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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Universidade Federal de Sao Carlos.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Andressa da Silva de Mello, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01422967
First received: August 19, 2011
Last updated: August 24, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- other clinical and neurobiological conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 April 22, 2014