NCT07809750

Brief Summary

This multicenter randomized crossover study will examine the acute effects of four classroom break conditions on executive functions, immediate academic performance, perceived exertion, and interest-enjoyment in university students. Each participant will complete four experimental sessions in which a different 15-minute condition will be implemented: a sedentary free break, a sedentary academic review break, an active break without academic content, and physically active learning combining movement with academic review. Cognitive performance will be assessed before and after each session using Stroop and N-Back tasks. Academic performance, perceived exertion, and interest-enjoyment will be assessed after each experimental session.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress6%
Sep 2026Jul 2027

First Submitted

Initial submission to the registry

September 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 3, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

Active breaksPhysically active learningExecutive functionsCognitive performanceAcademic performanceUniversity studentsPhysical activitySedentary behaviorWorking memoryInhibitory control

Outcome Measures

Primary Outcomes (3)

  • Change in Inhibitory Control Assessed by the Stroop Test

    Inhibitory control will be assessed using the Stroop task. Outcomes will include response accuracy and reaction time. Acute change will be calculated by comparing PRE and POST performance within each experimental session.

    Immediately before and approximately 10 minutes after the 15-minute experimental condition, during each of the four experimental sessions.

  • Change in Working Memory Assessed by the N-Back Test

    Working memory will be assessed using the N-Back task. Outcomes will include accuracy, omissions/errors, and reaction time. Acute change will be calculated from PRE to POST within each experimental session.

    Immediately before and approximately 10 minutes after the experimental condition, during each of the four experimental sessions.

  • Immediate Academic Performance

    Academic performance will be assessed using a 10-item multiple-choice test developed specifically for the academic content taught during each experimental session. Each question will have three response options and one correct answer. The outcome will be the number of correct responses, ranging from 0 to 10.

    Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.

Secondary Outcomes (2)

  • Interest-Enjoyment

    Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.

  • Rating of Perceived Exertion

    Approximately 10 minutes after the experimental condition, during each of the four experimental sessions.

Other Outcomes (1)

  • Physical Activity During Experimental Sessions

    Throughout each experimental classroom session, approximately 2 hours.

Study Arms (4)

Sedentary Free Break

NO INTERVENTION

Participants complete a 15-minute sedentary break without structured physical activity or academic review.

Sedentary Academic Review

EXPERIMENTAL

Participants remain sedentary during a 15-minute academic review activity based on true/false questions related to content presented during the preceding 45 minutes of class.

Behavioral: Sedentary Academic Review

Active Break Without Academic Content

EXPERIMENTAL

Participants complete a standardized 15-minute active break involving moderate physical activities without academic content.

Behavioral: Active Break

Physically Active Learning

EXPERIMENTAL

Participants complete a standardized 15-minute physically active learning session combining physical movements with true/false questions related to academic content presented during the preceding 45 minutes.

Behavioral: Physically Active Learning

Interventions

A 15-minute sedentary academic review activity using 10 true/false questions based on academic content presented during the first 45 minutes of the session.

Sedentary Academic Review
Active BreakBEHAVIORAL

A standardized 15-minute classroom physical activity break without academic content.

Active Break Without Academic Content

A standardized 15-minute intervention combining physical activity with academic true/false questions. Participants respond to academic questions through predefined physical movements.

Physically Active Learning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University students aged 18 years or older.
  • Currently enrolled in one of the participating university courses/classes.
  • Provision of informed consent.
  • Ability to participate safely in light-to-moderate classroom physical activity.
  • Ability to complete computerized cognitive assessments.

You may not qualify if:

  • Injury, illness, or medical condition contraindicating participation in physical activity.
  • Acute illness or other condition on the day of testing likely to substantially affect attention or cognitive performance.
  • Inability to complete the required computerized cognitive assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Pública de Navarra

Pamplona, Navarre, Spain

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Carlos Martín-Martínez, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR
  • Óscar Martínez de Quel Pérez, PhD

    Universidad Pública de Navarra

    STUDY DIRECTOR

Central Study Contacts

Carlos Martín-Martínez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will complete all four experimental conditions in a randomized and counterbalanced order. Experimental sessions will be separated by at least one week whenever feasible to reduce potential carryover and learning effects.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 9, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to data protection and confidentiality considerations. Aggregated and anonymized study results may be made available upon reasonable request, subject to institutional and ethical approval.

Locations