REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
- Conditions
- Heart Failure CongenitalSingle-ventricle
- Interventions
- Behavioral: Cardiac rehabilitationOther: Usual care
- Registration Number
- NCT06150950
- Lead Sponsor
- Stanford University
- Brief Summary
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.
1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
2. 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?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac rehabilitation Cardiac rehabilitation For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. Usual care Usual care For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.
- Primary Outcome Measures
Name Time Method Average daily step count 120 days (+/- 45 days) post-randomization Average daily step count during the intervention period measured by Fitbit 3 activity tracker
- Secondary Outcome Measures
Name Time Method Average daily sedentary minutes Baseline and 120 days (+/- 45 days) post-randomization Average daily sedentary minutes from Fitbit
Change in oxygen (O2) pulse Baseline and 120 days (+/- 45 days) post-randomization O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline
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 Exercise time on cardiopulmonary exercise testing
Change in respiratory exchange ratio (RER) as a measure of exhaustion Baseline and 120 days (+/- 45 days) post-randomization RER on cardiopulmonary exercise testing (exhaustion)
Change in mini-nutritional assessment short form (MNA-SF) score Baseline and 120 days (+/- 45 days) post-randomization Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status
Change in body fat percentage Baseline and 120 days (+/- 45 days) post-randomization Body fat percentage is a measure of body composition
Change in patient reported physical activity questionnaire score Baseline and 120 days (+/- 45 days) post-randomization The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity.
Average daily active minutes of moderate-high intensity activity Baseline and 120 days (+/- 45 days) post-randomization Average daily active minutes of moderate-high intensity activity from Fitbit
Change in grip strength Baseline and 120 days (+/- 45 days) post-randomization Change in anaerobic threshold Baseline and 120 days (+/- 45 days) post-randomization Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline
Change Patient Health Questionnaire-2 (PHQ-2) score Baseline and 120 days (+/- 45 days) post-randomization Mood assessment (Range 0-6, higher score indicates higher risk of depression, \>=3 suggestive of depression)
Average daily active minutes Baseline and 120 days (+/- 45 days) post-randomization Total average daily active minutes from Fitbit
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score Baseline and 120 days (+/- 45 days) post-randomization KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement.
Change in peak respiratory oxygen uptake (VO2) Baseline and 120 days (+/- 45 days) post-randomization Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline
Change in minute ventilation/carbon dioxide production (VE/VCO2) Baseline and 120 days (+/- 45 days) post-randomization VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline
Trial Locations
- Locations (2)
Stanford University
🇺🇸Stanford, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States