NCT06150950招募中不适用
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
适应症
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
- Average daily step count
研究概览
简要总结
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.
- Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
- Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
详细描述
REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.
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
- 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
- •Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF <50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 < 50% predicted (by FRIEND equation)
- •Age >= 18 years old
排除标准
- •Inotrope-dependence
- •Symptomatic, uncontrolled arrhythmias
- •Pregnancy
- •Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
- •Inability to comply with the protocol
- •Recent (<3 months) planned Fontan pathway percutaneous or surgical intervention
- •Resting hypoxemia with baseline oxygen saturation <80%
结局指标
主要结局
Average daily step count
时间窗: 120 days (+/- 45 days) post-randomization
Average daily step count during the intervention period measured by Fitbit 3 activity tracker
次要结局
- Average daily sedentary minutes(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in oxygen (O2) pulse(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in grip strength(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in 5-meter timed walk as a measure of slowness(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in exercise time as a measure of exhaustion(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in respiratory exchange ratio (RER) as a measure of exhaustion(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in mini-nutritional assessment short form (MNA-SF) score(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in body fat percentage(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in patient reported physical activity questionnaire score(Baseline and 120 days (+/- 45 days) post-randomization)
- Average daily active minutes of moderate-high intensity activity(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in anaerobic threshold(Baseline and 120 days (+/- 45 days) post-randomization)
- Change Patient Health Questionnaire-2 (PHQ-2) score(Baseline and 120 days (+/- 45 days) post-randomization)
- Average daily active minutes(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in peak respiratory oxygen uptake (VO2)(Baseline and 120 days (+/- 45 days) post-randomization)
- Change in minute ventilation/carbon dioxide production (VE/VCO2)(Baseline and 120 days (+/- 45 days) post-randomization)
研究者
Daniel Clark
Assistant Professor of Adult and Pediatric Cardiology
Stanford University
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Cardiac Rehabilitation for the Treatment of Refractory AnginaCoronary DiseaseAngina PectorisNCT00411359National Heart and Lung Institute42
终止
不适用
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19Long COVIDCOVID-19NCT05530317University of California, San Francisco13
Enrolling By Invitation
不适用
Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive FunctionsCongenital Heart DefectsCongenital Heart DiseaseNCT05195788Montreal Heart Institute100
已完成
2 期
Cardiac Resynchronization Therapy in Congenital Heart DefectsCongenital Heart DefectsNCT00450684Competence Network for Congenital Heart Defects55
尚未招募
不适用
Investigation of the effect of cardiac rehabilitation on patients with different types of heart rhythm management devices and their spousesCondition 1: Patients with different types of heart rhythm management devices. Condition 2: Spouses of patients with different types of heart rhythm management devices.IRCT20200302046662N1Shiraz University of Medical Sciences68