Remote Exercise Program for Pediatric ICU Survivors

N/ANot Yet RecruitingNCT07741942

Seoul National University Hospital10 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline through Week 12

Secondary Outcomes

Muscle Thickness by Ultrasound

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline through 12 weeks

Sit and Reach Test

Flexibility will be assessed using the Sit and Reach Test.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline through 16 weeks

Remote Exercise Program for Pediatric ICU Survivors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts