NCT07427329

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
434

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 29, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Mental FatiguePhysical ActivityEducational ProcessesPhysically active lessonsAcademic performancePsychological ProcessesSecondary Schools

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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

    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 at 6 time points across the academic year (Baseline up to 9 months).

  • Self-reported Sleep Duration

    Assessed at 6 time points across the academic year (Baseline up to 9 months).

  • Self-reported Screen Time

    Assessed at 6 time points across the academic year (Baseline up to 9 months).

  • Cognitive Performance (Neuropsychological Battery)

    Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).

  • +9 more secondary outcomes

Study Arms (4)

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).

Behavioral: Active breaksBehavioral: Physically active learningBehavioral: 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).

Behavioral: Active breaksBehavioral: Physically active learningBehavioral: 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).

Behavioral: Active breaksBehavioral: Physically active learningBehavioral: 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.

Interventions

Active breaksBEHAVIORAL

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.

Also known as: AB
Experimental: Rotation Sequence AExperimental: Rotation Sequence BExperimental: Rotation Sequence C

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.

Also known as: PAL
Experimental: Rotation Sequence AExperimental: Rotation Sequence BExperimental: Rotation Sequence C
Active RecessBEHAVIORAL

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.

Also known as: AR
Experimental: Rotation Sequence AExperimental: Rotation Sequence BExperimental: Rotation Sequence C

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Extremadura

Cáceres, 10003, Spain

Location

Related Publications (3)

  • 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.

    PMID: 31188721BACKGROUND
  • Bandera-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.

    PMID: 40144996BACKGROUND
  • Diaz-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.

    PMID: 35010678BACKGROUND

MeSH Terms

Conditions

Mental FatigueAdolescent BehaviorSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Inmaculada González-Ponce, PhD

    University of Extremadura - Faculty of Teacher Training

    PRINCIPAL INVESTIGATOR
  • Tomás García-Calvo, PhD

    University of Extremadura - Faculty of Sport Science

    PRINCIPAL INVESTIGATOR
  • Rosa Ayuso-Moreno, MSc

    University of Extremadura - Faculty of Sport Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

September 29, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available beginning 6 months following the publication of the main study findings and will remain accessible for up to 5 years after publication.
Access Criteria
Access to the de-identified IPD will be granted to qualified academic researchers who submit a methodologically sound proposal. Proposals must be directed to the Principal Investigator or the corresponding author of the published manuscript. To gain access, data requestors must sign a formal data access agreement confirming that the data will only be used for the approved research purposes and that no attempts will be made to re-identify the participants.

Locations