Benefits of Physical Activity During the School Day to Reduce Mental Fatigue and Optimize Cognitive and Psychosocial Processes in Secondary School Students
NCT07427329, Not applicable, Active not recruiting, University of Extremadura
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Benefits of Physical Activity During the School Day to Reduce Mental Fatigue and Optimize Cognitive and Psychosocial Processes in Secondary School Students | ClinicalTrials.gov |
| NCT number | NCT07427329 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 434 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Extremadura | ClinicalTrials.gov |
| Conditions | Mental Fatigue, Adolescent Behavior, Physical Inactivity | ClinicalTrials.gov |
| Interventions | Active breaks, Physically active learning, Active Recess | ClinicalTrials.gov |
| First posted | 2026-02-23 | ClinicalTrials.gov |
| Last updated | 2026-02-23 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Subjective Mental Fatigue (VAS-F) | Assessed at 6 time points across the academic year: beginning and end of trimesters 1, 2, and 3 (Baseline up to 9 months). | Assessed through the Visual Analogue Scale for Fatigue (VAS-F; Smith et al., 2019). It is a 100mm single-item measure of overall fatigue intensity. Scores range from 0 to 100, where higher scores indicate a higher perception of mental fatigue. | ClinicalTrials.gov |
| Primary | Multidimensional Mental Fatigue (PedsQL MFS) | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (Varni \& Limbers, 2008), 9-item Spanish version. It measures general, sleep/rest, and cognitive fatigue. A composite score is calculated as the mean across items. Higher scores indicate greater problems with fatigue. | ClinicalTrials.gov |
| Primary | Objective Neurophysiological Mental Fatigue (Brain Activity) | Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months). | Assessed via EEG recordings using Emotiv EPOC X headsets. Recordings are taken during resting-state and cognitive tasks (Stroop, PASAT, PVT-B) to characterize neural correlates (theta, alpha, and beta frequency bands) of cognitive performance under conditions of mental fatigue. | ClinicalTrials.gov |
| Primary | Objective Cardiovascular Indicators (Heart Rate and HRV) | Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months). | Fitbit Charge 6 devices worn continuously for one week at each measurement point to provide 24-hour assessments of heart rate and heart rate variability (HRV) as indicators of fatigue and autonomic nervous system state. | ClinicalTrials.gov |
| Secondary | Objective Physical Activity and Sleep Patterns | Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months). | Fitbit Charge 6 devices worn continuously for one week providing assessments of sleep metrics (duration, efficiency) and PA patterns (steps, intensity minutes, sedentary time). | ClinicalTrials.gov |
| Secondary | Self-reported Physical Activity Frequency | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Assessed via a single-item question asking participants about their weekly physical activity volume (including PE classes and outside school). Rated on a 5-point scale ranging from "None" to "More than 7 hours". | ClinicalTrials.gov |
| Secondary | Self-reported Sleep Duration | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Assessed via a single-item question asking about the average hours of sleep per day (including night sleep and naps). Responses range from "Less than 3 hours" to "More than 10 hours". | ClinicalTrials.gov |
| Secondary | Self-reported Screen Time | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Assessed separately for weekdays and weekends via a single question about hours spent on screens (TV, mobile, video games, social media). Rated on a 7-point scale ranging from "0 minutes" to "5 hours or more". | ClinicalTrials.gov |
| Secondary | Cognitive Performance (Neuropsychological Battery) | Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months). | A computerized battery assessing cognitive inhibition, selective attention, working memory, and sustained attention using three specific tasks: the Stroop task, the Paced Auditory Serial Addition Test (PASAT), and the Psychomotor Vigilance Task-Brief (PVT-B). | ClinicalTrials.gov |
| Secondary | Perceived Executive Functioning (WEBEX) | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Perceived difficulties and efficacy in everyday executive functioning evaluated using the WEBEX Scale (Morea \& Calvete, 2020). | ClinicalTrials.gov |
| Secondary | Academic Performance (GPA) | Assessed at 3 time points across the academic year (Baseline up to 9 months). | Grade point average (GPA) obtained from students' official academic records across all compulsory subjects. | ClinicalTrials.gov |
| Secondary | Academic Burnout (MBI-SS) | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Maslach Burnout Inventory-Student Survey (12 items). Comprises three dimensions: emotional exhaustion, cynicism, and academic efficacy. A composite burnout score is calculated. | ClinicalTrials.gov |
| Secondary | School Engagement (UWES-S) | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Assessed using 3 items from the Utrecht Work Engagement Scale for Students measuring vigor, dedication, and absorption. Items are rated on a 7-point scale (0-6). | ClinicalTrials.gov |
| Secondary | Perceived Mental Load | Assessed at 6 time points across the academic year (Baseline up to 9 months). | Assessed using an adapted 3-item scale (Díaz-García et al., 2018) measuring perceived physical, cognitive, and emotional demands of the school week. Rated on an 11-point scale (0-10). | ClinicalTrials.gov |
| Secondary | Motivation towards Exercise (BREQ-3) | Assessed at 3 time points: beginning, middle, and end of the academic year (Months 0, 4.5, and 9). | Assessed using 6 items representing the six regulation types of the Behavioral Regulation in Exercise Questionnaire-3. Rated on a 5-point scale (0-4). | ClinicalTrials.gov |
| Secondary | Classroom Social Dynamics (CCQ-SF) | Assessed at 3 time points: at the end of trimesters 1, 2, and 3 (Months 3, 6, and 9). | Class Cohesion Questionnaire Short-Form (Leo et al., 2023) measuring task and social cohesion (6 items total). | ClinicalTrials.gov |
| Secondary | Subjective Happiness (SHS) | Assessed at 2 time points: beginning and end of the academic year (Month 0 and Month 9). | Assessed using the Spanish adaptation of the Subjective Happiness Scale (Extremera \& Fernández-Berrocal, 2014). | ClinicalTrials.gov |
| Secondary | Adherence to the Mediterranean Diet (KIDMED 2.0) | Assessed at measurement point 5 (approximately Month 7.5 of the academic year). | Assessed using the KIDMED 2.0 questionnaire (Spanish version; López-Gajardo et al., 2022) to evaluate adherence to the Mediterranean diet. Higher scores indicate better adherence to healthy dietary habits. | 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 3
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 3
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 |
|---|---|---|
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary 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)