- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716582
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
Active, not recruiting
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
Interventional
Enrollment (Actual)
21
Phase
- 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
-
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Limburg
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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
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 |
Intervention / Treatment |
---|---|
Experimental: SIT group
participants will sitting 4 hours continuously.
|
Participants will watch documentary during prolonged sitting.
Other Names:
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Experimental: INTERRUPT group
participants will sitting 25 minutes with 5 minutes walking per half hour,40minutes walking in total
|
Each 30 minutes will be 25 minutes sitting followed by 5 minutes walking that designed as prescribed walking route outside laboratory corridor.
Other Names:
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Experimental: COGN group
participants will perform GED test as cognitive loading task during 4-hour sitting
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Participants will perform online cognitive task during prolonged sitting.
Other Names:
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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change from baseline after 4 hour intervention on day1, day8, day16
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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
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
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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.
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after each sitting condition, self discomfort level will be asked.0
means no discomfort,10 means the worst discomfort
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report discomfort level immediately after each sitting condition(each sitting posture lasts 5 minutes).it will be performed on another experiment day.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
June 7, 2019
Primary Completion (Actual)
October 20, 2020
Study Completion (Anticipated)
May 30, 2021
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 20, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID 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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