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

University of Michigan

Status

Enrolling

Conditions

Cardiac Rehabilitation

Cardiovascular Diseases

Treatments

Behavioral: Standard of Care (mixed-sex) rehab program

Behavioral: Women only Cardiac Rehab program

Study type

Interventional

Funder types

Other

Identifiers

NCT06784895

HUM00252649

Details and patient eligibility

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.

Full description

This registration was updated on 11/24/2025 due to amendments that were approved at the IRBMED.

Enrollment

60 estimated patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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) 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 criteria

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.