Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Exercise Adherence Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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
- 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)
- Maximal Inspiratory Pressure (MIP)(Baseline through Week 12)
- Maximal Expiratory Pressure (MEP)(Baseline through Week 12)
- Peak Cough Flow (PCF)(Baseline through Week 12)
- Pediatric Balance Scale(Baseline through Week 12)
- 10 Meter Walk Test(Baseline through 12 weeks)
- Movement Assessment Battery for Children-3 (MABC-3)(Baseline through Week 12)
- Physical Activity(Baseline through Week 16)
- Modified Barthel Index(Baseline through 16 weeks)
- Modified Rankin Scale(Baseline through 16 weeks)
- Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales(Baseline through 16 weeks)
- PROMIS Parent Proxy Anxiety(Baseline through 16 weeks)
- PROMIS Parent Proxy Depressive Symptoms(Baseline through 16 weeks)
Investigators
Sung Eun Hyun
Associate Professor
Seoul National University Hospital