Women's Cardiac Rehabilitation Program Adherence and Health Behaviours Following Referral to Three Different Program Models: A Randomized Controlled Trial

Cardiac rehabilitation (CR) participation is associated with significantly lower mortality and improved psychosocial well-being. However, women are less likely to participate than men. CR4HER was a single-blind, 3 parallel-arm, pragmatic, randomized controlled trial comparing CR program adherence, functional capacity, and health behaviors between women referred to mixed-sex, women-only, or home-based CR. The study occured between November 2009-July 2013. Low-risk patients with coronary artery disease were recruited from six sites in Ontario. Consenting participants completed a pre-program survey assessing health behaviors (physical activity, diet, medication adherence, and smoking), wore pedometers for 7 days, and clinical data were extracted from charts. Participants were referred to CR at one 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, and participants were mailed follow-up surveys and pedometers. Among 264 consenting patients, 169 (64.0%) were eligible and randomized. Twenty-seven (16.0%) did not attend CR and 43 (25.4%) attended a different model than that to which they were randomized, with most women switching to a model other than home-based CR. Program adherence was moderate overall (54.4635.14%). Analysis of variance revealed no significant differences based on per protocol analysis (PP; p=.63), but as-treated, home-based participants attended significantly more than women-only (p<.05). Overall, there was a significant increase in functional capacity pre to post-program (p<.001). While there were no significant differences in functional capacity by model at CR exit based on PP, 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 women attending home-based programs (p<.05). Self-reported physical activity increased among women randomized to, and who attended, mixed-sex and women-only CR (ps<.05). Diet improved among women attending women-only CR (p<.05). However, analyses adjusted for confounding variables revealed no significant differences in any outcome by model. Offering women alternative program models may not promote greater CR adherence, functional capacity, or behavioral outcomes. Nevertheless, replication is warranted. Other proven strategies such as action planning and self-monitoring should be applied.