Congenital Heart Disease (CHD)NCT06912412
Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease
A study testing Community-based supervised remote cardiac rehabilitation and Home-based cardiac rehabilitation program in people with Congenital Heart Disease (CHD) and Complex Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Complex Congenital Heart Disease, Congenital Heart Disease in Children
- What is being tested?
- Community-based supervised remote cardiac rehabilitation and Home-based cardiac rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2025to 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 between 8 and 18 years
- Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery
- At least 3 months post-cardiac surgery with a stable hemodynamic status
- Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver
- Either the participant or their caregiver agrees to study participation and has signed the informed consent form
Who cannot join
- Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.
- Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.
- Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.
- Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.
- Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).
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
Seoul National University Hospital
Seoul, 03080
Eunjeong Choi Researcher, CRC, MS, 82-10-7921-7182, snuhrmped@gmail.com
About this study
Official title: Development and Validation of a Community-Based Remote Cardiac Rehabilitation Program for Improving Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.
For these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility.
Read more
The investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status.
Interventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up.
Validity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state).
Safety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.
- Conditions
- Congenital Heart Disease (CHD), Complex Congenital Heart Disease, Congenital Heart Disease in Children
- Being tested
- Community-based supervised remote cardiac rehabilitation, Home-based cardiac rehabilitation program
- Keywords
- Complex congenital heart disease, remote cardiac rehabilitation, cardiac rehabilitation, children cardiac rehabilitation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based supervised remote cardiac rehabilitationOther
Community-based supervised remote cardiac rehabilitation begins with a weekly session led by exercise specialists, who use remote-based materials to match each participant's target heart rate and rate of perceived exertion (RPE). During these sessions, participants perform aerobic, strength, and respiratory exercises using progressive overload principles, with devices such as the POWERbreathe Plus supporting individualized respiratory training.
Depending on the risk classification for each participant, they will be provided with different intensity of exercises (depending on their measured HR max, HRR, and/or RPE).
Home-based cardiac rehabilitation programOther
Beyond the single supervised session, participants undertake four weekly home-based sessions.
- Low-Risk Group: Aerobic and respiratory exercises are performed four times per week, plus strength training once or twice weekly. Each 60-minute session includes a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. Indoor sessions use remote exercise content and respiratory training devices, while outdoor activities may involve walking, jogging, cycling, or swimming. Exercises progress in duration, intensity, and resistance.
- Moderate-Risk Group: Aerobic and respiratory exercises are done four times per week with an RPE of 8-13. Intensity and duration increase gradually, contingent on symptom stability and improved endurance.
- High-Risk Group: Aerobic and respiratory sessions occur four times a week at an RPE of 8-10, each lasting around 30 minutes (5-minute warm-up, 20-30-minute main exercise, 5-minute cool-down).
| Study group | Role | What they receive |
|---|---|---|
| Community-based remote cardiac rehabilitation group | Experimental | The group is provided with a single session of supervised remote cardiac rehabilitation session per week, and 4 sessions of home-based rehabilitation.
During the supervised remote session, the EKG signal, heart rate and SpO2 of the participants are monitored in real-time using a single lead EKG and SpO2 monitor. Their activity levels are also recorded using a smartwatch, in number of steps and minutes in moderate-vigorous physical activity time Receives: Other: Community-based supervised remote cardiac rehabilitation; Other: Home-based cardiac rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out rate
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Attendance rate
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Secondary outcomes (42)
oxygen consumption, VO2
Oxygen consumption (VO2) refers to the rate at which the body takes in and uses oxygen.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
maximal oxygen consumption, VO2 max
Maximal oxygen consumption (VO2 max) represents the highest rate at which an individual can take in, transport, and utilize oxygen during maximal or exhaustive exercise.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Respiratory exchange rate, RER
Respiratory Exchange Ratio (RER) is the ratio of the volume of carbon dioxide produced (VCO2) to the volume of oxygen consumed (VO2) in the body.
RER = VCO2 / VO2
Measured: baseline, 12 weeks after, 24 weeks after follow-up
minute ventilation (VE)
minute ventilation (VE) refers to the total volume of air inhaled or exhaled by an individual per minute.
VE = Tidal Volume (VT) x Respiratory Rate (RR)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
ventilation effectiveness, VE/VO2
Ventilation effectiveness, when expressed as the ratio of minute ventilation (VE) to oxygen consumption (VO2) (VE/VO2), represents the volume of air that needs to be breathed to consume one liter of oxygen.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
oxygen per pulse, O2 pulse
Measured: baseline, 12 weeks after, 24 weeks after follow-up
oxygen saturation, SpO2
Measured: baseline, 12 weeks after, 24 weeks after follow-up
maximal heart rate during exercise, HR max
Measured: baseline, 12 weeks after, 24 weeks after follow-up
heart rate by exercise intensity
Measured: baseline, 12 weeks after, 24 weeks after follow-up
average number of steps for 7 days using smartwatch
Measured: baseline, 12 weeks after, 24 weeks after follow-up
average moderate-vigorous physical activity time for 7days using smartwatch, minutes
Measured: baseline, 12 weeks after, 24 weeks after follow-up
skeletal muscle mass (kg)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
body fat mass (kg)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
body fat percentage
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Abdominal fat percentage
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Intracellular moisture, extracellular moisture
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Radial artery pulse wave amplification index: Augmentation index (AIx@75 index)
arterial stiffness and wave reflection at a heart rate of 75 beats per minute
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Carotid-femoral pulse wave velocity, c-f PWV
Carotid-femoral pulse wave velocity (c-f PWV) is a non-invasive medical test used to assess arterial stiffness, which is a measure of how rigid or flexible the arteries are.
c-f PWV = Distance between carotid and femoral sites / Time difference between pulse wave arrival at the two sites.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Flow-mediated dilation, FMD%
Flow-Mediated Dilation (FMD%) is a non-invasive ultrasound technique used to assess endothelial function, which is the ability of the inner lining of arteries (the endothelium) to relax and contract properly. FMD% specifically measures the percentage change in the diameter of an artery in response to an increase in blood flow
Measured: baseline, 12 weeks after, 24 weeks after follow-up
6 minutes walk test
total distance in meters
Measured: baseline, 12 weeks after, 24 weeks after follow-up
lower limb muscle strength test (peak torque/BW)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Upper extremity strength test: grip force (kg)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Flexibility check: Flexibility distance (cm)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Respiratory muscle strength test (MIP mmH2O)
Maximal Inspiratory Pressure (MIP) is a measurement in assessing the strength of inspiratory muscles. It reflects the strength of the diaphragm and other inspiratory muscles.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Global Physical Activity Questionnaire
The Global Physical Activity Questionnaire (GPAQ) doesn't have a fixed minimum and maximum score.
A score of 0 would indicate no reported physical activity. Higher scores means a better outcome in terms of physical activity levels.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents
Minimum Value (Total Score): 0 Maximum Value (Total Score): 100 Higher Scores Mean: A better outcome. Higher scores on the PedsQL™ indicate a better health-related quality of life, as reported by either the child/adolescent or their parent.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac
Minimum Value (Total Score): 0 Maximum Value (Total Score): 100 Higher Scores Mean: A better outcome. Higher scores on the PedsQL™ Cardiac module indicate a better health-related quality of life for the child with a cardiac condition.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Program satisfactory survey
Measured: 12 weeks
Resilience Scale for Youth, RS-Y
Minimum Value: 25 Maximum Value: 125 Higher Scores Mean: A better outcome. Higher scores on the Resilience Scale for Youth indicate a higher level of resilience in the individual.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Child Behavior Checklist for parents, CBCL
Minimum Value : 0 Maximum Value : 118 Higher Scores Mean: A worse outcome. Higher scores on the Total Problems scale of the CBCL indicate a greater number and severity of reported behavioral and emotional problems in the child.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
blood pressure by exercise intensity
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Children's Depression Inventory 2, K-CDI-2:SR
Minimum Value: 0 Maximum Value: 54 Higher Scores Mean: A worse outcome. Higher scores on the K-CDI-2:SR indicate higher levels of reported depressive symptoms.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Revised Children's Manifest Anxiety Scale 2, RCMAS-2
Minimum Value: 0 Maximum Value: 49 Higher Scores Mean: A worse outcome. Higher scores on the RCMAS-2 indicate higher levels of reported anxiety.
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Incidence proportion of adverse events and harm during exercise
Incidence proportion of participants with exercise-related adverse events as assessed by CTCAE v4.0
Measured: 12 weeks after, 24 weeks after follow-up
Incidence rate of adverse events and harm during exercise
Incidence rate of participants with exercise-related adverse events as assessed by CTCAE v4.0
Measured: 12 weeks after, 24 weeks after follow-up
Changes in pre- and post-workout heart rate
Measured: up to 12 weeks
Changes in pre- and post-workout oxygen saturation (SpO2)
Measured: up to 12 weeks
Changes in pre- and post-workout respiratory rate
Measured: up to 12 weeks
Rate of Perceived Exertion, Borg scale
Unabbreviated Scale Title: Rate of Perceived Exertion (RPE) Scale Minimum Value: 6 Maximum Value: 20 Higher Scores Mean: A worse outcome. Higher numbers on the Borg scale indicate a greater feeling of exertion.
Measured: up to 12 weeks
Upper extremity strength test: relative grip force (%)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
lower limb muscle strength test (peak torque)
Measured: baseline, 12 weeks after, 24 weeks after follow-up
extracellular moisture ratio
Measured: baseline, 12 weeks after, 24 weeks after follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start31 May 2025 (estimated)
- Primary completion31 Dec 2028 (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 Congenital Heart Disease (CHD)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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, Woo Hyung Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912412
- Sponsor's protocol ID
- FP-2024-00016
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Community-Based Remote Cardiac Rehabilitation Program for Improving Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06912412
- Acronym / sponsor ID
- FP-2024-00016
- Conditions
- Congenital Heart Disease (CHD), Complex Congenital Heart Disease, Congenital Heart Disease in Children
- Keywords
- Complex congenital heart disease, remote cardiac rehabilitation, cardiac rehabilitation, children cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- University of Seoul
- Study start
- 31 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Apr 2025 (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 is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.
For these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility.
The investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status.
Interventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up.
Validity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state).
Safety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-based remote cardiac rehabilitation group | Experimental | Other: Community-based supervised remote cardiac rehabilitation, Other: Home-based cardiac rehabilitation programThe group is provided with a single session of supervised remote cardiac rehabilitation session per week, and 4 sessions of home-based rehabilitation. During the supervised remote session, the EKG signal, heart rate and SpO2 of the participants are monitored in real-time using a single lead EKG and SpO2 monitor. Their activity levels are also recorded using a smartwatch, in number of steps and minutes in moderate-vigorous physical activity time |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 8 and 18 years
- Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery
- At least 3 months post-cardiac surgery with a stable hemodynamic status
- Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver
- Either the participant or their caregiver agrees to study participation and has signed the informed consent form
Key exclusion criteria (5 listed)
- Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.
- Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.
- Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.
- Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.
- Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 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 supervised remote cardiac rehabilitationCommunity-based supervised remote cardiac rehabilitation begins with a weekly session led by exercise specialists, who use remote-based materials to match each participant's target heart rate and rate of perceived exertion (RPE). During these sessions, participants perform aerobic, strength, and respiratory exercises using progressive overload principles, with devices such as the POWERbreathe Plus supporting individualized respiratory training. Depending on the risk classification for each participant, they will be provided with different intensity of exercises (depending on their measured HR max, HRR, and/or RPE). | Other | Community-based remote cardiac rehabilitation group |
| Home-based cardiac rehabilitation programBeyond the single supervised session, participants undertake four weekly home-based sessions. * Low-Risk Group: Aerobic and respiratory exercises are performed four times per week, plus strength training once or twice weekly. Each 60-minute session includes a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. Indoor sessions use remote exercise content and respiratory training devices, while outdoor activities may involve walking, jogging, cycling, or swimming. Exercises progress in duration, intensity, and resistance. * Moderate-Risk Group: Aerobic and respiratory exercises are done four times per week with an RPE of 8-13. Intensity and duration increase gradually, contingent on symptom stability and improved endurance. * High-Risk Group: Aerobic and respiratory sessions occur four times a week at an RPE of 8-10, each lasting around 30 minutes (5-minute warm-up, 20-30-minute main exercise, 5-minute cool-down). | Other | Community-based remote cardiac rehabilitation group |
Primary outcome
Drop-out rate
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Attendance rate
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
42 secondary outcomes
oxygen consumption, VO2
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
maximal oxygen consumption, VO2 max
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Respiratory exchange rate, RER
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
minute ventilation (VE)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
ventilation effectiveness, VE/VO2
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
oxygen per pulse, O2 pulse
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
oxygen saturation, SpO2
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
maximal heart rate during exercise, HR max
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
heart rate by exercise intensity
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
average number of steps for 7 days using smartwatch
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
average moderate-vigorous physical activity time for 7days using smartwatch, minutes
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
skeletal muscle mass (kg)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
body fat mass (kg)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
body fat percentage
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Abdominal fat percentage
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Intracellular moisture, extracellular moisture
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Radial artery pulse wave amplification index: Augmentation index (AIx@75 index)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Carotid-femoral pulse wave velocity, c-f PWV
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Flow-mediated dilation, FMD%
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
6 minutes walk test
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
lower limb muscle strength test (peak torque/BW)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Upper extremity strength test: grip force (kg)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Flexibility check: Flexibility distance (cm)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Respiratory muscle strength test (MIP mmH2O)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Global Physical Activity Questionnaire
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Program satisfactory survey
Time frame: 12 weeks
Resilience Scale for Youth, RS-Y
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Child Behavior Checklist for parents, CBCL
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
blood pressure by exercise intensity
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Children's Depression Inventory 2, K-CDI-2:SR
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Revised Children's Manifest Anxiety Scale 2, RCMAS-2
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
Incidence proportion of adverse events and harm during exercise
Time frame: 12 weeks after, 24 weeks after follow-up
Incidence rate of adverse events and harm during exercise
Time frame: 12 weeks after, 24 weeks after follow-up
Changes in pre- and post-workout heart rate
Time frame: up to 12 weeks
Changes in pre- and post-workout oxygen saturation (SpO2)
Time frame: up to 12 weeks
Changes in pre- and post-workout respiratory rate
Time frame: up to 12 weeks
Rate of Perceived Exertion, Borg scale
Time frame: up to 12 weeks
Upper extremity strength test: relative grip force (%)
Time frame: baseline, 12 weeks after, 24 weeks after follow-up
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 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
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 supervised remote cardiac rehabilitation and Home-based cardiac rehabilitation program in people with Congenital Heart Disease (CHD) and 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Apr 2025. 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 (82-10-9381-2299, rew277@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out rate (time frame: baseline, 12 weeks after, 24 weeks after follow-up). The study lists 2 primary outcomes in all. 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 4 Apr 2025.