NCT03944564

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

May 6, 2019

Last Update Submit

April 20, 2021

Conditions

Keywords

cognitionbrain activitycognitive reservework productivitymusculoskeletal discomfortattention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Oxygen uptake

    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

    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

    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

    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)

Study Arms (3)

Condition 1: sitting

ACTIVE COMPARATOR

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

Condition 2: static standing

ACTIVE COMPARATOR

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

Condition 3: dynamic standing

ACTIVE COMPARATOR

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

Interventions

SittingBEHAVIORAL

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)

Also known as: SIT
Condition 1: sitting
Static standingBEHAVIORAL

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)

Also known as: STAT
Condition 2: 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)

Also known as: DYN
Condition 3: dynamic standing

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Science and research centre Koper

Koper, 6000, Slovenia

RECRUITING

Related Publications (6)

  • 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.

    PMID: 11101470BACKGROUND
  • 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.

    PMID: 16026422BACKGROUND
  • 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.

    PMID: 17827399BACKGROUND
  • 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.

    PMID: 21947817BACKGROUND
  • 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.

    PMID: 16691085BACKGROUND
  • 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.

    PMID: 8455963BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Uros Marusic, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will receive a general information about the study protocol and received three conditions in a random order.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, controlled crossover trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 9, 2019

Study Start

September 10, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations