Effects of Seated Exercise on Fatigue Associated With Prolonged Sitting During High-Speed Rail Travel (ESEFA-PSDHRT)
Effects of a Standardized Seated Exercise Program on Multidimensional Fatigue Associated With Prolonged Sitting During High-Speed Rail Travel: A Randomized Crossover Controlled Trial
Prolonged sitting during high-speed rail travel may contribute to subjective fatigue, musculoskeletal discomfort, sleepiness, reduced alertness, cognitive impairment, and changes in physiological and neurophysiological function.
This randomized crossover controlled trial aims to evaluate the effects of a standardized age-specific seated exercise program on multidimensional fatigue associated with prolonged sitting during simulated high-speed rail travel.
Participants aged 7 to 60 years will be analyzed within three prespecified age groups: 7-18 years, 18-45 years, and 45-60 years. Each participant will complete both a seated exercise condition and a prolonged sitting control condition in randomized order.
Outcome measures will include subjective fatigue, sleepiness, local discomfort, mood, attention, psychomotor vigilance, working memory, inhibitory control, heart rate variability, salivary biomarkers, surface electromyography, plantar pressure and postural control measures, and electroencephalographic indices.
The study aims to determine whether brief standardized seated exercise performed periodically during prolonged sitting can reduce fatigue and maintain physical, cognitive, autonomic, and neurophysiological function during simulated high-speed rail travel.
調査の概要
状態
条件
詳細な説明
The study will use a randomized crossover design to evaluate a standardized seated exercise program under simulated prolonged high-speed rail travel conditions. Each participant will complete two experimental sessions in randomized order: a seated exercise condition and a prolonged sitting control condition. The two sessions will be separated by a washout period of at least 7 days to minimize potential carryover effects.
Each experimental session will last approximately 7 hours in a simulated high-speed rail seating environment. Baseline assessments will be completed before prolonged sitting. During the seated exercise condition, participants will perform a standardized age-appropriate seated exercise program according to a predefined schedule, with exercise repeated approximately once every hour during the prolonged sitting period. During the control condition, participants will remain seated under the same environmental and assessment conditions without performing the structured exercise program.
Standardized breaks for essential needs, including drinking water, meals, and restroom use, will be permitted and recorded. The timing of experimental sessions, pre-test requirements, assessment procedures, and environmental conditions will be standardized as far as possible between the two study periods.
Participants will be stratified into three prespecified age groups (7-18 years, 18-45 years, and 45-60 years). Age-appropriate instructions and assessment procedures will be used for younger participants. For participants younger than 18 years, written informed consent will be obtained from a parent or legal guardian together with age-appropriate assent from the participant.
The study is designed to determine whether brief, repeated seated exercise can attenuate the multidimensional effects of prolonged sitting and help maintain subjective well-being, cognitive performance, autonomic regulation, neuromuscular function, postural control, and neurophysiological function during prolonged simulated high-speed rail travel.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Shandong
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Jinan、Shandong、中国
- Jinan Public Works Section, China Railway
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female participants aged 7 to 60 years.
- Generally healthy and able to complete prolonged seated testing and the standardized seated exercise program.
- Able to understand and follow the study instructions and complete the required cognitive and physical assessments.
- Able to maintain a seated position for the experimental protocol, with standardized breaks permitted for essential needs.
- Willing to comply with study procedures and attend both crossover experimental sessions.
- Able to provide written informed consent.
- For participants younger than 18 years, written informed consent will be obtained from a parent or legal guardian, together with age-appropriate assent from the participant.
Exclusion Criteria:
- Diagnosed cardiovascular, cerebrovascular, neurological, or other major systemic disease that may affect safe participation or study outcomes.
- Musculoskeletal injury, pain, or disorder that limits prolonged sitting, standing, walking, or performance of the seated exercise intervention.
- Acute illness, fever, or significant physical discomfort at the time of testing.
- History of syncope, severe dizziness, or other conditions that may increase the risk associated with prolonged sitting or exercise testing.
- Current use of medications that may substantially affect autonomic nervous system function, alertness, cognitive performance, or salivary stress biomarkers, unless considered clinically stable and acceptable by the investigators.
- Known allergy or significant skin sensitivity to electrodes or adhesive materials used for EEG, ECG/HRV, or surface electromyography.
- Inability to adequately complete the cognitive assessment procedures because of communication, visual, auditory, or other functional limitations.
- Participation in vigorous exercise, alcohol consumption, or other behaviors inconsistent with the standardized pre-test requirements within the predefined period before testing.
- Any condition judged by the investigators to make participation unsafe or to substantially interfere with interpretation of the study outcomes.
研究計画
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Sequence AB: Seated Exercise Followed by Control
Participants will first complete the seated exercise condition during Period 1. After a washout period of at least 7 days, they will complete the prolonged sitting control condition during Period 2. |
A standardized seated exercise program designed for prolonged high-speed rail travel. The program consists of a predefined sequence of seated movements that can be performed within the spatial constraints of a high-speed rail seat. Age-specific instructional videos are used to standardize the exercise content, movement sequence, rhythm, duration, and instructions for participants aged 7-18 years, 18-45 years, and 45-60 years. During the seated exercise condition, participants perform the standardized exercise at the predefined intervention time point and approximately once every hour during the prolonged sitting period. |
|
実験的：Sequence BA: Control Followed by Seated Exercise
Participants will first complete the prolonged sitting control condition during Period 1. After a washout period of at least 7 days, they will complete the seated exercise condition during Period 2. |
Participants remain seated in the same simulated high-speed rail environment for approximately 7 hours and undergo the same assessment schedule as in the seated exercise condition, but do not perform the structured seated exercise program. Standardized brief breaks for essential needs, including restroom use, drinking water, and scheduled meals, are permitted and recorded. The duration and environmental conditions are standardized as far as practicable between the seated exercise and control conditions. |
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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Change in Subjective Fatigue
時間枠：Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
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Subjective fatigue will be assessed using an age-appropriate Visual Analog Scale (VAS). Participants aged 7-18 years will use an age-adapted visual scale, while adult participants will use a standard VAS. Scores will be standardized to a 0-100 scale for analysis, with higher scores indicating greater subjective fatigue. |
Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Subjective Sleepiness
時間枠：Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
Subjective sleepiness will be assessed using the Karolinska Sleepiness Scale (KSS) or an age-adapted version for younger participants. Higher scores indicate greater sleepiness. |
Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Local Musculoskeletal Discomfort
時間枠：Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
Local musculoskeletal discomfort will be assessed using a numerical rating scale or an age-appropriate facial rating scale. Higher scores indicate greater perceived discomfort or pain. |
Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Positive and Negative Affect
時間枠：Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
Mood will be assessed using the Positive and Negative Affect Schedule (PANAS) or an age-adapted version for younger participants. Positive and negative affect scores will be analyzed separately. |
Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
|
Change in Psychomotor Vigilance
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Psychomotor vigilance will be assessed using a 3-minute Psychomotor Vigilance Task (PVT). Outcomes will include reaction time and lapses, with longer reaction times and more lapses indicating poorer vigilance. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Working Memory Performance
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Working memory will be assessed using an n-back task. Accuracy and reaction time will be recorded. Age-appropriate task difficulty will be used for younger participants. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Inhibitory Control Performance
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Inhibitory control will be assessed using a Stroop task. Accuracy, reaction time, and interference-related performance will be recorded using age-appropriate task versions. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Heart Rate Variability
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Autonomic nervous system function will be assessed using heart rate variability (HRV). Primary HRV indices will include RMSSD and SDNN. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Change in Salivary Cortisol Concentration
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Salivary cortisol concentration will be measured as an indicator of physiological stress response. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Change in Salivary Alpha-Amylase Activity
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Salivary alpha-amylase activity will be measured as an additional biomarker of physiological stress and autonomic activation. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Change in Plantar Pressure and Postural Control
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Plantar pressure and postural control will be assessed using a plantar pressure platform. Outcomes will include plantar pressure distribution and center-of-pressure measures such as path length and mean velocity. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
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Change in Surface Electromyographic Indicators of Muscle Fatigue
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Surface electromyography (sEMG) will be used to assess neuromuscular changes associated with prolonged sitting. Amplitude- and frequency-domain indicators of muscle activity and fatigue will be analyzed. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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Change in Electroencephalographic Spectral Power
時間枠：Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
Electroencephalography (EEG) will be used to assess neurophysiological changes associated with prolonged sitting and seated exercise. Spectral power in the theta, alpha, and beta frequency bands will be analyzed. |
Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- CISS20260710
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?
IPD プランの説明
De-identified individual participant data underlying the main results of the study may be shared with qualified researchers upon reasonable request following publication of the primary study results. Shared data may include de-identified demographic, behavioral, physiological, and primary and secondary outcome data, subject to applicable ethical and data protection requirements.
IPD 共有時間枠
Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
IPD 共有アクセス基準
Data requests will be reviewed by the principal investigator and research team. Researchers requesting access should provide a scientifically justified research proposal, a data analysis plan, and evidence of appropriate ethical approval where applicable. Data will be shared only for legitimate scientific purposes and subject to a data use agreement and applicable privacy and ethical requirements.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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