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Cognitive and Motor Benefits of Standing (KOGIS)

Primary Purpose

Pain, Acute, Muscle Tone Abnormalities, Work-Related Condition

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Sitting
Static standing
Dynamic standing
Sponsored by
Science and Research Centre Koper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring cognition, brain activity, cognitive reserve, work productivity, musculoskeletal discomfort, attention

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Healthy adults (both gender, age range 18-64 years) who are currently employed.

Exclusion Criteria:

  1. Inability to stand or walk without an assistive device
  2. 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
  3. History of symptomatic cardiovascular or pulmonary disease
  4. History of rheumatic arthritis
  5. History of stroke or other neurologic conditions with residual sensorimotor deficits
  6. History of chronic pain syndrome requiring narcotic analgesics
  7. Neurological disorders
  8. Evidence of dementia
  9. Diabetics: low or poorly controlled blood glucose
  10. Any other history of medical or psychiatric comorbidity precluding safe participation in the project

Sites / Locations

  • Science and research centre KoperRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Condition 1: sitting

Condition 2: static standing

Condition 3: dynamic standing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Overall movement - accelerometry
Overall movement (counts/min)
Musculoskeletal discomfort
Rate of total musculoskeletal discomfort development (mm/min)
Leg swelling
Average swelling for both legs (cm)

Secondary Outcome Measures

Oxygen uptake
Oxygen uptake VO2 (ml/min/kg)
Attention levels
Measuring attention with Stroop test (seconds)
Executive control
Executive functions measured with TMT test (seconds)
Brain electrocortical activity
EEG measurements (frequency analysis and ERP analysis)

Full Information

First Posted
May 6, 2019
Last Updated
April 20, 2021
Sponsor
Science and Research Centre Koper
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03944564
Brief Title
Cognitive and Motor Benefits of Standing
Acronym
KOGIS
Official Title
Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Science and Research Centre Koper
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Muscle Tone Abnormalities, Work-Related Condition, Sensory Deficit
Keywords
cognition, brain activity, cognitive reserve, work productivity, musculoskeletal discomfort, attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, controlled crossover trial
Masking
None (Open Label)
Masking Description
Participants will receive a general information about the study protocol and received three conditions in a random order.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1: sitting
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Condition 2: static standing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Condition 3: dynamic standing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sitting
Other Intervention Name(s)
SIT
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Static standing
Other Intervention Name(s)
STAT
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Dynamic standing
Other Intervention Name(s)
DYN
Intervention Description
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)
Primary Outcome Measure Information:
Title
Overall movement - accelerometry
Description
Overall movement (counts/min)
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)
Title
Musculoskeletal discomfort
Description
Rate of total musculoskeletal discomfort development (mm/min)
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)
Title
Leg swelling
Description
Average swelling for both legs (cm)
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)
Secondary Outcome Measure Information:
Title
Oxygen uptake
Description
Oxygen uptake VO2 (ml/min/kg)
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)
Title
Attention levels
Description
Measuring attention with Stroop test (seconds)
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)
Title
Executive control
Description
Executive functions measured with TMT test (seconds)
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)
Title
Brain electrocortical activity
Description
EEG measurements (frequency analysis and ERP analysis)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Healthy adults (both gender, age range 18-64 years) who are currently employed. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uros Marusic, PhD
Phone
041529226
Email
uros.marusic@zrs-kp.si
Facility Information:
Facility Name
Science and research centre Koper
City
Koper
ZIP/Postal Code
6000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uros Marusic, PhD
Phone
+38641529226
Email
uros.marusic@zrs-kp.si
First Name & Middle Initial & Last Name & Degree
Matej KIeva, MS
Email
matej.kleva@zrs-kp.si

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not decided yet
Citations:
PubMed Identifier
11101470
Citation
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.
Results Reference
background
PubMed Identifier
16026422
Citation
Levine 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.
Results Reference
background
PubMed Identifier
17827399
Citation
Hamilton 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.
Results Reference
background
PubMed Identifier
21947817
Citation
Chau 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.
Results Reference
background
PubMed Identifier
16691085
Citation
Cook 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.
Results Reference
background
PubMed Identifier
8455963
Citation
Waddell 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.
Results Reference
background

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Cognitive and Motor Benefits of Standing

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