed . Objective : The objective of this study was to examine the reach , implementation , and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners ( NPs ) for adults at risk of type 2 diabetes . Methods : The NP sites ( n = 4 ) were r and omized to an enhanced st and ard care program ( one NP and one nutrition session ) or a lifestyle program ( enhanced st and ard care and six NP sessions ) . These NPs recruited adults at risk of diabetes from their practice ( n = 58 ) , with an acceptance rate of 70 % . Results : The program reached a diverse , obese , and moderately low income sample . The NPs were able to successfully implement the protocol s. The average length of the program was 9.3 months . Attendance was high ( 98 % ) , and attrition was low ( 12 % ) . The NPs were able to adopt the educational , behavioral , and psychosocial strategies of the intervention easily . Motivational interviewing was more difficult for NPs . Mixed-model repeated- measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior . Participants of the lifestyle program demonstrated trends for better high-density lipoprotein ( HDL ) and exercise behavior compared with the enhanced st and ard care participants . Twenty-five percent of lifestyle participants met treatment goals of 5 % weight loss compared with 11 % of st and ard care participants . Discussion : A lifestyle program can be implemented in primary care by NPs , reach the targeted population , and be modestly successful . Further research is indicated",
"Introduction Although lifestyle interventions are effective in delaying the onset of diabetes , translating these lessons to routine health care setting s remains a challenge . We investigated the effectiveness of a theory-based , brief , small-group weight loss intervention for diabetes prevention . A secondary purpose was to determine the potential reach of the intervention . Methods A total of 14,379 members of an integrated health care organization newly diagnosed with prediabetes were potentially eligible to participate in this matched cohort longitudinal study . Of this group , 1,030 attended a 90-minute , small-group session that targeted personal action planning for healthful eating , physical activity , and weight management . We accessed electronic medical records to select 1 to 2 controls ( matched on impaired fasting glucose measurement , sex , age , and body mass index ) for each member who attended the small-group session ( n = 760 ) . Weight change , as recorded in the medical record , was the primary outcome . Mixed models analyses were used to adjust for matching variables and covariates and to account for individual r and om effects over time . Results Small-group participants lost significantly more weight than did their matched controls . A significantly higher proportion of small-group participants lost at least 5 % of their body weight compared with controls . Conclusion A brief , small-group weight loss intervention was effective . However , it did not reach broadly into the population that was at risk for diabetes",
"Objective To evaluate the use and effectiveness of two “ in-home ” strategies for delivering diabetes prevention programming using cable television . Methods An individually r and omized , two-arm intervention trial including adults with diabetes risk factors living in two US cities . Interventions involved a 16-session lifestyle intervention delivered via “ video-on-dem and ” cable television , offered alone versus in combination with web-based lifestyle support tools . Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight . Results A total of 306 individuals were r and omized and offered the interventions . After 5 months , 265 ( 87 % ) participants viewed at least 1 , and 110 ( 36 % ) viewed ≥9 of the video episodes . A total of 262 ( 86 % ) participants completed a 5-month weight measurement . In intention-to-treat analysis with imputation of missing observations , mean weight loss at 5 months for both treatment groups combined was 3.3 % ( 95 % CI 0.7 - 5.0 % ) , regardless of intervention participation ( with no differences between r and omized groups ( P = 0.19 ) ) , and was 4.9 % ( 95 % CI 2.1 - 6.5 % ) for participants who viewed ≥9 episodes . Conclusions In-home delivery of evidence -based diabetes prevention programming in a reality television format , offered with or without online behavioral support tools , can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content",
"OBJECTIVE —The objective of this study was to determine if a community-based modified Diabetes Prevention Program Group Lifestyle Balance ( GLB ) intervention , for individuals with metabolic syndrome , was effective in decreasing risk for type 2 diabetes and cardiovascular disease ( CVD ) in an urban medically underserved community , and subsequently to determine if improvements in clinical outcomes could be sustained in the short term . RESEARCH DESIGN AND METHODS —This nonr and omized prospect i ve intervention study used a one-group design to test the effectiveness of a community-based GLB intervention . Residents from 11 targeted neighborhoods were screened for metabolic syndrome ( n = 573 ) and took part in a 12-week GLB intervention ( n = 88 ) that addressed safe weight loss and physical activity . RESULTS —A marked decline in weight ( 46.4 % lost ≥5 % and 26.1 % lost ≥7 % ) was observed in individuals after completion of the intervention . Of these subjects , 87.5 % ( n = 28 ) and 66.7 % ( n = 12 ) sustained the 5 % and 7 % reduction , respectively , at the 6-month re assessment . Over one-third of the population ( 43.5 % , n = 30 ) experienced improvements in one or more component of metabolic syndrome , and 73.3 % ( n = 22 ) sustained this improvement at the 6-month re assessment . Additional improvements occurred in waist circumference ( P ) and blood pressure levels ( P = 0.04 ) after adjustment for age , sex , race , mean number of GLB classes attended , and time . CONCLUSIONS —Adults in an urban medically underserved community can decrease their risk for type 2 diabetes and CVD through participation in a GLB intervention , and short-term sustainability is feasible . Future research will include long-term follow-up of these subjects",
"Type 2 diabetes mellitus is increasing worldwide largely as a result from increasing obesity and sedentary lifestyle . The Finnish Diabetes Prevention Study ( DPS ) is the first individually r and omized controlled clinical trial to test the feasibility and efficacy of lifestyle modification in high-risk subjects . We r and omly assigned 522 ( 172 men , 350 women ) middle-aged ( mean age 55 yr ) , overweight ( mean body mass index 31 kg/m(2 ) ) subjects with impaired glucose tolerance either to the lifestyle intervention or control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight and intake of total and saturated fat , and increasing intake of fiber and physical activity . An oral glucose tolerance test was performed annually to detect incident cases of diabetes and to measure changes in metabolic parameters . The mean ( + /- SD ) weight reduction from baseline to year 1 and to year 2 , respectively , was 4.2 + /- 5.1 kg and 3.5 + /- 5.5 in the intervention group and 0.8 + /- 3.7 kg and 0.8 + /- 4.4 in the control group ( P risk of diabetes was reduced by 58 % ( P reduction in the incidence of diabetes was directly associated with number and magnitude of lifestyle changes made . In conclusion , the DPS is the first controlled trial demonstrating that type 2 diabetes can be prevented by changes in lifestyle in high-risk subjects",
"CONTEXT Weight loss programs on the Internet appear promising for short-term weight loss but have not been studied for weight loss in individuals at risk of type 2 diabetes ; thus , the longer-term efficacy is unknown . OBJECTIVE To compare the effects of an Internet weight loss program alone vs with the addition of behavioral counseling via e-mail provided for 1 year to individuals at risk of type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized controlled trial conducted from September 2001 to September 2002 in Providence , RI , of 92 overweight adults whose mean ( SD ) age was 48.5 ( 9.4 ) years and body mass index , 33.1 ( 3.8 ) . INTERVENTIONS Participants were r and omized to a basic Internet ( n = 46 ) or to an Internet plus behavioral e-counseling program ( n = 46 ) . Both groups received 1 face-to-face counseling session and the same core Internet programs and were instructed to su bmi t weekly weights . Participants in e-counseling su bmi tted calorie and exercise information and received weekly e-mail behavioral counseling and feedback from a counselor . MAIN OUTCOME MEASURES Measured weight and waist circumference at 0 and 12 months . RESULTS Intent-to-treat analyses showed the behavioral e-counseling group lost more mean ( SD ) weight at 12 months than the basic Internet group ( -4.4 [ 6.2 ] vs -2.0 [ 5.7 ] kg ; P = .04 ) , and had greater decreases in percentage of initial body weight ( 4.8 % vs 2.2 % ; P = .03 ) , body mass index ( -1.6 [ 2.2 ] vs -0.8 [ 2.1 ] ; P = .03 ) , and waist circumference ( -7.2 [ 7.5 ] vs -4.4 [ 5.7 ] cm ; P = .05 ) . CONCLUSION Adding e-mail counseling to a basic Internet weight loss intervention program significantly improved weight loss in adults at risk of diabetes",
"OBJECTIVES Our community-academic partnership employed community-based participatory research to develop and pilot a simple , peer-led intervention to promote weight loss , which can prevent diabetes and eliminate racial/ethnic disparities in incident diabetes among overweight adults with prediabetes . METHODS We recruited overweight adults at community sites , performed oral glucose tolerance testing to identify persons with blood glucose levels in the prediabetes range , and r and omized eligible people to a peer-led lifestyle intervention group or delayed intervention in 1 year . Outcomes , including weight , blood pressure , and health behaviors , were measured at baseline and 3 , 6 , and 12 months . RESULTS More than half of those tested ( 56 % , or 99 of 178 ) had prediabetes and enrolled in the study . Participants were predominantly Spanish-speaking , low-income , undereducated women . The intervention group lost significantly more weight than the control group and maintained weight loss at 12 months ( 7.2 versus 2.4 pounds ; P to diabetes . CONCLUSIONS In underserved minority communities , prediabetes prevalence may be higher than previously reported . Low-cost , community-based interventions can succeed in encouraging weight loss to prevent diabetes",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"Purpose The purpose of this study was to evaluate the efficacy of Prevent , an online social network-based translation of the Diabetes Prevention Program ( DPP ) lifestyle intervention , against the Centers for Disease Control and Prevention ( CDC ) Diabetes Prevention and Recognition Program ( DPRP ) outcome st and ards and weight loss outcomes of other DPP translations . Methods Two hundred twenty participants previously diagnosed with prediabetes were recruited online and enrolled in Prevent , a DPP-based group lifestyle intervention that integrates a private online social network , weekly lessons , health coaching , and a wireless scale and pedometer . Participants underwent a core 16-week intensive lifestyle change intervention and were then offered to continue with a post-core lifestyle change maintenance intervention , with the entire intervention ( core plus post-core ) totaling 12 months . Results One hundred eighty-seven participants met inclusion criteria for the core program and achieved an average of 5.0 % and 4.8 % weight loss at 16 weeks and 12 months , respectively . They also had a 0.37 % reduction in their A1C level at final measurement . One hundred forty-four of these same participants also met inclusion criteria for the post-core program and achieved an average of 5.4 % and 5.2 % weight loss at 16 weeks and 12 months , respectively , and a 0.40 % reduction in A1C at final measurement . Conclusion Results indicate that Prevent meets CDC DPRP outcome st and ards for diabetes prevention programs and performs favorably to other DPP translations . Considering national initiatives to address the obesity and diabetes epidemics , online delivery platforms like Prevent offer an effective and scalable solution",
"The purpose of this study was to determine if the U.S. National Institutes of Health Diabetes Prevention Program ( DPP ) could be successfully implemented in a worksite setting . Thirty-seven adult employees of BD Medical Systems of S and y , Utah were enrolled in a single-group time-series study using the DPP . Two-hour oral glucose tolerance tests ( OGTT ) and other outcomes were measured at baseline , 6 months , and 12 months . Weight , body mass index , waist circumference , 2-hour OGTT , very low density lipoproteins , triglycerides , and aerobic fitness were significantly improved at 6 and 12 months and showed overall significant improvement across time . Fasting blood insulin , total cholesterol , low density lipoproteins , and total cholesterol/high density lipoproteins ratio were significantly improved at 6 months , but not at 12 months . Eighteen of the program participants ( 51 % ) were no longer in the pre-diabetes and diabetes categories after 1 year . Existing worksite health promotion and occupational health professionals can successfully offer the DPP and help employees improve glucose tolerance",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"Summary From a previously reported 5-year screening programme of 6,956 47–49-year-old Malmö males , a series of 41 subjects with early-stage Type 2 ( non-insulin-dependent ) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospect i ve study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes . A 5-year protocol , including an initial 6-months ( r and omised ) pilot study , consisting of dietary treatment and /or increase of physical activity or training with annual check-ups , was completed by 90 % of subjects . Body weight was reduced by 2.3–3.7 % among participants , whereas values increased by 0.5–1.7 % in non-intervened subjects with impaired glucose tolerance and in normal control subjects ( p oxygen uptake ( ml · min−1 · kg−1 ) was increased by 10–14 % vs decreased by 5–9 % , respectively ( p was normalized in > 50 % of subjects with impaired glucose tolerance , the accumulated incidence of diabetes was 10.6 % , and more than 50 % of the diabetic patients were in remission after a mean follow-up of 6 years . Blood pressure , lipids , and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved . Improvement in glucose tolerance was correlated to weight reduction ( r=0.19 , p ) and increased fitness ( r=0.22 , p ) . Treatment was safe , and mortality was low ( in fact 33 % lower than in the remainder of the cohort ) . We conclude that long-term intervention in the form of diet and physical exercise is feasible even on a large scale , and that substantial metabolic improvement can be achieved which may contribute to prevent or postpone manifest diabetes",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"OBJECTIVE To pilot test the feasibility and effectiveness of interactive voice response ( IVR ) calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes . METHODS Participants ( N=77 ) who engaged in a 90-min diabetes prevention class were r and omly assigned to receive IVR support targeting physical activity and nutrition weight loss strategies or to a no-contact control . Physical activity , dietary intake , and body weight were assessed prior to and following the 3-month intervention . RESULTS Eighty-five percent of the intervention participants completed at least half of the intervention . Participants assigned to receive the intervention lost an average of 2.6 % of body weight during the 3 months while control participants lost an average of 1.6 % . To determine the effect of the calls when used we found that those who used the system lost approximately 3 % of body weight which approached significance when compared to controls ( p IVR holds promise for follow-up encounters with patients with pre-diabetes . PRACTICE IMPLICATION S IVR can be used to provide physical activity and nutrition counseling that can enhance the potential reach and effectiveness of health professionals working with patients who have diabetes while placing a minimal burden on financial re sources and staff time",
"OBJECTIVES We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program ( DPP ) lifestyle intervention . METHODS Between July 2008 and November 2010 , we individually r and omized 509 overweight or obese , low-income , nondiabetic adults with elevated blood glucose in Indianapolis , Indiana , to receive st and ard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP ( YDPP ) . Primary outcome was mean weight loss difference at 12 months . In our intention-to-treat analyses , we used longitudinal linear or logistic regression , multiply imputing missing observations . We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons . RESULTS In the YDPP arm , 161 ( 62.6 % ) participants attended ≥ 1 lesson and 103 ( 40.0 % ) completed 9 or more lessons . In intention-to-treat analysis , mean 12-month weight loss was 2.3 kilograms ( 95 % confidence interval [ CI ] = 1.1 , 3.4 kg ) more for the YDPP arm than for st and ard care participants . In instrumental variable analyses , persons attending 9 or more lessons had a 5.3-kilogram ( 95 % CI = 2.8 , 7.9 kg ) greater weight loss than did those with st and ard care alone . CONCLUSIONS The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults",
"OBJECTIVE To describe the costs of the Diabetes Prevention Program ( DPP ) interventions to prevent or delay type 2 diabetes . RESEARCH DESIGN AND METHODS We describe the direct medical costs , direct nonmedical costs , and indirect costs of the placebo , metformin , and intensive lifestyle interventions over the 3-year study period of the DPP . Re source use and cost are summarized from the perspective of a large health system and society . Research costs are excluded . RESULTS The direct medical cost of laboratory tests to identify one subject with impaired glucose tolerance ( IGT ) was $ 139 . Over 3 years , the direct medical costs of the interventions were $ 79 per participant in the placebo group , $ 2,542 in the metformin group , and $ 2,780 in the lifestyle group . The direct medical costs of care outside the DPP were $ 272 less per participant in the metformin group and $ 432 less in the lifestyle group compared with the placebo group . Direct nonmedical costs were $ 9 less per participant in the metformin group and $ 1,445 greater in the lifestyle group compared with the placebo group . Indirect costs were $ 230 greater per participant in the metformin group and $ 174 less in the lifestyle group compared with the placebo group . From the perspective of a health system , the cost of the metformin intervention relative to the placebo intervention was $ 2,191 per participant and the cost of the lifestyle intervention was $ 2,269 per participant over 3 years . From the perspective of society , the cost of the metformin intervention relative to the placebo intervention was $ 2,412 per participant and the cost of the lifestyle intervention was $ 3,540 per participant over 3 years . CONCLUSIONS The metformin and lifestyle interventions are associated with modest incremental costs compared with the placebo intervention . The evaluation of costs relative to health benefits will determine the value of these interventions to health systems and society",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"OBJECTIVE The Diabetes Prevention Program ( DPP ) demonstrated that intensive lifestyle and metformin interventions reduced the incidence of type 2 diabetes compared with a placebo intervention . The aim of this study was to assess the cost-effectiveness of the lifestyle and metformin interventions relative to the placebo intervention . RESEARCH DESIGN AND METHODS Analyses were performed from a health system perspective that considered direct medical costs only and a societal perspective that considered direct medical costs , direct nonmedical costs , and indirect costs . Analyses were performed with the interventions as implemented in the DPP and as they might be implemented in clinical practice . RESULTS The lifestyle and metformin interventions required more re sources than the placebo intervention from a health system perspective , and over 3 years they cost approximately US dollars 2250 more per participant . As implemented in the DPP and from a societal perspective , the lifestyle and metformin interventions cost US dollars 24400 and US dollars 34500 , respectively , per case of diabetes delayed or prevented and US dollars 51600 and US dollars 99200 per quality -adjusted life-year ( QALY ) gained . As the interventions might be implemented in routine clinical practice and from a societal perspective , the lifestyle and metformin interventions cost US dollars 13200 and US dollars 14300 , respectively , per case of diabetes delayed or prevented and US dollars 27100 and US dollars 35000 per QALY gained . From a health system perspective , costs per case of diabetes delayed or prevented and costs per QALY gained tended to be lower . CONCLUSIONS Over 3 years , the lifestyle and metformin interventions were effective and were cost-effective from the perspective of a health system and society . Both interventions are likely to be affordable in routine clinical practice , especially if implemented in a group format and with generic medication pricing",
"OBJECTIVES The purpose of this study was to determine the feasibility of implementing a diabetes prevention program ( DPP ) in a rural African-American church . METHODS A six-session DPP , modeled after the successful National Institutes of Health ( NIH ) DPP , was implemented in a rural African-American church . Adult members of the church identified as high risk for diabetes , based on results of a risk question naire , were screened with a fasting glucose . Persons with prediabetes , a fasting glucose of 100 - 125 mg/dL , participated in the six-session , Lifestyle Balance Church DPP . The primary outcomes were attendance rates and changes in fasting glucose , weight and body mass index measured at baseline , six- and 12-month follow-up . RESULTS Ninety-nine adult church members were screened for diabetes risk . Eleven had impaired fasting glucose . Ten of 11 participated in the six-session intervention , for an attendance rate of 78 % . After the intervention and 12-month follow-up , there was a mean weight loss of 7.9 lbs and 10.6 lbs , respectively . CONCLUSIONS This pilot project suggests that a modified six-session DPP can be translated to a group format and successfully implemented in a church setting . Further r and omized studies are needed to determine the effectiveness of such an intervention",
"OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population",
"OBJECTIVE To up date outcomes of the Diet-Exercise-Activity-Lifestyle ( DEAL ) program , a clinic-based diabetes prevention intervention . METHODS Changes in weight , fasting blood glucose , and 2-hour glucose after a 75-g oral glucose tolerance test were evaluated in patients who enrolled in the DEAL program between January 2007 and August 2009 . RESULTS The 221 qualified participants had a mean age of 62 years , weight of 87.4 kg , body mass index of 31.2 kg/m² , fasting glucose level of 109 mg/dL , and 2-hour glucose value of 138 mg/dL. Among the program participants , 67 % were women and 88 % were white ; 56 % had isolated impaired fasting glucose , 5 % had impaired glucose tolerance only , and 39 % had both . The 6-month follow-up medical appointment was kept by 72 % of program participants , but only 56 % attended the 12-month visit . By 6 months after baseline , 59 % had significantly lower fasting glucose concentrations , 59 % had improvement in 2-hour glucose levels , and 61 % had weight loss . Nearly 40 % , however , were nonresponders and had increased fasting glucose , 2-hour glucose , and weight by 6 months . By the 12-month visit , significant declines in fasting glucose ( P ) , 2-hour glucose ( P ) , and weight ( P = .008 ) occurred in comparison with baseline values ; however , no significant changes occurred in these measures between the 6- and 12-month visits ( P>.30 for all ) . CONCLUSION Most DEAL participants showed improvement in glucose levels and weight , but some patients exhibited worsening glucose intolerance . Factors underlying nonresponse need to be identified . Ongoing experience and analysis should help revise the DEAL program so that outcomes for all participating patients will improve",
"Purpose This article reports the results of a community-based , culturally tailored diabetes prevention program for overweight Mexican American adults on weight loss , waist circumference , diet and physical activity self-efficacy , and diet behaviors . Methods The intervention used content from the Diabetes Prevention Program but culturally tailored the delivery methods into a community-based program for Spanish-speaking adults of Mexican descent . The design was a r and omized controlled trial ( N = 58 ) comparing the effects of a 5-month educational intervention with an attention control group . The primary study outcome was weight loss . Secondary outcomes included change in waist circumference , body mass index , diet self-efficacy , and physical activity self-efficacy . Results There were significant intervention effects for weight , waist circumference , body mass index , and diet self-efficacy , with the intervention group doing better than the control group . These effects did not change over time . Conclusions Findings support the conclusion that a community-based , culturally tailored intervention is effective in reducing diabetes risk factors in a 5-month program",
"BACKGROUND The Diabetes Prevention Program ( DPP ) demonstrated that lifestyle intervention reduces risk for type 2 diabetes and the metabolic syndrome . A universal framework for translation of multiple aspects of the DPP intervention , including training , support , and evaluation is needed to enhance treatment fidelity in a variety of setting s. PURPOSE This study aims to develop a comprehensive model for diabetes prevention translation using a modified DPP lifestyle intervention . METHODS The DPP lifestyle intervention was adapted to a 12-session group-based program called Group Lifestyle Balance for implementation in the community setting . A model for training and support mirroring that of the DPP was developed for prevention professionals administering the program . The process of training/support and program implementation was evaluated for feasibility and effectiveness using a nonr and omized prospect i ve design in two phases ( N=51 , Phase 1 : 2005 - 2006 ; N=42 , Phase 2 : 2007 - 2009 ; data analysis completed 2008 - 2009 ) . A total of 93 nondiabetic individuals with BMI > or=25 kg/m(2 ) and the metabolic syndrome or prediabetes participated . Measures were collected at baseline and post-intervention for all and 6 and 12 months post-intervention for Phase 2 . RESULTS Significant decreases in weight , waist circumference , and BMI were noted in both phases from baseline . Participants in Phase 2 also demonstrated decreases in total cholesterol , non-HDL cholesterol , and systolic and diastolic blood pressure that were maintained at 12 months . Average combined weight loss for both groups over the course of the 3-month intervention was 7.4 pounds ( 3.5 % relative loss , p weight loss , respectively . More than 80 % of those achieving 7 % weight loss in the Phase-2 group maintained their weight loss at 6 months . CONCLUSIONS A comprehensive diabetes prevention model for training , intervention delivery , and support was shown to be successful and was effective in reducing diabetes and cardiovascular disease risk factors in this group of high-risk individuals",
"BACKGROUND Programmes for lifestyle change are aim ed at improving health but little is known about their effectiveness in clinical setting s. The Veterans Health Administration ( VA ) MOVE ! lifestyle change programme is the largest in the USA . We investigated whether participation in MOVE ! is associated with reduced incidence of diabetes . METHODS We did a retrospective observational analysis of data from VA data bases in overweight patients and obese patients with a weight-related disorder who had undergone at least 3 years of continuous outpatient care in 2005 - 12 . We used generalised estimating equations to assess characteristics associated with MOVE ! participation , and Cox 's proportional hazards regression to analyse the association between participation and diabetes incidence . FINDINGS Of 1·8 million eligible individuals , 238 540 ( 13 % ) participated in the MOVE ! programme . 19 367 ( 1 % overall , 8 % of participants ) met criteria for intense and sustained participation ( at least eight sessions within 6 months over at least a 4-month span ) , which was associated with greater weight loss at 3 years than low-intensity or no participation ( -2·2 % vs -0·64 % or 0·46 % ) . Compared with non-participation , incidence of diabetes was reduced by intense and sustained participation ( hazard ratio 0·67 , 95 % CI 0·61 - 0·74 ) and low-intensity participation ( 0·80 , 0·77 - 0·83 ) in MOVE!. These patterns were consistent across sex , ethnic origin , and age . Participation was most beneficial in patients with high BMI or high r and om glucose concentrations at baseline ( both pinteraction Participation in the MOVE ! programme was associated with weight loss and reduced incidence of diabetes , but the rate of participation was low and , therefore , selection bias could have exaggerated these effects . FUNDING US Department of Veterans Affairs , National Institutes of Health",
"Purpose With growing numbers of people at risk for diabetes and cardiovascular disease , diabetes educators report increasing referrals for intervention in prevention of these conditions . Diabetes educators have expertise in diabetes self-management education ; however , they are generally not prepared for delivery of chronic disease primary prevention . The purpose of this project was to determine if individuals at risk for diabetes who participate in an intervention delivered by trained diabetes educators in existing diabetes self-management education community-based programs can reduce risk factors for diabetes and cardiovascular disease . Methods Diabetes educators in 3 outpatient-hospital programs ( urban , suburban , and rural ) received training and support for implementation of the Group Lifestyle Balance program , an adaptation of the Diabetes Prevention Program lifestyle intervention , from the Diabetes Prevention Support Center of the University of Pittsburgh . Adults with prediabetes and /or the metabolic syndrome were eligible to enroll in the program with physician referral . With use of existing diabetes educator networks , recruitment was completed via on-site physician in-services , informative letters , and e-mail contact as well as participant-directed newspaper advertisement . Results Eighty-one participants enrolled in the study ( 71 women , 10 men ) . Mean overall weight loss was 11.3 lb ( 5.1 % , P fasting plasma glucose , low-density lipoprotein cholesterol , triglycerides , and blood pressure . Conclusions These results suggest that the Group Lifestyle Balance program delivered by diabetes educators was successful in reducing risk for diabetes and cardiovascular disease in high-risk individuals . Furthermore , diabetes educators , already integrated within the existing health care system , provide yet another re source for delivery of primary prevention programs in the community"
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Objective The aim of the present study is to up date the results of two previous meta-analyses , published in 2006 and 2012 , on the survival percentages of atraumatic restorative treatment ( ART ) restorations and ART sealants . The current meta- analysis includes Chinese publications not investigated before . Material s and methods Until February 2017 , six data bases were interrogated ( two English , one Portuguese , one Spanish and two Chinese ) . Using six exclusion criteria , a group of six independent review ers selected 43 publications from a total of 1958 potentially relevant studies retrieved . Confidence intervals and /or st and ard errors were calculated and the heterogeneity variance of the survival rates was estimated . Results The survival percentages and st and ard errors of single-surface and multiple-surface ART restorations in primary posterior teeth over the first 2 years were 94.3 % ( ± 1.5 ) and 65.4 % ( ± 3.9 ) , respectively ; for single-surface ART restorations in permanent posterior teeth over the first 3 years , they were 87.1 % ( ± 3.2 ) ; and for multiple-surface ART restorations in permanent posterior teeth over the first 5 years , they were 77 % ( ± 9.0 ) . The mean annual dentine-carious-lesion-failure percentages in previously sealed pits and fissures using ART sealants in permanent posterior teeth over the first 3 and 5 years were 0.9 and 1.9 % , respectively . Conclusions ART single-surface restorations presented high survival percentages in both primary and permanent posterior teeth , whilst ART multiple-surface restorations presented lower survival percentages . ART sealants presented a high-caries-preventive effect . Clinical relevance ART is an effective evidence -based option for treating and preventing carious lesions in primary and permanent posterior teeth
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"Background Occlusal surfaces of erupting and newly erupted permanent molars are particularly susceptible to caries . The objective of the study was to assess and compare the effect of a single application of 38 % SDF with ART sealants and no treatment in preventing dentinal ( D3 ) caries lesions on occlusal surfaces of permanent first molars of school children who participated in a daily school-based toothbrushing program with fluoride toothpaste . Methods The prospect i ve community clinical trial in the Philippines was conducted over a period of 18 months and included 704 six- to eight-year-old school children in eight public elementary schools with a daily school-based fluoride toothpaste brushing program . Children were r and omly assigned for SDF application or ART sealant treatment . Children from two of the eight schools did not receive SDF or ART sealant treatment and served as controls . SDF or ART sealant treatment was applied on sound occlusal surfaces of permanent first molars . Surfaces that were originally defined as sound at baseline but which changed to dentinal ( D3 ) caries lesions were defined as surfaces with new caries ( caries increment ) . Non-compliance to the daily toothbrushing program in three schools offered the opportunity to analyze the caries preventive effect of SDF and sealants separately in fluoride toothpaste brushing and in non-toothbrushing children . Results In the brushing group , caries increment in the SDF treatment group was comparable with the non-treatment group but caries increment in the sealant group was lower than in the non-treatment group with a statistically significant lower hazard ratio of 0.12 ( 0.02 - 0.61 ) . In the non-brushing group , caries increment in the SDF treatment group and the sealant group was lower than the non-treatment group but the hazard ratio was only statistically significant for the sealant group ( HR 0.33 ; 0.20 - 0.54 ) . Caries increment was lower in toothbrushing children than in non-toothbrushing children . Hazard ratios reached statistical significance for the non-treated children ( HR 0.43 ; 0.21 - 0.87 ) and the sealant-treated children ( HR 0.15 ; 0.03 - 0.072 ) . Conclusions A one-time application of 38 % SDF on the occlusal surfaces of permanent first molars of six- to eight-year-old children is not an effective method to prevent dentinal ( D3 ) caries lesions . ART sealants significantly reduced the onset of caries over a period of 18 months . Trial registration numberGerman Clinical Trial Register",
"BACKGROUND Failed restorations in primary teeth are not always re-restored . Is re-restoration not required anymore ? OBJECTIVE To compare survival rates of primary molars with intact and defective amalgam and ART restorations . METHODS A total of 649 restored primary molars , of which 162 were assessed with defective restorations for mechanical reasons , from a cluster-r and omised controlled clinical trial , were followed up over a period of 3.5 years . Restored primary molars , extracted because of dental sepsis or toothache , were considered a failure . Primary molars with defective restorations were followed up from the time they were assessed defective . Data were analysed using PHREG model with frailty correction , Wald test , t-test , and jackknife procedure . RESULTS The survival rate of primary molars with intact restorations ( 96.3 % ) was statistically significantly higher than that of primary molars with defective restorations ( 75.9 % ) over a 3-year period ( P ( amalgam or ART ) ( P = 0.05 ) nor the type of surface ( single or multiple ) ( P = 0.73 ) was observed with respect to the survival rate of restored primary molars . CONCLUSIONS Survival rates for primary molars with intact and defective amalgam and ART restorations were high . The 3-year survival rate of primary molars with intact restorations was significantly higher than that of primary molars with defective restorations",
"Clinical trials are normally performed with well-known br and s of glass ionomer cement ( GIC ) , but the cost of these material s is high for public healthcare in less-affluent communities . Given the need to research cheaper material s , it seems pertinent to investigate the retention rate of a low-cost GIC applied as atraumatic restorative treatment ( ART ) sealants in two centers in Brazil . Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil . The children were r and omly divided into two groups , according to the tested GIC applied in the first permanent molars . The retention rate was evaluated after 3 , 6 and 12 months . Kaplan-Meier survival analysis and the log-rank test were performed . The variables were tested for association with sealant longevity , using logistic regression analyses ( α = 5 % ) . The retention rate of sealants after 12 months was 19.1 % . The high-cost GIC br and presented a 2-fold-more-likely-to-survive rate than the low-cost br and ( p higher sealant survival rate than Recife ( p retention rate of a low-cost GIC sealant br and was markedly lower than that of a well-known GIC sealant br and",
"Objectives This study aim ed to test the hypothesis that there is no difference in the survival rates of molars treated according to the conventional restorative treatment ( CRT ) using amalgam , atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer , and ultraconservative treatment ( UCT ) protocol after 3.5 years . Material s and methods Cavitated primary molars were treated according to CRT , ART , and UCT ( small cavities were restored with ART and medium/large cavities were daily cleaned with toothpaste/toothbrush under supervision ) . Molar extraction s result ing from toothache , sepsis , or pulp exposure were failures . The Kaplan – Meier method was used to estimate the survival curves . Results The numbers of treated teeth , among the 302 6–7-year-old children , were 341 ( CRT ) , 244 ( ART ) , and 281 ( for UCT group : 109 small ART , 166 open cavities , and 6 combinations ) . Protocol groups were similar at baseline regarding gender and mean decayed missing filled tooth score , but not regarding age and type of surface . The numbers of molars extracted were 22 ( CRT ) , 16 ( ART ) , and 26 ( UCT ) . Fistulae were most often recorded . After 3.5 years , the cumulative survival rate ± st and ard error for all molars treated was 90.9 ± 2.0 % with CRT , 90.4 ± 2.4 % with ART , and 88.6 ± 1.9 % with UCT ( p = 0.13 ) . Only a type of surface effect was observed over the 3.5-year period : survival rates for molars were higher for single- than for multiple-surface cavities . Conclusion There was no difference in the cumulative survival rates of primary molars treated according to the CRT , ART , and UCT protocol s over a 3.5-year period . Clinical relevance Keeping cavities in primary molars biofilm-free might be another treatment option alongside restoring such cavities through conventional and ART protocol",
"The aim was to test the None-hypothesis that there is no difference in the cumulative survival rate of retained composite resin ( CR ) sealants and a high-viscosity glass-ionomer Atraumatic Restorative Treatment ( ART ) sealant in first permanent molars calculated according to the traditional and the modified retention assessment criteria over a period of 3 years . This cluster-r and omized controlled clinical trial consisted of 123 schoolchildren , 6 - 7-years-old . At baseline , high-caries risk pits and fissures of fully erupted first permanent molars were treated with CR and ART sealants . Evaluations were performed after 0.5 , 1 , 2 and 3 years . Retention was scored for free-smooth surface and for each of three sections into which the occlusal surface had been divided . The modified criterion differed from the traditional in that it determined an occlusal sealant to be a failure when at least one section contained no visible sealant material . Data were analysed according to the PHREG model with frailty correction , Wald-test , ANOVA and t-test , using the Jackknife procedure . The cumulative survival rates for retained CR and ART sealants in free-smooth and occlusal surfaces for both criteria were not statistically significantly different over the 3 years . A higher percentage of retained CR sealants on occlusal surfaces was observed at longer evaluations . Cumulative survival rates were statistically significantly lower for the modified criterion in comparison to the traditional . The modified retention assessment criterion should be used in future sealant-retention studies",
"OBJECTIVES The aim of the present study was to investigate the caries-preventive effect of sealants produced with a high-viscosity glass-ionomer with an elevated powder-liquid ratio ( ART ) , of having energy added to this glass-ionomer , and that of glass-carbomer , in comparison to that of resin composite sealants . METHODS The r and omized controlled trial covered 407 children , with a mean age of 8 years . At a school compound three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 and 2 years . The Kaplan-Meier survival method , ANOVA and t-test were used in analyzing the data . RESULTS 1352 first permanent molars were sealed . 6.6 % of children and 6.8 % of sealants dropped out within 2 years . 27 re-exposed pits and fissures , 20 in occlusal and 7 in smooth surfaces , in 25 children , developed a dentin carious lesion . The cumulative survival of dentin carious lesion-free pits and fissures in the glass-carbomer sealant group was statistically significantly lower ( 97.4 % ) than those in the high-viscosity glass-ionomer with energy supplied ( 99 % ) and the resin-composite ( 98.9 % ) sealant groups . There was no statistically significant difference in the cumulative survival of dentin carious lesion-free pits and fissures , between the high-viscosity glass-ionomer with ( 99 % ) and without ( 98.3 % ) energy supplied sealant groups , after 2 years . SIGNIFICANCE The survival of dentin carious lesion-free pits and fissures was high in all sealant types . More dentin carious lesions were observed in the glass-carbomer sealant group",
"OBJECTIVES To assess and compare the cumulative survival rate of amalgam and atraumatic restorative treatment ( ART ) restorations in primary molars over 3 years . METHODS 280 children aged 6 - 7 years old were enrolled in a cluster r and omized controlled clinical trial using a parallel group design covering two treatment groups : conventional restorative treatment with amalgam ( CRT ) and atraumatic restorative treatment ( ART ) using a high-viscosity glass-ionomer ( HVGIC ) Ketac Molar Easymix . Three pedodontists placed 750 restorations ( 364 amalgam and 386 ART in 126 and 154 children , respectively ) which were evaluated at 0.5 , 1 , 2 and 3 years . The proportional hazard rate regression model with frailty correction , ANOVA and Wald tests , and the Jackknife procedure were applied in analysing the data . RESULTS The cumulative survival rates over 3 years for all , single- and multiple-surface CRT/amalgam restorations ( 72.6 % , 93.4 % , 64.7 % , respectively ) were no different from those of comparable ART/HVGIC restorations ( 66.8 % ; 90.1 % and 56.4 % , respectively ) ( p=0.10 ) . Single-surface restorations had higher survival rates than multiple-surface restorations for the both treatment procedures ( p failed because of mechanical reasons ( 94.8 % ) than of secondary caries ( 5.2 % ) . No difference in reasons for restoration failures between all types of amalgam and ART/HVGIC restorations were observed ( p=0.24 ) . SIGNIFICANCE The high-viscosity glass-ionomer used in this study in conjunction with the ART is a viable option for restoring carious dentin lesions in single surfaces in vital primary molars",
"OBJECTIVE The purpose of this study was to investigate the remineralization activation of the application of three fissure sealants ( FSs ) , alone or with gaseous ozone ( GO ) , on non-cavitated initial caries and evaluate the clinical success of FS . STUDY DESIGN Sixty children who had DIAGNOdent scores between 10 - 30 on bilateral symmetric m and ibular first permanent molars were included in study . In a split-mouth design , teeth were assigned to experimental ( with GO ) and control ( without GO ) groups . GO was applied to teeth on one side and then the same br and of r and omly selected FSs was applied to the teeth on both sides . Children were divided into 3 groups based on type of FS ( Group 1 : Aegis { Bosworth Co , North Hamlin Avenue Skokie , Illinois , USA } , Group 2 : Fuji Triage { GC , Tokyo , Japan } , Group 3 : Helioseal { Ivoclar Vivadent , Liechtenstein , Germany } ) . All FSs were then examined for retention rates at 1 , 3 , 6 , 9 , and 12 months ; at the end of 12 months , all FSs were removed with an air-abrasion device and DIAGNOdent scores noted to compare with the initial values . RESULTS The application of GO with either Fuji Triage or Aegis FS was effective on remineralization ( p Helioseal FSs was not effective ( p>0.05 ) . The 1(st ) and 12(th ) months ' full retention rates of Fuji Triage FSs was a significant difference ( p0.05 ) . CONCLUSIONS GO+Aegis FS showed the highest remineralization ; and , at the end of 12 months , its clinical success was higher than other FSs",
"OBJECTIVE To evaluate the clinical performance and radiographic outcome of glass ionomer cement ( GIC ) restoration in primary molars using three caries removal techniques . BASIC RESEARCH DESIGN R and omised clinical controlled trial . CLINICAL SETTING Two st and ard dental clinics in 2 hospitals near Bangkok . PARTICIPANTS A total of 276 children , aged 6 - 11 , having dentinal caries on the occlusal and /or proximal surface extending at least one-third of dentine without signs and /or symptoms of irreversible pulpitis . INTERVENTION Children were r and omly allocated into 3 study groups with different caries removal techniques : Group 1 , partial soft caries removal at enamel-dentine junction ( EDJ ) by spoon excavation ; Group 2 , complete soft caries removal by spoon excavation ; and Group 3 , conventional caries removal by steel burs . All cavity preparations were restored with GIC ( Fuji IX , GC Corp. , Japan ) . MAIN OUTCOME MEASURES Clinical and radiographic evaluations were carried out at 6 and 12 months after restoration . RESULTS After 12 months , 89 , 89 , and 88 restorations in Groups 1 , 2 and 3 were evaluated . The cumulative survival rates of GIC restorations in Groups 1 , 2 and 3 were 83 % , 83 % , and 89 % while the cumulative survival rates of pulp were 99 % , 100 % and 98 % respectively . There were no statistically significant differences in the survival of GIC restorations or pulp in the three groups ( p > 0.05 ) . CONCLUSION The clinical and radiographic evaluations after 12 months indicated that partial soft caries removal at EDJ followed by GIC restoration was comparable to that of ART and conventional approaches",
"Objective : The aim of this study was to evaluate the performance of a new glass ionomer filling material ( ChemFlex ™ ) using the atraumatic restorative treatment ( ART ) approach in class I cavities in the permanent dentition of Latvian schoolchildren . Methods : A total of 63 fillings ( 40 test and 23 control ) were placed using the ART technique in 41 schoolchildren in Riga at the Stomatology Institute of the Medical Academy of Latvia . These fillings were then blindly assessed after 2 years . Results : The complete success rate for both the test and the control material fillings were 92.5 and 94.9 % , respectively . Conclusion : The new glass ionomer filling has shown a good performance in terms of retention , marginal failure and fractures in class I cavities",
"BACKGROUND The high-viscosity consistency of glass ionomer cement ( GIC ) may lead to its incorrect adaptation into the cavity and therefore to restoration failure . AIM To compare two different insertion techniques for GIC in approximal atraumatic restorative treatment ( ART ) restorations and two different surface protection material s. DESIGN Approximal caries lesion in primary molars from 208 schoolchildren was r and omly assigned into four groups : G1 , conventional GIC insertion protected with petroleum jelly ( PJ ) ; G2 , bilayer technique protected with PJ ; G3 conventional GIC insertion protected with nano-filled particles coating for GIC ( NPC ) ; G4 , bilayer technique protected with NPC . Restorations were evaluated after 1 , 6 , 12 , 18 , 24 , and 36 months . Kaplan-Meier survival analysis and log-rank test were performed . Cox regression analysis ( α = 5 % ) was used to verify the influence of clinical factors . RESULTS Restoration survival was 52.8 % . Log-rank test indicated a better survival of the bilayer technique restorations , compared to conventional restorations ( P = 0.005 ) , whereas the coated conventional restorations presented higher survival than the uncoated ones ( P = 0.035 ) . Cox regression analysis showed no influence of any clinical tested variables . CONCLUSION The survival rate of the approximal ART restorations is positively influenced by the bilayer technique , and the application of nano-filled coating increases the longevity of the conventional approximal ART restorations",
"AIM To compare the survival rates of Class II Atraumatic Restorative Treatment ( ART ) restorations placed in primary molars using cotton rolls or rubber dam as isolation methods . METHODS A total of 232 children , 6 - 7 years old , both genders , were selected having one primary molar with proximal dentine lesion . The children were r and omly assigned into two groups : control group with Class II ART restoration made using cotton rolls and experimental group using rubber dam . The restorations were evaluated by eight calibrated evaluators ( Kappa > 0.8 ) after 6 , 12 , 18 and 24 months . RESULTS A total of 48 ( 20.7 % ) children were considered dropout , after 24 months . The cumulative survival rate after 6 , 12 , 18 and 24 months was 61.4 % , 39.0 % , 29.1 % and 18.0 % , respectively for the control group , and 64.1 % , 55.1 % , 40.1 % and 32.1 % , respectively for the rubber dam group . The log rank test for censored data showed no statistical significant difference between the groups ( P = 0.07 ) . The univariate Cox Regression showed no statistical significant difference after adjusting for independent variables ( P > 0.05 ) . CONCLUSION Both groups had similar survival rates , and after 2 years , the use of rubber dam does not increase the success of Class II ART restorations significantly",
"Objective Good survival rates ( SR ) have been reported for occlusal-atraumatic restorative treatment ( ART ) restorations but not for approximal-ART restorations . The high-viscosity consistency of the glass ionomer cement ( GIC ) may lead to its incorrect adaptation into the cavity and thus to failure of the restoration . Because the use of a flowable GIC layer seemed to improve its adaptation in approximal restorations in vitro , we evaluated whether the use of an intermediate flowable GIC layer would improve the SR of approximal-ART restorations . Methods A total of 208 children ( 6–7 years old ) with at least one occluso-proximal carious lesion in a primary molar were selected and r and omly allocated to two groups : G1 , conventional technique , one-layer GIC ( powder/liquid ratio 1:1 ) ; and G2 , two-layer technique , consisting of a first layer of GIC with a flowable consistency ( powder/liquid ratio 1:2 ) and a second layer of a regular consistency . Restorations were made by final-year students and evaluated after 1 , 6 , 12 and 18 months . Restoration survival was evaluated using Kaplan – Meier survival and logrank test . Poisson regression analyses ( α = 5 ) were used to verify the influence of factors such as insertion technique , restoration surface and operators . Results The overall SR of the restorations after 18 months was 68 % . There was no difference in SR between the techniques , neither did the other factors influence the SR . Conclusions Over 18 months , the use of an intermediate flowable GIC layer in approximal-ART restorations does not improve the restoration survival . Clinical relevance This study suggests that the two-layer technique is not the answer for increasing approximal-ART restoration longevity",
"PURPOSE The purpose of this study was to evaluate the performance of multiple-surface restorations employing 2 different glass ionomer cements ( GICs ) and the Atraumatic Restorative Treatment ( ART ) approach in permanent molar teeth . METHODS This study examined 60 restorations--36 Class I restorations involving 2 or more tooth surfaces and 24 Class II restorations -- that were placed in 46 schoolchildren ( 9 - 16 years of age ) by 2 dentists using the ART approach . The restorations were r and omly divided into 2 groups : ( a ) 30 cavities were filled with high strength GIC ( Ketac Molar-3 M ESPE ) , and ( b ) 30 cavities were filled with resin-modified GIC ( Fuji VIII-GC Corp ) . Two independent calibrated examiners carried out the evaluations according to ART criteria . The interexaminer kappa was 0.92 . Data were su bmi tted to chi-square , McNemar , and Fisher 's tests . A difference was statistically significant if P success rates of the restorations were 100 % and 93 % for Fuji VIII and Ketac Molar , respectively . There was no statistically significant difference between GICs , cavity types , or operators . CONCLUSIONS Based on a 12-month follow-up evaluation , the clinical performance of the multiple-surface atraumatic restorative treatment restorations of both glass ionomer cements ( high-strength and resin-modified ) was considered satisfactory with a high success rate",
"The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results",
"Introduction Despite the widespread acceptance of conventional treatment using composite resin in primary teeth , there is limited evidence that this approach is the best option in paediatric clinics . Atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies , is easy to h and le and is patient friendly . Therefore , the aim of this r and omised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth . As secondary outcomes , cost-efficacy and patient self-reported discomfort will also be tested . Methods and analysis Children aged 3–6 years presenting with at least one occlusal and /or occlusal-proximal cavity will be r and omly assigned to one of two groups according to the dental treatment : ART ( experimental group ) or composite resin restoration ( control group ) . The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP , Brazil . The unit of r and omisation will be the child . A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated . The primary outcome will be restoration longevity , which will be clinical ly assessed after 6 , 12 , 18 and 24 months by two examiners . The duration of the dental treatment and the cost of all material s used will be considered when estimating the cost-efficacy of each treatment . Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker . Ethics and dissemination This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo ( registration no. 1.556.018 ) . Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research . Trial registration number www . clinical trials.gov , NCT02562456 ; Pre- results",
"The present r and omised clinical trial was aim ed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material . The treatment approaches tested in parallel groups were : conventional in a university setting , modified-conventional and ultraconservative ( Atraumatic Restorative Treatment , ART ) approaches in a field setting . A split-mouth design was used in which the two restorative material s were r and omly placed in 430 matched contralateral pairs of permanent molar teeth . A total of 152 children from five primary schools were recruited and treated by a dental therapist . The restorations were evaluated after 6 years by 2 calibrated independent examiners . The 6-year successes for all occlusal amalgam and glass-ionomer restorations were 72.6 and 72.3 % , respectively . There were no statistically significant differences observed between the successes for both amalgam and glass-ionomer restorations placed either by the ART ( 68.6 % , with 95 % CI = 61–76 % ) approach or by the conventional ( 74.5 % , with 95 % CI = 65–82 % ) and the modified-conventional ( 75.8 % , with 95 % CI = 67–83 % ) approaches after 6 years . There was also no statistically significant difference observed between the successes of occlusal ART restorations with glass-ionomer ( 67.1 % , with 95 % CI = 56–77 % ) and occlusal conventional restorations with amalgam ( 74 % , with 95 % CI = 61–85 % ) after 6 years . ‘ Restoration fracture/marginal defects ’ and ‘ loss of material ’ were the most common causes for failure . The former was more often recorded in amalgam restorations and the latter in glass-ionomer restorations . Secondary caries was observed for 2 % of glass-ionomer and for 10 % of amalgam restorations . This difference was statistically significant ( p = 0.001 ) . The ART approach using glass-ionomer performed equally well as conventional restorative approaches using electrically driven equipment and amalgam for treating dentinal lesions in occlusal surfaces after 6 years",
"PURPOSE To test the hypotheses : 1 ) cumulative survival rates of fully and partially retained high-viscosity glass-ionomer ( HVGIC ) ART sealants with heat application and glass-carbomer sealants on occlusal and free-smooth surfaces are both higher than that of resin sealants ; 2 ) cumulative survival rate of fully and partially retained high-viscosity glass-ionomer ART sealant with heat application on occlusal and free-smooth surfaces is higher than that of comparable ART sealants without heat application . MATERIAL S AND METHODS The block-r and omised clinical trial covered 405 eight-year-old children . The HVGIC was Ketac Molar Easymix , the glass carbomer was GlassCarbomer and the resin sealant was Clinpro . Retention rates of sealants on occlusal and free-smooth surfaces using conventional and modified categorisation ( fully and partially retained sealants vs those completely lost [ at least one-third of surface re-exposed ] ) were the dependent variables . The Kaplan-Meier survival method was used . RESULTS The cumulative survival rate of completely and partially retained resin sealants on occlusal ( 81.2 % ) and free-smooth ( 81 % ) surfaces after 4 years was statistically significantly higher , and that of glass-carbomer sealants ( 10.8 % and 21.1 % , respectively ) was statistically significantly lower than those of the other sealant groups . There was no statistically significant difference in survival rates of completely and partially retained high-viscosity glass-ionomer ART sealants with ( 56 % for both surfaces ) or without heat application ( 56 % ) on occlusal and free-smooth surfaces ( 55.7 % and 59.1 % , respectively ) . CONCLUSIONS Resin sealants had the highest and glass-carbomer sealants the lowest retention rate after 4 years . Application of heat to high-viscosity glass-ionomer ART sealants did not result in a significantly higher sealant retention rate . Use of the modified categorisation for determining sealant retention is advocated",
"OBJECTIVE To compare the survival of glass ionomer cement ( GIC ) restorations placed in a dental clinic setting using both the atraumatic restorative treatment ( ART ) approach with h and instruments , and conventional cavity preparation with rotary instruments . METHOD AND MATERIAL S Two encapsulated high-strength conventional GICs ( Fuji IX GP , Ketac-Molar Aplicap ) were placed in 82 Class I and 53 Class II preparations and one encapsulated non-gamma 2 amalgam alloy ( GK-amalgam ) was placed in 32 Class I preparations , in the primary molars of 60 Chinese children with a mean age of 7.40 + /- 1.24 ( SD ) years . Thus , 9 treatment groups were formed . RESULTS After two years , there were no significant survival differences found among 7 of the 9 treatment groups ( p = 0.99 ) . However , two groups comprising Fuji IX GP and Ketac-Molar Aplicap placed in Class II cavities prepared using the ART approach showed significantly lower restoration survivals ( p GIC material . CONCLUSIONS In a clinic setting , both the ART h and instrument and conventional rotary instrument methods were equally suitable for high Class I restoration survival , but not for Class II restoration survival where the conventional cavity preparation method was preferable",
"The purpose of this study was to evaluate the clinical performance of glass ionomer cement ( GIC ) restorations comparing two minimally invasive methods in permanent teeth after 12 months . Fifty pregnant women ( second trimester of pregnancy ) , mean age 22 ± 5.30 years , were treated by two previously trained operators . The treatment approaches tested were : chemomechanical method ( CarisolvTM ; MediTeam ) and atraumatic restorative treatment ( ART ) . A split-mouth study design was used in which the two treatments were r and omly placed in 50 matched pairs of permanent teeth . The chemomechanical method ( CM ) was the test group and the ART was the control group . The treatments were performed in Public Health Centers . The tested restorative material was a high-strength GIC ( Ketac Molar ; 3M/ESPE ) . The restorations were placed according to the ART guidelines . Two calibrated independent examiners evaluated the restorations in accordance with ART criteria . The interexaminer kappa was 0.97 . Data were analyzed using 95 % confidence interval on the binomial distribution and Fisher 's exact test at 5 % significance level . In a 12-month follow-up , 86 % of the restorations were evaluated . In the test group ( CM ) , 100 % ( CI=93.3 - 100 % ) of the restorations were considered successful . In the control group ( ART ) 97.6 % ( CI=87.4 - 99.9 % ) of the restorations were considered successful and 2.4 % unsuccessful ( marginal defect > 0.5 mm ) . There was no statistically significant difference between the 12-mounth success rate for both groups ( Fisher 's exact test : P=0.49 ) and between the two operators ( Fisher 's exact test : P=1.00 ) . Both minimally invasive methods , chemomechanical method and ART , showed a similar clinical performance after 12 months of follow up",
"PURPOSE The objectives of this clinical study were to : evaluate the survival of occlusal atraumatic restorative treatment ( ART ) restorations , on a longitudinal basis , in the primary molars of children in Mosul/Iraq ; and compare the success rate of ART restorations placed with and without cavity conditioning . METHODS One dentist placed 96 ART restorations in 48 6- to 7-year-olds who had bilateral matched pairs of carious primary molars . A split-mouth design was used to place restorations with and without cavity conditioning , which were assigned r and omly to contralateral sides . Restorations were evaluated after 6 and 12 months using the ART criteria . RESULTS The survival rate of ART restorations placed with cavity conditioner was 89 % at the 6-month assessment and 74 % at the 12-month assessment . The success rates of ART restorations placed without cavity conditioning in the 2 assessment s were 84 % and 67 % , respectively . There was no statistically significant difference between the ART restorations placed with and without cavity conditioner in both assessment s ( P>0.05 ) . The main cause of failure was the loss of restoration . CONCLUSIONS The 1-year success rate of occlusal ART restorations in primary molars was moderately successful . The ART technique 's cavity conditioning step was not proven to be better than not using it for Class I lesions",
"OBJECTIVES This paper reports on a longitudinal evaluation of three material s ( glass ionomer , zinc oxide-eugenol cement , and composite ) employed in a minimal restorative intervention approach of 81 high caries-active pregnant women selected for a preventive oral health program in Brazil . The aim of the study was to evaluate the clinical behavior of the glass ionomer cement , currently indicated in programs for control of carious lesions . METHODS The patients were r and omly divided into two groups . Both groups were engaged in an oral health promotion approach . In Group 1 , 417 glass ionomer restorations were placed in 43 individuals , involving all types and sizes of cavities . In the second group , 213 posterior zinc oxide-eugenol ( ZOE ) restorations and 127 anterior composite restorations were placed in 38 patients . Minimal cavity preparations were made , in which only soft or infected dentin was removed , on the basis of clinical judgment . RESULTS After two years , the restorations were clinical ly evaluated by two examiners for marginal integrity , amount of wear , presence of fracture , carious lesions , and lost restorations . Statistical analysis ( chi-square test ) identified statistically significant difference between glass ionomer and ZOE ( 90.6 % vs 9.2 % ) . Comparing glass ionomer and composite , similar survival rates were observed . The success rate observed for the glass ionomer cement ranged from 77.1 percent to 92.5 percent , depending on the type and size of cavity in which it was applied . Four teeth restored with glass ionomer cement and one tooth restored with composite showed caries signs . Regarding the ZOE restorations , caries was always associated with other causes of failure such as excessive wear , restoration loss , or marginal defects , with no possibility of separate evaluation . Despite the preventive and therapeutic measurements employed , a mean increase of 2.15 new surfaces with cavities was observed in Group 1 , as well as 2.83 surfaces presenting the same status in Group 2 . CONCLUSIONS This study demonstrated that highly viscous glass ionomer cement applied in a minimal intervention approach provided high- quality preventive and restorative care after two years to a population at high risk for caries . The composite was employed in cavities exposed to lower stress , such as in the anterior teeth , and its behavior was comparable to that of the glass ionomer cement . The reinforced ZOE presented a high failure rate , thus contraindicating its use for such purpose",
"The hypotheses tested were : survival rate of fully and partially retained glass-carbomer sealants is higher than those of high-viscosity glass-ionomer , with and without energy supplied , and that of resin composite ; survival rate of fully and partially retained sealants of high-viscosity glass-ionomer with energy supplied is higher than those without energy supplied . The r and omized clinical trial covered 407 children , with a mean age of 8 years . The evaluation took place after 0.5 , 1 and 2 years . Survival of sealant material in occlusal and in smooth surfaces , using the traditional categorization ( fully and partially retained versus completely lost sealants ) and the modified categorization ( fully and more than 2/3 of the sealant retained versus completely lost sealants ) , were dependent variables . The Kaplan – Meier survival method was used . According to both categorizations of partially retained sealants , the survival of completely and partially retained resin composite sealants in occlusal and in smooth tooth surfaces was statistically significantly higher , and those of glass-carbomer sealants lower , than those of sealants of the other three groups . There was no statistically significant difference in the survival rates of completely and partially retained high-viscosity glass-ionomer sealants with and without energy supplied in occlusal and in smooth surfaces . After 2 years , glass-carbomer sealant retention was the poorest , adding energy to high-viscosity glass-ionomer sealant did not increase the retention rate and resin composite sealants were retained the longest . We suggest the use of the modified categorization of partially retained sealants in future studies . It seems not necessary to cure high-viscosity glass-ionomer sealants . The use of glass-carbomer sealants can not be recommended yet",
"OBJECTIVES Older dentate adults are a high caries risk group who could potentially benefit from the use of the atraumatic restorative treatment ( ART ) . This study aim ed to compare the survival of ART and a conventional restorative technique ( CT ) using rotary instruments and a resin-modified glass-ionomer for restoring carious lesions as part of a preventive and restorative programme for older adults after 2 years . METHODS In this r and omised controlled clinical trial , 99 independently living adults ( 65 - 90 years ) with carious lesions were r and omly allocated to receive either ART or conventional restorations . The survival of restorations was assessed by an independent and blinded examiner 6 months , 1 year and 2 years after restoration placement . RESULTS Ninety-six ( 67.6 % ) and 121 ( 76.6 % ) restorations were assessed in the ART and CT groups , respectively , after 2 years . The cumulative restoration survival percentages after 2 years were 85.4 % in the ART and 90.9 % in the CT group . No statistically significant between group differences were detected ( p=0.2050 , logistic regression analysis ) . CONCLUSIONS In terms of restoration survival , ART was as effective as a conventional restorative approach to treat older adults after 2 years . This technique could be a useful tool to provide dental care for older adults particularly in the non- clinical setting . ( TRIAL REGISTRATION NUMBER IS RCT N 76299321 ) . CLINICAL SIGNIFICANCE The results of this study show that ART presented survival rates similar to conventional restorations in older adults . ART appears to be a cost-effective way to provide dental care to elderly patients , particularly in out of surgery facilities , such as nursing homes",
"Background The oral condition in children undergoing oncohematological treatment can have a negative impact on the course of disease . Little is known about survival of tooth restorations in these patients . The aim of this study was to evaluate the longevity of restorations and sealants performed by Atraumatic Restoration Treatment ( ART ) in patients undergoing oncohematological treatment . Methods ART single surface restorations and sealants were performed in the experimental group ( E ) , which comprised children ( 2–13 years old ) undergoing oncohematological treatment , and in the control group ( C ) , in which patients did not undergo such treatment . The same examiner evaluated the ART at 1 , 3 , 6 and 12 months after preparation , using the same criteria for restorations and sealants . ART was successful if the sealant or restoration did not need a repair in the follow-up assessment . Descriptive , bivariate and Cox ’s proportional hazard analyses were performed at a significance level of 5 % . Results The two groups , one including 24 children ( E ) and the other 14 children ( C ) , received 101 and 52 ART procedures , respectively . The success rates were 95.0 % ( E ) and 100 % ( C ) at 1 month ( P = 0.233 ) ; 81.2 % ( E ) and 92.3 % ( C ) at 3 months ( P = 0.009 ) ; 72.2 % ( E ) and 80.8 % ( C ) at 6 months ( P = 0.050 ) and 48.5 % ( E ) and 73.1 % ( C ) at 12 months ( P = 0.001 ) . The final Cox ’s regression model for occurrence of ART failure needing repair did not show differences between groups ( E : OR = 1.6 , 95 % CI 0.8–2.9 ) ; primary teeth had a shorter survival than permanent teeth ( OR = 2.1 , 95 % CI 1.2–3.7 ) . Conclusions Oncohematological treatment did not interfere with the longevity of ART restorations and sealants , which suggests the potential use of this technique in children undergoing chemotherapy . Trial registration Brazilian Clinical Trials Registry ( REBEC ) RBR-2c3c52 . Registered 5 June 2014 .",
"Background Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making . The aim of this pragmatic r and omized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment ( ART ) premises compared with Conventional Treatment ( CT ) using bulk fill composite restorations in primary and permanent teeth . Methods / design A total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP , Brazil . The participants will be r and omly assigned into 2 groups : CT ( caries removal with bur and restoration performed with Scotchbond ™ Universal Adhesive system associated with Filtek Bulk Fill – 3 M/ESPE ) and ART ( Caries removal with h and instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix – 3 M/ESPE ) . Ten untrained dentists will perform the treatment in in dental offices located at public schools . The restorations will be evaluated after 6 , 12 and 24 months by an independent trained and calibrated examiner . The restoration and tooth survival , the cost-effectiveness analysis between the two groups and the operators ’ preferences regarding the techniques will be also evaluated . Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival . All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect . The significance level for all analyses will be 5 % . Discussion Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth , ART will present superior cost-effectiveness . The results of this trial will support decision-making by clinicians and policy makers . Trial registration NCT02568917 . Registered on May 10th 2015",
"Background The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a r and omized clinical trial conducted in southern China ( Clinical Trials.gov NCT01829334 ) . Methods After obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study . Included molars were r and omly allocated into one of four parallel study groups in units of left/right teeth per mouth . Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods . Fissure status of the molars in each group was evaluated every 6 months . Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report . Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere . Results At baseline , a total of 280 children ( 383 molars ) with mean age 7.8 years were involved for the two sealant groups . After 24 months , 261 children ( 357 molars ) were followed . Proportions of molars with dentine caries were 7.3 % and 3.9 % in the ART sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = 0.171 ) . Life-table survival analysis showed that sealant retention ( full and partial ) rate over 24 months for the resin sealant ( 73 % ) was significantly higher than that ( 50 % ) for the ART sealant ( p Molar survival ( no development of dentine caries ) rates in the ART sealant ( 93 % ) and fluoride-releasing resin sealant ( 96 % ) groups were not significantly different ( p = 0.169 ) . Multilevel logistic regression ( GEE modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding . Conclusions Though the retention of fluoride-releasing resin sealant was better than that of the ART sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months . ART sealants could be a good alternative when and where re sources for resin sealant placement are not readily available",
"OBJECTIVE To compare survival rates and cost differentials between the atraumatic restorative treatment ( ART ) technique and amalgams by type of dental personnel in Ecuador , Panama , and Uruguay . METHODS Children 7 to 9 years of age in rural and urban schools with at least one lesion with initial cavitated enamel caries or a dentinal lesion on a first permanent molar were selected and r and omized into the ART ( intervention ) or amalgam ( control ) group . Restoration failure was evaluated at 12 and 24 months . Cooperation and pain experienced during the procedures were measured . Cumulative and incident failure of restorations at 12 and 24 months was calculated for dentists who placed ART or amalgam restorations and auxiliaries who placed ART restorations at 12 months only . RESULTS The total sample comprised 1 629 children . Study groups were similar by country , gender , and geographic location . Cumulative failure rate at 12 months varied by group : dentists ' amalgam , 0.9 % to 5.7 % ; dentists ' ART , 2.0 % to 10.5 % ; and auxiliaries ' ART , 5.7 % to 15.8 % . At 24 months , higher cumulative failures were observed for the dentists ' amalgam group compared with the dentists ' ART group in Ecuador and Panama but not in Uruguay . Amalgam was least likely to have the best level of cooperation and an auxiliary using ART was associated with the least pain . The cost of using the ART approach for dental caries treatment , including retreatment , was roughly half that of using amalgam without retreatment . CONCLUSIONS Having auxiliary personnel perform ART will lead to treatment survival that is expected to be lower than dentists using amalgam or ART . In spite of the greater risk of failure , the rate is not unacceptable and potential cost savings are substantial",
"UNLABELLED The objective of the present study provides further data comparing retention , marginal integrity and caries preventive effects of two fissure sealants ( glass ionomer based ; GC Fuji VII Capsule [ Fuji VII ] and ormocer based ; Admira Seal [ AS ] ) in children . This study was design ed as a r and omized single-blind clinical trial . The permanent first molars ( PFMs ) of 50 children , 7 - 13 years of age ( mean age : 8.9 + /- 1.3 years ) , were sealed with a split-mouth design . Fissure sealants applied to the PFMs according to the manufacturer 's recommendations by one pediatric dentist . Clinical evaluation of the sealants was carried out to record retention , marginal integrity and presence of caries at 6 , 12 , 18 and 24 months after placement by the other pediatric dentist . Kaplan-Meier survival analysis and Cox 's regression models were used to estimate the probability of two sealants success . RESULTS Alpha and Bravo retention rates at the end of follow-up were 13 % and 80 % for Fuji VII and 3 % and 83 % for AS , respectively . For retention and marginal integrity between fissure sealants was found similar survival rates ( p > 0.05 ) . After 24 months , presence of caries was 16 % for Fuji VII and 32 % for AS ( p Fuji VII and AS exhibited similar retention and marginal integrity during 24 months . However Fuji VII was showed better results than AS for caries preventive effect . Consequently , Fuji VII sealants may be a better choice for preventing occlusal caries",
"Atraumatic restorative treatment ( ART ) and minimal intervention treatment ( MIT ) techniques were evaluated under field conditions in 5 regions of the Western Cape Province of South Africa , where caries prevalence exceeds 60 % and remains mostly untreated . The purpose of the study was to compare and evaluate results of ART and MIT techniques in the primary dentition of 6 - 9 year-old schoolchildren using glass-ionomer ( GI ) ( Fuji IX ) and compomer ( Dyract AP ) material s. At baseline 401 children were treated , and 1,119 restorations placed by 5 calibrated dentists , 53 % with ART ( using h and instruments only ) and 47 % with MIT ( minimal use of slow h and -piece ) techniques . Evaluations were done with a CPI periodontal probe to measure marginal defects and to detect decay . A pain assessment for the restoration procedures indicated that 80 % of subjects experienced no pain , 18 % discomfort and slight pain , and 2 % required local anaesthetic . After one year 90.5 % of subjects and 80 % of restorations were followed up ( 11.1 % lost as a result of exfoliation ) ; of these restorations 86 % were clinical ly acceptable ( 84.1 % of the ART and 88 % of the MIT ) . With the art technique 82.7 % of GI restorations and 85.6 % , of compomer restorations were acceptable . With the MIT technique 86.5 % of GI restorations and 89.9 % of compomer restorations were acceptable . Success of restorations per region varied significantly : regions 1 and 2 - 90 % , region 3 - 80 % , region 4 - 70 % and region 5 - 95 % . There were no significant statistical differences in respect of material s or methods employed . ART and MIT techniques were well accepted as complementary caries approaches by operators . One-year results show that ART and MIT techniques were successful , substantiating its use for the primary dentition in areas with high caries prevalence . Longer-term assessment s are required",
"OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) . STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments",
"OBJECTIVE The objectives of this clinical study were to : evaluate the survival of occlusal atraumatic restorative treatment ( ART ) restorations , on a longitudinal basis , in the primary molars of children ; and compare the success rate of ART restorations placed in school environment and in hospital dental setup . STUDY DESIGN One dentist placed 120 ART restorations in 60 five- to seven year-olds who had bilateral matched pairs of carious primary molars . A split-mouth design was used to place restorations in school and in hospital dental setup , which were assigned r and omly to contralateral sides . Restorations were evaluated after 6 and 12 months using the ART criteria . RESULTS The survival rate of ART restorations placed in school environment was 82.2 % at the 6-month assessment and 77.77 % at the 12-month assessment . The success rates of ART restorations placed in hospital dental setup in the 2 assessment s were 87.7 % and 81.48 % , respectively . There was no statistically significant difference between the ART restorations placed in school environment and hospital dental setup in both assessment s ( P > O.05 ) . The main cause of failure was the loss of restoration . CONCLUSIONS The one year success rate of occlusal ART restorations in primary molars was moderately successful . The ART technique 's done in hospital dental setup was not proven to be better than restorations placed in school environment",
"To investigate the effectiveness of 3 caries-preventive measures on high– and low – caries risk occlusal surfaces of first permanent molars over 3 y. This cluster-r and omized controlled clinical trial covered 242 schoolchildren , 6 to 7 y old , from low socioeconomic areas . At baseline , caries risk was assessed at the tooth surface level , through a combination of ICDAS II ( International Caries Detection and Assessment System ) and fissure depth codes . High – caries risk occlusal surfaces were treated according to daily supervised toothbrushing ( STB ) at school and 2 sealants : composite resin ( CR ) and atraumatic restorative treatment – high-viscosity glass-ionomer cement ( ART-GIC ) . Low – caries risk occlusal surfaces received STB or no intervention . Evaluations were performed after 0.5 , 1 , 2 , and 3 y. A cavitated dentine carious lesion was considered a failure . Data were analyzed according to the proportional hazard rate regression model with frailty correction , Wald test , analysis of variance , and t test , according to the jackknife procedure for calculating st and ard errors . The cumulative survival rates of cavitated dentine carious lesion – free , high – caries risk occlusal surfaces were 95.6 % , 91.4 % , and 90.2 % for STB , CR , and ART-GIC , respectively , over 3 y , which were not statistically significantly different . For low – caries risk occlusal surfaces , no statistically significant difference was observed between the cumulative survival rate of the STB group ( 94.8 % ) and the no-intervention group ( 92.1 % ) over 3 y. There was neither a difference among STB , CR , and ART-GIC on school premises in preventing cavitated dentine carious lesions in high – caries risk occlusal surfaces of first permanent molars nor a difference between STB and no intervention for low – caries risk occlusal surfaces of first permanent molars over 3",
"PURPOSE The aim of this study was to evaluate the performance of two different glass ionomer cements using the Atraumatic Restorative Treatment ( ART ) technique in permanent teeth . MATERIAL S AND METHODS A total of 473 ART restorations were placed in 208 schoolchildren ( 7 - 12 years of age ) by two previously trained operators , using high density and resin-modified glass ionomer cements . All the restorations were photographed at baseline and the patients were asked about postoperative sensitivity . After a period of 8 months , 193 patients were present after recall and 428 restorations were evaluated and photographed . Two independent examiners carried out the evaluation . RESULTS The results showed a success rate of 86.2 % for occlusal restorations with Fuji IX and 88.4 % for those restored with Fuji Plus . A total of 86.7 % of the approximal restorations with Fuji Plus were also judged to be successful after 8 months . No association was found between the material s and the clinical performance of the ART restorations in class I cavities . CONCLUSION The type of restorative material did not influence the success or failure rates in class I cavities within this period . Fuji IX showed promising performance for occlusal ART restorations and Fuji Plus is also a promising material for occlusal and approximal ART restorations",
"AIM To compare the clinical performance of two glass ionomer cements , Amalgomer CR and Fuji IX in small and medium cavities prepared using Atraumatic restorative treatment approach in India . STUDY DESIGN One hundred school children in the age group of 4 - 9 years who had bilateral matched pair of carious lesions in primary posterior teeth were included . A split mouth design was used in which two material s were r and omly placed in contralateral sides . The performance of the restorations was assessed after 1 year using Frenken 's criteria ( 1996 ) . Survival analysis of restoration was done using chi-square test . RESULTS The survival rate of Amalgomer CR and Fuji IX class I restorations were 97.4 % and 94.9 % , respectively . In class II cavities 95.1 % and 88.5 % of Amalgomer CR and Fuji IX restorations were successful . Amalgomer CR and Fuji IX showed a success of 94.2 % and 92.3 % in small sized class II cavities . Amalgomer CR showed a 100 % success for medium sized class I and II restorations . Whereas Fuji IX showed a 100 % and 66.7 % success in medium sized class I and II cavities . CONCLUSION The clinical performances of both material s were satisfactory at the end of 1 year and ART is suitable procedure to be done in a dental clinic for children",
"The purpose of the study was to evaluate , in a clinical study over 2 years , the deterioration of two glass ionomer cements used with the atraumatic restorative treatment ( ART ) technique or approach . Fifty-five Fuji IX and 45 ChemFil Superior restorations were placed r and omly in 23 adult patients , mainly in small occlusal preparations in molar teeth . The restorations were placed in a dental hospital by one dentist using the ART technique . Photographs , radiographs and replicas were obtained at baseline and subsequent recalls . Both cements were easy to mix and place , but the radiolucency of ChemFil Superior was a disadvantage . Both cements also showed early high losses of sealant and restorative material . After 2 years , 34.5 % of the sealants appeared to be completely lost , with caries recorded in 5.3 % of the exposed fissures . In some instances , these small lesions may have been present , but not detected clinical ly , at the time of sealing . Restoration failures of 7.0 % were from wear and fracture of the cements and recurrent caries . Mean cumulative wear was 83.1 microm for Fuji IX and 104.0 microm for ChemFil Superior , which was not statistically significant . The cements became darker after their placement to more closely match the restored teeth , but there were few exact matches . There was no surface staining and only minor marginal discrepancies and staining associated with the restorations . Although the short-term clinical performance of the two glass ionomer cements was reasonable , the material s require further improvements in their mechanical properties , to reduce sealant losses and wear . The cements evaluated appear suitable for restricted use only , in posterior teeth",
"OBJECTIVE To evaluate the safety and effectiveness of a new glass ionomer restorative , ChemFlex , and to compare its clinical performance and wear to another popular material , Fuji IX GP , when used with the atraumatic restorative treatment ( ART ) approach in posterior teeth in school children . METHODS Ninety-two subjects aged between 6 and 14 years who had bilateral matched pairs of carious posterior teeth were selected . A split-mouth experimental design was used in which the two restorative material s were r and omly placed on contralateral sides . The restorations were assessed directly and also indirectly from color transparencies and die replicas . RESULTS After one year , the success rates of ART restorations in the primary teeth were 96.6 % for ChemFlex restorations and 89.7 % for Fuji IX GP restorations placed in the Class I cavity preparations , whereas only 46.2 % ( ChemFlex ) and 61.5 % ( Fuji IX GP ) of Class II restorations were assessed as clinical ly satisfactory . In the permanent dentition , the success rates were 94.6 % and 98.2 % for ChemFlex and Fuji IX GP , respectively ; however , there was no statistically significant difference between the two restoratives for either the permanent or primary teeth . The mean occlusal wear after one year in the permanent teeth was 53.2 microns for ChemFlex and 56.3 microns for Fuji IX GP . Again , there were no statistically significant differences in wear between the two material s ( P > 0.05 ) . CONCLUSION The clinical performance of both ChemFlex and Fuji IX GP over a 12-month period was highly satisfactory and completely adequate for the ART technique , particularly in Class I cavities",
"AIM This was to evaluate the influence of two methods of tooth-isolation on the survival rate of proximal ART restorations in the primary molars . METHODS The study was conducted in two rural divisions in Kenya , with 7 operators r and omly paired to a group of 8 assistants . A total of 804 children each had one proximal cavity in a primary molar restored using the ART approach . During restorations 2 isolation methods , rubber dam or cotton wool rolls , and 3 br and s of glass ionomer cements were used by the operators . The restorations were then followed for a period of 2 years . STATISTICS SPSS 14.0 was used to analyse and relate the data obtained to the method of isolation used . RESULTS After 2 years 30.8 % of the ART restorations had survived . Higher survival rates of the restorations were obtained when using rubber dam irrespective of the GIC material or the operator . CONCLUSION Generally the survival rate of the proximal restorations in the present study was very low , but the use of rubber dam result ed in a higher survival rate of the restorations",
"OBJECTIVE To evaluate the clinical performance of atraumatic restorative treatment ( ART ) fillings using Fuji IX as a filling material in field conditions . DESIGN Longitudinal study of the ART fillings in permanent teeth of primary school children aged eight to fifteen years . SETTING Primary schools in Morogoro municipality , Tanzania . SUBJECTS AND METHODS St and ard 3 and 4 children in five primary schools r and omly selected from a list of 36 primary schools of Morogoro municipality were examined for dental caries and periodontal conditions . All 296 carious lesions that were indicated for restoration were treated using ART approach according to the instructions given in the manual for ART approach for the control of dental caries . Essential measurements for treated teeth and cavity were taken . The cavities were filled with Fuji IX glass ionomer cement as per manufacturer 's instructions . After one year , 238 restorations were evaluated using the criteria for evaluating ART restorations . MAIN OUTCOME MEASURE Clinical appearance of the surface of the restorations . RESULTS Ninety four per cent of the restorations evaluated were rated as good and intact , while 1.7 % were rated as having slight defects that needed no repair , giving a one year survival rate of 96.1 % . Mean working time was 14.5 minutes . CONCLUSIONS AND RECOMMENDATIONS The one-year survival rate of 96.1 % is high enough to recommend wide use of ART in Tanzania . Town and municipal councils should be encouraged to adopt ART in their school oral health programmes",
"BACKGROUND The authors undertook a study to evaluate the effect of two cavity preparation methods on the initial survival of two more-viscous glass ionomer cements , or GICs , placed in the occlusal surfaces of permanent molar teeth . METHODS Three dentists placed 149 restorations in 68 adult patients in a hospital clinic . They used either atraumatic restorative treatment , or ART , or conventional cavity preparation methods to place two encapsulated esthetic conventional GICs : Fuji IX GP ( GC International Corp. , Tokyo ) and Ketac-Molar Aplicap ( 3 M ESPE , Seefeld , Germany ) . For comparison , they used high-copper-content GK Amalgam Alloy ( Advanced Technology & Material s Co. Ltd. , Beijing ) in conventional preparations . They evaluated the restorations using both direct and indirect observation methods . RESULTS Cavity preparations for which the authors used ART h and instruments took approximately twice as long to complete as did those for which they used conventional rotary instruments . After 12 months , no restorations had failed , but restorations comprising both GICs showed early losses of adjacent sealant material . Both GICs also showed relatively high restoration wear . At 12 months , the mean cumulative net occlusal wear for Fuji IX GP was 77 + /- 47 micrometers , and for Ketac-Molar 83 + /- 51 microm , without statistical significance ( P > .05 ) . Color matching improved significantly with time ( P minor surface tarnishing and marginal discrepancies increased with time ( P restoration performance of the GICs . However , their deterioration requires long-term monitoring . Clinical Implication s. The more viscous GICs appear initially suitable for restricted use in clinical practice when placed using either of two cavity preparation methods in the occlusal surfaces of permanent molar teeth in adults",
"AIM To evaluate the effectiveness of three different types of glass ionomer restorations placed in children 's teeth using the ART technique two years after placement by either dentists or primary health care workers . SETTING The rural district of Palpa in western Nepal . METHOD An opportunistic non-r and omised field study , commenced in April 1997 . Three different glass ionomer restorative cements were used : Fuji IX ( GC ) , Dentsply Baseline ( DENTSPLY/DeTrey ) , and S.S. WhiteR ( S.S. White ) . The restorations were assessed two years later by an independent evaluator , who was blind to the type of restorations used and also blind to the operators . RESULTS Four primary health care workers and two dentists restored 163 primary and permanent teeth using h and instruments . One and two surface restorations were placed in 105 students ranging from 3 to 19 years of age from seven schools . After two years , 79 ( 75 % ) of the restorations survived and 27 ( 25 % ) failed , while 100 % of 21 evaluated single surface restorations placed on permanent molars with Fuji IX survived . There was no statistically significant difference in the survival of the restorations placed by dentists and placed by primary health care workers , which corroborates that both groups are both capable of performing the technique satisfactorily . CONCLUSIONS ART is very effective for one surface permanent molars using improved glass ionomer cements design ed for the ART technique",
"Pain during invasive treatment of dental caries is a common phenomenon , if no local analgesia has been used before cavity preparation . Atraumatic restorative technique ( ART ) is a suggested procedure which is at least less traumatic for the patient . Although the ART approach has been received well by both children and adults who belong to population groups hardly ever exposed to regular oral health care , it has not yet been proven that this particular procedure really causes less pain , compared to more conventional techniques with rotating instruments . In the present study , pain was reported in connection with tooth restoration in 19.3 percent of the cases , when the ART technique was used , which is significantly less than with a conventional restorative technique ( 35.7 percent ) . Finally the results show a clear relationship in the pain reports between the first and the following treatments in both ART and the conventional technique groups",
"AIM : To evaluate retention and caries prevention of a glass-ionomer cement ( GIC ) and a resin-based fissure sealant placed by fifth-year undergraduate dental students . METHODS : The study was conducted according to a split-mouth , r and omised clinical trial . Children with at least one pair of caries-free permanent first molars with deep pits and fissures were included in the study . The children were selected from a population that had a high risk for dental caries . Sealant material s were applied by fifth-year undergraduate dental students on 346 fissures of the first permanent molars in 173 children . The ages of the children ranged from 7–15 years ( mean 9.4 ) . Two research ers at the clinics supervised all of the procedures . Intra-examiner reproducibility and inter-examiner reproducibility were 0.90 and 0.86 , respectively , for the clinical assessment of sealant retention and caries evaluation . RESULTS : GIC sealants were completely lost in 31.9 % and resin-based sealants in 16.6 % ( p The total retention rates of GIC sealants and resin-based sealants were 13.8 % and 20.8 % , respectively . After 24 months , the caries increment was 3.4 % for GIC sealants and 4.8 % for resin-based sealants ( p>0.05 ) . CONCLUSIONS : The retention of GIC sealants was markedly inferior to the retention of resin-based sealants ; however , GIC when used as a pit and fissure sealant was slightly more effective in preventing occlusal caries ",
"BACKGROUND As the world population ages , the requirement for cost-effective methods of treating chronic disease conditions increases . In terms of oral health , there is a rapidly increasing number of dentate elderly with a high burden of maintenance . Population surveys indicate that older individuals are keeping their teeth for longer and are a higher caries risk group . Atraumatic Restorative Treatment ( ART ) could be suitable for patients in nursing homes or house-bound elderly , but very little research has been done on its use in adults . OBJECTIVES To compare the cost-effectiveness of ART and a conventional technique ( CT ) for restoring carious lesions as part of a preventive and restorative programme for older adults . METHODS In this r and omized clinical trial , 82 patients with carious lesions were r and omly allocated to receive either ART or conventional restorations . Treatment costs were measured based on treatment time , material s and labour . For the ART group , the cost of care provided by a dentist was also compared to the cost of having a hygienist to provide treatment . Effectiveness was measured using percentage of restorations that survived after a year . RESULTS Eighty-two patients received 260 restorations , that is , 128 ART and 132 conventional restorations . 91.1 % of the restorations were on one surface only . After a year , 252 restorations were assessed in 80 patients . The average cost for ART and conventional restorations was € 16.86 and € 28.71 respectively ; the restoration survival percentages were 91.1 % and 97.7 % , respectively . This result ed in a cost-effectiveness ratio of 0.18 ( ART ) and 0.29 ( CT ) . When the cost of a hygienist to provide ART was inserted in the analysis , the result ing ratio was 0.14 . CONCLUSIONS Atraumatic restorative treatment was found to be a more cost-effective alternative to treat older adults after 1 year , compared to conventional restorations , especially in out of surgery facilities and using alternative workforce such as hygienists . Atraumatic restorative treatment can be a useful tool to provide dental care for frail and fearful individuals who might not access dental treatment routinely",
"Atraumatic Restorative Treatment ( ART ) has been adopted around the world to avoid unnecessary extraction s , especially in non-industrialized countries . The development of specific glass ionomer cements marketed for the ART technique has contributed to the technical success rate . In this study , Ketac-Molar ( 3 M ESPE , Dental Medzin , Germany ) was used to restore 150 Class I cavities in 118 Brazilian public school children , aged from 7 - 12 years . At baseline and at subsequent recalls , CPI probes with a ball-end of 0.5 millimeters ( mm ) were used to assess loss of restorative material , and photographic color transparencies of restorations were made . After six months , 83 patients returned for follow-up examinations , with 71.8 % of their restorations design ated as acceptable . After three years , 49 patients with 57 ART-restorations were evaluated , with 21.0 % of these restorations grade d as acceptable . Another 29.8 % of their restorations had been replaced by more permanent material s. The main objective of the ART technique is tooth retention ; this was achieved for 94.7 % of the restored teeth in a high caries risk population who returned for recalls",
"OBJECTIVE The purpose of this study was to evaluate two glass-ionomer cements placed in the occlusal surfaces of permanent molar teeth , using two cavity preparation methods . METHOD AND MATERIAL S Three dentists placed 149 restorations for 68 patients in a hospital clinic . Atraumatic restorative treatment or conventional cavity preparation methods were used for two encapsulated , high-strength conventional glass-ionomer cements : Fuji IX GP and Ketac-Molar . Non-gamma 2 amalgam alloy was used in conventional preparations for comparison . RESULTS The restorative procedures were uneventful , but cavity preparations made with atraumatic restorative treatment h and instruments took approximately twice as long as did conventional rotary instrumentation . After 30 months , only one glass-ionomer cement restoration had failed . Both glass-ionomer cements showed high early losses of sealant material , but caries was not detected in the exposed fissures . Both glass-ionomer cements also showed relatively high restoration wear . At 30 months , the mean cumulative net occlusal wear was 119 + /- 12 mm for Fuji IX GP and 96 + /- 13 mm for Ketac-Molar ; the difference was not statistically significant . Color matching improved significantly by 6 months ; there was no significant difference in color match between the two glass-ionomer cements by 12 months . Minor surface tarnishing and marginal discrepancies were present in the amalgam restorations and increased with time . CONCLUSION The occlusal restorations performed satisfactorily over periods of up to 30 months . However , the continued deterioration of the cements requires longer-term studies to be undertaken",
"OBJECTIVE To compare survival rates of Atraumatic Restorative Treatment ( ART ) restorations placed with and without conditioners in occlusal cariouspermanent teeth after two years . MATERIAL AND METHODS The study was an experimental study among children , mean age 13.1 + /- 3.0 years . Two types of ART restorations were r and omly placed on 186 occlusal carious permanent teeth on contralateral sides using split mouth design . Ethical clearance to conduct the study was obtained from the UI/UCH Review Committee . ART was performed using GC Fuji IX GP and teeth that were conditioned with GC Dentine Conditioner . Time taken to place restorations and average material cost were recorded . Follow-up of subjects to evaluate integrity of restorations was conducted at 6 monthly intervals by one independent examiner . Proportions and percentages were generated ; student t-test was used to compare means . Cumulative survival rates were determined by the coded scores and st and ard criteria for evaluating ART restorations . RESULTS There was no significant difference in the mean time for placing ART restorations with or without conditioners and in the cumulative survival rates of both treatment types after 2 years ( p > 0.05 ) . CONCLUSION ART restorations placed without tooth conditioners can achieve similar result as those placed with conditioners",
"BACKGROUND Laboratory studies show diverse behaviour of different br and s of glass-ionomer cements ( GIC ) . AIM This study investigated the clinical performance [ survival rate ( SR ) ] of three GIC br and s applied to proximal atraumatic restorative treatment ( ART ) restorations . Additionally , the SR of the tooth was evaluated . DESIGN Proximal cavities of 262 primary molars were restored . The patients had been r and omly allocated to two operators and three GIC br and s : Fuji IX , Hi-Dense , and Maxxion R. Restorations were evaluated after 1 , 6 , 12 , 18 , 24 , 30 , and 36 months . Failed restorations were , if possible , repaired or replaced . Linear regression analyses were used to evaluate the effect of GIC br and , operator , and surface of restoration . Kaplan-Meier survival analysis and log-rank test were performed for both restoration survival and tooth survival ( α = 5 % ) . RESULTS After 3 years , 82.4 % of the restorations were evaluated . The SR of the restorations was 24.4 % , and there was no difference among GIC br and s ( log-rank test , P = 0.6 ) . In the first 18 months , a significant operator effect and significantly higher failures in distal surfaces were found . The SR of the tooth was 81.7 % . CONCLUSIONS The SR of proximal ART restorations was relatively low when compared with the SR of the tooth . There are no differences in the performance among the GIC br and s used in the study",
"UNLABELLED Several recent studies have demonstrated the success of the ART ( atraumatic restorative treatment ) technique under field conditions in developing countries . The ART technique involves removal of caries using only h and instruments , and placing a glass ionomer cement ( GIC ) restoration . OBJECTIVES To estimate the longevity of Fuji II GIC ART restorations placed in permanent teeth by dental nurse students under field conditions in rural Cambodia . DESIGN Clinical field trial . SETTING One high school in rural Cambodia . SAMPLE AND METHODS 53 subjects between the ages of 12 and 17 who had dental caries were selected to participate . Subjects were r and omly assigned to a dental nurse student for cavity preparation and placement of ART restorations ( without cavity conditioning ) . RESULTS 92.1 % of the carious lesions required class I or class V restorations , and 85.4 % were in the lower molars . 89 teeth were filled . At 1 and 3 years 86.4 % and 79.5 % of restorations were still present . Restorations were assessed by one dentist according to st and ard criteria . 76.3 % of the restorations were judged to be successful at 1 year , and 57.9 % at 3 years . CONCLUSIONS Factors which may have affected the success rates included : the material used , technical factors , failure to condition the cavity prior to restoration , and inexperience of the operators . The results suggest that ART restorations in permanent teeth using Fuji II GIC are only moderately successful after 3 years . Better results could be expected by using a dentine conditioner in conjunction with one of the newer stronger glass ionomer cements",
"This study compared the survival of restorations produced through the atraumatic restorative treatment ( ART ) approach using glass-ionomer with those produced through the traditional approach using amalgam ( MTA ) in deciduous dentitions over a period of 3 years . Using a parallel group design , 835 grade 1 children , aged 6–7 years , participated . A total of 482 children were treated through the ART and 353 children through the MTA approach . Eight dentists produced a total of 1,891 single- and multiple-surface restorations . After 3 years , 22.1 % of the restorations were lost for evaluation . There was a statistically significant difference in the combined survival of all single- and multiple-surface restorations between the two approaches in favour of the ART approach ( p = 0.04 ) . The study revealed a 3-year cumulative survival percentage of single-surface ART and MTA restorations of 86.1 and 79.6 % , respectively . The difference was statistically significant ( p = 0.03 ) . The main reasons for both single-surface ART and MTA restorations to fail was ‘ restoration missing ’ followed by ‘ gross marginal defect ’ . The 3-year cumulative survival percentages of multiple-surface ART and MTA restorations were 48.7 and 42.9 % , respectively . The difference was not statistically significant ( p > 0.05 ) . The 3-year survival percentages of single- and multiple- surface ART and MTA restorations varied widely amongst the 8 operators with an operator effect ( p = 0.001 ) for multiple-surface MTA restorations . It can be concluded that the ART approach using glass-ionomer yielded better results in treating dentinal lesions in deciduous teeth than did the traditional approach using amalgam after 3 years . It is recommended to select the ART approach to complement the other activities of the school oral health programme",
"BACKGROUND The authors evaluated the 24-month performance of a packable resin-based composite/dentin bonding system and a high-viscosity glass ionomer cement ( GIC ) in restorations placed in primary molars with the atraumatic restorative treatment ( ART ) approach . METHODS Three dentists placed 419 restorations in 219 children aged 6 through 10 years who had bilateral matched pairs of carious posterior Class I and II primary teeth . They used a split-mouth design to place the two material s , which were assigned r and omly to contralateral sides . The authors evaluated the restorations according to U.S. Public Health Service Ryge criteria . RESULTS After 24 months , 96.7 percent of the Class I GIC restorations and 91 percent of the resin-based composite restorations survived , while the success rates for the Class II restorations were 76.1 percent and 82 percent for the GIC and resin-based composite restorations , respectively . The survival rate of the Class II resin-based composite restorations was 5.9 percent higher than that of the GIC restorations at the 24-month evaluation , but this difference was not statistically significant . However , the study results showed a statistically significant difference in survival rates between Class I and II restorations for both material s. CONCLUSION AND CLINICAL IMPLICATION S The two-year clinical performance of both material s was satisfactory for the restoration of Class I and II primary molars using the ART approach",
"OBJECTIVES The aims of this study are to assess the feasibility of the Atraumatic Restorative Treatment ( ART ) approach in primary teeth and to compare the ART approach with traditional amalgam restorations in primary molars . METHODS This study was conducted in a paediatric dentistry clinic in Kuwait between April 1999 and December 2001 . The ART and amalgam restorations were placed r and omly on comparable pairs of primary molars , if available . In addition , the ART approach was used for other primary teeth that had no pulpal involvement and no perceived pain before treatment . The restorations were assessed by both the ART evaluation criteria and USPHS criteria in August-September 2000 and in August-December 2001 . The mean follow-up period for the restorations was 8.3 months in the first assessment ( 2000 ) and 22 months in the second assessment ( 2001 ) . The assessment was possible for 35 children ( mean age = 5.7 years ) , 18 of whom had comparable pairs ( n = 35 pairs ) of restorations in their primary molars . In addition , 48 other ART restorations were assessed in 2000 and 42 in 2001 . RESULTS In a 2-year follow-up , 89.6 % of all ART restorations were considered successful . The failure rate of the comparable pairs of ART and amalgam restorations was 5.7 % . There was no significant difference in success rate between ART and amalgam techniques . CONCLUSIONS Based on a 2-year follow-up evaluation , the class I ART restorations seemed to have a high success rate , indicating the appropriateness of the ART approach in primary teeth",
"PURPOSE The high-viscosity consistency of glass ionomer cement ( GIC ) contributes to its inappropriate adaptation , while the material 's premature exposure to humidity decreases its mechanical properties . This study 's purpose s were to : ( 1 ) investigate approximal atraumatic restorative treatment ( ART ) restorations ' survival in primary molars using two different insertion techniques and two surface protection material s ; and ( 2 ) compare the results of cities where treatments were performed . METHODS A total of 389 six- to seven-year-olds were selected from two cities in Brazil and r and omly assigned into four groups : ( 1 ) ART restorations plus petroleum jelly ( PJ ) ; ( 2 ) bilayer-ART restorations plus PJ ; ( 3 ) ART restorations plus nanofilled coating for GIC ( NC ) ; ( 4 ) bilayer-ART restorations plus NC . Restorations were evaluated after one , six , 12 , 18 , and 24 months . Kaplan-Meier survival analysis , log-rank test , and Cox regression analysis were performed . RESULTS Restorations ' cumulative survival was 46.4 percent . There was a higher survival of bilayer-ART restorations ( P=0.03 ) . No difference was observed between surface protection material s ( P=0.57 ) . Restorations made in Barueri were almost 2.5-fold more likely to survive than those from Recife ( P survival in primary molars . The nanofilled coating does not influence restorations ' survival rate , and the city where treatments were performed influences restoration survival",
"AIM : The objective of the study was to determine the influence of the experience of the operator and the assistant on the survival rate of proximal ART-restorations after 2 years when placed using two methods of tooth-isolation and three glass ionomer cement-br and s. STUDY DESIGN : A clinical intervention study . METHODS : Each of 804 children aged 6–8 years received one proximal restoration in their primary molars . The restorations were placed by ‘ experienced/inexperienced ’ operators r and omly paired with ‘ experienced/ inexperienced ’ assistants . The atraumatic restorative treatment ( ART ) approach was used with 3 br and s of glass ionomer cements ( GIC ) and 2 tooth-isolation methods ( rubber dam vs cotton rolls ) . Trained and calibrated evaluators evaluated the restorations , soon after placement and after 2 years . STSTISTICS : The data collected were analyzed using SPSS 14.0 , to determine and relate the survival rate of the restorations to the operator and assistant with respect to the other factors such as the restorative material used and the isolation method applied . RESULTS : After 2 years , the survival rate of the restorations was 30.8 % . In general , there were no statistical significant differences in the survival rate of the restorations made by the ‘ experienced ’ vs ‘ inexperienced ’ operators , but individually , the operator with more experience was associated with a significantly higher survival rate of the restorations . The experienced assistants were associated with significantly higher survival rates of the restorations . The most ‘ experienced ’ operator paired with any ‘ experienced ’ assistant and using rubber dam tooth-isolation method , was associated with a significantly higher survival rate of the restorations . CONCLUSION : The combination of the ‘ experienced ’ operator and assistant using rubber dam tooth-isolation method had the best chance of survival for proximal ART restorations , irrespective of the material -br and used",
"Dental caries continues to be a highly prevalent disease among Brazilian preschoolers , especially those with low socioeconomic status . The purpose of this r and omized , controlled trial was to evaluate in vivo 245 simplified restorations in deciduous molars using glass ionomer cements ( Vidrion R and Ketac-Molar ) . Dental restorations were evaluated at 6- and 12-month follow-ups . The teeth restored with Vidrion R ( SS White ) on a single tooth surface were successful in 87 % of the cases evaluated at 6 months and in 63 % at 12 months . The teeth restored with Ketac-Molar on one surface achieved a success rate of 95 % at 6 months and 82 % at 12 months . No recurrent caries or pulpal infection was evident . Logistic regression analysis demonstrated that teeth with cavities restricted to the occlusal surface on sclerotic dentin showed the best adhesion to the restorative material . The restorations with Ketac-Molar had a better clinical performance than those with Vidrion",
"OBJECTIVE The hypotheses tested were : the cumulative survival rates of dentin caries lesion-free pits and fissures of ART conventional high-viscosity glass-ionomer sealants with light-curing ( high-intensity LED ) and glass-carbomer sealants are higher than those of conventional ART sealants and resin-composite sealants after 4 years . METHODS The r and omized controlled clinical trial covered 405 children ( mean age 8-years ) . Three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 , 2 , 3 and 4 years . The Kaplan-Meier survival method , ANOVA and t-test were used in data analyses . RESULTS 1304 first permanent molars were sealed . 12.3 % of children and 15.4 % of sealants dropped out . 46 re-exposed pits and fissures , 39 ( occlusal ) 7 ( free smooth surfaces ) , in 42 children developed a dentin carious lesion . The cumulative survival of dentin caries lesion-free occlusal pits and fissures in ART plus LED group ( 98 % ) was statistically significantly higher than in the resin-composite group ( 96.4 % ) and in the glass-carbomer group ( 94.5 % ) . The cumulative survival of dentin caries lesion-free occlusal pits and fissures in the glass-carbomer group was statistically significantly lower than that in the conventional ART group ( 97.3 % ) . For the free smooth surfaces , there was no statistically significantly difference among the four sealant groups . SIGNIFICANCE Light-cured ART conventional high-viscosity glass-ionomer sealants prevented the occurrence of dentin cavities best",
"The present study was aim ed at comparing the effectiveness of three minimally invasive restorative treatment approaches for dentinal lesions in occlusal surfaces . The approaches tested comprised a conventional and a modified – conventional treatment and a modified Atraumatic Restorative Treatment ( ART ) . The conventional approach was performed in a university dental clinic whilst the modified – conventional , employing portable equipment , and the modified ART , using h and instruments and a caries removal solution ( Caridex ® ) , were carried out in the field . Using the split – mouth design , 430 matched contralateral pairs of occlusal cavities were restored with amalgam or glass – ionomers in permanent molars of 152 school children by one dental therapist . The restorations were assessed using a modified USPHS – Ryge criteria . After 2 years , the cumulative survival percentages for occlusal amalgam and glass – ionomer restorations were 92 and 96 % , respectively . The survival of all restorations in the conventional , modified – conventional and the modified ART group was 96 , 96 and 91 % , respectively . The survival of occlusal amalgam and glass – ionomer restorations per treatment group was as follows : 94 and 99 % , respectively ( conventional group ) ; 95 and 97 % , respectively ( modified – conventional group ) , and 89 and 93 % , respectively ( modified ART group ) . The differences in survival percentage between restorations with amalgam and glass – ionomer , and between the three restorative treatment approaches were not statistically significant . In countries facing scarcity in re sources for dental care , ART seems a promising restorative approach to occlusal caries in posterior teeth . However , a longer clinical observation period is required to substantiate this initial conclusion",
"A pragmatic r and omised controlled trial comparing a minimally invasive approach based on atraumatic restorative treatment ( ART ) procedures ( test ) was tested against the st and ard-care approach ( control ) to treat early childhood caries ( ECC ) in a primary -care setting in Perth , W.A. , Australia . Parent/child dyads with ECC were allocated to the test or control group using stratified block r and omisation . Children were examined at baseline and follow-up by two calibrated examiners blinded to group allocation status . Dental therapists trained in ART provided treatment to the test group and dentists treated the control group . Restoration quality was evaluated at follow-up using the ART criteria . Data were analysed on an intention-to-treat basis ; test of proportions , Wilcoxon rank test and logistic regression , controlling for clustering of teeth , were used . Two hundred and fifty-four children were r and omised ( test = 127 and control = 127 ) . There was no statistically significant difference in age , sex and baseline caries experience between the test and control groups . At follow-up ( mean interval 11.4 months , SD 3.1 ) , 220 children were examined ( test = 115 and control = 105 ) and 597 teeth ( test = 417 and control = 180 ) were evaluated for restoration quality , of which 16.8 % ( test ) and 6.7 % ( control ) were judged to have failed ( required replacement ; p multisurface restorations ( OR = 10.4 ) had significantly higher odds of failure , while referral for specialist paediatric care had significantly lower odds of restoration failure ( OR = 0.2 ) . The ART-based approach enabled more children and teeth to be treated , and multisurface restoration and treatment in a primary -care setting had higher odds of restoration failure",
"Extraction is the most common dental treatment provided for people in rural and suburban areas in many less-industrialised countries . By comparison , restorative care is rarely provided . In order to improve such situations , a treatment technique has been developed based only on h and excavation of carious lesions and using glass-ionomer cement as a filling material and a sealant . This Atraumatic Restorative Treatment ( ART ) technique follows the concept of minimal intervention and does not require electrically driven equipment . This paper reports on the longevity of fillings and sealants placed using the technique under field conditions in rural Thail and . Dental caries was treated using the ART technique in one village , whilst the population in a second village received restorative care ( amalgam fillings ) through mobile dental units . A third village was the control . After one year , 79 per cent of single surface ART fillings and 55 per cent of ART fillings of greater than one surface placed in deciduous teeth were judged successful . The success rate of ART fillings in the permanent dentition ( mainly single surface fillings ) was 93 per cent and the retention rate for sealants was 78 per cent . Children were pleased at having received treatment by this technique and showed little fear . The ART technique is a promising caries treatment procedure for use in rural and sub-urban areas in less-industrialised countries",
"OBJECTIVE This study compares the quality of class I restorations made with the atraumatic restorative treatment ( ART ) technique and conventional class I amalgam restorations . METHODS The study was carried out among secondary school students in Mzuzu , Malawi . First-year students in 1987 who needed at least two class I restorations were selected . Based on a split-mouth design , each participant received both ART and conventional restorations . The 89 pairs of class I cavities were divided r and omly into two groups , since two different cermet ionomer cement ( CIC ) filling material s were used . Impressions of the restorations and subsequent models were made shortly after restoration , after six months , one year , two years , and three years . The quality of the restorations was determined on the models following the US Public Health Service criteria . Bulk fracture , contour , marginal integrity , and surface texture of the restorations were recorded and evaluated separately . Survival rates were determined by the result ant score of all criteria . RESULTS Though conventional amalgam restorations performed better on all criteria , this difference was significant only for the contour criterion . The survival rates of ART restorations after three years ( 81.0 % ) were lower than those of amalgam restorations ( 90.4 % ) ( P=.067 ) . CONCLUSIONS The quality of ART class I restorations is competitive with that of conventional amalgam restorations",
"OBJECTIVE The purpose of this study was to compare the success rates of glass-ionomer cement restorations placed with the atraumatic restorative treatment approach and conventional cavity preparation methods . METHOD AND MATERIAL S Two encapsulated , high-strength , esthetic conventional glass-ionomer cements were placed in 82 Class I and 53 Class II atraumatic restorative treatment and conventional cavity preparations , and an encapsulated amalgam alloy was placed in 32 Class I conventional preparations , in vital primary molars of 60 Chinese children aged 7 to 9 years . RESULTS The atraumatic restorative treatment preparations , made with h and instruments only , took approximately 50 % longer to complete than did the preparations completed with conventional rotary instrumentation . After 1 year , there were no amalgam failures . For the glass-ionomer cement restorations , when the atraumatic restorative treatment method was used , significantly better survival rates were found for Class I ( 92.9 % ) than for Class II ( 64.7 % ) cavity preparations . There was also a strong trend for relatively better survival rates for the conventional cavity preparation method ( 86.7 % ) than for the atraumatic restorative treatment ( 64.7 % ) method for Class II cavity preparations . However , both the atraumatic restorative treatment and conventional methods appeared equally effective for Class I preparations . CONCLUSION In a clinic setting , the use of atraumatic restorative treatment h and instruments for cavity preparation is more time consuming , and the method may also provide less mechanical retention and /or bulk of glass-ionomer cement for some Class II preparations in primary molars than does the use of conventional rotary instruments",
"Objectives The aims of this study were to compare 2-year cumulative survival rates of amalgam and atraumatic restorative treatment ( ART ) restorations in primary molars and to investigate the determinants of the survival rate of restorations . Material s and methods A controlled clinical trial using a parallel group design was carried out on 258 children aged 6–7 years old , allocated to two treatment groups : conventional restorative treatment using amalgam and ART using high-viscosity glass ionomer . A total of 364 amalgam restorations and 386 ART restorations were placed by three pedodontists in 126 and 158 children , respectively , and were evaluated after 0.5 , 1 , and 2 years . Restorations were placed in vital primary molars with neither pain nor signs of pulp involvement . The survival analysis was conducted using the proportional hazard rate regression model with frailty correction . Results The 2-year cumulative survival rates for all amalgam ( 77.3 % ) and ART ( 73.5 % ) restorations were not statistically significantly different , but there was an effect of “ type of surface ” ( single/multiple ) and “ cavity filling time ” on the survival rates . Both amalgam and ART single-surface restorations had higher survival rates than multiple-surface restorations of the same material . Secondary caries was responsible for 36 and 38 % of failures in amalgam and ART restorations , respectively . Mean time for restoring all type of cavities with amalgam and ART restorations was 13.6 and 13.7 min , respectively . Conclusions Amalgam and ART restorations presented similar survival rates over a 2-year period for all , single-surface , and multiple-surface restorations . Clinical relevance In the cause of finding alternatives to amalgam , ART restorations using high-viscosity glass ionomer might be a suitable option for managing cavitated dentine carious lesions in vital primary molars",
"The atraumatic restorative treatment technique ( ART ) is based on removing infected tooth material using only h and instruments and filling the subsequently cleaned cavity with adhesive material such as glass ionomer . As its name suggests , the ART technique should be atraumatic during treatment , as well as for the tooth itself as for the patient . It was primarily developed for treating people living in underserved areas of the world where re sources and facilities such as electricity and trained manpower are limited . Many studies have evaluated the ART technique and the results have supported its application . However , a very limited number of studies have compared ART with more conventional techniques . For that reason , a study was conducted in Pakistan , to compare the ART technique with another more conventional treatment technique . The results of this study show that the preparations with h and instruments result ed in smaller sized cavities and therefore may be less traumatic to the tooth . It was also associated with less pain reactions compared to the more conventional technique . Although preparations with h and instruments required more time , this did not seem to affect the survival of restorations . The survival of glass ionomer cement restorations made with h and instruments was comparable with single surface amalgam restorations made with a more conventional technique . Recurrent caries was not associated with any glass ionomer cement restorations made with h and instruments . The retention rate of glass ionomer sealants was low , however one dentist had a sealant retention rate of 81.5 percent that suggests that this procedure can be performed satisfactorily in conjunction with a glass ionomer cement restoration . Operator variances did seem to affect the restorations . Survival of glass ionomer restorations made with both h and and rotary instruments varied for different operators . Similarly , the retention of fissure sealant also varied amongst operators . Operator differences also influenced the extent of tooth substance lost due to cavity preparation . The ART technique is a feasible approach towards the treatment of dental caries especially of one-surface lesions for underserved population",
"Aim : To assess the influence of different variables on the survival of class II glass ionomer cements ( GIC ) in a clinical study among 6–7 year old schoolchildren in and around Dar es Salaam , Tanzania . Methods : 217 children were r and omly divided into three groups . In the conventional group , Class-II cavities were excavated with burs , in the ART group they were excavated with h and instruments and in the Carisolv ™ group excavation took place with a chemical solution and special blunt h and instruments . The preparations in all groups were restored with h and mixed GIC ( Fuji IX ) by 4 operators . After restoration , residual caries and cervical gaps were assessed on bite-wing radiographs . The quality of the restorations was established and the survival rate determined in two subsequent evaluations . Results : 195 children ( 90 % ) were present at the first evaluation which took place after 7 months and 194 ( 89 % ) were present at the second evaluation , after one year . At the first evaluation the survival rate of the ART-restorations was 38 % , of the conventional restorations 50 % , and of the Carisolv ™ restorations 35 % . Survival rates at the time of the second evaluation were 30 % , 42 % and 28 % respectively . The differences between the three treatment groups were , however , not significant ( p=0.200 at t=1 and p=0.247 at t=2 ) . In the first evaluation 161 bitewings were available of the 195 restorations , while for the second evaluation 130 . There was no significant relation between residual caries and the success/failure rate ( p=0.140 at t=1 and p=0.201 at t=2 ) . Also , cervical gaps appeared to have no relation with the failure rate ( p=0.057 at t=1 and p=0.833 at t=2 ) However , together those variables have a significant influence on the survival rate ( p = 0.025 ) . Conclusion : The combination of two variables ( residual caries and cervical gaps ) has considerable influence on the survival rate of class II GIC restorations compared to each variable alone",
"Background : Although Atraumatic restorative treatment ( ART ) approach has been in existence for a while , the reasons for the poor performance of multisurface ART restorations are not very clear . Aim : The aim of this study is to investigate the effects of oral hygiene , residual caries and cervical marginal-gaps on survival of proximal ART restorations . Setting s : Two rural divisions in Kenya were selected for the study . Design : A r and omized clinical trial . Material and Methods : The 804 children in the study had their baseline- and 2-year dental plaque levels documented . Each child received one proximal restoration in a primary molar using ART approach , together with trained and pre-tested operators/assistants , three glass ionomer cements (GIC)-br and s and two tooth-isolation methods . The restorations were clinical ly evaluated soon after placement and after 2 years . Post-restorative bite-wing radiographs taken soon after restoration were also evaluated . Statistical analysis : Statistical Package for Social Sciences ( SPSS ) version 14 computer programme was used and results tested using Pearson 's correlation , Cox Proportional Hazards regression analysis and Multiple Logistic regression models tests . Results : At baseline and after 2 years , the mean cumulative survival and plaque index changed from 94.4 % to 30.8 % and 2.34 ( St and ard Deviation , or SD of 0.46 ) to 1.92 ( SD 2.1 ) respectively , with higher plaque indices associated with higher restoration failures . Of the 507 radiographs evaluated , 48 ( 9.5 % ) , 63 ( 12.4 % ) and 9 ( 1.8 % ) restorations had residual caries ( RC ) , cervical marginal-gaps ( CMG ) and both RC/CMG respectively . Survival of the restorations with RC/CMG was significantly lower ( p = 0.003 ) compared to those with RC or without RC . Conclusion : Low survival of proximal restorations in the study was associated with the presence of cervical marginal-gaps",
"OBJECTIVES The Atraumatic Restorative Treatment ( ART ) approach was compared with the traditional amalgam ( TA ) approach in order to test their appropriateness to complement a preventive and educational school oral health programme in Syria . METHODS Using a parallel group design , 370 and 311 grade 2 children were r and omly assigned to the ART and the TA group respectively . Eight dentists placed 1117 single- and multiple-surface restorations . A modified actuarial method was used to estimate survival curves . The jackknife method was applied to calculate the st and ard error in the cumulative survival percentages . RESULTS A statistically significant difference in cumulative survival percentages between single-surface non-occlusal ART and comparable amalgam restorations was observed after 4.3 , 5.3 and 6.3 years . The survival of single-surface non-occlusal ART posterior restorations ( 80.2 + /- 4.9 % ) was statistically significantly higher than that of occlusal posterior ART restorations ( 64.8 + /- 3.9 % ) at evaluation year 6.3 . There was no statistically significant difference observed between survival percentages of large ( 55.8 + /- 10 % ) and that of small ( 69.2 + /- 4.6 % ) single-surface posterior ART restorations after 6.3 years . There was an operator effect observed for single-surface ART and comparable amalgam restorations . Secondary caries was observed in 2.3 % of single-surface ART restorations and in 3.7 % of single-surface amalgam restorations during the 6.3 year observation period . CONCLUSIONS The ART approach provided higher survival percentages for single-surface restorations than the TA approach over 6.3 years and is therefore appropriate for use in school oral health programmes . Secondary caries was only a minor reason for ART restorations to fail . An operator effect was observed for both treatment approaches",
"The None hypothesis tested was that there is no difference in the survival percentages of all restorations placed through the Atraumatic Restorative Treatment ( ART ) approach , with high-viscosity glass ionomer , and those produced through the traditional approach , with amalgam ( TA ) , in the permanent dentitions of children after 6.3 years . Using a parallel group design , we r and omly assigned a total of 370 children , aged 6 to 9 years , to the ART group and 311 children , also aged 6 to 9 years , to the TA group . Eight dentists placed a total of 1117 single- and multiple-surface restorations . The cumulative survival percentages for ART glass-ionomer restorations were statistically significantly higher than those of amalgam restorations at all time intervals except the first ( p ≤ 0.044 ) . After 6.3 years , the cumulative survival percentages of ART and amalgam restorations were 66.1 % ( SE = 3.1 % ) and 57.0 % ( SE = 3.3 % ) , respectively . We concluded that the restorations produced with the ART approach , with high-viscosity glass ionomer , survived longer than those produced with the traditional approach , with amalgam , in the permanent teeth of young children",
"The purpose was to compare the retention and caries preventive effect of Fuji VII and a resin-based sealant in children at high risk ( HR ) and low risk ( LR ) of caries . Fifty-seven schoolchildren ( 150 teeth ) with completely erupted bilateral permanent first molars were included . The study was a split-mouth , r and omized trial . Sealant retention and caries were evaluated after 6 months , 1 year and 2 years . After 2 years , there was no statistically significant difference in the incidence of caries between Fuji VII and Concise in the HR and LR groups . With Concise , LR children were less likely to have dental caries than HR . With Fuji VII , there was no difference in caries incidence between LR and HR . Retention of Concise was superior to that of Fuji VII . Our results suggest that Fuji VII and Concise sealants had similar caries preventive effects in children at high and low risk of caries",
"Objectives : The aim of this study was to assess the feasibility of the resin-modified glass ionomer ( RMGI ) material in atraumatic restorative treatment ( ART ) approach and compare RMGI with the high-strength traditional glass ionomer cement ( GIC ) in permanent teeth with one or more surface-carious cavities . Material s and Methods : This study was conducted in a village school in rural southeastern Anatolia , Turkey . The RMGI and GIC restorations with the ART technique were placed r and omly employing a split mouth design . In addition , the ART approach was used when necessary for both primary and /or permanent teeth with no pulpal involvement and no perceived pain before treatment . Ninety-one fillings were placed on contralateral molar pairs of 37 children . Baseline and 6-month evaluation of the fillings were made with the classic ART , modified Ryge and USPHS criteria . Results : Based on the ART criteria , 100 % of RMGI and 92.4 % of GIC restorations were classified as successful after 6 months , and the difference between the 2 groups was statistically significant ( p = 0.009 ) . While marginal discoloration was the commonest failure in the RMGI group according to both the modified Ryge and USPHS criteria , unsatisfactory surface texture and low anatomic form were the commonly seen failures in the ART technique . Conclusion : Generally , for each rating system , RMGI exhibited better clinical performance than GIC in all categories , except for marginal discoloration . Results based on the 6-month evaluation show that RMGI can be an alternative material to the GIC",
"Objective : To compare the clinical performance of two glass – ionomer cements , ChemFlex ( Dentsply DeTrey ) and Fuji IX GP ( GC ) , when used with the atraumatic restorative treatment ( ART ) approach in China . Methods : Eighty – nine school children aged between 6 and 14 years who had bilateral matched pairs of carious posterior teeth were included . A split – mouth design was used in which the two material s were r and omly placed on contralateral sides . The performance of the restorations was assessed directly and also indirectly from die – stone replicas at baseline and after 6 , 12 , and 24 months . Results : The 24–month cumulative survival rates of ART restorations in the primary teeth were 93 and 90 % for the ChemFlex and Fuji IX GP class I restorations , respectively , while 40 and 46 % of class II restorations placed with the respective material s were satisfactory . In the permanent dentition , only class I restorations were involved and the cumulative survival rates were 95 and 96 % for ChemFlex and Fuji IX GP . For the primary teeth after 24 months , net mean occlusal wear was 87 µm for ChemFlex and 85 µm for Fuji IX GP . The occlusal wear in the permanent teeth was 75 µm for ChemFlex and 79 µm for Fuji IX GP . Conclusion : The clinical performance of both material s over a 24–month period was similar and the survival rates of class I ART restorations in both primary and permanent teeth were high",
"OBJECTIVES The objectives of this study were : to provide restorations using the ART approach to pre-school children in Southern China in a kindergarten environment , using a high-strength glass-ionomer restorative material ; to assess the acceptability of this approach and to evaluate on a longitudinal basis the restorations placed . SAMPLE AND METHODS A total of 170 ART restorations were placed in 95 children , aged 5.1 + /- 0.7 years , by seven final-year dental students using st and ard ART procedures and h and instruments . The restorations were evaluated every six months thereafter by two calibrated independent examiners using explorers and mouth-mirrors . RESULTS 93 % of the children reported that they did not feel pain during treatment and 86 % were willing to receive ART restorations again . The cumulative 12- and 30-month survival rates of Class I restorations were 91 % and 79 % , respectively . The corresponding figures for Class V restorations were 79 % and 70 % , while those for Class II restorations were 75 % and 51 % . The failure rates of Class III and IV restorations were high with more than half of them scored as missing within the first year . CONCLUSIONS The ART approach was shown to be acceptable to Chinese pre-school children for providing restorative dental care outside the traditional clinical setting . The success rates were high for Class I and V restorations in primary teeth , modest for Class II , and low for Class III and IV restorations",
"AIM To evaluate the influence of the size of proximal cavities on the survival rate of the atraumatic restorative treatment ( ART ) restorations . DESIGN A total of 804 children , aged 6 - 8 years , from a low socio-economic community , with an ART restorable proximal carious lesion in their primary molars , participated . Over a 3-week period , three ' experienced ' and four ' inexperienced ' operators r and omly paired with four ' experienced ' and four ' inexperienced ' assistants , made the restorations at site using h and instruments . They r and omly used Fuji IX , Ketac Molar Easymix and Ketac Molar Aplicap glass ionomer cements to restore the cavities , under r and omly selected rubber dam and cotton roll isolation methods . The fillings were independently evaluated by nine trained and calibrated evaluators . RESULTS After 1 year , the survival rate of the fillings evaluated in the study was 44.8 % . Irrespective of the other factors involved , restorations with the highest survival rate were of size between 2 and 3 mm ( mesio-distal , bucco-lingual , and depth ) or volumes 10.0 - 19.9 mm(3 ) ( Chi-square , P = 0.002 , KM mean survival of 345 days ) . CONCLUSIONS While the survival rates for class II ART restorations were still low , the choice of medium-sized proximal cavities gave better survival rates for this technique",
"OBJECTIVES Oral health care is not of major interest in developing countries because of lack of infrastructure and professional manpower . Therefore , atraumatic restorative treatment ( ART ) was introduced by the World Health Organization to be performed by dental auxiliary personnel . The aim of this study was to evaluate the performance of ART depending on operator-experience in The Republic of The Gambia . METHODS One hundred twenty-eight newly inserted restorations were followed up for 12 months using the clinical ART index in a prospect i ve and blinded study design . The patients were r and omly assigned to operators . The clinical performance was compared among three groups : trainees , experienced Community Oral Health Workers ( COHW ) , and professional dentists . The difference in success rates was calculated at a 95 percent confidence interval . RESULTS There was a statistically significant difference between trainees and dentists in performing leakage/gap-free one-surface restorations ( P 0.05 ) . Finally , both groups -- experienced COHWs and dentists -- performed restorations not showing statistically significant differences ( P > 0.05 ) . CONCLUSIONS For The Republic of The Gambia -- especially for areas with underdeveloped medical infrastructure -- training and assignment to perform ART can be recommended for auxiliary dental staff of Community Oral Health Workers",
"The Hall Technique ( HT ) is a method for managing carious primary molars . Decay is sealed under pre-formed metal crowns without any caries removal , tooth preparation , or local anesthesia . The aim of this study was to compare HT clinical /radiographic failure rates with General Dental Practitioners ’ ( GDPs ) st and ard ( control ) restorations . We conducted a split-mouth , r and omized control trial ( 132 children , aged 3 - 10 yrs , GDPs n = 17 ) in Scotl and . There were 264 study teeth with initial lesions , 42 % of which were radiographically > half-way into dentin , and 67 % of which had Class II restorations . Teeth were r and omized to HT ( intervention ) or GDPs ’ usual treatment ( control ) . Annual clinical /radiographic follow-up data were recorded . Ninety-one patients ( 69 % ) had 48 months ’ minimum follow-up . At 60 months , ‘ Major ’ failures ( irreversible pulpitis , loss of vitality , abscess , or unrestorable tooth ) were recorded : HT , 3 ( 3 % ) ; control restorations , 15 ( 16.5 % ) ( p = 0.000488 ; NNT 8) ; and ‘ Minor ’ failures ( reversible pulpitis , restoration loss/wear/fracture ; or secondary caries ) : HT , 4 ( 5 % ) ; control restorations , 38 ( 42 % ) ( p 130 patients ( 2 - 60 mos ) : ‘ Major ’ failures : HT , 3 ( 2 % ) ; control restorations , 22 ( 17 % ) ( p = 0.000004 ; NNT 7 ) ; and ‘ Minor ’ failures , HT , 7 ( 5 % ) ; control restorations , 60 ( 46 % ) ( p Sealing in caries by the Hall Technique statistically , and clinical ly , significantly outperformed GDPs ’ st and ard restorations in the long term ( Trial registration no. IS RCT N 47267892 )"
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Etanercept ( ETN ) has been widely applied in the treatment of ankylosing spondylitis ( AS ) . As the use of ETN has increased , associated adverse effects have been reported frequently . Previous meta-analyses have focused on comparing the differences in clinical outcomes between ETN and placebo ( PBO ) . The present meta- analysis evaluated r and omised controlled trials ( RCTs ) to compare the effects of ETN and a PBO or sulfasalazine ( SSZ ) in patients with AS . The study population characteristics and the main results , including the Assessment in AS 20 % response ( ASAS 20 ) , the Bath AS Disease Activity Index ( BASDAI ) and the Bath AS Functional Index ( BASFI ) , were extracted . The pooled odds ratios ( ORs ) or weighted mean differences ( MDs ) were calculated using a fixed or r and om effects model . Fifteen r and omised controlled trials ( RCTs ) involving 2,194 subjects were included . Compared with a PBO , ETN significantly improved the ASAS 20 [ P BASDAI ( P BASFI ( P SSZ , ETN significantly decreased the BASDAI ( P C-reactive protein ( CRP ) levels ( P adverse effect of ETN was an injection site reaction . This meta- analysis shows that ETN monotherapy is effective in improving physical function and reducing disease activity in patients with AS . Compared with SSZ , ETN markedly decreased the BASDAI and CRP levels . However , the efficacy of ETN in treating AS requires further evaluation by more RCTs in a larger population of patients prior to recommending ETN as a substitute for synthetic disease-modifying antirheumatic drug ( DMARD ) monotherapy , or combinations of synthetic DMARDs
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"Objective : A double blind , r and omised , placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis ( AS ) . Methods : Adult patients with AS at 14 European sites were r and omly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks . The primary efficacy end point was an improvement of at least 20 % in patient reported symptoms , based on the multicomponent Assessment s in Ankylosing Spondylitis ( ASAS ) response criteria ( ASAS 20 ) . Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , acute phase reactants , and spinal mobility tests . Safety was evaluated during scheduled visits . Results : Of 84 patients enrolled , 45 received etanercept and 39 received placebo . Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2 , and sustained differences were evident up to week 12 . Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2 , 4 , and 8 ; reported lower composite and fatigue BASDAI scores ; had lower acute phase reactant levels ; and had improved spinal flexion . Etanercept was well tolerated . Most adverse events were mild to moderate ; the only between-group difference was injection site reactions , which occurred significantly more often in etanercept patients . Conclusions : Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS",
"Objectives Patients with advanced ankylosing spondylitis ( AS ) experience disability because of reduced spinal mobility and pulmonary function impairment . This placebo-controlled study evaluated the effect of etanercept ( ETN ) in patients with advanced AS . Methods A multicentre r and omised double-blind placebo-controlled trial of 12 weeks ' duration was performed . Patients had definite ( modified New York criteria ) , active ( Bath AS Disease Activity Index ( BASDAI ) ≥40 ) , severe ( radiological intervertebral bridges ) AS refractory to non-steroidal anti-inflammatory drugs and were antitumour necrosis factor naive . They were treated with ETN 50 mg once weekly or identical placebo ( PBO ) . Results Of the 95 patients screened , 82 were r and omised to receive ETN ( n=39 ) or PBO ( n=43 ) . At baseline the disease was active ( mean BASDAI 61.0±13.4 , C reactive protein ( CRP ) 20.7±25.5 mg/l ) and severe ( mean Bath AS Metrology Index ( BASMI ) 5.7±1.3 , mSASSS 36.5±20.5 ) ; forced pulmonary vital capacity ( FVC ) was 3.3±0.7 l. Improvement in BASDAI ( normalised net incremental area under the curve between baseline and week 12 , primary end point ) was significantly greater in the ETN group than in the PBO group ( −19.8±16.5 vs −11.0±16.4 , p=0.019 ) . Moreover , at week 12 , ETN gave better results than PBO for the BASDAI ( −26.4±19.7 vs −14.4±19.7 ; p=0.008 ) , total back pain ( −29.2±24.0 vs −14.9±24.0 ; p=0.010 ) , BASFI ( −21.7±17.6 vs −10.1±17.6 ; p=0.004 ) , BASMI ( −0.6±0.6 vs −0.2±0.6 ; p=0.011 ) , CRP level ( −15.7±14.2 vs −1.3±14.2 ; p FVC ( + 160±280 ml vs −20±280 ml ; p=0.006 ) . Conclusions ETN has short-term efficacy for patients with advanced AS , as was previously reported for less advanced disease . The efficacy is observed for the main symptoms ( pain ) and on markers of inflammation ( CRP ) , as well as disease severity in terms of spinal mobility and pulmonary function",
"BACKGROUND Etanercept , a tumour-necrosis-factor inhibitor , has shown efficacy in the treatment of rheumatoid arthritis . Psoriatic arthritis and psoriasis are disease states in which tumour necrosis factor , a proinflammatory cytokine , is present in increased concentrations in joints and in the skin . Therefore , psoriatic arthritis and psoriasis may be appropriate therapeutic targets for etanercept . METHODS This r and omised , double-blind , placebo-controlled , 12 week study assessed the efficacy and safety of etanercept ( 25 mg twice-weekly subcutaneous injections ) or placebo in 60 patients with psoriatic arthritis and psoriasis . Psoriatic arthritis endpoints included the proportion of patients who met the Psoriatic Arthritis Response Criteria ( PsARC ) and who met the American College of Rheumatology preliminary criteria for improvement ( ACR20 ) . Psoriasis endpoints included improvement in the psoriasis area and severity index ( PASI ) and improvement in prospect ively-identified individual target lesions . FINDINGS In this 12 week study , 26 ( 87 % ) of etanercept-treated patients met the PsARC , compared with seven ( 23 % ) of placebo-controlled patients . The ARC20 was achieved by 22 ( 73 % ) of etanercept-treated patients compared with four ( 13 % ) of placebo-treated patients . Of the 19 patients in each treatment group who could be assessed for psoriasis ( > or = 3 % body surface area ) , five ( 26 % ) of etanercept-treated patients achieved a 75 % improvement in the PASI , compared with none of the placebo-treated patients ( p=0.015 ) . The median PASI improvement was 46 % in etanercept-treated patients versus 9 % in placebo-treated patients ; similarly , median target lesion improvements were 50 % and 0 , respectively . Etanercept was well tolerated . INTERPRETATION Etanercept offers patients with psoriatic arthritis and psoriasis a new therapeutic option for control of their disease",
"Ankylosing spondylitis is a chronic inflammatory disease that leads to significant loss of function and disability in patients . Current conventional therapies have not demonstrated improvement in axial symptoms and progressive ankylosis of the spine . The use of new biologic agents that block the actions of tumor necrosis factor-alpha have , for the first time , reported significant improvement in axial symptoms and reduction in spinal inflammation in short-term studies . Future studies with larger numbers of patients over long periods of time will eventually determine the long-term success and safety of these agents",
"OBJECTIVE To evaluate the efficacy and safety of etanercept 50 mg once-weekly treatment of Chinese patients with active ankylosing spondylitis ( AS ) . METHODS Four hundred patients with active AS , enrolled in six medical centers , were r and omly divided into either the treatment group or the placebo group in a 3:1 ratio . The total length of the study was 12 weeks . The first 6-week period was a double-blind placebo controlled treatment period and the second 6-week period was an open-labeled treatment period . During the first 6-week period , 300 patients in the treatment group received once-weekly subcutaneous injection of etanercept ( 50 mg ) , whereas the 100 patients in the placebo group received placebo injection . During the second 6-week period , patients in both groups received etanercept ( 50 mg once weekly subcutaneous injection ) . The primary end point was the percentage of patients achieving the Assessment s in Ankylosing Spondylitis ( ASAS ) 20 % response ( ASAS 20 ) at week 6 . Other outcome measures included the percentage of patients achieving ASAS 5/6 , partial remission and Bath AS disease activity index 50 ( BASDAI 50 ) responses at week 12 . RESULTS A total of 381 patients completed the trial , including 285 patients in the etanercept group and 96 patients in the placebo group . At week 2 , the percentage of patients achieving ASAS 20 in the etanercept group was 55.7 % , whereas the placebo group was only 17.0 % ( P etanercept group achieved ASAS 20 as compared with 32.3 % in the placebo group ( P etanercept group achieving the ASAS 20 was 89.5 % . Improvements of other measures were also significant in the etanercept group . Etanercept was well tolerated and no malignancy and life-threatening events were observed in this study . Most adverse events observed were mild injection-site reactions . CONCLUSION Etanercept 50 mg weekly treatment of Chinese patients with active ankylosing spondylitis is convenient , fast-acting , highly effective , and well tolerated",
"OBJECTIVE Etanercept , a fully human tumor necrosis factor ( TNF ) receptor , is an effective treatment in patients with ankylosing spondylitis ( AS ) . Sulfasalazine is frequently used for the treatment of both axial symptoms and peripheral symptoms of AS , and it has been the recommended therapy before the use of an anti-TNF agent when peripheral arthritis is present . Until now , no clinical trial has compared the efficacy and safety of a TNF blocker with that of sulfasalazine . This study was undertaken to compare the efficacy and safety of etanercept with that of sulfasalazine after 16 weeks of treatment in patients with axial and peripheral manifestations of AS . METHODS In this r and omized , double-blind study , patients received etanercept 50 mg once weekly ( n=379 ) or sulfasalazine titrated to a maximum of 3 gm/day ( n=187 ) for 16 weeks . The primary end point was the proportion of patients who achieved the Assessment of SpondyloArthritis international Society criteria for 20 % improvement ( ASAS20 ) at 16 weeks . Last observation carried forward was predefined for imputation of missing values . RESULTS The mean age of the patients was 41 years , 74 % were male , and the mean disease duration was 7.6 years . The proportion of ASAS20 responders at week 16 was greater among patients treated with etanercept compared with those treated with sulfasalazine ( 75.9 % versus 52.9 % ; P etanercept was found to be more effective than sulfasalazine ( P the axial symptoms and peripheral manifestations . Serious adverse events rarely occurred , and the rate of serious adverse events did not differ between groups . CONCLUSION In this population of patients with AS , etanercept was significantly more effective than sulfasalazine in improving the signs and symptoms of AS in the axial skeleton and peripheral joints",
"The pathogenesis of ankylosing spondylitis ( AS ) still remains an enigma . Although some studies have indicated the importance of T-cells and proinflammatory cytokines in the pathogenesis of the AS , it is still unknown whether co-stimulatory molecule CD154 participates in the pathogenesis of AS and how its level changes during the anti-TNF-α treatment of AS . This study is performed to evaluate the expression of CD154 in peripheral blood T-lymphocytes of patients with AS and observe the change of CD154 in etanercept-treated AS patient . We collected the peripheral blood and clinical data from 66 AS , 30 rheumatoid arthritis ( RA ) patients , and 30 healthy controls . Thirty-nine active AS patients were enrolled in a r and omized double-blind placebo-controlled trial . We followed up 37 cases that fulfilled the ASAS20 response criteria after they finished etanercept treatment till week 48 . The percentage of CD3+CD154 + in peripheral blood lymphocytes was evaluated by flow cytometry . We found that CD154 expression in AS patients was significantly higher than that in healthy volunteers and RA patients ( both P The expressions of CD154 in AS patients at active stage or with peripheral joint involvement were significantly higher than those at stable stage or with axial involvement alone ( P = 0.005 and 0.044 , respectively ) . The expression of CD154 decreased in AS patients treated with etanercept compared with patients treated with placebo at week 6 ( P the expression of CD154 in 16 AS patients who relapsed after finishing etanercept treatment was elevated again ( P = 0.012 ) . These findings show that co-stimulatory molecule CD154 is overexpressed on T-lymphocytes in peripheral blood of AS patients and can be down-regulated by etanercept treatment , which suggest that CD154 might be involved in the inflammatory evolvement of AS and might be a potential biomarker to monitor AS disease activity and the effect of etanercept treatment",
"OBJECTIVE To develop criteria for symptomatic improvement in patients with ankylosing spondylitis ( AS ) , using outcome domain data from placebo-controlled clinical trials of nonsteroidal antiinflammatory drugs ( NSAIDs ) . METHODS Patient data from 5 short-term , r and omized , controlled trials were used to assess equivalence , reliability , and responsiveness of multiple items in the 5 outcome domains for AS treatment : physical function , pain , spinal mobility , patient global assessment , and inflammation . At least one measure per domain was responsive ( st and ardized response mean of > 0.5 ) , except for the spinal mobility domain , which was omitted from the criteria . We developed and tested c and i date improvement criteria in a r and om two-thirds subset from the 3 largest trials and used the remaining one-third for validation . These 3 largest trials included 923 patients ( 631 receiving NSAIDs , 292 in placebo groups ) . We selected the multiple domain definition that best distinguished NSAID treatment from placebo by chi-square test and that had a placebo response rate of single domains and in multiple measure indices , as well as combinations of improvements in multiple domains . Worsening in a domain was defined as a change for the worse of > or = 20 % and a net change for the worse of > or = 10 units on a scale of 0 - 100 . Partial remission ( for comparison purpose s ) was defined as an end-of-trial value of or = 20 % and > or = 10 units in each of 3 domains and absence of worsening in the fourth discriminated best in the development subset ( 51 % of patients improved with NSAIDs , 25 % with placebo ; chi2 = 36.4 , P partial disease remission at the end of the trial had also improved by this criterion . Among all 923 patients , improvement rates using this criterion were 49 % for NSAID-treated patients and 24 % for placebo-treated patients . CONCLUSION Although further validation using data from new trials is still needed , we conclude that we have developed a clinical ly valid , easy-to-use measure of short-term improvement in AS",
"OBJECTIVE To determine the safety and efficacy of etanercept in a multicenter , r and omized , placebo-controlled , double-blind trial of adults with moderate to severe active ankylosing spondylitis ( AS ) . METHODS Patients ( n = 277 ) were treated with either etanercept 25 mg ( n = 138 ) or placebo ( n = 139 ) subcutaneously twice weekly for 24 weeks . The primary outcome measures were the percentages of patients achieving the Assessment s in Ankylosing Spondylitis 20 % response ( ASAS20 ) at weeks 12 and 24 . Other outcome measures included the percentage of patients achieving higher ASAS responses , and the safety of etanercept in patients with AS . All outcome measures were assessed at 2 , 4 , 8 , 12 , and 24 weeks . RESULTS Treatment with etanercept result ed in dramatic improvement . The ASAS20 was achieved by 59 % of patients in the etanercept group and by 28 % of patients in the placebo group ( P individual ASAS components , acute-phase reactant levels , and spinal mobility measures were also significantly improved . The safety profile of etanercept was similar to that reported in studies of patients with rheumatoid arthritis or psoriatic arthritis . The only adverse events that occurred significantly more often in the etanercept group were injection-site reactions , accidental injuries , and upper respiratory tract infections . CONCLUSION Etanercept is a highly effective and well tolerated treatment in patients with active AS",
"OBJECTIVE There is increasing evidence that tumor necrosis factor alpha ( TNFalpha ) is central ly involved in the pathogenesis of ankylosing spondylitis ( AS ) and other spondylarthritides . This study was design ed to investigate the efficacy of anti-TNFalpha therapy with etanercept , a 75-kd receptor fusion protein , in active AS . METHODS This multicenter trial had 2 phases : an initial placebo-controlled period of 6 weeks ' duration and an observational phase lasting 24 weeks . Thirty patients with active AS were included . They were r and omized into 2 groups , which received either etanercept ( 25 mg twice weekly ) ( n = 14 ) or placebo ( n = 16 ) for 6 weeks . Then both groups were treated with etanercept . Nonsteroidal antiinflammatory drug ( NSAID ) treatment could be continued , but disease-modifying antirheumatic drugs ( DMARDs ) and steroids had to be withdrawn prior to the study . All patients received etanercept for a total of 12 weeks and were followed up for at least 24 weeks . The Bath AS Disease Activity Index ( BASDAI ) , Bath AS Functional Index , Bath AS Metrology Index , pain level on a numeric rating scale , quality of life by the Short Form 36 , and C-reactive protein ( CRP ) level were assessed . The primary outcome parameter was a > or=50 % improvement in the BASDAI . RESULTS Treatment with etanercept result ed in at least a 50 % regression of disease activity in 57 % of these patients at week 6 , versus 6 % of the placebo-treated patients ( P = 0.004 ) . After the placebo-treated patients switched to etanercept , 56 % improved . The mean + /- SD BASDAI improved from 6.5 + /- 1.2 at baseline to 3.5 + /- 1.9 at week 6 in the etanercept group , with no improvement in the placebo group ( P = 0.003 between groups ) . Similarly , pain , function , mobility , and quality of life improved with etanercept but not with placebo at week 6 ( P Mean CRP levels decreased significantly with etanercept but not with placebo ( P = 0.001 ) . There was ongoing improvement in all parameters in both groups until week 12 and week 18 , respectively ( i.e. , throughout the period of etanercept treatment ) . Disease relapses occurred a mean + /- SD of 6.2 + /- 3.0 weeks after cessation of etanercept . No severe adverse events , including major infections , were observed during the trial . CONCLUSION This study shows that on a short-term basis ( 3 months ) , treatment with etanercept is clearly efficacious in patients with active AS who are receiving NSAID therapy but not DMARDs or steroids . After cessation of therapy , almost all patients experienced a relapse within a few weeks . Thus , it seems probable that etanercept must be administered continuously in most AS patients to achieve permanent inhibition of the inflammatory process"
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411656dc-06ff-11f0-808a-c43d1ab1c353
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The Indigenous population of Canada faces an increased burden of chronic disease , leading to decreased life expectancy . Physical activity is an important health behaviour that improves chronic disease risk factors and physical fitness . The objective of this systematic review was to evaluate physical activity interventions in the Indigenous population in Canada to determine effects on physical activity rates , physical fitness , and health outcomes . MEDLINE , PsycINFO , EMBASE , and CINAHL were search ed for peer- review ed journal articles . Inclusion criteria were studies that examined a physical activity intervention delivered in Indigenous communities in Canada for adults over 18 years of age . Data was extracted and two authors independently rated quality of the evidence . Five studies were included in the narrative synthesis . Interventions were community-based , and three were multi-component interventions focused on preventing or managing type II diabetes . The interventions varied in their success in altering physical activity rates , with increases ( n = 2 ) , a decrease ( n = 1 ) , or non-significant changes reported ( n = 2 ) . No study reported any measure of physical fitness . BMI was reported in four studies , with only one reporting a significant decrease . Decreases in systolic blood pressure and total cholesterol were reported in two studies . There is limited evidence and a lack of robust interventions that examine the impacts of physical activity on health and fitness status in the Canadian Indigenous population . Vali date d , culturally relevant tools for measuring physical activity may aid in program evaluation and focused educational material s could better support population health initiatives . Trial registration The review protocol was registered prospect ively with PROSPERO ( registration number : CRD42017055363 )
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"BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application",
"Context Obesity is a major public health problem in North America , particularly in Aboriginal people . Objective To determine if a household-based lifestyle intervention is effective at reducing energy intake and increasing physical activity among Aboriginal families after 6 months . Design , Participants , and InterventionR and omized , open trial of 57 Aboriginal households recruited between May 2004 and April 2005 from the Six Nations Reserve in Ohsweken , Canada . Aboriginal Health Counsellors made regular home visits to assist families in setting dietary and physical activity goals . Additional interventions included provision of filtered water , a physical activity program for children , and educational events about healthy lifestyles . Results 57 households involving 174 individuals were r and omized to intervention or usual care . Intervention households decreased consumption of fats , oils and sweets compared to usual care households ( -4.9 servings per day vs. -3 servings/day , p=0.006 ) , and this was associated with a reduction in trans fatty acids ( -0.2 vs. + 0.6 grams/day , p=0.02 ) . Water consumption increased ( + 0.3 vs. -0.1 servings/day , p soda pop consumption decreased ( -0.3 vs. -0.1 servings/day , p=0.02 ) in intervention households compared to usual care . A trend toward increased knowledge about healthy dietary practice s in children , increased leisure-time activity and decreased sedentary behaviours was observed , although these differences were not statistically significant . Conclusion A household-based intervention is associated with some positive changes in dietary practice s and activity patterns . A larger and longer-term intervention which addresses both individual change and structural barriers in the community is needed . Résumé Context eL’obésité est un problème de santé publique majeur en Amérique du Nord , particulièrement chez les Autochtones . ObjectifDéterminer si une intervention de modification du mode de vie centrée sur les ménages parvient à réduire l’apport énergétique et à accroître l’activité physique dans des familles autochtones au bout de six mois . Méthode , participants et interventionEssai ouvert aléatoire auprès de 57 ménages autochtones recrutés entre mai 2004 et avril 2005 dans la réserve des Six-Nations à Ohsweken ( Ontario ) , au Canada . Des conseillers en santé autochtone ont fait des visites à domicile périodiques pour aider les familles à se fixer des objectifs de saine alimentation et d’activité physique . D’autres mesures ont aussi été instaurées : on a fourni de l’eau filtrée aux ménages , offert un programme d’activité physique aux enfants et organisé des activités de sensibilisation aux modes de vie sains . RésultatsLes 57 ménages ( 174 personnes ) ont été répartis aléatoirement en deux groupes , l’un recevant les mesures d’intervention et l’autre , les soins habituels . Les ménages recevant les mesures d’intervention ont diminué leur consommation de matières grasses , d’huile et de sucreries par rapport aux ménages recevant les soins habituels ( -4,9 portions/jour contre -3 portions/jour , p=0,006 ) , et cette diminution était associée à une baisse de la consommation d’acides gras trans ( -0,2 contre + 0,6 g/jour , p=0,02 ) . Par ailleurs , leur consommation d’eau a augmenté ( + 0,3 contre -0,1 portion/jour , p consommation de boissons gazeuses a diminué ( -0,3 contre -0,1 portion/jour , p=0,02 ) . Nous avons aussi observé une amélioration des connaissances des enfants sur la saine alimentation , une augmentation de l’activité pendant les temps libres et une diminution des comportements sédentaires , mais ces changements n’étaient pas significatifs . Conclusion Une intervention centrée sur les ménages est associée à certains changements positifs dans l’alimentation et l’activité physique . Il faudrait élargir et prolonger l’initiative , en tenant compte à la fois des changements individuels et des obstacles structurels dans la communauté",
"BACKGROUND A high prevalence of gestational diabetes mellitus and type 2 diabetes has been observed among the Cree of James Bay , Quebec . To address this problem , a diet and activity intervention during pregnancy , which was based on social learning theory , was initiated in 4 Cree communities . METHODS A prospect i ve intervention compared dietary , weight and glycemic indicators for 107 control subjects and for 112 women who received the intervention during the course of their pregnancy . A control period in 4 communities ( July 1995-March 1996 ) was followed by an intervention period ( April 1996-January 1997 ) when subjects were offered regular , individual diet counselling , physical activity sessions and other activities related to nutrition . RESULTS The intervention and control groups did not differ at baseline regarding their mean age ( 24.3 years [ SD 6.29 ] v. 23.8 years [ SD 5.86 ] ) , mean prepregnancy weight ( 81.0 kg [ SD 19.46 ] v. 78.9 kg [ SD 17.54 ] ) and mean gestational age at recruitment ( 17.1 weeks [ SD 7.06 ] v. 18.5 weeks [ SD 6.92 ] ) . The intervention did not result in differences in diet measured at 24 - 30 weeks ' gestation , rate of weight gain over the second half of pregnancy ( 0.53 kg per week [ SD 0.32 ] v. 0.53 kg per week [ SD 0.27 ] ) or plasma glucose level ( 50 g oral glucose screen ) between 24 and 30 weeks ( 7.21 mmol/L [ SD 2.09 ] v. 7.43 mmol/L [ SD 2.10 ] ) . Mean birth weights were similar ( 3741 g [ SD 523 ] v. 3686 g [ SD 686 ] ) , as was maternal weight at 6 weeks post partum ( 88.1 kg [ SD 16.8 ] v. 86.4 kg [ SD 19.0 ] ) . The only changes in dietary intake were a reduction in caffeine ( pregnancy ) and an increase in folate ( post partum ) . INTERPRETATION This intervention had only a minor impact on diet ; finding ways of encouraging appropriate body weight and activity levels remains a challenge",
"This report presents the process and summative evaluation results from a community-based diabetes prevention and control project implemented in response to the increasing prevalence and impact of non-insulin-dependent diabetes mellitus ( NIDDM ) in the Canadian Aboriginal population . The 24-month project targeted the registered Indian population in British Columbia 's rural Okanagan region . A participatory approach was used to plan strategies by which diabetes could be addressed in ways acceptable and meaningful to the intervention community . The strategies emphasised a combination of changing behaviours and changing environments . The project was quasi-experimental . A single intervention community was matched to two comparison communities . Workers in the intervention community conducted interviews of individuals with or at risk for diabetes during a seven-month pre-intervention phase ( n = 59 ) . Qualitative analyses were conducted to yield strategies for intervention . Implementation began in the eighth month of the project . Trend measurements of diabetes risk factors were obtained for ' high-risk ' cohorts ( persons with or at familial risk for NIDDM ) ( n = 105 ) . Cohorts were tracked over a 16-month intervention phase , with measurements at baseline , the midpoint and completion of the study . Cross-sectional population surveys of diabetes risk factors were conducted at baseline and the end of the intervention phase ( n = 295 ) . Surveys of community systems were conducted three times . The project yielded few changes in quantifiable outcomes . Activation of the intervention community was insufficient to enable individual and collective change through dissemination of quality interventions for diabetes prevention and control . Theory and previous research were not sufficiently integrated with information from pre-intervention interviews . Interacting with these limitations were the short planning and intervention phases , just 8 and 16 months , respectively . The level of penetration of the interventions mounted was too limited to be effective . Attention to process is warranted and to the feasibility of achieving effects within 24 months"
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41165718-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Necrotizing enterocolitis continues to be a problem , particularly in preterm neonates . There have been reports published suggesting that the use of enteral antibiotics may be effective as prophylaxis . This systematic review was undertaken to clarify the issue . OBJECTIVES To evaluate the benefits and harms of enteral antibiotic prophylaxis for necrotizing enterocolitis in low birth weight and preterm infants . SEARCH STRATEGY Search es were made of the Oxford Data base of Perinatal trials , MEDLINE ( 1966 - June 2000 ; search terms : necrotizing enterocolitis , antibiotics ; limits : newborn infant ) , previous review s with cross references , abstract s , conference and symposia proceedings , expert informants and journal h and search ing in the fields of neonatal pediatrics and microbiology . SELECTION CRITERIA All r and omized or quasi-r and omized controlled trials where enteral antibiotics were used as prophylaxis against NEC in LBW ( DATA COLLECTION AND ANALYSIS The st and ard method of the Cochrane Collaboration and its Neonatal Review Group was used . The method ological quality of each trial was review ed by the second author who was blinded to the trial authors and institutions . Each author extracted data separately before comparison and resolution of differences . Relative risk ( RR ) , risk difference ( RD ) , and number needed to treat were used in the analysis . MAIN RESULTS Five eligible trials involving 456 infants were included . The administration of prophylactic enteral antibiotics result ed in a statistically significant reduction in NEC [ RR 0.47 ( 0.28 , 0.78 ) ; RD -0.10 ( -0.16 , -0.04 ) ; NNT 10 ( 6 , 25 ) ] . There was a statistically significant reduction in NEC-related deaths [ RR 0.32 ( 0.10 , 0.96 ) ; RD -0.07 ( -0.13 , 0.01 ) ; NNT 14 ( 8 , 100 ) ] . There was a trend towards a reduction in all deaths which was not significant [ RR 0.67(0.34 , 1.32 ) ] . There were no significant differences in NEC-like enteropathies ( one trial only ) . One study found a statistically significant increase in the incidence of colonization with resistant bacteria and the summary analysis of three trials gave an increase which was just significant [ RR 1.73 ( 1.00 , 2.97 ) ; RD 0.07 ( 0.00 , 0.13 ) ] . REVIEW ER 'S CONCLUSIONS Evidence suggests that oral antibiotics reduce the incidence of NEC in low birth weight infants . However concerns about adverse outcomes persist , particularly related to the development of resistant bacteria . To address this question further , a large trial would be required with a sample size sufficient to examine all the important benefits and harms . Adverse outcomes associated with infection should be evaluated , and microbiological studies looking for the development of resistant bacteria should be
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"Alimentary kanamycin , 15 mg/kg/day , was given as prophylaxis for neonatal necrotizing enterocolitis in a prospect i ve study . Newborn infants of less than 1,500 gm birth weight who survived until initiation of alimentary nutrition at the University of Florida Neonatal Intensive Care Unit were admitted to a control or study group based on the last digit of the hospital number . Alimentary kanamycin was not absorbed ; all blood levels determined were less than 0.5 μg/ml . The two groups had similar gestational ages , birth weights , severity of neonatal illness , and frequency of therapeutic procedures . In the study group of 35 infants , none developed neonatal necrotizing enterocolitis , whereas five cases occurred in the 40 control infants ( p=0.038 )",
"AIMS To evaluate the effectiveness of oral vancomycin in the prophylaxis of necrotising enterocolitis in preterm , very low birthweight infants . METHODS A prospect i ve , double blind , r and omised , placebo controlled study in a tertiary referral centre of a university teaching hospital was conducted on 140 very low birthweight infants consecutively admitted to the neonatal unit . The babies were r and omly allocated to receive oral vancomycin ( 15 mg/kg every 8 hours for 7 days ) or an equivalent volume of placebo solution . Prophylaxis was started 24 hours before the start of oral feeds . All suspected cases of necrotising enterocolitis were investigated with a full sepsis screen and serial abdominal radiographs . Necrotising enterocolitis was diagnosed and staged according to modified Bell ’s criteria . RESULTS Nine of 71 infants receiving oral vancomycin and 19 of 69 infants receiving the placebo solution developed necrotising enterocolitis ( p=0.035 ) . Infants with necrotising enterocolitis were associated with a significant increase in mortality ( p=0.026 ) and longer duration of hospital stay ( p = 0.002 ) . CONCLUSIONS Prophylactic oral vancomycin conferred protection against necrotising enterocolitis in preterm , very low birthweight infants and was associated with a 50 % reduction in the incidence . However , widespread implementation of this preventive measure is not recommended , as it would only be effective in necrotising enterocolitis caused by Gram positive organisms and could increase the danger of the emergence of vancomycin resistant or dependent organisms . Its use should be restricted to a high prevalence nursery for a short and well defined period in a selected group of high risk patients",
"The value of prophylactic oral gentamicin sulfate therapy in the prevention of necrotizing enterocolitis ( NEC ) was evaluated in a group of 42 high-risk neonates over a four-month period in a r and omized , double-blind controlled trial . Twenty babies in the treatment group received 2.5 mg/kg of gentamicin sulfate every six hours for one week after birth , and 22 babies received dextrose- and -water placebo in an equivalently small volume . None of the 20 gentamicin-treated babies developed NEC . Four of the control babies did . Two of these babies died , and their diagnosis was pathologically confirmed . This difference in the incidence of NEC between the treatment and control group was significant at the .05 level . These results support the prophylactic use of orally given gentamicin for selected babies at high risk for NEC , particularly those born prematurely and those who have a history of perinatal asphyxia or umbilical artery catheterization or both . Continued surveillance for changes in antimicrobial sensitivity patterns is recommended",
"A comparative study of bowel colonisation and incidence of necrotising enterocolitis in neonates admitted to an intensive care unit is reported . Neonates of less than 33 weeks gestational age requiring mechanical ventilation for respiratory distress syndrome were r and omised during the first week of life to receive either vancomycin and aztreonam or vancomycin and gentamicin for episodes of suspected sepsis after the first week of life . A higher proportion of neonates who received vancomycin and gentamicin had faecal colonisation with enterobacteriaceae at the end of the second , third , and fourth weeks of life . Treatment with vancomycin and aztreonam was associated with a rapid quantitative reduction in faecal colonisation with enterobacteriaceae , whereas there was no quantitative reduction in colonisation with enterobacteriaceae associated with treatment with vancomycin and gentamicin . There were no differences between the two groups in faecal colonisation with anaerobes , Enterococcus sp , Staphylococcus sp , or yeasts . Six ( 14.6 % ) of 41 who received vancomycin and gentamicin compared with 0 of 40 who received vancomycin and aztreonam subsequently developed necrotising enterocolitis",
"We conducted a prospect i ve r and omized trial to compare the efficacy of oral gentamicin versus oral IgA‐IgG for the prophylaxis of necrotizing enterocolitis ( NEC ) ; 200 newborns considered at high risk for NEC were assigned to group A ( oral IgA‐IgG , n= 100 ) or group B ( oral Gentamicin , n= 100 ) . NEC was diagnosed in 13 cases in group A and in 1 case in group B between the 3rd and 16th days of life . Surgical treatment was necessary in 3 cases ( 2 in group A ) . All infants survived . We conclude that oral gentamicin is more effective than oral IgA‐IgG in the prevention of NEC in infants at high risk",
"To evaluate the effects of oral kanamycin prophylaxis for necrotizing enterocolitis on stool flora , 99 high-risk infants were studied on a double-blind basis during the first month of life . Oral kanamycin prophylaxis result ed in a significant decrase in gram-negative enteric colonization on Days 3 to 5 , 10 , 17 , and 24 compared to control infants ( P P P = 0.2 ) . The data indicate that oral kanamycin prophylaxis significantly reduces the colonization rate and overgrowth of gram-negative enteric flora , but does not eliminate the occurrence of NEC in a high-risk group of infants",
"For an assessment of the efficacy of clindamycin in preventing bowel necrosis ( intestinal gangrene or perforation ) , 42 premature infants with radiographically confirmed necrotizing enterocolitis ( NEC ) ( pneumatosis , intraportal gas , or both ) were r and omly assigned to receive parenterally either ampicillin and gentamicin ( control group , n = 22 ) or ampicillin , gentamicin , and clindamycin ( n = 20 ) , 20 mg/kg/d at 8-hour intervals for 10 to 14 days . Infants who had received antibiotics for greater than 24 hours before r and omization and those developing intestinal gangrene or perforation less than 12 hours after r and omization were excluded . Intestinal gangrene or perforation developed in four infants in the control group and six in the clindamycin group . Four in each group died of NEC . In the control group , one of 18 survivors developed a late stricture requiring surgical resection , whereas six of 15 survivors in the clindamycin group developed such strictures ( P = 0.022 ) . Routine inclusion of clindamycin in medical treatment of NEC does not reduce the frequency of intestinal gangrene or perforation and may be associated with an increase in late stricture formation"
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41165754-06ff-11f0-808a-c43d1ab1c353
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( 1 ) Objective : to establish practical guidance for the design of future clinical trials in MS ( metabolic syndrome ) patients aged 18 and older , based on a systematic review of r and omized clinical trials connecting diet , physical exercise and changes in body composition . ( 2 ) Method : this systematic review of r and omized clinical trials ( RCT ) is based on the guidelines recommended by PRISMA ( Preferred Reporting Items for Systematic review s and Meta-Analyses ) . Criteria of selection : ≥18 years of age ; patients diagnosed with MS ; intervention programs including diet , physical exercise and /or modifications in the style of life as treatment , as well as the magnitude of changes in body composition ( BC ) ; r and omized clinical trial published between 2004 and 2018 . ( 3 ) Results : the multidisciplinary interventions describe major changes in BC , and the recurring pattern in these clinical trials is an energy reduction and control in the percentage of intake of macronutrients along with the performance of regularly structured exercise ; the most analyzed parameter was waist circumference ( 88.9 % of the trials ) , followed by body weight ( 85.2 % ) , BMI ( 77.8 % ) and body fat ( 55.6 % ) . ( 4 ) Conclusions : The analysis of the information here reported sheds light for the design of future clinical trials in adults with MS . The best anthropometric parameters and units of measurement to monitor the interventions are related to dietary and physical exercise interventions . A list of practical advice that is easy to implement in daily practice in consultation is here proposed in order to guarantee the best results in changes of body composition
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"OBJECTIVE Development of these guidelines is m and ated by the American Association of Clinical Endocrinologists ( AACE ) Board of Directors and the American College of Endocrinology ( ACE ) Board of Trustees and adheres to published AACE protocol s for the st and ardized production of clinical practice guidelines ( CPGs ) . METHODS Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors . RESULTS There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements ( 85 [ 53.1 % ] strong [ Grade A ] ; 48 [ 30.0 % ] intermediate [ Grade B ] , and 11 [ 6.9 % ] weak [ Grade C ] , with 16 [ 10.0 % ] based on expert opinion [ Grade D ] ) that build a comprehensive medical care plan for obesity . There were 133 ( 83.1 % ) statements based on strong ( best evidence level [ BEL ] 1 = 79 [ 49.4 % ] ) or intermediate ( BEL 2 = 54 [ 33.7 % ] ) levels of scientific substantiation . There were 34 ( 23.6 % ) evidence -based recommendation grade s ( Grade s A-C = 144 ) that were adjusted based on subjective factors . Among the 1,790 reference citations used in this CPG , 524 ( 29.3 % ) were based on strong ( evidence level [ EL ] 1 ) , 605 ( 33.8 % ) were based on intermediate ( EL 2 ) , and 308 ( 17.2 % ) were based on weak ( EL 3 ) scientific studies , with 353 ( 19.7 % ) based on review s and opinions ( EL 4 ) . CONCLUSION The final recommendations recognize that obesity is a complex , adiposity-based chronic disease , where management targets both weight-related complications and adiposity to improve overall health and quality of life . The detailed evidence -based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity , including screening , diagnosis , evaluation , selection of therapy , treatment goals , and individualization of care . The goal is to facilitate high- quality care of patients with obesity and provide a rational , scientific approach to management that optimizes health outcomes and safety . ABBREVIATIONS A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ACSM = American College of Sports Medicine ADA = American Diabetes Association ADAPT = Arthritis , Diet , and Activity Promotion Trial ADHD = attention-deficit hyperactivity disorder AHA = American Heart Association AHEAD = Action for Health in Diabetes AHI = apnea-hypopnea index ALT = alanine aminotransferase AMA = American Medical Association ARB = angiotensin receptor blocker ART = assisted reproductive technology AUC = area under the curve BDI = Beck Depression Inventory BED = binge eating disorder BEL = best evidence level BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management BLOSSOM = Behavioral Modification and Lorcaserin Second Study for Obesity Management BMI = body mass index BP = blood pressure C-SSRS = Columbia Suicidality Severity Rating Scale CAD = coronary artery disease CARDIA = Coronary Artery Risk Development in Young Adults CBT = cognitive behavioral therapy CCO = Consensus Conference on Obesity CHF = congestive heart failure CHO = carbohydrate CI = confidence interval COR-I = Contrave Obesity Research I CPG = clinical practice guideline CV = cardiovascular CVD = cardiovascular disease DASH = Dietary Approaches to Stop Hypertension DBP = diastolic blood pressure DEXA = dual-energy X-ray absorptiometry DPP = Diabetes Prevention Program DSE = diabetes support and education EL = evidence level ED = erectile dysfunction ER = extended release EWL = excess weight loss FDA = Food and Drug Administration FDG = 18F-fluorodeoxyglucose GABA = gamma-aminobutyric acid GERD = gastroesophageal reflux disease GI = gastrointestinal GLP-1 = glucagon-like peptide 1 HADS = Hospital Anxiety and Depression Scale HDL-c = high-density lipoprotein cholesterol HR = hazard ratio HTN = hypertension HUNT = Nord-Trøndelag Health Study ICSI = intracytoplasmic sperm injection IFG = impaired fasting glucose IGT = impaired glucose tolerance ILI = intensive lifestyle intervention IVF = in vitro fertilization LAGB = laparoscopic adjustable gastric b and ing LDL-c = low-density lipoprotein cholesterol LES = lower esophageal sphincter LSG = laparoscopic sleeve gastrectomy LV = left ventricle LVH = left ventricular hypertrophy LVBG = laparoscopic vertical b and ed gastroplasty MACE = major adverse cardiovascular events MAOI = monoamine oxidase inhibitor MI = myocardial infa rct ion MN RCT = meta- analysis of non-r and omized prospect i ve or case-controlled trials MRI = magnetic resonance imaging MUFA = monounsaturated fatty acid NAFLD = nonalcoholic fatty liver disease NASH = nonalcoholic steatohepatitis NES = night eating syndrome NHANES = National Health and Nutrition Examination Surveys NHLBI = National Heart , Lung , and Blood Institute NHS = Nurses ' Health Study NICE = National Institute for Health and Care Excellence OA = osteoarthritis OGTT = oral glucose tolerance test OR = odds ratio OSA = obstructive sleep apnea PHQ-9 = Patient Health Question naire PCOS = polycystic ovary syndrome PCP = primary care physician POMC = pro-opiomelanocortin POWER = Practice -Based Opportunities for Weight Reduction PPI = proton pump inhibitor PRIDE = Program to Reduce Incontinence by Diet and Exercise PSA = prostate specific antigen QOL = quality of life RA = receptor agonist RCT = r and omized controlled trial ROC = receiver operator characteristic RR = relative risk RYGB = Roux-en-Y gastric bypass SAD = sagittal abdominal diameter SBP = systolic blood pressure SCOUT = Sibutramine Cardiovascular Outcome Trial SG = sleeve gastrectomy SHBG = sex hormonebinding globulin SIEDY = Structured Interview on Erectile Dysfunction SNRI = serotonin-norepinephrine reuptake inhibitors SOS = Swedish Obese Subjects SS = surveillance study SSRI = selective serotonin reuptake inhibitors STORM = Sibutramine Trial on Obesity Reduction and Maintenance TCA = tricyclic antidepressant TONE = Trial of Nonpharmacologic Intervention in the Elderly TOS = The Obesity Society T2DM = type 2 diabetes mellitus UKPDS = United Kingdom Prospect i ve Diabetes Study U.S = United States VAT = visceral adipose tissue VLDL = very low-density lipoprotein WC = waist circumference WHO = World Health Organization WHR = waist-hip ratio WHtR = waist-to-height ratio WMD = weighted mean difference WOMAC = Western Ontario and McMaster Universities osteoarthritis index XENDOS = XEnical in the Prevention of Diabetes in Obese Subjects ",
"Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials",
"OBJECTIVE Few studies examined the association between time-of-day of nutrient intake and the metabolic syndrome . Our goal was to compare a weight loss diet with high caloric intake during breakfast to an isocaloric diet with high caloric intake at dinner . DESIGN AND METHODS Overweight and obese women ( BMI 32.4 ± 1.8 kg/m(2 ) ) with metabolic syndrome were r and omized into two isocaloric ( ~1400 kcal ) weight loss groups , a breakfast ( BF ) ( 700 kcal breakfast , 500 kcal lunch , 200 kcal dinner ) or a dinner ( D ) group ( 200 kcal breakfast , 500 kcal lunch , 700 kcal dinner ) for 12 weeks . RESULTS The BF group showed greater weight loss and waist circumference reduction . Although fasting glucose , insulin , and ghrelin were reduced in both groups , fasting glucose , insulin , and HOMA-IR decreased significantly to a greater extent in the BF group . Mean triglyceride levels decreased by 33.6 % in the BF group , but increased by 14.6 % in the D group . Oral glucose tolerance test led to a greater decrease of glucose and insulin in the BF group . In response to meal challenges , the overall daily glucose , insulin , ghrelin , and mean hunger scores were significantly lower , whereas mean satiety scores were significantly higher in the BF group . CONCLUSIONS High-calorie breakfast with reduced intake at dinner is beneficial and might be a useful alternative for the management of obesity and metabolic syndrome",
"BACKGROUND Preserving fat-free mass ( FFM ) during weight loss is important in older adults . The purpose was to examine a low-fat diet ( LFD ) versus a carbohydrate-restricted diet ( CRD ) with and without progressive resistance exercise ( PRE ) on preservation of FFM in older men with metabolic syndrome . METHODS A total of 42 men ( 59±7 years ) were matched [ body mass index ( BMI ) ] and r and omized to LFD , LFD&PRE , CRD , and CRD&PRE . PRE groups performed supervised strength training three times per week . Body weight , composition , metabolic syndrome criteria , and strength were measured at baseline and week 12 . A 3-day diet record was kept at baseline and at weeks 1 , 6 , and 12 . RESULTS Attrition ( 24 % ) was similar between groups . Depicted as % carbohydrate : fat : protein , the intervention diet was : LFD=55:24:18 , LFD&PRE=57:20:20 , CRD=16:54:28 , and CRD&PRE=12:56:31 . Weight ( lb ) decreased similarly in all groups ( LFD , -18.0±7.4 ; LFD&PRE , -19.8±12.8 ; CRD , -20.2±8.0 ; CRD&PRE , -22.7±6.0 ; P with metabolic syndrome decreased in all groups ( -3 , -6 , -3 , -4 , respectively ) . Percent of weight loss from appendicular FFM was 27.5 % , 15.9 % , 15.7 % , and 17.3 % respectively . A trend was found when comparing LFD and LFD&PRE ( P=0.068 ) , and when comparing LFD&CRD ( P=0.072 ) . Triglycerides improved more for the LFD&PRE , CRD , and CRD&PRE groups compared to the LFD group ( P ) . Improvements in high-density lipoprotein-cholesterol were better in the CRD&PRE group ( 4.1±5.1 mg/dL ) versus the LFD group ( -5.0±5.9 mg/dL ; P CONCLUSIONS LFD&PRE , CRD , and CRD&PRE preserve FFM similarly . PRE is an important component of a LFD during weight loss in this population",
"ABBREVIATIONS A1C = hemoglobin A1C ; AACE = American Association of Clinical Endocrinologists ; ACCORD = Action to Control Cardiovascular Risk in Diabetes ; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure ; ACEI = angiotensin-converting enzyme inhibitor ; ADVANCE = Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ; AGI = alpha-glucosidase inhibitor ; apo B = apolipoprotein B ; ASCVD = atherosclerotic cardiovascular disease ; BAS = bile acid sequestrant ; BCR-QR = bromocriptine quick release ; BMI = body mass index ; BP = blood pressure ; CCB = calcium channel blocker ; CHD = coronary heart disease ; CKD = chronic kidney disease ; CVD = cardiovascular disease ; DASH = Dietary Approaches to Stop Hypertension ; DPP4 = dipeptidyl peptidase 4 ; eGFR = estimated glomerular filtration rate ; ER = extended release ; FDA = Food and Drug Administration ; GLP1 = glucagon-like peptide 1 ; HDL-C = high-density lipoprotein cholesterol ; IMPROVE-IT = Improved Reduction of Outcomes : Vytorin Efficacy International Trial ; LDL-C = low-density lipoprotein cholesterol ; LDL-P = low-density lipoprotein particle ; Look AHEAD = Look Action for Health in Diabetes ; NPH = neutral protamine Hagedorn ; OSA = obstructive sleep apnea ; RCT = r and omized controlled trial ; SU = sulfonylurea ; SGLT2 = sodium glucose cotransporter-2 ; SMBG = self-monitoring of blood glucose ; T2D = type 2 diabetes ; TZD = thiazolidinedione ; VADT = Veterans Affairs Diabetes Trial"
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OBJECTIVE To provide a comprehensive synthesis of the effects of Zn supplementation on childhood body composition and adiposity-related hormone levels . DESIGN Five electronic data bases were search ed for r and omized controlled trials of Zn supplementation studies published before 28 February 2015 . No statistical pooling of results was carried out due to diversity in study design s. SETTING Community- or hospital-based , from fourteen developing and developed countries . SUBJECTS Children and adolescents aged 0 to 10 years . RESULTS Seven of the fourteen studies reported an overall or subgroup effect of Zn supplementation on at least one parameter of body composition , when determined by anthropometric measurements ( increased mid upper-arm circumference , triceps skinfold , subscapular skinfold and mid upper-arm muscle area , and decreased BMI ) . Three out of the fourteen studies reported increased mean value of total body water estimated by bio-impedance analysis and increased fat-free mass estimated by dual energy X-ray absorptiometry and by total body water . Zn supplementation was associated with increased fat-free mass among stunted children . One study found supplementation decreased leptin and insulin concentrations . CONCLUSIONS Due to the use of anthropometry when determining body composition , a majority of the studies could not accurately address whether alterations in the fat and /or fat-free mass components of the body were responsible for the observed changes in body composition . The effect of Zn supplementation on body composition is not consistent but may modify fat-free mass among children with pre-existing growth failure
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"Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results",
"The study was aim ed to test whether zinc supplementation , if initiated early , can prevent stunting and promote optimum body composition in full term infants . For this , full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum . Body mass index ( BMI ) was calculated from maternal weight and height that were collected one month after delivery . Infants ' weight , and length , head , chest and mid upper arm circumferences and skin fold thicknesses at triceps , biceps and subscapular area were collected at baseline ( before r and omization ) and once in three months up till 24 months . Three hundred and twenty four infants were r and omized and allocated to zinc ( 163 ) or placebo ( 161 ) groups respectively . Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months . The control ( placebo ) group of children received riboflavin 0.5 mg/day , whereas the intervention ( zinc ) group received 5 mg zinc plus riboflavin 0.5 mg/day . When infants were 18 months old , dietary intakes ( in 78 children ) were calculated by 24 hour diet recall method and hemoglobin , zinc , copper and vitamin A were quantified in blood sample s collected from 70 children . The results showed prevalence of undernutrition ( body mass index . Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively . Multiple linear regression models demonstrated maternal weight as a strong predictor of infants ' weight and length at 18 months of age . As expected , diarrhea duration impacted infants ' linear growth and weight gain adversely . Zinc supplementation for a mean period of 190 days , starting from 4 months up to 18 months of age , in full term normal infants , consuming an average energy of 590 Kcal/day , had significant effect on the skin fold thicknesses , but not on their linear growth . Trial Registration Clinical Trail Registration India ( CTRI )",
"Apparently healthy preschool children ( 46 boys , 52 girls ) aged 27 - 50 mo from low socioeconomic conditions who attended daycare centers in Santiago participated in a 14-mo long double-blind zinc supplementation trial . Unlike most previous studies , no additional inclusion criteria such as short stature or slow growth rate were considered . Subjects were pair matched according to sex and age and r and omly assigned to two experimental groups : the supplemented group , which received 10 mg Zn/d , and the placebo group . Selected anthropometric , clinical , dietary , biochemical , and functional indexes were determined at the beginning of the study and after 6 and 14 mo of intervention . Actual dietary zinc intake was 66 % of the recommended dietary allowance . Height gain after 14 mo was on average 0.5 cm higher in the supplemented group ( P = 0.10 ) . The response , however , was different between sexes . Boys from the supplemented group gained 0.9 cm more than those in the placebo group ( P = 0.045 ) . No effect was seen in girls . Although no significant differences were observed in the rest of the variables studied , trends ( 0.05 midarm muscle area in boys , improved response to tuberculin , and reduced rates of parasite reinfestation were noted . We conclude that in preschool children of low socioeconomic status , zinc is a limiting factor in the expression of growth potential",
"BACKGROUND Poor growth and delayed maturation in children with sickle cell disease ( SCD ) may be due , in part , to mild zinc deficiency . OBJECTIVE The objective was to determine the effects of zinc supplementation on growth and body composition in children with SCD . DESIGN Forty-two prepubertal children ( 20 girls and 22 boys ) aged 4 - 10 y with SCD-SS were r and omly assigned to receive 10 mg elemental Zn/d in cherry syrup ( zinc group ) or cherry syrup alone ( control group ) . The 2 groups were stratified by sex and initial height status . Dietary intakes were evaluated and anthropometric , high-precision knee-height , and plasma zinc measurements were made at baseline and at 3 , 6 , and 12 mo . Body composition was determined every 6 mo with dual-energy X-ray absorptiometry , and z scores for anthropometric variables were computed from national reference data . Longitudinal-mixed-effects analysis was used to test for differences between the groups over the 12-mo observation period . RESULTS Thirty-eight children completed the study . No significant differences were observed at baseline . After 12 mo , the zinc group had significantly greater mean ( + /- SE ) increases in height ( 0.66 + /- 0.29 cm/y ) , sitting height ( 0.97 + /- 0.40 cm/y ) , knee height ( 3.8 + /- 1.2 mm/y ) , and arm circumference z scores ( 0.27 + /- 0.12 cm/y ) . Height-for-age and weight-for-age z scores decreased significantly by 0.11 + /- 0.04 and 0.13 + /- 0.05 , respectively , in the control group but did not change significantly in the zinc group . CONCLUSIONS Prepubertal children with SCD-SS may have zinc deficiency and may benefit from zinc supplementation to improve linear growth and weight gain",
"BACKGROUND Despite ample food supplies , the incidence of childhood underweight and stunting remains high in Ug and a. Many factors contribute to this situation , but the role of low zinc intakes has not been adequately explored . OBJECTIVE Our objective was to study the effect of zinc supplementation on growth and body composition of preschool children by using the outcome measures of weight , height , and midupper arm circumference ( MUAC ) . DESIGN The study was r and omized , double-blind , placebo-controlled , parallel , and 8 mo long , and incorporated 6 mo of zinc supplementation . Children ( n = 153 ) aged 55.8 + /- 11.2 mo from 3 r and omly selected nursery schools of medium , low , and very low socioeconomic status in a suburb of Kampala took part . The intervention comprised 10 mg Zn ( as ZnSO4 ) or placebo daily in freshly prepared fruit juice , Monday to Friday inclusive . RESULTS Zinc supplementation increased MUAC by the end of the study ( P = 0.029 ) and led to greater weight gain in children from the school of medium socioeconomic status at 3 and 8 mo ( P = 0.019 and P = 0.038 , respectively ) . There was no effect on weight gain of the children from the other schools . Zinc supplementation had no influence on height . Infection rates ( of which 82 % were recorded as malaria ) were lower in the zinc-supplemented group than in control subjects ( P = 0.063 ) . CONCLUSIONS Zinc supplementation may counter the age-related decrease in MUAC often observed in preschool children in developing countries . The study provides evidence that zinc may not be the most limiting nutrient for weight gain in children of poor nutritional status , but may become so as nutritional status improves",
"Thirty-four malnourished children were rehabilitated on either a cow 's milk or a soya protein based formula diet . The soya diet contained 25 % less zinc than the cow 's milk diet and 1.33 mmol/l phytic acid . When the marasmic children were given either of these diets they had a dramatic fall in their plasma zinc concentration . Children given the soya formula had an even more profound drop in plasma zinc , to levels associated with acrodermatitis enteropathica . Plasma zinc remained low throughout the phase of rapid weight gain , but rose when a mixed diet was given and the children ceased gaining weight . There was a negative correlation between the rate of weight gain and the plasma zinc concentration , the rate of new tissue synthesis being the predominant modulator of the plasma zinc concentration . The energy cost of tissue deposition was initially low on the cow 's milk diet and relatively high on the soya diet . Later , the energy costs rose in the cow 's milk fed children . The rate of weight gain was less on the soya diet ; however , the appetite , as measured by the ad libitum dietary intakes , did not differ between the diets , or correlate with the plasma zinc concentration . This may be due to the relatively low protein content of the diets used . It is concluded that dietary zinc may limit the rate of weight gain during periods of recovery in body mass and may be a cause for the excessive deposition of adipose tissue",
"To determine whether zinc deficiency might be involved in the failure to thrive observed in undernourished Vietnamese children , we assessed growth , incidence of infections , and circulating insulin-like growth factor I ( IGF-I ) concentrations in a double-blind study of zinc supplementation . Growth-retarded children ( n=146 ) aged 4 - 36 mo were paired according to age , sex , commune , Z scores for weight ( WAZ ) and for height ( HAZ ) , and number of siblings , and were r and omly assigned to receive either 153 micromol ( 10 mg ) Zn/d or a placebo for 5 mo . Weight , height , and episodes of infection were recorded each month and plasma IGF-I was measured 1 and 5 mo after the start of zinc supplementation . Multiple-linear-regression analysis for paired data showed that zinc supplementation increased weight ( + 0.5 + /- 0.1 kg ; P height ( + 1.5+/-0.2 cm ; P placebo treatment . The relative risk of infectious episodes in the zinc-treated subjects was reduced 3-fold for diarrhea ( P=0.012 ) and 2.5-fold for respiratory infections ( p=0.057 ) . The probability of having at least two episodes of diarrhea or respiratory infection was 2.9- and 3.2-fold lower , respectively , in zinc-treated subjects between 1 and 5 mo ( P=0.018 ) , whereas they did not change in placebo-treated subjects ( P-0.584 ) . After 1 mo , IGF-I concentration ( -x+/-SD ) in zinc-treated subjects was 2.8+/-0.3 nmol/L compared with 1.9+/-0.2 nmol/L in placebo-treated subjects ( P=0.021 ) . After 5 mo , the values were 3.4+/-0.5 nmol/L ( zinc-treated ) and 2.0+/-0.3 nmol/L ( placebo-treated ; P=0.044 ) . Our study suggests that zinc deficiency may limit growth in nutritionally deprived children . Because the increase in growth velocity result ing from zinc supplementation was associated with increased plasma IGF-I concentrations , we suggest that the growth-stimulating effect of zinc might be mediated through changes in circulating",
"The exact mechanism whereby zinc influences growth is unknown , although it has been postulated that zinc may stimulate appetite and energy intake or enhance fat-free mass ( FFM ) accrual directly . We compared energy intake , reported appetite , and body composition of 6- to 8-mo-old Peruvian children with initial length-for-age Z-score ( LAZ ) 3 mg/d zinc in a liquid supplement ; 2 ) 3 mg/d zinc in a fortified porridge ; or 3 ) no extra zinc in either the supplement or porridge . There were no group-wise differences in changes in dietary energy intakes or body composition or in the prevalence of reported poor appetite . However , among children with an initial LAZ less than the median ( -1.1 SD ) , those who received zinc as a liquid supplement had a 0.41 kg greater increase in FFM than those who did not receive zinc ( P energy intake or reported appetite . Among children with initial mild-to-moderate stunting , those who received the zinc supplement had a greater increase in FFM than those who did not receive additional zinc . It is possible that the growth-restricted children were more likely to be zinc deficient and that FFM accrual may be an early growth response to supplemental zinc . Zinc supplements may be more efficacious than the same dose of zinc provided in fortified food ; therefore , further research is needed on the optimal level of zinc fortification that will result in improved health outcomes in population s with high rates of zinc deficiency ",
"The impact of zinc supplementation on the growth and body composition of Guatemalan infants was assessed in a community-based , double-blind intervention trial . Infants aged 6 - 9 mo were assigned r and omly to receive 4 mL of a beverage containing 10 mg of zinc as zinc sulfate ( n = 45 ) or a placebo ( n = 44 ) daily ( 7 d/wk ) for an average of 6.9 mo . The children 's weight , length , mid-upper arm and head circumferences , and triceps skinfolds were measured at baseline and at 1 - 2 mo intervals until the end of supplementation . Midarm muscle area ( MMA ) was derived from the mid-upper arm circumference and triceps skinfolds measurements . Maternal anthropometry and family socioeconomic and demographic characteristics also were obtained . Zinc supplementation was associated with an overall increase of 0.61 cm2 in MMA ( P = 0.02 ) . Children who received zinc supplements had a mean length increment that was 0.75 cm greater than those who did not ( P = 0.12 ) . However , there was a significant interaction between treatment group and initial length-for-age status ( P = 0.04 ) , such that supplemented children who were stunted at baseline ( length-for-age Z score less than -2 ) gained 1.40 cm more than stunted children who received the placebo . We conclude that zinc supplementation of these rural Guatemalan infants during 6 . 9 mo increased accretion of fat-free mass and enhanced the linear growth of those who were stunted at baseline . Further research is required to determine whether zinc supplementation during longer periods of time may achieve larger and more generalized effects on physical growth",
"BACKGROUND It has been documented that growth patterns differ between breastfed and formula-fed infants . Some investigators have suggested that these differences may be related to differences in zinc nutriture . OBJECTIVE The objective of this study was to examine the effect of zinc supplementation on growth , morbidity , and motor development in healthy , term , breastfed infants . DESIGN We conducted a r and omized double-blind intervention comparing zinc supplementation ( 5 mg/d as zinc sulfate ) with placebo in breastfed infants aged 4 - 10 mo . Growth and indexes of body composition and gross motor development were measured monthly from 3 to 10 mo . Morbidity data were collected weekly . RESULTS Eighty-five infants were enrolled , and 70 completed the study . The baseline characteristics , attained weight or length at 10 mo , growth velocity , gross motor development , and morbidity did not differ significantly between groups , even after control for potentially confounding variables . CONCLUSIONS The dietary zinc intake of these breastfed infants appeared to be adequate , given that zinc supplementation did not affect growth , development , or risk of infection ( although sample size for detection of differences in development or infection was limited ) . Previously described differences in growth between breastfed and formula-fed infants in such population s do not appear to be due to differences in zinc nutriture",
"Changes in growth , body composition , and zinc indexes were evaluated after 25 wk in a double-blind zinc-supplementation study of 162 periurban Guatemalan children aged 81.5 + /- 7.0 mo ( mean + /- SD ) . Children receiving the zinc supplement ( 10 mg Zn/d as amino acid chelate ) for 90.1 + /- 9.2 d had higher mean fasting plasma zinc ( 16.2 + /- 2.9 vs 14.9 + /- 2.1 mumol/L , P median triceps skinfold Z score ( 0.50 vs 0.38 , P median midarm circumference ( MAC ) Z score ( -0.03 vs -0.20 , P hair zinc classified as 1.68 mumol/g was the only laboratory variable that explained some of the variance in final Z scores of midarm-muscle area ( P MAC ( P zinc supplement with changes in indexes of body composition rather than growth",
"BACKGROUND Leptin , ghrelin , and insulin are hormonal regulators of energy balance and , therefore , may be related to growth during infancy . Zinc is essential for growth , and its growth effects may be mediated through these hormones . OBJECTIVE We examined the effects of supplemental zinc on plasma leptin , ghrelin , and insulin concentrations among young children at risk of zinc deficiency and examined the relations between these hormones and physical growth . DESIGN Children ( n = 142 ) aged 6 - 8 mo were r and omly assigned to receive 3 mg Zn/d as a supplement , in a fortified food , or as a placebo for 6 mo . Relations between hormones and anthropometric z scores , body composition , and growth rates were examined at baseline and 3 and 6 mo after the start of the intervention . RESULTS No treatment group-related differences were found in plasma leptin , ghrelin , or glucose concentrations or in anthropometric z scores at 3 or 6 mo after the start of the zinc intervention . Neither plasma leptin nor ghrelin concentrations at baseline or 3 mo were predictive of subsequent changes in growth . However , changes in weight-for-age z scores over the two 3-mo time intervals were positively associated with subsequent leptin concentrations and inversely associated with subsequent plasma ghrelin concentrations . CONCLUSIONS Supplemental zinc did not affect the children 's growth , anthropometric indexes , or plasma hormone concentrations in this study population . Our results suggest that plasma leptin and ghrelin concentrations in later infancy are a consequence of previous weight changes rather than predictors of short-term growth",
"Background : Obese individuals are more likely to have either lower blood concentrations or lower bioavailability of minerals and /or vitamins . However , there are limited data on the effects of nutritional supplementation on body weight ( BW ) control , energy homeostasis and lipid metabolism in obese subjects . Objective : The purpose of this study is to evaluate the effects of supplementation with multivitamin and multimineral on adiposity , energy expenditure and lipid profiles in obese Chinese women . Design : A total of 96 obese Chinese women ( body mass index ( BMI ) 28 kg m−2 ) aged 18–55 years participated in a 26-week r and omized , double-blind , placebo-controlled intervention study . Subjects were r and omized into three groups , receiving either one tablet of multivitamin and mineral supplement ( MMS ) , or calcium 162 mg ( Calcium ) or identical placebo daily during the study period . BW , BMI , waist circumference ( WC ) , fat mass ( FM ) , fat-free mass , resting energy expenditure ( REE ) , respiratory quotient ( RQ ) , blood pressure , fasting plasma glucose and serum insulin , total cholesterol ( TC ) , low- and high-density lipoprotein-cholesterol ( LDL-C and HDL-C ) and triglycerides ( TGs ) were measured at baseline and 26 weeks . Results : A total of 87 subjects completed the study . After 26 weeks , compared with the placebo group , the MMS group had significantly lower BW , BMI , FM , TC and LDL-C , significantly higher REE and HDL-C , as well as a borderline significant trend of lower RQ ( P=0.053 ) and WC ( P=0.071 ) . The calcium group also had significantly higher HDL-C and lower LDL-C levels compared with the placebo group . Conclusion : The results suggest that , in obese individuals , multivitamin and mineral supplementation could reduce BW and fatness and improve serum lipid profiles , possibly through increased energy expenditure and fat oxidation . Supplementation of calcium alone ( 162 mg per day ) only improved lipid profiles",
"BACKGROUND Stunting is highly prevalent in Ethiopia and many other developing countries but the reason for it is poorly understood . Zinc is essential for growth but diets in such countries often do not contain zinc in sufficient quantity or of sufficient bioavailability . Thus zinc deficiency may play a major role in stunting . The aim of the study was to investigate whether the low rate of linear growth of apparently healthy breastfed infants in a rural village in Ethiopia could be improved by zinc supplementation . METHODS A r and omised , double-blind , placebo-controlled trial was done on apparently healthy breastfed infants aged 6 - 12 months . 100 non-stunted ( length-for-age , Z score -2 ) infants . Infants , both stunted and non stunted , were matched by sex , age ( within 2 months ) and recumbent length ( within 3 cm ) for r and om assignment , to receive a zinc supplement ( 10 mg zinc per day , as zinc sulphate ) or placebo , 6 days a week for 6 months . Anthropometric measurements were taken monthly , data on illness and appetite were collected daily , and sample s of serum and hair were taken at the end of the intervention for the analysis of zinc . FINDINGS The length of stunted infants increased significantly more ( p zinc ( 7.0 cm [ SE 1.1 ] ) than with placebo ( 2.8 cm [ 0.9 ] ) ; and the effect was greater ( p weight of stunted children ( 1.73 [ 0.39 ] vs 0.95 [ 0.39 ] kg for the corresponding placebo group , p non-stunted children ( 1.19 [ 0.39 ] vs 1.02 [ 0.32 ] kg for the corresponding placebo group , p incidence of anorexia and morbidity from cough , diarrhoea , fever , and vomiting in the stunted children . The total number of these conditions per child was 1.56 and 1.11 in the stunted and non-stunted zinc supplemented children versus 3.38 and 1.64 in the stunted and non-stunted placebo-treated children , respectively . At the end of the intervention period , the concentrations of zinc in serum and hair of stunted infants , who had not been supplemented with zinc , were lower than the respective concentrations of zinc in serum and hair of their non-stunted counterparts . INTERPRETATION Combating zinc deficiency can increase the growth rate of stunted children to that of non-stunted infants in rural Ethiopia . This would appear to be due , at least in part , to reduction in morbidity from infection and increased appetite",
"OBJECTIVES To analyse the effect of zinc supplementation in growth and nutritional status of a homogeneous group of newborns with intra uterine growth retardation and asymmetric growth . The effect of changes of zinc status on growth and leptin serum concentrations was also analysed . POPULATION AND METHODS A double blind , r and omised clinical trial was design ed in order to detect differences in growth between zinc and placebo groups during the first 6 months of life . 31 infants were included either to the zinc group ( n = 14 ) ( 38.8+/-1.4 weeks GA , 2,171+/-253 g body weight ) or the placebo group ( n = 17 ) ( 38.9+/-1.1 weeks GA , 2,249+/-220 g body weight ) . The zinc group received a supplement of 3 mg elemental zinc per day ( as zinc sulphate ) . RESULTS There were not significant differences between groups for anthropometric measurements through the study period . We found a significant effect of the study group , in hair zinc concentrations , but not in serum zinc concentrations ; post-hoc comparisons for hair zinc revealed that there were significant differences between groups at 1 , 2 , and 6 months of age . Changes in serum and hair zinc concentrations from baseline to 6 months , showed significant correlations with changes in weight/age and length/age z-scores , in the supplement group . Changes in leptin serum concentrations during follow-up , showed significant correlations with changes in sum of 4 skinfolds and weight/age z-score , in the placebo group . Changes in hair zinc concentration through the study period showed significant correlations with changes in leptin serum concentrations from baseline to 6 months of follow-up . CONCLUSIONS In a homogeneous group of intra uterine growth retardation infants with asymmetric growth , 3 mg/day zinc supplementation do not show significant improvements in weight and length growth . Changes in zinc status were related with changes in weight and length during the first 6 months of life . Changes in leptin serum concentrations were related with changes in the anthropometric indices of body fat accretion",
"BACKGROUND Information is needed on the fractional absorption of zinc ( FAZ ) and absorbed zinc ( AZ ) during prolonged exposure to zinc-fortified foods . OBJECTIVE The objective was to measure FAZ and AZ from diets fortified with different amounts of zinc and to determine whether zinc absorption changes over approximately 7 wk . DESIGN Forty-one stunted , moderately anemic children received daily , at breakfast and lunch , 100 g wheat products fortified with 3 mg Fe ( ferrous sulfate ) and 0 ( group Zn-0 ) , 3 ( group Zn-3 ) , or 9 ( group Zn-9 ) mg Zn ( zinc sulfate ) per 100 g flour . FAZ was measured on days 2 - 3 and 51 - 52 ; meal-specific AZs were calculated as the product of FAZ and zinc intake . RESULTS For the breakfast and lunch meals combined , mean total zinc intakes were 2.14 , 4.72 , and 10.04 mg/d in groups Zn-0 , Zn-3 , and Zn-9 , respectively , during the initial absorption studies ; mean ( + /-SD ) FAZ values were 0.341 + /- 0.111 , 0.237 + /- 0.052 , and 0.133 + /- 0.041 , respectively , on days 2 - 3 ( P Mean initial AZ was positively related to zinc intake ( 0.71 + /- 0.18 , 1.11 + /- 0.21 , and 1.34 + /- 0.47 mg/d , respectively ; P AZ from meals containing zinc-fortified wheat products increases in young children relative to the level of fortification and changes only slightly during approximately 7-wk periods of consumption . Although consumption of zinc-fortified foods may reduce FAZ , zinc fortification at the levels studied positively affects total daily zinc absorption , even after nearly 2 mo of exposure to zinc-fortified diets",
"The present study tested the hypothesis that inadequate Zn intake might be responsible for failure to thrive and impaired catch-up growth in young rural Gambian children , and that Zn supplements might be beneficial . Gambian children might be deprived of Zn because of its poor availability from their predominantly plant-based diet . Rural Gambian children ( 110 ; fifty boys , sixty girls ) aged between 0.57 and 2.30 years were divided into two matched groups , one to receive 70 mg Zn twice weekly for 1.25 years , and the other a placebo . Growth and mid-upper-arm circumference were measured at weekly intervals throughout the study and illnesses were monitored . Capillary blood and urine sample s were collected at 0 , 2 and 8 weeks . Body weights and arm circumferences showed a linear increase , plus a seasonal effect ( rainy season faltering ) . For body weight there was no significant overall effect of the supplement . For arm circumference , a very small ( 2 % ) but significant ( P Plasma thymulin was much lower at the first clinic than at the second and third clinics , and in vitro Zn stimulation was greater at the first clinic . There was , however , no effect of Zn in vivo . Likewise , Zn did not significantly benefit T-cell numbers or ratios , secretory IgA in urine , circulating hormone levels or biochemical indices of Zn status . One index of intestinal permeability , i.e. lactulose : creatinine , was improved ( P rural Gambian children 's ability to thrive , and blanket Zn supplementation is not justified . There may , however , be vulnerable sub-groups who would benefit from Zn supplements",
"This cross-sectional study was conducted to determine the association of high body fat per cent measured by bioelectric impedance analysis with known risk factors of obesity as well as with serum levels of vitamins , trace elements and magnesium and oxidative stress in an urban population in India . There were 850 men aged 25 - 64 years , r and omly selected from the city of Moradabad . Subjects were divided into high body fat per cent ( n = 357 ) , over fat per cent ( n = 230 ) , desirable fat ( n = 200 ) and low fat ( n = 63 ) based on criteria of body fat per cent analysis . The prevalence of central obesity , sedentary lifestyle , family history and higher visible fat intake showed significant association with higher over fat per cent . Postpr and ial plasma insulin and glucose and serum iron and oxidative stress were significantly higher and plasma levels of vitamin C and E and serum zinc/insulin ratio as well as serum magnesium/insulin ratio showed inverse association with high body fat per cent . Multivariate logistic regression analysis after adjustment of age showed a significant positive association of body mass index ( odds ratio 0.97 ) , sedentary lifestyle ( odds ratio 1.12 ) and serum iron ( OR 1.00 ) with higher body fat per cent . Zinc ( OR 1.03 ) , magnesium ( OR 1.02 ) , vitamins C ( OR 1.08 and E ( OR 1.09 ) deficiency were risk factors of higher body per cent and central obesity . It is possible that some Indian men can benefit by increased intake of zinc , magnesium , vitamin C and vitamin E in conjunction with lifestyle changes",
"Leptin is thought to be a lipostatic signal that contributes to body weight regulation . Zinc might play an important role in appetite regulation and its administration stimulates leptin production . However , there are few reports in the literature on its role on leptin levels in the obese population . The present work asseses the effect of zinc supplementation on serum leptin levels in insulin resistance ( IR ) . A prospect i ve double-blind , r and omized , clinical , placebo-controlled study was conducted . Fifty-six normal glucose-tolerant obese women ( age : 25–45 yr , body mass index [ BMI ] = 36.2 ±2.3 kg/m2 ) were r and omized for treatment with 30 mg zinc daily for 4 wk . Baseline values of both groups were similar for age , BMI , caloric intake , insulin concentration , insulin resistance , and zinc concentration in diet , plasma , urine , and erythrocytes . Insulin and leptin were measured by radioimmunoassay and IR was estimated by the homeostasis model assessment ( HOMA ) . The determinations of zinc in plasma , erythrocytes , and 24-h urine were performed by using atomic absorption spectrophotometry . After 4 wk , BMI , fasting glucose , and zinc concentration in plasma and erythrocyte did not change in either group , although zinc concentration in the urine increased from 385.9±259.3 to 470.2±241.2±μg/24 h in the group with zinc supplementation ( p Insulin did not change in the placebo group , whereas there was a significant decrease of this hormone in the supplemented group . HOMA also decreased from 5.8±2.6 to 4.3±1.7 ( p group . Leptin did not change in the placebo group . In the zinc group , leptin was 23.6±12.3 μg/L and did not change . More human data from a unique population of obese individuals with documented insulin resistance would be useful in guiding future studies on zinc supplementation ( with higher doses or longer intervals ) or different measures",
"OBJECTIVES : To assess the effect of zinc supplementation on growth and body composition among schoolchildren . DESIGN : R and omized , double-blind , placebo-controlled trial . SETTING AND SUBJECTS : 313 rural Zimbabwean schoolchildren ( 144 boys and 169 girls ) , 11–17 y ) . INTERVENTIONS : Supplementation with zinc ( 30 or 50 mg ) or placebo on schooldays for 12 months . Due to drought , a food programme was in operation during the last eight months of the study .VARIABLES : Weight , height , upper arm circumference , triceps skinfold thickness , and weight-for-age , height-for-age , weight-for-height , arm muscle-area-for-age and arm fat-area-for-age Z-scores . RESULTS : Significant effects on weight gain ( 0.51 vs 0.14 kg , P=0.01 ) , weight-for-age Z ( −0.08 vs −0.14 , P=0.01 ) and arm muscle area-for-age Z-score ( 0.10 vs 0.01 , P=0.03 ) were seen over the first three months , whereas no effects were seen over the full 12 months . CONCLUSIONS : Zinc deficiency impairing lean body mass and weight gain was documented . However , the effect of zinc seen over the first three months vanished during the last nine months when the food programme was in operation . Zinc deficiency may have persisted , but another nutrient may have become growth limiting during the last nine months . SPONSORSHIP : Danish International Development Assistance",
"Serum zinc and hair zinc concentrations of some New Zeal and children aged 11 yr , were examined in relation to selected anthropometric indices . Serum zinc concentrations ( n=453 ) in boys and girls were similar and were unrelated to anthropometric indices and hair zinc concentrations . Mean hair zinc concentration ( n=620 ) of the girls was higher than that for the boys ( 2.95±0.49 vs 2.46±0.47 µmol/g ; p to hair zinc concentration and that the confounding effects of mid-parent height and the timing of the adolescent growth spurt was small . Results for the girls were similar but less significant . Dichotomizing the hair zinc results divided both the boys and girls into two groups : those with hair zinc 2.44 µmol/g . The results demonstrate that in these healthy New Zeal and children , those with lower hair zinc concentrations are fatter and heavier than their high-hair-zinc counterparts",
"We assessed the effect of zinc supplementation on growth velocity in 79 children and adolescents ( 48 males , 38 females ) with idiopathic short stature . Their height‐for‐age was Patients were assigned r and omly to a supplemented group ( S ) to receive Zn 10 mg/day or to a placebo ( P ) group , according to gender and age , and were followed‐up for 12 months using a double‐blind design . Weight , height , armspan , length of lower segment and plasma and hair concentrations of Zn were measured at 0 , 3 , 6 and 12 months . On admission and at 6 months , energy , protein , dietary fiber and zinc intakes were similar for groups S and P ; mean zinc intake was found in plasma zinc , hair zinc , weight . armspan or lower segment increments . Pre‐adolescent males in group S had a significantly greater increase in stature compared with group P ( 6.2 ± 2.1 versus 4.5 ± 1.2 cm/year p score improved from —2.42 to —2.24 in group S and from — 2.63 to — 2.61 in group P. For adolescent males , the difference was also significant ( 8.3 ± 1.5 versus 6.2 & 2.1 cm/year ; p Chilean male schoolchildren and adolescents with idiopathic short stature , zinc supplementation increases growth velocity over a 12‐month period",
"In rural Mexico and in many developing countries micronutrient deficiencies , growth stunting , and morbidity from infectious diseases are highly prevalent in young children . We assessed the extent to which growth stunting could be reversed and the number of infectious disease episodes reduced by zinc and /or iron supplementation . In a double-blind , r and omized community trial 219 Mexican preschoolers were supplemented with either 20 mg Zn as zinc methionine , 20 mg Fe as ferrous sulfate , 20 mg Zn + 20 mg Fe , or a placebo . After 12 mo , plasma zinc increased significantly in the two zinc-treated groups , and plasma ferritin was significantly higher in the two iron-treated groups . There was no effect of treatments on growth velocity or body composition . Children in both zinc-supplemented groups had fewer episodes of disease ( zinc alone , 3.9 + /- 0.3 ; zinc+iron , 3.7 + /- 0.4 ; placebo , 4.6 + /- 0.5 ; P diarrhea ( zinc alone , 0.7 + /- 0.1 ; zinc+iron , 0.8 + /- 0.1 ; placebo , 1.1 + /- 0.2 ; P Zinc and zinc+iron supplements reduced morbidity but had no effect on growth or body composition",
"OBJECTIVE The aim of our study was to evaluate the effect of zinc supplementation on linear growth , body composition , and growth factors in premature infants . DESIGN Thirty-six preterm infants ( gestational age : 32.0 + /- 2.1 weeks , birth weight : 1704 + /- 364 g ) participated in a longitudinal double-blind , r and omized clinical trial . They were r and omly allocated either to the supplemental ( S ) group fed with a st and ard term formula supplemented with zinc ( final content 10 mg/L ) and a small quantity of copper ( final content 0.6 mg/L ) , or to the placebo group fed with the same formula without supplementation ( final content of zinc : 5 mg/L and copper : 0.4 mg/L ) , from 36 weeks postconceptional age until 6 months corrected postnatal age . At each evaluation , anthropometric variables and bioelectrical impedance were measured , a 3-day dietary record was collected , and a blood sample was taken . We analyzed serum levels of total alkaline phosphatase , skeletal alkaline phosphatase ( sALP ) , insulin growth factor (IGF)-I , IGF binding protein-3 , IGF binding protein-1 , zinc and copper , and the concentrations of zinc in erythrocytes . RESULTS The S group had significantly higher zinc levels in serum and erythrocytes and lower serum copper levels with respect to the placebo group . We found that the S group had a greater linear growth ( from baseline to 3 months corrected age : Delta score deviation st and ard length : 1.32 + /-.8 vs.38 + /-.8 ) . The increase in total body water and in serum levels of sALP was also significantly higher in the S group ( total body water : 3 months ; corrected age : 3.8 + /-.5 vs 3.5 + /-.4 kg , 6 months ; corrected age : 4.5 + /-.5 vs 4.2 + /-.4 kg ; sALP : 3 months ; corrected age : 140.2 + /- 28.7 vs 118.7 + /- 18.8 micro g/L ) . CONCLUSIONS Zinc supplementation has a positive effect on linear growth in premature infants",
"The objective of this study was to determine whether zinc deficiency is one of the factors involved in nutritional failure to thrive in infants and toddlers . Participants were selected on the basis of anthropometric criteria , particularly a decline in weight velocity preceding changes in length gains . The investigation was design ed as a double-blind , r and omized , pair-matched , controlled study of dietary zinc supplementation of 6 months ' duration . Anthropometric data were collected at 0 , 1 , 3 , and 6 months . Twenty-five pairs of infants completed the project . When compared with placebo-treated control children , the zinc-supplemented group ( combined sexes ) and the supplemented boys showed significant improvements in st and ard deviation scores for weight for all three intervals , the largest differences occurring for the 0- to 3-month interval ( P less than or equal to .0001 ) . The zinc-supplemented girls demonstrated a trend toward improvements in changes in st and ard deviation scores for weight ( P = .056 ) . There were no differences in length gains for either boys or girls . This improvement in weight gains after zinc supplementation demonstrates that mild zinc deficiency can be one of the etiologic factors in nutritional failure to thrive during infancy"
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INTRODUCTION Iodine is an essential micronutrient and component of the thyroid hormones . Sufficient ingestion of iodine is necessary for normal growth and development . If iodine requirements are not met , growth can be impaired . Salt iodisation and supplementation with iodine can prevent iodine deficiency disorders and stunted growth . No systematic review has yet collated the evidence linking iodine to growth . With an increased emphasis on stunting within the WHO Global Nutrition Targets for 2025 , we propose a systematic review to address this question . METHODS AND ANALYSIS We will undertake a systematic review , and if appropriate , meta-analyses , evaluating the effects of iodised salt or iodine supplements on prenatal and postnatal somatic growth , until age 18 . We will search a number of data bases , including MEDLINE , EMBASE , Web of Science , CINAHL , PsychINFO , the Cochrane Library , including the CENTRAL register of Controlled Trials and also the WHO library and ICTRP ( International Clinical Trials Registry Platform ) , which includes the Clinical trials.gov repository . We will also search Wanfang Data and the China Knowledge Re source Integrated Data base . Included studies must have compared exposure to iodised salt , iodine supplements or iodised oil , to placebo , non-iodised salt or no intervention . Primary outcomes will be continuous and categorical markers of prenatal and postnatal somatic growth . Secondary outcomes will cover further measures of growth , including growth rates and indirect markers of growth such as insulin-like growth factor-1 ( IGF-1 ) . ETHICS AND DISSEMINATION The systematic review will be published in a peer- review ed journal , and will be sent directly to the WHO , United Nations Children 's Fund , International Council for the Control of Iodine Deficiency Disorders and other stakeholders . The results generated from this systematic review will provide evidence to support future programme recommendations regarding iodine fortification or supplementation and child growth . TRIAL REGISTRATION NUMBER PROSPERO CRD42014012940
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"Adequate iodine status in early life is crucial for neurodevelopment . However , little is known about the effects of maternal iodine status during pregnancy on fetal growth . The present study investigated the potential impact of maternal iodine status during pregnancy on offspring birth size . This large prospect i ve cohort study was nested in a Bangladeshi population -based r and omized supplementation trial in pregnant women [ MINIMat ( Maternal and Infant Nutrition Interventions in Matlab ) ] . Urine sample s obtained at 8 wk of gestation from 1617 women were analyzed for iodine and other elements , such as arsenic and cadmium , using inductively coupled plasma mass spectrometry . Anthropometric measurements at birth included weight , length , and head and chest circumference . Maternal urinary iodine concentrations ( UICs ) ranged from 0.020 to 10 mg/L , with a median of 0.30 mg/L. Below ∼1.0 mg/L , UIC was significantly positively associated with birth weight and length . Birth weight and length increased by 9.3 g ( 95 % CI : 2.9 , 16 ) and 0.042 cm ( 95 % CI : 0.0066 , 0.076 ) , respectively , for each 0.1-mg/L increase in maternal UIC . No associations were observed between UIC and head or chest circumference . When we stratified the analyses by newborn sex , the positive associations between maternal UIC ( the mean weight , length , and head circumference increased by 70 g ( P = 0.019 ) , 0.41 cm ( P = 0.013 ) , and 0.28 cm ( P = 0.031 ) for every 0.5-mg/L increase in maternal UIC . Maternal iodine status was positively associated with weight , length , and head circumference in boys up to ∼1 mg/L , which is well above the recommended maximum concentration of 0.5 mg/L. The associations leveled off at UIC ≥ 1 mg/L. Our findings support previous conclusions that the advantages of correcting potential iodine deficiency outweigh the risks of excess exposure",
"The prevalence of iodine deficiency disorders and the thyroid status of the population were studied in an endemic goitre area in Algeria . After oral administration of lipiodol ( 0.5 ml ) , three treated groups of mother-newborn couples were compared to an untreated group : group A , mothers treated 1 - 3 months before conception ; group B , mothers treated during the first month of pregnancy ; group C , mothers treated during the third month of pregnancy . Untreated mothers were used as a control ( group D ) . After lipiodol treatment , all newborn babies and mothers were clinical ly euthyroid . All tested newborn babies were full term and no goitre was observed in the four groups . In the mothers , goitre prevalence and thyrotrophin levels decreased significantly , whereas maternal milk and urinary iodine and serum-free thyroxine levels were significantly higher after treatment . The rate of prematurity , stillbirths and abortions in the treated groups was reduced when compared to the untreated group , whereas placental and birth weights were significantly higher . In group D two cases of neonatal hypothyroidism were detected . Their re-evaluation confirmed that hypothyroidism was transient . Groups A , B and C were statistically different from group D with regard to neonatal thyrotrophin and thyroxine . Positive correlations were found between neonatal thyroxine and birth weights and placental weights on the one h and , and maternal urinary iodine and free thyroxine on the other . Consequently , these data indicate that oral administration of lipiodol before or during the first trimester of pregnancy normalizes thyroid function in newborn babies and mothers , increases placental and birth weight and reduces the frequency of iodine deficiency disorders . ( ABSTRACT TRUNCATED AT 250 WORDS",
"CONTEXT Iodine deficiency in utero impairs fetal growth , but the relationship between iodine deficiency and postnatal growth is less clear . OBJECTIVE The objective of the study was to determine whether iodine repletion improves somatic growth in iodine-deficient children and investigate the role of IGF-I and IGF binding protein (IGFBP)-3 in this effect . DESIGN , PARTICIPANTS , AND INTERVENTIONS Three prospect i ve , double-blind intervention studies were done : 1 ) in a 10-month study , severely iodine-deficient , 7- to 10-yr-old Moroccan children ( n = 71 ) were provided iodized salt and compared with children not using iodized salt ; 2 ) in a 6-month study , moderately iodine-deficient , 10- to 12-yr-old Albanian children ( n = 310 ) were given 400 mg iodine as oral iodized oil or placebo ; 3 ) in a 6-month study , mildly iodine-deficient 5- to 14-yr-old South African children ( n = 188 ) were given two doses of 200 mg iodine as oral iodized oil or placebo . At baseline and follow-up , height , weight , urinary iodine ( UI ) , total T4 ( TT4 ) , TSH , and IGF-I were measured ; in Albania and South Africa , IGFBP-3 was also measured . RESULTS In all three studies , iodine treatment increased median UI to more than 100 microg/liter , whereas median UI in the controls remained unchanged . In South Africa , iodine repletion modestly increased IGF-I but did not have a significant effect on IGFBP-3 , TT4 , or growth . In Albania and Morocco , iodine repletion significantly increased TT4 , IGF-I , IGFBP-3 , weight-for-age z scores , and height-for-age z scores . CONCLUSION This is the first controlled study to clearly demonstrate that iodine repletion in school-age children increases IGF-I and IGFBP-3 concentrations and improves somatic growth"
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Background Bariatric surgery has demonstrated to be effective in remission of type 2 diabetes in obese patients , but it is unclear in non-obese patients . The aim of this study is to investigate if metabolic surgery is effective in diabetes resolution in patients with BMI Material s and Methods A systematic review was performed and the content of the PubMed , Ovid , and the Cochrane Library data bases covering the period January 2008 to April 2018 was search ed . Studies with metabolic surgery performed in patients with type 2 diabetes , BMI . Type 2 diabetes remission rate and metabolic parameters changes were measured . A meta- analysis was conducted with the selected studies . Results Twenty-six studies were included in the meta- analysis ( 1105 patients ) . The mixed-effects meta- analysis model for overall diabetes remission rate produced an estimate of 43 % ( 95 % IC 34–53 % , p variables race , preoperative HbA1c , BMI , months of follow-up , duration of diabetes , and age on diabetes remission were also assessed , with no significant effects being found in any of them . A reduction in BMI ( − 3.57 kg/m2 ) , fasting blood glucose ( − 55.93 mg/dL ) and HbA1c ( − 2.08 % ) was observed after surgery . Conclusions Metabolic surgery could be effective in remission of type 2 diabetes in BMI but r and omized and long-term studies are necessary . The scientific community should agree in a single definition of type 2 diabetes remission , in order to know the real effect of metabolic surgery in this group of patients
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"Abstract Roux-en-Y gastric bypass surgery ( RYGB ) has been demonstrated to be successful for treating type-II diabetes mellitus ( T2DM ) patients with a body mass index ( BMI ) , but reports of RYGB for T2DM patients with a BMI are lacking . T2DM patients with a BMI prospect ively recruited to participate in this study in four hospitals . The endpoint was T2DM remission ( defined by fasting blood glucose ( FBG ) level hemoglobin (Hb)A1c level Eighty-six patients were assessed . Eighty-five patients underwent RYGB , with one conversion to open surgery . We compared the values of various variables before and after surgery . The mean BMI decreased from 24.68±2.12 to 21.72±2.43 kg/m2 ( P drugs or insulin after surgery , and 20 patients ( 23.3 % ) had complete remission of T2DM at 12 months after surgery with an acceptable number of complications . The mean HbA1c level in the remission group was significantly lower than that in the non-remission group . Patients with a higher weight , lower HbA1c level , higher C-peptide level , and higher FBG level were more likely to have T2DM remission in multivariate analyses . In conclusion , RYGB was effective and safe for treating T2DM patients with a BMI Complete remission can be predicted by cases having a higher weight , lower HbA1c level , higher C-peptide level , and higher FBG level",
"Purpose The goals of this study are to evaluate the effect of duodenojejunal bypass ( DJB ) for type 2 diabetes mellitus ( T2DM ) patients below body mass index ( BMI ) 25 kg/m2 in one year follow-up , and to compare the results of 1 week which we have reported in 2011 . Methods In this prospect i ve observational study , there were 31 type 2 diabetic patients who underwent DJB at Inha University Hospital from July 2009 to January 2011 . We did laboratories such as 75-g oral glucose tolerance test ( OGTT ) , insulin level and hemoglobin A1c ( HbA1c ) , etc . and compared their changes of preoperative , a week , 3 months , and 12 months . Results Mean BMI was 23.1 ± 1.3 kg/m2 , mean duration of T2DM was 8.3 ± 4.7 and mean age was 46.6 ± 7.7 years . There were a significant decrease of 75-g OGTT levels and increase of insulin secretion after 3 months . 13.3 % showed diabetic remission ( HbA1c showed diabetic improvement . The rates of remission and improvement much declined comparing with that of postoperative 1 week although those were determined by fasting and postpr and ial 2 hour level of glucose . Conclusion This is the first study of metabolic surgery in Korean diabetes patients in the healthy weight range . DJB exerted positive influences on insulin resistance as well as beta cell function . Early effects on T2DM after DJB could be estimated as one of good modalities , although the effectiveness seems to be unacceptable . Further studies are m and atory for evaluation of the effectiveness of metabolic surgery and finding prognostic factors",
"Background Recently , many studies focused on type 2 diabetes mellitus ( T2DM ) patients with body mass index ( BMI ) and suggested that those patients might benefit from Roux-en-Y gastric bypass ( RYGB ) . However , evidence on its effectiveness to improve T2DM patients with BMI similar surgical effect from RYGB compared with those patients with BMI > 30 kg/m2 . Methodology Seventy patients with uncontrolled T2DM underwent laparoscopic RYGB from May 2010 to December 2015 in the GI Department of Daping Hospital . Weight , BMI , waist circumference , glucose , and lipid metabolic parameters were collected and evaluated at baseline and 1 , 3 , 6 , 12 , and 24 months postsurgery . Patients with BMI 30 kg/m2 . Results Among the 70 patients , 47 ( 67.1 % ) BMI 30 kg/m2 . Patients with BMI are significantly older ; they are female predominant and have longer duration of diabetes . The complete remission of T2DM was 28.2 % of the BMI 30 kg/m2 group ( p = 0.029 ) . There was no significant difference in the change of glucose and lipid metabolic parameters of both groups . FPG , 2hPG , and HbA1c% levels were significantly improved after 1 month ( p RYGB is a safe and effective procedure in treating T2DM with BMI 30 kg/m2 group",
"Background Medical treatment of type 2 diabetes has often insufficient clinical results at long term . Although the surgical option is a well-established alternative for obese patients , the procedures in non-obese are currently being developed . Methods A 12-month prospect i ve trial with ten diabetic non-obese patients who underwent laparoscopic sleeve gastrectomy with duodenojejunal bypass is presented . Changes in fasting blood glucose , HbA1c , weight , and BMI were determined . Results There was a significant reduction in fasting glycemia and HbA1c at 1 year postoperative ( p intra-abdominal bleeding and a wound infection treated with blood transfusion and antibiotic therapy , respectively . The BMI decreased 12.1 % and in any case it was reduced to less than 20 kg/m2 . Conclusions Laparoscopic sleeve gastrectomy with duodenojejunal bypass is a promising procedure for the treatment of non-obese patients with type 2 diabetes . Studies with large number of patients and longer follow-up are necessary to make definitive conclusions",
"BACKGROUND Our objective was to evaluate the long-term results of laparoscopic Roux-en-Y gastric bypass on excess weight loss , remission of the metabolic syndrome , and complications in Indian patients with uncontrolled type 2 diabetes mellitus ( T2DM ) with a body mass index of 30 - 35 kg/m(2 ) . The setting was a corporate hospital in Mumbai , India . METHODS The present prospect i ve observational study was begun in January 2006 . A total of 52 patients with uncontrolled T2DM and a body mass index of 30 - 35 kg/m(2 ) elected to undergo laparoscopic Roux-en-Y gastric bypass . The duration of T2DM was 3.5 - 14.5 years ( median 8.4 ) . Of the 52 patients , 61.5 % had hypertension and 59.6 % had dyslipidemia . Remission of T2DM and other components of the metabolic syndrome were assessed . All patients were followed up for 5 years . RESULTS The median percentage of excess weight loss was 72.2 % at 1 year and 67.8 % at 5 years . Of the 52 patients , 84.6 % had achieved euglycemia and 73.1 % had achieved complete remission , 23.1 % partial remission , and 3.84 % no remission at 1 year . Weight regain occurred in 8 patients . They required antihypertensive drugs and statins , decreasing the complete remission rate to 57.7 % and partial remission rate to 38.5 % at 5 years . However , 96.2 % improvement in metabolic status was found at the end of 5 years . CONCLUSION Laparoscopic Roux-en-Y gastric bypass is a safe , efficacious , and cost-effective treatment for uncontrolled T2DM in patients with a body mass index of 30 - 35 kg/m(2 ) . Early-onset T2DM , better weight loss , and greater C-peptide levels were predictors of success after surgery . The improvement after surgery in hyperglycemia , hypertension , and dyslipidemia could help in controlling the occurrence of micro- and macrovascular complications and decrease the morbidity and mortality associated with T2DM",
"AIM To assess factors influencing glycaemic control following gastric bypass surgery in patients with Type 2 diabetes and BMI METHODS Prospect i ve longitudinal study of 103 patients with inadequate glycaemic control who underwent gastric bypass surgery at Soonchunhyang University , Seoul , Korea ( n = 66 ) and Min-Sheng General Hospital , Taipei , Taiwan ( n = 37 ) . Procedures were performed August 2009 to January 2011 . Key outcome measures were excellent glycaemic control of Type 2 diabetes defined as HbA1c inadequate response defined as HbA1c > 53 mmol/mol ( > 7 % ) . Analysis was conducted using binary logistic regression , and cut-points obtained from receiver operator characteristics . RESULTS Excellent glycaemic control was achieved in 31 ( 30 % ) at 1 year . Diabetes duration of 27 kg/m(2 ) provided independent predictors and useful cut-points . Likelihood of excellent glycaemic control for an individual could be estimated using loge ( Odds ) = -6.7 + ( 0.26 × BMI ) + ( -1.2 × diabetes duration ) . Baseline BMI of poor glycaemic response . In those with favourable baseline characteristics percentage weight loss ( % WL ) had a dominant influence on glycaemic outcomes . Baseline C-peptide ( > 2.4 ng/ml ) and subsequent percentage weight loss ( > 16 % ) were associated with excellent glycaemic control . Higher BMI was associated with greater percentage weight loss . CONCLUSION In patients with Type 2 diabetes and BMI , glycaemic response to gastric bypass is predicted by higher baseline BMI , shorter disease duration and higher fasting C-peptide . Post-surgery weight loss has a dominant effect . Baseline BMI and weight loss have a major influence on outcomes",
"Background Beneficial effects of BPD on T2DM in BMI > 35 kg/m2 patients are far better than those in patients with BMI 25–35 . This study was aim ed at investigating if a similar difference exists between patients with mild obesity ( OB , BMI 30–35 ) or simple overweight ( OW , BMI 25–30 ) . Methods Fifteen OB ( six M ) and 15 OW ( 13 M ) , diabetic for ≥3 years , with HbA1c ≥7.5 % despite medical therapy , underwent BPD . OB/OW : age 55.1 ± 8.0/57.8 ± 6.7 years , BMI 33.1 ± 1.5/28.0 ± 1.3 kg/m2 , diabetes duration 11.6 ± 8.0/11.1 ± 6.1 years , insulin therapy 4/8 p. FSG and HbA1c were determined preoperatively and up to 2 years . Insulin resistance and beta-cell function were explored by means of HOMA-IR and IVGTT ( AIR ) . Thirty-eight diabetic patients on medical therapy served as controls . Results Mean BMI stabilized around 27 since the 4th month in OB , and 24 since 1st month in OW . FSG in OB/OW preop , 1 , 12 , 24 months : 234 ± 76/206 ± 62 mg/dL , 154 ± 49/176 ± 75 , 131 ± 32/167 ± 48 , 134 ± 41/154 ± 41 ( cross-sectional n.s . at all times ) ; HbA1c : 9.5 ± 1.6/9.1 ± 1.3 , 7.3 ± 1.1/7.3 ± 1.2 , 5.9 ± 0.6/7.1 ± 1.1 ( p 1.1 ( p HOMA-IR , preoperatively 10.7 ± 5.8/7.5 ± 5.4 , went below 3.0 at 1 month and remained such until 2 years in both groups . AIR , preoperatively 1.11 ± 3.17/1.27 ± 2.68 μIU/mL , in OB significantly increased at 4 months to 7.63 ± 5.79 , maintained up to 2 years with 6.95 ± 3.19 , whereas in OW , statistical significance was reached only at 2 years with 5.02 ± 4.87 . Conclusions Significantly different BPD effect , thus biological severity of T2DM , also exists between mildly obese and simply overweight patients . The rise of AIR allows hoping that an increase of beta-cell mass may occur in the long run . Clinical Trials.gov Identifier :",
"BACKGROUND The beneficial role of laparoscopic Roux-en-Y gastric bypass ( LRYGB ) for type 2 diabetes mellitus ( T2 DM ) in morbidly obese patients has been established ; however , there is scant evidence supporting its effectiveness in nonobese T2 DM Asian patients . The objective of this study was to evaluate the effect of LRYGB in nonobese T2 DM patients and eluci date the predictors of DM remission after one year follow-up . METHODS Between June 2009 and May 2011 , twenty-nine nonobese ( body mass index ( BMI ) LRYGB were enrolled . All patients were prospect ively followed up for one year . Baseline demographic characteristics , diabetic status , and clinical and biochemical data were collected preoperatively and one year after LRYGB . DM remission was defined as those with hemoglobin A1 c ( HbA1 c) DM remission group were compared with the nonremission group and analyzed . RESULTS All clinical and biochemical parameters , except uric acid , were significantly improved . DM remission was achieved in eleven patients ( 37.9 % ) of whom five ( 45.5 % ) were male . Blood glucose , HbA1 c , c-peptide , homeostatic model assessment ( HOMA-%B ) , and low density lipoprotein (LDL)-cholesterol were the significant variables in patients with DM remission ; however , multiple logistic regression showed that only preoperative HOMA-%B ( odds ratio ( OR ) = 1.13 , 95 % CI = 1.03 - 1.24 ) was a predictor for DM remission . Though no mortality was seen , the complication rate was 20.7 % , of which 17.3 % was related to marginal ulcers . CONCLUSION LRYGB result ed in significant clinical and biochemical improvements in nonobese Asian patients , with HOMA-%B indicating β-cell function as the main predictor of T2 DM remission . Appropriate patient selection with better β-cell function and evidence from long-term follow-up may justify this therapeutic approach",
"BACKGROUND Bariatric surgery improves glycaemia in obese people with type 2 diabetes , but its effects are uncertain in overweight people with this disease . We aim ed to identify whether laparoscopic adjustable gastric b and surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese . METHODS We did an open-label , parallel-group , r and omised controlled trial between Nov 1 , 2009 , and June 30 , 2013 , at one centre in Melbourne , Australia . Patients aged 18 - 65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were r and omly assigned ( 1:1 ) , by computer-generated r and om sequence , to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric b and surgery or multidisciplinary diabetes care alone . The primary outcome was diabetes remission 2 years after r and omisation , defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose , at least two days after stopping glucose-lowering drugs . Analysis was by intention to treat . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12609000286246 . FINDINGS 51 patients were r and omised to the multidisciplinary care plus gastric b and group ( n=25 ) or the multidisciplinary care only group ( n=26 ) , of whom 23 participants and 25 participants , respectively , completed follow-up to 2 years . 12 ( 52 % ) participants in the multidisciplinary care plus gastric b and group and two ( 8 % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions 0.44 , 95 % CI 0.17 - 0.71 ; p=0.0012 ) . One ( 4 % ) participant in the gastric b and group needed revisional surgery and four others ( 17 % ) had a total of five episodes of food intolerance due to excessive adjustment of the b and . INTERPRETATION When added to multidisciplinary care , laparoscopic adjustable gastric b and surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile . Laparoscopic adjustable gastric b and surgery is a reasonable treatment option for this population . FUNDING Monash University Centre for Obesity Research and Education and Allergan",
"CONTEXT Diabetes remission is frequent after biliopancreatic diversion ( BPD ) in morbidly obese patients with type 2 diabetes ( T2D ) . Data , mechanisms , and clinical indications in nonobese T2D patients are scanty . OBJECTIVE The objective of the study was to assess remission and investigate insulin sensitivity and β-cell function after BPD in nonobese patients with long-st and ing T2D . DESIGN , SETTING , AND PATIENTS This was a clinical research study comparing 15 T2D patients ( aged 55 ± 1 years , duration of 16 ± 2 years , body mass index of 28.3 ± 0.6 kg/m² , glycosylated hemoglobin 8.6 % ± 1.3 % ) with 15 gender- , age- , and body mass index-matched nondiabetic controls . Before surgery and 2 months and 1 year later , a 3-hour oral glucose tolerance test , a 5-hour mixed-meal test , and a 3-hour euglycemic clamp were performed . INTERVENTION The intervention included a BPD ( distal gastrectomy , proximal ileum anastomosed to remaining stomach , biliopancreatic limb anastomosed to ileum 50 cm from the ileocecal valve ) . RESULTS Glycemia improved in all patients , but remission ( glycosylated hemoglobin patients . Insulin resistance ( 19.8 ± 0.8 μmol · min⁻¹ · kg(ffm)⁻¹ , P although insulin-mediated suppression of endogenous glucose production remained impaired . In contrast , β-cell glucose sensitivity ( 19 [ 12 ] pmol · min⁻¹ · m⁻² · mM⁻¹ vs 96 [ 73 ] of controls , P nonobese patients with long-st and ing T2D , BPD improves metabolic control but induces remission in only approximately 40 % of patients . Peripheral insulin sensitivity is restored early after surgery and similarly in remitters and nonremitters , indicating a weight-independent effect of the operation . The initial extent of β-cell incompetence is the main predictor of the metabolic outcome "
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41165844-06ff-11f0-808a-c43d1ab1c353
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