• Mayo Clinic proceedings · Feb 2016

    Randomized Controlled Trial Pragmatic Clinical Trial

    Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial.

    • Sherry L Grace, Liz Midence, Paul Oh, Stephanie Brister, Caroline Chessex, Donna E Stewart, and Heather M Arthur.
    • York University, Toronto, Ontario, Canada; University Health Network, Toronto, Ontario, Canada. Electronic address: sgrace@yorku.ca.
    • Mayo Clin. Proc. 2016 Feb 1; 91 (2): 140-8.

    ObjectiveTo compare program adherence and functional capacity between women referred to supervised mixed-sex, supervised women-only, or home-based cardiac rehabilitation (CR).Patients And MethodsCardiac Rehabilitation for Heart Event Recovery (CR4HER) was a single-blind, 3 parallel-arm, pragmatic randomized controlled trial. The study took place between November 1, 2009, and July 31, 2013. Low-risk patients with coronary artery disease were recruited from 6 hospitals in Ontario, Canada. Consenting participants completed a preprogram survey, and clinical data were extracted from charts. Participants were referred to CR at 1 of 3 sites. After intake assessment, including a graded exercise stress test, eligible patients were randomized to supervised mixed-sex, supervised women-only, or home-based CR. Six months later, CR adherence and exit assessment data were ascertained.ResultsOf the 264 consenting patients, 169 (64.0%) were eligible and randomized. Twenty-seven (16.0%) did not attend, and 43 (25.4%) attended a different model. Program adherence was moderate overall (54.46%±35.14%). Analysis of variance revealed no significant differences based on per-protocol analysis (P=.63), but as-treated, home-based participants attended significantly more than did women-only participants (P<.05). Overall, there was a significant increase in functional capacity preprogram to postprogram (P<.001). Although there were no significant differences in functional capacity by model at CR exit based on per-protocol analysis, there was a significant difference on an as-treated basis, which sustained adjustment. Women attending mixed-sex CR attained significantly higher post-CR functional capacity than did women attending home-based programs (P<.05).ConclusionOffering women alternative program models may not promote greater CR adherence or functional capacity; however, replication is warranted. Other proven strategies such as action planning and self-monitoring should be applied.Trial Registrationclinicaltrials.gov Identifier: NCT01019135.Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

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