Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis
1 other identifier
observational
90
1 country
1
Brief Summary
Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is estimated that the RA reaches about 0.5% of the population. According to data from DATASUS, was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in 2005-2007. The main bodily changes are related to joint problems, however, systemic manifestations are also found in organs such as lung and heart. Although cardiovascular diseases are the most responsible of the deaths AR, pulmonary complications are common and account for 10% to 15% of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes significant morbidity and mortality in these patients. Although pulmonary involvement is a frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not yet been precisely established. Several lung disorders such as interstitial pulmonary fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that studies of lung function appear to be a valuable helper for radiography in the evaluation of pulmonary involvement in connective tissue diseases. Previous studies indicate that patients with RA have an increased incidence of abnormal lung function, according to assessments including spirometry, lung volume tests and diffusion capacity of carbon monoxide. Thus, the main objective of this study is to analyze the respiratory mechanics of patients with RA. Specific objectives were to seek to understand whether a relationship exists between duration of rheumatoid disease and lung function in these patients. For this, the investigators used 18 subjects in the control group, free of pulmonary disease and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4 groups of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15 years and\> or = 16 years). It is noteworthy that all patients in the RA group will also be non-smokers, since it is already known in the literature that smoking impairs lung function. All individuals will perform the function test with a trained technician and qualified to function. The examinations will be conducted: Forced oscillation technique and spirometry, in that order.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 17, 2012
July 1, 2012
2.4 years
March 13, 2012
July 16, 2012
Conditions
Keywords
Study Arms (5)
Control Group
Group of nonsmokers individuals without respiratory disease.
RA patients 1
RA patients nonsmokers with up to five years of disease.
RA group 2
RA patients nonsmokers with six to ten years of disease.
RA group 3
RA patients nonsmokers with eleven to fifteen years of disease.
RA group 4
RA patients nonsmokers with sixteen or more years of disease
Eligibility Criteria
The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations. The group of patients with rheumatoid arthritis will be comprised of individuals treated at the Department of Rheumatology (Hospital Universitártio Pedro Ernesto) nonsmokers, who had no episode of respiratory infection thirty days before the examinations.
You may qualify if:
- Volunteers with Rheumatoid Arthritis for Patients Group;
- Volunteers without any respiratory disease for the control group.
You may not qualify if:
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratório de Instrumentação Biomédica
Rio de Janeiro, Rio de Janeiro, 21550-013, Brazil
Related Publications (2)
Faria AD, Lopes AJ, Jansen JM, Pinheiro GC, Melo PL. Diagnostic performance of the Forced Oscillation Technique in the detection of early respiratory changes in rheumatoid arthritis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:6034-7. doi: 10.1109/IEMBS.2010.5627605.
PMID: 21097117RESULTFaria AC, Barbosa WR, Lopes AJ, Pinheiro Gda R, Melo PL. Contrasting diagnosis performance of forced oscillation and spirometry in patients with rheumatoid arthritis and respiratory symptoms. Clinics (Sao Paulo). 2012 Sep;67(9):987-94. doi: 10.6061/clinics/2012(09)01.
PMID: 23018292DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pedro L de Melo
State University of Rio de Janeiro
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 13, 2012
First Posted
July 17, 2012
Study Start
July 1, 2010
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
July 17, 2012
Record last verified: 2012-07