Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease

NCT06912412 | Not Yet Recruiting

• 1 other identifier: FP-2024-00016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• Drop-out rate

  baseline, 12 weeks after, 24 weeks after follow-up

• Attendance rate

  baseline, 12 weeks after, 24 weeks after follow-up

Secondary Outcomes (42)

• oxygen consumption, VO2

  baseline, 12 weeks after, 24 weeks after follow-up

• maximal oxygen consumption, VO2 max

  baseline, 12 weeks after, 24 weeks after follow-up

• Respiratory exchange rate, RER

  baseline, 12 weeks after, 24 weeks after follow-up

• minute ventilation (VE)

  baseline, 12 weeks after, 24 weeks after follow-up

• ventilation effectiveness, VE/VO2

  baseline, 12 weeks after, 24 weeks after follow-up

Study Arms (1)

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

Other: Community-based supervised remote cardiac rehabilitation; Other: Home-based cardiac rehabilitation program

Interventions

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).

Community-based remote cardiac rehabilitation group

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).

Community-based remote cardiac rehabilitation group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead
• University of Seoul: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sungbae Jo Research professor, Ph. D

CONTACT

82-10-9381-2299; rew277@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 4, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

KR (1)