High Intensity Interval Training for Congenital Heart Disease

Overseen By Rae Foshaug

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Non-English speaking, Space limitations, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 41

Duration: 12 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based exercise program using the MedBIKE, a video game-linked exercise bike, can enhance fitness and health quality of life for children aged 10-18 with repaired congenital heart disease (CHD). CHD can limit exercise ability, which is associated with health issues later in life. The researchers aim to determine if high-intensity interval training (HIIT) can improve exercise capacity, similar to the benefits of cardiac rehab for adults. Children with repaired moderate to complex CHD who have not participated in similar programs before may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve long-term health outcomes for children with CHD.

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 prior data suggests that this high-intensity interval training program is safe for children with congenital heart disease?

Research has shown that high-intensity interval training (HIIT) is generally safe for individuals with heart conditions, including congenital heart disease (CHD). One study found that HIIT improved exercise capacity and overall quality of life without major safety concerns. Another study demonstrated that using the MedBIKE™ for HIIT in children with CHD was both safe and practical. These findings suggest that the MedBIKE HIIT program is well-tolerated and can safely enhance heart health in young people with repaired CHD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for congenital heart disease that often focus on medication or surgical intervention, the MedBIKE HIIT program introduces a new exercise approach. High-intensity interval training (HIIT) is distinct because it involves short bursts of intense activity followed by rest, which can improve heart function and fitness more efficiently than steady-state exercise. Researchers are excited about this method because it could offer a non-invasive, scalable way to enhance cardiovascular health and quality of life for patients with congenital heart disease, without the need for extensive medical interventions.

What evidence suggests that MedBIKE HIIT is effective for congenital heart disease?

Research has shown that the MedBIKE high-intensity interval training (HIIT) program, which participants in this trial will undergo, could benefit children with congenital heart disease (CHD). A small initial study found promising results, suggesting that the program might enhance exercise capacity and activity levels in these children. This is crucial because children with CHD often have reduced exercise ability, impacting their quality of life. Some studies also anticipate that MedBIKE HIIT will boost self-confidence and improve blood vessel health. These findings offer hope for using HIIT to help young people manage challenges related to CHD. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Khoury, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• MedBIKE HIIT

Trial Overview The 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.

How Is the Trial Designed?

Group I: MedBIKE HIIT Experimental Treatment 1 Intervention

MedBIKE HIIT Exercise Program

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Published Research Related to This Trial

A 12-week home-based resistance training program for children with congenital heart disease (CHD) showed a medium effect on improving muscle oxygen extraction, indicated by a decrease in tissue oxygenation index (TOI) during peak exercise.

The training also resulted in a small increase in exercise tolerance, measured as V˙O2 reserve, suggesting that resistance training can help improve physical performance in children with CHD, although their overall TOI and V˙O2 reserve remained lower than healthy controls.

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]

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]

In a study of 146 adults with congenital heart disease, those who engaged in frequent moderate physical activity (at least twice a week) showed a significant improvement in exercise capacity, measured by an increase in pVO2, compared to those with low or occasional activity levels over a median follow-up of 13.2 months.

Patients who increased their frequency of physical activity were more likely to experience clinically significant improvements in exercise capacity, with 27.3% showing a notable increase in pVO2, compared to only 11% of those who maintained or decreased their activity levels.

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]

The FORCE tool, which classifies patients with congenital heart disease (CHD) based on hemodynamic factors, was successfully implemented in 98% of cases, demonstrating its feasibility for risk stratification in exercise prescriptions.

No adverse events were reported during nearly 1000 exercise training sessions, indicating that the FORCE tool is safe for guiding cardiac rehabilitation in patients under 22 years old.

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]

Children and adolescents with congenital heart disease (CHD) should not be absolutely restricted from physical activity, as active lifestyles are crucial for their health, similar to the general population.

Physicians should provide clear guidance on recommended physical activities and personalized exercise prescriptions, starting early in childhood, to promote long-term physical activity and monitor adherence and responses to exercise.

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]

Youth with congenital heart disease (CHD) often have reduced exercise capacity and lower quality of life, highlighting the need for effective exercise interventions, particularly home-based programs that can be monitored via telemedicine.

A new 12-week randomized crossover trial is being conducted to evaluate the effectiveness of a home-based high-intensity interval training program using a video game-linked cycle ergometer, which may provide better cardiorespiratory benefits compared to traditional moderate-intensity exercises.

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]

This multicentre randomized controlled trial will compare high-intensity interval training (HIIT) and moderate-intensity steady state (MISS) exercise in 510 patients with coronary heart disease (CHD) over 8 weeks, aiming to determine which method is more effective in improving peak oxygen uptake (VO2 peak).

HIIT is expected to provide greater improvements in VO2 peak compared to traditional MISS training, potentially leading to updated exercise guidelines for cardiac rehabilitation in the UK.

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]

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]

Patients with congenital heart disease are at risk for being overweight and having low physical activity, making lifestyle measures crucial for their health.

Exercise testing is primarily used to ensure safety during physical activity, and systematic training programs have been shown to be safe for small groups of these patients, although data on their effects are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04575883

HIIT in Youth With Congenital Heart Disease (MedBIKE) 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.

2. canadianjournalofdiabetes.com canadianjournalofdiabetes.com/article/S1499-2671(23)00273-3/fulltext

HIGH INTENSITY INTERVAL TRAINING IN YOUTH WITH ... CONCLUSION. We anticipate significant and sustained improvements in exercise capacity, PA, self-efficacy, and endothelial function in patients with repaired CHD ...

3. withpower.com withpower.com/trial/phase-heart-diseases-4-2021-7261e

High Intensity Interval Training for Congenital Heart Disease The pilot study with the MedBIKE has shown promising results. ... What data supports the effectiveness of the treatment MedBIKE HIIT for congenital heart disease?

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642108/

Evaluating a Telemedicine Video Game–Linked High-Intensity ... We anticipate that the proposed home-based MedBIKE HIIT programme will be feasible and safely yield sustained improvements in exercise capacity, PA, HRQoL, and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X23016288

Review Exploring the Promise of Telemedicine Exercise ... Youth with congenital heart disease (CHD) have reduced exercise capacity via various physical and psychosocial mechanisms. In addition to limited ...

6. actionlearningnetwork.org actionlearningnetwork.org/publications/cardiac-rehabilitation-with-medbike/

Cardiac Rehabilitation with the MedBIKE™ Researchers assessed the safety and practicality of high-intensity interval training with a novel MedBIKE™ in children with Fontan ...