Actively Recruiting
Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Led by University of Michigan · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
95 weeks
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
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.
CONDITIONS
Official Title
Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and availability for study duration
- Identify as a female
- Aged between 40 and 80 years, inclusive
- Documented diagnosis of cardiac rehabilitation indications including stable angina pectoris, acute myocardial infarction within past 6 months, percutaneous coronary interventions, surgical and transvalvular aortic valve replacement, post-aortic surgery with or without aortic valve, coronary artery bypass grafting, and mitral valve replacement or repair with or without coronary artery bypass grafting
- Referred to outpatient cardiac rehabilitation at University of Michigan, Domino's Farms, or Brighton Center for Specialty Care Cardiac Rehabilitation site according to Michigan Medicine policy
You will not qualify if you...
- Not cleared for cardiac rehabilitation by Michigan Medicine's Division of Cardiovascular Medicine
- Prior participation in cardiac rehabilitation
- Inability to understand spoken and written English due to language barrier or cognitive limitations including deafness or blindness
- Frailty, fall risk, or muscle, joint, or back pain that limits activities of daily living or mild physical activity such as walking up one flight of stairs unaided
- Specific indications excluding cardiac rehabilitation such as aortic dissection repair, untreated or severe congestive heart failure, coronary artery dissection without coronary artery disease, fibromuscular hyperplasia, stress cardiomyopathy, or cardiac transplant candidate or recipient
- Life-threatening ventricular arrhythmias without implanted defibrillator, frequent premature ventricular or atrial contractions, or poorly controlled atrial fibrillation
- More than mild valvular heart disease, untreated congestive heart failure, unstable angina or chest pain with minimal activity, or angina or heart failure limiting stair climbing ability (NYHA Functional Classification >2)
- Severe pulmonary hypertension, heart clot, recent venous thrombosis or pulmonary embolism, or significant lung disease causing dyspnea
- Chronic kidney disease with creatinine >2 mg/dL, symptomatic active or chronic liver disease (except nonalcoholic fatty liver disease), kidney dialysis or transplant, or recent rise in serum creatinine
- Poorly controlled diabetes with elevated HbA1c above specified thresholds
- Immunosuppressive drug use, acute or chronic anemia with hemoglobin <10 mg/mL
- Limiting chronic musculoskeletal pain, fall risk from poor balance or neurological syndromes, or frailty in older adults
- Untreated or active substance abuse or addiction, depression or severe anxiety unless approved by mental health provider
- Severe obesity (BMI ≥40), use of weight loss drugs unless target weight achieved or for diabetes glycemic control, history of bariatric surgery, or chronic venous insufficiency with cellulitis or significant edema unless controlled with support hose
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
B
Beth Perrotta
CONTACT
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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