Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis

NCT ID: NCT01641705

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis respiratory mechanics time of disease

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control Group

Group of nonsmokers individuals without respiratory disease.

No interventions assigned to this group

RA patients 1

RA patients nonsmokers with up to five years of disease.

No interventions assigned to this group

RA group 2

RA patients nonsmokers with six to ten years of disease.

No interventions assigned to this group

RA group 3

RA patients nonsmokers with eleven to fifteen years of disease.

No interventions assigned to this group

RA group 4

RA patients nonsmokers with sixteen or more years of disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role lead

Responsible Party

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Alvaro Camilo Dias Faria

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro L de Melo

Role: STUDY_DIRECTOR

State University of Rio de Janeiro

Locations

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Laboratório de Instrumentação Biomédica

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Alvaro Camilo D Faria

Role: CONTACT

Phone: (5521)2334-0705

Email: [email protected]

Facility Contacts

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Alvaro Camilo D Faria

Role: primary

References

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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.

Reference Type RESULT
PMID: 21097117 (View on PubMed)

Faria 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.

Reference Type DERIVED
PMID: 23018292 (View on PubMed)

Other Identifiers

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AR-01

Identifier Type: -

Identifier Source: org_study_id