None listed
Conditions
Interventions
Behavioral : Participants assigned to the intervention group of this study will maintain their standard outpatient care while participating in a 12-week remote cardiac rehabilitation program, followed
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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): 1) KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below. 2) Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Maximal Oxygen Consumption (VO2 max) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pediatric Quality of Life Inventory (PedsQL) Total Score;Cardiac Rehabilitation Program Attendance Rate;Drop-out Rate;Change in Oxygen Consumption (VO2);Change in Carbon Dioxide Production (VCO2);Change in Respiratory Exchange Ratio (RER);Change in Minute Ventilation (VE);Change in Ventilatory Equivalent for Oxygen (VE/VO2);Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2);Change in Oxygen Pulse (O2 Pulse);Change in Peripheral Capillary Oxygen Saturation (SpO2);Change in Maximal Heart Rate (HRmax);Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA);Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA);Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA);Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA);Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA);Change in Radial Artery Augmentation Index (AIx);Change in Carotid-femoral Pulse Wave Velocity (c-f PWV);Change in Flow-Mediated Dilation (FMD);Change in 6-Minute Walk Test (6MWT) Distance;Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex);Change in Lower Limb Muscular Endurance measured by 1-minute squats;Change in Upper Limb Strength (Grip Strength);Change in Flexibility measured by sit and reach test;Change in Maximal Inspiratory Pressure (MIP);Change in Global Physical Activity Questionnaire (GPAQ) Score;Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score;Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score;Change in Resilience Scale for Youth (RS-Y) Score;Change in Child Behavior Checklist (CBCL) Score;Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score;Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score;Incidence of Adverse Events (Safety) | — |
Countries
Korea, Republic of
Contacts
Public ContactSungbae Jo
Seoul National University Hospital
Outcome results
None listed