Fontan Fitness Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorChildren's Hospital of Philadelphia
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to complete an EST at any time (i.e. limited physical or executive function)
Uncontrolled lymphatic disorders
Uncontrolled noncardiac conditions
Exercise induced or uncontrolled arrhythmias
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Exercise Intervention
BehavioralSubjects randomized to the intervention arm will receive the same as the enhanced usual care arm but will be additionally exposed to: (1) personalized plans for aerobic-based PA, (2) personalized resistance exercise sessions, and (3) financial and non-financial engagement strategies. These intervention components will be delivered continuously using an advanced digital health informatics platform during the 6 months of the intervention. The intervention will be overseen and supplemented by the exercise physiologist, who will meet with participants on a weekly, then biweekly and finally monthly basis over 6 months.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Digital Exercise InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
MIMS-units
Change in total volume of physical activity (PA) operationalized as a Monitor Independent Movement Summary (MIMS) units, expressed as a percentile based on what is expected for their age and sex.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.2
Absolute peak VO2
Change in absolute peak VO2, the maximum amount of oxygen the body consumes during exercise without regard to body weight (liters/minute).
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.3
Percent predicted peak VO2
Change in percent predicted peak VO2, the maximum amount of oxygen the body consumes during exercise expressed as a percentage of what is expected for their age and sex.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.4
Leg lean mass
Change in leg lean mass presented as a z-score. Leg lean mass z-score compares an individual's leg muscle mass to the average for their age and sex, with values below -2.0 indicating lower-than-expected muscle mass.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.Secondary outcomes
1
MVPA
Change in time spent in moderate to vigorous physical activity (MVPA), in terms of minutes per day.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.2
Forearm strength
Change in forearm strength measured via handgrip test and presented as a z-score. Z-scores are used to standardize measurements across individuals with different demographics (i.e. age, sex, body size).
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.3
Lower extremity strength
Change in lower extremity strength measured via knee and ankle peak torsion and presented as a z-score.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.4
PROMIS Pediatric Profile-25 T-score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-25. This 25-item questionnaire provides a T-score based on physical function, anxiety, depression, fatigue, peer relationships and pain. Children and parents will complete a PROMIS questionnaire. Children will answer questions about themselves and parents will answer questions in regard to their child.
Time frame
0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov