RECRUITINGINTERVENTIONAL

HIIT in Youth With Congenital Heart Disease (MedBIKE)

High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Children and adolescents aged 10-18 years - Repaired moderate-complex congenital heart disease Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

MedBIKE HIIT

Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)

Locations (1)

University of Alberta

Edmonton, Alberta, Canada