Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program

This study is looking at whether a special cardiac rehabilitation (heart recovery) program designed just for women works better than the standard program. You would either join a 12-week 'Women only Cardiac Rehab program' with 36 sessions and women-specific education, or the 'Standard of Care (mixed-sex) rehab program' which also lasts 12 weeks with up to 36 sessions. Researchers want to see if the women-only program leads to better attendance, completion rates, and health improvements. This study is open to women aged 40 to 80 who have certain heart conditions. The study is currently recruiting 60 participants, but its overall status is unclear.

Study design: This is a randomized study, meaning you would be randomly assigned to one of two groups. It plans to enroll 60 women.
What's involved: You would participate in a 12-week program with 36 sessions, 3 times a week. There will also be a 24-week follow-up visit after you start the program.
Compensation: Not stated in the trial record.
Follow-up: You will have a follow-up visit 24 weeks after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program

Recruiting

NAAges 40–80InterventionalTreatment

University of Michigan

~60 participants

Updated 2025-12-04 on ClinicalTrials.gov

What's tested:Women only Cardiac Rehab programStandard of Care (mixed-sex) rehab program

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Cardiac Rehabilitation (CR) attendance rate

Measured over 12 weeks (post CR)

+1 more outcome measured

Conditions

Cardiac Rehabilitation

Cardiovascular Diseases

Where it's being run

1 sites across 1 states

Michigan1

Study leadership

Melvyn Rubenfire, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Beth Perrotta

[email protected]

734-232-6865

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) and mitral valve replacement or repair with or without CABG

Referred to outpatient CR at the University of Michigan, Domino's Farms or Brighton Center for Specialty Care Cardiac Rehabilitation site based on Michigan Medicine's Division of Cardiovascular Medicine Policy and Procedure.

Exclusion

Not being "cleared" for CR based on Michigan Medicine's Division of Cardiovascular Medicine Policy and Procedures

Prior participation in CR

Inability to understand spoken and written English, either due to language barrier or cognitive limitation for any reason, including deaf or blind

Frailty, fall risk, or muscle, joint or back pain as defined as the inability to perform activities of daily living without limitations and engage in mild physical activity (i.e. unable to walk up 1 flight of stairs unaided)

Any of the following as the indication for CR: aortic repair or replacement for aortic dissection, untreated or greater than New York Heart Association (NYHA) class II congestive heart failure, coronary artery dissection without coronary artery disease, fibromuscular hyperplasia, stress cardiomyopathy, cardiac transplant candidate or recipient

Life threatening ventricular arrythmias without an implanted defibrillator; very frequent premature ventricular contraction or premature atrial contractions symptomatic or not; poorly controlled atrial fibrillation

Associated more than mild valvular heart disease, untreated congestive heart failure; unstable angina or heart pain with minimal activity; angina or congestive heart failure limiting ability to climb one flight of stairs without help (NHYA Functional Classification \>2)

Severe pulmonary hypertension (right heart systolic pressure greater than 60 millimeters of mercury); clot in the heart; treated venous thrombosis with or without pulmonary embolism in past 6 months; more than mild dyspnea related to chronic lung disease or asthma

Chronic kidney disease (creatinine \>2 milligrams per deciliter (mg/dl)); symptomatic active liver disease (infectious or inflammatory), symptomatic chronic liver disease (except for nonalcoholic fatty liver disease), kidney dialysis or kidney transplant recipient, active or chronic renal disease (rise by 0.5mg/dL in past 3 months or chronic elevated serum creatinine 2.0 milligrams per milliliter (mg/mL) or greater.

Poorly controlled diabetes defined as uninterrupted HbA1c \>8.0% for ≥1 year despite standard care, baseline HbA1c prior to CR \> 8.5%.

Immunosuppressive drug requirement, acute anemia, chronic anemia with Hemoglobin \< 10mg/mL

Limiting chronic muscle, joint, or back pain; identified as fall risk from poor balance or neurologic syndromes; frailty defined as the inability to perform activities of daily living in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality

Untreated or active substance abuse/addiction including alcohol and drugs; depression (defined as a score ≥ 15 or depression positive answer to #8 or #9 on Patient Health Questionnaire-9) unless deemed acceptable by mental health care provider; severe anxiety

Severe obesity (Body mass index ≥ 40 kilograms/meters squared), on weight loss drugs (unless target body weight has been achieved or use is for glycemic control in diabetes), history of bariatric surgery; chronic venous insufficiency with cellulitis or \> 1+ edema unless controlled with support hose.

What this trial measures

Cardiac Rehabilitation (CR) attendance rate12 weeks (post CR)
CR completion rate defined as number of patients that "graduated" or completed CR programming versus the number of patients that started CR programming \[i.e. attended 75% or more of the prescribed sessions (≥27 out of 36)\], expressed as a percentage of participants per arm.
Cardiac Rehabilitation (CR) attendance rate - percentage12 weeks (post CR)
Number of CR sessions attended out of number of CR sessions prescribed, expressed as a percentage

Trialytics