HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)

NCT05451979 | Recruiting DMC

• 1 other identifier: Pro00109855
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Transplant; Failure, Heart; Pediatric ALL

Keywords

Cardiac rehabilitation; High Intensity Interval Training; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients.

  Pediatric heart transplant participants will be provided with a MedBIKE™ system to complete a video game linked 12-week high intensity interval training program equipped with telemedicine capabilities. Feasibility will be defined as adequate recruitment of eligible participants (greater than 60 percent), high session compliance (greater than 80 percent), low drop-out rate (less than 10 percent) and safety in terms of no severe adverse events related to the intervention.

  12 weeks

Secondary Outcomes (4)

• Exercise capacity through the change in VO2peak (mL/kg/min) measured using CPET testing.

  13 months

• Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention

  13 months

• Changes in cardiac specific health-related quality of life will be measured using the PedsQL Cardiac Module questionnaire.

  13 months

• Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.

  13 months

Study Arms (2)

MedBIKE HIIT

EXPERIMENTAL

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.

Device: MedBIKE HIIT

Standard of Care

NO INTERVENTION

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 DEVICE

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

MedBIKE HIIT

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Donation and Transplantation Research Program: collaborator
• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (2)

• Khoury M, Phillips DB, Wood PW, Mott WR, Stickland MK, Boulanger P, Rempel GR, Conway J, Mackie AS, Khoo NS. Cardiac rehabilitation in the paediatric Fontan population: development of a home-based high-intensity interval training programme. Cardiol Young. 2020 Oct;30(10):1409-1416. doi: 10.1017/S1047951120002097. Epub 2020 Jul 27.

  PMID: 32716280 RESULT

• Nytroen K, Rolid K. A Review of High-Intensity Interval Training in Heart Transplant Recipients: Current Knowledge and Future Perspectives. J Cardiopulm Rehabil Prev. 2024 May 1;44(3):150-156. doi: 10.1097/HCR.0000000000000847. Epub 2024 Mar 15.

  PMID: 38488139 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Khoury, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rae Foshaug

CONTACT

7804077499; raef@ualberta.ca

Michael Khoury, MD

CONTACT

7804920103; khoury1@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover study design.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: July 11, 2022
• Study Start: February 22, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)