HIIT in Youth With Congenital Heart Disease (MedBIKE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorUniversity of Alberta
About this trial
Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life.
Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents aged 10-18 years
Repaired moderate-complex congenital heart disease
Disqualifiers
Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
Home environment cannot accommodate the MedBIKE™ system (space limitations)
Previous involvement in a cardiac rehab or exercise intervention program
Primary cardiologist has exercise restricted the participant or counsels against participation
Trial design
Design model
Single group
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
44 Participants
are divided into 1 treatment groupGroup A: MedBIKE HIITExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
CPET (Exercise Stress Test and 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. We will also evaluate changes in VE/VCO2, peak power output (W), and HRmax (maximum heart rate).
Time frame
Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-interventionSecondary outcomes
1
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
Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention2
Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.
Participants will be asked to complete the TNO AZL Children's Quality of Life (TACQOL) questionnaire. This questionnaire is a validated multidimensional instrument to assess the health-related quality of life in youth. The overall score of this questionnaire 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
Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention3
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 is a validated tool designed to assess self-perceptions of adequacy and predilection towards physical activity in youth. 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
Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention4
Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.
Changes in endothelial function will be measured using an EndoPAT 2000. The EndoPAT is an observer-independent assessment that evaluates changes in arterial volume via finger plethysmography by capturing beat-to-beat variations in arterial pulse wave amplitude, thus generating a peripheral arterial tone (PAT) signal. The EndoPAT score will be compared pre- and post-MedBIKE intervention and again at 6 and 12-months post-intervention to evaluate sustained changes.
Time frame
Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
Source ClinicalTrials.gov