NCT07624084

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 28, 2026

Last Update Submit

June 3, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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

    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

    3-weeks

Study Arms (3)

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

Interventions

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.

Exergame-based Physical Activity Break (PABEx)

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.

Outdoor Physical Activity Break (OPAB),

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • enrolled full-time
  • years old at the time of data collection
  • physically able to stand and perform brief bouts of physical activity safely

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi di Bari "Aldo Moro"

Bari, Bari, 70123, Italy

Location

Study Officials

  • Luca Poli, P.hd.

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
P.hd.

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

March 10, 2025

Primary Completion

April 22, 2025

Study Completion

April 30, 2025

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations