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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05880342
Other study ID # G095422N
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2023
Est. completion date March 2025

Study information

Verified date May 2023
Source Vrije Universiteit Brussel
Contact Yahaira Laurisa Arenales Arauz, Msc
Phone +31615076269
Email laurisa.arenales@vub.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Reboxetine Pill
8 mg
Methylphenidate Oral Product
20 mg

Locations

Country Name City State
Belgium Brussels Labo voor Inspanning & Topsport U-residence Brussels

Sponsors (2)

Lead Sponsor Collaborator
Vrije Universiteit Brussel Science and Research Centre Koper

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of repetitions Number of repetitions during knee extension task 30 minutes
Primary Electroencephalography (spectral analysis) measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta) 80 minutes
Primary Electroencephalography (event related potentials) measurement of cortical activity with 64 channels (event related potentials) 80 minutes
Primary Electromyography Target muscles are rectus femoris and vastus lateralis (median frequency) 60 minutes
Primary Accuracy Accuracy of correct answers during Stroop task 60 minutes
Primary Reaction time Reaction time for answers during Stroop task 60 minutes
Secondary Perceived stress scale questionnaire (PSS-10) Result is the score of the questionnaire (may 40 points) 5 minites
Secondary the international physical activity questionnaire short form (IPAQ-SF) Result is the score of the questionnaire 2 minutes
Secondary The Brunel Mood Scale (BRUMS) Result is the score of the questionnaire (each subscale max 0-16) 5 minutes
Secondary Motivation with visual analog score (Moti-VAS) Result is the score between 0 and 100 1 minute
Secondary The National Aeronautics and Space Administration Task Load Index (NASA-TLX) Result is the score of the questionnaire 3 minutes
Secondary Subjective feeling of Mental Fatigue with visual analog score (M-VAS) Result is the score between 0 and 100 1 minute
Secondary Subjective feeling of physical fatigue with visual analog score (P-VAS) Result is the score between 0 and 100 1 minute
Secondary Karolinska Sleepiness Scale (KSS) Result is the score of the questionnaire (max 24) 5 minutes
Secondary Internal load of the physical performance (CR100 RPE) Result is the score between 0 and 100 30 minutes
Secondary Heart Rate continuously assessed by using the POLAR H10 sensor 60 minutes
Secondary 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) 5 minutes
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