NCT05451979Recruiting
HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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™).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 8 Nov 2021
- Start date
- 22 Feb 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Alberta
- NCT number
- NCT05451979
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 22 Feb 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- History of multiorgan transplant
- History of chest pain on exertion
- 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
Other
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
- Adult unavailable to supervise the home-based exercise sessions
- Primary cardiologist has exercise restricted the participant or counsels against participation
- Resting arterial saturation \<85% or oxygen requirements
- Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- Unrepaired/unpalliated CHD
- Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
Who the study is looking for
- Pediatric heart transplant recipients, at least 6-months post heart transplantation
- Aged 10-18 years
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.