Cognitive FatigueNCT07624084
Effects of Short Physical Activity Breaks on Thinking Skills After University Lectures in Undergraduate Students
A study testing Exergame-based Physical Activity Break and Outdoor Physical Activity Break in people with Cognitive Fatigue, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Fatigue
- What is being tested?
- Exergame-based Physical Activity Break and Outdoor Physical Activity Break
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
- Conditions
- Cognitive Fatigue
- Being tested
- Exergame-based Physical Activity Break, Outdoor Physical Activity Break
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-based Physical Activity BreakOther
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.
Outdoor Physical Activity BreakOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame-based Physical Activity Break (PABEx) | Experimental | Not described Receives: Other: Exergame-based Physical Activity Break |
| Outdoor Physical Activity Break (OPAB), | Experimental | Not described Receives: Other: Outdoor Physical Activity Break |
| No Physical Activity Break (NPAB) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test A (TMT-A): Completion time
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
Measured: 3-weeks
The Stroop Color and Word Test (SCWT): Completion Time
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
Measured: 3-weeks
Trail Making Test B (TMT-B): Completion Time
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
Measured: 3-weeks
The Stroop Color and Word Test (SCWT): Errors
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
Measured: 3-weeks
Trail Making Test A (TMT-A): Errors
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
Measured: 3-weeks
Trail Making Test B (TMT-B): Errors
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
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Mar 2025
- Primary completion22 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Poli, University of Bari Aldo Moro
- Investigators
- Luca Poli, P.hd., Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624084
- Sponsor's protocol ID
- 116866
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pepe I, Petrelli A, Poli L, Fischetti F, Cataldi S, Greco G. Acute Cognitive Effects of Brief Physical Activity Breaks After Lecture-Based Academic Activity in Undergraduate University Students: A Randomized Crossover Study. Healthcare (Basel). 2026 Jul 6;14(13):2010. doi: 10.3390/healthcare14132010.
PubMed 42451020
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cognitive Effects of Brief Physical Activity Breaks After Lecture-Based Academic Activity in Undergraduate University Students: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07624084
- Acronym / sponsor ID
- 116866
- Conditions
- Cognitive Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Jun 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergame-based Physical Activity Break (PABEx) | Experimental | Other: Exergame-based Physical Activity Break |
| Outdoor Physical Activity Break (OPAB), | Experimental | Other: Outdoor Physical Activity Break |
| No Physical Activity Break (NPAB) | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Exergame-based Physical Activity BreakThe 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. | Other | Exergame-based Physical Activity Break (PABEx) |
| Outdoor Physical Activity BreakThe 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. | Other | Outdoor Physical Activity Break (OPAB), |
Primary outcome
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42451020Pepe I, Petrelli A, Poli L, Fischetti F, Cataldi S, Greco G. Acute Cognitive Effects of Brief Physical Activity Breaks After Lecture-Based Academic Activity in Undergraduate University Students: A Randomized Crossover Study. Healthcare (Basel). 2026 Jul 6;14(13):2010. doi: 10.3390/healthcare14132010.
- Individual participant dataSharing planned: No
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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.
Luca Poli, P.hd. principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-based Physical Activity Break and Outdoor Physical Activity Break in people with Cognitive Fatigue, run by University of Bari Aldo Moro at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 5 Jun 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trail Making Test A (TMT-A): Completion time (time frame: 3-weeks). The study lists 6 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 NCT07624084, which also lists 1 linked publication.
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 5 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.