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NCT Number: NCT06912412

Community-Based Remote Cardiac Rehabilitation Program for 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.

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Complex Congenital Heart Disease Congenital Abnormalities Congenital Heart Disease in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Community-based supervised remote cardiac rehabilitation

Other

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 program

Other

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).

Primary outcomes

  1. Drop-out rate

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  2. Attendance rate

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

Secondary outcomes

  1. oxygen consumption, VO2

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    Oxygen consumption (VO2) refers to the rate at which the body takes in and uses oxygen.

  2. maximal oxygen consumption, VO2 max

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  3. Respiratory exchange rate, RER

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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

  4. minute ventilation (VE)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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)

  5. ventilation effectiveness, VE/VO2

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  6. oxygen per pulse, O2 pulse

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  7. oxygen saturation, SpO2

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  8. maximal heart rate during exercise, HR max

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  9. heart rate by exercise intensity

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  10. average number of steps for 7 days using smartwatch

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  11. average moderate-vigorous physical activity time for 7days using smartwatch, minutes

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  12. skeletal muscle mass (kg)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  13. body fat mass (kg)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  14. body fat percentage

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  15. Abdominal fat percentage

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  16. Intracellular moisture, extracellular moisture

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  17. Radial artery pulse wave amplification index: Augmentation index (AIx@75 index)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    arterial stiffness and wave reflection at a heart rate of 75 beats per minute

  18. Carotid-femoral pulse wave velocity, c-f PWV

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  19. Flow-mediated dilation, FMD%

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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

  20. 6 minutes walk test

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    total distance in meters

  21. lower limb muscle strength test (peak torque/BW)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  22. Upper extremity strength test: grip force (kg)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  23. Flexibility check: Flexibility distance (cm)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  24. Respiratory muscle strength test (MIP mmH2O)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  25. Global Physical Activity Questionnaire

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  26. Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  27. Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  28. Program satisfactory survey

    Time frame: 12 weeks

  29. Resilience Scale for Youth, RS-Y

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  30. Child Behavior Checklist for parents, CBCL

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  31. blood pressure by exercise intensity

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  32. Children's Depression Inventory 2, K-CDI-2:SR

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    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.

  33. Revised Children's Manifest Anxiety Scale 2, RCMAS-2

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

    Minimum Value: 0 Maximum Value: 49 Higher Scores Mean: A worse outcome. Higher scores on the RCMAS-2 indicate higher levels of reported anxiety.

  34. Incidence proportion of adverse events and harm during exercise

    Time frame: 12 weeks after, 24 weeks after follow-up

    Incidence proportion of participants with exercise-related adverse events as assessed by CTCAE v4.0

  35. Incidence rate of adverse events and harm during exercise

    Time frame: 12 weeks after, 24 weeks after follow-up

    Incidence rate of participants with exercise-related adverse events as assessed by CTCAE v4.0

  36. Changes in pre- and post-workout heart rate

    Time frame: up to 12 weeks

  37. Changes in pre- and post-workout oxygen saturation (SpO2)

    Time frame: up to 12 weeks

  38. Changes in pre- and post-workout respiratory rate

    Time frame: up to 12 weeks

  39. Rate of Perceived Exertion, Borg scale

    Time frame: up to 12 weeks

    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.

  40. Upper extremity strength test: relative grip force (%)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  41. lower limb muscle strength test (peak torque)

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

  42. extracellular moisture ratio

    Time frame: baseline, 12 weeks after, 24 weeks after follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Sungbae Jo Research professor, Ph. D

CONTACT

[email protected]

82-10-9381-2299

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • University of Seoul

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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