Sedentary BehaviorNCT06482047
Boosting Executive Function With Brain Exercise
A study testing Moderate-intensity cycling, Vigorous-intensity cycling and Uninterrupted sitting in people with Sedentary Behavior, run by Liye Zou at 1 site in China.
Trial 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. How do short exercise breaks affect executive function in college students? 2. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Moderate-intensity cycling, Vigorous-intensity cycling and Uninterrupted sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 15 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
China1 site
Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University
Shenzhen
About this study
Official title: Rejuvenating the Brain and Boosting Executive Function With Exercise Intervention
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:
- How do short exercise breaks affect executive function in college students?
- 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.
- Conditions
- Sedentary Behavior
- Being tested
- Moderate-intensity cycling, Vigorous-intensity cycling, Uninterrupted sitting
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity cyclingBehavioural
Moderate-intensity cycling on Ergoline Ergoselect 100
Vigorous-intensity cyclingBehavioural
Vigorous-intensity cycling on Ergoline Ergoselect 100
Uninterrupted sittingBehavioural
Uninterrupted sitting in a quiet room
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity cycling | Experimental | Moderate-intensity cycling on Ergoline Ergoselect 100 Receives: Behavioral: Moderate-intensity cycling; Behavioral: Uninterrupted sitting |
| Vigorous-intensity cycling | Experimental | Vigorous-intensity cycling on Ergoline Ergoselect 100 Receives: Behavioral: Vigorous-intensity cycling; Behavioral: Uninterrupted sitting |
| Uninterrupted sitting | Experimental | Uninterrupted sitting in a quiet room Receives: Behavioral: Uninterrupted sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
This primary outcome measure is assessed by the modified dual-task Stroop paradigm.
Measured: 3 weeks
Retinal Vessel Diameter
Retinal Vessel Diameter is assessed by the fully automated fundus camera.
Measured: 3 weeks
Brain Connectivity
Brain connectivity is assessed by the NIRSport2 device
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 posted1 Jul 2024
- Study start2 Jul 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liye Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liye Zou, Shenzhen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482047
- Sponsor's protocol ID
- ShenzhenUExerciseIntervention
- Status last verified
- Jun 2024
- First submitted
- 3 Jan 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rejuvenating the Brain and Boosting Executive Function With Exercise Intervention
- ClinicalTrials.gov ID
- NCT06482047
- Acronym / sponsor ID
- ShenzhenUExerciseIntervention
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Liye ZouUniversity, hospital or other
- Study start
- 2 Jul 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 1 Jul 2024 (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 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:
- How do short exercise breaks affect executive function in college students?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity cycling | Experimental | Behavioral: Moderate-intensity cycling, Behavioral: Uninterrupted sittingModerate-intensity cycling on Ergoline Ergoselect 100 |
| Vigorous-intensity cycling | Experimental | Behavioral: Vigorous-intensity cycling, Behavioral: Uninterrupted sittingVigorous-intensity cycling on Ergoline Ergoselect 100 |
| Uninterrupted sitting | Experimental | Behavioral: Uninterrupted sittingUninterrupted sitting in a quiet room |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (1 listed)
- -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.
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 |
|---|---|---|
| Moderate-intensity cyclingModerate-intensity cycling on Ergoline Ergoselect 100 | Behavioural | Moderate-intensity cycling |
| Vigorous-intensity cyclingVigorous-intensity cycling on Ergoline Ergoselect 100 | Behavioural | Vigorous-intensity cycling |
| Uninterrupted sittingUninterrupted sitting in a quiet room | Behavioural | Moderate-intensity cycling, Uninterrupted sitting, Vigorous-intensity cycling |
Primary outcome
Cognitive function
Time frame: 3 weeks
This primary outcome measure is assessed by the modified dual-task Stroop paradigm.
Retinal Vessel Diameter
Time frame: 3 weeks
Retinal Vessel Diameter is assessed by the fully automated fundus camera.
Brain Connectivity
Time frame: 3 weeks
Brain connectivity is assessed by the NIRSport2 device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity cycling, Vigorous-intensity cycling and Uninterrupted sitting in people with Sedentary Behavior, run by Liye Zou at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liye Zou, Dr. (18823437684, liyezou123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.