Home-based high intensity interval training for youth with congenital heart disease
High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
This study is testing if a home workout program using a special bike can help kids and teens with heart problems get stronger and feel better over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04575883 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a home-based high intensity interval training (HIIT) program using a telemedicine-enabled cycle ergometer called MedBIKE™ for children and adolescents aged 10-18 with repaired moderate-complex congenital heart disease (CHD). The study aims to improve exercise capacity, physical activity levels, and overall quality of life by engaging participants in an eight-week HIIT regimen. The trial will assess various outcomes, including exercise capacity, sedentary time, and endothelial function, with follow-up evaluations extending up to one year post-intervention. This approach addresses the limited data on sustained exercise interventions in the pediatric CHD population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 10-18 years who have repaired moderate-complex congenital heart disease.
Not a fit: Patients who may not benefit include those with severe exercise restrictions, unrepaired congenital heart defects, or significant cardiac dysfunction.
Why it matters
Potential benefit: If successful, this program could significantly enhance exercise capacity and quality of life for youth with congenital heart disease.
How similar studies have performed: Previous studies have shown promising results for exercise interventions in pediatric populations, but this specific approach using MedBIKE™ is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and adolescents aged 10-18 years * Repaired moderate-complex congenital heart disease Exclusion Criteria: * Non-English speaking (thus limiting communication during the MedBIKE™ sessions) * Home environment cannot accommodate the MedBIKE™ system (space limitations) * Previous involvement in a cardiac rehab or exercise intervention program * Primary cardiologist has exercise restricted the participant or counsels against participation * 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 * Resting arterial saturation \<85% or oxygen requirements * Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram * History of chest pain on exertion * Unrepaired/unpalliated CHD * 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 * Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Khoury, MD — University of Alberta
- Study coordinator: Rae Foshaug
- Email: rae.foshaug@albertahealthservices.ca
- Phone: 7804077499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.