Pediatric Post-Intensive Care SyndromeNCT07741942
Remote Exercise Program for Pediatric ICU Survivors
A study testing Remote Exercise Intervention Program in people with Pediatric Post-Intensive Care Syndrome and Critical Illness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Post-Intensive Care Syndrome, Critical Illness
- What is being tested?
- Remote Exercise Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Mar 2027
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3 to 18 years.
- Discharged from the pediatric intensive care unit (PICU) after at least 48 hours of treatment.
- Has not recovered to the pre-PICU level of physical function (walking and mobility), confirmed using the Pediatric Overall Performance Category Scale (POPC) and the Gross Motor Function Classification System Family Report Questionnaire (GMFCS Family Report).
- Has sufficient cognitive and physical ability to understand and participate in the home-based exercise intervention.
- Able to maintain adequate attention for exercise training, assessed using the Richmond Agitation-Sedation Scale (RASS) and age-appropriate delirium assessment (psCAM-ICU or pCAM-ICU), when applicable.
- Written informed consent provided by the parent or legal guardian.
Who cannot join
- Newly developed neuromuscular disease after PICU admission that prevents participation in the video-based exercise program without therapist assistance.
- Medical conditions, indwelling catheters, or implanted medical devices requiring restriction of limb movement.
- Language or cognitive impairment that prevents understanding of the video-based exercise program.
- Uncontrolled hypertension, arrhythmia, persistent fever due to infection, or any condition making exercise unsafe.
- Declines to participate in the study.
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
Seung Ha Lee, M.S., +82-2-2072-3608, pedshlee@gmail.com
About this study
Official title: Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors
This pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Children aged 3 to 18 years who received intensive care for at least 48 hours and have not recovered to their pre-admission functional status will participate in an individualized home-based exercise program for 12 weeks. The intervention includes remotely supervised exercise sessions, prescribed self-exercise, and weekly monitoring using videoconferencing. Study assessments will be performed at baseline, immediately before intervention initiation, monthly during the 12-week intervention, and 1 month after completion of the intervention to evaluate feasibility, safety, functional recovery, and maintenance of treatment effects.
Read the detailed description
Pediatric survivors of critical illness are at risk of developing pediatric post-intensive care syndrome (PICS-p), which includes physical, cognitive, emotional, and social impairments that may persist after discharge from the pediatric intensive care unit (PICU). Although early rehabilitation is recognized as an important strategy for improving recovery, sustained rehabilitation after hospital discharge remains challenging because of barriers such as repeated hospital visits and limited accessibility.
The purpose of this single-arm pilot clinical trial is to evaluate the feasibility and safety of a remote exercise intervention program for children at risk of PICS-p after PICU discharge and to generate preliminary data for a future confirmatory clinical trial.
Eligible participants are children aged 3 to 18 years who received treatment in the PICU for at least 48 hours and have not recovered to their pre-admission functional status. Participants will receive an individualized home-based exercise program consisting of remotely supervised exercise sessions, prescribed self-exercise using instructional video content, and weekly monitoring and feedback through videoconferencing.
The intervention will be delivered over 12 weeks. Outcome assessments will be conducted after PICU discharge (baseline), immediately before intervention initiation, monthly during the intervention, and 1 month after completion of the intervention to evaluate maintenance of treatment effects.
The primary outcomes include feasibility and safety, including adherence, completion rate, user satisfaction, adverse events, and reasons for discontinuation. Secondary outcomes include exploratory changes in physical function, respiratory function, balance, gait speed, muscle strength, motor performance, physical activity, activities of daily living, disability, quality of life, anxiety, and depressive symptoms. The findings will be used to optimize the intervention protocol and support the design of a future confirmatory clinical trial.
- Being tested
- Remote Exercise Intervention Program
- Keywords
- Pediatric intensive care unit, Post-intensive care syndrome, Remote exercise, Telerehabilitation, Pediatric rehabilitation
- Medical subject headings
- Critical Illness, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Exercise Intervention ProgramBehavioural
Participants will receive an individualized home-based remote exercise intervention program for 12 weeks. The intervention consists of individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing. The exercise program will be tailored and progressively adjusted according to each participant's functional status and clinical progress.
| Study group | Role | What they receive |
|---|---|---|
| Remote Exercise Intervention | Experimental | Participants will receive an individualized home-based remote exercise intervention program for 12 weeks following discharge from the pediatric intensive care unit. The intervention includes individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing. Receives: Behavioral: Remote Exercise Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Adherence Rate
Exercise adherence rate will be calculated as the percentage of prescribed exercise sessions completed by each participant during the 12-week remote exercise intervention.
Measured: Baseline through Week 12
Exercise Completion Rate
Exercise completion rate will be calculated as the percentage of participants who complete the 12-week remote exercise intervention as specified in the study protocol.
Measured: At Week 12
Participant Satisfaction Score
Participant satisfaction with the remote exercise intervention will be assessed using a study-specific satisfaction questionnaire at pre-intervention and at Months 1, 2, 3, and 4. Total scores range from 6 to 30, with higher scores indicating greater satisfaction.
Measured: Pre-intervention and at Months 1, 2, 3, and 4
Intervention-Related Adverse Events
The number of intervention-related adverse events occurring during the study period will be recorded.
Measured: Baseline through Month 4
Exercise Intervention Discontinuation
The number of participants who discontinue the remote exercise intervention will be recorded. Reasons for discontinuation will also be documented.
Measured: Baseline through Week 12
Secondary outcomes (17)
Muscle Thickness by Ultrasound
Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.
Measured: Baseline through 12 weeks
Medical Research Council Sum Score (MRC-SS)
Muscle strength will be assessed using the Medical Research Council Sum Score (MRC-SS). Total scores range from 0 to 60, with higher scores indicating greater muscle strength.
Measured: Baseline through Week 12
Hand Grip Strength
Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater hand grip strength.
Measured: Baseline through 12 weeks
Body Weight
Body weight will be measured using a digital scale and recorded in kilograms (kg) to monitor physical changes during the intervention.
Measured: Baseline through 12 weeks
Sit and Reach Test
Flexibility will be assessed using the Sit and Reach Test.
Measured: Baseline through 12 weeks
Maximal Inspiratory Pressure (MIP)
Inspiratory muscle strength will be assessed using maximal inspiratory pressure (MIP), measured in centimeters of water pressure (cmH₂O). Higher values indicate greater inspiratory muscle strength.
Measured: Baseline through Week 12
Maximal Expiratory Pressure (MEP)
Expiratory muscle strength will be assessed using maximal expiratory pressure (MEP), measured in centimeters of water pressure (cmH₂O). Higher values indicate greater expiratory muscle strength.
Measured: Baseline through Week 12
Peak Cough Flow (PCF)
Cough effectiveness will be assessed using peak cough flow (PCF), measured in liters per minute (L/min). Higher values indicate better cough function.
Measured: Baseline through Week 12
Pediatric Balance Scale
Balance function will be assessed using the Pediatric Balance Scale. Total scores range from 0 to 56, with higher scores indicating better balance function.
Measured: Baseline through Week 12
10 Meter Walk Test
Walking ability will be assessed using the 10 Meter Walk Test. Walking speed will be recorded in meters per second (m/s). Higher values indicate faster walking speed.
Measured: Baseline through 12 weeks
Movement Assessment Battery for Children-3 (MABC-3)
Motor performance will be assessed using the Movement Assessment Battery for Children-3 (MABC-3). Total standard scores range from 1 to 19, with higher scores indicating better motor performance.
Measured: Baseline through Week 12
Physical Activity
Physical activity will be continuously monitored using a smartwatch and quantified as metabolic equivalents (METs). Higher MET values indicate greater physical activity levels.
Measured: Baseline through Week 16
Modified Barthel Index
Functional independence in activities of daily living will be assessed using the Modified Barthel Index. Total scores range from 0 to 100, with higher scores indicating greater functional independence in activities of daily living.
Measured: Baseline through 16 weeks
Modified Rankin Scale
Overall functional disability will be assessed using the Modified Rankin Scale. Total scores range from 0 to 6, with higher scores indicating greater functional disability.
Measured: Baseline through 16 weeks
Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales. Total scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline through 16 weeks
PROMIS Parent Proxy Anxiety
Anxiety symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Anxiety (Short Form 8a v2.0). Raw summed scores range from 8 to 40 and are converted to standardized T-scores for analysis. Higher T-scores indicate greater anxiety symptoms.
Measured: Baseline through 16 weeks
PROMIS Parent Proxy Depressive Symptoms
Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms (Short Form 6a v2.0). Raw summed scores range from 6 to 30 and are converted to standardized T-scores for analysis. Higher T-scores indicate greater depressive symptoms.
Measured: Baseline through 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Post-Intensive Care SyndromeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the same individualized remote exercise intervention program. There is no comparison group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Eun Hyun, Seoul National University Hospital
- Investigators
- Sung Eun Hyun, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741942
- Sponsor's protocol ID
- H-2606-206-1764
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors
- ClinicalTrials.gov ID
- NCT07741942
- Acronym / sponsor ID
- H-2606-206-1764
- Keywords
- Pediatric intensive care unit, Post-intensive care syndrome, Remote exercise, Telerehabilitation, Pediatric rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Aug 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 pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Children aged 3 to 18 years who received intensive care for at least 48 hours and have not recovered to their pre-admission functional status will participate in an individualized home-based exercise program for 12 weeks. The intervention includes remotely supervised exercise sessions, prescribed self-exercise, and weekly monitoring using videoconferencing. Study assessments will be performed at baseline, immediately before intervention initiation, monthly during the 12-week intervention, and 1 month after completion of the intervention to evaluate feasibility, safety, functional recovery, and maintenance of treatment effects.
Detailed description
Pediatric survivors of critical illness are at risk of developing pediatric post-intensive care syndrome (PICS-p), which includes physical, cognitive, emotional, and social impairments that may persist after discharge from the pediatric intensive care unit (PICU). Although early rehabilitation is recognized as an important strategy for improving recovery, sustained rehabilitation after hospital discharge remains challenging because of barriers such as repeated hospital visits and limited accessibility.
The purpose of this single-arm pilot clinical trial is to evaluate the feasibility and safety of a remote exercise intervention program for children at risk of PICS-p after PICU discharge and to generate preliminary data for a future confirmatory clinical trial.
Eligible participants are children aged 3 to 18 years who received treatment in the PICU for at least 48 hours and have not recovered to their pre-admission functional status. Participants will receive an individualized home-based exercise program consisting of remotely supervised exercise sessions, prescribed self-exercise using instructional video content, and weekly monitoring and feedback through videoconferencing.
The intervention will be delivered over 12 weeks. Outcome assessments will be conducted after PICU discharge (baseline), immediately before intervention initiation, monthly during the intervention, and 1 month after completion of the intervention to evaluate maintenance of treatment effects.
The primary outcomes include feasibility and safety, including adherence, completion rate, user satisfaction, adverse events, and reasons for discontinuation. Secondary outcomes include exploratory changes in physical function, respiratory function, balance, gait speed, muscle strength, motor performance, physical activity, activities of daily living, disability, quality of life, anxiety, and depressive symptoms. The findings will be used to optimize the intervention protocol and support the design of a future confirmatory clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the same individualized remote exercise intervention program. There is no comparison group.
| Arm | Type | Receives |
|---|---|---|
| Remote Exercise Intervention | Experimental | Behavioral: Remote Exercise Intervention ProgramParticipants will receive an individualized home-based remote exercise intervention program for 12 weeks following discharge from the pediatric intensive care unit. The intervention includes individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 3 to 18 years.
- Discharged from the pediatric intensive care unit (PICU) after at least 48 hours of treatment.
- Has not recovered to the pre-PICU level of physical function (walking and mobility), confirmed using the Pediatric Overall Performance Category Scale (POPC) and the Gross Motor Function Classification System Family Report Questionnaire (GMFCS Family Report).
- Has sufficient cognitive and physical ability to understand and participate in the home-based exercise intervention.
- Able to maintain adequate attention for exercise training, assessed using the Richmond Agitation-Sedation Scale (RASS) and age-appropriate delirium assessment (psCAM-ICU or pCAM-ICU), when applicable.
Key exclusion criteria (5 listed)
- Newly developed neuromuscular disease after PICU admission that prevents participation in the video-based exercise program without therapist assistance.
- Medical conditions, indwelling catheters, or implanted medical devices requiring restriction of limb movement.
- Language or cognitive impairment that prevents understanding of the video-based exercise program.
- Uncontrolled hypertension, arrhythmia, persistent fever due to infection, or any condition making exercise unsafe.
- Declines to participate in the study.
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 |
|---|---|---|
| Remote Exercise Intervention ProgramParticipants will receive an individualized home-based remote exercise intervention program for 12 weeks. The intervention consists of individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing. The exercise program will be tailored and progressively adjusted according to each participant's functional status and clinical progress. | Behavioural | Remote Exercise Intervention |
Primary outcome
Exercise Adherence Rate
Time frame: Baseline through Week 12
Exercise adherence rate will be calculated as the percentage of prescribed exercise sessions completed by each participant during the 12-week remote exercise intervention.
Exercise Completion Rate
Time frame: At Week 12
Exercise completion rate will be calculated as the percentage of participants who complete the 12-week remote exercise intervention as specified in the study protocol.
Participant Satisfaction Score
Time frame: Pre-intervention and at Months 1, 2, 3, and 4
Participant satisfaction with the remote exercise intervention will be assessed using a study-specific satisfaction questionnaire at pre-intervention and at Months 1, 2, 3, and 4. Total scores range from 6 to 30, with higher scores indicating greater satisfaction.
Intervention-Related Adverse Events
Time frame: Baseline through Month 4
The number of intervention-related adverse events occurring during the study period will be recorded.
Exercise Intervention Discontinuation
Time frame: Baseline through Week 12
The number of participants who discontinue the remote exercise intervention will be recorded. Reasons for discontinuation will also be documented.
17 secondary outcomes
Muscle Thickness by Ultrasound
Time frame: Baseline through 12 weeks
Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline through Week 12
Hand Grip Strength
Time frame: Baseline through 12 weeks
Body Weight
Time frame: Baseline through 12 weeks
Sit and Reach Test
Time frame: Baseline through 12 weeks
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline through Week 12
Maximal Expiratory Pressure (MEP)
Time frame: Baseline through Week 12
Peak Cough Flow (PCF)
Time frame: Baseline through Week 12
Pediatric Balance Scale
Time frame: Baseline through Week 12
10 Meter Walk Test
Time frame: Baseline through 12 weeks
Movement Assessment Battery for Children-3 (MABC-3)
Time frame: Baseline through Week 12
Physical Activity
Time frame: Baseline through Week 16
Modified Barthel Index
Time frame: Baseline through 16 weeks
Modified Rankin Scale
Time frame: Baseline through 16 weeks
Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales
Time frame: Baseline through 16 weeks
PROMIS Parent Proxy Anxiety
Time frame: Baseline through 16 weeks
PROMIS Parent Proxy Depressive Symptoms
Time frame: Baseline through 16 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 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
Related trials for Pediatric Post-Intensive Care Syndrome
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
RecruitingObservational study
Surviving the Pediatric Intensive Care Unit (PICU)
Post Intensive Care Syndrome (PICS)
RecruitingObservational study
Experiences Reported by Siblings of Children Hospitalized in the PICU
Intensive Care Pediatric
Not yet recruitingObservational study
Outcomes of Children After Hospitalization in Intensive Care Unit
Renal Disease, Liver Diseases
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.
Sung Eun Hyun, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Exercise Intervention Program in people with Pediatric Post-Intensive Care Syndrome and Critical Illness, 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 6 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 3 Aug 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 Seung Ha Lee, M.S. (+82-2-2072-3608, pedshlee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Adherence Rate (time frame: Baseline through Week 12). The study lists 5 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 3 Aug 2026.