NCT04716582

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

September 21, 2020

Last Update Submit

January 19, 2021

Conditions

Keywords

sedentary behaviorlight physical activityexecutive functionactive sitting

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • mood status assessed by tension score

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

  • mood status assessed by anger score

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

  • mood status assessed by depression score

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

  • mood status assessed by vigor score

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

  • mood status assessed by esteem-related effect score

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

  • +5 more secondary outcomes

Study Arms (3)

SIT group

EXPERIMENTAL

participants will sitting 4 hours continuously.

Behavioral: uninterrupted sitting

INTERRUPT group

EXPERIMENTAL

participants will sitting 25 minutes with 5 minutes walking per half hour,40minutes walking in total

Behavioral: Sitting interrupted by light physical activity

COGN group

EXPERIMENTAL

participants will perform GED test as cognitive loading task during 4-hour sitting

Behavioral: Sitting with cognitive task

Interventions

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

Also known as: INTERRUPT
INTERRUPT group

Participants will perform online cognitive task during prolonged sitting.

Also known as: COGN
COGN group

Participants will watch documentary during prolonged sitting.

Also known as: SIT
SIT group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health, Medicine and Life Sciences

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hans HCM Savelberg, PhD

    Maastricht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

January 20, 2021

Study Start

June 7, 2019

Primary Completion

October 20, 2020

Study Completion

May 30, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

there is no sharing individual participant data

Locations