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Cognitive and Motor Benefits of Standing (KOGIS)

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ClinicalTrials.gov Identifier: NCT03944564
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Science and Research Centre Koper

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.

Condition or disease Intervention/treatment Phase
Pain, Acute Muscle Tone Abnormalities Work-Related Condition Sensory Deficit Behavioral: Sitting Behavioral: Static standing Behavioral: Dynamic standing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Active Comparator: Condition 1: sitting
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.
Behavioral: Sitting
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)
Other Name: SIT

Active Comparator: Condition 2: static standing
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.
Behavioral: Static standing
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)
Other Name: STAT

Active Comparator: Condition 3: dynamic standing
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.
Behavioral: Dynamic standing
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)
Other Name: DYN




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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) ]
    Oxygen uptake VO2 (ml/min/kg)

  2. 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) ]
    Measuring attention with Stroop test (seconds)

  3. 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) ]
    Executive functions measured with TMT test (seconds)

  4. 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) ]
    EEG measurements (frequency analysis and ERP analysis)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944564


Contacts
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Contact: Uros Marusic, PhD 041529226 uros.marusic@zrs-kp.si

Locations
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Slovenia
Science and research centre Koper Recruiting
Koper, Slovenia, 6000
Contact: Uros Marusic, PhD    +38641529226    uros.marusic@zrs-kp.si   
Contact: Matej KIeva, MS       matej.kleva@zrs-kp.si   
Sponsors and Collaborators
Science and Research Centre Koper
University of Michigan
Publications:
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Responsible Party: Science and Research Centre Koper
ClinicalTrials.gov Identifier: NCT03944564    
Other Study ID Numbers: KOGIS
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not decided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Science and Research Centre Koper:
cognition
brain activity
cognitive reserve
work productivity
musculoskeletal discomfort
attention
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations