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Evaluation of Physical and Cognitive Industrial Workload

Primary Purpose

Work-Related Condition, Physical Stress, Mental Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Industrial work
Physical load
Cognitive load
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Work-Related Condition focused on measuring Fatigue Mental, Fatigue Signs and Symptoms, Behavioral Symptoms, Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • male
  • 18 - 65 yrs old

Exclusion Criteria:

  • injury

Sites / Locations

  • Lichamelijk Opvoeding en KinesitherapieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

industrial-physical-cognitive

industrial- cognitive-physical

physical- industrial- cognitive

physical-cognitive- industrial

cognitive- industrial-physical

cognitive-physical-industrial

Arm Description

Outcomes

Primary Outcome Measures

EEG: change in power spectral density (change in mental fatigue: physiological component)
The power of different frequency bands during a cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.

Secondary Outcome Measures

EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)
Event related potentials during cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.
Change in mental fatigue (behavioral component: part 1)
Reaction time during cognitive stroop task
Change in mental fatigue (behavioral component: part 2)
Accuracy time during cognitive stroop task
Change in mental fatigue (subjective component)
Questionnaire (sRPE) before and after performing each 90 min task

Full Information

First Posted
May 11, 2018
Last Updated
January 25, 2021
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03580304
Brief Title
Evaluation of Physical and Cognitive Industrial Workload
Official Title
Evaluation of Mental and Physical Load During Lab-simulated Industrial Work
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In this stage of the project, a study analysing the physical and mental load during occupational work will be carried out. High risk tasks will be identified in the field and simulated in lab-setting to analyse physical and mental load using physiological and biomechanical data.These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front of, to the side of, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work-Related Condition, Physical Stress, Mental Fatigue
Keywords
Fatigue Mental, Fatigue Signs and Symptoms, Behavioral Symptoms, Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
industrial-physical-cognitive
Arm Type
Experimental
Arm Title
industrial- cognitive-physical
Arm Type
Experimental
Arm Title
physical- industrial- cognitive
Arm Type
Experimental
Arm Title
physical-cognitive- industrial
Arm Type
Experimental
Arm Title
cognitive- industrial-physical
Arm Type
Experimental
Arm Title
cognitive-physical-industrial
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Industrial work
Intervention Description
Subjects perform simulated industrial work in lab setting. The industrial task exists of a physical component and a cognitive component. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Mental fatigue will be determined by questionnaires and a cognitive stroop task before and after the trial.
Intervention Type
Behavioral
Intervention Name(s)
Physical load
Intervention Description
The physical load of an industrial task will be simulated during this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive load
Intervention Description
The cognitive load of an industrial task will be simulated in this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)
Primary Outcome Measure Information:
Title
EEG: change in power spectral density (change in mental fatigue: physiological component)
Description
The power of different frequency bands during a cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.
Time Frame
Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Secondary Outcome Measure Information:
Title
EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)
Description
Event related potentials during cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.
Time Frame
Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Title
Change in mental fatigue (behavioral component: part 1)
Description
Reaction time during cognitive stroop task
Time Frame
Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Title
Change in mental fatigue (behavioral component: part 2)
Description
Accuracy time during cognitive stroop task
Time Frame
Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Title
Change in mental fatigue (subjective component)
Description
Questionnaire (sRPE) before and after performing each 90 min task
Time Frame
Before and after each 90 minute task subjective questionnaire will be filled out

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male 18 - 65 yrs old Exclusion Criteria: injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sander De Bock
Phone
+32 2 629 22 22
Email
sander.de.bock@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin De Pauw, PhD
Phone
+32 2 629 22 22
Email
kevin.de.pauw@vub.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Meeusen, Prof. Dr.
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lichamelijk Opvoeding en Kinesitherapie
City
Brussel
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Physical and Cognitive Industrial Workload

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