REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inotrope-dependence
Symptomatic, uncontrolled arrhythmias
Pregnancy
Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiac rehabilitation
BehavioralCardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation \<50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.
Usual care
Other interventionFor participants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cardiac rehabilitationExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average daily step count
Average daily step count during the intervention period measured by Fitbit 3 activity tracker
Time frame
120 days (+/- 45 days) post-randomizationSecondary outcomes
1
Change in 5-meter timed walk as a measure of slowness
Time frame
Baseline and 120 days (+/- 45 days) post-randomization2
Change in exercise time as a measure of exhaustion
Exercise time on cardiopulmonary exercise testing
Time frame
Baseline and 120 days (+/- 45 days) post-randomization3
Change in respiratory exchange ratio (RER) as a measure of exhaustion
RER on cardiopulmonary exercise testing (exhaustion)
Time frame
Baseline and 120 days (+/- 45 days) post-randomization4
Change in mini-nutritional assessment short form (MNA-SF) score
Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status
Time frame
Baseline and 120 days (+/- 45 days) post-randomizationOther outcomes
1
Exploratory outcome: number of participants with exercise-induced clinical ailment
Sustained arrhythmia or hemodynamic change necessitating hospitalization, heart failure hospitalization, or all-cause death within 30 days of completion of cardiac rehabilitation
Time frame
120 days (+/- 45 days) post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Adult Congenital Heart Association
Collaborator
Julie Fletcher Memorial Fund
Collaborator
Pete Huttlinger Memorial Fund
Collaborator
Source ClinicalTrials.gov