Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
NCT05451979

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)

Led by University of Alberta · Updated on 2026-03-13

10

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

W

Women and Children's Health Research Institute, Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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™).

CONDITIONS

Official Title

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric heart transplant recipients at least 6 months post-transplant
  • Aged between 10 and 18 years
Not Eligible

You will not qualify if you...

  • Non-English speaking limiting communication during sessions
  • Home environment unable to accommodate the MedBIKE™ system
  • History of multiorgan transplant
  • No adult available to supervise home exercise sessions
  • Clinical antibody- or cellular-mediated rejection episode within 3 months before baseline
  • Previous participation in cardiac rehabilitation or exercise intervention programs
  • Primary cardiologist restricts exercise or advises against participation
  • Previous exercise stress test showing sustained arrhythmias, significant ST segment changes, abnormal blood pressure response, chest pain, or syncope
  • Resting arterial oxygen saturation below 85% or oxygen requirement
  • Moderate or worse ventricular systolic dysfunction on recent echocardiogram
  • History of chest pain during exercise
  • Unrepaired or unpalliated congenital heart disease
  • Arrhythmias in the past year including serious types
  • New York Heart Association class II or worse symptoms
  • Active medical illness limiting participation
  • Cognitive impairment limiting communication for the program
  • Extracardiac or congenital abnormalities limiting ability to exercise

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

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Research Team

R

Rae Foshaug

CONTACT

M

Michael Khoury, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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