High intensity interval training for pediatric heart transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of a 12-week home-based high intensity interval training program, MedBIKE™, for pediatric heart transplant recipients. The program will focus on improving exercise capacity, physical activity levels, self-efficacy towards physical activity, and health-related quality of life. The researchers will assess participant enrollment, session compliance, and dropout rates, while monitoring for any adverse events related to the intervention. This is particularly important as there is a significant lack of literature on exercise interventions in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pediatric heart transplant recipients, at least 6-months post heart transplantation
* Aged 10-18 years

Exclusion Criteria:

* Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
* Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
* History of multiorgan transplant
* Adult unavailable to supervise the home-based exercise sessions
* Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment
* Previous involvement in a cardiac rehabilitation 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
* 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

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Michael Khoury, MD — University of Alberta
• Study coordinator: Rae Foshaug
• Email: raef@ualberta.ca
• Phone: 7804077499

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transplanting abdominal wall tissue to repair defects

  This study is testing if transplanting abdominal wall tissue can safely fix defects in the abdominal area for people who need it.

  Recruiting Duke University · Durham, North Carolina · NCT03310905

• XVIVO Heart Box non-ischemic preservation for transporting donor hearts.

  This program tests whether the XVIVO non-ischemic heart preservation system can safely preserve extended-criteria donor hearts for adults waiting for a heart transplant.

  Recruiting at 14 sites XVIVO Perfusion · La Jolla, California and 13 other locations · NCT06895070

• How cardiopulmonary exercise affects AlloSure donor-derived cell-free DNA in heart transplant recipients

  This will test whether exercise changes donor-derived cell-free DNA measured by AlloSure in people who have had heart transplants.

  Recruiting Baylor Research Institute · Dallas, Texas · NCT04656080

• Using hearts from donors with active hepatitis C (HCV NAT+) for transplantation

  This tests whether receiving a heart from a donor with active hepatitis C (HCV NAT+) is safe and leads to acceptable outcomes for people having a heart transplant.

  Recruiting Baylor Research Institute · Dallas, Texas · NCT04493385

• Nature-based program feasibility in preschools near public housing

  This feasibility study tests whether a nature-based program in preschools near public housing can be run smoothly and whether families will participate and benefit.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Frederiksberg · NCT07780123

• Comparing two ultrasound methods for femoral artery access in children

  This trial tests whether a modified ultrasound technique helps anesthesia residents place femoral arterial lines faster and with fewer attempts in infants and children having heart surgery.

  Recruiting American University of Beirut Medical Center · Beirut · NCT07059624

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.