Remote Exercise Program for Pediatric ICU Survivors

NCT07741942 | Not Yet Recruiting

• 1 other identifier: H-2606-206-1764
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Post-Intensive Care Syndrome; Critical Illness

Keywords

Pediatric intensive care unit; Post-intensive care syndrome; Remote exercise; Telerehabilitation; Pediatric rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (17)

• Muscle Thickness by Ultrasound

  Baseline through 12 weeks

• Medical Research Council Sum Score (MRC-SS)

  Baseline through Week 12

• Hand Grip Strength

  Baseline through 12 weeks

• Body Weight

  Baseline through 12 weeks

• Sit and Reach Test

  Baseline through 12 weeks

Study Arms (1)

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.

Behavioral: Remote Exercise Intervention Program

Interventions

Remote Exercise Intervention Program BEHAVIORAL

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.

Remote Exercise Intervention

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sung Eun Hyun, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Ha Lee, M.S.

CONTACT

+82-2-2072-3608; pedshlee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All enrolled participants will receive the same individualized remote exercise intervention program. There is no comparison group.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)