Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis: Effect of Duration of Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01641705
• Other study ID #: AR-01
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: July 16, 2012
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: Hospital Universitario Pedro Ernesto
• Contact: Alvaro Camilo D Faria
• Phone: (5521)2334-0705
• Email: acdffisio[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Volunteers with Rheumatoid Arthritis for Patients Group;

• Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

Smokers

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Brazil	Laboratório de Instrumentação Biomédica	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Conf Proc IEEE Eng Med Biol Soc. 2010;2010:6034-7. doi: 10.1109/IEMBS.20 — View Citation