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HIIT in Youth With Congenital Heart Disease (MedBIKE)

NCT04575883 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-05

No results posted yet for this 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.

Conditions

  • Congenital Heart Disease
  • Pediatric ALL

Interventions

DEVICE

MedBIKE HIIT

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

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Michael Khoury, MD · University of Alberta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575883 on ClinicalTrials.gov