Home-based high intensity interval training for youth with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.