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This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.
Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | 130 patients who underwent open heart surgery and are cleared for exercise.These will include patients who enter supervised cardiac rehabilitation as well as patients who enter a supervised exercise program focusing strength training, endurance of functional training. |
|
| Additional controls | No Intervention | 5 patients who choose not to enter any organized exercise program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Exercise Program | Behavioral | Participants who enrolled in cardiac exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness | Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness) | Baseline and 2 weeks after completing exercise program |
| Change in strength | Change in strength as measured by grip strength (Higher values indicate better strength). | Baseline and 2 weeks after completing exercise program |
| Change in functional fitness. | Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness) | Baseline and 2 weeks after completing exercise program |
| Change in cognition | Measured by standardized tests of cognition such as Montreal Cognitive Assessment (MoCA) (Higher values indicate better cognition with scores less than 23-26 adjusting for education indicative of impaired cognition) | Baseline and 2 weeks after completing exercise program |
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Inclusion Criteria:
- Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basmah Safdar, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Church Street Research Unit (CSRU) | New Haven | Connecticut | 06511 | United States |
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Intervention study with organized exercise program in intervention arm, no organized exercise in control arm
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