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

NCT06945003 | Not Yet Recruiting DMC

• 1 other identifier: 322580
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Keywords

children; adolescents; congenital heart disease; physical activity; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Exercise Capacity

  The primary outcome measure will be exercise capacity to measure cardiorespiratory function among this population. Exercise capacity will be assessed by cardiopulmonary exercise testing (C-PET) to assess the individual's ability to exercise and the response of the individual's heart, lungs and muscles to exercise. C-PET remains the gold standard when assessing the functional limitations of cardiac patient and is a standard, low-risk, non-invasive, diagnostic test frequently used among this population and has been frequently used within intellectual disability populations. This will be performed on either a cycle ergometer or treadmill and will be conducted by a qualified cardiac physiologist in the presence of a paediatric cardiologist at RBHSC.

  9 months

Secondary Outcomes (9)

• Physical Activity Levels

  9 months

• Weight Measurements

  9 months

• Height Measurements

  9 months

• Body Mass Index

  9 months

• Waist Circumference

  9 months

Study Arms (2)

Control Group

OTHER

Those randomised to the control trial will be instructed to maintain their normal physical activity behaviours. If a participant is part of the control group, they will not receive the individualised physical activity plan, however their role is still very valuable. Control groups allow us as researchers to see if our 12-week individualised physical activity plan is effective at increasing exercise capacity and physical activity levels among children and adolescents with congenital heart disease. This information will help inform research and information given to families of children and adolescents with congenital heart disease in the future. At the end of the intervention, participants will be emailed the pre-recorded videos led by the fitness instructor demonstrating short games and activities that can be done as a family at home, that are fun and safe for children with congenital heart disease.

Behavioral: Exercise Intervention

Intervention Group

EXPERIMENTAL

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.

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

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.

Also known as: SHAPE

Control Group; Intervention Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with congenital heart disease aged 5-18 years (all diagnoses).
• Children with congenital heart disease aged 5-18 years and an intellectual disability.

You may not qualify if:

• Children or parents/guardians who do not wish to give assent or consent to participate in this study.
• Children with an underlying health condition and or physical disability in addition to congenital heart disease, to minimize the risk of confounding variables.

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Royal Belfast Hospital for Sick Children

Belfast, United Kingdom

Location

Related Publications (14)

• Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78.

  PMID: 22726453 BACKGROUND

• Stuart G, Forsythe L. Exercise prescription in young children with congenital heart disease: time for a change in culture. Open Heart. 2021 Jun;8(1):e001669. doi: 10.1136/openhrt-2021-001669. No abstract available.

  PMID: 34083390 BACKGROUND

• Sparacino PS, Tong EM, Messias DK, Foote D, Chesla CA, Gilliss CL. The dilemmas of parents of adolescents and young adults with congenital heart disease. Heart Lung. 1997 May-Jun;26(3):187-95. doi: 10.1016/s0147-9563(97)90055-8.

  PMID: 9176686 BACKGROUND

• Morrison ML, Sands AJ, McCusker CG, McKeown PP, McMahon M, Gordon J, Grant B, Craig BG, Casey FA. Exercise training improves activity in adolescents with congenital heart disease. Heart. 2013 Aug;99(15):1122-8. doi: 10.1136/heartjnl-2013-303849. Epub 2013 Jun 7.

  PMID: 23749780 BACKGROUND

• Moola F, Faulkner GE, Kirsh JA, Kilburn J. Physical activity and sport participation in youth with congenital heart disease: perceptions of children and parents. Adapt Phys Activ Q. 2008 Jan;25(1):49-70. doi: 10.1123/apaq.25.1.49.

  PMID: 18209244 BACKGROUND

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Matza LS, Swensen AR, Flood EM, Secnik K, Leidy NK. Assessment of health-related quality of life in children: a review of conceptual, methodological, and regulatory issues. Value Health. 2004 Jan-Feb;7(1):79-92. doi: 10.1111/j.1524-4733.2004.71273.x.

  PMID: 14720133 BACKGROUND

• Longmuir PE, Corey M, McCrindle BW. Interactions with Home and Health Environments Discourage Physical Activity: Reports from Children with Complex Congenital Heart Disease and Their Parents. Int J Environ Res Public Health. 2021 May 4;18(9):4903. doi: 10.3390/ijerph18094903.

  PMID: 34064527 BACKGROUND

• Kenzik KM, Tuli SY, Revicki DA, Shenkman EA, Huang IC. Comparison of 4 Pediatric Health-Related Quality-of-Life Instruments: A Study on a Medicaid Population. Med Decis Making. 2014 Jul;34(5):590-602. doi: 10.1177/0272989X14529846. Epub 2014 Apr 16.

  PMID: 24739533 BACKGROUND

• Hinckson EA, Curtis A. Measuring physical activity in children and youth living with intellectual disabilities: a systematic review. Res Dev Disabil. 2013 Jan;34(1):72-86. doi: 10.1016/j.ridd.2012.07.022. Epub 2012 Aug 30.

  PMID: 22940161 BACKGROUND

• Department of Health, 2019. Start active, stay active: a report on physical activity from the four home countries. Chief Medical Officers, London.

  BACKGROUND

• Connolly S, Carlin A, Johnston A, Woods C, Powell C, Belton S, O'Brien W, Saunders J, Duff C, Farmer O, Murphy M. Physical Activity, Sport and Physical Education in Northern Ireland School Children: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Sep 19;17(18):6849. doi: 10.3390/ijerph17186849.

  PMID: 32961784 BACKGROUND

• Callaghan S, Morrison ML, McKeown PP, Tennyson C, Sands AJ, McCrossan B, Grant B, Craig BG, Casey FA. Exercise prescription improves exercise tolerance in young children with CHD: a randomised clinical trial. Open Heart. 2021 May;8(1):e001599. doi: 10.1136/openhrt-2021-001599.

  PMID: 33990433 BACKGROUND

• Blanchard J, McCrindle BW, Longmuir PE. The Impact of Physical Activity Restrictions on Health-Related Fitness in Children with Congenital Heart Disease. Int J Environ Res Public Health. 2022 Apr 7;19(8):4426. doi: 10.3390/ijerph19084426.

  PMID: 35457294 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Professor Casey

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Bell, BSc, MSc and PhD Researcher

CONTACT

+447738412938; bell-n23@ulster.ac.uk

Professor Casey

CONTACT

+44 7791 2810 87; f.casey2@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 25, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)