An observational study in Univentricular Heart, sponsored by Children's Health Ireland. Status unknown at 1 site in Ireland. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Children's Health Ireland · Observational
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:
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:
104 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 41 observational studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Children's Health Ireland is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 8 to 18 years old, who are living with a Fontan circulation, who have met the eligibility criteria listed above.
Exclusion Criteria:
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.
Time frame: After a 20 week Exercise training program
Exercise Capacity
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in functional exercise capacity, which will be objectively assessed using cardiopulmonary exercise test.
Time frame: After a 20 week Exercise training program
Self-perceived Quality of life - Generic
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using Paediatric Quality of Life Inventory, PedsQL v4.0
Time frame: After a 20 week Exercise training program
Self-perceived Quality of life - Cardiac module
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using PedsQL Cardiac Module v3.0
Time frame: After a 20 week Exercise training program
Skeletal muscle mass
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in the skeletal muscle mass, which will be assessed using a non-invasive bio-impedance analyser.
Time frame: After a 20 week Exercise training program
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Children's Health Ireland