Telemedicine-based home exercise program for individuals with Fontan physiology
Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation
This study tests whether a home exercise program delivered through telemedicine can help people with Fontan heart physiology improve their fitness and reduce frailty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05543733 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a structured home exercise program delivered via telemedicine on frailty and exercise capacity in individuals with Fontan heart physiology. Participants will undergo two in-person visits for various assessments, including cardiopulmonary exercise tests and liver ultrasounds, alongside virtual follow-ups. The goal is to reduce barriers to exercise training and assess the program's impact on markers of Fontan-associated liver disease.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 19 and older with Fontan physiology.
Not a fit: Patients with severe cardiac dysfunction or other significant medical conditions that prevent exercise testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance exercise capacity and overall health in patients with Fontan physiology, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise in using telemedicine for exercise programs, but this specific approach for Fontan physiology is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females with Fontan physiology * 19 years old at age of enrollment Exclusion Criteria: * Height less than 130 centimeter (cm) * Pregnancy or the plan to become pregnant during the study period * 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, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results
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.