Only 10 spots left

~10 spots leftby Dec 2025

High Intensity Interval Training for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

Overseen byMichael Khoury, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: Non-English speaking, Space limitations, Others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MedBIKE HIIT for congenital heart disease?

High-intensity interval training (HIIT) has been shown to improve aerobic fitness and cardiovascular function in patients with coronary heart disease, suggesting it could also benefit those with congenital heart disease. Additionally, home-based telemedicine exercise interventions, like MedBIKE HIIT, offer improved access and convenience, which is important for patients who live far from specialized care centers.¹ ² ³ ⁴ ⁵

Is high-intensity interval training (HIIT) safe for people with congenital heart disease?

Research shows that high-intensity interval training (HIIT) is generally safe for people with cardiovascular conditions, including congenital heart disease. A systematic review found a low rate of major adverse events during HIIT sessions, suggesting it can be a safe exercise option when properly supervised.¹ ² ⁶ ⁷ ⁸

How is MedBIKE HIIT different from other treatments for congenital heart disease?

MedBIKE HIIT is unique because it uses high-intensity interval training (short bursts of intense exercise followed by rest) combined with a video game-linked cycle ergometer, making it a fun and engaging home-based exercise option for children with congenital heart disease. This approach is novel as it incorporates telemedicine, allowing real-time monitoring and guidance, which is particularly beneficial for patients who live far from specialized care centers.¹ ² ⁴ ⁹ ¹⁰

Research Team

Michael Khoury, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for children and teens aged 10-18 with repaired moderate-complex congenital heart disease. They must speak English, have space at home for the MedBIKE system, and not be restricted from exercising by their cardiologist. Those with severe symptoms, cognitive impairments affecting communication, or recent serious arrhythmias cannot participate.

Inclusion Criteria

I am between 10 and 18 years old.

I had surgery to fix a moderate to complex heart defect.

Exclusion Criteria

My heart condition limits my physical activity.

Active medical inter-current illness limiting ability to participate

I have difficulty communicating which may affect my participation in the HIIT program.

See 11 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments including TACQOL and CSAPPA questionnaires, EndoPAT testing, and CPET testing

1 week

1 visit (in-person)

Treatment

Participants undergo a 12-week, home-based HIIT program using the MedBIKE, with 3 sessions per week

12 weeks

36 sessions (home-based)

Post-Intervention Assessment

Follow-up assessment including questionnaires, EndoPAT, CPET, and accelerometer wear

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for sustained changes in exercise capacity and secondary outcomes at 6 and 12 months post-intervention

12 months

2 visits (in-person)

Treatment Details

Interventions

MedBIKE HIIT (Behavioural Intervention)

Trial OverviewThe study tests a home-based high-intensity interval training (HIIT) program using a telemedicine-equipped video game-linked cycle ergometer called MedBIKE™. It aims to improve exercise capacity in youth with congenital heart disease through this novel cardiac rehabilitation approach.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MedBIKE HIITExperimental Treatment1 Intervention

MedBIKE HIIT Exercise Program

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

University of AlbertaEdmonton, Canada

Loading ...

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Patients Recruited

437,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Patients Recruited

72,600+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease.Spence, C., Khoo, N., Mackie, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation.McGregor, G., Nichols, S., Hamborg, T., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs.Gauthier, N., Reynolds, L., Curran, T., et al.[2023]

High-intensity interval training (HIIT) is a promising alternative to continuous aerobic exercise training (CAET) for patients with coronary heart disease (CHD), showing benefits in aerobic fitness, cardiovascular function, and quality of life.

Short interval HIIT is particularly effective for patients with lower aerobic fitness, while medium and long interval HIIT is better suited for those with higher fitness levels, allowing for tailored rehabilitation programs based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in patients with coronary heart disease: Prescription models and perspectives.Ribeiro, PAB., Boidin, M., Juneau, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Promotion in Pediatric Congenital Heart Disease: Are We Running Late?Caterini, JE., Campisi, ES., Cifra, B.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and training in adults with congenital heart disease.Thaulow, E., Fredriksen, PM.[2007]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity is associated with improved aerobic exercise capacity over time in adults with congenital heart disease.Tikkanen, AU., Opotowsky, AR., Bhatt, AB., et al.[2021]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review.Wewege, MA., Ahn, D., Yu, J., et al.[2021]

Exercise training significantly improves exercise capacity, motor skills, muscular function, and quality of life in children and adolescents with congenital heart disease (CHD), based on a review of 3256 patients across various study types.

While sports and exercise training is effective and safe for CHD patients, there is a need for specialized rehabilitation programs, especially for those with complex CHD, as current training programs are not widely reimbursed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sports, Exercise Training, and Physical Activity in Children with Congenital Heart Disease-A Review of the Published Evidence.Dold, SK., Haas, NA., Apitz, C.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 12-Week Home-based Resistance Training on Peripheral Muscle Oxygenation in Children With Congenital Heart Disease: A CHAMPS Study.Lahti, DS., Pockett, C., Boyes, NG., et al.[2023]