Ecologically optimizing exercise maintenance in men and women post-cardiac rehabilitation: Protocol for a randomized controlled trial of efficacy with economics (ECO-PCR)

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• 作者：Robert Reid^a ; ^{breid@ottawaheart.ca" class="auth_mail" title="E-mail the corresponding author} ; Chris M. Blanchard^b ; ^{chris.blanchard@Dal.Ca" class="auth_mail" title="E-mail the corresponding author} ; Evyanne Wooding^a ; ^{EWooding@ottawaheart.ca" class="auth_mail" title="E-mail the corresponding author} ; Jennifer Harris^a ; ^{jharris@ottawaheart.ca" class="auth_mail" title="E-mail the corresponding author} ; Murray Krahn^c ; ^{murray.krahn@theta.utoronto.ca" class="auth_mail" title="E-mail the corresponding author} ; Andrew Pipe^a ; ^{apipe@ottawaheart.ca" class="auth_mail" title="E-mail the corresponding author} ; Caroline Chessex^d ; ^{caroline.chessex@uhn.ca" class="auth_mail" title="E-mail the corresponding author} ; Sherry L. Grace^d ; ^e ; ^{sgrace@yorku.ca" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Exercise ; physical ; Heart diseases ; Rehabilitation ; Health care economics
• 刊名：Contemporary Clinical Trials
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：50
• 期：Complete
• 页码：116-123
• 全文大小：463 K

文摘

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 a social 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 (1:1 concealed allocation) to intervention or usual care. A 50-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 individual and 5 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 to 52 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 52 week follow-up (2 [arm] × 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.