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Recruiting Not applicable

HIIT in Youth With Congenital Heart Disease (MedBIKE)

NCT04575883 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-11-22
Last updated
2026-02-05

Condition(s) studied

Congenital Heart DiseasePediatric ALL

Investigational drug(s) / intervention(s)

MedBIKE HIIT

MedBIKE HIIT: Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)

Study 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

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing — Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
    CPET (Exercise Stress Test and Spirometry) will be done to measure the VO2peak (mL/kg/min) output of participants. A comparison will be done pre- and post-MedBIKE intervention, as well as 6 and 12-months post, to determine the change in overall VO2peak of participants. We will also evaluate changes in VE/VCO2, peak power output (W), and HRmax (maximum heart rate).

Trial sites (1)

FacilityCityRegionStatus
University of Alberta Edmonton Alberta Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04575883 on ClinicalTrials.gov ↗ ← All trials in Canada