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| Name | Class |
|---|---|
| Reuben Phoenix Schostak Fontan Wellness Project Fund | UNKNOWN |
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This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.
There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.
The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wellness education and Home exercise programs | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WE BEAT Group Wellness Education program - phase 1 | Behavioral | Participants will be assigned into a small group with 3-6 other participants and will participate in a weekly, 45-50 minute intervention session for 5 weeks, delivered by a licensed clinical psychologist or limited licensed clinical psychology fellow using University of Michigan (UM) Zoom. Each session will focus on a particular skill related to wellness and resiliency. There will also be a short battery of questionnaires to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Connor-Davidson Resilience Scale 10 | This is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (high Resilience). | baseline, 6 weeks |
| Change in the Lurz-Wilde pediatric frailty score | The Lurz-Wilde Frailty score is the sum of points scored across 5 domains of physical and mental functioning (weakness, slowness, shrinkage, exhaustion, diminished physical activity). The maximum score is 10. If a patient accumulates > 5 points, they are considered frail. If a patient accumulates 4-5 points, they are considered pre-frail. | baseline (prior to home exercise start), after exercise program (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled | up to approximately 18 months | |
| Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse Hansen, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| HEART Club Home Exercise program - phase 2 | Behavioral | This is an individualized home exercise program adapted from the exercise programs used in traditional, hospital-based cardiac rehabilitation. A complete cardiopulmonary exercise test (CPET) may be completed if needed for a baseline and one will be done at the last visit. The exercise physiology team will discuss participants exercise goals, interests, and available resources to help develop the exercise plan for the research study. Once the program is designed, participants will complete the exercise activities in the plan. Over time, participants will advance through various stages in the program and then will be gradually introduced to the principles of exercise rehabilitation and more intense physical exercise. Participants will be asked to wear a wearable activity tracker and have scheduled video check-ins with the exercise physiology team. Throughout the program participants will complete a short battery of surveys. |
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| up to approximately 18 months |
| Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention |
| 6 months |
| Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a | This is a 4-item questionnaire that asks participants about their level of physical activity in the past 7 days. Items are scored on a 5-point scale. Scores range from 4 to 20 with 4 indicating low physical activity and 20 indicating high physical activity (better outcome). | baseline (prior to home exercise start), after exercise program (6 months) |
| Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25) | PROMIS-25 measures quality of life (i.e., depression, anxiety, and pain interference). The 25 items are on a 1-5 scale and are scored using the Health Measures Scoring Service with higher scores indicating a lower quality of life. | baseline (prior to home exercise start), after exercise program (6 months) |
| Seven day running average step counts | baseline (week 1 of exercise program), last week of exercise program (6 months) |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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