Clinical trial NCT06784895: Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Official title: Designing and Assessing a Women Only Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Cardiovascular Diseases
Keywords: Female only CR program
Standard of care rehab program
Education sessions
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2025-01-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and cleared for outpatient CR at the University of Michigan, Domino's Farms Cardiac Rehabilitation site based on Michigan Medicine 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 injectable weight loss drugs unless long term and stable, history of bariatric surgery; chronic venous insufficiency with cellulitis or \> 1+ edema unless controlled with support hose.

Primary outcomes:
measure: Cardiac Rehabilitation (CR) attendance rate
timeFrame: 12 weeks (post CR)
measure: Cardiac Rehabilitation (CR) attendance rate - percentage
timeFrame: 12 weeks (post CR)
Secondary outcomes:
measure: Optimal blood pressure (BP) control
timeFrame: 12 weeks (post CR)
measure: Change in resting systolic blood pressure (SBP)
timeFrame: Baseline, 12 weeks (post CR)
measure: Change in resting diastolic blood pressure (DBP)
timeFrame: Baseline, 12 weeks (post CR)
measure: Improvement in depression based on the Patient Health Questionnaire (PHQ)-9
timeFrame: Baseline to 12 weeks (post CR)
measure: Change in Patient Health Questionnaire (PHQ)-9 score
timeFrame: Baseline to 12 weeks (post CR)
measure: Change in Patient Health Questionnaire (PHQ)-9 score
timeFrame: 12 weeks (post CR), 24 weeks
measure: Improvement in functional capacity measured by the six-minute walk test
timeFrame: Baseline, up to 12 weeks (post CR)
measure: Change in 6-minute walk test distance
timeFrame: Baseline, 12 weeks (post CR)
measure: Improvement in functional capacity Metabolic Equivalents (METs)
timeFrame: Baseline, 12 weeks (post CR)
measure: Change in estimated exercise session peak METs
timeFrame: Baseline, up to 12 weeks (post CR)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Melvyn Rubenfire, MD
role: PRINCIPAL_INVESTIGATOR
References: