NCT05617534

Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients

A Single-centre, Prospective Case Control Study Evaluating the Impact of a Standardised Aerobic and Strength Exercise Regime on Exercise Capacity, Ventricular Function, and Perceived Quality of Life in Paediatric Fontan Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Children's Health Ireland · Other Government
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: —

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

Conditions

• Univentricular Heart

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-11-15
• Last updated: 2022-12-21

Locations

1 site across 1 country: Ireland