Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
NCT07572435

Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

Led by Seoul National University Hospital · Updated on 2026-05-07

45

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Hospital

Lead Sponsor

U

University of Seoul

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 8 to 18 years.
  • Diagnosed with complex congenital heart disease 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 survey indicating moderate-to-vigorous physical activity time of less than 420 minutes per week.
Not Eligible

You will not qualify if you...

  • 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.
  • Inability to cooperate with study tests such as Cardiopulmonary Exercise Test, Electrocardiogram, and 6-Minute Walk Test.
  • Currently wearing an artificial pacemaker.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

S

Sungbae Jo Research Professor, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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