Fontan Fitness Trial

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

Conditions

Single-ventricle, Congenital Heart Disease

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Study Overview

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Study Details

Study overview

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

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

Fontan Fitness Trial

Condition
Single-ventricle
Intervention / Treatment

-

Contacts and Locations

Philadelphia

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Fontan Circulation present
  • * Girls ≥11 years of age or menstruating must have negative urine pregnancy test
  • * Neurodevelopmental capacity to complete all study procedures
  • * Physical capacity to complete all study procedures
  • * English speaking with at least one English speaking parent/guardian
  • * 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)
  • * Inability to complete an EST at any time (i.e. limited physical or executive function)
  • * Uncontrolled lymphatic disorders
  • * Exercise induced or uncontrolled arrhythmias
  • * Pacemaker or internal cardiac defibrillator (ICD)
  • * Peak VO2 \<45% age-sex predicted
  • * Having had or under consideration for a heart transplant
  • * Pregnant or lactating females
  • * Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

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

Study Record Dates

2029-04