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.