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Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Sponsor
Federal University of Uberlandia (Other)
Overall Status
Completed
CT.gov ID
NCT02736864
Collaborator
(none)
60
Enrollment
1
Location
12.1
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae
    Actual Study Start Date :
    Sep 28, 2016
    Actual Primary Completion Date :
    Oct 1, 2017
    Actual Study Completion Date :
    Oct 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry [At least one year after completion of the tuberculosis treatment]

      High resolution computed tomography of the lungs will be evaluated by radiologists and the extent of pulmonary abnormalities will be score subjectively. Spirometry will permit assessment of lung volumes: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment);

    • Treatment finalized at least one year before.

    Exclusion Criteria:

    • Physically impaired to perform the functional tests;

    • Coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis);

    • Pregnants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama) Uberlândia Minas Gerais Brazil 38405-320

    Sponsors and Collaborators

    • Federal University of Uberlandia

    Investigators

    • Principal Investigator: Thulio Cunha, Federal University of Uberlandia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michelle Godoy Canazza Damian, Post-graduating in Clinical Sciences of Federal University of Uberlândia; Radiologist., Federal University of Uberlandia
    ClinicalTrials.gov Identifier:
    NCT02736864
    Other Study ID Numbers:
    • FUUMGCD
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Tuberculosis
    Tuberculosis, Pulmonary

    Study Results

    No Results Posted as of Feb 14, 2018