Work-Related ConditionNCT03580304
Evaluation of Physical and Cognitive Industrial Workload
A study testing Industrial work, Physical load and Cognitive load in people with Work-Related Condition and Physical Stress, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition, Physical Stress, Mental Fatigue
- What is being tested?
- Industrial work, Physical load and Cognitive load
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- 18 - 65 yrs old
Who cannot join
- injury
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Lichamelijk Opvoeding en Kinesitherapie
Brussels, 1050
About this study
Official title: 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.
- Conditions
- Work-Related Condition, Physical Stress, Mental Fatigue
- Being tested
- Industrial work, Physical load, Cognitive load
- Keywords
- Fatigue Mental, Fatigue Signs and Symptoms, Behavioral Symptoms, Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation
- Medical subject headings
- Mental Fatigue, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Industrial workBehavioural
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.
Physical loadBehavioural
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)
Cognitive loadBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| industrial-physical-cognitive | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
| industrial- cognitive-physical | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
| physical- industrial- cognitive | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
| physical-cognitive- industrial | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
| cognitive- industrial-physical | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
| cognitive-physical-industrial | Experimental | Not described Receives: Behavioral: Industrial work; Behavioral: Physical load; Behavioral: Cognitive load |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after each 90 minute task subjective questionnaire will be filled out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Apr 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
- Investigators
- Romain Meeusen, Prof. Dr., Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580304
- Sponsor's protocol ID
- S008517N
- Status last verified
- Jan 2021
- First submitted
- 11 May 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mental and Physical Load During Lab-simulated Industrial Work
- ClinicalTrials.gov ID
- NCT03580304
- Acronym / sponsor ID
- S008517N
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| industrial-physical-cognitive | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
| industrial- cognitive-physical | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
| physical- industrial- cognitive | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
| physical-cognitive- industrial | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
| cognitive- industrial-physical | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
| cognitive-physical-industrial | Experimental | Behavioral: Industrial work, Behavioral: Physical load, Behavioral: Cognitive load |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male
- 18 - 65 yrs old
Key exclusion criteria (1 listed)
- injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Industrial workSubjects 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. | Behavioural | cognitive- industrial-physical, cognitive-physical-industrial, industrial- cognitive-physical, industrial-physical-cognitive, physical- industrial- cognitive, physical-cognitive- industrial |
| Physical loadThe 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) | Behavioural | cognitive- industrial-physical, cognitive-physical-industrial, industrial- cognitive-physical, industrial-physical-cognitive, physical- industrial- cognitive, physical-cognitive- industrial |
| Cognitive loadThe 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) | Behavioural | cognitive- industrial-physical, cognitive-physical-industrial, industrial- cognitive-physical, industrial-physical-cognitive, physical- industrial- cognitive, physical-cognitive- industrial |
Primary outcome
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.
4 secondary outcomes
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
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
Change in mental fatigue (behavioral component: part 2)
Time frame: Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (subjective component)
Time frame: Before and after each 90 minute task subjective questionnaire will be filled out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Meeusen, Prof. Dr. principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Industrial work, Physical load and Cognitive load in people with Work-Related Condition and Physical Stress, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander De Bock (+32 2 629 22 22, sander.de.bock@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.