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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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Shandong
      • Jinan, Shandong, 중국
        • Jinan Public Works Section, China Railway

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Male or female participants aged 7 to 60 years.
  2. Generally healthy and able to complete prolonged seated testing and the standardized seated exercise program.
  3. Able to understand and follow the study instructions and complete the required cognitive and physical assessments.
  4. Able to maintain a seated position for the experimental protocol, with standardized breaks permitted for essential needs.
  5. Willing to comply with study procedures and attend both crossover experimental sessions.
  6. Able to provide written informed consent.
  7. 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:

  1. Diagnosed cardiovascular, cerebrovascular, neurological, or other major systemic disease that may affect safe participation or study outcomes.
  2. Musculoskeletal injury, pain, or disorder that limits prolonged sitting, standing, walking, or performance of the seated exercise intervention.
  3. Acute illness, fever, or significant physical discomfort at the time of testing.
  4. History of syncope, severe dizziness, or other conditions that may increase the risk associated with prolonged sitting or exercise testing.
  5. 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.
  6. Known allergy or significant skin sensitivity to electrodes or adhesive materials used for EEG, ECG/HRV, or surface electromyography.
  7. Inability to adequately complete the cognitive assessment procedures because of communication, visual, auditory, or other functional limitations.
  8. Participation in vigorous exercise, alcohol consumption, or other behaviors inconsistent with the standardized pre-test requirements within the predefined period before testing.
  9. Any condition judged by the investigators to make participation unsafe or to substantially interfere with interpretation of the study outcomes.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Subjective Fatigue
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Subjective Sleepiness
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 1일

기본 완료 (실제)

2026년 10월 20일

연구 완료 (실제)

2026년 10월 20일

연구 등록 날짜

최초 제출

2026년 11월 2일

QC 기준을 충족하는 최초 제출

2026년 11월 2일

처음 게시됨 (실제)

2026년 11월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CISS20260710

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .