Actively Recruiting
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Led by Stanford University · Updated on 2026-01-05
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effects of cardiac rehabilitation versus usual care on adults with Fontan failure, a condition related to heart failure after a specific heart surgery. The study evaluates whether cardiac rehabilitation can improve daily physical activity, exercise tolerance, frailty, and quality of life. It is a multi-center, randomized clinical trial involving patients being seen at Adult Congenital Heart Disease centers. Participants are randomly assigned to either a cardiac rehabilitation program or usual care. Those in the rehabilitation group are referred to a community-based program called Heart Fit for Life, which may be in-person, hybrid, or fully virtual, depending on location. The program includes three sessions per week for 12 weeks. Those in usual care do not start cardiac rehabilitation during the first 16 weeks after randomization. All participants receive a Fitbit to track daily activity. During the study, researchers monitor physical activity through Fitbit step counts and assess exercise tolerance using tests like cardiopulmonary exercise testing. Various measures of frailty, strength, nutrition, and quality of life are also recorded at the start and after about 4 months. Participants receive weekly reminders to encourage engagement. The study observes changes over a period of approximately 120 days after randomization to understand the impact of cardiac rehabilitation on their health and daily functioning.
CONDITIONS
Brief Title
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of Fontan procedure with evidence of Fontan failure, including systemic ventricular EF <50%, protein losing enteropathy, plastic bronchitis, chronic diuretic use, or peak VO2 <50% predicted
- Age 18 years or older
You will not qualify if you...
- Dependence on inotropes
- Symptomatic, uncontrolled arrhythmias
- Pregnancy
- Contraindication to cardiac rehabilitation or already enrolled in cardiac rehabilitation
- Inability to comply with the study protocol
- Planned Fontan pathway intervention within the past 3 months
- Resting oxygen saturation below 80%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are randomized to either cardiac rehabilitation involving supervised exercise sessions or to usual care without cardiac rehabilitation. Cardiac rehabilitation sessions occur 3 times per week for 12 weeks. All participants will receive a Fitbit for daily activity tracking.
3 sessions per week
Duration - Approximately 4 months post-randomization
Participants are monitored for changes in exercise tolerance and physical activity up to approximately 4 months after randomization.
1 follow-up visit
Trial Site Locations
Total: 2 locations
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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