Mental FatigueMENTALFITNCT07427329
Benefits of Physical Activity During the School Day to Reduce Mental Fatigue and Optimize Cognitive and Psychosocial Processes in Secondary School Students
A study testing Active breaks, Physically active learning and Active Recess in people with Mental Fatigue and Adolescent Behavior, run by University of Extremadura at 1 site in Spain.
Trial summary
The main aim of the MENTALFIT project is to test the effectiveness of physically active teaching methodologies to reduce mental fatigue and optimize cognitive, emotional, and motivational processes in secondary school students. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Adolescent Behavior, Physical Inactivity
- What is being tested?
- Active breaks, Physically active learning and Active Recess
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSpain
- Study dates
- 29 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolment in the 3rd or 4th year of compulsory secondary education (Educación Secundaria Obligatoria).
- Attending one of the participating secondary schools.
- Providing written informed consent from parents/guardians and verbal assent from the students.
Who cannot join
- Medical or physical inability to participate in the physically active interventions.
- Refusal to participate or lack of parental consent.
- Schools participating in any other physical activity or health promotion program
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of the MENTALFIT project is to test the effectiveness of physically active teaching methodologies to reduce mental fatigue and optimize cognitive, emotional, and motivational processes in secondary school students. Specifically, the study aims to examine differences depending on the type of physically active strategy implemented (physically active learning, active breaks, and active recesses) on students' mental fatigue, cognitive function, group dynamics, and motivational processes. Furthermore, the project aims to compare whether learning and academic performance are similar in traditional classes versus classes employing a physically active teaching methodology. Finally, a secondary objective of the project is to create and validate new instruments to assess the different psychobiological and educational processes included in this project.
Read the detailed description
Background and Rationale Mental Fatigue (MF) is a dynamic psychobiological state induced by prolonged cognitive and emotional demands. In educational contexts, particularly in secondary education, it manifests as a cascading deterioration affecting attention, executive function, emotional regulation, and learning capacity. Despite its relevance, MF remains understudied in adolescents. Secondary school students face substantial sedentary demands, spending an average of 78% of the school day in sedentary activities. These schedules, characterized by extended periods of continuous instruction with minimal breaks, create conditions conducive to MF development. The MENTALFIT project aims to address this by reintegrating movement into school routines to counteract MF and its associated cognitive decrements.
Study Design and Methodology This quasi-experimental study (Study 3 of the MENTALFIT overarching protocol) employs a multifactorial design to evaluate the differential effectiveness of three physical activity (PA) interventions. The study is conducted over a full academic year (2024-2025) across several secondary schools in Extremadura, Spain. The sample comprises adolescents in their 3rd and 4th year of secondary education (aged 13-17).
The sample is divided into four groups: one control group ("business as usual") and three experimental groups. To compare the effectiveness of different approaches, each experimental center implements three distinct physically active strategies in a counterbalanced rotation across the three trimesters. This ensures that each experimental group receives every type of intervention while controlling for order effects.
Intervention Components
The multicomponent intervention includes:
Physically Active Lessons (PAL): Integrating motor activities with curriculum content.
Active Breaks (AB): Short bouts of physical activity delivered between or during lessons.
Active Recess (AR): Structured opportunities for physical activity during break times.
Data Collection Data are collected at six measurement points throughout the academic year (at the beginning and end of each trimester). Assessments include standardized self-report measures evaluating mental fatigue perception, academic burnout, school engagement, academic motivation, and well-being. Furthermore, objective measures are collected, including academic grades (GPA), computerised neuropsychological batteries (Stroop, PASAT, PVT-B), continuous heart rate and physical activity monitoring via Fitbit devices, and brain activity via Electroencephalography (EEG) in a selected subsample to capture objective neural correlates of mental fatigue.
- Conditions
- Mental Fatigue, Adolescent Behavior, Physical Inactivity
- Being tested
- Active breaks, Physically active learning, Active Recess
- Keywords
- Mental Fatigue, Physical Activity, Educational Processes, Physically active lessons, Academic performance, Psychological Processes, Secondary Schools
- Medical subject headings
- Mental Fatigue, Adolescent Behavior, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active breaksBehavioural
Also called AB
AB are implemented three times per week on days without physical education classes, providing a total of six active break sessions weekly (two per day on intervention days). Each session consists of 5 minutes of physical activity scheduled after the second and fifth academic periods to interrupt prolonged sedentary behaviour. Delivered over 9 weeks per trimester. A specialised facilitator provides direct support during all intervention sessions to coordinate the timing and implementation of activities.
Physically active learningBehavioural
Also called PAL
PAL integrates physical movement into academic instruction. Two 55-minute lessons per week are dedicated to integrating motor activities with curriculum content. The intervention is coordinated by a specialised facilitator who co-designs the sessions with subject-matter teachers to maintain academic rigor while promoting physical engagement. Delivered over 9 weeks per trimester.
Active RecessBehavioural
Also called AR
AR provides structured opportunities for physical activity during school breaks. Every day of the week, two activities are offered during recess: one involving moderate physical activity and another involving more vigorous or intense activity (alternative games). The intervention modifies playground spaces and provides diverse sports equipment to encourage movement. Delivered over 9 weeks per trimester. A specialised facilitator provides direct support during all intervention sessions to coordinate the implementation of the activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Rotation Sequence A | Experimental | Experimental center 1. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Physically Active Lessons in Trimester 1, Active Breaks in Trimester 2, and Active Recess in Trimester 3). Receives: Behavioral: Active breaks; Behavioral: Physically active learning; Behavioral: Active Recess |
| Experimental: Rotation Sequence B | Experimental | Experimental center 2. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Breaks in Trimester 1, Active Recess in Trimester 2, and Physically Active Lessons in Trimester 3). Receives: Behavioral: Active breaks; Behavioral: Physically active learning; Behavioral: Active Recess |
| Experimental: Rotation Sequence C | Experimental | Experimental center 3. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Recess in Trimester 1, Physically Active Lessons in Trimester 2, and Active Breaks in Trimester 3). Receives: Behavioral: Active breaks; Behavioral: Physically active learning; Behavioral: Active Recess |
| No Intervention: Control Group | No intervention | The control group will maintain their regular academic schedule and usual classroom routines (business as usual) without any additional physically active interventions during the academic year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Mental Fatigue (VAS-F)
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.
Measured: Assessed at 6 time points across the academic year: beginning and end of trimesters 1, 2, and 3 (Baseline up to 9 months).
Multidimensional Mental Fatigue (PedsQL MFS)
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.
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Objective Neurophysiological Mental Fatigue (Brain Activity)
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.
Measured: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Objective Cardiovascular Indicators (Heart Rate and HRV)
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.
Measured: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Secondary outcomes (14)
Objective Physical Activity and Sleep Patterns
Fitbit Charge 6 devices worn continuously for one week providing assessments of sleep metrics (duration, efficiency) and PA patterns (steps, intensity minutes, sedentary time).
Measured: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Self-reported Physical Activity Frequency
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".
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Self-reported Sleep Duration
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".
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Self-reported Screen Time
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".
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Cognitive Performance (Neuropsychological Battery)
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).
Measured: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Perceived Executive Functioning (WEBEX)
Perceived difficulties and efficacy in everyday executive functioning evaluated using the WEBEX Scale (Morea \& Calvete, 2020).
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Academic Performance (GPA)
Grade point average (GPA) obtained from students' official academic records across all compulsory subjects.
Measured: Assessed at 3 time points across the academic year (Baseline up to 9 months).
Academic Burnout (MBI-SS)
Maslach Burnout Inventory-Student Survey (12 items). Comprises three dimensions: emotional exhaustion, cynicism, and academic efficacy. A composite burnout score is calculated.
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
School Engagement (UWES-S)
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).
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Perceived Mental Load
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).
Measured: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Motivation towards Exercise (BREQ-3)
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).
Measured: Assessed at 3 time points: beginning, middle, and end of the academic year (Months 0, 4.5, and 9).
Classroom Social Dynamics (CCQ-SF)
Class Cohesion Questionnaire Short-Form (Leo et al., 2023) measuring task and social cohesion (6 items total).
Measured: Assessed at 3 time points: at the end of trimesters 1, 2, and 3 (Months 3, 6, and 9).
Subjective Happiness (SHS)
Assessed using the Spanish adaptation of the Subjective Happiness Scale (Extremera \& Fernández-Berrocal, 2014).
Measured: Assessed at 2 time points: beginning and end of the academic year (Month 0 and Month 9).
Adherence to the Mediterranean Diet (KIDMED 2.0)
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.
Measured: Assessed at measurement point 5 (approximately Month 7.5 of the academic year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start29 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study employs a multifactorial quasi-experimental design. The sample is divided into three experimental groups and one control group. Each experimental group receives a different physically active intervention (Physically Active Lessons, Active Breaks, and Active Recess) each trimester in a counterbalanced rotation across a full academic year. The control group maintains its regular academic schedule without additional interventions.
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Inmaculada González Ponce, University of Extremadura
- Investigators
- Inmaculada González-Ponce, PhD, Principal investigator, University of Extremadura - Faculty of Teacher TrainingTomás García-Calvo, PhD, Principal investigator, University of Extremadura - Faculty of Sport ScienceRosa Ayuso-Moreno, MSc, Study director, University of Extremadura - Faculty of Sport Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427329
- Sponsor's protocol ID
- PID2022-140903NB-I00
- Acronym
- MENTALFIT
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared. This includes data regarding self-reported mental fatigue, cognitive performance, psychosocial variables, and objective physical activity metrics, after removing any identifying information to protect the privacy of the adolescent participants.
Publications
Smith MR, Chai R, Nguyen HT, Marcora SM, Coutts AJ. Comparing the Effects of Three Cognitive Tasks on Indicators of Mental Fatigue. J Psychol. 2019;153(8):759-783. doi: 10.1080/00223980.2019.1611530. Epub 2019 Jun 12.
PubMed 31188721Bandera-Campos FJ, Grao-Cruces A, Camiletti-Moiron D, Martin-Acosta F, Munoz-Gonzalez R, Gonzalez-Perez M, Ruiz-Hermosa A, Vaquero-Solis M, Padilla-Moledo C, Sanchez-Oliva D. Effectiveness of a multicomponent intervention to promote physical activity during the school day: rationale and methods of the MOVESCHOOL study. Front Public Health. 2025 Mar 12;13:1565914. doi: 10.3389/fpubh.2025.1565914. eCollection 2025.
PubMed 40144996Diaz-Garcia J, Gonzalez-Ponce I, Ponce-Bordon JC, Lopez-Gajardo MA, Ramirez-Bravo I, Rubio-Morales A, Garcia-Calvo T. Mental Load and Fatigue Assessment Instruments: A Systematic Review. Int J Environ Res Public Health. 2021 Dec 31;19(1):419. doi: 10.3390/ijerph19010419.
PubMed 35010678
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 ID
- NCT07427329
- Acronym / sponsor ID
- MENTALFIT / PID2022-140903NB-I00
- Conditions
- Mental Fatigue, Adolescent Behavior, Physical Inactivity
- Keywords
- Mental Fatigue, Physical Activity, Educational Processes, Physically active lessons, Academic performance, Psychological Processes, Secondary Schools
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the MENTALFIT project is to test the effectiveness of physically active teaching methodologies to reduce mental fatigue and optimize cognitive, emotional, and motivational processes in secondary school students. Specifically, the study aims to examine differences depending on the type of physically active strategy implemented (physically active learning, active breaks, and active recesses) on students' mental fatigue, cognitive function, group dynamics, and motivational processes. Furthermore, the project aims to compare whether learning and academic performance are similar in traditional classes versus classes employing a physically active teaching methodology. Finally, a secondary objective of the project is to create and validate new instruments to assess the different psychobiological and educational processes included in this project.
Detailed description
Background and Rationale Mental Fatigue (MF) is a dynamic psychobiological state induced by prolonged cognitive and emotional demands. In educational contexts, particularly in secondary education, it manifests as a cascading deterioration affecting attention, executive function, emotional regulation, and learning capacity. Despite its relevance, MF remains understudied in adolescents. Secondary school students face substantial sedentary demands, spending an average of 78% of the school day in sedentary activities. These schedules, characterized by extended periods of continuous instruction with minimal breaks, create conditions conducive to MF development. The MENTALFIT project aims to address this by reintegrating movement into school routines to counteract MF and its associated cognitive decrements.
Study Design and Methodology This quasi-experimental study (Study 3 of the MENTALFIT overarching protocol) employs a multifactorial design to evaluate the differential effectiveness of three physical activity (PA) interventions. The study is conducted over a full academic year (2024-2025) across several secondary schools in Extremadura, Spain. The sample comprises adolescents in their 3rd and 4th year of secondary education (aged 13-17).
The sample is divided into four groups: one control group ("business as usual") and three experimental groups. To compare the effectiveness of different approaches, each experimental center implements three distinct physically active strategies in a counterbalanced rotation across the three trimesters. This ensures that each experimental group receives every type of intervention while controlling for order effects.
Intervention Components
The multicomponent intervention includes:
Physically Active Lessons (PAL): Integrating motor activities with curriculum content.
Active Breaks (AB): Short bouts of physical activity delivered between or during lessons.
Active Recess (AR): Structured opportunities for physical activity during break times.
Data Collection Data are collected at six measurement points throughout the academic year (at the beginning and end of each trimester). Assessments include standardized self-report measures evaluating mental fatigue perception, academic burnout, school engagement, academic motivation, and well-being. Furthermore, objective measures are collected, including academic grades (GPA), computerised neuropsychological batteries (Stroop, PASAT, PVT-B), continuous heart rate and physical activity monitoring via Fitbit devices, and brain activity via Electroencephalography (EEG) in a selected subsample to capture objective neural correlates of mental fatigue.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study employs a multifactorial quasi-experimental design. The sample is divided into three experimental groups and one control group. Each experimental group receives a different physically active intervention (Physically Active Lessons, Active Breaks, and Active Recess) each trimester in a counterbalanced rotation across a full academic year. The control group maintains its regular academic schedule without additional interventions.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Rotation Sequence A | Experimental | Behavioral: Active breaks, Behavioral: Physically active learning, Behavioral: Active RecessExperimental center 1. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Physically Active Lessons in Trimester 1, Active Breaks in Trimester 2, and Active Recess in Trimester 3). |
| Experimental: Rotation Sequence B | Experimental | Behavioral: Active breaks, Behavioral: Physically active learning, Behavioral: Active RecessExperimental center 2. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Breaks in Trimester 1, Active Recess in Trimester 2, and Physically Active Lessons in Trimester 3). |
| Experimental: Rotation Sequence C | Experimental | Behavioral: Active breaks, Behavioral: Physically active learning, Behavioral: Active RecessExperimental center 3. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Recess in Trimester 1, Physically Active Lessons in Trimester 2, and Active Breaks in Trimester 3). |
| No Intervention: Control Group | No intervention | –The control group will maintain their regular academic schedule and usual classroom routines (business as usual) without any additional physically active interventions during the academic year. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Enrolment in the 3rd or 4th year of compulsory secondary education (Educación Secundaria Obligatoria).
- Attending one of the participating secondary schools.
- Providing written informed consent from parents/guardians and verbal assent from the students.
Key exclusion criteria (3 listed)
- Medical or physical inability to participate in the physically active interventions.
- Refusal to participate or lack of parental consent.
- Schools participating in any other physical activity or health promotion program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active breaksAlso: ABAB are implemented three times per week on days without physical education classes, providing a total of six active break sessions weekly (two per day on intervention days). Each session consists of 5 minutes of physical activity scheduled after the second and fifth academic periods to interrupt prolonged sedentary behaviour. Delivered over 9 weeks per trimester. A specialised facilitator provides direct support during all intervention sessions to coordinate the timing and implementation of activities. | Behavioural | Experimental: Rotation Sequence A, Experimental: Rotation Sequence B, Experimental: Rotation Sequence C |
| Physically active learningAlso: PALPAL integrates physical movement into academic instruction. Two 55-minute lessons per week are dedicated to integrating motor activities with curriculum content. The intervention is coordinated by a specialised facilitator who co-designs the sessions with subject-matter teachers to maintain academic rigor while promoting physical engagement. Delivered over 9 weeks per trimester. | Behavioural | Experimental: Rotation Sequence A, Experimental: Rotation Sequence B, Experimental: Rotation Sequence C |
| Active RecessAlso: ARAR provides structured opportunities for physical activity during school breaks. Every day of the week, two activities are offered during recess: one involving moderate physical activity and another involving more vigorous or intense activity (alternative games). The intervention modifies playground spaces and provides diverse sports equipment to encourage movement. Delivered over 9 weeks per trimester. A specialised facilitator provides direct support during all intervention sessions to coordinate the implementation of the activities. | Behavioural | Experimental: Rotation Sequence A, Experimental: Rotation Sequence B, Experimental: Rotation Sequence C |
Primary outcome
Subjective Mental Fatigue (VAS-F)
Time frame: 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.
Multidimensional Mental Fatigue (PedsQL MFS)
Time frame: 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.
Objective Neurophysiological Mental Fatigue (Brain Activity)
Time frame: 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.
Objective Cardiovascular Indicators (Heart Rate and HRV)
Time frame: 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.
14 secondary outcomes
Objective Physical Activity and Sleep Patterns
Time frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Self-reported Physical Activity Frequency
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Self-reported Sleep Duration
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Self-reported Screen Time
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Cognitive Performance (Neuropsychological Battery)
Time frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
Perceived Executive Functioning (WEBEX)
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Academic Performance (GPA)
Time frame: Assessed at 3 time points across the academic year (Baseline up to 9 months).
Academic Burnout (MBI-SS)
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
School Engagement (UWES-S)
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Perceived Mental Load
Time frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
Motivation towards Exercise (BREQ-3)
Time frame: Assessed at 3 time points: beginning, middle, and end of the academic year (Months 0, 4.5, and 9).
Classroom Social Dynamics (CCQ-SF)
Time frame: Assessed at 3 time points: at the end of trimesters 1, 2, and 3 (Months 3, 6, and 9).
Subjective Happiness (SHS)
Time frame: Assessed at 2 time points: beginning and end of the academic year (Month 0 and Month 9).
Adherence to the Mediterranean Diet (KIDMED 2.0)
Time frame: Assessed at measurement point 5 (approximately Month 7.5 of the academic year).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 31188721Smith MR, Chai R, Nguyen HT, Marcora SM, Coutts AJ. Comparing the Effects of Three Cognitive Tasks on Indicators of Mental Fatigue. J Psychol. 2019;153(8):759-783. doi: 10.1080/00223980.2019.1611530. Epub 2019 Jun 12.
- Background: PubMed 40144996Bandera-Campos FJ, Grao-Cruces A, Camiletti-Moiron D, Martin-Acosta F, Munoz-Gonzalez R, Gonzalez-Perez M, Ruiz-Hermosa A, Vaquero-Solis M, Padilla-Moledo C, Sanchez-Oliva D. Effectiveness of a multicomponent intervention to promote physical activity during the school day: rationale and methods of the MOVESCHOOL study. Front Public Health. 2025 Mar 12;13:1565914. doi: 10.3389/fpubh.2025.1565914. eCollection 2025.
- Background: PubMed 35010678Diaz-Garcia J, Gonzalez-Ponce I, Ponce-Bordon JC, Lopez-Gajardo MA, Ramirez-Bravo I, Rubio-Morales A, Garcia-Calvo T. Mental Load and Fatigue Assessment Instruments: A Systematic Review. Int J Environ Res Public Health. 2021 Dec 31;19(1):419. doi: 10.3390/ijerph19010419.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared. This includes data regarding self-reported mental fatigue, cognitive performance, psychosocial variables, and objective physical activity metrics, after removing any identifying information to protect the privacy of the adolescent participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada González-Ponce, PhD principal investigator
University of Extremadura - Faculty of Teacher Training
Tomás García-Calvo, PhD principal investigator
University of Extremadura - Faculty of Sport Science
Rosa Ayuso-Moreno, MSc study director
University of Extremadura - Faculty of Sport Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active breaks, Physically active learning and Active Recess in people with Mental Fatigue and Adolescent Behavior, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Mental Fatigue (VAS-F) (time frame: Assessed at 6 time points across the academic year: beginning and end of trimesters 1, 2, and 3 (Baseline up to 9 months).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427329, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.