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Home-Based Interval Exercise for Children After Heart Transplant

Tests a home video game bike exercise program in children after heart transplant.

Key facts

Who runs it
University of Alberta
Where
Edmonton, CanadaSee the site
Trial code
Registry title
HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
Status
Recruiting
People taking part
10 people, planned
Started
22 Feb 2022
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • MedBIKE HIIT
Record updated
13 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 10-18 years who had a heart transplant at least 6-months ago. It tests a home exercise program on a video game-linked bike.

Age
10-18 years
Sex
Boys and girls can both join.
Disease stage
Heart transplant recipients, at least 6-months after the transplant. Heart failure symptoms of New York Heart Association class II or worse, moderate or worse weakness of the heart pumping, and unrepaired congenital heart disease are not allowed.
Earlier treatment
A heart transplant at least 6-months ago is needed. No earlier cardiac rehabilitation or exercise program, and no multiorgan transplant.

Main reasons for not taking part

  • Rejection of the transplant within the last 3-months
  • Exercise restricted or advised against by the child's heart doctor
  • Heart rhythm problems in the last year, or chest pain on exertion
  • No adult at home to supervise the exercise sessions
  • Does not speak English, or the home has no space for the bike system

This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: Pediatric heart transplant recipients, at least 6-months post heart transplantation

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Pediatric heart transplant recipients, at least 6-months post heart transplantation
  • Aged 10-18 years

Who cannot take part

  • 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
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 18 years old?

Where in Canada

  • University of AlbertaEdmonton, CanadaContact: Rae FoshaugTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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™).

The 2 groups in the trial

  • MedBIKE HIITTreatment being tested

    Participants will complete the baseline assessments and begin the MedBIKE HIIT Exercise Program intervention within 2-weeks. After the completion of the 12-week program, participants will return for follow-up assessments which will be repeated at 6- and 12-months post intervention.

  • Standard of CareNo study treatment, for comparison

    Participants will complete the baseline assessments and continue with standard of care (no intervention) for 12-weeks then return for a repeat assessment. Participants will then crossover into the MedBIKE HIIT Exercise Program intervention group for 12-weeks. A post-intervention assessment will be completed and follow-up assessments at 6- and 12-months post intervention.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)
Plain-language title
Home-Based Interval Exercise for Children After Heart TransplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05451979, who can take part
Record updated
13 March 2026