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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04716582
Other study ID # DSIT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 7, 2019
Est. completion date May 30, 2021

Study information

Verified date January 2021
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 21
Est. completion date May 30, 2021
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Sitting with cognitive task
Participants will perform online cognitive task during prolonged sitting.
uninterrupted sitting
Participants will watch documentary during prolonged sitting.

Locations

Country Name City State
Netherlands Faculty of Health, Medicine and Life Sciences Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 change from baseline after 4 hour intervention on day1, day8, day16
Primary 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. change from baseline after 4 hour intervention on day1, day8, day16
Primary 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. change from baseline after 4 hour intervention on day1, day8, day16
Primary 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. change from baseline after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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. change from baseline all mood outcomes after 4 hour intervention on day1, day8, day16
Secondary 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 recording 5 minutes' muscle activity for each sitting posture, average RMS will be collected.it will be performed on another experiment day.
Secondary discomfort level 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.
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