HIIT in Youth With Congenital Heart Disease (MedBIKE)

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease, Pediatric ALL

In brief

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.

Key facts

Study ID

NCT04575883

Run by

University of Alberta

People needed

44

Starts

2022-11-22

Expected to finish

2026-12-31

Last updated by the study team

2026-02-05

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents aged 10-18 years
• Repaired moderate-complex congenital heart disease

You may not qualify if…

• 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

Where it is running

• University of Alberta — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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