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

NCT ID: NCT01422967

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-12-31

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).

Conditions

Osteoathritis and Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Osteoarthritis group

Group Type: ACTIVE_COMPARATOR

Balance and muscle strength

Intervention Type: BEHAVIORAL

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

without osteoarthritis

Group Type: ACTIVE_COMPARATOR

Balance and muscle strength

Intervention Type: BEHAVIORAL

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

Interventions

Balance and muscle strength

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• other clinical and neurobiological conditions

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Andressa da Silva de Mello

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stela Mattiello, PhD

Role: PRINCIPAL_INVESTIGATOR

UFSCar

Locations

Centro de Estudos em Psicobiologia e Exercicio

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Andressa Mello, Msc

Role: CONTACT

silvadressa@gmail.com

+551155720177

Mattiello Stela, PhD

Role: CONTACT

stela@ufscar.br

+551184039880

Facility Contacts

Andressa Mello, Msc

Role: primary

silvadressa@gmail.com

+551155720177

Stela Mattiello, PhD

Role: backup

stela@ufscar.br

+551155720177

References

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.

Reference Type: DERIVED

PMID: 29351822 (View on PubMed)

Other Identifiers

109/2011

Identifier Type: -

Identifier Source: org_study_id