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

August 24, 2011 updated by: Andressa da Silva de Mello, Universidade Federal de Sao Carlos

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04020-050
        • Recruiting
        • Centro de Estudos em Psicobiologia e Exercicio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stela Mattiello, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

- other clinical and neurobiological conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
only one night of the evaluation
Bipodal and Unipodal Balance
Time Frame: only an assessment
The balance test will assessed by force plate, the test lasts for thirty minutes.
only an assessment
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.
only an assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Collaborators

Federal University of São Paulo

Investigators

  • Principal Investigator: Stela Mattiello, PhD, Ufscar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 24, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoathritis and Sleep

Clinical Trials on Balance and muscle strength

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe