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Respiratory Function in Patients With Post-tuberculosis Lung Impairment

NCT03821285 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-29

No results posted yet for this study

Summary

Pulmonary tuberculosis (TB) is an important risk factor for chronic respiratory disease due to residual lung damage. A recent review of the literature on TB sequelae and rehabilitation has provided clear evidence that TB is definitively responsible for lung function impairment. Functional evaluation of TB patients after completion of pulmonary tuberculosis treatment or spontaneous healing should be considered as part of clinical care. Unfortunately, few studies are available in the literature investigating the physiopathology of lung damage, its impact on quality of life, the potential need for pulmonary rehabilitation (PR), and the effects of a PR program.Objectives of this prospective multicentre international study are: Primary Objective-to assess the exercise capacity 6-min walking test in patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment or after spontaneous healing. Secondary Objectives-to assess the effects of the PR program on dyspnoea symptoms and muscle fatigue, quality of life.

Conditions

  • Lung Diseases, Obstructive
  • Pulmonary Rehabilitation
  • Lung TB

Interventions

PROCEDURE

Pulmonary Rehabilitation

Pulmonary rehabilitation programme:15 aerobic-training sessions, 15 strength-training sessions for peripheral muscles, 3 face to face and/or Group educational sessions, if needed airways clearance techniques and/or inspiratory muscles training

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    collaborator OTHER

  • Azienda Ospedaliero Universitaria di Sassari

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Giovan Battista Migliori, Prof · ICS Maugeri, IRCCS

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2020-07-31
Completion
2021-01-14

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03821285 on ClinicalTrials.gov