Single-ventricleNCT06918795
Fontan Fitness Trial
A study testing Digital Exercise Intervention in people with Single-ventricle and Congenital Heart Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Single-ventricle, Congenital Heart Disease
- What is being tested?
- Digital Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
- Pacemaker or internal cardiac defibrillator (ICD)
- Peak VO2 <45% age-sex predicted
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zoe Lincoln, MS contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Elizabeth Goldmuntz, MD, goldmuntz@chop.edu
Zoe Lincoln, MS, lincolnz@chop.edu
About this study
Official title: Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
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?
Read more
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
Read the detailed description
The Fontan Circulation is associated with poor exercise performance and reduced quality of life. Current standard of care encourages physical activity (PA) in this population, but few structured interventions exist. Participants will be randomly assigned to either enhanced usual care (PA tracker and standard encouragement) or an interactive digital intervention that includes personalized aerobic and resistance exercises with behavioral engagement strategies. This study will evaluate a home-based, digital intervention delivered through a mobile health platform to promote PA and improve fitness among youth with FC.
The study will recruit up to 200 participants aged 10-17 years with FC. After initial testing and a two-week run-in period, 120 participants with peak VO2 between 45% and 80% of predicted norms will be randomized. The intervention will last 6 months, followed by a 5.5-month monitoring phase. Outcomes will include changes in PA (measured via accelerometry), peak VO2, muscle strength, body composition, and quality of life.
- Conditions
- Single-ventricle, Congenital Heart Disease
- Being tested
- Digital Exercise Intervention
- Keywords
- Fontan, Single ventricle disease, exercise intervention, digital health, adolescents, randomized control trial
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Exercise InterventionBehavioural
Subjects 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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Exercise Intervention | Experimental | The exercise intervention arm includes access to a digital application to receive the following over the 6-month intervention:
* personalized plans for aerobic-based PA
* personalized resistance exercise sessions
* engagement strategies. Receives: Behavioral: Digital Exercise Intervention |
| Enhanced Usual Care | No intervention | The enhanced usual care arm will receive their usual care in addition to a passive physical activity tracker device. No intervention materials will be delivered to these participants over the course of their enrollment in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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).
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Secondary outcomes (5)
MVPA
Change in time spent in moderate to vigorous physical activity (MVPA), in terms of minutes per day.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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).
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Lower extremity strength
Change in lower extremity strength measured via knee and ankle peak torsion and presented as a z-score.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
PCQLI score
Change in Pediatric Cardiac Quality of Life Instrument (PCQLI) total and sub-scale scores (i.e. Disease Impact, Psychosocial Impact).The PCQLI is a cardiac-specific health-related quality-of-life instrument. Children will answer questions about themselves and parents will answer questions in regard to their child.
Measured: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start9 Jun 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Goldmuntz, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918795
- Sponsor's protocol ID
- 24-022619
- Other IDs
- 1R61HL171110-01A1
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NHLBI data sharing regulations will be followed. No data will be shared before study conclusion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation
- ClinicalTrials.gov ID
- NCT06918795
- Acronym / sponsor ID
- 24-022619
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- Fontan, Single ventricle disease, exercise intervention, digital health, adolescents, randomized control trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The Fontan Circulation is associated with poor exercise performance and reduced quality of life. Current standard of care encourages physical activity (PA) in this population, but few structured interventions exist. Participants will be randomly assigned to either enhanced usual care (PA tracker and standard encouragement) or an interactive digital intervention that includes personalized aerobic and resistance exercises with behavioral engagement strategies. This study will evaluate a home-based, digital intervention delivered through a mobile health platform to promote PA and improve fitness among youth with FC.
The study will recruit up to 200 participants aged 10-17 years with FC. After initial testing and a two-week run-in period, 120 participants with peak VO2 between 45% and 80% of predicted norms will be randomized. The intervention will last 6 months, followed by a 5.5-month monitoring phase. Outcomes will include changes in PA (measured via accelerometry), peak VO2, muscle strength, body composition, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Exercise Intervention | Experimental | Behavioral: Digital Exercise InterventionThe exercise intervention arm includes access to a digital application to receive the following over the 6-month intervention: * personalized plans for aerobic-based PA * personalized resistance exercise sessions * engagement strategies. |
| Enhanced Usual Care | No intervention | –The enhanced usual care arm will receive their usual care in addition to a passive physical activity tracker device. No intervention materials will be delivered to these participants over the course of their enrollment in the study. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Pacemaker or internal cardiac defibrillator (ICD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Exercise InterventionSubjects 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. | Behavioural | Digital Exercise Intervention |
Primary outcome
MIMS-units
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
Absolute peak VO2
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Change in absolute peak VO2, the maximum amount of oxygen the body consumes during exercise without regard to body weight (liters/minute).
Percent predicted peak VO2
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
Leg lean mass
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
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.
5 secondary outcomes
MVPA
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Forearm strength
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Lower extremity strength
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
PROMIS Pediatric Profile-25 T-score
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
PCQLI score
Time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. NHLBI data sharing regulations will be followed. No data will be shared before study conclusion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoe Lincoln, MS contact
Elizabeth Goldmuntz, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Exercise Intervention in people with Single-ventricle and Congenital Heart Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Goldmuntz, MD (215-590-3354, goldmuntz@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIMS-units (time frame: 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.