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

NCT05617534 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-12-21

No results posted yet for this study

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

Sponsors & Collaborators

  • CHI Research & Innovation Office

    collaborator UNKNOWN

  • Children's Health Ireland

    lead OTHER_GOV

Principal Investigators

  • Adam James, MD · Children's Health Ireland

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617534 on ClinicalTrials.gov