Evaluation of Physical and Cognitive Industrial Workload

Evaluation of Mental and Physical Load During Lab-simulated Industrial Work

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Fatigue; Physical Stress; Work-Related Condition
• Intervention / Treatment: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sander De Bock; Phone Number: +32 2 629 22 22; Email: sander.de.bock@vub.be
• Study Contact Backup: Name: Kevin De Pauw, PhD; Phone Number: +32 2 629 22 22; Email: kevin.de.pauw@vub.be

Study Locations

• Belgium
  • Brussel, Belgium, 1050
    • Recruiting
    • Lichamelijk Opvoeding en Kinesitherapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• male
• 18 - 65 yrs old

Exclusion Criteria:

• injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: industrial-physical-cognitive	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)
Experimental: industrial- cognitive-physical	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)
Experimental: physical- industrial- cognitive	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)
Experimental: physical-cognitive- industrial	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)
Experimental: cognitive- industrial-physical	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)
Experimental: cognitive-physical-industrial	Behavioral: Industrial work; 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.; Behavioral: Physical load; 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); Behavioral: Cognitive load; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 1)	Reaction time during cognitive stroop task	Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 2)	Accuracy time during cognitive stroop task	Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (subjective component)	Questionnaire (sRPE) before and after performing each 90 min task	Before and after each 90 minute task subjective questionnaire will be filled out

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Investigators: Principal Investigator: Romain Meeusen, Prof. Dr., Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Behavioral Symptoms; Fatigue Mental; Fatigue Signs and Symptoms; Industrial work; physical effort; mental effort; questionnaires; ergonomic evaluation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: S008517N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No