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

Not Applicable

• Conditions: Osteoathritis and Sleep
• Interventions: Behavioral: Balance and muscle strength

• Registration Number: NCT01422967
• Lead Sponsor: Universidade Federal de Sao Carlos

Brief 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).

Study Timeline

• Study Start: 2010-06
• Status Verified: 2011-08
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-23
• Last Update Submitted: 2011-08-24
• Study First Posted: 2011-08-25
• Last Update Posted: 2011-08-26
• Primary Completion: 2012-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• other clinical and neurobiological conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Osteoarthritis group	Balance and muscle strength	-
without osteoarthritis	Balance and muscle strength	-

Primary Outcome Measures

Name	Time	Method
SLEEP PATTERN	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	only an assessment	The balance test will assessed by force plate, the test lasts for thirty minutes.
Isokinetic test of knee	only an assessment	The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.

Trial Locations

Locations (1)

Centro de Estudos em Psicobiologia e Exercicio; 🇧🇷 Sao Paulo, SP, Brazil