Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Amyloidosis
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of participants that complete at least 75% of prescribed cardiac rehab sessions
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18
- •New York Heart Association (NYHA) Class I-III Heart Failure
- •Able to Exercise
- •On stable treatment for their cardiac amyloidosis or under active surveillance
- •Life expectancy of at least 6 months
- •Ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities
- •Participant must be able and willing to follow the cardiac rehabilitation activities
Exclusion Criteria
- •Inability to provide informed consent
- •Inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks
- •NYHA Class IV Heart Failure
- •Pulmonary disease requiring home oxygen
- •Gait instability or history of prior falls
- •In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.
Outcomes
Primary Outcomes
Number of participants that complete at least 75% of prescribed cardiac rehab sessions
Time Frame: Week 12
Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions.
Secondary Outcomes
- Change in cardiorespiratory fitness - maximal VO2 rates(Week 12)
- Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates(Week 12)
- Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores(Week 12)
- Change in cardiorespiratory fitness - chronotropic incompetence scores(Week 12)
- Change in cardiorespiratory fitness - 6-minute walk test distance(Week 12)