Women's Health Behaviours and Psychosocial Well-Being by Cardiac Rehabilitation Program Model: A Randomized Controlled Trial

Abstract 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.