Critical Illness, Pediatric Post-Intensive Care Syndrome
Conditions
Keywords
Pediatric intensive care unit, Post-intensive care syndrome, Remote exercise, Telerehabilitation, Pediatric rehabilitation
Brief 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). 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.
Interventions
BEHAVIORALRemote Exercise Intervention Program
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All enrolled participants will receive the same individualized remote exercise intervention program. There is no comparison group.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Adherence Rate | 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 | 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 | 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 | Baseline through Month 4 | The number of intervention-related adverse events occurring during the study period will be recorded. |
| Exercise Intervention Discontinuation | Baseline through Week 12 | The number of participants who discontinue the remote exercise intervention will be recorded. Reasons for discontinuation will also be documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Thickness by Ultrasound | Baseline through 12 weeks | Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention. |
| Medical Research Council Sum Score (MRC-SS) | Baseline through Week 12 | 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. |
| Hand Grip Strength | Baseline through 12 weeks | Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater hand grip strength. |
| Body Weight | Baseline through 12 weeks | Body weight will be measured using a digital scale and recorded in kilograms (kg) to monitor physical changes during the intervention. |
| Sit and Reach Test | Baseline through 12 weeks | Flexibility will be assessed using the Sit and Reach Test. |
| Maximal Inspiratory Pressure (MIP) | Baseline through Week 12 | 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. |
| Maximal Expiratory Pressure (MEP) | Baseline through Week 12 | 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. |
| Peak Cough Flow (PCF) | Baseline through Week 12 | Cough effectiveness will be assessed using peak cough flow (PCF), measured in liters per minute (L/min). Higher values indicate better cough function. |
| Pediatric Balance Scale | Baseline through Week 12 | Balance function will be assessed using the Pediatric Balance Scale. Total scores range from 0 to 56, with higher scores indicating better balance function. |
| 10 Meter Walk Test | Baseline through 12 weeks | 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. |
| Movement Assessment Battery for Children-3 (MABC-3) | Baseline through Week 12 | 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. |
| Physical Activity | Baseline through Week 16 | Physical activity will be continuously monitored using a smartwatch and quantified as metabolic equivalents (METs). Higher MET values indicate greater physical activity levels. |
| Modified Barthel Index | Baseline through 16 weeks | 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. |
| Modified Rankin Scale | Baseline through 16 weeks | 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. |
| Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales | Baseline through 16 weeks | 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. |
| PROMIS Parent Proxy Anxiety | Baseline through 16 weeks | 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. |
| PROMIS Parent Proxy Depressive Symptoms | Baseline through 16 weeks | 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. |
Countries
South Korea
Contacts
CONTACTSeung Ha Lee, M.S.
PRINCIPAL_INVESTIGATORSung Eun Hyun, M.D., Ph.D.
Seoul National University Hospital
Outcome results
None listed