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Completed
NCT05199857
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
Conditions: Fontan Physiology, Frailty, Single Ventricle Heart Disease
Sex: All
Ages: 13 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
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
Eligibility Criteria
Inclusion Criteria:
* Males and females with Fontan physiology who are 13 to \
Source: ClinicalTrials.gov (NCT05199857). StuddyBuddy aggregates publicly available trial information.