Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: Protocol for a Randomized Controlled Trial of Efficacy with Economics (ECO-PCR)

Background: Exercise-based cardiac rehabilitation (CR) participation results in increased cardio-metabolic fitness, which is associated with reduced mortality. However, many graduates fail to maintain exercise post-program. ECO-PCR investigates the efficacy and cost-effectiveness of asocial ecologically-based intervention to increase long-term exercise maintenance following the completion of CR. Methods/Design: A three-site,2-group, parallel randomized controlled trial is underway.412 male and 192 female (N=604) supervised CR participants are being recruited just before CR graduation. Participants are randomized (1:1concealed allocation) to intervention or usual care. A50-week exercise facilitator intervention has been designed to assist CR graduates in the transition from structured, supervised exercise to self-managed home-or community-based (e.g., Heart Wise Exercise programs) exercise. The intervention consists of 8 telephone contacts over the 50 week period:3 individualand5 group. Assessments occur at CR graduation, and 26, 52 and 78 weeks post-randomization. The primary outcome is change in minutes of accelerometer-measured moderate to vigorous-intensity physical activity (MVPA)from CR graduation to52 weeks post-randomization. Secondary measures include exercise capacity, quality of life, and cardiovascular risk factors. Analyses will be undertaken based on intention-to-treat. For the primary outcome, an analysis of variance will be computed to test the change in minutes of MVPA in each group between CR graduation and 52week follow-up(2 [arm] x 2 [time]). Secondary objectives will be assessed using mixed-model repeated measures analyses to compare differences between groups over time. Mean costs and quality-adjusted life years for each arm will be estimated.Funding: This work has been supported by the Heart and Stroke Foundation of Canada [grant #G-14-0006126]. The funder has no role in the conduct of the study

A Longitudinal Examination of the Social-Ecological Correlates of Exercise in Men and Women Following Cardiac Rehabilitation

Cardiac patients who engage in ≥150 min of moderate- to vigorous-intensity physical activity (MVPA)/week have lower mortality, yet MVPA declines even following cardiac rehabilitation (CR), and is lower in women. A randomized trial of nine socioecological theory-based exercise facilitation contacts over 50 weeks versus usual care (1:1 parallel arms) was undertaken (NCT01658683). The tertiary objective, as presented in this paper, was to test whether the intervention impacted socioecological elements, and in turn their association with MVPA. The 449 participants wore an accelerometer and completed questionnaires post-CR, and 26, 52 and 78 weeks later. At 52 weeks, exercise task self-efficacy was significantly greater in the intervention arm (p = 0.01), but no other differences were observed except more encouragement from other cardiac patients at 26 weeks (favoring controls). Among women adherent to the intervention, the group in whom the intervention was proven effective, physical activity (PA) intentions at 26 weeks were significantly greater in the intervention arm (p = 0.04), with no other differences. There were some differences in socioecological elements associated with MVPA by arm. There were also some differences by sex, with MVPA more often associated with exercise benefits/barriers in men, versus with working and the physical environment in women

A Randomized Controlled Trial of an Exercise Maintenance Intervention in Men and Women After Cardiac Rehabilitation (ECO-PCR Trial)

Background Exercise maintenance interventions are needed for cardiac rehabilitation (CR) graduates to maintain moderate and vigorous-intensity physical activity (MVPA). We tested an exercise facilitator intervention (EFI) to promote exercise maintenance compared with usual care (UC) separately in men and women. Methods This was a 3-site, randomized (1:1), parallel-group, superiority trial (ECO-PCR). CR graduates were stratified by site and sex and randomly allocated (concealed). EFI participants received a face-to-face introductory session, 5 small-group counseling teleconferences, and 3 personal calls from a trained facilitator over 50 weeks. In-person assessments were undertaken at baseline and 26 and 52 weeks after randomization. The primary outcome was weekly minutes of MVPA, measured by accelerometer. Secondary outcomes were exercise capacity, risk factors, quality of life, and enrollment in community-based exercise programs. Effects were tested with the use of linear mixed models. Results A total of 449 CR graduates (135 women, 314 men) were randomised (n = 226 EFI, n = 223 UC). In the intention-to-treat analysis for men and for women, there were no significant effects for treatment or time on MVPA. In a planned secondary analysis that considered only those adherent to EFI (completed ≥ 66% of sessions; per-protocol), bouted MVPA (ie, in sustained bouts of ≥ 10 min) was higher in women in the EFI group (mean = 132.6 ± 135.2 min/wk at 52 weeks) compared with UC (111.8 ± 113.1; P = 0.013). Regarding secondary outcomes, in women, a treatment group main effect was observed for blood pressure (P = 0.011) and exercise capacity (P = 0.019; both per-protocol) favouring EFI; no other differences were observed. Conclusions In this trial of CR completers, an EFI showed promise for women, but was ineffective in men.This trial was supported by Heart and Stroke Foundation of Canada grant-in-aid #G-14-0006126. S.L.G. is supported in her work by the Toronto General & Toronto Western Hospital Foundation and the Peter Munk Cardiac Centre, University Health Network. The sponsor had no involvement in: the design of the study; the collection, analysis and interpretation of the data; or in the decision to approve publication of the finished manuscript

Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherapy

Abstract Background Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge. The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial. Methods Breast cancer patients in Edmonton, Vancouver, and Ottawa, Canada receiving chemotherapy (N = 301) were randomized to a standard dose of 25–30 minutes of aerobic exercise (STAN), a higher dose of 50–60 minutes of aerobic exercise (HIGH), or a higher dose of 50–60 minutes of combined aerobic and resistance exercise (COMB). Predictors included demographic, medical, fitness, and quality of life variables. Exercise adherence was measured as the percentage of supervised exercise sessions completed. Results Overall adherence to the supervised exercise sessions was 73% (SD = 24%). In a multivariate regression model, six independent predictors explained 26.4% (p < 0.001) of the variance in exercise adherence. Higher exercise adherence was achieved by breast cancer patients in Vancouver (p < 0.001), with fewer endocrine symptoms (p = 0.009), randomized to STAN (p = 0.009), with fewer exercise limitations (p = 0.009), receiving shorter chemotherapy protocols (p = 0.015), and with higher VO2peak (p = 0.017). Disease stage (p for interaction = 0.015) and body mass index (p for interaction = 0.030) interacted with group assignment to predict adherence. For disease stage, patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions. For body mass index, healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB; and obese patients adhered best to STAN and worst to HIGH. Conclusions Determinants of exercise adherence in breast cancer patients receiving chemotherapy are multidisciplinary and may vary by the exercise prescription

Open Access

Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherap

Effects of exercise dose and type on sleep quality in breast cancer patients receiving chemotherapy: A multicenter randomized trial

To examine the effects of different doses and types of exercise on sleep quality in breast cancer patients receiving chemotherapy. A multicenter trial in Canada randomized 301 breast cancer patients between 2008 and 2011 to thrice weekly, supervised exercise during chemotherapy consisting of either a standard dose of 25–30 min of aerobic exercise (STAN; n = 96), a higher dose of 50–60 min of aerobic exercise (HIGH; n = 101), or a combined dose of 50–60 min of aerobic and resistance exercise (COMB; n = 104). The secondary sleep outcomes in the trial were assessed by the Pittsburgh Sleep Quality Index (PSQI) at baseline, twice during chemotherapy, and postchemotherapy. We analyzed the global PSQI and the component scores. Repeated measures analyses of variance indicated that the HIGH group was statistically superior to the STAN group for global sleep quality (mean group difference = −0.90; 95 % CI −0.05 to −1.76; p = 0.039) as well as subjective sleep quality (p = 0.028) and sleep latency (p = 0.049). The COMB group was borderline statistically superior to the STAN group for global sleep quality (mean group difference = −0.76; 95 % CI +0.11 to −1.62; p = 0.085) as well as sleep duration (p = 0.051); and statistically superior for sleep efficiency (p = 0.040), and percentage of poor sleepers (p = 0.045). Compared to a standard volume of aerobic exercise, higher volumes of both aerobic and combined exercise improved some aspects of sleep quality during breast cancer chemotherapy. Exercise may be an attractive option to manage sleep dysfunction in cancer patients during chemotherapy

Effects of exercise dose and type during breast cancer chemotherapy: Multicenter randomized trial

BackgroundExercise improves physical functioning and symptom management during breast cancer chemotherapy, but the effects of different doses and types of exercise are unknown.MethodsA multicenter trial in Canada randomized 301 breast cancer patients to thrice-weekly supervised exercise during chemotherapy consisting of either a standard dose of 25 to 30 minutes of aerobic exercise (STAN; n = 96), a higher dose of 50 to 60 minutes of aerobic exercise (HIGH; n = 101), or a combined dose of 50 to 60 minutes of aerobic and resistance exercise (COMB; n = 104). The primary endpoint was physical functioning assessed by the Medical Outcomes Survey-Short Form (SF)–36. Secondary endpoints were other physical functioning scales, symptoms, fitness, and chemotherapy completion. All statistical tests were linear mixed model analyses, and the P values were two-sided.ResultsFollow-up assessment of patient-reported outcomes was 99.0%. Adjusted linear mixed-model analyses showed that neither HIGH (+0.8; 95% confidence interval [CI] = −0.8 to 2.4; P = .30) nor COMB (+0.5; 95% CI = −1.1 to 2.1; P = .52] were superior to STAN for the primary outcome. In secondary analyses not adjusted for multiple comparisons, HIGH was superior to STAN for the SF-36 physical component summary (P = .04), SF-36 bodily pain (P = .02), and endocrine symptoms (P = .02). COMB was superior to STAN for endocrine symptoms (P = .009) and superior to STAN (P < .001) and HIGH (P < .001) for muscular strength. HIGH was superior to COMB for the SF-36 bodily pain (P = .04) and aerobic fitness (P = .03). No differences emerged for body composition or chemotherapy completion.ConclusionsA higher volume of aerobic or combined exercise is achievable and safe during breast cancer chemotherapy and may manage declines in physical functioning and worsening symptoms better than standard volumes