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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Shandong
-
Jinan, Shandong, Китай
- Jinan Public Works Section, China Railway
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Subjective Fatigue
Временное ограничение: Baseline (T0), immediately after the initial intervention (T1), and at the end of the approximately 7-hour sitting session (T2)
|
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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Subjective Sleepiness
Временное ограничение: 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)
|
|
Change in Local Musculoskeletal Discomfort
Временное ограничение: 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)
|
|
Change in Positive and Negative Affect
Временное ограничение: 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
Временное ограничение: 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)
|
|
Change in Working Memory Performance
Временное ограничение: 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)
|
|
Change in Inhibitory Control Performance
Временное ограничение: 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)
|
|
Change in Heart Rate Variability
Временное ограничение: 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)
|
|
Change in Salivary Cortisol Concentration
Временное ограничение: Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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)
|
|
Change in Salivary Alpha-Amylase Activity
Временное ограничение: Baseline (T0) and at the end of the approximately 7-hour sitting session (T2)
|
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)
|
|
Change in Plantar Pressure and Postural Control
Временное ограничение: 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)
|
|
Change in Surface Electromyographic Indicators of Muscle Fatigue
Временное ограничение: 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)
|
|
Change in Electroencephalographic Spectral Power
Временное ограничение: 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)
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CISS20260710
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Сроки обмена IPD
Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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