HIIT in Youth With Congenital Heart Disease (MedBIKE)
Condition(s) studied
Investigational drug(s) / intervention(s)
MedBIKE HIIT: Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)
Study summary
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.
Eligibility
Primary outcome measure(s)
- Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing — Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Recruiting |
More University of Alberta trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04575883 on ClinicalTrials.gov ↗ ← All trials in Canada