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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Women only Cardiac Rehab program
BehavioralThis 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
BehavioralThis 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Women only Cardiac Rehab programExperimental treatment 1 intervention
Group B: Standard of Care (mixed-sex) rehab programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiac Rehabilitation (CR) attendance rate
CR completion rate defined as number of patients that "graduated" or completed CR programming versus the number of patients that started CR programming \[i.e. attended 75% or more of the prescribed sessions (≥27 out of 36)\], expressed as a percentage of participants per arm.
Time frame
12 weeks (post CR)2
Cardiac Rehabilitation (CR) attendance rate - percentage
Number of CR sessions attended out of number of CR sessions prescribed, expressed as a percentage
Time frame
12 weeks (post CR)Secondary outcomes
1
Optimal blood pressure (BP) control
Percentage of patients that have optimal BP control at program discharge, defined as systolic blood pressure (SBP) less than 130 mmHg and diastolic blood pressure (DBP) less than 80 Millimeters of mercury (mmHg).
Time frame
12 weeks (post CR)2
Change in resting systolic blood pressure (SBP)
Change in resting SBP from baseline to CR completion, measured using an automated blood pressure monitor and expressed in mmHg.
Time frame
Baseline, 12 weeks (post CR)3
Change in resting diastolic blood pressure (DBP)
Change in resting DBP from baseline to CR completion, measured using an automated blood pressure monitor and expressed in mmHg.
Time frame
Baseline, 12 weeks (post CR)4
Improvement in depression based on the Patient Health Questionnaire (PHQ)-9
Percentage (%) of patients with a positive depressive screen at CR entrance that experience a decrease in depressive symptoms (reduction in one or more levels of severity) as measured by changes in the Patient Health Questionnaire (PHQ)-9 score from baseline to completion of CR. The PHQ-9 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response options of 0, 1, 2 or 3. The total score scale ranges from 0 to 27. Higher scores indicate more symptoms of depression.
Time frame
Baseline to 12 weeks (post CR)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
University of Texas
Collaborator
Source ClinicalTrials.gov