Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
NCT ID: NCT06784895
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-05
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
* Mask the Cardiopulmonary Exercise Test (CPET)/Volume of Oxygen consumed (VO2) test technicians that will be administering these assessments from knowing which treatment arm the participant is receiving.
* Mask the registered dietician as to which study participants are in the control group and are receiving the standard CR programming (unable to blind for experimental group due to the nature of the group CR sessions)
* Mask the statistician as to which group received which CR programming during data analysis.
* Limit contact and conversation between participants and non-CR staff; example lab technicians, nurses, medical assistants, and dietitians
Study Groups
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Women only Cardiac Rehab program
Women only Cardiac Rehab program
This is a 12-week program and will include 36 sessions 3 times a week. This group will also have Women-Only Education sessions. Participants will also have a 24-week follow-up visit from the time of entry.
Women-specific education content will be provided monthly in addition to the standard weekly "mini-teaches." This education content will be developed and delivered by experience health care professionals that are experts in women's health.
Standard of Care (mixed-sex) rehab program
Standard of Care (mixed-sex) rehab program
This is a 12-week program and will include up to 36 sessions 3 times a week. Participants will also have a 24-week follow-up visit from the time of entry. Exercise classes are medically supervised, and each program is individualized based upon medical history, cardiac risk factors, goals, and initial fitness level. Educational programs are arranged in a continuing series, with sessions taught by experts in nutrition therapy, stress reduction therapy, and exercise.
Interventions
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Standard of Care (mixed-sex) rehab program
This is a 12-week program and will include up to 36 sessions 3 times a week. Participants will also have a 24-week follow-up visit from the time of entry. Exercise classes are medically supervised, and each program is individualized based upon medical history, cardiac risk factors, goals, and initial fitness level. Educational programs are arranged in a continuing series, with sessions taught by experts in nutrition therapy, stress reduction therapy, and exercise.
Women only Cardiac Rehab program
This is a 12-week program and will include 36 sessions 3 times a week. This group will also have Women-Only Education sessions. Participants will also have a 24-week follow-up visit from the time of entry.
Women-specific education content will be provided monthly in addition to the standard weekly "mini-teaches." This education content will be developed and delivered by experience health care professionals that are experts in women's health.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
80 Years
FEMALE
No
Sponsors
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University of Texas
OTHER
University of Michigan
OTHER
Responsible Party
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Melvyn Rubenfire
Professor of Internal Medicine
Principal Investigators
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Melvyn Rubenfire, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00252649
Identifier Type: -
Identifier Source: org_study_id
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