- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Bari
-
Bari, Bari, Italien, 70123
- Università degli studi di Bari "Aldo Moro"
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Kein Eingriff: No Physical Activity Break (NPAB)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Trail Making Test A (TMT-A): Completion time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Luca Poli, P.hd., University of Bari Aldo Moro
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 116866
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Exergame-based Physical Activity Break
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH); National Institute on Aging (NIA)AbgeschlossenArthroseVereinigte Staaten
-
Istinye UniversityAbgeschlossenPhysische Aktivität | Jugend | Barrieren für körperliche Aktivität | Moderatoren für körperliche AktivitätTruthahn
-
Creighton UniversityNational Institutes of Health (NIH)AbgeschlossenLeichte kognitive Einschränkung | Burnout der PflegekraftVereinigte Staaten
-
Emory UniversityNational Institute on Aging (NIA)AbgeschlossenDemenz | Alzheimer ErkrankungVereinigte Staaten
-
The University of Hong KongRekrutierungDemenz | Belastung der Pflegekraft | Kognitive Beeinträchtigung, leicht | Demenz, leichtHongkong
-
Fatih Sultan Mehmet Training and Research HospitalAktiv, nicht rekrutierendCOVID-19 | Lifestyle-FaktorenTruthahn
-
Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological AssociationRekrutierungAutismus-Spektrum-Störung (ASD)Vereinigte Staaten
-
University of PittsburghNational Center for Advancing Translational Sciences (NCATS)AbgeschlossenÜbergewicht und Adipositas | Sitzendes Verhalten | Herz-Kreislauf-Risikofaktor | PrädiabetesVereinigte Staaten
-
University of PittsburghAbgeschlossenÜbergewicht und Adipositas | Sitzendes Verhalten | Herz-Kreislauf-Risikofaktor | PrädiabetesVereinigte Staaten
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)AbgeschlossenPhysische Aktivität | Parkinson Krankheit | Balance | Fallen | KinesiophobieTruthahn