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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Andressa da Silva de Mello, Universidade Federal de Sao Carlos.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422967
First Posted: August 25, 2011
Last Update Posted: August 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Andressa da Silva de Mello, Universidade Federal de Sao Carlos
  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: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Andressa da Silva de Mello, Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • SLEEP PATTERN [ Time Frame: only one night of the evaluation ]

    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 ]
    The balance test will assessed by force plate, the test lasts for thirty minutes.

  • Isokinetic test of knee [ Time Frame: only an assessment ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- other clinical and neurobiological conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422967


Contacts
Contact: Andressa Mello, Msc +551155720177 silvadressa@gmail.com
Contact: Mattiello Stela, PhD +551184039880 stela@ufscar.br

Locations
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         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Federal University of São Paulo
Investigators
Principal Investigator: Stela Mattiello, PhD UFSCar
  More Information

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
First Submitted: August 19, 2011
First Posted: August 25, 2011
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Andressa da Silva de Mello, Universidade Federal de Sao Carlos:
Osteoarthritis
Sleep
muscle strength
balance

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases