| 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 |
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 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, 2022 |
| Estimated Study Completion Date : | September 1, 2022 |
| 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.
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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
|
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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
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|
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
|
| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Healthy adults (both gender, age range 18-64 years) who are currently employed.
Exclusion Criteria:
| Contact: Uros Marusic, PhD | 041529226 | uros.marusic@zrs-kp.si |
| 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 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 6, 2019 | ||||
| First Posted Date ICMJE | May 9, 2019 | ||||
| Last Update Posted Date | April 22, 2021 | ||||
| Actual Study Start Date ICMJE | September 10, 2019 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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)
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive and Motor Benefits of Standing | ||||
| Official Title ICMJE | Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS) | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
20 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 1, 2022 | ||||
| Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: 1. Healthy adults (both gender, age range 18-64 years) who are currently employed. Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 64 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Slovenia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03944564 | ||||
| Other Study ID Numbers ICMJE | KOGIS | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Science and Research Centre Koper | ||||
| Study Sponsor ICMJE | Science and Research Centre Koper | ||||
| Collaborators ICMJE | University of Michigan | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Science and Research Centre Koper | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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