- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624084
Effects of Short Physical Activity Breaks on Thinking Skills After University Lectures in Undergraduate Students
Acute Cognitive Effects of Brief Physical Activity Breaks After Lecture-Based Academic Activity in Undergraduate University Students: A Randomized Crossover Study
The goal of this randomized crossover study is to evaluate whether brief Physical Activity Breaks (PABs), implemented immediately after lecture-based academic activity, can improve attentional processing and executive functioning in undergraduate university students. The main questions it aims to answer are:
Do OPAB or PABEx improve attentional and executive performance compared to a no-break control condition (NPAB)? Does PABEx provide superior cognitive benefits compared to OPAB?
Researchers will compare:
OPAB (a standardized 10-minute outdoor walking protocol) PABEx (a 10-minute exergame-based break using Fruit Ninja Kinect)
to see if these interventions improve cognitive performance compared to NPAB (supervised passive seated rest), and whether significant differences in cognitive outcomes emerge between OPAB and PABEx.
Participants will:
Complete cognitive assessments (Trail Making Test A-B and Stroop Color-Word Test) immediately after each condition.
Be randomly assigned, in counterbalanced order, to all three conditions across three consecutive weeks separated by a 7-day washout interval.
Engage in a 10-minute structured break (OPAB or PABEx) or passive rest (NPAB) following two consecutive hours of seated university lectures, including:
Warm-up (2 minutes): low-intensity dynamic movements. Main session (6 minutes): light-to-moderate outdoor walking (OPAB) or Fruit Ninja Kinect exergaming (PABEx).
Cool-down (2 minutes): relaxation and gentle stretching exercises.
This study will provide insights into the efficacy of brief active breaks as a pragmatic strategy to enhance cognitive efficiency in university students during academically demanding periods.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bari
-
Bari, Bari, Italy, 70123
- Università degli studi di Bari "Aldo Moro"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- enrolled full-time
- 18-35 years old at the time of data collection
- physically able to stand and perform brief bouts of physical activity safely
Exclusion Criteria:
- musculoskeletal disorders
- current or recent lower-limb injuries
- acute or chronic medical conditions that could limit safe participation in light-to-moderate physical activity
- unable to comply with the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exergame-based Physical Activity Break (PABEx)
|
The PABEx condition consisted of a 10-minute non-immersive exergaming session structured into three phases: (i) Warm-up (2 min): the same dynamic warm-up used in OPAB.
(ii) Exergame phase (6 min): participants played Fruit Ninja Kinect, standing at approximately 1.5-2.0
m from a television screen and using a Kinect motion-sensing controller to perform rapid upper-limb movements to slice virtual fruit, combining physical engagement with visuomotor coordination and sustained attentional demands.
(iii) Cool-down (2 min): the same relaxation and stretching exercises used in OPAB.
Although duration, game, setting, and instructions were standardized, physiological intensity was not objectively monitored and may have varied across individuals.
Session duration, sequencing, supervision, and timing of cognitive testing were kept constant across all conditions.
|
|
Experimental: Outdoor Physical Activity Break (OPAB),
|
The OPAB condition consisted of a standardized 10-minute outdoor protocol structured into three phases: (i) Warm-up (2 min): low-intensity dynamic movements targeting major joints (ankles, knees, hips, and shoulders) combined with light marching in place.
(ii) Walking phase (6 min): participants walked along a predefined outdoor route at approximately 4.5 km·h-¹, providing a light-to-moderate aerobic stimulus; exercise intensity was not objectively monitored.
(iii) Cool-down (2 min): relaxation and gentle stretching exercises targeting lower-limb muscle groups and breathing regulation.
|
|
No Intervention: No Physical Activity Break (NPAB)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trail Making Test A (TMT-A): Completion time
Time Frame: 3-weeks
|
Trail Making Test A (TMT-A) assesses visual attention and processing speed. The outcome is the time required to complete the task, measured in seconds. Lower completion times indicate better cognitive performance. Possible scores range from 0 seconds to no predefined maximum value. Unit of Measure Seconds |
3-weeks
|
|
The Stroop Color and Word Test (SCWT): Completion Time
Time Frame: 3-weeks
|
The Stroop Color and Word Test (SCWT) assesses selective attention, cognitive flexibility, and inhibitory control. Participants are required to name the color of visual stimuli and to identify the ink color of color words printed in incongruent colors. The outcome measure is the time required to complete the test, expressed in seconds. Scores range from 0 seconds to no predefined maximum value. Lower scores indicate better cognitive performance. Unit of Measure Seconds |
3-weeks
|
|
Trail Making Test B (TMT-B): Completion Time
Time Frame: 3-weeks
|
Trail Making Test B (TMT-B) assesses executive function, cognitive flexibility, and set-shifting ability. The outcome is the time required to complete the task, measured in seconds. Lower completion times indicate better cognitive performance. Possible scores range from 0 seconds to no predefined maximum value. Unit of Measure Seconds |
3-weeks
|
|
The Stroop Color and Word Test (SCWT): Errors
Time Frame: 3-weeks
|
The Stroop Color and Word Test (SCWT) assesses selective attention, cognitive flexibility, and inhibitory control. The outcome measure is the number of errors committed during test performance. Scores range from 0 errors to no predefined maximum value. Lower scores indicate better cognitive performance. Unit of Measure Errors |
3-weeks
|
|
Trail Making Test A (TMT-A): Errors
Time Frame: 3-weeks
|
The Trail Making Test A (TMT-A) assesses visual attention, visual scanning, and processing speed. The outcome measure is the number of errors committed while completing the task. Scores range from 0 errors to no predefined maximum value. Lower scores indicate better cognitive performance. Unit of Measure Errors |
3-weeks
|
|
Trail Making Test B (TMT-B): Errors
Time Frame: 3-weeks
|
The Trail Making Test B (TMT-B) assesses executive function, cognitive flexibility, and set-shifting ability. The outcome measure is the number of errors committed during task performance. Scores range from 0 errors to no predefined maximum value. Lower scores indicate better cognitive performance. Unit of Measure Errors |
3-weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luca Poli, P.hd., University of Bari Aldo Moro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 116866
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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