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HIIT in Youth With Congenital Heart Disease (MedBIKE)

Key facts

Where
Edmonton, CanadaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 18 years old?

Source: NCT04575883, who can take part

Where in Canada

  • University of AlbertaEdmonton, CanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Alberta
Trial code
NCT04575883
Record updated
5 February 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Children and adolescents aged 10-18 years; Repaired moderate-complex congenital heart disease.

Exclusion: Previous involvement in a cardiac rehab or exercise intervention program; 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; History of chest pain on exertion; 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; Non-English speaking (thus limiting communication during the MedBIKE™ sessions); Home environment cannot accommodate the MedBIKE™ system (space limitations); Primary cardiologist has exercise restricted the participant or counsels against participation; Resting arterial saturation <85% or oxygen requirements; Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram; Unrepaired/unpalliated CHD; Extracardiac or congenital abnormality limiting the participant's functional ability to exercise.

ClinicalTrials.gov NCT04575883