Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
Primary Purpose
Osteoathritis and Sleep
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Balance and muscle strength
Sponsored by
About this trial
This is an interventional health services research trial for Osteoathritis and Sleep focused on measuring Osteoarthritis, Sleep, muscle strength, balance
Eligibility Criteria
Inclusion Criteria:
- with and without osteoartrhitis
- no other health problems
- sedentary
Exclusion Criteria:
- other clinical and neurobiological conditions
Sites / Locations
- Centro de Estudos em Psicobiologia e ExercicioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Osteoarthritis group
without osteoarthritis
Arm Description
Outcomes
Primary Outcome Measures
SLEEP PATTERN
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
The balance test will assessed by force plate, the test lasts for thirty minutes.
Isokinetic test of knee
The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.
Secondary Outcome Measures
Full Information
NCT ID
NCT01422967
First Posted
August 19, 2011
Last Updated
August 24, 2011
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01422967
Brief Title
Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
Official Title
Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoathritis and Sleep
Keywords
Osteoarthritis, Sleep, muscle strength, balance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteoarthritis group
Arm Type
Active Comparator
Arm Title
without osteoarthritis
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Balance and muscle strength
Intervention Description
Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic
Primary Outcome Measure Information:
Title
SLEEP PATTERN
Description
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
Time Frame
only one night of the evaluation
Title
Bipodal and Unipodal Balance
Description
The balance test will assessed by force plate, the test lasts for thirty minutes.
Time Frame
only an assessment
Title
Isokinetic test of knee
Description
The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.
Time Frame
only an assessment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
with and without osteoartrhitis
no other health problems
sedentary
Exclusion Criteria:
- other clinical and neurobiological conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andressa Mello, Msc
Phone
+551155720177
Email
silvadressa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mattiello Stela, PhD
Phone
+551184039880
Email
stela@ufscar.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stela Mattiello, PhD
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudos em Psicobiologia e Exercicio
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andressa Mello, Msc
Phone
+551155720177
Email
silvadressa@gmail.com
First Name & Middle Initial & Last Name & Degree
Stela Mattiello, PhD
Phone
+551155720177
Email
stela@ufscar.br
First Name & Middle Initial & Last Name & Degree
Stela Mattiello, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
29351822
Citation
Silva A, Mello MT, Serrao PR, Luz RP, Ruiz F, Bittencourt LR, Tufik S, Mattiello SM. Influence of Obstructive Sleep Apnea in the Functional Aspects of Patients With Osteoarthritis. J Clin Sleep Med. 2018 Feb 15;14(2):265-270. doi: 10.5664/jcsm.6950.
Results Reference
derived
Learn more about this trial
Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
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