Controlled Trial Of Exercise Research Articles

Converting Physical Function Testing to the Remote Setting: Adapting Our Research Protocol During COVID-19

Objective measurement of physical function can be a more sensitive predictor of future disability and changes over time than self-report measures. However, objective measures require in-person assessments which can limit their use in hard-to-reach populations. During the COVID-19 pandemic, laboratory assessment of physical functioning in our two large randomized controlled exercise trials in older adults with cancer was temporarily suspended. We adapted testing protocols for administering the short physical performance battery (PPB), including chair stand (CS; sec) and 4m usual walk (4MW; m/s) tests, and timed-up-and go (TUG; sec) tests of physical functioning for remote assessment by video conferencing technology. We report on interim assessments of inter and intra-rater reliability and validity against newly resumed in-person tests. Repeat assessments were conducted on the same participant 1-2 weeks apart, by the same assessor (intra-rater reliability) or by another assessor (inter-rater reliability) for remote visits and by the same assessor for in-person tests (validity). Pearson-product moment correlations are provided for PPB, CS, 4MW and TUG, in that order. Intra-rater reliability values are: 0.97, 0.88, 0.90, and 0.96; Inter-rater reliability values are: 0.79, 0.14, 0.40, and 0.99; Validity values (no TUG) are: 0.66, 0.81, 0.78. Reliability of conducting remote PPB by video is very high when using the same assessor, while TUG reliability is high within and between assessors. Remote PPB administration has a good correlation with in-person visits, but the two modes of delivery should not yet be used interchangeably in longitudinal studies until sources of error can be determined and minimized.

Recruitment for a multi‐site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial

AbstractBackgroundEXERT is a large multi‐site randomized controlled trial testing the effects of aerobic exercise vs. stretching (control) on cognition and biomarkers of brain health in sedentary adults with MCI. Here, we describe challenges and successes of strategies used to recruit the EXERT cohort.MethodEXERT recruited sedentary adults 65‐89 years old who were willing to exercise 4 days/week at the YMCA with trainer supervision for 12 months, and unsupervised for an additional 6 months. The trial is conducted at 14 clinical sites that include 30 corresponding YMCAs. The ADCS serves as the Coordinating Center, and intervention oversight is provided by Wake Forest School of Medicine in partnership with the YMCA.ResultEXERT recruitment occurred over 43 months and several strategies were deployed to address recruitment challenges. The most notable challenge was that EXERT aimed to recruit adults with a cognitive impairment that is mentally/physically taxing given the expectations of an intensive exercise intervention study. For these individuals, transportation to the YMCA was also often a barrier to participation. Early recruitment methods relied on memory clinic patient rosters and electronic health records, which yielded only a few enrollments. Use of other common strategies (e.g., newspaper advertising) was only minimally successful in identifying candidates. Recruitment gained momentum only after geotargeted mailings of pictorial postcards and brochures were initiated. After the first mailing at 3 sites, the rate of in‐person screenings increased by more than 100% (Figure 1). In total, 500,000 geotargeted mailings across all sites were sent from which more than 50% of all randomized participants were recruited. Recruitment also benefited from high‐profile media coverage (Maria Shriver video, NPR) in 2018 and 2019. Early in 2019, the ADCS established centralized telephone prescreening to reduce burden on site staff. A total of 692 mailing responders were prescreened by the ADCS, of whom 228 were referred to sites. As of January 2020, 984 study candidates completed in‐person screening and 278 participants were enrolled into EXERT.ConclusionAge and geotargeted mass mailings combined with centralized telephone prescreening and national media campaigns proved to be effective strategies for enrolling people with MCI in a long‐term exercise trial.

Effects of Interval-Training Exercise on People Who Have Had Persistent Post-Concussive Symptoms for Less Than One Year: A Pilot Study.

This study is to examine the effects of a 12-session moderate intensity-interval-training program with blood flow restriction (BFR) and body cooling (BC) on people who have had persistent post-concussive symptoms (PPCS) for <1 year. A single-blind randomized controlled trial of interval-training exercise with BFR and BC was conducted. Twenty-five adults with PPCS were assigned to the experimental group (n = 14) or the control group (n = 11). Both groups rode a recumbent elliptical machine for 21 min at moderate intensity (65% predicted maximum heart rate) twice a week for 6 weeks, but only the experimental group received BFR and BC while riding. The variances of overall PPCS scale scores and their sub-domain scores for individuals during the 6-week intervention and 6-week follow-up period were calculated. During the intervention, the fluctuation of overall symptom severity, severity in the cognitive domain and severity in the mood domain were significantly less in the experimental group (p = 0.03; p = 0.02; p = 0.02). During the follow-up period, the number of symptoms remained more stable in the experimental group (p = 0.02), and a trend toward less fluctuation of symptom severity (p = 0.05) was also observed. The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p = 0.007; p = 0.02). The severity of mood and sleep symptoms also remained more stable during the follow-up period in the experimental group (p = 0.04). More stable recovery was found in individuals who exercised using BFR and BC than in those who underwent exercise without BFR and BC. Moderate intensity-interval-training exercise with BFR and BC alleviated post-concussive symptoms in people who have had PPCS <1 year.

Randomized controlled trial of passive and Motivative exercise of brain function using NIRS and MRI

Randomized controlled trial of passive and Motivative exercise of brain function using NIRS and MRI

Randomized controlled trial of bikram yoga and aerobic exercise for depression in women: Efficacy and stress-based mechanisms

BackgroundThe current study presents a randomized controlled 8-week trial of Bikram yoga, aerobic exercise, and waitlist for depression. Bikram yoga was chosen specifically for its standardized nature. Further, we examined changes in three stress-related constructs—perceived stress, rumination, and mindfulness—as mediators of antidepressant effects. MethodFifty-three women (age 18–65; 74% White) with a unipolar depressive disorder were randomly assigned to one of the three conditions. Response was defined as >50% reduction on the Hamilton Rating Scale for Depression (HAM-D). Remission was defined as no longer meeting criteria for depression and a HAM-D ≤ 7. Self-reported perceived stress, rumination, and mindfulness were assessed weekly. ResultsIn the intention-to-treat sample (n = 53), response rates were significantly higher in the Bikram yoga (61.1%; χ2 = 10.48, p = .001) and aerobic exercise (60.0%; χ2 = 10.44, p = .001) conditions relative to waitlist (6.7%). In the completer sample (n = 42), 73.3% (χ2 = 11.41, p = .001) of women in yoga and 80.0% (χ2 = 13.72, p < .001) in exercise achieved response compared to 8.3% in waitlist. Reductions in rumination significantly mediated HAM-D change for both active treatments, and mindful acceptance was a partial mediator in the exercise condition. LimitationsThe sample was small in size, consisted of women only, and was ethnically homogenous. Inter-rater reliability was not assessed, aerobic exercise was not standardized, and mediators were assessed by self-report. ConclusionsBikram yoga showed descriptively similar efficacy to aerobic exercise and both may work, in part, by helping individuals interrupt negative thinking.

BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD

BackgroundDespite therapeutic advances, the management of chronic obstructive pulmonary disease (COPD) remains complex. There is growing interest in multidimensional, mind-body exercises to improve both physical and psychosocial aspects of COPD...

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail...

A randomized controlled trial of resistance and balance exercise for sarcopenic patients aged 80\u201399\xa0years

We compared a mixed exercise program (i.e., balance exercise plus resistance exercise) with resistance exercise in a single-blind, randomized controlled trial in a post-acute care unit. In total, 60 sarcopenic patients were randomly assigned to an intervention group (12-week mixed exercise) and a control group (12-week resistance exercise). The primary outcomes were the change of the Barthel Index and the number of fallers. The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9–15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3–10.4). The mixed exercise program provided a significant benefit over resistance exercise (adjusted mean difference of the change of Barthel Index: 6.8 points; 95% CI 1.4–12.1). The number of fallers was 13.3% and 23.3% in the intervention and control groups, respectively, but the difference was not significant (risk ratio (RR) 0.89, 95% CI 0.69–1.13, p = 0.506). In conclusion, compared with resistance exercise, the mixed exercise program appears to further improve the activities of daily living and physical performance in our study population. Under the monitoring of experienced physiotherapists, both exercise programs are feasible and safe for this population.

A randomized controlled trial of NSAIDs or exercise to reduce delayed local pain after influenza vaccination

Delayed pain is a common vaccine adverse event after inactivated influenza vaccine (IIV) receipt. Nonsteroidal anti-inflammatory drugs (NSAIDs) are a typical intervention, and within military lore, pushups are reputed to be an effective preventive measure. We studied the effect of prescription strength ibuprofen and exercise in the form of pushups on delayed pain and local inflammation symptoms after receipt of IIV and their impact on immunogenicity in military Service Members (SMs).

The effect of Baduanjin exercise on the quality of life in patients recovering from COVID-19: A protocol for systematic review and meta-analysis.

Background:Since the outbreak of COVID-19, the number of COVID-19 patients has been on the rise. With the improvement of diagnosis and treatment level in various countries, more and more patients have recovered. Baduanjin exercise is a traditional Chinese health care method with a long history, easy-to-learn, and remarkable effect. It is not subject to the constraints of the field and can be practiced at any time. It can be used as an alternative therapy for COVID-19 rehabilitation patients. At present, there are no relevant articles for systematic review.Methods:We will retrieve a randomized controlled trial of Baduanjin exercise for COVID-19 from the beginning to July 2020. The following databases are areas of concern: Published randomized Cochrane Central Register of Controlled Trials (Central), PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wan-fang Database-controlled trials in Chinese and English related to Baduanjin exercise and COVID-19 were included. The main result was the effect of Baduanjin exercise on the quality of life in patients recovering from COVID-19. Secondary results to accompany symptoms (such as muscle pain, cough, sputum, runny nose, sore throat, chest tightness, shortness of breath, difficulty breathing, fatigue, headache, nausea, vomiting, anorexia, diarrhea), disappearance rate, 2 consecutive (not on the same day) COVID-19 negative rate of nucleic acid test results, the quality of life improved, improve CT images, the average hospitalization time, severe form of common clinical cure rate and mortality.Results:The results of this study will provide researchers in the field of COVID-19 with a current synthesis of high-quality evidence.Conclusion:The conclusion of this study will provide evidence for judging whether Baduanjin exercise is an effective intervention for the quality of life of rehabilitative patients.PROSPERO registration number:CRD42020199443

Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.

Breast lymphoedema can occur following surgical treatment for breast cancer. We investigated whether an exercise program reduced breast lymphoedema symptoms compared to a non-exercise control group. A single-blinded randomised controlled trial was conducted in which women with stable breast lymphoedema (n = 89) were randomised into an exercise (n = 41) or control (n = 47) group. The intervention comprised a 12-week combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist. All participants completed a weekly symptoms diary and were assessed monthly to ensure that there was no exacerbation of their lymphoedema. Changes in the breast were captured physically with ultrasound and bioimpedance spectroscopy and changes in symptoms were captured using European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires. The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions. Measures of extracellular fluid, assessed with bioimpedance spectroscopy ratio, decreased in the exercise group compared to the control group. No significant difference was detected in dermal thickness in the breast, assessed by ultrasound. Session attendance in the exercise sessions was high, with two musculoskeletal adverse events reported, but no exacerbations of lymphoedema observed. Combined resistance and aerobic exercise training is safe for women living with breast lymphoedema. Preliminary data suggest exercise training can reduce breast lymphoedema symptoms to a greater extent than usual care.

Inter-individual differences in body mass index were not observed as a result of aerobic exercise in children and adolescents with overweight and obesity.

Exercise has been recommended as an important intervention for reducing adiposity in children and adolescents with overweight and obesity. Determine whether inter-individual differences exist in relation to exercise-induced changes in adiposity among children and adolescents with overweight and obesity. Meta-analysis of randomized controlled aerobic exercise trials and body mass index (BMI) in kg · m-2 . Change outcome standard deviations were pooled using the inverse-variance heterogeneity model. Twenty-eight studies (1185 participants) were included. Inter-individual differences in BMI were -0.1 (95% compatibility interval, -0.7 to 0.7). The 95% prediction interval for inter-individual responses in a future study was -2.9 to 2.9. The probability of a clinically meaningful difference in variability was 29% (possibly clinically important) in favour of controls vs exercisers. Inter-individual differences for BMI in kg · m-2 were not observed as a result of aerobic exercise in children and adolescents with overweight and obesity.

Exercise for people with a fragility fracture of the pelvis or lower limb: a systematic review of interventions evaluated in clinical trials and reporting quality

BackgroundTo aid design of exercise trials for people with pelvic and lower limb fragility fractures a systematic review was conducted to identify what types of exercise interventions and mobility outcomes have been assessed, investigate intervention reporting quality, and evaluate risk of bias in published trials.MethodsSystematic searches of electronic databases (CENTRAL, MEDLINE, EMBASE, PEDro) 1996–2019 were conducted to identify randomised controlled trials of exercise for pelvic or lower limb fragility fractures. Two reviewers independently screened titles and abstracts. One reviewer extracted data, a second verified. Two reviewers independently assessed risk of bias. Intervention reporting quality was based on TIDieR, assessed by one reviewer and verified by a second. Narrative synthesis was undertaken. Registration: PROSPERO CRD42017060905.ResultsSearches identified 37 trials including 3564 participants, median sample size 81 (IQR 48–124), participants aged 81 years (IQR 79–82) and 76% (2536/3356) female. All trials focussed on people with hip fracture except one on ankle fracture. Exercise types focussed on resistance exercise in 14 trials, weight bearing exercise in 5 trials, 13 varied dose of sessions with health professionals, and 2 trials each focussed on treadmill gait training, timing of weight bearing or aerobic exercise. 30/37 (81%) of trials reported adequate sequence generation, 25/37 (68%) sufficient allocation concealment. 10/37 (27%) trials lacked outcome assessor blinding. Of 65 exercise interventions, reporting was clear for 33 (51%) in terms of when started, 61 (94%) for where delivered, 49 (75%) for who delivered, 47 (72%) for group or individual, 29 (45%) for duration, 46 (71%) for session frequency, 8 (12%) for full prescription details to enable the exercises to be reproduced, 32 (49%) clearly reported tailoring or modification, and 23 (35%) reported exercise adherence. Subjectively assessed mobility was assessed in 22/37 (59%) studies and 29/37 (78%) used an objective measure.ConclusionsAll trials focussed on hip fracture, apart from one ankle fracture trial. Research into pelvic and other lower limb fragility fractures is indicated. A range of exercise types were investigated but to date deficiencies in intervention reporting hamper reproducibility. Adoption of TIDieR and CERT guidelines should improve intervention reporting as use increases. Trials would be improved by consistent blinded outcome assessor use and with consensus on which mobility outcomes should be assessed.

Association between change in maternal physical activity during pregnancy and infant size, in a sample overweight or obese women

ABSTRACT Physical activity (PA) naturally declines during pregnancy and its effects on infant size are unclear, especially in overweight or obese pregnancies, a low-active subpopulation that tends deliver heavier infants. The objective of this study was to evaluate changes in prenatal PA and infant birthweight in a group of overweight or obese pregnant women. We employed a prospective analysis using data from a randomized controlled exercise trial (2001 to 2006) in sedentary, overweight or obese pregnant women in Michigan. Women with complete data on peak oxygen consumption, daily PA (via pedometers) and birthweight were included in the analyses. Change in PA was estimated via repeated measures analyses, and then its influence on infant birthweight was assessed via linear regression. Eighty-nine pregnant women were included and considered low-active (6,579.91 ± 2379.17 steps/day). PA declined from months 4 to 8 (−399.73 ± 371.38 steps∙day−1∙month−1). Analyses showed that the decline in PA (β = −0.28 g, 95%CI: −0.70, 0.25 g, p = .35) was not associated with birthweight. The findings of this study demonstrated that the decline in maternal PA during mid- to late-pregnancy, in overweight or obese women, was unrelated to infant birthweight. Future investigations should employ rigorous measurements of PA and infant anthropometry in this subpopulation.

Chasing Protection in Parkinson's Disease: Does Exercise Reduce Risk and Progression?

Exercise may be the most commonly offered yet least consistently followed therapeutic advice for people with Parkinson’s disease (PD). Epidemiological studies of prospectively followed cohorts have shown a lower risk for later developing PD in healthy people who report moderate to high levels of physical activity, and slower rates of motor and non-motor symptom progression in people with PD who report higher baseline physical activity. In animal models of PD, exercise can reduce inflammation, decrease α-synuclein expression, reduce mitochondrial dysfunction, and increase neurotrophic growth factor expression. Randomized controlled trials of exercise in PD have provided clear evidence for short-term benefits on many PD measurements scales, ranging from disease severity to quality of life. In this review, we present these convergent epidemiological and laboratory data with particular attention to translationally relevant features of exercise (e.g., intensity requirements, gender differences, and associated biomarkers). In the context of these findings we will discuss clinical trial experience, design challenges, and emerging opportunities for determining whether exercise can prevent PD or slow its long-term progression.

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial.

People with cancer who undergo allogeneic hematological stem cell transplant (allo-HSCT) experience significant deconditioning that can compromise quality of life. Exercise has shown to be beneficial before or after allo-HSCT; however, little is known about exercise therapy delivered across the continuum of care. We conducted a feasibility randomized controlled trial of exercise delivered prior to admission, during the inpatient stay, and after discharge versus control in people with planned allo-HSCT. Feasibility was assessed via recruitment and retention rates, the incidence of adverse events, and adherence to the exercise prescription. Estimates of efficacy were measured at baseline, one week prior to hospital admission, and 100 days and one year after transplant. The recruitment and retention rates were 20% and 33%, respectively. One serious adverse event occurred during the baseline six-minute walk test that precluded participation in the study and no adverse events were associated with the intervention. From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: −18.0 to 108.7)—a finding that warrants further investigation with an adequately powered trial. Our study contributes important feasibility considerations and pilot data for future exercise intervention research in allo-HSCT recipients.

Aerobic exercise impacts the anterior cingulate cortex in adolescents with subthreshold mood syndromes: a randomized controlled trial study

Aerobic exercise is effective in alleviating mood symptoms while the mechanism is poorly understood. There are limited clinical trials that investigated the effect of exercise on the anterior cingulate cortex (ACC), a key brain region involved in mood regulations, in adolescents with subthreshold mood syndromes. This randomized controlled trial (RCT) of aerobic exercise was undertaken in a middle school in Guangzhou, China. Participants were adolescents aged 12–14 with subthreshold mood syndromes including depressive and manic symptoms and were randomly assigned to an aerobic exercise intervention or a psychoeducation control group. Participants in the exercise group received moderate-intensity exercise intervention, consisting of 30 mins running, 4 days per week for 3 months. The primary outcome in this study was structural changes in the ACC from baseline to post intervention. The trial was registered with ClinicalTrial.gov (NCT03300778). Of 56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively. At baseline, demographic information (e.g., age and sex), clinical symptoms, and the gray matter volume and cortical thickness of ACC were matched between the two groups. After 12 weeks of treatment, participants in the exercise group displayed increased gray matter volume of the left rostral ACC (F1,30 = 5.73, p = 0.02) and increased cortical thickness of the right rostral ACC (F1,30 = 7.83, p = 0.01) when compared with the control group. No significant differences were found for caudal ACC cortical thickness and gray matter volume. Our data demonstrate that 12-week, moderate-intensity aerobic exercise can induce structural changes in the rostral ACC in adolescents with subthreshold mood syndromes.

TOPS – a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan

BackgroundThis a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). ObjectivesTOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. MethodsTOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. DiscussionThis paper will provide a detailed description of the planned analyses for the TOPS trial. Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12615000939594).

Combined group and home exercise programmes in community‐dwelling falls‐risk older adults: Systematic review and meta‐analysis

The objectives of this review were to (a) determine the effectiveness of combined group and home exercise programmes on falls risk factors and falls in community-dwelling older adults at risk of falling compared to no exercise controls; and (b) explore adherence and the behaviour change techniques employed in delivering these interventions. Five databases were selected to identify randomized controlled trials of exercise and/or physical activity interventions to prevent falls or to improve functional performance. PROSPERO CRD42018106111. Eighteen trials involving 5,960 participants were included. Meta-analyses showed significant improvements in mobility after combined programmes measured by five times sit to stand (-1.42 times, 95% confidence interval [CI] -2.00 to -0.83), timed up and go (-0.94 s, 95% CI -1.76 to -0.12), and gait speed (0.05 m/s, 95% CI 0.02 to 0.07), but not single leg stance time, compared to controls. Combined programmes reduced injurious falls rate (0.77, 95% CI 0.65 to 0.91, I2 = 0%) but not rate of falls (0.86, 95% CI 0.68 to 1.08, I2 = 66%) compared to controls. There was no change in physical activity. Adherence ranged from 55-96%, with variability in the method of measurement of adherence. There was no clear relationship between adherence and outcomes. Most interventions used the behaviour change techniques of instruction/rehearsal/demonstration and feedback/monitoring. Group exercise with a home programme resulted in better functional performance and falls-related outcomes compared with a no exercise control group. Further research is needed to identify behaviour change techniques to improve adherence to exercise in this population.

Socio-ecological correlates of physical activity in breast and colon cancer survivors 4 years after participation in a randomized controlled exercise trial (PACT study)

Having a physically active lifestyle after cancer diagnosis is beneficial for health, and this needs to be continued into survivorship to optimize long-term benefits. We found that patients, who participated in an 18-week exercise intervention, reported significant higher physical activity (PA) levels 4 years after participation in a randomized controlled trial of supervised exercise delivered during chemotherapy (PACT study). This study aimed to identify social-ecological correlates of PA levels in breast and colon cancer survivors 4 years after participation in the PACT study. Self-reported PA levels and potential correlates (e.g. physical fitness, fatigue, exercise history, and built environment) were assessed in 127 breast and colon cancer survivors shortly after diagnosis (baseline), post-intervention and 4 years later. Multivariable linear regression analyses were performed to identify social-ecological correlates of PA 4 years post-baseline. The final model revealed that lower baseline physical fatigue (β = -0.25, 95% CI -0.26; -0.24) and higher baseline total PA (0.06, 95% CI, 0.03; 0.10) were correlated with higher total PA levels 4 years post-baseline. Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (-8.07, 95% CI -14.00; -2.13), and having a positive change in physical fatigue during the intervention period (0.04, 95% CI 0.001; 0.07) were correlates of sport and leisure PA levels 4 years post-baseline. This study suggests that baseline and 4-year post-baseline physical fatigue, and past exercise behaviour, were significant correlates of PA 4 years after participation in an exercise trial. Additionally, this study suggests that the built environment should be taken into account when promoting PA. Understanding of socio-ecological correlates of PA can provide insights into how future exercise interventions should be designed to promote long-term exercise behaviour. Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on 9 December 2009, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2138.