Congenital Heart DiseaseNCT04575883
HIIT in Youth With Congenital Heart Disease (MedBIKE)
A study testing MedBIKE HIIT in people with Congenital Heart Disease and Pediatric ALL, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Pediatric ALL
- What is being tested?
- MedBIKE HIIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 10-18 years
- Repaired moderate-complex congenital heart disease
Who cannot join
- 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
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2B7
Rae Foshaug, 7804077499, raef@ualberta.ca
Michael Khoury, MD, 7804920103, khoury1@ualberta.ca
About this study
Official title: High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
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.
Read the detailed description
Purpose: This project is a prospective clinical trial of a home-based high intensity interval training (HIIT) exercise program using a novel telemedicine-enabled and video game-linked customizable cycle ergometer (MedBIKE™) in the pediatric congenital heart disease (CHD) population.
Hypothesis: The home-based the MedBIKE™ HIIT program will significantly improve exercise capacity. The MedBIKE intervention will significantly improve time spent in MVPA and reduce sedentary time, improve HRQoL and self-efficacy towards PA, and improve endothelial function. Moreover, the investigators hypothesize that the improvements in exercise capacity, along with the improvements in the secondary outcomes will remain significantly improved up to one-year post- MedBIKE intervention, when compared to pre-intervention values.
Justification: Exercise intervention studies in the pediatric CHD population have been limited by small sample sizes and there is limited data pertaining to the sustained effects of exercise interventions on exercise capacity, physical activity, endothelial function, and quality of life. This study, using standardized and largely operator-independent measure, will be one of the largest exercise intervention clinical trials in the pediatric CHD population.
Primary Objective: Evaluate the impact of an eight-week, home-based HIIT MedBIKE™ program on exercise capacity in youth with repaired moderate-complex CHD.
Secondary Objectives: Evaluate the impact of the MedBIKE™ intervention on 1) PA; 2) HRQoL and self-efficacy towards PA; 3) endothelial function; and 4) sustained changes in the primary and secondary outcomes.
Research Method: This will be a single-center, prospective clinical trial. Potential participants and families will be approached first by a clinical team member. In addition, flyers with key study information will be placed in waiting rooms of the pediatric cardiology clinics. Participants and parents expressing interest will meet with a research coordinator who, along with one of the investigators and the clinical team will screen for eligibility. Written consent and assent (if applicable) will be obtained from participants who are deemed eligible.
Following recruitment, participants will be administered the TACQOL and CSAPPA questionnaires and an accelerometer to be worn for 7-days, after which participants will arrive for the baseline assessment. As participants must be NPO for EndoPAT testing, they will have a small meal following EndoPAT testing and at least two hours prior to CPET testing. A MedBIKE will be installed in the participants home within 2-weeks of the baseline CPET at which time an orientation session will occur to review the manual, safety procedures and the telemedicine component. Participation will consist of a 12-week, 3-times per week (36 sessions in total) HIIT program. All sessions will be supervised by an exercise physiologist. Protocol completion will be considered a minimum of 27 of the 36 sessions (75%). Following the completion of the intervention, the MedBIKE will be removed by the participants home and returned to the Stollery Children's Hospital.
A follow-up assessment, identical to that of the baseline (questionnaires, EndoPAT, CPET, interviews and a 7-day week wear of an accelerometer) will occur 3-14 days post-intervention. These assessments will be repeated at 6- and 12-months post-intervention.
- Conditions
- Congenital Heart Disease, Pediatric ALL
- Being tested
- MedBIKE HIIT
- Keywords
- Cardiac rehabilitation, High Intensity Interval Training, Telemedicine
- Medical subject headings
- Heart Defects, Congenital, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedBIKE HIITDevice
Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)
| Study group | Role | What they receive |
|---|---|---|
| MedBIKE HIIT | Experimental | MedBIKE HIIT Exercise Program Receives: Device: MedBIKE HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Secondary outcomes (4)
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.
Measured: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
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.
Measured: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-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.
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.
Measured: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
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.
Measured: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start22 Nov 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Michael Khoury, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575883
- Sponsor's protocol ID
- Pro00102421
- Status last verified
- Feb 2026
- First submitted
- 28 Aug 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. All data will be de-identified prior to analysis and published.
Publications
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.
PubMed 32716280
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
- ClinicalTrials.gov ID
- NCT04575883
- Acronym / sponsor ID
- Pro00102421
- Conditions
- Congenital Heart Disease, Pediatric ALL
- Keywords
- Cardiac rehabilitation, High Intensity Interval Training, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: This project is a prospective clinical trial of a home-based high intensity interval training (HIIT) exercise program using a novel telemedicine-enabled and video game-linked customizable cycle ergometer (MedBIKE™) in the pediatric congenital heart disease (CHD) population.
Hypothesis: The home-based the MedBIKE™ HIIT program will significantly improve exercise capacity. The MedBIKE intervention will significantly improve time spent in MVPA and reduce sedentary time, improve HRQoL and self-efficacy towards PA, and improve endothelial function. Moreover, the investigators hypothesize that the improvements in exercise capacity, along with the improvements in the secondary outcomes will remain significantly improved up to one-year post- MedBIKE intervention, when compared to pre-intervention values.
Justification: Exercise intervention studies in the pediatric CHD population have been limited by small sample sizes and there is limited data pertaining to the sustained effects of exercise interventions on exercise capacity, physical activity, endothelial function, and quality of life. This study, using standardized and largely operator-independent measure, will be one of the largest exercise intervention clinical trials in the pediatric CHD population.
Primary Objective: Evaluate the impact of an eight-week, home-based HIIT MedBIKE™ program on exercise capacity in youth with repaired moderate-complex CHD.
Secondary Objectives: Evaluate the impact of the MedBIKE™ intervention on 1) PA; 2) HRQoL and self-efficacy towards PA; 3) endothelial function; and 4) sustained changes in the primary and secondary outcomes.
Research Method: This will be a single-center, prospective clinical trial. Potential participants and families will be approached first by a clinical team member. In addition, flyers with key study information will be placed in waiting rooms of the pediatric cardiology clinics. Participants and parents expressing interest will meet with a research coordinator who, along with one of the investigators and the clinical team will screen for eligibility. Written consent and assent (if applicable) will be obtained from participants who are deemed eligible.
Following recruitment, participants will be administered the TACQOL and CSAPPA questionnaires and an accelerometer to be worn for 7-days, after which participants will arrive for the baseline assessment. As participants must be NPO for EndoPAT testing, they will have a small meal following EndoPAT testing and at least two hours prior to CPET testing. A MedBIKE will be installed in the participants home within 2-weeks of the baseline CPET at which time an orientation session will occur to review the manual, safety procedures and the telemedicine component. Participation will consist of a 12-week, 3-times per week (36 sessions in total) HIIT program. All sessions will be supervised by an exercise physiologist. Protocol completion will be considered a minimum of 27 of the 36 sessions (75%). Following the completion of the intervention, the MedBIKE will be removed by the participants home and returned to the Stollery Children's Hospital.
A follow-up assessment, identical to that of the baseline (questionnaires, EndoPAT, CPET, interviews and a 7-day week wear of an accelerometer) will occur 3-14 days post-intervention. These assessments will be repeated at 6- and 12-months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedBIKE HIIT | Experimental | Device: MedBIKE HIITMedBIKE HIIT Exercise Program |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and adolescents aged 10-18 years
- Repaired moderate-complex congenital heart disease
Key exclusion criteria (14 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedBIKE HIITParticipants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total) | Device | MedBIKE HIIT |
Primary outcome
Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
Time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
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).
4 secondary outcomes
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
Time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.
Time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-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.
Time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.
Time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 32716280Khoury 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. All data will be de-identified prior to analysis and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Khoury, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedBIKE HIIT in people with Congenital Heart Disease and Pediatric ALL, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rae Foshaug (7804077499, rae.foshaug@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing (time frame: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.