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Behavioural Intervention
High Intensity Interval Training for Congenital Heart Disease
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
Children and adolescents aged 10-18 years
Repaired moderate-complex congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Awards & highlights
Study Summary
This trial will study the effects of a home-based high intensity interval training program on exercise capacity in adolescents with repaired congenital heart disease.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, HIIT programs can generally cause increased heart rate during exercise, fatigue afterwards, muscle soreness and may pose risks if there's an underlying health condition that hasn't been adequately assessed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 18 years old.
Select...
I had surgery to fix a moderate to complex heart defect.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
Secondary outcome measures
Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.
Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.
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
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MedBIKE HIITExperimental Treatment1 Intervention
MedBIKE HIIT Exercise Program
Find a Location
Who is running the clinical trial?
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
72,066 Total Patients Enrolled
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,090 Total Patients Enrolled
Michael Khoury, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition limits my physical activity.I have difficulty communicating which may affect my participation in the HIIT program.I have a heart or birth defect that limits my ability to exercise.I am between 10 and 18 years old.I have experienced chest pain when I exert myself.I have not had serious heart rhythm problems in the last year.You had a previous exercise test showing certain heart problems like abnormal heart rhythms, significant changes in the ECG, or dangerous changes in blood pressure.My oxygen levels are often below 85% without support.Your heart's pumping function is not strong based on the most recent heart ultrasound.I had surgery to fix a moderate to complex heart defect.Your home doesn't have enough space for the MedBIKE™ system.You have participated in a program for heart rehabilitation or exercise before.I am not fluent in English, which may limit my participation.You have a heart defect that has not been fixed or treated.
Research Study Groups:
This trial has the following groups:- Group 1: MedBIKE HIIT
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.
How many enrollees are participating in this experiment?
"Affirmative. Records on clinicaltrials.gov verify that this medical study, first advertised on November 22nd 2022, is currently accepting participants. Approximately 44 individuals are sought from one healthcare facility."
Answered by AI
Is this experiment currently seeking participants?
"Indeed, data hosted on clinicaltrials.gov corroborates that this medical experiment is actively searching for participants. This trial was first posted on November 22nd 2022 and has been updated recently on the 25th of November 2022 with a demand for 44 patients from 1 location."
Answered by AI
Might I qualify for participation in this medical experiment?
"This experiment calls for 44 participants between the ages of 10 and 18 who are suffering from congenital heart disease (CHD)."
Answered by AI
Does the research include geriatric participants?
"Patients that meet the standards of this medical study must be between 10 and 18 years old. There are 120 trials open to minors, while a total of 273 clinical trails accept seniors over 65."
Answered by AI
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