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
1 other identifier
observational
30
1 country
1
Brief 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:
- Echocardiogram
- Cardiopulmonary exercise test
- Body composition scan using a bio-impedance analyser
- Quality of life questionnaires
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 21, 2022
December 1, 2022
12 months
October 24, 2022
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Single ventricle Function
By implementing a prescribed exercise training regime over a 20 week period, a change will be noted in ventricular function at the subclinical state using Echocardiography parameters.
After a 20 week Exercise training program
Secondary Outcomes (4)
Exercise Capacity
After a 20 week Exercise training program
Self-perceived Quality of life - Generic
After a 20 week Exercise training program
Self-perceived Quality of life - Cardiac module
After a 20 week Exercise training program
Skeletal muscle mass
After a 20 week Exercise training program
Eligibility Criteria
Children aged 8 to 18 years old, who are living with a Fontan circulation, who have met the eligibility criteria listed above.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Health Irelandlead
- CHI Research & Innovation Officecollaborator
Study Sites (1)
Children's Health Ireland
Dublin, D12 N512, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam James, MD
Children's Health Ireland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Paediatric Cardiologist
Study Record Dates
First Submitted
October 24, 2022
First Posted
November 15, 2022
Study Start
January 10, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share