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The Role of the Brain in Mental and Physical Fatigue

Primary Purpose

Fatigue

Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Reboxetine Pill
Methylphenidate Oral Product
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy trained individuals (exercises at least 1x per week, no neurological, cardiovascular internal or musculoskeletal disorders of any kind) No use of chronic or occasional prescribed medication (except for contraceptives) Non-smoker Exclusion Criteria: Injuries of any kind in the past 6 months Pregnancy Specific food or drink allergies (e.g. lactose and/or gluten intolerance) Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal) Participating in any concomitant care or research trials History of suffering from any mental/psychiatric disorders: Suffering from a higher risk of burn out, indicated by a total score of more than 2.59 on the Burn out assessment tool (BAT) Suffering from high general fatigue, indicated by a score of more than 57 on the Multidimensional fatigue inventory (MFI) Suffering from depression, indicated by a score of more than16 on the Beck depression inventory-II (BDI-II) Use of medication Chronic use with an exception for contraceptives Prescribed medication in between or before trials Use of non-prescribed occasional medication 24 hours prior each trial Use of caffeine and heavy efforts 24 hours prior each trial Suffering from colour vision deficiencies Not eating a standardized meal, the morning of each trial

Sites / Locations

  • Brussels Labo voor Inspanning & Topsport U-residenceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Mental fatigue group

Physical fatigue group

Combined group

Arm Description

Outcomes

Primary Outcome Measures

Number of repetitions
Number of repetitions during knee extension task
Electroencephalography (spectral analysis)
measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta)
Electroencephalography (event related potentials)
measurement of cortical activity with 64 channels (event related potentials)
Electromyography
Target muscles are rectus femoris and vastus lateralis (median frequency)
Accuracy
Accuracy of correct answers during Stroop task
Reaction time
Reaction time for answers during Stroop task

Secondary Outcome Measures

Perceived stress scale questionnaire (PSS-10)
Result is the score of the questionnaire (may 40 points)
the international physical activity questionnaire short form (IPAQ-SF)
Result is the score of the questionnaire
The Brunel Mood Scale (BRUMS)
Result is the score of the questionnaire (each subscale max 0-16)
Motivation with visual analog score (Moti-VAS)
Result is the score between 0 and 100
The National Aeronautics and Space Administration Task Load Index (NASA-TLX)
Result is the score of the questionnaire
Subjective feeling of Mental Fatigue with visual analog score (M-VAS)
Result is the score between 0 and 100
Subjective feeling of physical fatigue with visual analog score (P-VAS)
Result is the score between 0 and 100
Karolinska Sleepiness Scale (KSS)
Result is the score of the questionnaire (max 24)
Internal load of the physical performance (CR100 RPE)
Result is the score between 0 and 100
Heart Rate
continuously assessed by using the POLAR H10 sensor
Lactate concentration
blood lactate will be measured at the beginning and end of the trial at the finger tip of the participant (unit = mmol/L)

Full Information

First Posted
May 9, 2023
Last Updated
May 19, 2023
Sponsor
Vrije Universiteit Brussel
Collaborators
Science and Research Centre Koper
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1. Study Identification

Unique Protocol Identification Number
NCT05880342
Brief Title
The Role of the Brain in Mental and Physical Fatigue
Official Title
Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
Science and Research Centre Koper

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical trial is to determine the role of brain neurotransmission in the onset of fatigue, identify the brain areas involved, and determine how brain activity and neuromuscular efficiency changes during onset of fatigue. Three different experimental studies (physical fatigue, mental fatigue and combined) will be performed with a randomized, single-blinded, placebo controlled, counter-balanced, cross-over design. The objectives of the projects are as follows: To experimentally assess the role of a dopamine, and a noradrenalin reuptake inhibitor in the onset of exercise-induced fatigue To identify changes in brain activation associated with altered PF and fatigue perception To experimentally assess the effect of a NA or DA reuptake inhibitor on MF, brain activation and the sources of changes in brain activation To experimentally assess the role of brain neurotransmitters (DA, NA) in the interaction between mental and PF from a neurophysiological perspective. Participants will be healthy young adults. In each study, they will start with a familiarization trial followed by two experimental trials and one control trial with a randomized treatment order. At each visit, different drugs will be administered to elicit different neurotransmitter response. The trials will be performed at the MFYS exercise lab (BLITS, VUB campus Etterbeek, Boulevard General Jaques 271, 1050 Elsene (Brussels)). Depending on the type of study they are participating in, participants will perform three distinct tasks: In the first experimental study participants will perform a 60-min Stroop Task to elicit mental fatigue. In the second experimental study participants will perform a knee-extension exercise until exhaustion to elicit physical fatigue. In third experimental study participants will first preform a mental fatiguing task (Stroop taks) followed by physical fatigue task (knee extension). While participants will perform above mentioned task their EEG signal and heart rate will be measured. At the same time, participants will report on their subjective feeling of fatigue during these tasks. In addition, all participants will be administered cognitive tasks before and after the study, along with questionnaires. In the second and third experiments, tensiomyography and electromyography will also be recorded from the quadriceps muscle of the leg used for knee extension. Researchers will compare physiological and behavioural changes in response to specific neurotransmitter drug to answer the main question: what the role of a DA and a NA reuptake inhibitor on the onset of mental and physical fatigue is.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental fatigue group
Arm Type
Other
Arm Title
Physical fatigue group
Arm Type
Other
Arm Title
Combined group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Reboxetine Pill
Intervention Description
8 mg
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Oral Product
Intervention Description
20 mg
Primary Outcome Measure Information:
Title
Number of repetitions
Description
Number of repetitions during knee extension task
Time Frame
30 minutes
Title
Electroencephalography (spectral analysis)
Description
measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta)
Time Frame
80 minutes
Title
Electroencephalography (event related potentials)
Description
measurement of cortical activity with 64 channels (event related potentials)
Time Frame
80 minutes
Title
Electromyography
Description
Target muscles are rectus femoris and vastus lateralis (median frequency)
Time Frame
60 minutes
Title
Accuracy
Description
Accuracy of correct answers during Stroop task
Time Frame
60 minutes
Title
Reaction time
Description
Reaction time for answers during Stroop task
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Perceived stress scale questionnaire (PSS-10)
Description
Result is the score of the questionnaire (may 40 points)
Time Frame
5 minites
Title
the international physical activity questionnaire short form (IPAQ-SF)
Description
Result is the score of the questionnaire
Time Frame
2 minutes
Title
The Brunel Mood Scale (BRUMS)
Description
Result is the score of the questionnaire (each subscale max 0-16)
Time Frame
5 minutes
Title
Motivation with visual analog score (Moti-VAS)
Description
Result is the score between 0 and 100
Time Frame
1 minute
Title
The National Aeronautics and Space Administration Task Load Index (NASA-TLX)
Description
Result is the score of the questionnaire
Time Frame
3 minutes
Title
Subjective feeling of Mental Fatigue with visual analog score (M-VAS)
Description
Result is the score between 0 and 100
Time Frame
1 minute
Title
Subjective feeling of physical fatigue with visual analog score (P-VAS)
Description
Result is the score between 0 and 100
Time Frame
1 minute
Title
Karolinska Sleepiness Scale (KSS)
Description
Result is the score of the questionnaire (max 24)
Time Frame
5 minutes
Title
Internal load of the physical performance (CR100 RPE)
Description
Result is the score between 0 and 100
Time Frame
30 minutes
Title
Heart Rate
Description
continuously assessed by using the POLAR H10 sensor
Time Frame
60 minutes
Title
Lactate concentration
Description
blood lactate will be measured at the beginning and end of the trial at the finger tip of the participant (unit = mmol/L)
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy trained individuals (exercises at least 1x per week, no neurological, cardiovascular internal or musculoskeletal disorders of any kind) No use of chronic or occasional prescribed medication (except for contraceptives) Non-smoker Exclusion Criteria: Injuries of any kind in the past 6 months Pregnancy Specific food or drink allergies (e.g. lactose and/or gluten intolerance) Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal) Participating in any concomitant care or research trials History of suffering from any mental/psychiatric disorders: Suffering from a higher risk of burn out, indicated by a total score of more than 2.59 on the Burn out assessment tool (BAT) Suffering from high general fatigue, indicated by a score of more than 57 on the Multidimensional fatigue inventory (MFI) Suffering from depression, indicated by a score of more than16 on the Beck depression inventory-II (BDI-II) Use of medication Chronic use with an exception for contraceptives Prescribed medication in between or before trials Use of non-prescribed occasional medication 24 hours prior each trial Use of caffeine and heavy efforts 24 hours prior each trial Suffering from colour vision deficiencies Not eating a standardized meal, the morning of each trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahaira Laurisa Arenales Arauz, Msc
Phone
+31615076269
Email
laurisa.arenales@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Tjaša Ocvirk, Msc
Phone
+38631278074
Email
tjasa.ocvirk@vub.be
Facility Information:
Facility Name
Brussels Labo voor Inspanning & Topsport U-residence
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+32 (0)2 629 22 22

12. IPD Sharing Statement

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The Role of the Brain in Mental and Physical Fatigue

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