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Women's health behaviours and psychosocial well-being by cardiac rehabilitation program model: a randomized controlled trial
Midence L, Arthur HM, Oh P, Stewart DE, Grace SL
The Canadian Journal of Cardiology 2016 Aug;32(8):956-962
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Cardiac rehabilitation (CR) is associated with significantly lower mortality and improved psychosocial well-being. However, women are less likely to participate than men. This trial tested whether participation in women-only CR results in better health behaviours and psychosocial outcomes than do other models. METHODS: Cardiac Rehabilitation for her Heart Event Recovery (CR4HER) was a single-blind randomized trial with 3 parallel arms. Low-risk cardiac patients were recruited from 6 sites in Ontario. Consenting participants completed surveys assessing health behaviours (physical activity, diet, medication adherence, smoking) and psychosocial well-being (social support, quality of life, depressive symptoms) and wore pedometers for 7 days. After intake assessment, eligible participants were randomized to mixed-sex, women-only, or home-based CR. Participants were mailed follow-up surveys and pedometers 6 months later. RESULTS: One hundred sixty-nine patients were randomized, and 116 (68.6%) were retained. Self-reported physical activity increased among women in mixed-sex and women-only CR groups (per protocol and as treated, p < 0.05). Diet improved among women in women-only CR groups (as treated, p < 0.05). Quality of life improved among women in mixed-sex (per protocol and as treated, p < 0.05) and women-only CR groups (per protocol, p < 0.05; as treated, p < 0.01). After testing, women in the mixed-sex CR group had higher anxiety symptoms than did those in the women-only group (per protocol, p = 0.017), and those in the mixed-sex CR group had higher depressive symptoms than did those in the women-only group (as treated, p = 0.001). Analyses adjusted for confounding variables revealed no significant differences in any outcome by model. Post hoc equivalency tests were computed on a per-protocol basis, and all outcomes were equivalent by model. CONCLUSIONS: Behavioural and psychosocial outcomes were largely equivalent regardless of model; however, women-only programs may confer an advantage for anxiety and depressive symptoms.

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