Exercise program for children with single-ventricle hearts
RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients
This study tests whether a special exercise program can help children with single-ventricle hearts get stronger and healthier compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 8 Years to 19 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT04195451 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on improving the health and exercise capacity of children aged 8-19 who have undergone Fontan palliation for single-ventricle heart conditions. Participants will engage in a live-video-supervised exercise intervention aimed at enhancing muscle mass, strength, and overall cardiovascular health. The study seeks to understand the impact of structured exercise on long-term outcomes for these patients, who are at high risk for heart failure and other complications. By comparing the exercise intervention to usual care, the trial aims to provide insights into effective management strategies for this unique patient population.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-19 who have undergone Fontan palliation and have received cardiac clearance to exercise.
Not a fit: Patients with severe heart failure or other significant health issues may not benefit from this exercise intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and long-term health outcomes for children with single-ventricle hearts.
How similar studies have performed: Other studies have shown that exercise interventions can improve outcomes in heart failure patients, suggesting potential success for this approach in Fontan patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * NYHA Class IV (severe heart failure) * Acute illness within the past three months * Active protein losing enteropathy (albumin \<2.5 mg/dL) * Implanted pacemaker * Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
Where this trial is running
Palo Alto, California
- Stanford University, Lucile Packard Children Hospital — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Seda Tierney
- Email: tierneys@stanford.edu
- Phone: 650-334-7156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.