Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06945003
NA

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

Sponsor: University of Ulster

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.

Official title: Evaluating the Effectiveness of an Individualised Physical Activity Plan to Increase Exercise Capacity and Physical Activity Levels in Children With Congenital Heart Disease: A Randomised Control Trial

Key Details

Gender

All

Age Range

5 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-05-15

Completion Date

2026-06-30

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Exercise Intervention

Those assigned to the intervention group will be invited to attend one of three group activity sessions with their parent/guardian that will occur at one of Ulster University's sport centres. Three group activity sessions will be delivered separately for each cohort (i.e Primary, Post-Primary and those with an Intellectual Disability) and their respective parent/guardian.) Parents/guardians and their child will then meet one-to-one with Professor Frank Casey, a paediatric cardiologist, will discuss with them, their child's results from their cardiopulmonary exercise test and from wearing their activity monitor. Using these results, alongside their age and diagnosis and likes and dislikes, Professor Casey will provide an individualised physical activity recommendation plan for each child that will be safe and beneficial to them, to be implemented at home over 12-weeks.

Locations (1)

Royal Belfast Hospital for Sick Children

Belfast, United Kingdom