Recruiting

HIIT

Sponsor:

University of Alberta

Code:

NCT05451979

Conditions

Pediatric ALL

Transplant; Failure, Heart

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

MedBIKE HIIT

Study Details

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™).

Conditions

Pediatric ALL

Transplant; Failure, Heart

Study ID

NCT05451979

Start date

Feb 22, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: MedBIKE HIIT

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.

no intervention: Standard of Care

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.

Interventions

MedBIKE HIIT

Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)

Primary outcome measure

  • Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Rae Foshaug

7804077499raef@ualberta.ca

Michael Khoury, MD

7804920103khoury1@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Rae Foshaug

7804077499raef@ualberta.ca

Michael Khoury, MD

7804920103khoury1@ualberta.ca

Principal Investigator:

Michael Khoury, MD

More Information

Sponsor

University of Alberta

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Cardiac rehabilitation
  • High Intensity Interval Training
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-13.