Rheumatoid ArthritisNCT02730286
Activity Limitations in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Federal University of Minas Gerais.
Trial summary
Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- observational study
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Aug 2010
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For this cross-sectional study, 81 patients treated between June 2009 and August 2010 in Clinics Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil were recruited by convenience sampling
Who may be able to join
- Age over 18 years,
- Clinical diagnosis rheumatic arthritis
- Mental competence by the Mini-Mental State Examination
Who cannot join
- Had undergone upper limb surgery,
- Had an uncorrected visual deficit that could compromise functionality
About this study
Official title: Factors Associated With Activity Limitations in Individuals With Rheumatoid Arthritis
Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model.
Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.
Read the detailed description
The investigators used the ICF model to analyze factors reported to be associated with functioning and disability in individuals with RA, including dexterity fatigue, stiffness , pinch, handgrip, strength, range of motion (ROM) deficit, deformities , mental health, vitality, and pain .
- Conditions
- Rheumatoid Arthritis
- Being tested
- observational study
- Keywords
- human activity, International Classification of Functioning
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
application of several standard instruments in patients with rheumatoid arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis
The TEMPA is assessing the performance of the upper extremities and consists of eight standardized tasks. Scoring of the task analysis dimension ranges from zero to 150 (a score of zero indicates no disability). The TEMPA is scored according to the time required (in seconds) to complete each task; the higher the score, the greater the disability
Measured: up to thirty minutes
Model 2- Sequential Occupational Dexterity Assessment (SODA)
The SODA in patient population with RA score ranges from zero to 108 across these 12 tasks, has been validated for RA patients
Measured: up to thirty minutes
Model 3 and 4- SF-36=Short form health survey-36
The SF-36 has eight scales and a final score ranging from zero to 100 for each of the eight dimensions (a score of 100 represents the best state of health). The Brazilian Portuguese version of the SF-36 in patient population with RA has been demonstrated to be a reproducible and valid.
Measured: up to thirty minutes
Model 5 - AIMS=Arthritis impact measurement scale
The score ranges from zero to 10 (a score of 10 indicates the worst state of health) in patient population with RA. The Portuguese version of AIMS2 has been shown to be satisfactory
Measured: up to thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2010
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 Rheumatoid ArthritisStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Júnia Amorim Andrade, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730286
- Sponsor's protocol ID
- MS ID#: AJOT/2015/017467
- Status last verified
- Mar 2016
- First submitted
- 29 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Andrade JA, Brandao MB, Pinto MR, Lanna CC. Factors Associated With Activity Limitations in People With Rheumatoid Arthritis. Am J Occup Ther. 2016 Jul-Aug;70(4):7004290030p1-7. doi: 10.5014/ajot.2016.017467.
PubMed 27294995
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Activity Limitations in Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02730286
- Acronym / sponsor ID
- MS ID#: AJOT/2015/017467
- Conditions
- Rheumatoid Arthritis
- Keywords
- human activity, International Classification of Functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Apr 2016 (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.
Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model.
Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.
Detailed description
The investigators used the ICF model to analyze factors reported to be associated with functioning and disability in individuals with RA, including dexterity fatigue, stiffness , pinch, handgrip, strength, range of motion (ROM) deficit, deformities , mental health, vitality, and pain .
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For this cross-sectional study, 81 patients treated between June 2009 and August 2010 in Clinics Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil were recruited by convenience sampling
Key inclusion criteria (3 listed)
- Age over 18 years,
- Clinical diagnosis rheumatic arthritis
- Mental competence by the Mini-Mental State Examination
Key exclusion criteria (2 listed)
- Had undergone upper limb surgery,
- Had an uncorrected visual deficit that could compromise functionality
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 |
|---|---|---|
| observational studyapplication of several standard instruments in patients with rheumatoid arthritis | Other | – |
Primary outcome
Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis
Time frame: up to thirty minutes
The TEMPA is assessing the performance of the upper extremities and consists of eight standardized tasks. Scoring of the task analysis dimension ranges from zero to 150 (a score of zero indicates no disability). The TEMPA is scored according to the time required (in seconds) to complete each task; the higher the score, the greater the disability
Model 2- Sequential Occupational Dexterity Assessment (SODA)
Time frame: up to thirty minutes
The SODA in patient population with RA score ranges from zero to 108 across these 12 tasks, has been validated for RA patients
Model 3 and 4- SF-36=Short form health survey-36
Time frame: up to thirty minutes
The SF-36 has eight scales and a final score ranging from zero to 100 for each of the eight dimensions (a score of 100 represents the best state of health). The Brazilian Portuguese version of the SF-36 in patient population with RA has been demonstrated to be a reproducible and valid.
Model 5 - AIMS=Arthritis impact measurement scale
Time frame: up to thirty minutes
The score ranges from zero to 10 (a score of 10 indicates the worst state of health) in patient population with RA. The Portuguese version of AIMS2 has been shown to be satisfactory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 27294995Andrade JA, Brandao MB, Pinto MR, Lanna CC. Factors Associated With Activity Limitations in People With Rheumatoid Arthritis. Am J Occup Ther. 2016 Jul-Aug;70(4):7004290030p1-7. doi: 10.5014/ajot.2016.017467.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Federal University of Minas Gerais.
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 2 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: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis (time frame: up to thirty minutes). The study lists 4 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 NCT02730286, 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 6 Apr 2016.