Actively Recruiting
Designing and Assessing a Women Only Cardiac Rehabilitation Program
Led by University of Michigan · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
U
University of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of a women-only cardiac rehabilitation (CR) program compared to the standard mixed-sex CR program. This study aims to assess if the women-specific program improves attendance, completion rates, and clinical outcomes for women aged 40 to 80 years who have cardiac conditions such as stable angina, recent myocardial infarction, or post-cardiac surgeries. The trial is randomized and single-masked, sponsored by the University of Michigan. The study involves two groups: one receiving a 12-week women-only CR program with 36 sessions held three times a week, including monthly women-specific education sessions by experts in women's health; and the other receiving the standard mixed-sex CR program, also lasting 12 weeks with up to 36 sessions and weekly educational sessions on nutrition, stress reduction, and exercise. Both groups have a 24-week follow-up visit after starting the program. Participants will attend exercise sessions and educational classes, with medical supervision and personalized programs based on their health history and fitness levels. Researchers will measure attendance rates at 12 weeks, blood pressure control, depression symptoms using the Patient Health Questionnaire-9, and functional capacity through six-minute walk tests and metabolic equivalents. Safety and progress will be monitored through regular assessments over the study and follow-up periods.
CONDITIONS
Brief Title
Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent
- Willingness to comply with all study procedures and availability for the study duration
- Identify as a female
- Be between 40 and 80 years old, inclusive
- Documented diagnosis indicating cardiac rehabilitation such as stable angina, recent myocardial infarction, percutaneous coronary intervention, cardiac surgeries, or valve replacements
- Referred to outpatient cardiac rehabilitation at the University of Michigan or associated specialty care centers
You will not qualify if you...
- Not cleared for cardiac rehabilitation per Michigan Medicine policies
- Prior participation in cardiac rehabilitation
- Inability to understand spoken or written English due to language barrier or cognitive limitations
- Frailty, fall risk, or muscle, joint, or back pain limiting daily activities and mild physical activity
- Certain cardiac conditions like aortic dissection repair, severe congestive heart failure, coronary artery dissection without disease, or cardiac transplant status
- Life-threatening arrhythmias without an implanted defibrillator or poorly controlled atrial fibrillation
- More than mild valvular heart disease or unstable angina limiting stair climbing
- Severe pulmonary hypertension, recent clot in the heart or lungs, or serious lung disease symptoms
- Severe kidney or liver disease, dialysis, transplant, or active renal disease
- Poorly controlled diabetes with high HbA1c levels despite care
- Need for immunosuppressive drugs or anemia with low hemoglobin
- Chronic pain or neurologic conditions causing fall risk or frailty
- Untreated substance abuse, severe depression or anxiety unless managed
- Severe obesity, current weight loss drugs unless specific conditions met, history of bariatric surgery, or chronic venous insufficiency with complications unless controlled with support hose
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants attend a 12-week cardiac rehabilitation program which includes up to 36 exercise sessions held three times a week. Women in the women-only program also attend monthly women-specific education sessions in addition to weekly educational mini-teaches. The standard care group participates in mixed-sex rehabilitation with expert-led education on nutrition, stress reduction, and exercise.
Up to 36 sessions (in-person, 3 times per week)
Duration - Up to 24 weeks from entry
Participants have a follow-up visit to assess outcomes 24 weeks from the time of entry into the study.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
B
Beth Perrotta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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