Effects of Seated Exercise on Fatigue Associated With Prolonged Sitting During High-Speed Rail Travel (ESEFA-PSDHRT)

November 2, 2026 updated by: Aiyoudong Children and Youth Sports Health Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Standardized Age-Specific Seated Exercise Program

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.
Experimental: 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.
Other: Prolonged Sitting Control

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Subjective Fatigue
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Subjective Sleepiness
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aiyoudong Children and Youth Sports Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
All-China Federation of Railway Trade Unions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CISS20260710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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