NCT04575883Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 28 Aug 2020
- Start date
- 22 Nov 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- University of Alberta
- NCT number
- NCT04575883
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 22 Nov 2022 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- Children and adolescents aged 10-18 years
- Repaired moderate-complex congenital heart disease
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.