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Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.
The Atrium Health cardiac rehabilitation program delivers a comprehensive approach to improve cardiac performance including supervised exercise programs and has the ideal infrastructure to offer cardio-oncology rehabilitation (CORE) to all our cancer patients in the future. Currently neither CORE nor cardiac rehabilitation for HFpEF are covered by insurance, and hence the targeting of a higher risk cancer and non-cancer population of cardiac amyloidosis patients to objectively measure the benefits of a supervised exercise program ultimately to expand eligibility to all cancer patients and shape the treatment and payor landscape in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac rehabilitation group | Experimental | Intervention group will have baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing followed by supervised cardiac rehabilitation program including planned 3 one hour sessions a week for a total of 12 weeks (planned 36 sessions). A post intervention 6-minute walk test and CPET test will be performed within 2 weeks of completion of the 12 week program. |
|
| control group - no intervention | No Intervention | Control Group will have baseline 6-minute walk test and CPET testing followed by a repeat 6-minute walk test and CPET test in 12-14 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • Cardiac Rehabilitation | Behavioral | Intervention group will have baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing followed by supervised cardiac rehabilitation program including planned 3 one hour sessions a week for a total of 12 weeks (planned 36 sessions). A post intervention 6-minute walk test and CPET test will be performed within 2 weeks of completion of the 12 week program. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that complete at least 75% of prescribed cardiac rehab sessions | Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness - maximal VO2 rates | Change in cardiorespiratory fitness as assessed by maximal (max) rate (V) of oxygen (O₂) your body is able to use during exercise VO2 (ml/kg/min ) on cardiopulmonary exercise test (CPET). Vo2 Max scores can vary based on a number of factors in addition to fitness, such as your gender, age and genetics, but a vo2 max measurement for an average person in their mid 30s to mid 40s is likely to be around: Women - 31 ml oxygen/kg of body weight/minute. Men - 42 ml oxygen/kg of body weight/minute. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana B Amaro, RN | Contact | 704-355-4692 | Dana.Amaro@atriumhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jai Singh, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanger Heart and Vascular Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Enrollment in supervised cardiac rehabilitation for 3 one-hour sessions a week for a total of 12 weeks (36 sessions)
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| Week 12 |
| Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates | Ventilatory equivalent for carbon dioxide ( ˙VE/ ˙VCO2) identifies the second ventilatory threshold, namely, the point in time when ventilatory drive starts increasing relative to ˙VCO2 (i.e., when hyperventilation occurs). | Week 12 |
| Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores | KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. | Week 12 |
| Change in cardiorespiratory fitness - chronotropic incompetence scores | the inability of the heart to increase its rate commensurate with increased activity or demand, is common in patients with cardiovascular disease, produces exercise intolerance which impairs quality-of-life - chronotropic incompetence is usually defined as failure to achieve a chronotropic index of 0.8 or higher (i.e., falling below 97.5 percent of healthy adults). | Week 12 |
| Change in cardiorespiratory fitness - 6-minute walk test distance | In healthy subjects, the 6-min walk distance (6MWD) ranges from 400 to 700 m, the main predictor variables being gender, age and height. | Week 12 |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |