BridgeMD
Tests treatment safety and results for Complex Congenital Heart Disease
Official title Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
ClinicalTrials.gov ID: NCT07572435
What this study is testing
- What it's testing
- This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- Aged 8 to 18 years.
- Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.
- At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.
- Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.
- Participant or guardian has agreed to participate and signed the written informed consent form.
You likely can't join if
- Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.
- Neurological or musculoskeletal disorders that make independent exercise impossible.
- Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.
- Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's...
- Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).
- Currently wearing an artificial pacemaker.
See the full eligibility criteria
- Aged 8 to 18 years.
- Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.
- At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.
- Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.
- Participant or guardian has agreed to participate and signed the written informed consent form.
- Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):
- KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.
- Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.
- Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.
- Neurological or musculoskeletal disorders that make independent exercise impossible.
- Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.
- Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report [K-CDI-2:SR] and Revised...
- Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).
- Currently wearing an artificial pacemaker.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.