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Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641705
First Posted: July 17, 2012
Last Update Posted: July 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis: Effect of Duration of Disease

Resource links provided by NLM:


Further study details as provided by Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto:

Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Smokers

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641705


Contacts
Contact: Alvaro Camilo D Faria (5521)2334-0705 acdffisio@gmail.com

Locations
Brazil
Laboratório de Instrumentação Biomédica Recruiting
Rio de Janeiro, Brazil, 21550-013
Contact: Alvaro Camilo D Faria    (5521)78201688    acdffisio@gmail.com   
Principal Investigator: Alvaro Camilo D Faria         
Principal Investigator: Pedro L de Melo         
Principal Investigator: Geraldo Castelar         
Principal Investigator: Agnaldo J Lopes         
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Investigators
Study Director: Pedro L de Melo State University of Rio de Janeiro
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alvaro Camilo Dias Faria, Professor, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01641705     History of Changes
Other Study ID Numbers: AR-01
First Submitted: March 13, 2012
First Posted: July 17, 2012
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto:
rheumatoid arthritis
respiratory mechanics
time of disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases