Complex Congenital Heart DiseaseNCT07572435
Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease
A study testing Community-Based Remote Cardiac Rehabilitation Program in people with Complex Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Complex Congenital Heart Disease
- What is being tested?
- Community-Based Remote Cardiac Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sungbae Jo Research Professor, Ph.D, 82-2-2072-4178, sungbaejo@snuh.org
About this study
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
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.
- Conditions
- Complex Congenital Heart Disease
- Being tested
- Community-Based Remote Cardiac Rehabilitation Program, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Based Remote Cardiac Rehabilitation ProgramBehavioural
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.
standard of careBehavioural
Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.
| Study group | Role | What they receive |
|---|---|---|
| Remote Cardiac Rehabilitation Group | Experimental | 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). Receives: Behavioral: Community-Based Remote Cardiac Rehabilitation Program; Behavioral: standard of care |
| Control Group | Active comparator | 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. Receives: Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Oxygen Consumption (VO2 max)
Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.
Measured: Baseline (Week 0), 12 weeks
Secondary outcomes (36)
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
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).
Measured: Baseline (Week 0), 12 weeks, 24 weeks
Cardiac Rehabilitation Program Attendance Rate
Calculated as the number of participated sessions divided by the total number of provided sessions (%).
Measured: 12 weeks, 24 weeks
Drop-out Rate
Percentage of participants who dropped out related to the intervention
Measured: 12 weeks, 24 weeks
Change in Physical Activity Level
Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.
Measured: Baseline, 12 weeks, 24 weeks
Change in Global Physical Activity Questionnaire (GPAQ) Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Parent Proxy-Report Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Parent Proxy-Report Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Resilience Scale for Youth (RS-Y) Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Child Behavior Checklist (CBCL) Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Korean Children's Depression Inventory 2: Self-Report (K-CDI-2:SR) Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Change in Revised Children's Manifest Anxiety Scale, Second Edition (RCMAS-2) Score
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).
Measured: Baseline, 12 weeks, 24 weeks
Incidence of Adverse Events (Safety)
Proportion and rate of adverse events and serious adverse events occurring during exercise.
Measured: 12 weeks, 24 weeks
Change in Oxygen Consumption (VO2)
The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min.
Measured: Baseline, 12 weeks, 24 weeks
Change in Carbon Dioxide Production (VCO2)
The volume of carbon dioxide produced per minute during the cardiopulmonary exercise test. Unit: L/min.
Measured: Baseline, 12 weeks, 24 weeks
Change in Respiratory Exchange Ratio (RER)
The ratio of carbon dioxide production to oxygen consumption during the cardiopulmonary exercise test. Unit: Ratio
Measured: Baseline, 12 weeks, 24 weeks
Change in Minute Ventilation (VE)
The total volume of air inhaled and exhaled per minute during the cardiopulmonary exercise test. Unit: L/min.
Measured: Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Oxygen (VE/VO2)
The ratio of minute ventilation to oxygen consumption, reflecting ventilatory efficiency. Unit: Ratio
Measured: Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)
The ratio of minute ventilation to carbon dioxide production, reflecting ventilatory efficiency. Unit: Ratio
Measured: Baseline, 12 weeks, 24 weeks
Change in Oxygen Pulse (O2 Pulse)
The amount of oxygen consumed per heart beat during the cardiopulmonary exercise test. Unit: mL/beat.
Measured: Baseline, 12 weeks, 24 weeks
Change in Peripheral Capillary Oxygen Saturation (SpO2)
The blood oxygen saturation level measured via pulse oximetry during the cardiopulmonary exercise test. Unit: %.
Measured: Baseline, 12 weeks, 24 weeks
Change in Maximal Heart Rate (HRmax)
The highest heart rate achieved during the cardiopulmonary exercise test. Unit: beats per minute (bpm).
Measured: Baseline, 12 weeks, 24 weeks
Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA)
The total weight of skeletal muscle in the body measured by bioelectrical impedance analysis. Unit: kg.
Measured: Baseline, 12 weeks, 24 weeks
Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA)
The total weight of fat in the body measured by bioelectrical impedance analysis. Unit: kg.
Measured: Baseline, 12 weeks, 24 weeks
Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA)
The percentage of total body weight that consists of fat, measured by bioelectrical impedance analysis. Unit: %.
Measured: Baseline, 12 weeks, 24 weeks 13.
Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA)
The ratio of abdominal fat, evaluated by waist-to-hip circumference ratio via bioelectrical impedance analysis. Unit: %.
Measured: Baseline, 12 weeks, 24 weeks
Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA)
The ratio of extracellular water to total body water, measured by bioelectrical impedance analysis. Unit: %.
Measured: Baseline, 12 weeks, 24 weeks
Change in Radial Artery Augmentation Index (AIx)
A measure of arterial stiffness derived from the radial artery pulse wave, standardized to a heart rate of 75 bpm (AIx@75). Unit: %.
Measured: Baseline, 12 weeks, 24 weeks
Change in Carotid-femoral Pulse Wave Velocity (c-f PWV)
The speed of the arterial pulse propagating from the carotid to the femoral artery, reflecting arterial stiffness. Unit: m/s.
Measured: Baseline, 12 weeks, 24 weeks
Change in Flow-Mediated Dilation (FMD)
The percentage increase in brachial artery diameter following a period of ischemia, assessing endothelial function. Unit: %.
Measured: Baseline, 12 weeks, 24 weeks
Change in 6-Minute Walk Test (6MWT) Distance
The total distance a participant can walk on a flat, hard surface in exactly 6 minutes. Unit: meters (m).
Measured: Baseline, 12 weeks, 24 weeks
Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex)
The maximum isometric knee extension peak torque measured by an isokinetic dynamometer. Unit: Newton meters (N.m).
Measured: Baseline, 12 weeks, 24 weeks
Change in Lower Limb Muscular Endurance measured by 1-minute squats
The total number of chair stand squats completed within exactly one minute. Unit: repetitions.
Measured: Baseline, 12 weeks, 24 weeks
Change in Upper Limb Strength (Grip Strength)
The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg.
Measured: Baseline, 12 weeks, 24 weeks
Change in Flexibility measured by sit and reach test
The maximum distance reached forward while sitting with legs extended, assessing lower back and hamstring flexibility. Unit: cm.
Measured: Baseline, 12 weeks, 24 weeks
Change in Maximal Inspiratory Pressure (MIP)
The maximum pressure generated during inspiration against an occluded airway, assessing respiratory muscle strength. Unit: mmH2O.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seoul
- Responsible party
- Principal investigator, Sung Eun Hyun, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572435
- Sponsor's protocol ID
- 2511-022-1690
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07572435
- Acronym / sponsor ID
- 2511-022-1690
- Conditions
- Complex Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- University of Seoul
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Cardiac Rehabilitation Group | Experimental | Behavioral: Community-Based Remote Cardiac Rehabilitation Program, Behavioral: standard of careParticipants 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). |
| Control Group | Active comparator | Behavioral: standard of careParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-Based Remote Cardiac Rehabilitation ProgramThe 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. | Behavioural | Remote Cardiac Rehabilitation Group |
| standard of careParticipants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention. | Behavioural | Control Group, Remote Cardiac Rehabilitation Group |
Primary outcome
Change in Maximal Oxygen Consumption (VO2 max)
Time frame: 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.
36 secondary outcomes
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
Incidence of Adverse Events (Safety)
Time frame: 12 weeks, 24 weeks
Change in Oxygen Consumption (VO2)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Carbon Dioxide Production (VCO2)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Respiratory Exchange Ratio (RER)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Minute Ventilation (VE)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Oxygen (VE/VO2)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Ventilatory Equivalent for Carbon Dioxide (VE/VCO2)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Oxygen Pulse (O2 Pulse)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Peripheral Capillary Oxygen Saturation (SpO2)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Maximal Heart Rate (HRmax)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Skeletal Muscle Mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Fat Mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Percent Body Fat measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, 12 weeks, 24 weeks 13.
Change in Abdominal Fat Ratio measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Extracellular Water Ratio measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Radial Artery Augmentation Index (AIx)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Carotid-femoral Pulse Wave Velocity (c-f PWV)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Flow-Mediated Dilation (FMD)
Time frame: Baseline, 12 weeks, 24 weeks
Change in 6-Minute Walk Test (6MWT) Distance
Time frame: Baseline, 12 weeks, 24 weeks
Change in Lower Limb Strength measured by isokinetic dynamometer (Biodex)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Lower Limb Muscular Endurance measured by 1-minute squats
Time frame: Baseline, 12 weeks, 24 weeks
Change in Upper Limb Strength (Grip Strength)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Flexibility measured by sit and reach test
Time frame: Baseline, 12 weeks, 24 weeks
Change in Maximal Inspiratory Pressure (MIP)
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Based Remote Cardiac Rehabilitation Program in people with Complex Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungbae Jo Research Professor, Ph.D (82-2-2072-4178, sungbaejo@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Oxygen Consumption (VO2 max) (time frame: Baseline (Week 0), 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.