Muscle FatigueNCT03576391
The Influence of Fatigue on Trunk Motor Control and Brain Activity
A study testing Rapid Arm Movements, Physical fatigue condition and Cognitive fatigue condition in people with Muscle Fatigue and Mental Fatigue, run by University Ghent at 1 site in Belgium.
Trial summary
This study aims at examining the influence of both physically and cognitively induced fatigue on trunk motor control on the one hand and brain activity related to movement preparation on the other hand, in healthy adult subjects. Furthermore, a comparison between the effects of both types of fatigue will be made. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue, Mental Fatigue, Event-related Potentials
- What is being tested?
- Rapid Arm Movements, Physical fatigue condition and Cognitive fatigue condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2016to 24 Feb 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects.
Who cannot join
- People with a history of pain or current pain
- severe pathologies
- traumata
- cardiorespiratory disorders
- neurological disorders
- vestibular disorders
Show all 20Show fewer
- endocrinologic disorders
- psychiatric and cognitive disorders
- colour blindness
- sleeping disorders
- psychological disorders or major depressions
- major surgery to the spine or upper limbs
- clinically relevant malalignments and deformities
- malignancies
- substance abuse of alcohol or drugs
- consumption of analgesics without prescription 24 hours or with prescription two weeks before testing
- use of psychotropic medication
- extreme physical activities two days before testing
- professional athletes
- pregnant women or women < 1 year postnatally
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vakgroep REVAKI (Ghent University - Ghent University Hospital)
Ghent, 9000
About this study
Official title: Examining the Influence of Fatigue on Anticipatory Postural Adjustments of the Trunk Muscles and Movement-related Cortical Potentials in Healthy Subjects During a Rapid Arm Task Perturbation
This study aims at examining the influence of both physically and cognitively induced fatigue on trunk motor control on the one hand and brain activity related to movement preparation on the other hand, in healthy adult subjects. Furthermore, a comparison between the effects of both types of fatigue will be made. For this purpose a motor control task will be performed and compared before and after 3 specific interventions: i.e. a control intervention, a physical task and a cognitive task. Muscle and brain activity will be measured during each motor control task.
It is hypothesised that motor control will not be altered after a control task, i.e. seated rest for 45 minutes. With regards to the physical fatigue condition, it is expected that trunk muscles will contract earlier after this task than before due to altered motor control. Cognitive fatigue is hypothesised to have similar underlying processes as physical fatigue, thus a similar earlier muscle contraction is also expected after cognitive fatigue.
Read more
Lastly, as both types of fatigue are expected to induce a similar effect on motor control no significant differences between cognitive and physical fatigue are hypothesised. However, it is possible that the magnitude of this effect differs between types of fatigue, i.e. that 1 of both types has a bigger effect on motor control than the other.
With regards to brain activity in preparation of a motor control task similar hypotheses are formulated: no effect of the control task on brain activity, earlier and possibly increased brain activity after both fatiguing tasks, and no differences between both types of fatigue besides a possible difference in magnitude of effect.
Read the detailed description
September 2016 - January 2017. 16 healthy, adult male and female participants aged 18-45 were tested for 3 conditions on 2 separate days, i.e. a control condition on test day 1; a physical and cognitive fatiguing condition in randomised order on test day 2.
2 blocks of 80 rapid arm movements (RAM1 and RAM2) with the dominant arm were performed per condition, while electroencephalography (EEG) of the brain and surface electromyography (sEMG) of the Internal Oblique/Transversus Abdominis, External Oblique, Multifidus and Iliocostalis Lumborum pars Thoracis muscles were measured bilaterally. sEMG of the Anterior Deltoid muscle of the dominant arm was also measured. These RAM's were used to induce an internal perturbation to the postural balance of subjects and is an often used task in the study of trunk motor control. In between 2 blocks of the RAM the condition-specific interventions were given. The control condition consisted of RAM1 - 45 minute rest - RAM2; the physical fatigue condition consisted of RAM1 - 45 minute physical fatigue task - RAM2; the cognitive fatigue condition consisted of RAM1 - 45 minute cognitive fatigue task - RAM2.
The physical fatiguing task was a static endurance task for the paravertebral muscles, i.e. modified Biering-Sörensen task, followed by a static endurance task for the abdominal muscles, i.e. a static abdominal curl in 45° of trunk flexion while seated.
The cognitive fatiguing task was a modified incongruent Stroop color-word task for 45 minutes.
At the beginning of each test day several questionnaires were also administered to control for fatigue and physical activity, i.e. Checklist Individual Strength (CIS), Profile Of Mood States (POMS) and International Physical Activity Questionnaire (IPAQ).
January - February 2018. an additional 6 subjects were tested in order to increase the sample size of this study.
Statistical analysis will be performed to assess whether and to what extent both physical and cognitive fatigue might influence motor control as measured with EMG during RAM. Furthermore, the effect of both types of fatigue on cortical movement preparation will also be assessed based on the EEG measurements.
- Conditions
- Muscle Fatigue, Mental Fatigue, Event-related Potentials
- Being tested
- Control condition, Rapid Arm Movements, Physical fatigue condition, Cognitive fatigue condition
- Keywords
- Sensorimotor control, Feedforward, Physical Fatigue, Cognitive Fatigue, Event-related potentials
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control conditionBehavioural
45 minute rest while seated. Watching an animated movie, sleeping was not allowed.
Rapid Arm MovementsBehavioural
2 blocks of 80 trials of RAM in either a forward (n = 40) or backward (n = 40) shoulder flexion direction and back to neutral as fast as possible, with maintaining extension in the elbow. Visual cues (arrows) indicated the movement direction.
Physical fatigue conditionBehavioural
40 minutes rest while seated followed by static endurance tasks, i.e. modified Biering-Sörensen task and static abdominal curl task.
Cognitive fatigue conditionBehavioural
45 minutes of a cognitively fatiguing condition consisting of a modified incongruent Stroop color-word task.
| Study group | Role | What they receive |
|---|---|---|
| Control condition | Experimental | Control condition to assess whether the repetition of a RAM task without fatiguing task in between 2 repetitions affects trunk motor control and cortical movement preparation. Receives: Behavioral: Control condition; Behavioral: Rapid Arm Movements |
| Physical Fatigue condition | Experimental | Fatigue condition to assess whether a physical fatiguing task in between 2 RAM tasks affects trunk motor control and cortical movement preparation for the 2nd RAM. Receives: Behavioral: Rapid Arm Movements; Behavioral: Physical fatigue condition |
| Cognitive Fatigue condition | Experimental | Fatigue condition to assess whether a cognitive fatiguing task in between 2 RAM tasks affects trunk motor control and cortical movement preparation for the 2nd RAM. Receives: Behavioral: Rapid Arm Movements; Behavioral: Cognitive fatigue condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk muscle EMG latency
Latency of the activation onset of the trunk muscles on EMG compared to prime mover onset (Anterior Deltoid) in milliseconds.
Measured: 2 hours
Contingent Negative Variation
A cortical EEG-potential that reflects movement preparation in the timeframe between a warning cue and a go cue in Volt.
Measured: 2 hours
Secondary outcomes (7)
Visual Analogue Scale for Fatigue
A self-reported rating by participants for experienced general fatigue, which was assessed at baseline, after every RAM and after the condition-specific interventions. Participants had to indicate on a horizontal axis of 10 cm how fatigued they were with at the left side of the axis (0) 'not fatigued at all' and on the right side of the axis (10) 'maximally fatigued/worst fatigue ever experienced'. The numeric score (0-10) was calculated by the researcher and was not visible for participants.
Measured: 10 seconds for every measurement
Rating of Perceived Exertion/Borg
A self-reported rating by participants for assessing how fatiguing a specific task/intervention was. This was assessed after every RAM task and after the physical and cognitive fatigue tasks. This is a vertical scale ranging from 6 at the top (no exertion) to 20 at the bottom ('maximal exertion') of the scale. Participants saw both incremental numbers from 6-20 and descriptions at numbers 7 ('very very light'), 9 ('very light'), 11 ('reasonably light'), 13 ('quite heavy'), 15 ('heavy'), 17 ('very heavy'), 19 ('very very heavy'), 20 ('maximal exertion').
Measured: 5 seconds for every measurement
Checklist Individual Strength
For this study the CIS-fatigue subscale scores were used in order to quantify the subjective amount of fatigue subjects were experiencing at the onset of each test session.
Measured: 5 minutes at the beginning of each test day
Profile Of Mood States-Short Form
The POMS-Short Form questionnaire required subjects to rate 32 words on a five-point, Likert-type scale ranging from 0-4 (0 = not at all, 4 = extremely) in accordance with their state of mood at that moment. These thirty-two items were divided into four negative subscales and one positive subscale, the total score of a subject consists of the difference of the sum of the negative scales and the positive scale. This means the lower the total score, the higher the positive mood of the subject.
Measured: 5 minutes at the beginning of each test day
International Physical Activities Questionnaire
The IPAQ was administered before each test session to question participants about the physical activities they performed during the last 7 days. This in order to control for week-to-week differences in physical exertion levels and in order to compare physical activity between subjects. Based on these scores 3 levels of physical activity could be determined with level 1 (low), 2 (moderate) and 3 (high) physical activity. These levels are calculated based on the amount of hours low, moderate and high exerting activities had been performed the last 7 days.
Measured: 15 minutes at the beginning of each test day
General questionnaire
Demographical and physical characteristics were questioned in a self-developed general questionnaire as well as educational/occupational levels, substance and medication use, general physical and mental health, and sleep quality and quantity of the week and night at the beginning of test day 1.
Measured: 10 minutes at the beginning of test day 1
General questionnaire-Short
Only a short part of the General Questionnaire was repeated at the start of test day two. Demographic, physical and educational/occupational information would not alter between 2 test days, so these sections were unnecessary to question again at test day 2. Therefore a shorter version with only questions about substance and medication use since the previous test day, general physical and mental health, and sleep quality and quantity of the week and night before the test session was administered on test day 2.
Measured: 10 minutes at the beginning of test day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start15 Sep 2016
- Primary completion24 Feb 2018
- Study completion24 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Model description
- Each participant will perform all 3 experimental conditions spread out over 2 test days. At test day 1 the control condition is performed. Test day 2 follows at least 5 days after the 1st one in order to make sure participants are physically and mentally recovered as the protocol at test day 1 might induce some physical or mental fatigue. On test day 2 the other 2 conditions are tested in a randomised order: either first the physical fatigue condition, followed by the cognitive fatigue condition or vice versa.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Danneels, PT, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576391
- Sponsor's protocol ID
- 2016/0951
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Influence of Fatigue on Anticipatory Postural Adjustments of the Trunk Muscles and Movement-related Cortical Potentials in Healthy Subjects During a Rapid Arm Task Perturbation
- ClinicalTrials.gov ID
- NCT03576391
- Acronym / sponsor ID
- 2016/0951
- Conditions
- Muscle Fatigue, Mental Fatigue, Event-related Potentials
- Keywords
- Sensorimotor control, Feedforward, Physical Fatigue, Cognitive Fatigue, Event-related potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 24 Feb 2018 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 3 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.
This study aims at examining the influence of both physically and cognitively induced fatigue on trunk motor control on the one hand and brain activity related to movement preparation on the other hand, in healthy adult subjects. Furthermore, a comparison between the effects of both types of fatigue will be made. For this purpose a motor control task will be performed and compared before and after 3 specific interventions: i.e. a control intervention, a physical task and a cognitive task. Muscle and brain activity will be measured during each motor control task.
It is hypothesised that motor control will not be altered after a control task, i.e. seated rest for 45 minutes. With regards to the physical fatigue condition, it is expected that trunk muscles will contract earlier after this task than before due to altered motor control. Cognitive fatigue is hypothesised to have similar underlying processes as physical fatigue, thus a similar earlier muscle contraction is also expected after cognitive fatigue.
Lastly, as both types of fatigue are expected to induce a similar effect on motor control no significant differences between cognitive and physical fatigue are hypothesised. However, it is possible that the magnitude of this effect differs between types of fatigue, i.e. that 1 of both types has a bigger effect on motor control than the other.
With regards to brain activity in preparation of a motor control task similar hypotheses are formulated: no effect of the control task on brain activity, earlier and possibly increased brain activity after both fatiguing tasks, and no differences between both types of fatigue besides a possible difference in magnitude of effect.
Detailed description
September 2016 - January 2017. 16 healthy, adult male and female participants aged 18-45 were tested for 3 conditions on 2 separate days, i.e. a control condition on test day 1; a physical and cognitive fatiguing condition in randomised order on test day 2.
2 blocks of 80 rapid arm movements (RAM1 and RAM2) with the dominant arm were performed per condition, while electroencephalography (EEG) of the brain and surface electromyography (sEMG) of the Internal Oblique/Transversus Abdominis, External Oblique, Multifidus and Iliocostalis Lumborum pars Thoracis muscles were measured bilaterally. sEMG of the Anterior Deltoid muscle of the dominant arm was also measured. These RAM's were used to induce an internal perturbation to the postural balance of subjects and is an often used task in the study of trunk motor control. In between 2 blocks of the RAM the condition-specific interventions were given. The control condition consisted of RAM1 - 45 minute rest - RAM2; the physical fatigue condition consisted of RAM1 - 45 minute physical fatigue task - RAM2; the cognitive fatigue condition consisted of RAM1 - 45 minute cognitive fatigue task - RAM2.
The physical fatiguing task was a static endurance task for the paravertebral muscles, i.e. modified Biering-Sörensen task, followed by a static endurance task for the abdominal muscles, i.e. a static abdominal curl in 45° of trunk flexion while seated.
The cognitive fatiguing task was a modified incongruent Stroop color-word task for 45 minutes.
At the beginning of each test day several questionnaires were also administered to control for fatigue and physical activity, i.e. Checklist Individual Strength (CIS), Profile Of Mood States (POMS) and International Physical Activity Questionnaire (IPAQ).
January - February 2018. an additional 6 subjects were tested in order to increase the sample size of this study.
Statistical analysis will be performed to assess whether and to what extent both physical and cognitive fatigue might influence motor control as measured with EMG during RAM. Furthermore, the effect of both types of fatigue on cortical movement preparation will also be assessed based on the EEG measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will perform all 3 experimental conditions spread out over 2 test days. At test day 1 the control condition is performed. Test day 2 follows at least 5 days after the 1st one in order to make sure participants are physically and mentally recovered as the protocol at test day 1 might induce some physical or mental fatigue. On test day 2 the other 2 conditions are tested in a randomised order: either first the physical fatigue condition, followed by the cognitive fatigue condition or vice versa.
| Arm | Type | Receives |
|---|---|---|
| Control condition | Experimental | Behavioral: Control condition, Behavioral: Rapid Arm MovementsControl condition to assess whether the repetition of a RAM task without fatiguing task in between 2 repetitions affects trunk motor control and cortical movement preparation. |
| Physical Fatigue condition | Experimental | Behavioral: Rapid Arm Movements, Behavioral: Physical fatigue conditionFatigue condition to assess whether a physical fatiguing task in between 2 RAM tasks affects trunk motor control and cortical movement preparation for the 2nd RAM. |
| Cognitive Fatigue condition | Experimental | Behavioral: Rapid Arm Movements, Behavioral: Cognitive fatigue conditionFatigue condition to assess whether a cognitive fatiguing task in between 2 RAM tasks affects trunk motor control and cortical movement preparation for the 2nd RAM. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult subjects.
Key exclusion criteria (20 listed)
- People with a history of pain or current pain
- severe pathologies
- traumata
- cardiorespiratory disorders
- neurological disorders
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 |
|---|---|---|
| Control condition45 minute rest while seated. Watching an animated movie, sleeping was not allowed. | Behavioural | Control condition |
| Rapid Arm Movements2 blocks of 80 trials of RAM in either a forward (n = 40) or backward (n = 40) shoulder flexion direction and back to neutral as fast as possible, with maintaining extension in the elbow. Visual cues (arrows) indicated the movement direction. | Behavioural | Cognitive Fatigue condition, Control condition, Physical Fatigue condition |
| Physical fatigue condition40 minutes rest while seated followed by static endurance tasks, i.e. modified Biering-Sörensen task and static abdominal curl task. | Behavioural | Physical Fatigue condition |
| Cognitive fatigue condition45 minutes of a cognitively fatiguing condition consisting of a modified incongruent Stroop color-word task. | Behavioural | Cognitive Fatigue condition |
Primary outcome
Trunk muscle EMG latency
Time frame: 2 hours
Latency of the activation onset of the trunk muscles on EMG compared to prime mover onset (Anterior Deltoid) in milliseconds.
Contingent Negative Variation
Time frame: 2 hours
A cortical EEG-potential that reflects movement preparation in the timeframe between a warning cue and a go cue in Volt.
7 secondary outcomes
Visual Analogue Scale for Fatigue
Time frame: 10 seconds for every measurement
Rating of Perceived Exertion/Borg
Time frame: 5 seconds for every measurement
Checklist Individual Strength
Time frame: 5 minutes at the beginning of each test day
Profile Of Mood States-Short Form
Time frame: 5 minutes at the beginning of each test day
International Physical Activities Questionnaire
Time frame: 15 minutes at the beginning of each test day
General questionnaire
Time frame: 10 minutes at the beginning of test day 1
General questionnaire-Short
Time frame: 10 minutes at the beginning of test day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No. No individual participant data will be shared after completion of the study.
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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.
Lieven Danneels, PT, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Arm Movements, Physical fatigue condition and Cognitive fatigue condition in people with Muscle Fatigue and Mental Fatigue, run by University Ghent 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 1 inclusion and 20 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: finished, as of the sponsor's last update on 18 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk muscle EMG latency (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 18 Dec 2023.