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

WHY THIS RESEARCH MATTERS The ability to take part in 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 be active for at least 60 minutes per day, however in Northern Ireland, only 13% of children are meeting these guidelines. This is worrying, as children with CHD are less active than healthy children, and it has been observed that children with complex CHD such as Fontan patients are less physically active than those with moderate CHD and their exercise capacity can be as low as 60% of reference value and further declines in adolescence and adulthood. This may be due to parents not allowing their child to fully participate in PA due to worries about their child's condition and non-cardiac comorbidities such as intellectual disabilities. Studies have suggested that parents of children with CHD are often apprehensive about their child's participation in PA, as a focus group study reported that parents and siblings often discouraged PA within the home, despite no clinical recommendation to do so. This study hypothesized that similarly, to parents, teachers and coaches may be apprehensive and unsure of the child's capabilities. However, no study to date has spoken to parents/guardians and teachers/coaches to investigate concerns faced regarding PA in children with CHD. Therefore, the investigators have conducted interviews with parents/guardians and teachers/coaches as in order to develop an effective and sustainable intervention, it is important to identify and address the concerns faced from those in the home and school environment who can either encourage or discourage PA among this population (Bagley et al. 2016; Ten Velde et al. 2021).

Previous studies have explored the effects of an individualised PA plan within children (5-10 years) and adolescents (12-20 years) however studies have shown that children are less active when they go to secondary school as PE lessons start to include more competitive sports (Callaghan et al. 2021; Morrison et al. 2013). Yet, no study to date has included all school-aged children (5-18 years) to identify if there are differences in PA levels when children transition from primary to secondary school.

In addition, children with intellectual disabilities such as those with Down Syndrome have been excluded from previous studies, even though they are less active than their peers. Therefore, this study will include all school aged children with CHD and an intellectual disability to participate in a PA intervention which will involve a PA plan, specific to each child, to be implemented at home. It is hypothesized that this study will improve PA levels and exercise capacity which will improve the child's health related quality of life.

This study is novel as it conducted qualitative interviews to inform an intervention that will be acceptable to the target population as parents/guardians and teachers/coaches have stated they would appreciate tailored PA as they highlighted that PA is not routinely discussed at appointments, despite the fact that relevant bodies published a statement recommending that encouraging daily participation in appropriate PA among children and adults should be a part of each patient encounter. Therefore, the investigators will develop an individualized home-based PA plan, with the aim of improving exercise capacity and PA levels which will in turn improve the child's health related quality of life and prognosis.

WHO WILL IT HELP There is currently no provision for individualized PA plans among this population despite recommendations from relevant bodies and qualitative interview feedback. Therefore this low-cost intervention aims to address this. By participating in this study, parents/guardians, children with CHD and teachers/coaches will have the opportunity to be provided with tailored PA and exercise recommendations on what is appropriate for them. This aims to reduce any anxiety parents/guardians, the children, and teachers/coaches may have about their participation in PA/exercise. PA can help improve children with congenital heart disease overall health, by improving their strength, muscle mass, reducing their risk of obesity and type 2 diabetes. PA can also help improve symptoms of anxiety and depression and overall quality of life and improve academic performance. Furthermore, the knowledge gained from this research will help improve the information and services surrounding physical activity provided to children with congenital heart disease and their families in the future.