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

NCT01422967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-08-26

No results posted yet for this study

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).

Conditions

  • Osteoathritis and Sleep

Interventions

BEHAVIORAL

Balance and muscle strength

Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER

  • Universidade Federal de Sao Carlos

    lead OTHER

Principal Investigators

  • Stela Mattiello, PhD · UFSCar

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422967 on ClinicalTrials.gov