Clinical Trial

Study of Exercise Capacity and Physical Activity in Children With Congenital Heart Disease

Study acronym: SHAPE
Completed
View on ClinicalTrials.gov →
Summary
Congenital heart disease (CHD) is the most common birth defect worldwide and occurs in every 8-10 per 1000 live births in Northern Ireland. The ability to participate in physical activity (PA) is an important aspect to an individual's quality of life. The UK Chief Medical Officer currently recommends that children aged 5-18 years should aim to achieve a minimum of 60 minutes PA per day. However, in Northern Ireland, only 8% of children with CHD are meeting these guidelines. This may be attributed to parents not allowing their child to fully participate in PA due to anxiety regarding its effect on their child's condition. Whilst, several studies to date have investigated the concerns faced by parents/guardians, this study is novel in its inclusion of teachers/coaches. Therefore, the investigators conducted interviews with parents/guardians and teachers/coaches to identify their concerns, highlighting that an individualised PA plan would help alleviate these fears. This has informed a PA intervention, whereby the intervention group will receive an individualised PA plan to implement at home over a 12 week period with a 3 and 6 month follow up. This plan will also be sent out to teachers/coaches to inform them of what PA is both safe and beneficial for each child. The PA plan is adapted specifically for each child to increase their exercise capacity as this will increase their cardiorespiratory function and health related quality of life. It is also anticipated that it will increase PA level, thus increasing the percentage of children with CHD meeting current PA guidelines. Therefore, the overall aim of this randomised control trial (RCT) is to assess the effectiveness of an individualised PA programme on exercise capacity and PA levels in children and adolescents with CHD. This will be assessed using both qualitative and quantitative methods.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-17.
Status change: Not Yet Recruiting → Completed 2026-06-18
Trial Details
NCT Number NCT06945003
Lead Sponsor University of Ulster
Collaborators: Belfast Health and Social Care Trust
Conditions Congenital Heart Disease
Enrollment 60 participants
Start Date 2025-05-12
Primary Completion 2026-04-14 (estimated)
Study Completion 2026-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-06-23