Cognitive and Motor Benefits of Standing

Study Overview
=================
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.

Official Title
-----------------
Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)

Conditions
-----------------
Pain, Acute, Muscle Tone Abnormalities, Work-Related Condition, Sensory Deficit

Intervention / Treatment
-----------------
* Behavioral: Sitting
* Behavioral: Static standing
* Behavioral: Dynamic standing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, controlled crossover trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Condition 1: sitting<br>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<br>* 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)<br>* Other names: SIT;|
| Active Comparator: Condition 2: static standing<br>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<br>* 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)<br>* Other names: STAT;|
| Active Comparator: Condition 3: dynamic standing<br>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<br>* 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)<br>* Other names: DYN;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall movement - accelerometry | Overall movement (counts/min) | 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) | 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) | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake | Oxygen uptake VO2 (ml/min/kg) | 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) | 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) | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, brain activity, cognitive reserve, work productivity, musculoskeletal discomfort, attention