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New treatment option for Congenital Heart Disease in Children
Official title Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
ClinicalTrials.gov ID: NCT06015191
What this study is testing
- What it's testing
- The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 19
You may be able to join if
- Age 12-19 years old
- Male or Female
- Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation Tetralogy of Fallot with transannular patch...
- Primary Cardiology clearance for exercise participation
- Internet access in their homes
You likely can't join if
- Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
- Participating in \> 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school...
- Height less than 132cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
- Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
- Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
See the full eligibility criteria
- Age 12-19 years old
- Male or Female
- Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation Tetralogy of Fallot with transannular patch Dextro-transposition of the great arteries with arterial switch operation
- Primary Cardiology clearance for exercise participation
- Internet access in their homes
- Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week
- English Speaking
- Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by...
- Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
- Participating in \> 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).
- Height less than 132cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
- Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
- Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
- Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural...
- Uncontrolled or poorly controlled asthma
- Presence of implanted cardioverter-defibrillator
- Pacemaker with rate-responsive function initiated
- Reliance on ventricular assist device
- Prescribed milrinone medication
- Listed for heart transplantation
- Active engagement in hormone replacement for gender transition
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
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, 12 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. 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.