Remote Exercise Program for Pediatric ICU Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Pediatric Post-Intensive Care Syndrome
• Intervention / Treatment: Behavioral: Remote Exercise Intervention Program

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Ha Lee, M.S.; Phone Number: +82-2-2072-3608; Email: pedshlee@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
    • Contact: Seung Ha Lee, M.S.; Phone Number: +82-2-2072-3608; Email: pedshlee@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote Exercise Intervention; 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.

Behavioral: Remote 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline through Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Thickness by Ultrasound	Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.	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.	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.	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.	Baseline through 12 weeks
Sit and Reach Test	Flexibility will be assessed using the Sit and Reach Test.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline through 16 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Sung Eun Hyun, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; Remote exercise; Pediatric rehabilitation; Pediatric intensive care unit; Post-intensive care syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; postintensive care syndrome
• Other Study ID Numbers: H-2606-206-1764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not planned to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No