The Role of the Brain in Mental and Physical Fatigue

Sponsor
Vrije Universiteit Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05880342
Collaborator
Science and Research Centre Koper (Other)
62
1
3
21.9
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Reboxetine Pill
  • Drug: Methylphenidate Oral Product
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial
Actual Study Start Date :
May 3, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Mental fatigue group

Drug: Reboxetine Pill
8 mg

Drug: Methylphenidate Oral Product
20 mg

Other: Physical fatigue group

Drug: Reboxetine Pill
8 mg

Drug: Methylphenidate Oral Product
20 mg

Other: Combined group

Drug: Reboxetine Pill
8 mg

Drug: Methylphenidate Oral Product
20 mg

Outcome Measures

Primary Outcome Measures

  1. Number of repetitions [30 minutes]

    Number of repetitions during knee extension task

  2. Electroencephalography (spectral analysis) [80 minutes]

    measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta)

  3. Electroencephalography (event related potentials) [80 minutes]

    measurement of cortical activity with 64 channels (event related potentials)

  4. Electromyography [60 minutes]

    Target muscles are rectus femoris and vastus lateralis (median frequency)

  5. Accuracy [60 minutes]

    Accuracy of correct answers during Stroop task

  6. Reaction time [60 minutes]

    Reaction time for answers during Stroop task

Secondary Outcome Measures

  1. Perceived stress scale questionnaire (PSS-10) [5 minites]

    Result is the score of the questionnaire (may 40 points)

  2. the international physical activity questionnaire short form (IPAQ-SF) [2 minutes]

    Result is the score of the questionnaire

  3. The Brunel Mood Scale (BRUMS) [5 minutes]

    Result is the score of the questionnaire (each subscale max 0-16)

  4. Motivation with visual analog score (Moti-VAS) [1 minute]

    Result is the score between 0 and 100

  5. The National Aeronautics and Space Administration Task Load Index (NASA-TLX) [3 minutes]

    Result is the score of the questionnaire

  6. Subjective feeling of Mental Fatigue with visual analog score (M-VAS) [1 minute]

    Result is the score between 0 and 100

  7. Subjective feeling of physical fatigue with visual analog score (P-VAS) [1 minute]

    Result is the score between 0 and 100

  8. Karolinska Sleepiness Scale (KSS) [5 minutes]

    Result is the score of the questionnaire (max 24)

  9. Internal load of the physical performance (CR100 RPE) [30 minutes]

    Result is the score between 0 and 100

  10. Heart Rate [60 minutes]

    continuously assessed by using the POLAR H10 sensor

  11. Lactate concentration [5 minutes]

    blood lactate will be measured at the beginning and end of the trial at the finger tip of the participant (unit = mmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brussels Labo voor Inspanning & Topsport U-residence Brussels Belgium 1050

Sponsors and Collaborators

  • Vrije Universiteit Brussel
  • Science and Research Centre Koper

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yahaira Laurisa Arenales Arauz, Yahaira Laurisa Arenales Arauz, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT05880342
Other Study ID Numbers:
  • G095422N
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023