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

Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01422967
Enrollment
60
Registered
2011-08-25
Start date
2010-06-30
Completion date
2013-12-31
Last updated
2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoathritis and Sleep

Keywords

Osteoarthritis, Sleep, muscle strength, balance

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).

Interventions

BEHAVIORALBalance and muscle strength

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

Sponsors

Federal University of São Paulo
CollaboratorOTHER
Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\- other clinical and neurobiological conditions

Design outcomes

Primary

MeasureTime frameDescription
SLEEP PATTERNonly one night of the evaluationSleep 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 Balanceonly an assessmentThe balance test will assessed by force plate, the test lasts for thirty minutes.
Isokinetic test of kneeonly an assessmentThe isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.

Countries

Brazil

Contacts

Primary ContactAndressa Mello, Msc
silvadressa@gmail.com+551155720177
Backup ContactMattiello Stela, PhD
stela@ufscar.br+551184039880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026