- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538453
Active Breaks and Executive Function in Scholars (ACTISTOP)
Active-breaks, Learning, Creativity and Emotional Health in Preadolescent Students (ACTISTOP)
Study Overview
Status
Intervention / Treatment
Detailed Description
This study investigates the effects of short classroom-based physical activity breaks on cognitive performance, creativity and emotional wellbeing in primary school children aged 11 to 12 years. Many children spend long periods sitting during the school day, which may negatively affect attention, learning, and overall health. Introducing brief "active breaks" during class time has been proposed as a practical strategy to interrupt sedentary behavior and promote both physical and cognitive benefits.
In this study, participants will be randomly assigned to one of three groups: an aerobic exercise group, a strength-based (neuromuscular) exercise group, or a control group that remains seated and watches a low-demand video. All interventions will last approximately 10 minutes and will be delivered in a standardized format including a warm-up, main activity, and cool-down.
To better reflect real classroom conditions, participants will perform academic tasks (e.g., reading and mathematics) prior to the intervention to induce cognitive fatigue. At baseline, before and after the intervention, children will complete a series of simple tasks and questionnaires designed to assess key aspects of cognitive function, such as attention, working memory, and inhibitory control, as well as creativity and emotional state.
In addition, participants will undergo physical fitness assessments (e.g., strength, cardiorespiratory fitness, and body composition). These measures will be used as potential moderating variables or to explore associations between physical fitness levels and cognitive and emotional responses to the activity breaks.
The main objective of the study is to determine whether these short activity breaks can produce immediate improvements in cognitive, creativity and emotional outcomes, and whether different types of exercise (aerobic vs. strength-based) have distinct effects. The results of this study may help schools and educators design effective, evidence-based strategies to integrate physical activity into daily classroom routines, with the goal of improving students' learning, wellbeing, and overall development.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diego Moliner-Urdiales, PhD
- Phone Number: +34 964 729782
- Email: dmoliner@uji.es
Study Contact Backup
- Name: Carlos Babiloni-Lopez, PhD
- Phone Number: +34 964 729840
- Email: cbabilon@uji.es
Study Locations
-
-
Castellón
-
Castellon, Castellón, Spain, 12071
- Recruiting
- Universitat Jaume I
-
Contact:
- Diego Moliner-Urdiales, PhD
- Phone Number: +34 964 729782
- Email: dmoliner@uji.es
-
Contact:
- Carlos Babiloni-Lopez, PhD
- Phone Number: +34 964 729840
- Email: cbabilon@uji.es
-
Sub-Investigator:
- Mireia Adelantado-Renau, PhD
-
Sub-Investigator:
- Maria Reyes Beltrán-Valls, PhD
-
Sub-Investigator:
- Maria Dolores Temprado-Albalat, PhD
-
Sub-Investigator:
- Jose Vicente Beltrán-Garrido, PhD
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Sub-Investigator:
- Noelia Linares-Ayala, MsC
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Sub-Investigator:
- Carlos Bou-Sospedra, PhD
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Sub-Investigator:
- Irene Monzonís-Carda, PhD
-
Sub-Investigator:
- Alessandra de Maria, PhD
-
Sub-Investigator:
- Martín Sánchez-Gómez, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students enrolled in the 5th and 6th grades of primary education in the city of Castellón, with continuous academic progression and no history of grade retention.
- Students without diagnosed physical, neurological, or cognitive disorders.
Exclusion Criteria:
- Students with a history of grade retention.
- Students with diagnosed learning difficulties or neurodevelopmental disorders.
- Students presenting any medical or psychiatric disease.
- Students undergoing chronic pharmacological treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Rest Break
Participants in the control group will remain seated while watching a silent video with low cognitive load and without verbal interaction for 10 min.
|
|
|
Experimental: Strength Active Break
Participants assigned to the exercise strength group will perform a vigorous-intensity neuromuscular protocol based on a Tabata structure (20 s work / 10 s rest).
The session includes two blocks of four exercises targeting upper body, lower body, and core musculature in alternating sequences designed to ensure balanced neuromuscular stimulation while limiting localized fatigue
|
A 10-min active break format was selected to maximize feasibility within school settings.
All conditions followed an identical temporal structure consisting of a 1-min warm-up, an 8-min main activity phase, and a 1-min cool-down delivered through standardized instructional videos that guided students in reproducing and observing the correct technique and execution of the exercises.
|
|
Experimental: Aerobic Active Break
Participants assigned to the aerobic exercise group will perform continuous cardiovascular exercises at moderate intensity.
The main phase will consist of two exercise blocks repeated twice, including four aerobic movements performed for 30 s. Exercise sequencing alternates upper- and lower-body movements to promote whole-body involvement and progressive cardiovascular demand.
Within each block, the first minute was performed at a low-to-moderate intensity, whereas the second minute was performed at a slightly higher intensity.
This intensity pattern was maintained consistently across block repetitions.
|
A 10-min active break format was selected to maximize feasibility within school settings.
All conditions followed an identical temporal structure consisting of a 1-min warm-up, an 8-min main activity phase, and a 1-min cool-down delivered through standardized instructional videos that guided students in reproducing and observing the correct technique and execution of the exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-perceived emotional state
Time Frame: Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
Assessed using a paper-based measure following the Russell's circumplex model of affect, which conceptualizes emotions according to two primary dimensions: activation level (0 = low to 10 = high) and well-being or happiness level (0 = low to 10 = high).
|
Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
|
Executive Function
Time Frame: Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
The Eriksen Flanker Task and forward and backward digit span tests will be administered online and in paper format, respectively.
|
Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
|
Creativity
Time Frame: Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
Guilford's divergent thinking test will be administered in paper format.
|
Example assessment timeline: baseline assessment (9:00 a.m.); pre-intervention assessment (following cognitively demanding tasks; 10:00 a.m.); and post-intervention assessment (immediately after the active break protocol; 10:25 a.m.).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socioeconomic status
Time Frame: Measured once (one-week before the intervention)
|
Socioeconomic status will be assessed using the Family Affluence Scale III (FAS III), a self-reported questionnaire with higher scores indicating higher family affluence.
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Measured once (one-week before the intervention)
|
|
Sleep Pattern
Time Frame: Measured once (one-week before the intervention)
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-reported questionnaire with a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
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Measured once (one-week before the intervention)
|
|
Self-reported Physical Fitness
Time Frame: Measured once (one-week before the intervention)
|
Self-reported physical fitness will be assessed using the International Fitness Scale (IFIS), which evaluates overall fitness, cardiorespiratory fitness, muscular strength, speed-agility, and flexibility using a 5-point Likert scale (1 = very poor to 5 = very good), where higher scores indicate better perceived physical fitness.
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Measured once (one-week before the intervention)
|
|
Diet Pattern
Time Frame: Measured once (one-week before the intervention)
|
Adherence to the Mediterranean diet will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED), with scores ranging from -4 to 12, where higher scores indicate better adherence to the Mediterranean diet.
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Measured once (one-week before the intervention)
|
|
Physical Activity Enjoyment
Time Frame: Measured once (one-week before the intervention)
|
Enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES), consisting of 16 items rated on a 5-point Likert scale (1 to 5), with total scores ranging from 16 to 80, where higher scores indicate greater enjoyment of physical activity.
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Measured once (one-week before the intervention)
|
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Affective State
Time Frame: Measured once (one-week before the intervention)
|
Negative affect will be assessed using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS), which consists of 10 items rated on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely), with total scores ranging from 10 to 50, where higher scores indicate greater negative affect.
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Measured once (one-week before the intervention)
|
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Sedentary Behavior
Time Frame: Measured once (one-week before the intervention)
|
Sedentary behavior will be assessed using the Children and Adolescents Physical Activity and Sedentary Questionnaire (CAPAS-Q), which estimates daily time spent in sedentary activities.
Results are expressed in minutes per day, where higher values indicate greater sedentary behavior.
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Measured once (one-week before the intervention)
|
|
Resting Heart Rate
Time Frame: Measured once (one-week before the intervention)
|
Resting heart rate will be assessed using a heart rate monitor, expressed in beats per minute (bpm), with lower values indicating better cardiovascular fitness.
|
Measured once (one-week before the intervention)
|
|
Systolic Blood Pressure
Time Frame: Measured once (one-week before the intervention)
|
Systolic blood pressure will be measured using an automated sphygmomanometer and expressed in millimeters of mercury (mmHg).
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Measured once (one-week before the intervention)
|
|
Diastolic Blood Pressure
Time Frame: Measured once (one-week before the intervention)
|
Diastolic blood pressure will be measured using an automated sphygmomanometer and expressed in millimeters of mercury (mmHg).
|
Measured once (one-week before the intervention)
|
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Daily physical activity
Time Frame: During one week before the intervention procedure.
|
Students will wear an accelerometer (GENEActiv; Activinsights Ltd, Kimbolton, UK) during one week.
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During one week before the intervention procedure.
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Handgrip Strength Test
Time Frame: Measured once (one-week before the intervention)
|
Upper-body muscular strength will be assessed using the handgrip strength test with a dynamometer, expressed in kilograms (kg), where higher values indicate greater muscular strength.
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Measured once (one-week before the intervention)
|
|
20-m Shuttle Run Test
Time Frame: Measured once (one-week before the intervention)
|
Cardiorespiratory fitness will be assessed using the 20-m shuttle run test, with performance expressed as the number of completed stages or laps, where higher values indicate better cardiorespiratory fitness.
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Measured once (one-week before the intervention)
|
|
Standing Long Jump Test
Time Frame: Measured once (one-week before the intervention)
|
Lower-body muscular power will be assessed using the standing long jump test, expressed in centimeters (cm), where greater distances indicate higher muscular power.
|
Measured once (one-week before the intervention)
|
|
4x10-m Shuttle Run Test
Time Frame: Measured once (one-week before the intervention)
|
Speed and agility will be assessed using the 4 × 10-m shuttle run test, with performance expressed in seconds (s), where lower times indicate better performance.
|
Measured once (one-week before the intervention)
|
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Body Weight
Time Frame: Measured once (one-week before the intervention)
|
Body weight will be measured using electrical bioimpedance (Tanita DC-360 portable S) and expressed in kilograms (kg).
|
Measured once (one-week before the intervention)
|
|
Height
Time Frame: Measured once (one-week before the intervention)
|
Height will be measured using a stadiometer (SECA 213) and expressed in centimeters (cm).
|
Measured once (one-week before the intervention)
|
|
Body Mass Index (BMI)
Time Frame: Measured once (one-week before the intervention)
|
Body mass index (BMI) will be calculated from weight and height measurements and expressed in kilograms per square meter (kg/m²).
|
Measured once (one-week before the intervention)
|
|
Body Fat Percentage
Time Frame: Measured once (one-week before the intervention)
|
Body fat percentage will be assessed using electrical bioimpedance (Tanita DC-360 portable S) and expressed as a percentage (%), where higher values indicate higher adiposity.
|
Measured once (one-week before the intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: During the experimental condition, which will last 10 minutes.
|
Monitored second-by-second during all three conditions using a Polar H10 monitor, which includes a chest strap.
|
During the experimental condition, which will last 10 minutes.
|
|
Rating of Perceived Exertion
Time Frame: During the experimental condition, which will last 10 minutes.
|
Perceived exertion will be assessed using a child-adapted Rating of Perceived Exertion (RPE) scale ranging from 0 to 10, where 0 indicates no exertion and 10 indicates maximal exertion, with higher scores reflecting greater perceived effort.
|
During the experimental condition, which will last 10 minutes.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Diego Moliner-Urdiales, PhD, Universitat Jaume I
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2023-148956OB-I00
- CEISH/21/2025 (Other Identifier: Universitat Jaume I)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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