HIIT in Youth With Congenital Heart Disease (MedBIKE)

NCT04575883 | Recruiting DMC

• 1 other identifier: Pro00102421
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac rehabilitation; High Intensity Interval Training; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing

  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).

  Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

Secondary Outcomes (4)

• Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention

  Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

• Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.

  Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

• Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.

  Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

• Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.

  Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

Study Arms (1)

MedBIKE HIIT

EXPERIMENTAL

MedBIKE HIIT Exercise Program

Device: MedBIKE HIIT

Interventions

MedBIKE HIIT DEVICE

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

MedBIKE HIIT

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 10-18 years
• Repaired moderate-complex congenital heart disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (1)

• Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27.

  PMID: 32716280 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Khoury, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rae Foshaug

CONTACT

7804077499; rae.foshaug@albertahealthservices.ca

Michael Khoury, MD

CONTACT

7804920103; khoury1@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: October 5, 2020
• Study Start: November 22, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)