Development and validation of remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease

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: A Prospective, Explorative Pilot Study for Feasibility and Safety

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010413

Enrollment

Registered

2025-04-11

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Community-Based Remote Cardiac Rehabilitation Program) : Community-based supervised remote cardiac rehabilitation begins with a weekly session led by exercise specialists, who use remote-based

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 8 and 18 years 2. Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery 3. At least 3 months post-cardiac surgery with a stable hemodynamic status 4. Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver 5. Either the participant or their caregiver agrees to study participation and has signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions. 2. Patients who are unable to exercise independently due to neurological or musculoskeletal disorders. 3. Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment. 4. Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS. 5. Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).

Design outcomes

Primary

Measure	Time frame
maximal oxygen consumption, VO2 max	—

Secondary

Measure	Time frame
Attendance rate;Drop-out rate;oxygen consumption, VO2;Respiratory exchange rate, RER;minute ventilation, VE;ventilation effectiveness, VE/VO2;oxygen per pulse, O2 pulse;oxygen saturation, SpO2;maximal heart rate during exercise, HR max;heart rate and blood pressure by exercise intensity;average number of steps for 7days using smartwatch;average moderate-vigorous physical activity time for 7days using smartwatch, minutes;skeletal muscle mass;body fat mass;body fat percentage;Abdominal fat percentage;Intracellular moisture, extracellular moisture, extracellular moisture ratio;Radial artery pulse wave amplification index;carotid-femoral pulse wave propagation velocity;brachial artery vascular endothelial cell function;6 minutes walk test;lower limb muscle strength test (peak torque & peak torque/BW);Upper extremity strength test: grip force (kg), relative grip force (%);Flexibility check: Flexibility distance (cm);Respiratory muscle strength test (MIP mmH2O);Global Physical Activity Questionnaire;Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents;Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac;Program satisfactory survey;Resilience Scale for Youth, RS-Y;Child Behavior Checklist for parents, CBCL;Children’s Depression Inventory 2, K-CDI-2:SR;Revised Children’s Manifest Anxiety Scale 2, RCMAS-2;Incidence proportion of adverse events and harm during exercise;Incidence rate of adverse events and harm during exercise;Changes in pre- and post-workout heart rate, oxygen saturation (SpO2), and respiratory rate;Rate of Perceived Exertion, Borg scale	—

Measure

Time frame

Attendance rate;Drop-out rate;oxygen consumption, VO2;Respiratory exchange rate, RER;minute ventilation, VE;ventilation effectiveness, VE/VO2;oxygen per pulse, O2 pulse;oxygen saturation, SpO2;maximal heart rate during exercise, HR max;heart rate and blood pressure by exercise intensity;average number of steps for 7days using smartwatch;average moderate-vigorous physical activity time for 7days using smartwatch, minutes;skeletal muscle mass;body fat mass;body fat percentage;Abdominal fat percentage;Intracellular moisture, extracellular moisture, extracellular moisture ratio;Radial artery pulse wave amplification index;carotid-femoral pulse wave propagation velocity;brachial artery vascular endothelial cell function;6 minutes walk test;lower limb muscle strength test (peak torque & peak torque/BW);Upper extremity strength test: grip force (kg), relative grip force (%);Flexibility check: Flexibility distance (cm);Respiratory muscle strength test (MIP mmH2O);Global Physical Activity Questionnaire;Pediatric Quality of Life Inventory™ (PedsQL™) for subjects and parents;Pediatric Quality of Life Inventory Cardiac, PedsQL™ Cardiac;Program satisfactory survey;Resilience Scale for Youth, RS-Y;Child Behavior Checklist for parents, CBCL;Children’s Depression Inventory 2, K-CDI-2:SR;Revised Children’s Manifest Anxiety Scale 2, RCMAS-2;Incidence proportion of adverse events and harm during exercise;Incidence rate of adverse events and harm during exercise;Changes in pre- and post-workout heart rate, oxygen saturation (SpO2), and respiratory rate;Rate of Perceived Exertion, Borg scale

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Countries

Korea, Republic of

Contacts

Public ContactSungbae Jo

Seoul National University Hospital

rew277@gmail.com+82-2-2072-4178

Outcome results