Status:
RECRUITING
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Reuben Phoenix Schostak Fontan Wellness Project Fund
Conditions:
Fontan Physiology
Frailty
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief 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,...
Eligibility Criteria
Inclusion
- Males and females with Fontan physiology who are 13 to \<19 years of age at enrollment
- Own a mobile device capable of installing the University of Michigan Patient Portal application
- Fluent in English
- Participant consent or parental/guardian consent and participant assent
Exclusion
- Height \< 130 centimeters
- Current intravenous inotropic drugs
- Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
- Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
- History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms).
- Inability to complete exercise testing at baseline screening.
- Noncardiac medical, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
- Suicidality or homicidality in the past 6 months.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05199857
Start Date
March 30 2022
End Date
July 1 2026
Last Update
July 4 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109