Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Tuberculosis

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38405-320
      • Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cured pulmonary tuberculosis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry	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).	At least one year after completion of the tuberculosis treatment

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Thulio Cunha, Federal University of Uberlandia

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 2, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: FUUMGCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO