RECRUITING

Fontan Fitness Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are: * Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention? Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective. All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months. In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components: * aerobic exercise * resistance exercise * engagement strategies

Official Title

Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation

Quick Facts

Study Start:2025-05
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06918795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Fontan Circulation present
  2. * Girls ≥11 years of age or menstruating must have negative urine pregnancy test
  3. * Neurodevelopmental capacity to complete all study procedures
  4. * Physical capacity to complete all study procedures
  5. * English speaking with at least one English speaking parent/guardian
  6. * To enroll in the randomized control trial, percent predicted peak VO2 \<80% of age-sex matched normal controls on the baseline exercise stress test (EST)
  1. * Inability to complete an EST at any time (i.e. limited physical or executive function)
  2. * Uncontrolled lymphatic disorders
  3. * Exercise induced or uncontrolled arrhythmias
  4. * Pacemaker or internal cardiac defibrillator (ICD)
  5. * Peak VO2 \<45% age-sex predicted
  6. * Having had or under consideration for a heart transplant
  7. * Pregnant or lactating females
  8. * Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Contacts and Locations

Study Contact

Elizabeth Goldmuntz, MD
CONTACT
215-590-3354
goldmuntz@chop.edu
Zoe Lincoln, MS
CONTACT
lincolnz@chop.edu

Principal Investigator

Elizabeth Goldmuntz, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Elizabeth Goldmuntz, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2029-04

Study Record Updates

Study Start Date2025-05
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • Fontan
  • Single ventricle disease
  • exercise intervention
  • digital health
  • adolescents
  • randomized control trial

Additional Relevant MeSH Terms

  • Single-ventricle
  • Congenital Heart Disease