NCT05451979 HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
| NCT ID | NCT05451979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Pediatric ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-02-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2022-02-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels. Pediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population. Most exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).
Eligibility 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
Contact & Investigator
Michael Khoury, MD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05451979 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Pediatric ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05451979 currently recruiting?
Yes, NCT05451979 is actively recruiting participants. Contact the research team at raef@ualberta.ca for enrollment information.
Where is the NCT05451979 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05451979 clinical trial?
NCT05451979 is sponsored by University of Alberta. The principal investigator is Michael Khoury, MD at University of Alberta. The trial plans to enroll 10 participants.