A virtual program to promote wellness and prevent frailty in teens with Fontan physiology
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
This study is testing a virtual wellness and exercise program for teens with Fontan physiology to see if it helps them feel better and stay active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05199857 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a small-group wellness education program combined with a personalized exercise regimen for pediatric patients aged 13 to 19 with Fontan physiology. The study consists of two phases: the initial WE BEAT Group Wellness Education Program followed by the HEART Club Home Exercise program. It aims to assess the feasibility and acceptability of these interventions while measuring their impact on wellness, resiliency, and daily activity levels. Key outcomes include the reduction of frailty and improvement in physical fitness as indicated by peak oxygen consumption and step counts.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 13 to 19 with Fontan physiology who can use a mobile device for program participation.
Not a fit: Patients with severe cardiac dysfunction or other significant health issues that prevent safe participation in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the overall wellness and physical activity levels of adolescents with Fontan physiology, potentially reducing frailty.
How similar studies have performed: While similar wellness and exercise interventions have shown promise in other populations, this specific approach for Fontan patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jesse Hansen, MD — University of Michigan
- Study coordinator: Blake Armstrong
- Email: blar@umich.edu
- Phone: 734-615-4899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.