MedBIKE HIIT for ALL, Pediatric

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta, Edmonton, Canada
ALL, Pediatric+1 More
MedBIKE HIIT - Device
Eligibility
< 65
All Sexes
What conditions do you have?
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Study 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™).

Eligible Conditions

  • ALL, Pediatric
  • Transplant; Failure, Heart

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for ALL, Pediatric

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 13 months

12 weeks
Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients.
13 months
Changes in cardiac specific health-related quality of life will be measured using the PedsQL Cardiac Module questionnaire.
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
Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.
Exercise capacity through the change in VO2peak (mL/kg/min) measured using CPET testing.

Trial Safety

Safety Progress

1 of 3

Other trials for ALL, Pediatric

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
MedBIKE HIIT
1 of 2
Active Control
Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: MedBIKE HIIT · No Placebo Group · N/A

MedBIKE HIIT
Device
Experimental Group · 1 Intervention: MedBIKE HIIT · Intervention Types: Device
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 13 months

Trial Background

Prof. Michael Khoury, Assistant Professor, Faculty of Medicine & Dentistry, Department of Pediatrics
Principal Investigator
University of Alberta
Closest Location: University of Alberta · Edmonton, Canada
Photo of university of alberta hospital  1Photo of university of alberta hospital  2Photo of university of alberta hospital  3
2006First Recorded Clinical Trial
3 TrialsResearching ALL, Pediatric
298 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a pediatric heart transplant recipient, at least 6-months post heart transplantation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.