HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorUniversity of Alberta
About this trial
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™).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric heart transplant recipients, at least 6-months post heart transplantation
Aged 10-18 years
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
MedBIKE HIIT
DeviceParticipants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: MedBIKE HIITExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
1
Exercise capacity through the change in VO2peak (mL/kg/min) measured using CPET testing.
CPET (Exercise Stress Test with Spirometry) will be done to measure the VO2peak (mL/kg/min) output of participants. A comparison will be done pre- and post-MedBIKE intervention, as well as 6 and 12-months post, to determine the change in overall VO2peak of participants.
Time frame
13 months2
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
Participants will be provided with an accelerometer to wear for 7-days prior to the start of the MedBIKE intervention program and again for 7-days post intervention and again at 6 and 12-months post intervention. The accelerometer will measure the time spent in moderate to vigorous physical activity (MVPA) and the sedentary time. A comparison will be done pre- and post-MedBIKE intervention to determine changes in the physical activity levels. The 6-month and 12-month time points will be used for a comparison on the sustained changes of the intervention.
Time frame
13 months3
Changes in cardiac specific health-related quality of life will be measured using the PedsQL Cardiac Module questionnaire.
Participants will be asked to complete the PedsQL Cardiac Module questionnaire. This questionnaire is a validated multidimensional instrument to assess cardiac specific health-related quality of life in youth. This questionnaire is scored on a scale of 0-100, where a higher score indicates a better quality of life. These scores will be compared pre- and post-MedBIKE intervention to determine changes in health-related quality of life. The 6-month and 12-month time points will be used for a comparison on the sustained changes of the intervention.
Time frame
13 months4
Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.
Participants will be asked to complete the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale. This questionnaire consists of 19 questions and is a validated tool designed to assess self-perceptions of adequacy and predilection towards physical activity in youth on a scale of low, moderate and high in terms of attitudes towards physical activity. The overall score of this questionnaire will be compared pre- and post-MedBIKE intervention and again at 6 and 12-months post-intervention to evaluate sustained changes.
Time frame
13 monthsSponsors and contacts
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University of Alberta
Lead sponsor
Women and Children's Health Research Institute, Canada
Collaborator
Canadian Donation and Transplantation Research Program
Collaborator
Source ClinicalTrials.gov