Respiratory Function in Patients With Post-tuberculosis Lung Impairment
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ClinicalTrials.gov Identifier: NCT03821285 |
Recruitment Status : Unknown
Verified January 2019 by Dina Visca, Università degli Studi dell'Insubria.
Recruitment status was: Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Diseases, Obstructive Pulmonary Rehabilitation Lung TB | Procedure: Pulmonary Rehabilitation | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: pulmonary rehabilitation
Pulmonary rehabilitation program
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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 |
- 6-min walking test [ Time Frame: 1 year ]Exercise capacity
- dyspnoea [ Time Frame: 1 year ]Modified BORG scale (0-10) 0 better, 10 worse
- muscle fatigue [ Time Frame: 1 year ]Modified Borg scale (0-10) 0 better, 10 worse
- health related quality of life [ Time Frame: 1 year ]st. George Respiratory Questionnaire 0 better, 100 worse
- health status [ Time Frame: 1 year ]COPD Assessment test-CAT (0-40) 0 better, 40 worse

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Dina Visca, Dr | +390331829111 | dina.visca@icsmaugeri.it | |
Contact: Elisabetta Zampogna, Dr | +390331829503 | elisabetta.zampogna@icsmaugeri.it |
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 |
Study Director: | Giovan Battista Migliori, Prof | ICS Maugeri, IRCCS |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
TB Pulmonary rehabilitation Lung function |
Tuberculosis Lung Diseases Lung Diseases, Obstructive Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Respiratory Tract Diseases |