NCT06784895

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

Designing and Assessing a Women Only Cardiac Rehabilitation Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Cardiac Rehabilitation
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-01-20
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States