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

6 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Sungbae Jo Research Professor, Ph.D
  • Telefoonnummer: 82-2-2072-4178
  • E-mail: sungbaejo@snuh.org

Studie Locaties

  • Zuid -Korea
      • Seoul, Zuid -Korea, 03080
        • Werving
        • Seoul National University Hospital
        • Contact:
          • Sungbae Jo Research Professor, Ph.D
          • Telefoonnummer: 82-2-2072-4178
          • E-mail: sungbaejo@snuh.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: 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.
Gedragsmatig: standard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
Actieve vergelijker: 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.
Gedragsmatig: standard of care
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Maximal Oxygen Consumption (VO2 max)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 weeks, 24 weeks
Percentage of participants who dropped out related to the intervention
12 weeks, 24 weeks
Change in Physical Activity Level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seoul National University Hospital

Medewerkers

University of Seoul

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

31 oktober 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

23 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2511-022-1690

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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