High intensity interval training for pediatric heart transplant recipients
High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)
This study is testing a 12-week home workout program to see if it can help kids who have had a heart transplant get stronger and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05451979 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a 12-week home-based high intensity interval training program, MedBIKE™, for pediatric heart transplant recipients. The program will focus on improving exercise capacity, physical activity levels, self-efficacy towards physical activity, and health-related quality of life. The researchers will assess participant enrollment, session compliance, and dropout rates, while monitoring for any adverse events related to the intervention. This is particularly important as there is a significant lack of literature on exercise interventions in this population.
Who should consider this trial
Good fit: Ideal candidates are pediatric heart transplant recipients aged 10-18 years who are at least 6 months post-transplant.
Not a fit: Patients who may not benefit include those with recent rejection episodes, significant exercise restrictions, or unsuitable home environments for the MedBIKE™ system.
Why it matters
Potential benefit: If successful, this program could enhance the physical fitness and overall quality of life for pediatric heart transplant recipients.
How similar studies have performed: While exercise interventions have shown promise in adult heart transplant recipients, this specific approach using HIIT in pediatric patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric heart transplant recipients, at least 6-months post heart transplantation * Aged 10-18 years Exclusion Criteria: * Non-English speaking (thus limiting communication during the MedBIKE™ sessions) * Home environment cannot accommodate the MedBIKE™ system (for example, space limitations) * History of multiorgan transplant * Adult unavailable to supervise the home-based exercise sessions * Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment * Previous involvement in a cardiac rehabilitation 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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Khoury, MD — University of Alberta
- Study coordinator: Rae Foshaug
- Email: raef@ualberta.ca
- Phone: 7804077499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.