Osteoathritis and SleepNCT01422967
Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis
A study testing Balance and muscle strength in people with Osteoathritis and Sleep, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoathritis and Sleep
- What is being tested?
- Balance and muscle strength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- with and without osteoartrhitis
- no other health problems
- sedentary
Who cannot join
- other clinical and neurobiological conditions
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Estudos em Psicobiologia e Exercicio
São Paulo, São Paulo, 04020-050
Andressa Mello, Msc, +551155720177, silvadressa@gmail.com
Stela Mattiello, PhD, +551155720177, stela@ufscar.br
About this study
Official title: 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).
Read the 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).
- Conditions
- Osteoathritis and Sleep
- Being tested
- Balance and muscle strength
- Keywords
- Osteoarthritis, Sleep, muscle strength, balance
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and muscle strengthBehavioural
Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis group | Active comparator | Not described Receives: Behavioral: Balance and muscle strength |
| without osteoarthritis | Active comparator | Not described Receives: Behavioral: Balance and muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: only one night of the evaluation
Bipodal and Unipodal Balance
The balance test will assessed by force plate, the test lasts for thirty minutes.
Measured: only an assessment
Isokinetic test of knee
The isokinetc tets will assessed by isokinetc dynamometer - Biodex Multi-Joint System 3. The test lasts for forty minutes.
Measured: only an assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoathritis and SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Andressa da Silva de Mello, Universidade Federal de Sao Carlos
- Investigators
- Stela Mattiello, PhD, Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422967
- Sponsor's protocol ID
- 109/2011
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29351822
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Sleep on the Sensorimotor and Cytokine in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01422967
- Acronym / sponsor ID
- 109/2011
- Conditions
- Osteoathritis and Sleep
- Keywords
- Osteoarthritis, Sleep, muscle strength, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis group | Active comparator | Behavioral: Balance and muscle strength |
| without osteoarthritis | Active comparator | Behavioral: Balance and muscle strength |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- with and without osteoartrhitis
- no other health problems
- sedentary
Key exclusion criteria (1 listed)
- other clinical and neurobiological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance and muscle strengthBalance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic | Behavioural | Osteoarthritis group, without osteoarthritis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- Derived from this study: PubMed 29351822Silva 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stela Mattiello, PhD principal investigator
UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and muscle strength in people with Osteoathritis and Sleep, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andressa Mello, Msc (+551155720177, silvadressa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLEEP PATTERN (time frame: only one night of the evaluation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.