Recruiting NCT07572435
Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community-Based Remote Cardiac Rehabilitation Program, standard of care.
- Who it may be relevant to
- Registry conditions: Complex Congenital Heart Disease. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Behavioral Community-Based Remote Cardiac Rehabilitation Program
The program consists of supervised remote exercise via ZOOM once a week (approx. 60 minutes, including warm-up, aerobic, resistance, respiratory, and cool-down exercises) and self-directed exercise 3 to 7 times a week. Biological signals (ECG, heart rate, SpO2) are monitored using wearable devices (mobiCARE, pulse oximeter, and smartwatch). A respiratory muscle training device (POWERbreathe) is also utilized. - Behavioral standard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Primary outcome measures
- Change in Maximal Oxygen Consumption (VO2 max) [Time frame: Baseline (Week 0), 12 weeks]
Secondary outcome measures (12)
- Change in Pediatric Quality of Life Inventory (PedsQL) Total Score [Time frame: Baseline (Week 0), 12 weeks, 24 weeks]
- Cardiac Rehabilitation Program Attendance Rate [Time frame: 12 weeks, 24 weeks]
- Drop-out Rate [Time frame: 12 weeks, 24 weeks]
- Change in Physical Activity Level [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Global Physical Activity Questionnaire (GPAQ) Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Resilience Scale for Youth (RS-Y) Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Child Behavior Checklist (CBCL) Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score [Time frame: Baseline, 12 weeks, 24 weeks]
Eligibility 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):
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07572435 · 2511-022-1690