NCT05355493

Brief Summary

The experiment will consist of 3 consecutive trials performed in a sound-insulated climate chamber (20°C and 40% RH) at the VUB. Participants will be asked to return 3 successive weeks. Trained staff (pre-doctoral researchers and trained master students) will be present during the experimental trials. The first visit will be a familiarization trial in which they will complete all procedures as if it was an experimental trial, except for the interventional 60min Stroop task. Instead of the 60-min Stroop task the participants' maximal cognitive capacity will be determined. The participant wil come in, perform a cognitive performance test, will then perform the intervention/control procedure, which will be followed by an additional conduction of the same cognitive performance test as before the intervention/control, as well as a physical performance test (time to exhaustion cycling test). The intervention will consist of a 60 min Stroop task, while the control trial will consist of watching a documentary of the same duration. Multiple different questionnaires (e.g. to assess the mentally fatigued state of participants) will be assessed throughout the experimental/control trial. The aim of this study will be to research if mental fatigue influences prefrontal cortex oxygenation during a time to exhaustion cycling test. Marcora et al. (2009) already showed a decrease in cycling performance during the exact same protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

February 8, 2022

Last Update Submit

April 25, 2022

Conditions

Keywords

NIRSTime to exhaustionPrefrontal cortexCerebral oxygenation

Outcome Measures

Primary Outcomes (3)

  • Cerebral oxygenation

    Prefrontal cortex oxygenation = relative changes in oxy- and deoxy hemoglobin concentrations at the prefrontal cortex. During the whole frame, participants are equipped with a Near Infrared Spectroscopy device that measures cerebral oxygenation continuously at 10hz.

    2 hours

  • Mental Fatigue

    Results of a visual analogue scale for mental fatigue (1 to 100) Higher score is more mentally fatigued

    60 minutes

  • Time to exhaustion cycling

    Cycling at a power output corresponding to the subject's respiratory compensation point until exhaustion

    1hour

Secondary Outcomes (1)

  • Cognition

    7 minutes

Other Outcomes (3)

  • Hemoglobin concentration

    10 minutes

  • Blood glucose concentration

    10 minutes

  • Blood Lactate concentration

    1 hour

Study Arms (2)

Mental Fatigue condition

EXPERIMENTAL

A Stroop task, of approximately 60 min, partitioned in 6 blocks of 336 stimuli, will be used as the mentally fatiguing task. In this task, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself. If, however, the ink color is red, the button to be pressed will be the button linked to the real meaning of the word, not the ink color. The word presented and its ink color will be randomly selected by the computer (100% incongruent), with all incongruent word-color combinations being equally common (meaning, in each block 84 words will be presented in the color red, yellow, green and blue). Subjects will be instructed to respond as quickly and accurately as possible. To assess performance accuracy (ACC) and reaction time (RT) will be collected and averaged every block.

Behavioral: Time to Exhaustion cycling testBehavioral: Go/NoGo task

Control condition

ACTIVE COMPARATOR

In the control task subjects will have to watch a documentary during 60 min on the same computer screen as that used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several episodes (One Planet, Frozen Worlds, Jungles, Costal Seas, From Desserts to Grasslands, The High Seas, Fresh Water and Forests) of the Netflix documentary "Our Planet, 2019" as proposed by the research team. During the control task physiological and psychological measures will be assessed at the same time points as during the mental fatigue trial.

Behavioral: Time to Exhaustion cycling testBehavioral: Go/NoGo task

Interventions

After completing the MF/control task. Participants will be asked to take place on the cycle ergometer. Participants will perform a 3-min warm-up at 40% of peak power output followed by a rectangular workload at a power output corresponding to their predetermined respiratory compensation point (±80% PPO). RPM was freely chosen between 60 and 100 RPM and was recorded every minute. TTE was measured from the start until the pedal frequency was less than 60 RPM for more than 5s. This TTE task was chosen, based on a previous study of Marcora et al. (2009), who found that mental fatigue impairs physical performance. A researcher will sit behind the subject to ensure compliance with treatment. Subjects will be equipped with a heart rate monitor to continuously follow up heart rate. Subjective psychological assessment will take place with a M-VAS-scale, the NASA-TLX, the success motivation and intrinsic motivation scales, Karolinska Sleepiness Scale and visual analog scale for boredom.

Control conditionMental Fatigue condition
Go/NoGo taskBEHAVIORAL

Participants are to react to different stimuli displayed on a computer screen, preceded by a screen with general instructions. Two different stimuli were present at the same time: a Go or NoGo stimulus, and a left or right stimulus (meaning that four combinations are possible: GoRight, GoLeft, NoGoRight and NoGoLeft). If a Go-stimulus is presented, participants are instructed to react to the left or right stimuli with the corresponding arrows. However, if a NoGo stimulus is presented, participants are instructed to refrain from reacting to the either the left or right stimuli. This proposed paradigm measures attention, response inhibition and working memory. Stimuli will be presented for 500 ms, with a varying interstimulus time between 1100 and 1700 ms. Outcomes for Go trials include reaction time and accuracy while the outcome for NoGo trials is only accuracy.

Control conditionMental Fatigue condition

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (No neurological or cardiovascular disorders)
  • Male or female
  • No medication
  • Non-smoker • Between 18 and 35 years old
  • Recreational athlete population; performance level 2 or 3 for men according to De Pauw et al. (2013)(De Pauw et al., 2013) and performance level 2 or 3 for woman according to Decroix et al. (2015)(Decroix et al., 2015)
  • Non-acclimatized to altitude (at least 2 months)

You may not qualify if:

  • Injuries
  • Acclimated to altitude
  • Use of medication
  • Use of caffeine and heavy efforts 24 hours prior each trial
  • Not eating a standardized meal, the morning of each trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Physiology - MFYS

Brussels, Brussels Capital, 1050, Belgium

Location

MeSH Terms

Conditions

Mental FatigueDisease

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2022

First Posted

May 2, 2022

Study Start

May 1, 2022

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

May 2, 2022

Record last verified: 2022-04

Locations