Congenital Heart Disease (CHD) Clinical Trials

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Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Sungbae Jo Research Professor, Ph.D
sungbaejo@snuh.org
82-2-2072-4178
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 45
Treatments
Experimental: Remote Cardiac Rehabilitation Group
Participants randomly assigned to this group will receive a 12-week remote cardiac rehabilitation program followed by a 12-week follow-up period (total 24 weeks).
Active_comparator: Control Group
Participants randomly assigned to this group will receive the standard of care for 24 weeks. After the 24-week evaluation, they will be offered a 1-month exercise education program opportunity.
Related Therapeutic Areas
Sponsors
Collaborators: University of Seoul
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov