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Search / Trial NCT05451979

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)

Launched by UNIVERSITY OF ALBERTA · Jul 6, 2022

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

Cardiac Rehabilitation High Intensity Interval Training Telemedicine

ClinConnect Summary

This clinical trial, called MedBIKE™, is exploring a new exercise program for children who have received a heart transplant. The focus is on using a special video game-connected exercise bike to help these kids improve their fitness and overall health. Since many pediatric heart transplant recipients struggle with physical activity and may not be as fit as their peers, this trial aims to see if a home-based high-intensity interval training (HIIT) program can help them become more active and feel better after their transplant.

To participate, children need to be between 10 and 18 years old and at least six months post-heart transplant. However, there are some important criteria that may prevent participation, such as needing a caregiver at home to supervise the exercise, or having recent heart complications. If eligible, participants can expect to engage in fun, intense exercise sessions from the comfort of their home, which could lead to improved fitness levels and better long-term health outcomes.

Gender

ALL

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

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Edmonton, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Michael Khoury, MD

Principal Investigator

University of Alberta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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