- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07934030
Breaks in Sedentary Behaviour and Executive Function
Investigating Effects of Breaks in Sedentary Behaviour on Executive Function Among University Students: A Functional Near-Infrared Spectroscopy Study
This randomized controlled trial aims to investigate whether interrupting prolonged sitting with physical activity breaks can improve executive function in university students and to explore the potential underlying neural mechanisms. Participants will complete three experimental conditions in a randomized, within-subject crossover design: uninterrupted sitting (control condition), sitting interrupted by physical activity breaks, and a moderate-intensity exercise condition (exercise control). Executive function will be assessed before and after each condition using a computerized Stroop task. Functional near-infrared spectroscopy (fNIRS) will simultaneously monitor changes in cortical oxygenation, particularly in the prefrontal and parietal regions. The study hypothesizes that interrupting prolonged sitting with physical activity breaks will acutely improve executive function, particularly inhibitory control, compared with uninterrupted sitting. It is also expected that changes in cortical oxygenation may be associated with improvements in cognitive performance.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liye Zou
- Phone Number: 18823437684
- Email: liyezou123@gmail.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China
- Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University
-
Contact:
- Liye Zou, Dr.
- Phone Number: 18823437684
- Email: liyezou123@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- right-handed (how was handedness assessed; i.e., "What hand do you write with?")
- normal or corrected-to-normal vision and normal color vision
Exclusion Criteria:
- reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, cognitive impairment, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Uninterrupted sitting
Participants will complete 100 minutes of uninterrupted sitting in a quiet room. |
Uninterrupted sitting in a quiet room. |
|
Experimental: Sitting interrupted by physical activity breaks
Participants will complete two 10-minute bouts of moderate-intensity cycling, each separated by 40 minutes of uninterrupted sitting. |
Uninterrupted sitting in a quiet room. Moderate-intensity cycling on Ergoline Ergoselect 100. |
|
Experimental: Preceding moderate-intensity exercise
Participants will complete 20 minutes of moderate-intensity cycling followed by 80 minutes of uninterrupted sitting, serving as the exercise control condition. |
Uninterrupted sitting in a quiet room. Moderate-intensity cycling on Ergoline Ergoselect 100. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: Immediately before and after each 100-minute experimental condition.
|
This primary outcome measure is assessed by the modified Stroop paradigm. |
Immediately before and after each 100-minute experimental condition.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cortical Oxygenated Hemoglobin (Oxy-Hb)
Time Frame: During the Stroop task administered immediately before and after each 100-minute experimental condition.
|
Functional near-infrared spectroscopy (fNIRS) will be used to assess changes in cortical oxygenated hemoglobin (Oxy-Hb) concentration, with a particular focus on the prefrontal and parietal regions. |
During the Stroop task administered immediately before and after each 100-minute experimental condition.
|
|
Brain Connectivity
Time Frame: During the Stroop task administered immediately before and after each 100-minute experimental condition.
|
Brain connectivity is assessed by the functional near-infrared spectroscopy (fNIRS) . |
During the Stroop task administered immediately before and after each 100-minute experimental condition.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZUSBBreak
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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