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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61HL171110-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Pennsylvania | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Exercise Intervention | Experimental | The exercise intervention arm includes access to a digital application to receive the following over the 6-month intervention:
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Exercise Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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. | 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| MVPA | Change in time spent in moderate to vigorous physical activity (MVPA), in terms of minutes per day. | 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months. |
| Forearm strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Goldmuntz, MD | Contact | 215-590-3354 | goldmuntz@chop.edu | |
| Zoe Lincoln, MS | Contact | lincolnz@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Goldmuntz, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
NHLBI data sharing regulations will be followed. No data will be shared before study conclusion.
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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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).
| 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. | 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. | 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. | 0 to 12 months. Evaluated from baseline to 6 months, baseline to 12 months, and 6 to 12 months. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |