(Focus) Posture Effect on Cognitive PerformancePhase 1/2sitstandcefNCT01641588
Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions
A Phase 1/2 study testing posture: sitting or standing in people with (Focus) Posture Effect on Cognitive Performance, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- (Focus) Posture Effect on Cognitive Performance
- What is being tested?
- posture: sitting or standing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Mar 2012
- Phase
- Phase 1/2
- 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- computer savvy
- advanced education degree
Who cannot join
- ADD
- on any medication
- currently a person who uses a standing desk
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO171BJ
About this study
Official title: Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions Using Assessments From CNS Vital Signs Test Battery
The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.
Read the detailed description
The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.
Methods: This counterbalanced controlled trial involved 17 men (mean age +/-SD: 29.8 +/- 5.5) all with a science background and graduate degrees. The participants were accustomed to working in an open environment and none of whom currently using standing desks. We used a modified version of the CNS Vital Signs (CNSVS) test battery to assess cognitive executive function (CEF) in two typical work positions - standing and seated. Participants were randomly assigned to a standing or seated position to begin the testing procedure. Upon completion of the first test round they were instructed to rest for 10 min. in a dark room with no distractions before commencing the second round of testing positioned in the alternate fashion. The main outcome measure was a CNSVS score in each of the six CEF domains in the two different work positions
- Being tested
- posture: sitting or standing
- Keywords
- cognitive executive function, posture, cognitive performance, heart rate, eeg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posture: sitting or standingBehavioural
Also called (no other names)
Intervention: postural position - whether seated or standing. The person carries out a battery of cognitive executive functioning assessments delivered via a laptop and carried out with the laptop keyboard while either seated or standing.
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of postural effect on cognitive performance
use of standard cognitive exectutive function measures carried out in seated / standing position.
Measured: within the hour
Secondary outcomes (1)
Interaction between posture and phyiological state against cognitive executive function performance
Other key measures that will be used to evaluate the intervention are heart rate variablility, heart rate and eeg.
Measured: with the hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for (Focus) Posture Effect on Cognitive PerformanceStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Academy of Engineering, Microsoft Research
- Responsible party
- Principal investigator, M C Schraefel, University of Southampton
- Investigators
- m.c. schraefel, phd, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641588
- Sponsor's protocol ID
- 1497
- Other IDs
- RAEngSRF
- Acronym
- sitstandcef
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions Using Assessments From CNS Vital Signs Test Battery
- ClinicalTrials.gov ID
- NCT01641588
- Acronym / sponsor ID
- sitstandcef / 1497
- Keywords
- cognitive executive function, posture, cognitive performance, heart rate, eeg
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Royal Academy of Engineering, Microsoft Research
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Jul 2012 (estimated)
- 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 aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.
Detailed description
The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.
Methods: This counterbalanced controlled trial involved 17 men (mean age +/-SD: 29.8 +/- 5.5) all with a science background and graduate degrees. The participants were accustomed to working in an open environment and none of whom currently using standing desks. We used a modified version of the CNS Vital Signs (CNSVS) test battery to assess cognitive executive function (CEF) in two typical work positions - standing and seated. Participants were randomly assigned to a standing or seated position to begin the testing procedure. Upon completion of the first test round they were instructed to rest for 10 min. in a dark room with no distractions before commencing the second round of testing positioned in the alternate fashion. The main outcome measure was a CNSVS score in each of the six CEF domains in the two different work positions
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- computer savvy
- advanced education degree
Key exclusion criteria (3 listed)
- ADD
- on any medication
- currently a person who uses a standing desk
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 |
|---|---|---|
| posture: sitting or standingAlso: (no other names)Intervention: postural position - whether seated or standing. The person carries out a battery of cognitive executive functioning assessments delivered via a laptop and carried out with the laptop keyboard while either seated or standing. | Behavioural | – |
Primary outcome
evidence of postural effect on cognitive performance
Time frame: within the hour
use of standard cognitive exectutive function measures carried out in seated / standing position.
1 secondary outcome
Interaction between posture and phyiological state against cognitive executive function performance
Time frame: with the hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- initial tech report related to this studyLink provided by the sponsor.
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.
m.c. schraefel, phd principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing posture: sitting or standing in people with (Focus) Posture Effect on Cognitive Performance, run by University of Southampton at 1 site in United Kingdom.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jul 2012. 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 United Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of postural effect on cognitive performance (time frame: within the hour). 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 17 Jul 2012.