Remote Exercise Program for Pediatric ICU Survivors

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Exercise Adherence Rate [Срок оценки: Baseline through Week 12]
• Exercise Completion Rate [Срок оценки: At Week 12]
• Participant Satisfaction Score [Срок оценки: Pre-intervention and at Months 1, 2, 3, and 4]
• Intervention-Related Adverse Events [Срок оценки: Baseline through Month 4]
• Exercise Intervention Discontinuation [Срок оценки: Baseline through Week 12]

Вторичные конечные точки (12)

• Muscle Thickness by Ultrasound [Срок оценки: Baseline through 12 weeks]
• Medical Research Council Sum Score (MRC-SS) [Срок оценки: Baseline through Week 12]
• Hand Grip Strength [Срок оценки: Baseline through 12 weeks]
• Body Weight [Срок оценки: Baseline through 12 weeks]
• Sit and Reach Test [Срок оценки: Baseline through 12 weeks]
• Maximal Inspiratory Pressure (MIP) [Срок оценки: Baseline through Week 12]
• Maximal Expiratory Pressure (MEP) [Срок оценки: Baseline through Week 12]
• Peak Cough Flow (PCF) [Срок оценки: Baseline through Week 12]
• Pediatric Balance Scale [Срок оценки: Baseline through Week 12]
• 10 Meter Walk Test [Срок оценки: Baseline through 12 weeks]
• Movement Assessment Battery for Children-3 (MABC-3) [Срок оценки: Baseline through Week 12]
• Physical Activity [Срок оценки: Baseline through Week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07741942 · H-2606-206-1764

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗