The Role of the Brain in Mental and Physical Fatigue
NCT05880342, Phase 3, Recruiting, Vrije Universiteit Brussel
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Role of the Brain in Mental and Physical Fatigue | ClinicalTrials.gov |
| NCT number | NCT05880342 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 62 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vrije Universiteit Brussel | ClinicalTrials.gov |
| Conditions | Fatigue | ClinicalTrials.gov |
| Interventions | Reboxetine Pill, Methylphenidate Oral Product | ClinicalTrials.gov |
| First posted | 2023-05-30 | ClinicalTrials.gov |
| Last updated | 2025-06-18 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of repetitions | 30 minutes | Number of repetitions during knee extension task | ClinicalTrials.gov |
| Primary | Electroencephalography (spectral analysis) | 80 minutes | measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta) | ClinicalTrials.gov |
| Primary | Electroencephalography (event related potentials) | 80 minutes | measurement of cortical activity with 64 channels (event related potentials) | ClinicalTrials.gov |
| Primary | Electromyography | 60 minutes | Target muscles are rectus femoris and vastus lateralis (median frequency) | ClinicalTrials.gov |
| Primary | Accuracy | 60 minutes | Accuracy of correct answers during Stroop task | ClinicalTrials.gov |
| Primary | Reaction time | 60 minutes | Reaction time for answers during Stroop task | ClinicalTrials.gov |
| Secondary | Perceived stress scale questionnaire (PSS-10) | 5 minites | Result is the score of the questionnaire (may 40 points) | ClinicalTrials.gov |
| Secondary | the international physical activity questionnaire short form (IPAQ-SF) | 2 minutes | Result is the score of the questionnaire | ClinicalTrials.gov |
| Secondary | The Brunel Mood Scale (BRUMS) | 5 minutes | Result is the score of the questionnaire (each subscale max 0-16) | ClinicalTrials.gov |
| Secondary | Motivation with visual analog score (Moti-VAS) | 1 minute | Result is the score between 0 and 100 | ClinicalTrials.gov |
| Secondary | The National Aeronautics and Space Administration Task Load Index (NASA-TLX) | 3 minutes | Result is the score of the questionnaire | ClinicalTrials.gov |
| Secondary | Subjective feeling of Mental Fatigue with visual analog score (M-VAS) | 1 minute | Result is the score between 0 and 100 | ClinicalTrials.gov |
| Secondary | Subjective feeling of physical fatigue with visual analog score (P-VAS) | 1 minute | Result is the score between 0 and 100 | ClinicalTrials.gov |
| Secondary | Karolinska Sleepiness Scale (KSS) | 5 minutes | Result is the score of the questionnaire (max 24) | ClinicalTrials.gov |
| Secondary | Internal load of the physical performance (CR100 RPE) | 30 minutes | Result is the score between 0 and 100 | ClinicalTrials.gov |
| Secondary | Heart Rate | 60 minutes | continuously assessed by using the POLAR H10 sensor | ClinicalTrials.gov |
| Secondary | 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) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)