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Remote Exercise Program for Pediatric ICU Survivors

28 juillet 2026 mis à jour par: Sung Eun Hyun, Seoul National University Hospital

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Seung Ha Lee, M.S.
  • Numéro de téléphone: +82-2-2072-3608
  • E-mail: pedshlee@gmail.com

Lieux d'étude

  • Corée du Sud
      • Seoul, Corée du Sud, 03080
        • Seoul National University Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Remote Exercise Intervention
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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Exercise Adherence Rate
Délai: 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.
Baseline through Week 12
Exercise Completion Rate
Délai: 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.
At Week 12
Participant Satisfaction Score
Délai: 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.
Pre-intervention and at Months 1, 2, 3, and 4
Intervention-Related Adverse Events
Délai: Baseline through Month 4
The number of intervention-related adverse events occurring during the study period will be recorded.
Baseline through Month 4
Exercise Intervention Discontinuation
Délai: Baseline through Week 12
The number of participants who discontinue the remote exercise intervention will be recorded. Reasons for discontinuation will also be documented.
Baseline through Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Muscle Thickness by Ultrasound
Délai: Baseline through 12 weeks
Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.
Baseline through 12 weeks
Medical Research Council Sum Score (MRC-SS)
Délai: 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.
Baseline through Week 12
Hand Grip Strength
Délai: 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.
Baseline through 12 weeks
Body Weight
Délai: 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.
Baseline through 12 weeks
Sit and Reach Test
Délai: Baseline through 12 weeks
Flexibility will be assessed using the Sit and Reach Test.
Baseline through 12 weeks
Maximal Inspiratory Pressure (MIP)
Délai: 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.
Baseline through Week 12
Maximal Expiratory Pressure (MEP)
Délai: 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.
Baseline through Week 12
Peak Cough Flow (PCF)
Délai: 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.
Baseline through Week 12
Pediatric Balance Scale
Délai: 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.
Baseline through Week 12
10 Meter Walk Test
Délai: 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.
Baseline through 12 weeks
Movement Assessment Battery for Children-3 (MABC-3)
Délai: 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.
Baseline through Week 12
Physical Activity
Délai: 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.
Baseline through Week 16
Modified Barthel Index
Délai: 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.
Baseline through 16 weeks
Modified Rankin Scale
Délai: 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.
Baseline through 16 weeks
Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales
Délai: 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.
Baseline through 16 weeks
PROMIS Parent Proxy Anxiety
Délai: 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.
Baseline through 16 weeks
PROMIS Parent Proxy Depressive Symptoms
Délai: 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.
Baseline through 16 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Seoul National University Hospital

Les enquêteurs

  • Chercheur principal: Sung Eun Hyun, M.D., Ph.D., Seoul National University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

23 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H-2606-206-1764

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data are not planned to be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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