Evaluation of Physical and Cognitive Industrial Workload

• ClinicalTrials.gov Identifier: NCT03580304
• Recruitment Status: Recruiting
• First Posted: July 9, 2018
• Last Update Posted: January 26, 2021
• Sponsor: Vrije Universiteit Brussel
• Information provided by (Responsible Party): Romain Meeusen, Vrije Universiteit Brussel

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.

Condition or disease	Intervention/treatment	Phase
Work-Related Condition; Physical Stress; Mental Fatigue	Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of Mental and Physical Load During Lab-simulated Industrial Work
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. EEG: change in power spectral density (change in mental fatigue: physiological component) [ Time Frame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task ]
   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 :

1. EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component) [ Time Frame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task ]
   Event related potentials during cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.
2. Change in mental fatigue (behavioral component: part 1) [ Time Frame: Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task ]
   Reaction time during cognitive stroop task
3. Change in mental fatigue (behavioral component: part 2) [ Time Frame: Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task ]
   Accuracy time during cognitive stroop task
4. Change in mental fatigue (subjective component) [ Time Frame: Before and after each 90 minute task subjective questionnaire will be filled out ]
   Questionnaire (sRPE) before and after performing each 90 min task

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• male
• 18 - 65 yrs old

Exclusion Criteria:

• injury

Contacts and Locations

Contacts

Contact: Sander De Bock; +32 2 629 22 22; sander.de.bock@vub.be

Contact: Kevin De Pauw, PhD; +32 2 629 22 22; kevin.de.pauw@vub.be

Locations

Belgium

Lichamelijk Opvoeding en Kinesitherapie; Recruiting

Brussel, Belgium, 1050

Sponsors and Collaborators

Vrije Universiteit Brussel

Investigators

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

  Study Documents (Full-Text)

Documents provided by Romain Meeusen, Vrije Universiteit Brussel:

Study Protocol and Statistical Analysis Plan  [PDF] June 11, 2018

More Information

• Responsible Party: Romain Meeusen, Prof. Dr., Vrije Universiteit Brussel
• ClinicalTrials.gov Identifier: NCT03580304
• Other Study ID Numbers: S008517N
• First Posted: July 9, 2018
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romain Meeusen, Vrije Universiteit Brussel:

Fatigue Mental; Fatigue Signs and Symptoms; Behavioral Symptoms; Industrial work; physical effort; mental effort; questionnaires; ergonomic evaluation

Additional relevant MeSH terms:

Fatigue; Mental Fatigue; Behavioral Symptoms