Pilot Study Evaluating Supervised Cardiac Rehabilitation in Patients With Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants that complete at least 75% of prescribed cardiac rehab sessions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
control group - 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
cardiac rehabilitation group
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.
干预措施: • Cardiac Rehabilitation (Behavioral)
结局指标
主要结局
Number of participants that complete at least 75% of prescribed cardiac rehab sessions
时间窗: Week 12
Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions.
次要结局
- 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)