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Sedentary BehaviorNCT04716582

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

A study testing Sitting interrupted by light physical activity, Sitting with cognitive task and uninterrupted sitting in people with Sedentary Behavior and Light Intensity Physical Activity, run by Maastricht University at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Sitting interrupted by light physical activity, Sitting with cognitive task and uninterrupted sitting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteNetherlands
Study dates
7 Jun 2019to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Faculty of Health, Medicine and Life Sciences

    Maastricht, Limburg, 6229 ER

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Sitting interrupted by light physical activity, Sitting with cognitive task, uninterrupted sitting
Keywords
sedentary behavior, light physical activity, executive function, active sitting
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sitting interrupted by light physical activityBehavioural

    Also called INTERRUPT

    Each 30 minutes will be 25 minutes sitting followed by 5 minutes walking that designed as prescribed walking route outside laboratory corridor.

  • Sitting with cognitive taskBehavioural

    Also called COGN

    Participants will perform online cognitive task during prolonged sitting.

  • uninterrupted sittingBehavioural

    Also called SIT

    Participants will watch documentary during prolonged sitting.

Study groups in NCT04716582
Study groupRoleWhat they receive
SIT groupExperimentalparticipants will sitting 4 hours continuously.
Receives: Behavioral: uninterrupted sitting
INTERRUPT groupExperimentalparticipants will sitting 25 minutes with 5 minutes walking per half hour,40minutes walking in total
Receives: Behavioral: Sitting interrupted by light physical activity
COGN groupExperimentalparticipants will perform GED test as cognitive loading task during 4-hour sitting
Receives: Behavioral: Sitting with cognitive task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive processes as assessed using Stroop test

    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

    Measured: change from baseline after 4 hour intervention on day1, day8, day16

  2. Cognitive processes as assessed using D2 attention test

    D2 attention test is a paper and pencil test to assess attention. Concentration performance will be collected before and after the intervention.

    Measured: change from baseline after 4 hour intervention on day1, day8, day16

  3. Cognitive processes as assessed using N back test

    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.

    Measured: change from baseline after 4 hour intervention on day1, day8, day16

  4. Cognitive processes as assessed using Trail making test

    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.

    Measured: change from baseline after 4 hour intervention on day1, day8, day16

Secondary outcomes (10)

  1. mood status assessed by tension score

    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.

    Measured: change from baseline after 4 hour intervention on day1, day8, day16

  2. mood status assessed by anger score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  3. mood status assessed by depression score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  4. mood status assessed by vigor score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  5. mood status assessed by esteem-related effect score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  6. mood status assessed by confusion score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  7. mood status assessed by fatigue score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  8. mood status assessed by total mood level score

    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.

    Measured: change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16

  9. muscle activity

    Muscle activity is measured by the electromyograph （EMG）machine. RMS values will be collected and calculated as muscle activation during each sittings condition

    Measured: recording 5 minutes' muscle activity for each sitting posture, average RMS will be collected.it will be performed on another experiment day.

  10. discomfort level

    after each sitting condition, self discomfort level will be asked.0 means no discomfort,10 means the worst discomfort

    Measured: report discomfort level immediately after each sitting condition(each sitting posture lasts 5 minutes).it will be performed on another experiment day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start7 Jun 2019
  3. Primary completion20 Oct 2020
  4. Study completion30 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716582
Sponsor's protocol ID
DSIT
Status last verified
Jan 2021
First submitted
21 Sep 2020
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no sharing individual participant data

Questions about this trial

What is this clinical trial studying?

A study testing Sitting interrupted by light physical activity, Sitting with cognitive task and uninterrupted sitting in people with Sedentary Behavior and Light Intensity Physical Activity, run by Maastricht University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive processes as assessed using Stroop test (time frame: change from baseline after 4 hour intervention on day1, day8, day16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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