Actively Recruiting
HIIT in Youth With Congenital Heart Disease (MedBIKE)
Led by University of Alberta · Updated on 2026-02-05
44
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HIIT in Youth With Congenital Heart Disease (MedBIKE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 10 to 18 years
- Diagnosed with repaired moderate to complex congenital heart disease
You will not qualify if you...
- Non-English speaking limiting communication during MedBIKE sessions
- Home environment cannot accommodate the MedBIKE system due to space
- Previous participation in cardiac rehabilitation or exercise intervention programs
- Exercise restricted or counseled against by primary cardiologist
- History of exercise stress test showing sustained arrhythmias or significant blood pressure abnormalities
- Resting arterial oxygen saturation below 85% or requiring oxygen
- Moderate or worse ventricular systolic dysfunction on recent echocardiogram
- History of chest pain on exertion
- Unrepaired or unpalliated congenital heart disease
- Arrhythmias in the past year including serious types
- New York Heart Association class II or worse symptoms
- Active medical illness limiting participation
- Cognitive impairment limiting communication for HIIT program
- Other extracardiac or congenital abnormalities limiting ability to exercise
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
Research Team
R
Rae Foshaug
CONTACT
M
Michael Khoury, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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