NCT03576391

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

June 11, 2018

Last Update Submit

December 12, 2023

Conditions

Keywords

Sensorimotor controlFeedforwardPhysical FatigueCognitive FatigueEvent-related potentials

Outcome Measures

Primary Outcomes (2)

  • Trunk muscle EMG latency

    Latency of the activation onset of the trunk muscles on EMG compared to prime mover onset (Anterior Deltoid) in milliseconds.

    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.

    2 hours

Secondary Outcomes (7)

  • Visual Analogue Scale for Fatigue

    10 seconds for every measurement

  • Rating of Perceived Exertion/Borg

    5 seconds for every measurement

  • Checklist Individual Strength

    5 minutes at the beginning of each test day

  • Profile Of Mood States-Short Form

    5 minutes at the beginning of each test day

  • International Physical Activities Questionnaire

    15 minutes at the beginning of each test day

  • +2 more secondary outcomes

Study Arms (3)

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.

Behavioral: Control conditionBehavioral: 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.

Behavioral: Rapid Arm MovementsBehavioral: 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.

Behavioral: Rapid Arm MovementsBehavioral: Cognitive fatigue condition

Interventions

45 minute rest while seated. Watching an animated movie, sleeping was not allowed.

Control condition

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.

Cognitive Fatigue conditionControl conditionPhysical Fatigue condition

40 minutes rest while seated followed by static endurance tasks, i.e. modified Biering-Sörensen task and static abdominal curl task.

Physical Fatigue condition

45 minutes of a cognitively fatiguing condition consisting of a modified incongruent Stroop color-word task.

Cognitive Fatigue condition

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult subjects.

You may not qualify if:

  • People with a history of pain or current pain
  • severe pathologies
  • traumata
  • cardiorespiratory disorders
  • neurological disorders
  • vestibular disorders
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep REVAKI (Ghent University - Ghent University Hospital)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Lieven Danneels, PT, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher that will perform the EMG-analysis, i.e. onset determination of the various muscles that were measured, will be blinded for participant, condition and muscle during that process.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 3, 2018

Study Start

September 15, 2016

Primary Completion

February 24, 2018

Study Completion

February 24, 2018

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared after completion of the study.

Locations