High-Intensity Interval Training for Pediatric Heart Transplant Recipients

Overseen by Michael 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, Multiorgan transplant, Arrhythmias, others

No Placebo Group

Trial Summary

What is the purpose of 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™).

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 pediatric heart transplant recipients?

High-intensity interval training (HIIT) has been shown to improve exercise capacity and health-related quality of life in adult heart transplant recipients. Although HIIT has not yet been evaluated in pediatric heart transplant recipients, the MedBIKE HIIT program aims to safely improve exercise capacity and quality of life in this group, based on the positive outcomes seen in adults. ^{1 2 3 4 5}

Is high-intensity interval training safe for heart transplant recipients?

High-intensity interval training (HIIT) has been found to be safe for heart transplant recipients, with studies showing a low rate of major adverse events. It has been well tolerated and effective in improving exercise capacity and quality of life in both adult and pediatric heart transplant patients. ^{1 2 5 6 7}

How is the MedBIKE HIIT treatment different from other treatments for pediatric heart transplant recipients?

The MedBIKE HIIT treatment is unique because it combines high-intensity interval training with a video game-linked exercise program that can be done at home using a cycle ergometer, and it includes telemedicine and remote monitoring. This approach is novel for pediatric heart transplant recipients, as it aims to improve exercise capacity, physical activity, and quality of life, which have not been extensively studied in this group before. ^{1 3 7 8 9}

Research Team

Michael Khoury, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for pediatric heart transplant recipients aged 10-18 years, who are at least 6 months post-transplant. It's not for those with multiple organ transplants, non-English speakers, or if their home can't fit the MedBIKE™ system. Kids with exercise restrictions from doctors, recent rejections, serious heart dysfunction, chest pain during exertion, certain arrhythmias or illnesses that limit exercise aren't eligible.

Inclusion Criteria

I am a child who received a heart transplant more than 6 months ago.

I am between 10 and 18 years old.

Exclusion Criteria

My heart's pumping ability is moderately reduced or worse.

I have experienced chest pain when I exert myself.

Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)

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 PedsQL and CSAPPA questionnaires, accelerometer wear, and CPET

1 week

1 visit (in-person)

Treatment

Participants undergo a 12-week home-based HIIT program using the MedBIKE™ system

12 weeks

Telemedicine-based, ongoing monitoring

Post-Intervention Assessment

Participants complete post-intervention assessments including repeat questionnaires, CPET, and accelerometer wear

1-2 weeks

1 visit (in-person)

Follow-up

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

12 months

Coordinated with clinical appointments

Treatment Details

Interventions

• MedBIKE HIIT (Behavioural Intervention)

Trial Overview The study tests a home-based high-intensity interval training (HIIT) program using MedBIKE™—a video game-linked bike—for improving fitness in kids who've had a heart transplant. The goal is to see if this intense but short burst workout method can boost their cardiorespiratory health more than traditional moderate exercises.

Participant Groups

Group I: MedBIKE HIIT Experimental Treatment 1 Intervention

Participants will complete the baseline assessments and begin the MedBIKE HIIT Exercise Program intervention within 2-weeks. After the completion of the 12-week program, participants will return for follow-up assessments which will be repeated at 6- and 12-months post intervention.

Group II: Standard of Care Active Control 1 Intervention

Participants will complete the baseline assessments and continue with standard of care (no intervention) for 12-weeks then return for a repeat assessment. Participants will then crossover into the MedBIKE HIIT Exercise Program intervention group for 12-weeks. A post-intervention assessment will be completed and follow-up assessments at 6- and 12-months post intervention.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Women and Children's Health Research Institute, Canada

Collaborator

Trials

18

Recruited

24,800+

Canadian Donation and Transplantation Research Program

Collaborator

Trials

2

Recruited

40+

Findings from Research

This study aims to evaluate the safety and feasibility of a 12-week high-intensity interval training (HIIT) intervention using a video game-linked cycle ergometer in pediatric heart transplant recipients, addressing a gap in exercise interventions for this population.

The researchers expect that this home-based intervention will lead to sustained improvements in exercise capacity, physical activity, health-related quality of life, and self-efficacy towards physical activity, setting the stage for a larger multicenter trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Telemedicine Video Game-Linked High-Intensity Interval Training Exercise Programme in Paediatric Heart Transplant Recipients. Spence, CM., Foshaug, R., Rowland, S., et al.[2023]

In a study of 81 de novo heart transplant recipients, high-intensity interval training (HIT) over 9 months significantly improved cardiac function, as shown by better global longitudinal strain and increased end-diastolic volume compared to standard care exercise.

HIT also suggested improvements in coronary microcirculation, although this finding was not statistically significant, indicating potential benefits in both structural and functional cardiovascular adaptations early after heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on cardiac remodelling, function and coronary microcirculation in de novo heart transplant patients: a substudy of the HITTS randomised controlled trial. Rafique, M., Solberg, OG., Gullestad, L., et al.[2023]

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]

High-intensity interval training (HIIT) significantly improved exercise capacity in 52 stable heart transplant recipients over one year, increasing their peak oxygen uptake (VO2peak) from 27.7 to 30.9 ml/kg/min, while the control group showed no change.

Despite the improvements in exercise capacity, HIIT did not significantly affect cardiac function (systolic and diastolic) in these patients, suggesting that the benefits of HIIT may be due to adaptations outside the heart rather than direct improvements in cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Rustad, LA., Nytrøen, K., Amundsen, BH., et al.[2014]

Pediatric heart transplant recipients exhibit smaller left ventricular dimensions and volumes compared to matched controls, but they can achieve similar oxygen consumption levels during exercise, indicating a unique adaptation in their cardiovascular response.

Despite having reduced heart rate and cardiac index during exercise, heart transplant recipients compensate by increasing peripheral oxygen extraction, which helps them maintain metabolic responses similar to those of healthy peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Responses to Exercise in Pediatric Heart Transplant Recipients. Bovard, JM., DE Souza, AM., Harris, KC., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating a Telemedicine Video Game-Linked High-Intensity Interval Training Exercise Programme in Paediatric Heart Transplant Recipients. [2023]

2. Denmark pubmed.ncbi.nlm.nih.gov

Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on cardiac remodelling, function and coronary microcirculation in de novo heart transplant patients: a substudy of the HITTS randomised controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of high-intensity training vs moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized-controlled HITTS study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia. [2020]

6. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

7. Brazil pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training on Aerobic Capacity and Heart Rate Control of Heart Transplant Recipients: a Systematic Review with Meta-Analysis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Physiological Responses to Exercise in Pediatric Heart Transplant Recipients. [2019]