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

6 maggio 2026 aggiornato da: Sung Eun Hyun, Seoul National University Hospital

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Sungbae Jo Research Professor, Ph.D
  • Numero di telefono: 82-2-2072-4178
  • Email: sungbaejo@snuh.org

Luoghi di studio

  • Corea del Sud
      • Seoul, Corea del Sud, 03080
        • Reclutamento
        • Seoul National University Hospital
        • Contatto:
          • Sungbae Jo Research Professor, Ph.D
          • Numero di telefono: 82-2-2072-4178
          • Email: sungbaejo@snuh.org

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comportamentale: 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.
Comportamentale: standard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Comparatore attivo: 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.
Comportamentale: standard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Maximal Oxygen Consumption (VO2 max)
Lasso di tempo: Baseline (Week 0), 12 weeks
Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.
Baseline (Week 0), 12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
Lasso di tempo: Baseline (Week 0), 12 weeks, 24 weeks
Health-related quality of life assessed by the PedsQL questionnaire. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).
Baseline (Week 0), 12 weeks, 24 weeks
Cardiac Rehabilitation Program Attendance Rate
Lasso di tempo: 12 weeks, 24 weeks
Calculated as the number of participated sessions divided by the total number of provided sessions (%).
12 weeks, 24 weeks
Drop-out Rate
Lasso di tempo: 12 weeks, 24 weeks
Percentage of participants who dropped out related to the intervention
12 weeks, 24 weeks
Change in Physical Activity Level
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.
Baseline, 12 weeks, 24 weeks
Change in Global Physical Activity Questionnaire (GPAQ) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Assesses levels of physical activity in three domains (activity at work/school, travel to and from places, recreational activities) and sedentary behavior. The Global Physical Activity Questionnaire (GPAQ) calculates physical activity volume in Metabolic Equivalent of Task (MET)-minutes per week, with a minimum value of 0 and no defined maximum limit, where higher values indicate a better outcome (greater physical activity).
Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Assesses health-related quality of life of the pediatric patient from the perspective of the parents or guardians. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).
Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
A disease-specific module designed to measure health-related quality of life specifically in pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).
Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
A disease-specific module designed to measure health-related quality of life specifically in parent proxy-report of pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).
Baseline, 12 weeks, 24 weeks
Change in Resilience Scale for Youth (RS-Y) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Assesses the level of psychological resilience in children and adolescents. Total scores range from 37 to 185 (based on 37 items), where higher scores indicate a better outcome (greater psychological resilience).
Baseline, 12 weeks, 24 weeks
Change in Child Behavior Checklist (CBCL) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
Evaluates behavioral and emotional problems in children and adolescents, as reported by parents or guardians. Results are reported as T-scores typically ranging from 28 to 100, where higher scores indicate a worse outcome (more severe behavioral or emotional problems).
Baseline, 12 weeks, 24 weeks
Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
A self-report assessment to evaluate the presence and severity of depressive symptoms in children and adolescents. Scores range from 0 to 56, where higher scores indicate a worse outcome (more severe depressive symptoms).
Baseline, 12 weeks, 24 weeks
Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score
Lasso di tempo: Baseline, 12 weeks, 24 weeks
A self-report instrument designed to assess the level and nature of anxiety in children and adolescents. Results are reported as scores typically ranging from 0 to 40, where higher scores indicate a worse outcome (greater severity of anxiety).
Baseline, 12 weeks, 24 weeks
Incidence of Adverse Events (Safety)
Lasso di tempo: 12 weeks, 24 weeks
Proportion and rate of adverse events and serious adverse events occurring during exercise.
12 weeks, 24 weeks
Change in Oxygen Consumption (VO2)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min.
Baseline, 12 weeks, 24 weeks
Change in Carbon Dioxide Production (VCO2)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The volume of carbon dioxide produced per minute during the cardiopulmonary exercise test. Unit: L/min.
Baseline, 12 weeks, 24 weeks
Change in Respiratory Exchange Ratio (RER)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The ratio of carbon dioxide production to oxygen consumption during the cardiopulmonary exercise test. Unit: Ratio
Baseline, 12 weeks, 24 weeks
Change in Minute Ventilation (VE)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The total volume of air inhaled and exhaled per minute during the cardiopulmonary exercise test. Unit: L/min.
Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Oxygen (VE/VO2)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The ratio of minute ventilation to oxygen consumption, reflecting ventilatory efficiency. Unit: Ratio
Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The ratio of minute ventilation to carbon dioxide production, reflecting ventilatory efficiency. Unit: Ratio
Baseline, 12 weeks, 24 weeks
Change in Oxygen Pulse (O2 Pulse)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The amount of oxygen consumed per heart beat during the cardiopulmonary exercise test. Unit: mL/beat.
Baseline, 12 weeks, 24 weeks
Change in Peripheral Capillary Oxygen Saturation (SpO2)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The blood oxygen saturation level measured via pulse oximetry during the cardiopulmonary exercise test. Unit: %.
Baseline, 12 weeks, 24 weeks
Change in Maximal Heart Rate (HRmax)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The highest heart rate achieved during the cardiopulmonary exercise test. Unit: beats per minute (bpm).
Baseline, 12 weeks, 24 weeks
Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The total weight of skeletal muscle in the body measured by bioelectrical impedance analysis. Unit: kg.
Baseline, 12 weeks, 24 weeks
Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The total weight of fat in the body measured by bioelectrical impedance analysis. Unit: kg.
Baseline, 12 weeks, 24 weeks
Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, 12 weeks, 24 weeks 13.
The percentage of total body weight that consists of fat, measured by bioelectrical impedance analysis. Unit: %.
Baseline, 12 weeks, 24 weeks 13.
Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The ratio of abdominal fat, evaluated by waist-to-hip circumference ratio via bioelectrical impedance analysis. Unit: %.
Baseline, 12 weeks, 24 weeks
Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The ratio of extracellular water to total body water, measured by bioelectrical impedance analysis. Unit: %.
Baseline, 12 weeks, 24 weeks
Change in Radial Artery Augmentation Index (AIx)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
A measure of arterial stiffness derived from the radial artery pulse wave, standardized to a heart rate of 75 bpm (AIx@75). Unit: %.
Baseline, 12 weeks, 24 weeks
Change in Carotid-femoral Pulse Wave Velocity (c-f PWV)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The speed of the arterial pulse propagating from the carotid to the femoral artery, reflecting arterial stiffness. Unit: m/s.
Baseline, 12 weeks, 24 weeks
Change in Flow-Mediated Dilation (FMD)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The percentage increase in brachial artery diameter following a period of ischemia, assessing endothelial function. Unit: %.
Baseline, 12 weeks, 24 weeks
Change in 6-Minute Walk Test (6MWT) Distance
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The total distance a participant can walk on a flat, hard surface in exactly 6 minutes. Unit: meters (m).
Baseline, 12 weeks, 24 weeks
Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The maximum isometric knee extension peak torque measured by an isokinetic dynamometer. Unit: Newton meters (N.m).
Baseline, 12 weeks, 24 weeks
Change in Lower Limb Muscular Endurance measured by 1-minute squats
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The total number of chair stand squats completed within exactly one minute. Unit: repetitions.
Baseline, 12 weeks, 24 weeks
Change in Upper Limb Strength (Grip Strength)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg.
Baseline, 12 weeks, 24 weeks
Change in Flexibility measured by sit and reach test
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The maximum distance reached forward while sitting with legs extended, assessing lower back and hamstring flexibility. Unit: cm.
Baseline, 12 weeks, 24 weeks
Change in Maximal Inspiratory Pressure (MIP)
Lasso di tempo: Baseline, 12 weeks, 24 weeks
The maximum pressure generated during inspiration against an occluded airway, assessing respiratory muscle strength. Unit: mmH2O.
Baseline, 12 weeks, 24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seoul National University Hospital

Collaboratori

University of Seoul

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

31 ottobre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2511-022-1690

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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