12-week home heart rehabilitation program for children with complex congenital heart disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 8 to 18 who are at least three months post-cardiac surgery and have reduced physical activity will be enrolled. Participants are randomly assigned to a 12-week community-based remote cardiac rehabilitation program delivered via mobile apps and video platforms or to standard of care. Outcomes include cardiopulmonary function and quality of life measured before and after the program, with remote monitoring and guardian technical support. The trial tests preliminary efficacy and feasibility of delivering rehabilitation in the home setting for patients with complex congenital heart disease.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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 Children's Manifest Anxiety Scale, Second Edition \[RCMAS-2\]).
* 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.

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sungbae Jo Research Professor, Ph.D
• Email: sungbaejo@snuh.org
• Phone: 82-2-2072-4178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Wireless NIRS Sensor Use in the NICU for Monitoring on Neonates

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.