NCT03821285

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

January 14, 2019

Last Update Submit

January 28, 2019

Conditions

Lung Diseases, ObstructivePulmonary RehabilitationLung TB

Keywords

TBPulmonary rehabilitationLung function

Outcome Measures

Primary Outcomes (1)

  • 6-min walking test

    Exercise capacity

    1 year

Secondary Outcomes (4)

  • dyspnoea

    1 year

  • muscle fatigue

    1 year

  • health related quality of life

    1 year

  • health status

    1 year

Study Arms (1)

pulmonary rehabilitation

EXPERIMENTAL

Pulmonary rehabilitation program

Procedure: Pulmonary Rehabilitation

Interventions

Pulmonary RehabilitationPROCEDURE

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

pulmonary rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment - Patients with post- TB impairment after spontaneous healing

You may not qualify if:

  • Any unstable medical condition
  • Musculoskeletal disorders contraindicating participation in the PR program
  • Cognitive impairment (Mini Mental State Examination \<22)
  • Unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICS Maugeri, IRCCS

Tradate, Varese, 21049, Italy

RECRUITING

Related Publications (2)

  • Tiberi S, Munoz-Torrico M, Duarte R, Dalcolmo M, D'Ambrosio L, Migliori GB. New drugs and perspectives for new anti-tuberculosis regimens. Pulmonology. 2018 Mar-Apr;24(2):86-98. doi: 10.1016/j.rppnen.2017.10.009. Epub 2018 Feb 24.

    PMID: 29487031BACKGROUND

  • Munoz-Torrico M, Rendon A, Centis R, D'Ambrosio L, Fuentes Z, Torres-Duque C, Mello F, Dalcolmo M, Perez-Padilla R, Spanevello A, Migliori GB. Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis? J Bras Pneumol. 2016 Sep-Oct;42(5):374-385. doi: 10.1590/S1806-37562016000000226.

    PMID: 27812638RESULT

MeSH Terms

Conditions

Lung Diseases, ObstructiveTuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract Infections

Study Officials

  • Giovan Battista Migliori, Prof

    ICS Maugeri, IRCCS

    STUDY DIRECTOR

Central Study Contacts

Dina Visca, Dr

CONTACT

+390331829111dina.visca@icsmaugeri.it

Elisabetta Zampogna, Dr

CONTACT

+390331829503elisabetta.zampogna@icsmaugeri.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicentre international
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 29, 2019

Study Start

February 14, 2019

Primary Completion

July 31, 2020

Study Completion

January 14, 2021

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

IT(1)