Univentricular Heart Clinical Trial
Official title:
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
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A | |
| Recruiting |
NCT05563376 -
Fontan-Sprechstunde
|
N/A | |
| Completed |
NCT04026542 -
Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle
|
||
| Recruiting |
NCT04581668 -
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
|
N/A | |
| Withdrawn |
NCT04035317 -
Aesculus Hippocastanum L. on Fontan Circulation
|
Phase 2 | |
| Completed |
NCT03818373 -
Respiratory Drive in Patients With Univentricular Congenital Heart Disease
|
N/A | |
| Recruiting |
NCT05620030 -
Prospective Evaluation of Univentricular Hearts
|
N/A | |
| Recruiting |
NCT05744934 -
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
|
Early Phase 1 | |
| Withdrawn |
NCT03997097 -
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
|
Phase 3 | |
| Recruiting |
NCT04782232 -
Registry to Assess the Safety and Feasibility of the Subpulmonary Support With the Novel Venous Cannula in Patients With Failing/Absence of the Right Heart
|
||
| Completed |
NCT04394507 -
Lymphatic Function in Patients With a Fontan Circulation From Brazil
|
||
| Completed |
NCT02283255 -
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
|
N/A | |
| Completed |
NCT04163653 -
Lymphatic Morphology of Fontan Patients
|
||
| Recruiting |
NCT05647213 -
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
|
Phase 1 | |
| Recruiting |
NCT05454254 -
Effect of Muscle Strengthening Training in Adults With Fontan Circulation
|
N/A | |
| Active, not recruiting |
NCT03379805 -
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
|
N/A |