Recruiting

HIIT

Sponsor:

University of Alberta

Code:

NCT04575883

Conditions

Congenital Heart Disease

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

MedBIKE HIIT

Study Details

Brief 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

Study ID

NCT04575883

Start date

Nov 22, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MedBIKE HIIT

MedBIKE HIIT Exercise Program

Interventions

MedBIKE HIIT

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

Primary outcome measure

  • Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing [ Time Frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention ]

Central Contacts and Locations

Central contacts

Rae Foshaug

7804077499rae.foshaug@albertahealthservices.ca

Michael Khoury, MD

7804920103khoury1@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Rae Foshaug

7804077499raef@ualberta.ca

Michael Khoury, MD

7804920103khoury1@ualberta.ca

Principal Investigator:

Michael Khoury, MD

More Information

Sponsor

University of Alberta

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Cardiac rehabilitation
  • High Intensity Interval Training
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-02-05.