Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients (NCT05617534) | Clinical Trial Compass
UnknownNot Applicable
Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients
Ireland30 participantsStarted 2023-01-10
Plain-language summary
The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.
From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one functioning ventricle. With advancement in surgical technique and medical care, there are increasing number of children living with Fontan circulating surviving into adulthood.
A significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. Many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life.
Exercise training is a well-established therapy used in adult population with heart failure. It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes.
The main question\[s\] it aims to answer are the impact of a Exercise Training program on:
1. Single ventricle function
2. Exercise capacity
3. Self-perceived quality of life
4. Skeletal muscle mass
Participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. The following tests will be performed prior to starting and upon completion of the exercise program:
* Echocardiogram
* Cardiopulmonary exercise test
* Body composition scan using a bio-impedance analyser
* Quality of life questionnaires
Who can participate
Age range
8 Years – 18 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:
* Patients with Fontan circulation, age range 8 to 18 years
* Ability to perform a cardiopulmonary exercise stress test (CPET)
* Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance
* Who have had a Fontan operation at least six months prior.
Exclusion Criteria:
* Existing neuro-disability i.e. with paresis post cerebrovascular accident
* Neurodevelopmental issue with inability to comply with commands.
* Documented life-threatening arrhythmia without implantable cardioverter defibrillator
* Moderate or severe atrio-ventricular valve regurgitation
* Moderate or severe ventricular dysfunction by echocardiography exams
* Acute inflammatory cardiac disease
* documented coronary artery stenosis and/or myocardial ischaemia
* Heart failure requiring hospitalisation in the past year
* Evidence of systemic venous pathway obstruction by echocardiography or catheterisation
* Resting oxygen saturation \< 90%
* Systemic ventricular outflow tract stenosis with peak resting systolic gradient \> 50mmHg
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
Single ventricle Function
Timeframe: After a 20 week Exercise training program