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New treatment option for Congenital Heart Disease
Official title HIIT in Youth With Congenital Heart Disease (MedBIKE)
ClinicalTrials.gov ID: NCT04575883
What this study is testing
- What it's testing
- Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- Children and adolescents aged 10-18 years
- Repaired moderate-complex congenital heart disease
You likely can't join if
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (space limitations)
- Previous involvement in a cardiac rehab 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...
- Resting arterial saturation \<85% or oxygen requirements
See the full eligibility criteria
- Children and adolescents aged 10-18 years
- Repaired moderate-complex congenital heart disease
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (space limitations)
- Previous involvement in a cardiac rehab 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) (\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.