Sharing Individual Participant Data from Clinical Trials: An Opinion Survey Regarding the Establishment of a Central Repository Effect of a short bout of exercise on tobacco withdrawal symptoms and desire to smoke Acute effects of a short bout of moderate versus light intensity exercise versus inactivity on tobacco withdrawal symptoms in sedentary smokers Does exercise have an acute effect on desire to smoke, mood and withdrawal symptoms in abstaining adolescent smokers? Effect of dignity therapy on end-of-life psychological distress in terminally ill Portuguese patients: A randomized controlled trial. The effect of exercise in reducing desire to smoke and cigarette withdrawal symptoms is not caused by distraction. What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors Can trial quality be reliably assessed from published reports of cancer trials: evaluation of risk of bias assessments in systematic reviews The Effects of Physical Activity on Health and Quality of Life in Adolescent Cancer Survivors: A Systematic Review Effects of physical activity on cancer survival: a systematic review. Effects of workplace-based dietary and/or physical activity interventions for weight management targeting healthcare professionals: a systematic review of randomised controlled trials Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews A systematic review of the use of financial incentives and penalties to encourage uptake of healthy behaviors: protocol Acute effect of glucose tablets on desire to smoke Patterns of Sedentary Behavior and Mortality in U.S. Middle-Aged and Older Adults Acute effect of isometric exercise on desire to smoke and tobacco withdrawal symptoms. Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review Effect of isometric exercise and body scanning on cigarette cravings and withdrawal symptoms. The Effect of Pelvic Floor Muscle Exercise on Female Sexual Function During Pregnancy and Postpartum: A Systematic Review. The effectiveness of yoga to prevent diabetes mellitus type 2 Acute exercise effects on smoking withdrawal symptoms and desire to smoke are not related to expectation INVITED COMMENTARY: Rating the Quality of Trials in Systematic Reviews of Physical Therapy Interventions
Background Calls have been made for increased access to individual participant data ( IPD ) from clinical trials , to ensure that complete evidence is available . However , despite the obvious benefits , progress towards this is frustratingly slow . In the meantime , many systematic review s have already collected IPD from clinical trials . We propose that a central repository for these IPD should be established to ensure that these data sets are safeguarded and made available for use by others , building on the strengths and advantages of the collaborative groups that have been brought together in developing the data sets . Objective Evaluate the level of support , and identify major issues , for establishing a central repository of IPD . Design On-line survey with email reminders . Participants 71 review ers affiliated with the Cochrane Collaboration 's IPD Meta- analysis Methods Group were invited to participate . Results 30 ( 42 % ) invitees responded : 28 ( 93 % ) had been involved in an IPD review and 24 ( 80 % ) had been involved in a r and omised trial . 25 ( 83 % ) agreed that a central repository was a good idea and 25 ( 83 % ) agreed that they would provide their IPD for central storage . Several benefits of a central repository were noted : safeguarding and st and ardisation of data , increased efficiency of IPD meta-analyses , knowledge advancement , and facilitating future clinical , and method ological research . The main concerns were gaining permission from trial data owners , uncertainty about the purpose of the repository , potential re source implication s , and increased workload for IPD review ers . Restricted access requiring approval , data security , anonymisation of data , and oversight committees were highlighted as issues under governance of the repository . Conclusion There is support in this community of IPD review ers , many of whom are also involved in clinical trials , for storing IPD in a central repository . Results from this survey are informing further work on developing a repository of IPD which is currently underway by our group Abstract . Rationale : Previous research suggests that a long bout of vigorous intensity exercise may reduce tobacco withdrawal symptoms and desire to smoke during abstinence . Objective : In the present study , we investigated whether a short bout of moderate intensity exercise reduced desire to smoke and withdrawal symptoms in abstaining smokers . Methods : Seventy-eight smokers attended the laboratory in the afternoon having not smoked since the previous evening . They rated their desire to smoke and withdrawal symptoms immediately before , during and after 10 min of moderate intensity exercise on a stationary cycle ( experimental condition ) , or after waiting passively ( control condition 1 ) or watching a video ( control condition 2 ) . Results : Ratings of desire to smoke and withdrawal symptoms decreased more in the experimental group than in both control groups , which did not differ from each other . The effect was evident at all measurement points and was maintained for at least 10 min following exercise . Conclusion : A single bout of 10 min of moderate intensity exercise has a rapid and measurable effect on desire to smoke and tobacco withdrawal symptoms in abstaining smokers . Short bouts of exercise may be useful in helping to reduce desire to smoke and withdrawal symptoms during smoking cessation Rationale A previous study found that a 10-min bout of moderate intensity exercise reduced cigarette withdrawal symptoms and desire to smoke in sedentary smokers but the effect may have been due to participants focusing attention on physical activity rather than the activity itself . Objectives This study examined the effect of 5 min of moderate intensity exercise and 5 min of light intensity exercise on tobacco withdrawal symptoms  amongst sedentary smokers . Methods Eighty-four smokers attended a laboratory session having abstained from smoking for between 11 and 14 h. Participants were r and omly allocated to one of three conditions : ( i ) light intensity exercise [ n=28 ; 10–20 % of heart rate reserve ( HRR ) ] ; ( ii ) moderate intensity exercise ( n=28 ; 40–60 % HRR ) , ( iii ) a passive control condition ( n=28 ) . Both exercise conditions involved 5 min of stationary cycling and participants rated tobacco withdrawal symptoms and cravings immediately before exercise ( baseline ) , during exercise at 2.5 min , immediately following exercise , then after 5 and 10 min of rest . Control participants made the same ratings across an equivalent time period . Results For moderate intensity exercise compared to light intensity exercise and control there was a significant reduction in strength of desire to smoke , relative to baseline , both during exercise and up to 5 min post-exercise . Relative to baseline , there were also significant reductions in restlessness , stress , tension and poor concentration at 5 and 10 min post-exercise , for moderate intensity exercise compared to light intensity exercise and control . Conclusions Five minutes of moderate intensity exercise is associated with a short-term reduction in desire to smoke and tobacco withdrawal symptoms . Very brief bouts of exercise may therefore be useful as an aid to smoking cessation OBJECTIVE Previous studies have shown that exercise acutely reduces desire to smoke and withdrawal symptoms among adult smokers ; however , no study has examined these effects in younger smokers . This study investigated the impact of a short bout of moderate intensity exercise on desire to smoke , withdrawal symptoms and exercise-induced affect in temporarily abstinent adolescent smokers . METHODS Thirty-seven low-active male and female smokers aged 16 - 19 years , abstained from smoking overnight and were assigned to either ( i ) 10 min of moderate intensity cycle ergometry ( n=18 ) or ( ii ) a placebo control condition that involved very light intensity cycle ergometry ( n=19 ) . Measures of desire to smoke , the Mood and Physical Symptoms Scale ( MPSS ) and Subjective Exercise Experience Scale ( SEES ) were administered at baseline , 5 min during , 5 min after and 30 min after both conditions . RESULTS AND CONCLUSION A significant interaction effect for group by time was recorded for psychological distress scores , when the baseline value was covaried . Follow-up tests indicated that the exercise group reported significantly higher PD scores than the placebo control during exercise , but not at any other time point . No other significant effects were found for any other variables . Unlike research involving adult population s , a short bout of moderate intensity exercise did not alter desire to smoke among abstaining adolescent smokers and may negatively impact affective responses during exercise OBJECTIVE Dignity therapy ( DT ) is a brief form of psychotherapy developed for patients living with a life-limiting illness that has demonstrated efficacy in treating several dimensions of end-of-life psychological distress . Our aim was to determine the influence of DT on demoralization syndrome ( DS ) , the desire for death ( DfD ) , and a sense of dignity ( SoD ) in terminally ill in patients experiencing a high level of distress in a palliative care unit . METHOD A nonblinded phase II r and omized controlled trial was conducted with 80 patients who were r and omly assigned to one of two groups : the intervention group ( DT + st and ard palliative care [ SPC ] ) or the control group ( SPC alone ) . The main outcomes were DS , DfD , and SoD , as measured according to DS criteria , the Desire for Death Rating Scale , and the Patient Dignity Inventory ( PDI ) , respectively . All scales were assessed at baseline ( day 1 ) and at day 4 of follow-up . This study is registered with http://www.controlled-trials.com/IS RCT N34354086 . RESULTS Of the 80 participants , 41 were r and omized to DT and 39 to SPC . Baseline characteristics were similar between the two groups . DT was associated with a significant decrease in DS compared with SPC ( DT DS prevalence = 12.1 % ; SPC DS prevalence = 60.0 % ; p < 0.001 ) . Similarly , DT was associated with a significant decrease in DfD prevalence ( DT DfD prevalence = 0 % ; SPC DfD prevalence = 14.3 % ; p = 0.054 ) . Compared with participants allocated to the control group , those who received DT showed a statistically significant reduction in 19 of 25 PDI items . SIGNIFICANCE OF RESULTS Dignity therapy had a beneficial effect on the psychological distress encountered by patients near the end of life . Our research suggests that DT is an important psychotherapeutic approach that should be included in clinical care programs , and it could help more patients to cope with their end-of-life experiences AIMS AND DESIGN Moderate-intensity exercise has been shown to reduce common smoking withdrawal symptoms and desire to smoke in acutely abstinent smokers . The aim of the present study was to determine if this was caused by distraction . A secondary aim was to determine whether exercise-related changes in affect were related to a reduction in symptoms . METHODS Forty ' sedentary ' participants who had smoked at least 10 or more cigarettes per day for at least 3 years were assigned r and omly to one of two groups . They completed either 10 minutes of moderate-intensity exercise on a stationary bicycle ergometer or 10 minutes of a cognitive distraction task ( paced visual serial addition task , PVSAT ) after 11 - 15 hours of smoking abstinence . Participants rated smoking withdrawal symptoms and desire to smoke using st and ard scales at 10 , 5 and 0 minutes before the experimental intervention , then at 5 and 10 minutes after the start of the intervention and 5 and 10 minutes after its completion . FINDINGS Significant group x time interactions were observed for ratings of desire to smoke and several withdrawal symptoms ( irritability , depression , restlessness , difficulty concentrating and stress ) . There was a reduction in ratings during and immediately following exercise that was not observed with cognitive distraction . Also it was found the effects were not mediated by changes in affect observed in the exercise condition . CONCLUSIONS A brief bout of moderate-intensity exercise can lead to a rapid reduction in desire to smoke and withdrawal discomfort , which is not due to the distracting effect of exercise or the effects of mood . These findings support recommendations to smokers to use exercise as a means of helping cope with the difficulties encountered when they try to stop Introduction Large proportions of the population are not meeting recommended levels of physical activity and have increasingly sedentary lifestyles . Low levels of physical activity are predictive of poor health outcomes and time spent sedentary is related to a host of risk factors independently of physical activity levels . Building an evidence base of the best approaches to intervene in the lifestyles of inactive individuals is crucial in preventing long-term disease , disability and higher mortality rates . Methods and analysis Systematic search es will be conducted on all relevant data bases ( eg , PubMed , Scopus , CINAHL , PsycINFO ) . Studies will be included if they assess interventions aim ed at changing physical activity or sedentary behaviour levels in adults ( over 18 ) who are inactive and do not suffer from chronic conditions . Studies must also be r and omised controlled trials ( RCTs ) , have a primary outcome of physical activity or sedentary behaviour , and measure outcomes at least 6 months after intervention completion . Studies will be coded using the Behaviour Change Technique ( BCT ) taxonomy v1 and Template for Intervention Description and Replication ( TIDieR ) guidelines . 2 review ers will independently screen full-text articles and extract data on study characteristics , participants , BCTs , intervention features and outcome measures . Study quality will also be assessed independently by 2 review ers using the Cochrane risk of bias tool . A meta- analysis will be considered if there is sufficient homogeneity across outcomes . GRADE criteria will be used to assess quality of evidence . Dissemination This will be the first review to systematic ally appraise interventions aim ed at changing the physical activity or sedentary behaviour of inactive individuals using RCT design s with a 6-month follow-up post-intervention . This review will better inform intervention design ers targeting inactive population s and inform the design of a future complex intervention . Review registration number This protocol was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) on 17 October 2014 ( registration number : CRD42014014321 ) Over the past 15 years , targeted therapy has revolutionized the systemic treatment of cancer . In parallel , there has been a growing debate on the choice of end points in clinical trials in oncology . This debate basically hinges on the choice between overall survival ( OS ) and  progression-free survival ( PFS ) . PFS is advantageous because it is measured earlier than OS , requires a smaller sample size than OS to achieve the desired power , and is not influenced by cross-over . On the other h and , PFS is prone to measurement error and bias , and may not capture the entire treatment effect on the outcomes of most interest to patients with an incurable disease : a prolonged survival and improved quality of life . Therefore , how can we choose between two imperfect end points ? The answer to this question would certainly be made easier if PFS could be demonstrated to be a valid surrogate for OS . The validation of a surrogate end point is best made using  individual-patient data ( IPD ) from r and omized trials , which allows for st and ardized assessment s of the patient-level and the trial-level correlations between surrogate and final end points . Proper IPD meta-analytical evaluations for targeted agents have still been rare , and to our knowledge only three studies on this topic are currently available in the metastatic setting : one in breast cancer , one in colorectal cancer and one in lung cancer . Although these three studies suffer from limitations inherent to the availability of IPD and the design of the original clinical trials , they have not been able to vali date PFS as surrogate for OS , because only modest correlations were found between these two end points , both at the patient and at the trial level . Even if properly conducted surrogate-endpoint evaluations have thus far been unsuccessful , these evaluations are a step in the right direction and can be expected to be applied on a much larger scale in the era of data sharing of clinical trials Objective To evaluate the reliability of risk of bias assessment s based on published trial reports , for determining trial inclusion in meta-analyses . Design Reliability evaluation of risk of bias assessment s. Data sources 13 published individual participant data ( IPD ) meta-analyses in cancer were used to source 95 r and omised controlled trials . Review methods Risk of bias was assessed using the Cochrane risk of bias tool ( RevMan5.1 ) and accompanying guidance . Assessment s were made for individual risk of bias domains and overall for each trial , using information from either trial reports alone or trial reports with additional information collected for IPD meta-analyses . Percentage agreements were calculated for individual domains and overall ( < 66%=low , ≥66%=fair , ≥90%=good ) . The two approaches were considered similarly reliable only when agreement was good . Results Percentage agreement between the two methods for sequence generation and incomplete outcome data was fair ( 69.5 % ( 95 % confidence interval 60.2 % to 78.7 % ) and 80.0 % ( 72.0 % to 88.0 % ) , respectively ) . However , percentage agreement was low for allocation concealment , selective outcome reporting , and overall risk of bias ( 48.4 % ( 38.4 % to 58.5 % ) , 42.1 % ( 32.2 % to 52.0 % ) , and 54.7 % ( 44.7 % to 64.7 % ) , respectively ) . Supplementary information reduced the proportion of unclear assessment s for all individual domains , consequently increasing the number of trials assessed as low risk of bias ( and therefore available for inclusion in meta-analyses ) from 23 ( 23 % ) based on publications alone to 66 ( 66 % ) based on publications with additional information . Conclusions Using cancer trial publications alone to assess risk of bias could be unreliable ; thus , review ers should be cautious about using them as a basis for trial inclusion , particularly for those trials assessed as unclear risk . Supplementary information from trialists should be sought to enable appropriate assessment s and potentially reduce or overcome some risks of bias . Furthermore , guidance should ensure clarity on what constitutes risk of bias , particularly for the more subjective domains Background There are numerous published controlled trials assessing the safety and the benefits of physical activity ( PA ) for child and adult cancer survivors . However , trials exclusively comprised of adolescent cancer survivors aged 13 - 19 years , who may experience different health and quality of life ( QOL ) effects as a function of their developmental status , are lacking . Rather , some trials have included both adolescent and child cancer survivors together . Objective The aim of this systematic review was to synthesize the findings from r and omized controlled trails ( RCTs ) and controlled clinical trials ( CCTs ) investigating the effects of PA on health and QOL outcomes in sample s comprised of > 50 % adolescent cancer survivors to summarize the current state of evidence , identify knowledge gaps , and highlight areas in need of additional research within this population . Methods Using a search strategy developed for this review , 10 electronic data bases were search ed for RCTs and CCTs that reported on the effects of PA on at least 1 health and /or QOL outcome in sample s comprised of > 50 % adolescent cancer survivors . Results From the 2249 articles identified , 2 CCTs met the predetermined eligibility criteria and were included in this review . Combined , 28 adolescents ( of 41 participants ) who were receiving active treatment participated in the 2 studies review ed . A total of 4 health and QOL outcomes ( ie , bone mass , fatigue , grip strength , QOL ) were assessed pre- and post-PA intervention . Conclusions On the basis of the 2 studies review ed , PA appears to be safe and feasible .  PA also shows promise to mitigate reductions in bone mass and might be a viable strategy to improve fatigue , grip strength , and QOL . High- quality controlled trials with larger sample s exclusively comprised of adolescent cancer survivors that assess a wide range of outcomes are needed to determine the effects of PA on health and QOL outcomes in this population PURPOSE Physical activity ( PA ) has been suggested to help increase the survival of individuals with cancer . The objective of this review was to systematic ally evaluate and summarize the available evidence investigating the effect of PA on the survival of individuals with cancer . METHODS Electronic data bases ( CINAHL , EMBASE , and MEDLINE ) were systematic ally search ed for r and omized controlled trials and cohort studies . Selected studies were assessed by two independent investigators for method ological quality , using the PEDro scale . RESULTS Ten prospect i ve cohort studies met the inclusion criteria . Quality - assessment scores averaged 5/10 on the PEDro scale , with two articles obtaining a score of 6/10 . The majority of studies found that individuals participating in higher levels of physical activity had a reduced risk of cancer-related mortality . This trend was observed specifically for breast , colon , and colorectal cancers . On average , it appears that engaging in higher levels of metabolic equivalent hours per week may help to improve survival rates among individuals diagnosed with cancer . CONCLUSION Patients diagnosed with cancer demonstrated a trend toward increased survival with greater levels of PA . However , because only prospect i ve cohort studies were included in the study , the conclusions drawn should be regarded with caution Background The prevalence of overweight and obesity is high amongst healthcare professionals and there is growing interest in delivering weight loss interventions in the workplace . We conducted a systematic review to ( i ) examine the effectiveness of workplace-based diet and /or physical activity interventions aim ed at healthcare professionals and to ( ii ) identify and describe key components of effective interventions . Seven electronic data bases were systematic ally search ed . Results Thirteen r and omised controlled trials met the inclusion criteria , of which seven had data available for meta- analysis . Where meta- analysis was possible , studies were grouped according to length of follow-up ( < 12 months and ≥12 months ) and behavioural target ( diet only , physical activity only or diet and physical activity ) , with outcome data pooled using a weighted r and om effects model . Nine studies reported statistically significant ( between-group ) differences . Four studies reported being informed by a behaviour change theory . Meta- analysis of all trials reporting weight data demonstrated healthcare professionals allocated to dietary and physical activity interventions lost significantly more body weight ( −3.95 Kg , [ 95 % CI −4.96 to- 2.95 Kg ] ) than controls up to 12 months follow up . Conclusions Workplace diet and /or physical activity interventions targeting healthcare professionals are limited in number and are heterogeneous . To improve the evidence base , we recommend additional evaluations of theory-based interventions and adequate reporting of intervention content Objectives : This umbrella review aim ed to determine the effectiveness of exercise interventions , alone or in combination with other interventions , in improving physical function in community-dwelling older people identified as pre-frail or frail . Introduction : Exercise is said to have a positive impact on muscle mass and strength which improves physical function and hence is beneficial for the treatment of frailty . Several systematic review s discuss the effects of exercise interventions on physical function parameters , such as strength , mobility , gait , balance and physical performance , and indicate that multi-component exercise , including resistance , aerobic , balance and flexibility training , appears to be the best way in which to improve physical function parameters in frail older people . However , there is still uncertainty as to which exercise characteristics ( type , frequency , intensity , duration and combinations ) are the most effective and sustainable over the long-term . Inclusion criteria : Participants were adults , 60 years or over , living in the community and identified as pre-frail or frail . Quantitative systematic review s , with or without meta- analysis that examined the effectiveness of exercise interventions of any form , duration , frequency and intensity , alone or in combination with other interventions design ed to alter physical function parameters in frail older people , were considered . The quantitative outcome measures were physical function , including muscular strength , gait , balance , mobility and physical performance . Methods : An iterative search strategy for ten bibliometric data bases and gray literature was developed . Critical appraisal of seven systematic review s was conducted independently by two review ers using a st and ard Joanna Briggs Institute tool . Data was extracted independently by two review ers using a st and ard Joanna Briggs Institute data extraction tool and summarized using a narrative synthesis approach . Results : Seven systematic review s were included in this umbrella review , with a total of 58 relevant r and omized controlled trials and 6927 participants . Five systematic review s examined the effects of exercise only , while two systematic review s reported on exercise in combination with a nutritional approach , including protein supplementations , as well as fruit and dairy products . The average  exercise frequency was 2–3 times per week ( mean 3.0 ± 1.5 times per week ; range 1–7 weekly ) for 10–90 minutes per session ( mean of 52.0 ± 16.5 mins ) and a total duration of 5–72 weeks with the majority lasting a minimum of 2.5 months ( mean 22.7 ± 17.7 weeks ) . Multi-component exercise interventions can currently be recommended for pre-frail and frail older adults to improve muscular strength , gait speed , balance and physical performance , including resistance , aerobic , balance and flexibility tasks . Resistance training alone also appeared to be beneficial , in particular for improving muscular strength , gait speed and physical performance . Other types of exercise were not sufficiently studied and their effectiveness is yet to be established . Conclusions : Interventions for pre-frail and frail older adults should include multi-component exercises , including in particular resistance training , as well as aerobic , balance and flexibility tasks . Future research should adopt a consistent definition of frailty and investigate the effects of other types of exercise alone or in combination with nutritional interventions so that more specific recommendations can be made Background The use of financial incentives and penalties to encourage uptake of healthy behaviors is increasingly seen as a viable intervention in developed countries . Previous review s of the effectiveness of financial incentives and penalties for encouraging the uptake of healthy behaviors have focused on individual behaviors making it difficult to draw overall conclusions about the effectiveness of such interventions . This systematic review will explore the effectiveness of financial incentives and penalties for encouraging a wide range of behaviors , including : smoking cessation , increased physical activity , healthier dietary intake , sensible patterns of alcohol consumption , safe sun , safe sex , and primary preventive clinical behaviors . Methods Systematic methods will be used to search existing literature and screen studies for inclusion . All studies that meet the following inclusion criteria will be included in the review : participants were 18 years old or older and living in high-income countries ; interventions included cash or cash-like incentives to promote the uptake of healthy behaviors , or cash or cash-like penalties to discourage unhealthy behaviors ; the comparator was usual care or no intervention ; study design was r and omized controlled trial , cluster r and omized controlled trial , controlled before and after study , or interrupted time series analysis . Two review ers will independently screen the publications to ensure they meet the inclusion criteria . Quality will be assessed by two research ers , working independently , using the Cochrane risk of bias tool . Meta- analysis will be conducted , if appropriate . Any studies identified as at ‘ high risk of bias ’ will be excluded from meta- analysis . Discussion This systematic review will provide policy-relevant recommendations for the use of financial incentives and penalties as a method of encouraging uptake of healthy behaviors Abstract Rationale : Previous research suggests that glucose may reduce desire to smoke during periods of abstinence but a definitive test is needed . Objective : The present study aim ed to determine whether a single administration of oral glucose would reduce desire to smoke in abstaining smokers . Methods : Thirty-eight smokers attended the laboratory in the afternoon having not smoked since the previous evening . They rated their desire to smoke immediately before and at 5-min intervals for 20 min after chewing four 3-g glucose tablets ( experimental group ) or four matched placebo tablets ( control group ) . Results : Ratings of desire to smoke decreased to a greater extent in the experimental than the control group . The effect was apparent after 10 min . There was no difference between the groups in terms of feeling ” sick ” or ” satisfied ” . Conclusion : A single dose of glucose has a relatively rapid and detectable effect on desire to smoke and the effect is not mediated by feeling sick . Glucose tablets may be useful in helping to control desire to smoke during periods of abstinence Adults are sedentary for an alarming 9 to 10 hours per day ( 1 ) . Accordingly , the popular press has coined the phrase sitting is the new smoking to describe a current epidemic of developed nations ( 24 ) . Evidence indicates that sedentary time is associated with incident cardiovascular disease , incidence of cardiovascular diseaserelated risk factors , and mortality ( 5 , 6 ) . Of note , the risk conferred by prolonged sedentariness is eliminated only by high levels of moderate- to vigorous-intensity physical activity ( MVPA ) ( about 60 to 75 min/d ) , which exceed physical activity recommendations ( 7 , 8) . As such , sedentary behavior is now believed to represent a clinical ly important aspect of a person 's physical activity profile and is no longer considered simply the extreme low end of the physical activity continuum ( 5 ) . Studies linking sedentary behavior to health outcomes have relied almost exclusively on self-reported  sedentary time  , which is subject to reporting bias and measurement error ( 9 ) . A 2015 systematic review ( 5 ) identified only 1 study ( NHANES [ National Health and Nutrition Examination Survey ] ) that examined the association between objective ly measured sedentary time and health outcomes , a study limited by a small event rate ( 10 ) . New studies using NHANES data have since been published , with longer follow-up and higher event rates ( 1115 ) . However , some of these studies have reported an association between objective ly measured sedentary time and mortality ( 11 , 14 , 15 ) , but others have not ( 12 , 13 ) . Additional cohort studies are thus needed to rectify evidence gaps . Furthermore , studies using accelerometers to objective ly measure sedentary behavior conventionally operationalize sedentary time as the total number of sedentary minutes per day . This approach ignores patterns of accumulated sedentary behavior over time . For example , accumulation of sedentary time in a few long bouts or many short bouts represents 2 distinct patterns of sedentary time accrual . Experimental studies have shown that acute periods of prolonged , uninterrupted sedentary behavior cause greater detrimental cardiometabolic effects than sedentary behavior that is periodically interrupted ( 1618 ) , suggestive that it is not just total sedentary time that is relevant to health outcomes , but also the manner in which it is accumulated . Few longitudinal studies , however , have explored the association between prolonged , uninterrupted sedentary behavior and mortality to corroborate these findings . To inform guidelines on reducing sedentary behavior ( target reductions in overall sedentary time or target interruption of prolonged sedentary bouts ) , evidence from prospect i ve studies is needed to 1 ) confirm the association between total sedentary time and mortality using objective measures , 2 ) determine whether prolonged sedentary bouts confer risk for death , and 3 ) eluci date whether the total volume of sedentary time and its pattern of accumulation individually or jointly contribute to risk for death . The purpose of this study , therefore , was to examine the association between objective ly measured sedentary time ( both total volume and accrual in prolonged bouts ) and all-cause mortality in a national cohort of U.S. middle-aged and older adults enrolled in the REGARDS ( Reasons for Geographic and Racial Differences in Stroke ) study . Methods Study Population REGARDS is a population -based study design ed to examine racial and regional disparities in stroke . It comprises 30239 white and black adults aged 45 years or older enrolled between 2003 and 2007 from across the contiguous United States ( 19 , 20 ) . Detailed design and methods for REGARDS are described elsewhere ( 21 ) . Briefly , demographic and cardiovascular risk factor data were collected by telephone interview and an in-home physical assessment on enrollment . A detailed summary of baseline measures is provided in the Supplement . Participants ( or their proxies ) were then followed for 6-month intervals to ascertain vital status . Objective measurements of sedentary behavior were collected from active REGARDS participants from 2009 to 2013 ( mean time from study enrollment , 5.7 years [ SD , 1.5 ] ; range , 1.9 to 9.5 years ) ( 22 ) . A total of 7985 participants adhered to accelerometer wear requirements ( 4 days with accelerometer wear 10 hours ) , provided follow-up data , and were available for the current analyses ( Supplement Figure 1 ) . Supplement Table 1 shows the characteristics of included versus excluded REGARDS participants . The REGARDS study protocol was approved by the institutional review boards of participating institutions . All participants provided informed consent . Supplement . Supplementary Material Accelerometer Data Collection Methods for accelerometer data collection are described elsewhere ( 22 ) . Briefly , participants were fitted with an Actical ( Philips Respironics ) accelerometer secured to their right hip using a nylon belt and were instructed to wear the device during waking hours for 7 consecutive days . The Actical had been vali date d formeasurement of physical activity and sedentary behavior and was shown to have acceptable reliability ( 2325 ) . Activity counts were summed over 1-minute epochs . Nonwear periods were defined as at least 150 consecutive minutes of 0 activity counts . This nonwear algorithm was previously vali date d against daily log sheets in REGARDS participants ( 26 ) . Measurements of 0 to 49 , 50 to 1064 , and at least 1065 counts per minute were defined as sedentary behavior , light-intensity physical activity , and MVPA , respectively , as determined in a laboratory-based calibration study ( 27 ) . A sedentary bout was defined as consecutive minutes in which the accelerometer registered fewer than 50 counts per minute . A sedentary break was defined as at least 1 minute in which 50 or more counts per minute were registered after a sedentary bout . Both sedentary bouts and breaks were exclusively continuous periods , with no interruptions or nonwear intervals allowed in the definition . Outcome Ascertainment All-cause mortality was the primary outcome , defined as any death after completion of the accelerometer protocol regardless of cause . Date s of death were confirmed through review of death certificates , medical records , and administrative data bases . Deaths through 4 September 2015 were included in the current analysis . Statistical Analysis Sedentary and physical activity variables were averaged across compliant days ( 10 hours of wear ) . Because of a high correlation between total sedentary time and wear time ( Supplement Figure 2 ) , we corrected for the influence of wear time by st and ardizing total sedentary time to 16 hours of wear time per day using the residuals obtained when regressing total sedentary time on wear time ( see Methods section of the Supplement ) ( 2830 ) . Participants were stratified into quartiles according to total sedentary time and , separately , mean sedentary bout duration ( a measure of overall prolonged , uninterrupted sedentary behavior ) . Cox proportional hazards regression modeling was used to calculate the hazard ratio ( HR ) for all-cause mortality associated with quartiles of total sedentary time ( and separately , mean sedentary bout length ) . Crude HRs were initially calculated . Subsequent HRs were calculated after adjustment for age , race , sex , region of residence , education , and season the accelerometer was worn ( model 1 ) , with further adjustment for current smoking , alcohol use , body mass index ( BMI ) , diabetes , hypertension , dyslipidemia , estimated glomerular filtration rate less than 60 mL/min/1.73 m2 , atrial fibrillation , history of coronary heart disease , and history of stroke ( model 2 ) . Models were additionally adjusted for MVPA expressed continuously ( model 3 ) . Tests for linear trend across quartiles were conducted by including the quartile for each participant as an ordinal variable in regression models . Proportional hazards assumptions were confirmed with a Kolmogorov-type supremum test ( 31 ) . The above analyses were then repeated in a fully adjusted model , testing interactions for age ( < 65 and 65 years ) , sex ( male and female ) , race ( black and white ) , BMI category ( normal weight and overweight or obese ) , and MVPA category ( < 150 min/wk and 150 min/wk ) . As a secondary analysis , we examined the continuous doseresponse relationship between each sedentary characteristic and all-cause mortality in a fully adjusted model ( model 3 ) using restricted cubic splines ( 32 ) . Cubic polynomials were fitted with the mean of each sedentary characteristic set as the reference and knots placed at the 5th , 35th , 65th , and 95th percentiles ( 33 ) . Nonlinear associations were evaluated using the likelihood ratio test . For nonlinear associations , spline models were used to describe the associations and when the association was determined to be linear , a linear model was used . Because of multicollinearity between total sedentary time and mean sedentary bout duration ( r= 0.61 ) , both variables were not included in the same model . Alternatively , to examine the individual and joint associations of total sedentary time and prolonged , uninterrupted sedentary behavior with mortality , participants were classified into 4 categories : low total sedentary time ( < 750 min/d ) and low prolonged sedentary bout time ( < 10 min/bout ) , low total sedentary time  and high prolonged sedentary bout time  ( 10 min/bout ) , high total sedentary time  ( 750 min/d ) and low prolonged sedentary bout time , and high total sedentary time and high prolonged sedentary bout time . Hazard ratios for all-cause mortality were calculated for each joint category in comparison with the lowlow group in a fully adjusted model ( model 3 ) . Thresholds for total sedentary time ( 750 min/d ) and mean sedentary bout duration ( 10 min/bout ) were selected on the basis of the restricted cubic splines and were confirmed using a method described by Contal and O'Quigley ( see Methods section of the Supplement ) ( 34 ) . To allow for the possibility that sedentary bouts A brief bout of aerobic exercise ( e.g. stationary bicycle ) has been shown to result in an acute reduction in tobacco withdrawal symptoms and cravings in abstinent smokers . However , aerobic exercise is often not practical and it is of interest to examine whether non-aerobic exercise has a similar effect . We investigated whether isometric exercise ( involving muscular contractions against resistance without movement , e.g. placing the palms of the h and s together and pushing ) reduces desire to smoke and tobacco withdrawal symptoms .  Following overnight abstinence smokers were r and omized to 5-min of : isometric exercises ( n = 20 ) , body scanning ( focusing attention on sensations in different areas of the body , n = 20 , control ) , or sitting passively ( n = 20 , control ) . Desire to smoke and tobacco withdrawal symptoms ( ' irritable ' , ' depressed ' , ' stressed ' , ' tense ' , ' restless ' and ' poor concentration ' ) were rated at baseline , immediately post-intervention , and 5- , 10- , 15- and 20-min post-intervention . Isometric exercise produced a significantly greater reduction in desire to smoke versus passive control at immediate post-intervention and 5-min post-intervention , relative to baseline ( p < 0.05 ) . Most withdrawal symptoms were significantly moderated by exercise versus controls at some point between 5- to 20-min post-intervention , relative to baseline ( p < 0.05 ) . Brief isometric exercise has potential for offering immediate relief from a desire to smoke Background Diabetic retinopathy ( DR ) is a common microvascular complication of diabetes mellitus , and more than 75 % of patients who have had diabetes for more than 20 years will have some degree of DR . This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age . The current mainstay of treatment is laser photocoagulation , which causes impairment of vision and discomfort to patients . Thus , finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable . Objective To assess the efficacy and safety of the drugs in the statin and /or fibrate groups for the prevention and treatment of DR . Methods In this systematic review , we will select r and omized controlled trials of fibrates or statins used for the treatment or prevention of DR . Our search strategy will include free text terms and controlled vocabulary ( eg , MeSH , Emtree ) for , “ diabetic retinopathy ” , “ statins ” , “ fibrates ” , “ hypolipidemic agents ” , and for drugs from both groups . Data bases that will be used include Medical Literature Analysis and Retrieval System/ PubMed , Embase , Cochrane Central Register of Controlled Trials , Latin American and Caribbean Center on Health Sciences Information , Clinical trials.gov , World Health Organization International Clinical Trials Registry Platform , and OpenGrey , and we will not have language or date limits . Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration ’s tool . We will report structured summaries of the included studies and , if possible , conduct meta-analyses . Results This is a protocol for a systematic review , therefore results are not available . We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion . Conclusions Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients . Both macrovascular and microvascular events in diabetic patients appear to have a common pathway , starting with endothelial injury . Thus , prevention and treatment of microvascular events may benefit from the same interventions . In the review for which we have written this protocol , we will assess whether the use of lipid-lowering oral drugs of the statin and /or fibrate groups may prevent and /or retard progression of DR , with the added benefit of preserving visual acuity . Trial Registration PROSPERO AIMS To examine the acute effects of a guided relaxation routine ( body scan ) and isometric exercise on  desire to smoke and tobacco withdrawal symptoms .  DESIGN Experimental comparison of three conditions . PARTICIPANTS Forty-eight individuals reporting smoking > or = 10 cigarettes daily . INTERVENTION R and om assignment to one of three interventions delivered via a 10-minute audio : isometric exercise ( IE , n = 14 ) , body scanning ( BS , n = 18 ) or a reading about natural history ( control group , n = 16 ) . Interventions were delivered twice on the same day : in the laboratory , then in their ' normal ' environment . MEASUREMENTS Desire to smoke ( primary outcome ) and withdrawal symptoms were rated at pre-intervention and up to 30 minutes post-intervention . FINDINGS Controlling for baseline scores , post-intervention desire to smoke and withdrawal symptoms were significantly lower for IE and BS groups , compared with the controls , in both environments . There were no significant differences for IE versus BS . For desire to smoke , controlling for baseline values , ratings in the laboratory were significantly lower for IE and BS versus the control up to 30 minutes post-intervention . In the normal environment , these ratings were significantly lower only up to 5 minutes post-intervention . CONCLUSIONS Brief IE and BS interventions are effective for reducing desire to smoke and withdrawal symptoms in temporarily abstaining smokers . These interventions were found to be more effective in the laboratory than in the smoker 's normal environment , but this may be an artefact of there not being a sufficient ' wash-out ' period between interventions . These techniques may be beneficial for managing desire to smoke and tobacco withdrawal INTRODUCTION Pelvic floor muscle exercise ( PFME ) is recommended as a first-line treatment for  urinary incontinence . However , a review of the literature suggests the effect of PFME on sexual function ( SF ) , particularly during pregnancy and the postpartum period , is understudied . AIM To assess the effect of PFME on SF during pregnancy and the postpartum period . METHODS The following data bases were search ed : CINAHL ( EBSCOhost ) , Health Collection ( Informit ) , PubMed ( National Center for Biotechnology Information ) , Embase ( Ovid ) , MEDLINE , Cochrane , Health Source , Scopus , Wiley , Health & Medical Complete ( ProQuest ) , Joanna Briggs Institute , and Google Scholar . Results from published r and omized controlled trials ( RCTs ) and non- RCTs from 2004 to January 2018 on pregnant and postnatal women were included . PEDro and Critical Appraisal Skills Programme scores were used to assess the quality of studies . Data were analysed using a qualitative approach . MAIN OUTCOME MEASURE The primary outcome was the impact of antenatal or postnatal PFME on at least 1 SF variable , including desire , arousal , orgasm , pain , lubrication , and satisfaction . The secondary outcome was the impact of PFME on PFM strength . RESULTS We identified 10 studies with a total of 3607 participants . These included 4 RCTs , 1 quasi-experimental study , 3 interventional cohort studies , and 2 long-term follow up cohort studies . No studies examined the effect of PFME on SF during pregnancy . 7 studies reported that PFME alone improved sexual desire , arousal , orgasm , and satisfaction in the postpartum period . CONCLUSION The current data needs to be interpreted in the context of the studies ' risk of bias , small sample sizes , and varying outcome assessment tools . The majority of the included studies reported that postnatal PFME was effective in improving SF . However , there is a lack of studies describing the effect of PFME on SF during pregnancy , and only minimal data are available on the postpartum period . More RCTs are needed in this area . Sobhgol SS , Priddis H , Smith CA , et al. The Effect of Pelvic Floor Muscle Exercise on Female Sexual Function During Pregnancy and Postpartum : A Systematic Review . Sex Med Rev 2019;7:13 - 28 Background : Type 2 diabetes mellitus ( T2DM ) is becoming a leading problem worldwide . Emerging reports reveal alarming evidence of increasing prevalence of T2DM that has reached p and emic levels . Despite the significant incidence , there are limited reliable data re sources and comprehensive systematic review and meta- analysis on the effects of yoga on people who are a prediabetic or high risk for developing T2DM . Objective : The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the effects of yoga on people who are prediabetes or high risk of developing T2DM . Methods : The articles enrolled in the study will be retrieved from the online data bases between 2002 and the date the search es are executed . The search es will be repeated just before the final analyses and further relevant studies for inclusion . We will conduct a bibliographic search in data bases : Medline / PubMed , Scopus , Cochrane Library , EBSCO , and IndMED using keywords including prediabetes state , high risk for diabetes , metabolic syndrome , and yoga . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . There will be no language restrictions . Ethics and dissemination : The proposed study will be based on published studies and publicly available anonymized data without directly involving human participants and therefore requires neither formal human ethical review nor approval by a human research ethics committee . We published an outline of the protocol in the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in 2018 . We plan to disseminate the findings of this systematic review and meta- analysis through publication in a peer- review ed journal and presentation at relevant conference proceedings . In addition , we believe the results of the systematic review will have implication s for policy and practice . We will prepare policymaker summary using a vali date d format , disseminate through social media and email discussion groups . Review registration number : PROSPERO registration number CRD Rationale Recent research has shown that 10 min of moderate intensity exercise reduce smoking withdrawal symptoms and desire to smoke in acutely abstinent smokers . The aim of the current study was to determine whether the reductions are related to participant expectation of these effects . Material s and methods Forty-five sedentary participants who had smoked ten or more cigarettes per day for at least 3 years reported their expectation of the effects of exercise on smoking withdrawal symptoms .  Approximately 1 month later , participants were r and omly assigned to one of three groups after 11–15 h of overnight smoking abstinence . Each group read either a positive , negative or neutral statement concerning exercise effects on smoking withdrawal symptoms . They rated their expectation again and then completed 10 min of moderate intensity exercise on a stationary bicycle ergometer . Using st and ardised scales , participants rated smoking withdrawal symptoms and desire to smoke at 10 , 5 and 0 min before exercise , then at 5 and 10 min during exercise and 15 and 20 min post-exercise . Results Expectation of exercise effects on withdrawal were manipulated in the predicted directions . No significant group main effects were found for any symptom . Significant reductions in symptoms and desire to smoke occurred during and after exercise regardless of participant expectation . Conclusions Ten minutes of moderate intensity exercise can lead to reductions in desire to smoke and smoking withdrawal symptoms , which are not due to the participant ’s expectation of exercise effects . These findings support the use of short periods of exercise as an aid to smoking cessation & NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a  cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy
There is strong evidence that physical activity acutely reduces cigarette craving
AIMS To conduct an up date d systematic review and the first meta- analysis of experimental trials investigating the acute effects of short bouts of physical activity ( PA ) on strength of desire ( SoD ) and desire to smoke ( DtS ) using individual participant data ( IPD ) .