Osteoathritis and Sleep Clinical Trial
Official title:
Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis
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).
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 40 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - with and without osteoartrhitis - no other health problems - sedentary Exclusion Criteria: - other clinical and neurobiological conditions |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Centro de Estudos em Psicobiologia e Exercicio | Sao Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Federal de Sao Carlos | Federal University of São Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SLEEP PATTERN | 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 |
only one night of the evaluation | Yes |
| Primary | Bipodal and Unipodal Balance | The balance test will assessed by force plate, the test lasts for thirty minutes. | only an assessment | Yes |
| Primary | Isokinetic test of knee | The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes. | only an assessment | Yes |