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UnknownNCT01422967

Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Universidade Federal de Sao Carlos · Academic / Other
Sex
Male
Age
40 Years – 60 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALBalance and muscle strengthBalance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic

Timeline

Start date
2010-06-01
Primary completion
2012-10-01
Completion
2013-12-01
First posted
2011-08-25
Last updated
2011-08-26

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01422967. Inclusion in this directory is not an endorsement.

Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis (NCT01422967) · Clinical Trials Directory