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Respiratory Function in Patients With Post-tuberculosis Lung Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821285
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Fondazione Salvatore Maugeri
Azienda Ospedaliero Universitaria di Sassari
Instituto Nacional de Enfermedades Respiratorias
Information provided by (Responsible Party):
Dina Visca, Università degli Studi dell'Insubria

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.

Condition or disease Intervention/treatment Phase
Lung Diseases, Obstructive Pulmonary Rehabilitation Lung TB Procedure: Pulmonary Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicentre international
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Respiratory Function in Patients With Post-tuberculosis Lung Impairment After Pulmonary Tuberculosis Treatment or After Spontaneous Healing
Estimated Study Start Date : February 14, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pulmonary rehabilitation
Pulmonary rehabilitation program
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




Primary Outcome Measures :
  1. 6-min walking test [ Time Frame: 1 year ]
    Exercise capacity


Secondary Outcome Measures :
  1. dyspnoea [ Time Frame: 1 year ]
    Modified BORG scale (0-10) 0 better, 10 worse

  2. muscle fatigue [ Time Frame: 1 year ]
    Modified Borg scale (0-10) 0 better, 10 worse

  3. health related quality of life [ Time Frame: 1 year ]
    st. George Respiratory Questionnaire 0 better, 100 worse

  4. health status [ Time Frame: 1 year ]
    COPD Assessment test-CAT (0-40) 0 better, 40 worse



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821285


Contacts
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Contact: Dina Visca, Dr +390331829111 dina.visca@icsmaugeri.it
Contact: Elisabetta Zampogna, Dr +390331829503 elisabetta.zampogna@icsmaugeri.it

Locations
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Italy
ICS Maugeri, IRCCS Recruiting
Tradate, Varese, Italy, 21049
Contact: Dina Visca, Dr    +390331829111    dina.visca@icsmaugeri.it   
Contact: Elisabetta Zampogna, Dr    +390331829503    elisabetta.zampogna@icsmaugeri.it   
Sponsors and Collaborators
Università degli Studi dell'Insubria
Fondazione Salvatore Maugeri
Azienda Ospedaliero Universitaria di Sassari
Instituto Nacional de Enfermedades Respiratorias
Investigators
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Study Director: Giovan Battista Migliori, Prof ICS Maugeri, IRCCS
Publications of Results:
Other Publications:
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Responsible Party: Dina Visca, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03821285    
Other Study ID Numbers: 2215CE
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina Visca, Università degli Studi dell'Insubria:
TB
Pulmonary rehabilitation
Lung function
Additional relevant MeSH terms:
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Tuberculosis
Lung Diseases
Lung Diseases, Obstructive
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases