RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Survival of children with single ventricles (half a heart) beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an exercise prescription to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 19
Healthy Volunteers: f
View:

• 8-19 years of age

• Fontan palliation

• Ability to fast overnight

• Cardiac clearance to exercise by primary cardiologist

• Presence of an adult at home during exercise sessions for patients \<14 years old

• English-speaking patient.

Locations
United States
California
Stanford University, Lucile Packard Children Hospital
RECRUITING
Palo Alto
Contact Information
Primary
Seda Tierney
tierneys@stanford.edu
650-334-7156
Time Frame
Start Date: 2020-08-06
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 150
Treatments
Experimental: Live Video-Supervised Exercise Intervention Arm
Patients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
Experimental: Live-Video-Supervised Exercise Control Arm
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: The Methodist Hospital Research Institute, National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov