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

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 behaviors and psychosocial outcomes versus other models. Methods: CR4HER was a single-blind, 3 parallel-arm, randomized trial. Low-risk cardiac patients were recruited from 6 sites in Ontario. Consenting participants completed surveys assessing health behaviors (physical activity, diet, medication adherence, smoking) and psychosocial well-being(social support, quality of life, depressive symptoms)and wore pedometers for 7 days. Following intake assessment, eligible participants were randomized to mixed-sex, women-only or home-based CR. Participants were mailed follow-up surveys and pedometers6 months later. Results: 169 patients were randomized, and 116 (68.6%) were retained. Self-reported physical activity increased among women in mixed-sex and women-only CR (per-protocol and as-treated, ps<.05). Diet improved among women in women-only CR (as-treated, p<.05). Quality of life improved among women inmixed-sex (per-protocol and as-treated, ps<.05)and women-only CR(per-protocol, p<.05; as-treated, p<.01). Post-test, women inmixed-sex CR had higher anxious symptoms versus those in women-only (per-protocol, p=.017), and those who in mixed-sex CR had higher depressive symptoms versus those in women-only (as-treated, p=.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. Conclusion: Behavioral and psychosocial outcomes were largely equivalent regardless of model, however women-only programs may confer an advantage for anxiety and depressive symptoms.