NCT05199857

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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: * be delivered without any associated serious cardiac events; * will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. * will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. * will result in increased step counts measured monthly from baseline to end of intervention * will improve self-reported quality of life from baseline to post-intervention. * will result in increased patient reported activity level from baseline to post-intervention

Conditions

• Fontan Physiology
• Frailty
• Single Ventricle Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	WE BEAT Group Wellness Education program - phase 1	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.
BEHAVIORAL	HEART Club Home Exercise program - phase 2	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.

Timeline

• Start date: 2022-03-30
• Primary completion: 2026-04-01
• Completion: 2026-07-31
• First posted: 2022-01-20
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States