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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06784895
Status
Recruiting
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Conditions

  • Cardiac Rehabilitation
  • Cardiovascular Diseases

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Women only Cardiac Rehab program — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Women only Cardiac Rehab program
  • Active Comparator: Standard of Care (mixed-sex) rehab program

Primary Outcome Measure

Cardiac Rehabilitation (CR) attendance rate [ Time Frame: 12 weeks (post CR) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Beth Perotta
[email protected]
734-232-6865
Melvyn Rubenfire, MD (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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