NCT06482047

Brief Summary

The goal of this study is to explore the impact of a 15-minute exercise break on brain function and cognitive performance in a simulated classroom setting. The main questions it aims to answer are:

  1. 1.How do short exercise breaks affect executive function in college students?
  2. 2.What changes occur in brain connectivity and microcirculation after these exercise breaks? Participants were college students who engaged in sessions of continuous sitting or sitting interspersed with exercise. The study used cognitive tasks and brain imaging techniques to measure the effects. The findings reveal improvements in cognitive performance and brain function, suggesting that short exercise breaks are beneficial in educational contexts.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 3, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

January 3, 2024

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cognitive function

    This primary outcome measure is assessed by the modified dual-task Stroop paradigm.

    3 weeks

  • Retinal Vessel Diameter

    Retinal Vessel Diameter is assessed by the fully automated fundus camera.

    3 weeks

  • Brain Connectivity

    Brain connectivity is assessed by the NIRSport2 device

    3 weeks

Study Arms (3)

Moderate-intensity cycling

EXPERIMENTAL

Moderate-intensity cycling on Ergoline Ergoselect 100

Behavioral: Moderate-intensity cyclingBehavioral: Uninterrupted sitting

Vigorous-intensity cycling

EXPERIMENTAL

Vigorous-intensity cycling on Ergoline Ergoselect 100

Behavioral: Vigorous-intensity cyclingBehavioral: Uninterrupted sitting

Uninterrupted sitting

EXPERIMENTAL

Uninterrupted sitting in a quiet room

Behavioral: Uninterrupted sitting

Interventions

Moderate-intensity cycling on Ergoline Ergoselect 100

Moderate-intensity cycling

Vigorous-intensity cycling on Ergoline Ergoselect 100

Vigorous-intensity cycling

Uninterrupted sitting in a quiet room

Moderate-intensity cyclingUninterrupted sittingVigorous-intensity cycling

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed (how was handedness assessed; i.e., "What hand do you write with?") with normal or corrected-to-normal vision and normal color vision

You may not qualify if:

  • reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University

Shenzhen, China

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The study used a within-participant cross-over design with pre-and post-test comparisons. Participants completed the three following experimental conditions in pseudo-counterbalanced (cannot be completely counterbalanced given that an odd number of participants - hence, was pseudo-counterbalanced) order (odd number of participants) with at least a 7-day washout period between conditions: (i) 115-minute uninterrupted sitting \[control\]; (ii) 50-minute sitting + 15-minute moderate-intensity cycling + 50-minute sitting \[experimental condition 1\]; (iii) 50-minute sitting + 15-minute vigorous-intensity cycling + 50-minute sitting \[experimental condition 2\]. A familiarization session was completed about three days before the experiment started, during which participants were familiarized with the cognitive assessment and cycling protocols.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

July 1, 2024

Study Start

July 2, 2024

Primary Completion

March 30, 2025

Study Completion

April 15, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations