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临床试验/NCT01422967
NCT01422967Unknown不适用

Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
SLEEP PATTERN

研究概览

简要总结

Osteoarthritis (OA) is one of the major health problems and their prevalence has increased in recent decades. It has been shown that OA causes negative effects on sleep and that these changes in sleep see to be correlated with the function and physical performance of patients with OA. However, no study to date has demonstrated the effects of sleep changes in sensorimotor control and systemic inflammatory response in patients with OA. The objective of this study is to assess the influence of sleep changes in sensorimotor control (postural and neuromuscular control) and inflammatory markers (cytokines) in patients with knee OA grade I or II. Participate in this study, 60 male volunteers, aged between 40 and 65. These volunteers will be divided into four groups: Group 1 (n = 15): Osteoarthritis and good quality sleep, Group 2 (n = 15): Osteoarthritis and poor quality sleep, Group 3 (n = 15): Without good and Osteoarthritis quality of sleep, Group 4 (n = 15): Without Osteoarthritis and poor quality of sleep. All volunteers will perform a polysomnography to detect the presence or not of changes in sleep. Further testing on the isokinetic dynamometer to evaluate the acceleration time, maximum isometric torque and isokinetic concentric and eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular control. Also there will be a test on the force platform to assess the uni-and bipedal postural control, as well as respond to the WOMAC questionnaire that assesses the quality of life in patients with OA. Blood will be collected for analysis of inflammatory cytokines (TNF-alpha, IL-1alpha, IL-1beta, IL-6, IL-8, IL-12, IL-10, TGF-beta). The significance level is 5% (p ≤ 0.05).

详细描述

The experimental design of each volunteer (all groups) will be evaluated by a physician before beginning the study and posteriomente will perform a polysomnography. The day after polysomnography voluntary blood will be collected. A week after the volunteer will perform the balance test (force platform) and the test of strength (isokinetic).

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • with and without osteoartrhitis
  • no other health problems
  • sedentary

排除标准

  • other clinical and neurobiological conditions

结局指标

主要结局

SLEEP PATTERN

时间窗: only one night of the evaluation

Sleep pattern assessed using Polissonography overnight in the Sleep Institute. In all of the protocol the patient must attend two days in the laboratory, and a night nescessaria for polysomnography, and two periods during the day to the test of balance and strength

Bipodal and Unipodal Balance

时间窗: only an assessment

The balance test will assessed by force plate, the test lasts for thirty minutes.

Isokinetic test of knee

时间窗: only an assessment

The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.

次要结局

未报告次要终点

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andressa da Silva de Mello

Msc

Universidade Federal de Sao Carlos

研究点 (2)

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