Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 4
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
详细描述
Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings.
A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned. The experimental intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness, functional capacity, and quality of life. These will be measured at baseline, end of intervention, and 12-month follow-up.
The pragmatic, comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patients with HF of New York Heart Association functional class II or III.
- •Meets HF diagnostic criteria of Guidelines
- •On optimal tolerated medical therapy.
- •Deemed by the treating physician as stable for at least 1 month.
- •Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months
- •Owns a mobile phone
- •Patient consents to participate in the study by signing an informed consent form.
排除标准
- •Chronic kidney disease with glomerular filtration rate < 20 mL/min.
- •Decompensated thyroid disease.
- •End-stage liver failure or Child-Pugh C.
- •Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.
- •Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).
- •Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.
- •Active neoplasm with life expectancy <2 years.
- •Inclusion in another interventional study.
- •Explicit contraindications to performing exercise.
- •Comorbidities that preclude the patient from engaging in a CR program.
- •Musculoskeletal or neurological disease that precludes the patient from performing exercise.
研究组 & 干预措施
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Comprehensive Initial Assessment (Other)
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Continuous evaluation (Other)
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Interval Exercise (Other)
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Psychosocial support (Behavioral)
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Diet management (Other)
Comprehensive Hybrid Cardiac Rehabilitation
The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.
干预措施: Resistance exercise (Other)
Exercise and center-based Cardiac Rehabilitation
Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
干预措施: Resistance exercise (Other)
Exercise and center-based Cardiac Rehabilitation
Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
干预措施: Continuous exercise (Other)
Exercise and center-based Cardiac Rehabilitation
Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
干预措施: Initial Assessment (Other)
结局指标
主要结局
Cardiorespiratory fitness
时间窗: Baseline, 6 months and 12 months.
Will be assessed during a symptom-limited cardiopulmonary exercise test using an individualized gradual incremental ramp test designed to obtain oxygen consumption (VO2max).
Functional capacity
时间窗: Baseline, 6 months and 12 months.
Will be assessed by the six-minute walk test (6MWT)
Health Related Quality of Life
时间窗: Baseline, 6 months and 12 months.
Will be evaluated with the Minnesota Living with Heart Failure Questionnaire (MLHFQ). This questionnaire has 21 questions, which are answered on a scale of 1 to 5. The score of the questionnaire is obtained by the sum of the answers to the 21 questions, the higher the score, the worse the quality of life.
次要结局
- Cost(6 months)
- Program adherence and completion(6 months)
- Concentration of Pro-B-type Natriuretic Peptide(Baseline, 6 months and 12 months.)
- Mortality and Hospital admission(12 months)
- Lower-body muscle strength(Baseline, 6 months and 12 months.)
- Upper-body muscle strength(Baseline, 6 months and 12 months.)
- Functioning(Baseline, 6 months and 12 months.)
研究者
Pamela Serón
Principal Investigator
Universidad de La Frontera