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Behavioural Intervention
High-Intensity Interval Training for Pediatric Heart Transplant Recipients
N/A
Recruiting
Led By Michael Khoury, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights
Study Summary
This trial is testing a new way to do high-intensity interval training at home using a video game and a bike. They want to see if it's feasible and if it leads to better outcomes for pediatric heart transplant recipients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of HIIT on pediatric heart transplant patients are not detailed here and may vary individually, common reactions to intense exercise could include muscle soreness, fatigue and in rare cases exacerbation of underlying cardiac conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the feasibility of a 12-week, home-based HIIT MedBIKE™ intervention in pediatric heart transplant recipients.
Secondary outcome measures
Changes in cardiac specific health-related quality of life will be measured using the PedsQL Cardiac Module questionnaire.
Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention
Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MedBIKE HIITExperimental Treatment1 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 CareActive Control1 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.
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Who is running the clinical trial?
Women and Children's Health Research Institute, CanadaOTHER
17 Previous Clinical Trials
24,930 Total Patients Enrolled
Canadian Donation and Transplantation Research ProgramUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,948 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is moderately reduced or worse.I have experienced chest pain when I exert myself.I am a child who received a heart transplant more than 6 months ago.I do not have an adult to supervise my home exercises.I am between 10 and 18 years old.I am not fluent in English, which may affect my participation.I had a rejection episode due to antibodies or cells within the last 3 months.I have not had serious heart rhythm problems in the last year.My heart condition limits my physical activity.I have a heart or birth defect that limits my ability to exercise.I need extra oxygen or my oxygen levels are below 85% when resting.I have difficulty communicating due to cognitive issues.
Research Study Groups:
This trial has the following groups:- Group 1: MedBIKE HIIT
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being considered as trial participants?
"This research project is recruiting participants who are between the ages of 10 and 18."
Answered by AI
Are there any vacancies remaining in this experiment?
"Clinicaltrials.gov informs us that this clinical trial is currently enrolling patients, having been initially listed on February 22nd 2022 and last edited on July 6th 2022."
Answered by AI
Am I eligible to join this research endeavor?
"The investigators of this medical trial seek 10 minors, aged between 10 and 18 years old, who have previously undergone a pediatric heart transplantation. Moreover, the participants must be at least 6 months out from their surgery."
Answered by AI
How many participants has this research endeavor recruited thus far?
"Affirmative. Per the information presented on clinicaltrials.gov, this medical trial is actively recruiting patients as of July 6th 2022. This study was originally posted to the website on February 22nd and 10 individuals are required from 1 location."
Answered by AI
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