Congenital Heart Disease Clinical Trial
Official title:
High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life. Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - Children and adolescents aged 10-18 years - Repaired moderate-complex congenital heart disease Exclusion Criteria: - Non-English speaking (thus limiting communication during the MedBIKE™ sessions) - Home environment cannot accommodate the MedBIKE™ system (space limitations) - Previous involvement in a cardiac rehab or exercise intervention program - Primary cardiologist has exercise restricted the participant or counsels against participation - Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope - Resting arterial saturation <85% or oxygen requirements - Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram - History of chest pain on exertion - Unrepaired/unpalliated CHD - Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse)) - New York Heart Association class II or worse symptoms - Active medical inter-current illness limiting ability to participate - Cognitive impairment limiting the communication needed for the HIIT program - Extracardiac or congenital abnormality limiting the participant's functional ability to exercise |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Heart and Stroke Foundation of Canada |
Canada,
Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing | CPET (Exercise Stress Test and Spirometry) will be done to measure the VO2peak (mL/kg/min) output of participants. A comparison will be done pre- and post-MedBIKE intervention, as well as 6 and 12-months post, to determine the change in overall VO2peak of participants. We will also evaluate changes in VE/VCO2, peak power output (W), and HRmax (maximum heart rate). | Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention | |
Secondary | Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention | Participants will be provided with an accelerometer to wear for 7-days prior to the start of the MedBIKE intervention program and again for 7-days post intervention and again at 6 and 12-months post intervention. The accelerometer will measure the time spent in moderate to vigorous physical activity (MVPA) and the sedentary time. A comparison will be done pre- and post-MedBIKE intervention to determine changes in the physical activity levels. The 6-month and 12-month time points will be used for a comparison on the sustained changes of the intervention. | Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention | |
Secondary | Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire. | Participants will be asked to complete the TNO AZL Children's Quality of Life (TACQOL) questionnaire. This questionnaire is a validated multidimensional instrument to assess the health-related quality of life in youth. The overall score of this questionnaire will be compared pre- and post-MedBIKE intervention to determine changes in health-related quality of life. The 6-month and 12-month time points will be used for a comparison on the sustained changes of the intervention. | Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention | |
Secondary | Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale. | Participants will be asked to complete the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale. This questionnaire is a validated tool designed to assess self-perceptions of adequacy and predilection towards physical activity in youth. The overall score of this questionnaire will be compared pre- and post-MedBIKE intervention and again at 6 and 12-months post-intervention to evaluate sustained changes. | Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention | |
Secondary | Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument. | Changes in endothelial function will be measured using an EndoPAT 2000. The EndoPAT is an observer-independent assessment that evaluates changes in arterial volume via finger plethysmography by capturing beat-to-beat variations in arterial pulse wave amplitude, thus generating a peripheral arterial tone (PAT) signal. The EndoPAT score will be compared pre- and post-MedBIKE intervention and again at 6 and 12-months post-intervention to evaluate sustained changes. | Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention |
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