Pain, AcuteKOGISNCT03944564
Cognitive and Motor Benefits of Standing
A study testing Sitting, Static standing and Dynamic standing in people with Pain, Acute and Muscle Tone Abnormalities, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial summary
Upright-working has been proven to benefit health by combating the negative effects of physical inactivity. However, long-term commitment to static standing regimens may be limited due to symptoms of musculoskeletal fatigue that may develop during prolonged static standing in the absence of facilitated weight… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Muscle Tone Abnormalities, Work-Related Condition
- What is being tested?
- Sitting, Static standing and Dynamic standing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Sep 2019to 1 Sep 2022
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy adults (both gender, age range 18-64 years) who are currently employed.
Who cannot join
- Inability to stand or walk without an assistive device
- History of symptoms in stance that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, or medication side effects
- History of symptomatic cardiovascular or pulmonary disease
- History of rheumatic arthritis
- History of stroke or other neurologic conditions with residual sensorimotor deficits
- History of chronic pain syndrome requiring narcotic analgesics
Show all 10Show fewer
- Neurological disorders
- Evidence of dementia
- Diabetics: low or poorly controlled blood glucose
- Any other history of medical or psychiatric comorbidity precluding safe participation in the project
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Science and research centre Koper
Koper, 6000
Uros Marusic, PhD, +38641529226, uros.marusic@zrs-kp.si
Matej KIeva, MS, matej.kleva@zrs-kp.si
About this study
Official title: Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)
Upright-working has been proven to benefit health by combating the negative effects of physical inactivity. However, long-term commitment to static standing regimens may be limited due to symptoms of musculoskeletal fatigue that may develop during prolonged static standing in the absence of facilitated weight shifting. We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification.
Read the detailed description
Within-group design to study the effects of standing-and-working accompanied by periodic movement compared to standing-and-working and to sitting-and-working on measures of musculoskeletal fatigue and discomfort, and physiological measures, in healthy normal control subjects, middle-aged to older adults. Measures of musculoskeletal and subjective discomfort and fatigue will be assessed in three sessions, i.e. "seated", "static standing", and "dynamic standing" (see below). During these test sessions subjects will perform small assignments using a computer mimicking light office work, including several tests measuring attention span. The first session will be the seated condition for all participants. Sessions 2 and 3 will be randomized between static or dynamic standing.
Prior to any research procedures, written informed consent will be obtained from each subject followed by initial study eligibility screening. Eligibility screening includes clinical screening questions, including, but not limited to, questions regarding significant history of cardiovascular disease, history of lower extremity pain and fractures, back pain, and migraines.
Subjects will stand behind a height adjustable table that is positioned about 0.5 meters from a wall. For the "static standing" position subjects will be asked to stand behind the table. No specific restrictions for standing will be imposed on subjects (e.g. "do not move" or "stand quietly"). For the "dynamic standing" condition participants will stand behind the same table but received periodic cues to induce weight-shifting steps. A seated control session condition will also be used to get baseline musculoskeletal subjective ratings for the same time period. Each sitting or standing session will not exceed 4 hour. As many rest breaks will be provided to the subject as needed. The entire test session may take up to approximately 5 hours.
The experimental testing protocol will be conducted preferably in the morning over three or more different days. Each day will be dedicated to one testing condition. Subjects will stand on an anti-fatigue mat during the static and dynamic standing sessions. For the standing conditions, rest breaks (e.g. sitting or walking around) will be provided as needed. During the study session caffeine consumption will be prohibited in order to standardize the stimulant effect of caffeine across subjects.
- Being tested
- Sitting, Static standing, Dynamic standing
- Keywords
- cognition, brain activity, cognitive reserve, work productivity, musculoskeletal discomfort, attention
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
Also called SIT
We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
Static standingBehavioural
Also called STAT
We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
Dynamic standingBehavioural
Also called DYN
We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: sitting | Active comparator | Four hours of sitting condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. Receives: Behavioral: Sitting |
| Condition 2: static standing | Active comparator | Four hours of static standing condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. Receives: Behavioral: Static standing |
| Condition 3: dynamic standing | Active comparator | Four hours of static standing condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. Receives: Behavioral: Dynamic standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall movement - accelerometry
Overall movement (counts/min)
Measured: change in activity levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Musculoskeletal discomfort
Rate of total musculoskeletal discomfort development (mm/min)
Measured: change in musculoskeletal discomfort levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Leg swelling
Average swelling for both legs (cm)
Measured: change in leg swelling levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Secondary outcomes (4)
Oxygen uptake
Oxygen uptake VO2 (ml/min/kg)
Measured: change in oxygen consumption between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Attention levels
Measuring attention with Stroop test (seconds)
Measured: change in attentional levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Executive control
Executive functions measured with TMT test (seconds)
Measured: change in executive control and cognitive switching levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Brain electrocortical activity
EEG measurements (frequency analysis and ERP analysis)
Measured: change in electrocortical activity levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start10 Sep 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled crossover trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944564
- Sponsor's protocol ID
- KOGIS
- Acronym
- KOGIS
- Status last verified
- Apr 2021
- First submitted
- 6 May 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Levine JA, Schleusner SJ, Jensen MD. Energy expenditure of nonexercise activity. Am J Clin Nutr. 2000 Dec;72(6):1451-4. doi: 10.1093/ajcn/72.6.1451.
PubMed 11101470Levine JA, Kotz CM. NEAT--non-exercise activity thermogenesis--egocentric & geocentric environmental factors vs. biological regulation. Acta Physiol Scand. 2005 Aug;184(4):309-18. doi: 10.1111/j.1365-201X.2005.01467.x.
PubMed 16026422Hamilton MT, Hamilton DG, Zderic TW. Role of low energy expenditure and sitting in obesity, metabolic syndrome, type 2 diabetes, and cardiovascular disease. Diabetes. 2007 Nov;56(11):2655-67. doi: 10.2337/db07-0882. Epub 2007 Sep 7.
PubMed 17827399Chau JY, van der Ploeg HP, Dunn S, Kurko J, Bauman AE. A tool for measuring workers' sitting time by domain: the Workforce Sitting Questionnaire. Br J Sports Med. 2011 Dec;45(15):1216-22. doi: 10.1136/bjsports-2011-090214. Epub 2011 Sep 22.
PubMed 21947817Cook AJ, Degood DE. The cognitive risk profile for pain: development of a self-report inventory for identifying beliefs and attitudes that interfere with pain management. Clin J Pain. 2006 May;22(4):332-45. doi: 10.1097/01.ajp.0000209801.78043.91.
PubMed 16691085Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
PubMed 8455963
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)
- ClinicalTrials.gov ID
- NCT03944564
- Acronym / sponsor ID
- KOGIS / KOGIS
- Keywords
- cognition, brain activity, cognitive reserve, work productivity, musculoskeletal discomfort, attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 9 May 2019 (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.
Upright-working has been proven to benefit health by combating the negative effects of physical inactivity. However, long-term commitment to static standing regimens may be limited due to symptoms of musculoskeletal fatigue that may develop during prolonged static standing in the absence of facilitated weight shifting. We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification.
Detailed description
Within-group design to study the effects of standing-and-working accompanied by periodic movement compared to standing-and-working and to sitting-and-working on measures of musculoskeletal fatigue and discomfort, and physiological measures, in healthy normal control subjects, middle-aged to older adults. Measures of musculoskeletal and subjective discomfort and fatigue will be assessed in three sessions, i.e. "seated", "static standing", and "dynamic standing" (see below). During these test sessions subjects will perform small assignments using a computer mimicking light office work, including several tests measuring attention span. The first session will be the seated condition for all participants. Sessions 2 and 3 will be randomized between static or dynamic standing.
Prior to any research procedures, written informed consent will be obtained from each subject followed by initial study eligibility screening. Eligibility screening includes clinical screening questions, including, but not limited to, questions regarding significant history of cardiovascular disease, history of lower extremity pain and fractures, back pain, and migraines.
Subjects will stand behind a height adjustable table that is positioned about 0.5 meters from a wall. For the "static standing" position subjects will be asked to stand behind the table. No specific restrictions for standing will be imposed on subjects (e.g. "do not move" or "stand quietly"). For the "dynamic standing" condition participants will stand behind the same table but received periodic cues to induce weight-shifting steps. A seated control session condition will also be used to get baseline musculoskeletal subjective ratings for the same time period. Each sitting or standing session will not exceed 4 hour. As many rest breaks will be provided to the subject as needed. The entire test session may take up to approximately 5 hours.
The experimental testing protocol will be conducted preferably in the morning over three or more different days. Each day will be dedicated to one testing condition. Subjects will stand on an anti-fatigue mat during the static and dynamic standing sessions. For the standing conditions, rest breaks (e.g. sitting or walking around) will be provided as needed. During the study session caffeine consumption will be prohibited in order to standardize the stimulant effect of caffeine across subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Condition 1: sitting | Active comparator | Behavioral: SittingFour hours of sitting condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. |
| Condition 2: static standing | Active comparator | Behavioral: Static standingFour hours of static standing condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. |
| Condition 3: dynamic standing | Active comparator | Behavioral: Dynamic standingFour hours of static standing condition will be applied with ad-libitum breaks for toilet use and stretching. During this condition all cognitive, motor and pain scales will be monitored. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy adults (both gender, age range 18-64 years) who are currently employed.
Key exclusion criteria (10 listed)
- Inability to stand or walk without an assistive device
- History of symptoms in stance that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, or medication side effects
- History of symptomatic cardiovascular or pulmonary disease
- History of rheumatic arthritis
- History of stroke or other neurologic conditions with residual sensorimotor deficits
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 |
|---|---|---|
| SittingAlso: SITWe propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Condition 1: sitting |
| Static standingAlso: STATWe propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Condition 2: static standing |
| Dynamic standingAlso: DYNWe propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA) | Behavioural | Condition 3: dynamic standing |
Primary outcome
Overall movement - accelerometry
Time frame: change in activity levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Overall movement (counts/min)
Musculoskeletal discomfort
Time frame: change in musculoskeletal discomfort levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Rate of total musculoskeletal discomfort development (mm/min)
Leg swelling
Time frame: change in leg swelling levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Average swelling for both legs (cm)
4 secondary outcomes
Oxygen uptake
Time frame: change in oxygen consumption between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Attention levels
Time frame: change in attentional levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Executive control
Time frame: change in executive control and cognitive switching levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Brain electrocortical activity
Time frame: change in electrocortical activity levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Background: PubMed 11101470Levine JA, Schleusner SJ, Jensen MD. Energy expenditure of nonexercise activity. Am J Clin Nutr. 2000 Dec;72(6):1451-4. doi: 10.1093/ajcn/72.6.1451.
- Background: PubMed 16026422Levine JA, Kotz CM. NEAT--non-exercise activity thermogenesis--egocentric & geocentric environmental factors vs. biological regulation. Acta Physiol Scand. 2005 Aug;184(4):309-18. doi: 10.1111/j.1365-201X.2005.01467.x.
- Background: PubMed 17827399Hamilton MT, Hamilton DG, Zderic TW. Role of low energy expenditure and sitting in obesity, metabolic syndrome, type 2 diabetes, and cardiovascular disease. Diabetes. 2007 Nov;56(11):2655-67. doi: 10.2337/db07-0882. Epub 2007 Sep 7.
- Background: PubMed 21947817Chau JY, van der Ploeg HP, Dunn S, Kurko J, Bauman AE. A tool for measuring workers' sitting time by domain: the Workforce Sitting Questionnaire. Br J Sports Med. 2011 Dec;45(15):1216-22. doi: 10.1136/bjsports-2011-090214. Epub 2011 Sep 22.
- Background: PubMed 16691085Cook AJ, Degood DE. The cognitive risk profile for pain: development of a self-report inventory for identifying beliefs and attitudes that interfere with pain management. Clin J Pain. 2006 May;22(4):332-45. doi: 10.1097/01.ajp.0000209801.78043.91.
- Background: PubMed 8455963Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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 Sitting, Static standing and Dynamic standing in people with Pain, Acute and Muscle Tone Abnormalities, run by Science and Research Centre Koper at 1 site in Slovenia.
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 10 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 22 Apr 2021. 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 Slovenia. 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 Uros Marusic, PhD (041529226, uros.marusic@zrs-kp.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall movement - accelerometry (time frame: change in activity levels between all three conditions, which will be measured on average 3 days in-between (maximum length of measurements per subject = 15 days)). 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?
On the ClinicalTrials.gov record for NCT03944564, which also lists 6 linked publications.
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 22 Apr 2021.