Cognitive and Motor Benefits of Standing

Pain, Acute Clinical Trial

— KOGIS  

Official title:

Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03944564
• Other study ID #: KOGIS
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2021
• Source: Science and Research Centre Koper
• Contact: Uros Marusic, PhD
• Phone: 041529226
• Email: uros.marusic[@]zrs-kp.si
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Slovenia	Science and research centre Koper	Koper

Sponsors (2)

Lead Sponsor	Collaborator
Science and Research Centre Koper	University of Michigan

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

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. — View 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. — View 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. Epub 2007 Sep 7. Review. — View 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. Review. — View Citation

Levine JA, Schleusner SJ, Jensen MD. Energy expenditure of nonexercise activity. Am J Clin Nutr. 2000 Dec;72(6):1451-4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)