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NCT Number: NCT07741942

Remote Exercise Program for Pediatric ICU 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.

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Key information

Conditions

Pediatric Post-Intensive Care Syndrome Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms postintensive care syndrome

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Muscle Thickness by Ultrasound

    Time frame: Baseline through 12 weeks

    Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.

  2. Medical Research Council Sum Score (MRC-SS)

    Time frame: 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.

  3. Hand Grip Strength

    Time frame: 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.

  4. Body Weight

    Time frame: 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.

  5. Sit and Reach Test

    Time frame: Baseline through 12 weeks

    Flexibility will be assessed using the Sit and Reach Test.

  6. Maximal Inspiratory Pressure (MIP)

    Time frame: 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.

  7. Maximal Expiratory Pressure (MEP)

    Time frame: 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.

  8. Peak Cough Flow (PCF)

    Time frame: 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.

  9. Pediatric Balance Scale

    Time frame: 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. 10 Meter Walk Test

    Time frame: 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.

  11. Movement Assessment Battery for Children-3 (MABC-3)

    Time frame: 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.

  12. Physical Activity

    Time frame: 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.

  13. Modified Barthel Index

    Time frame: 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.

  14. Modified Rankin Scale

    Time frame: 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.

  15. Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales

    Time frame: 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.

  16. PROMIS Parent Proxy Anxiety

    Time frame: 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.

  17. PROMIS Parent Proxy Depressive Symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seung Ha Lee, M.S.

CONTACT

[email protected]

+82-2-2072-3608

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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