跳至主要内容
临床试验/NCT03944564
NCT03944564Unknown不适用

Kognitivne in Gibalne Prednosti stoječega Delovnega Mesta (KOGIS)

Science and Research Centre Koper1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Overall movement - accelerometry

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

Participants will receive a general information about the study protocol and received three conditions in a random order.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Sitting (Behavioral)

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.

干预措施: Static standing (Behavioral)

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.

干预措施: Dynamic standing (Behavioral)

结局指标

主要结局

Overall movement - accelerometry

时间窗: 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)

Musculoskeletal discomfort

时间窗: 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)

Leg swelling

时间窗: 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)

次要结局

  • 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))

研究者

发起方
Science and Research Centre Koper
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验