NCT06784895 Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
| NCT ID | NCT06784895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Cardiac Rehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-05-05 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Melvyn Rubenfire, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06784895 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 80 Years, studying Cardiac Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06784895 currently recruiting?
Yes, NCT06784895 is actively recruiting participants. Contact the research team at eperrott@umich.edu for enrollment information.
Where is the NCT06784895 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06784895 clinical trial?
NCT06784895 is sponsored by University of Michigan. The principal investigator is Melvyn Rubenfire, MD at University of Michigan. The trial plans to enroll 60 participants.