Clinical trial NCT01422967: Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
Official title: Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoathritis and Sleep
Keywords: Osteoarthritis
Sleep
muscle strength
balance
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2011-08-25
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- other clinical and neurobiological conditions

Primary outcomes:
measure: SLEEP PATTERN
timeFrame: only one night of the evaluation
measure: Bipodal and Unipodal Balance
timeFrame: only an assessment
measure: Isokinetic test of knee
timeFrame: only an assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercicio
state: SP
Study officials:
affiliation: UFSCar
name: Stela Mattiello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva A, Mello MT, Serrao PR, Luz RP, Ruiz F, Bittencourt LR, Tufik S, Mattiello SM. Influence of Obstructive Sleep Apnea in the Functional Aspects of Patients With Osteoarthritis. J Clin Sleep Med. 2018 Feb 15;14(2):265-270. doi: 10.5664/jcsm.6950.