WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
Launched by UNIVERSITY OF MICHIGAN · Jan 7, 2022
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
The WE BEAT - HEART Club Fontan Wellness Project is a clinical trial designed to help young patients with a specific heart condition called Fontan physiology. This trial is looking at how a small-group wellness education program, along with personalized exercise plans, can improve the health and daily activities of these pediatric patients. The study will assess whether this program is safe and acceptable, and it aims to see if participants become less frail, improve their physical fitness, increase their daily activity levels, and report a better quality of life after completing the program.
To be eligible for the trial, participants must be between 13 and 19 years old, have Fontan physiology, and be able to use a mobile device for program activities. They should also have the consent of a parent or guardian. During the trial, participants will take part in both educational sessions and exercise programs over a period of time, and they will be monitored for progress and safety. Overall, this study hopes to promote better health and well-being for young people living with this heart condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About University Of Michigan
The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Ann Arbor, Michigan, United States
Patients applied
Trial Officials
Jesse Hansen, MD
Principal Investigator
University of Michigan
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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