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Remote Exercise Program for Pediatric ICU Survivors

tiistai 28. heinäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

10

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Seung Ha Lee, M.S.
  • Puhelinnumero: +82-2-2072-3608
  • Sähköposti: pedshlee@gmail.com

Opiskelupaikat

  • Etelä -Korea
      • Seoul, Etelä -Korea, 03080
        • Seoul National University Hospital
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Exercise Adherence Rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Muscle Thickness by Ultrasound
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline through 12 weeks
Flexibility will be assessed using the Sit and Reach Test.
Baseline through 12 weeks
Maximal Inspiratory Pressure (MIP)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Seoul National University Hospital

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • H-2606-206-1764

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

Individual participant data are not planned to be shared.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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