RecruitingNot ApplicableNCT04575883

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


Sponsor

University of Alberta

Enrollment

44 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a home-based high-intensity interval training (HIIT) bike program called MedBIKE for children and teenagers with repaired congenital heart disease. The goal is to see if structured, supervised exercise at home can safely improve fitness and quality of life for young people with heart conditions. **You may be eligible if...** - Your child is 10–18 years old - Your child has had surgery to repair a moderate-to-complex congenital heart defect - Your home can fit the MedBIKE equipment - Your child's heart doctor has not restricted exercise **You may NOT be eligible if...** - Your child does not speak English (needed for communication during sessions) - Your child's heart doctor has advised against exercise - Your child has had concerning results on a prior exercise stress test (arrhythmias, abnormal blood pressure, chest pain, or fainting) - Your child has an oxygen level at rest below 85% or needs supplemental oxygen - Your child has moderate-to-severe ventricular dysfunction - Your child has had a heart rhythm problem in the last year - Your child has an unrepaired heart defect Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedBIKE 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

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NCT04575883


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