Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorUniversity of Michigan
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Women only Cardiac Rehab program
- Standard of Care (mixed-sex) rehab program
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
University of Texas
Collaborator
Source ClinicalTrials.gov