Home Exercise And Resiliency Training (Heart) Club (NCT05543733) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Home Exercise And Resiliency Training (Heart) Club
United States53 participantsStarted 2023-03-01
Plain-language summary
The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Frailty score by the Fried frailty instrument
Timeframe: day 1 (baseline), week 26 (final visit)