The Effect of Different Ways of Sitting on Cognitive Performance and Muscle Activity

January 19, 2021 updated by: Maastricht University
Academic educations concurs with a lot of sitting. Studies have shown that prolonged sitting not only has disruptive effects on physical health, but also influence mental health and cognition negatively. For physical health evidence grows that short light intense interruptions of sitting time effectively counterbalance the impact of prolonged sitting. It is not clear of light intense physical activity breaks have a similar positive effect on cognitive performance. Also, it is unclear whether cognitive loading might be able to compensate the impact of prolonged sitting.This study compares the effects of uninterrupted sitting with or without cognitive loading and interrupted sitting on cognitive functioning; muscle activation of leg and trunk muscles under various modes of sitting with walking, in order to calibrate the physical impact of different sitting modes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

healthy university students will attend three separate intervention visits with 6-days (no more than 14 days) washout in between: 1) uninterrupted sitting (SIT); 2) uninterrupted sitting with a cognitive task (COGN); 3) sitting interrupted by light physical activity (INTERRUPT). For the SIT and INTERRUPT conditions, subjects watch a series of documentaries while sitting. In the COGN condition, while sitting, participants undergo the online GED test as cognitive load. Four cognitive tests (D2 test, stroop test, trail making test and 2-BACK test) and mood states will be performed before and after each intervention. On a separate day, using surface electromyography, activations of major leg and trunk muscles of sitting on chair, active and passive sitting on a yoga ball and walking were assessed.

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.
21

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

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 ER
        • Faculty of Health, Medicine and Life Sciences

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-30 years
  • BMI between 18-28
  • steady dietary habits
  • generally healthy
  • Female on contraceptive pills/Male

Exclusion Criteria:

  • High score (score: 11-21) in the Hospital Anxiety and Depression Scale

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: Basic Science
  • 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: SIT group
participants will sitting 4 hours continuously.
Behavioral: uninterrupted sitting
Participants will watch documentary during prolonged sitting.
Other Names:
  • SIT
Experimental: INTERRUPT group
participants will sitting 25 minutes with 5 minutes walking per half hour,40minutes walking in total
Behavioral: Sitting interrupted by light physical activity
Each 30 minutes will be 25 minutes sitting followed by 5 minutes walking that designed as prescribed walking route outside laboratory corridor.
Other Names:
  • INTERRUPT
Experimental: COGN group
participants will perform GED test as cognitive loading task during 4-hour sitting
Behavioral: Sitting with cognitive task
Participants will perform online cognitive task during prolonged sitting.
Other Names:
  • COGN

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
Cognitive processes as assessed using Stroop test
Time Frame: change from baseline after 4 hour intervention on day1, day8, day16
Stroop test is a computer-based Stroop word and color test, including congruent trials and incongruent trials to assess inhibition. Reaction time and accuracy of the Stroop test will be collected before and after the intervention
change from baseline after 4 hour intervention on day1, day8, day16
Cognitive processes as assessed using D2 attention test
Time Frame: change from baseline after 4 hour intervention on day1, day8, day16
D2 attention test is a paper and pencil test to assess attention. Concentration performance will be collected before and after the intervention.
change from baseline after 4 hour intervention on day1, day8, day16
Cognitive processes as assessed using N back test
Time Frame: change from baseline after 4 hour intervention on day1, day8, day16
N back test is a computer-based test, including target images and non-target images. this test is for updating and working memory. The correct reaction number of N back test will be collected before and after the intervention.
change from baseline after 4 hour intervention on day1, day8, day16
Cognitive processes as assessed using Trail making test
Time Frame: change from baseline after 4 hour intervention on day1, day8, day16
Trail making test is a computer-based test to assess task-switching. reaction time and accuracy of the trail making test will be collected before and after the intervention.
change from baseline after 4 hour intervention on day1, day8, day16

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
mood status assessed by tension score
Time Frame: change from baseline after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline after 4 hour intervention on day1, day8, day16
mood status assessed by anger score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by depression score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by vigor score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by esteem-related effect score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by confusion score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by fatigue score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood status assessed by total mood level score
Time Frame: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
mood questionnaire(an abbreviated version of Profile of Mood States (POMS)) will be used before and after the intervention, such as tension, anger, depression, vigor, esteem-related effect, confusion, fatigue, total mood level data included. The scale is 0 to 4.
change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
muscle activity
Time Frame: recording 5 minutes' muscle activity for each sitting posture, average RMS will be collected.it will be performed on another experiment day.
Muscle activity is measured by the electromyograph （EMG）machine. RMS values will be collected and calculated as muscle activation during each sittings condition
recording 5 minutes' muscle activity for each sitting posture, average RMS will be collected.it will be performed on another experiment day.
discomfort level
Time Frame: report discomfort level immediately after each sitting condition(each sitting posture lasts 5 minutes).it will be performed on another experiment day.
after each sitting condition, self discomfort level will be asked.0 means no discomfort,10 means the worst discomfort
report discomfort level immediately after each sitting condition(each sitting posture lasts 5 minutes).it will be performed on another experiment day.

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.
Maastricht University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hans HCM Savelberg, PhD, Maastricht University

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.
June 7, 2019

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, 2020

Study Completion (Anticipated)

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.
May 30, 2021

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).
September 21, 2020

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.
January 19, 2021

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.
January 20, 2021

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.
January 20, 2021

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.
January 19, 2021

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.
January 1, 2021

More Information

Terms related to this study

Keywords

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.
  • DSIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

there is no sharing individual participant data

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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