Designing and Assessing a Women Only Cardiac Rehabilitation Program
University of Michigan
Summary
The purpose of this randomized controlled study is to investigate the effect(s) of a pilot women-only cardiac rehabilitation (CR) program. The study team will be testing the effectiveness, compliance and enjoyment of this women's only cardiac rehabilitation (CR) program by comparing outcomes to those randomized to receive Michigan Medicine's current CR program (standard care), which includes people of all genders. Study hypotheses: * Women randomized to women-specific CR programming will have superior attendance and completion rates compared to women attending mixed-sex CR programming. * Women randomized to women-specific CR programming will experience greater improvement in clinical outcomes in comparison to those in mixed-sex CR programming.
Description
This registration was updated on 11/24/2025 due to amendments that were approved at the IRBMED.
Eligibility
- Age range
- 40–80 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability to participate in study procedures for the duration of the study * Identify as a female * Be between the ages of 40-80 years, inclusive * Documented diagnosis of CR indications of stable angina pectoris, acute myocardial infarction (MI) within the preceding 6 months, percutaneous coronary interventions (PCI), surgical and transvalvular aortic valve replacement, post-aortic surgery with or without aortic valve, coronary artery bypass grafting (CABG…
Interventions
- BehavioralWomen only Cardiac Rehab program
This is a 12-week program and will include 36 sessions 3 times a week. This group will also have Women-Only Education sessions. Participants will also have a 24-week follow-up visit from the time of entry. Women-specific education content will be provided monthly in addition to the standard weekly "mini-teaches." This education content will be developed and delivered by experience health care professionals that are experts in women's health.
- BehavioralStandard of Care (mixed-sex) rehab program
This is a 12-week program and will include up to 36 sessions 3 times a week. Participants will also have a 24-week follow-up visit from the time of entry. Exercise classes are medically supervised, and each program is individualized based upon medical history, cardiac risk factors, goals, and initial fitness level. Educational programs are arranged in a continuing series, with sessions taught by experts in nutrition therapy, stress reduction therapy, and exercise.
Location
- University of MichiganAnn Arbor, Michigan