Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Osteoathritis and Sleep |
Behavioral: Balance and muscle strength |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis |
- SLEEP PATTERN [ Time Frame: only one night of the evaluation ] [ Designated as safety issue: Yes ]
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 [ Time Frame: only an assessment ] [ Designated as safety issue: Yes ]The balance test will assessed by force plate, the test lasts for thirty minutes.
- Isokinetic test of knee [ Time Frame: only an assessment ] [ Designated as safety issue: Yes ]The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Osteoarthritis group |
Behavioral: Balance and muscle strength
Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic
|
| Active Comparator: without osteoarthritis |
Behavioral: Balance and muscle strength
Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic
|
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| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- with and without osteoartrhitis
- no other health problems
- sedentary
Exclusion Criteria:
- other clinical and neurobiological conditions
Contacts and Locations| Contact: Andressa Mello, Msc | +551155720177 | silvadressa@gmail.com |
| Contact: Mattiello Stela, PhD | +551184039880 | stela@ufscar.br |
| Brazil | |
| Centro de Estudos em Psicobiologia e Exercicio | Recruiting |
| Sao Paulo, SP, Brazil, 04020-050 | |
| Contact: Andressa Mello, Msc +551155720177 silvadressa@gmail.com | |
| Contact: Stela Mattiello, PhD +551155720177 stela@ufscar.br | |
| Principal Investigator: Stela Mattiello, PhD | |
| Principal Investigator: | Stela Mattiello, PhD | UFSCar |
More Information
No publications provided
| Responsible Party: | Andressa da Silva de Mello, Msc, Universidade Federal de Sao Carlos |
| ClinicalTrials.gov Identifier: | NCT01422967 History of Changes |
| Other Study ID Numbers: | 109/2011 |
| Study First Received: | August 19, 2011 |
| Last Updated: | August 24, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Federal de Sao Carlos:
|
Osteoarthritis Sleep muscle strength balance |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013