Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis

July 16, 2012 updated by: Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto

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

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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Rio de Janeiro, Brazil, 21550-013
        • Recruiting
        • Laboratório de Instrumentação Biomédica
        • Contact:
        • Principal Investigator:
          • Alvaro Camilo D Faria
        • Principal Investigator:
          • Pedro L de Melo
        • Principal Investigator:
          • Geraldo Castelar
        • Principal Investigator:
          • Agnaldo J Lopes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Volunteers with Rheumatoid Arthritis for Patients Group;
  • Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pedro L de Melo, State University of Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

3
Subscribe