High-Intensity Interval Training for Pediatric Heart Transplant Recipients

Overseen By Michael Khoury, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Non-English speaking, Multiorgan transplant, Arrhythmias, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program called MedBIKE HIIT (High-Intensity Interval Training) to determine if it can improve fitness and overall health in children who have had heart transplants. The program includes short bursts of intense exercise using a special bike connected to video games, making workouts more engaging. The goal is to assess whether this exercise type can enhance heart and lung fitness more effectively than traditional methods. Children aged 10-18, who are at least 6 months post-heart transplant and have no recent major heart issues, may be suitable for this study.

As an unphased trial, this study provides a unique opportunity to explore innovative exercise methods that could enhance children's health and fitness in an enjoyable and engaging manner.

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 is safe for pediatric heart transplant recipients?

Research has shown that high-intensity interval training (HIIT) could enhance exercise ability in heart transplant recipients. Although researchers have not specifically tested this exercise in children with heart transplants, studies in adults indicate that HIIT can boost fitness levels without major safety concerns. The MedBIKE HIIT program, a new method, uses an exercise bike connected to a video game for home workouts. It aims to help children with heart transplants safely improve their fitness and quality of life. Current evidence suggests that HIIT is generally safe, but more research is needed to confirm this for children with heart transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MedBIKE HIIT program because it offers a fresh approach to improving the health of pediatric heart transplant recipients. Unlike the standard of care, which typically involves general physical activity guidance without a structured exercise regimen, MedBIKE HIIT provides a high-intensity interval training approach specifically tailored for these patients. This program is unique because it combines bursts of intense exercise with periods of rest, potentially boosting cardiovascular fitness and overall health more effectively than traditional methods. Additionally, it aims to make exercise more engaging and feasible for young patients, which could lead to better adherence and long-term health benefits.

What evidence suggests that MedBIKE HIIT is effective for improving exercise capacity in pediatric heart transplant recipients?

Research shows that high-intensity interval training (HIIT) can enhance exercise ability in adults who have undergone heart transplants. Studies have found that HIIT significantly boosts heart and lung fitness, crucial for maintaining health post-transplant. One study found that participants engaging in HIIT showed greater improvements in peak oxygen use, a key fitness measure, compared to those doing other exercises. Although data on children with heart transplants is limited, these results suggest HIIT could benefit them as well. In this trial, participants will either continue with their standard care or engage in the MedBIKE HIIT program, which combines exercise with a fun video game to safely improve exercise ability and quality of life for young patients. ^{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 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.

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)

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 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

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 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.

How Is the Trial Designed?

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+

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+

Published Research Related to This Trial

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]

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 (HIT) significantly improved VO2peak in heart transplant patients initially, but this benefit decreased over the following 4 years, indicating that ongoing HIT may be necessary to maintain fitness gains.

Patients who participated in HIT reported significantly lower anxiety symptoms compared to those receiving usual care, suggesting that HIT may also help improve mental health after heart transplantation.

NCBI (Pubmed)

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. Yardley, M., Gullestad, L., Bendz, B., et al.[2022]

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]

A 3-year follow-up of the HITTS study showed that high-intensity interval training (HIT) led to significant improvements in peak oxygen consumption (VO2peak) in heart transplant recipients during the first year, but these benefits did not significantly differ from moderate training after 2 years.

Despite the lack of difference in VO2peak at 2 years, the HIT group maintained better anaerobic threshold and muscle endurance, suggesting that early HIT can have lasting positive effects on certain physical capabilities post-transplant.

NCBI (Pubmed)

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. Rolid, K., Andreassen, AK., Yardley, M., et al.[2023]

High-intensity interval training (HIT) is safe and well-tolerated for patients who have recently undergone heart transplantation, with no serious exercise-related adverse events reported in a study of 81 patients.

HIT led to clinically meaningful improvements in exercise capacity, with a 1.8 mL·kg-1·min-1 increase in peak oxygen consumption (Vo2peak) compared to moderate-intensity continuous training, indicating that HIT is more effective in enhancing aerobic fitness in the early post-transplant period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia. Nytrøen, K., Rolid, K., Andreassen, AK., et al.[2020]

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]

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]

High-intensity interval training (HIIT) significantly improves exercise capacity in heart transplant recipients, as evidenced by increased peak oxygen consumption (peakVO2) and peak heart rate compared to moderate-intensity continuous training (MICT).

HIIT also shows better outcomes than no exercise training, indicating that it is a safe and effective exercise regimen for enhancing cardiovascular fitness in heart transplant patients.

NCBI (Pubmed)

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. Conceição, LSR., Gois, CO., Fernandes, RES., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05451979

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™) | ... Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are ...

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

Evaluating a Telemedicine Video Game–Linked High-Intensity ... Paediatric heart transplant recipients (HTRs) have reduced exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and self-efficacy ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05451979/hiit-in-pediatric-heart-transplant-recipients-medbiketm?page=6&country=Canada&city=Edmonton

HIIT in Pediatric Heart Transplant Recipients (MedBIKE™) With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This ...

4. withpower.com withpower.com/trial/phase-transplant-failure-heart-1-2022-29a0f?lat=34.60184&lng=-117.81218

High-Intensity Interval Training for Pediatric Heart Transplant ... Although HIIT has not yet been evaluated in pediatric heart transplant recipients, the MedBIKE HIIT program aims to safely improve exercise capacity and quality ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7271535/

Effect of high-intensity interval training in young heart ... The high-intensity interval training group had a significantly higher improvement in peak oxygen consumption at 1-year follow-up compared to the ...

6. researchgate.net researchgate.net/publication/369952693_Evaluating_a_Telemedicine_Video_Game-Linked_High-Intensity_Interval_Training_Exercise_Program_in_Pediatric_Heart_Transplant_Recipients

(PDF) Evaluating a Telemedicine Video Game-Linked High ... Paediatric heart transplant recipients (HTRs) have reduced exercise capacity, physical activity (PA), health-related quality of life (HRQoL), ...