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| Name | Class |
|---|---|
| University of Texas | OTHER |
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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:
This registration was updated on 11/24/2025 due to amendments that were approved at the IRBMED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women only Cardiac Rehab program | Experimental |
| |
| Standard of Care (mixed-sex) rehab program | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks (post CR) |
| Cardiac Rehabilitation (CR) attendance rate - percentage | Number of CR sessions attended out of number of CR sessions prescribed, expressed as a percentage | 12 weeks (post CR) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks (post CR) |
| Change in resting systolic blood pressure (SBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Perrotta | Contact | 734-232-6865 | eperrott@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melvyn Rubenfire, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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The study team will make every effort to:
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| 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. |
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Change in resting SBP from baseline to CR completion, measured using an automated blood pressure monitor and expressed in mmHg. |
| Baseline, 12 weeks (post CR) |
| 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. | Baseline, 12 weeks (post CR) |
| 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. | Baseline to 12 weeks (post CR) |
| Change in Patient Health Questionnaire (PHQ)-9 score | A change in PHQ-9 scores will be measured during the first 12 weeks of the study. 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. | Baseline to 12 weeks (post CR) |
| Change in Patient Health Questionnaire (PHQ)-9 score | 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. A change in PHQ-9 scores will be measured during the first 12 weeks of the study and will be repeated 12 weeks following program completion. | 12 weeks (post CR), 24 weeks |
| Improvement in functional capacity measured by the six-minute walk test | Percentage of patients that achieve an increase in distance walked, in meters, by at least 10%, after participation in CR as measured by the 6-minute walk test (6MWT). | Baseline, up to 12 weeks (post CR) |
| Change in 6-minute walk test distance | The distance walked in six minutes on a standard course will be measured in meters at baseline and CR Exit | Baseline, 12 weeks (post CR) |
| Improvement in functional capacity Metabolic Equivalents (METs) | Percentage of patients that display an overall mean increase in estimated METs (0.93 METs, 12.4%): with greatest increase occurring in "low" fitness patients < 5 METs (1.3 METs, 35% increase), followed by "moderate" fitness 5-8 METs (1.03 METs, 16% increase), and "high" fitness > 8 METs (0.77 METs, 8% increase)2,3 after participation in CR as measured by estimated exercise session peak METs. | Baseline, 12 weeks (post CR) |
| Change in estimated exercise session peak METs | The difference in estimated peak METs between baseline (defined as the third session to account for learning effect) and program completion. | Baseline, up to 12 weeks (post CR) |