Remote Exercise Program for Pediatric ICU Survivors
2026年7月28日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Seung Ha Lee, M.S.
- 電話番号：+82-2-2072-3608
- メール：pedshlee@gmail.com
研究場所
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Seoul、韓国、03080
- Seoul National University Hospital
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コンタクト：
- Seung Ha Lee, M.S.
- 電話番号：+82-2-2072-3608
- メール：pedshlee@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exercise Adherence Rate
時間枠：Baseline through Week 12
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Exercise adherence rate will be calculated as the percentage of prescribed exercise sessions completed by each participant during the 12-week remote exercise intervention.
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Baseline through Week 12
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Exercise Completion Rate
時間枠：At Week 12
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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.
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At Week 12
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Participant Satisfaction Score
時間枠：Pre-intervention and at Months 1, 2, 3, and 4
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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.
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Pre-intervention and at Months 1, 2, 3, and 4
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Intervention-Related Adverse Events
時間枠：Baseline through Month 4
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The number of intervention-related adverse events occurring during the study period will be recorded.
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Baseline through Month 4
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Exercise Intervention Discontinuation
時間枠：Baseline through Week 12
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The number of participants who discontinue the remote exercise intervention will be recorded.
Reasons for discontinuation will also be documented.
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Baseline through Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle Thickness by Ultrasound
時間枠：Baseline through 12 weeks
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Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.
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Baseline through 12 weeks
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Medical Research Council Sum Score (MRC-SS)
時間枠：Baseline through Week 12
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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.
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Baseline through Week 12
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Hand Grip Strength
時間枠：Baseline through 12 weeks
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Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg).
Higher values indicate greater hand grip strength.
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Baseline through 12 weeks
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Body Weight
時間枠：Baseline through 12 weeks
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Body weight will be measured using a digital scale and recorded in kilograms (kg) to monitor physical changes during the intervention.
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Baseline through 12 weeks
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Sit and Reach Test
時間枠：Baseline through 12 weeks
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Flexibility will be assessed using the Sit and Reach Test.
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Baseline through 12 weeks
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Maximal Inspiratory Pressure (MIP)
時間枠：Baseline through Week 12
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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.
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Baseline through Week 12
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Maximal Expiratory Pressure (MEP)
時間枠：Baseline through Week 12
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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.
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Baseline through Week 12
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Peak Cough Flow (PCF)
時間枠：Baseline through Week 12
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Cough effectiveness will be assessed using peak cough flow (PCF), measured in liters per minute (L/min).
Higher values indicate better cough function.
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Baseline through Week 12
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Pediatric Balance Scale
時間枠：Baseline through Week 12
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Balance function will be assessed using the Pediatric Balance Scale.
Total scores range from 0 to 56, with higher scores indicating better balance function.
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Baseline through Week 12
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10 Meter Walk Test
時間枠：Baseline through 12 weeks
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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.
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Baseline through 12 weeks
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Movement Assessment Battery for Children-3 (MABC-3)
時間枠：Baseline through Week 12
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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.
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Baseline through Week 12
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Physical Activity
時間枠：Baseline through Week 16
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Physical activity will be continuously monitored using a smartwatch and quantified as metabolic equivalents (METs).
Higher MET values indicate greater physical activity levels.
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Baseline through Week 16
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Modified Barthel Index
時間枠：Baseline through 16 weeks
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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.
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Baseline through 16 weeks
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Modified Rankin Scale
時間枠：Baseline through 16 weeks
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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.
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Baseline through 16 weeks
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Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales
時間枠：Baseline through 16 weeks
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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.
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Baseline through 16 weeks
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PROMIS Parent Proxy Anxiety
時間枠：Baseline through 16 weeks
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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.
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Baseline through 16 weeks
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PROMIS Parent Proxy Depressive Symptoms
時間枠：Baseline through 16 weeks
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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.
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Baseline through 16 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Sung Eun Hyun, M.D., Ph.D.、Seoul National University Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H-2606-206-1764
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data are not planned to be shared.
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いいえ
米国FDA規制機器製品の研究
いいえ
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