Clinical trial · Interventional
HIIT in Youth With Congenital Heart Disease (MedBIKE)
High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Heart Disease | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MedBIKE HIIT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MedBIKE HIIT
- description
- MedBIKE HIIT Exercise Program
- interventionNames
- Device: MedBIKE HIIT
Primary outcomes (1)
- measure
- Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
- timeFrame
- Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
- description
- 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).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKhoury 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