Lung Diseases, Obstructive Clinical Trial
Official title:
Evaluation of Respiratory Function in Patients With Post-tuberculosis Lung Impairment After Pulmonary Tuberculosis Treatment or After Spontaneous Healing
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 14, 2021 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | ICS Maugeri, IRCCS | Tradate | Varese |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi dell'Insubria | Azienda Ospedaliero Universitaria di Sassari, Fondazione Salvatore Maugeri, Instituto Nacional de Enfermedades Respiratorias |
Italy,
Muñoz-Torrico M, Rendon A, Centis R, D'Ambrosio L, Fuentes Z, Torres-Duque C, Mello F, Dalcolmo M, Pérez-Padilla R, Spanevello A, Migliori GB. Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis? J Bras Pne — View Citation
Tiberi S, Muñoz-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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-min walking test | Exercise capacity | 1 year | |
Secondary | dyspnoea | Modified BORG scale (0-10) 0 better, 10 worse | 1 year | |
Secondary | muscle fatigue | Modified Borg scale (0-10) 0 better, 10 worse | 1 year | |
Secondary | health related quality of life | st. George Respiratory Questionnaire 0 better, 100 worse | 1 year | |
Secondary | health status | COPD Assessment test-CAT (0-40) 0 better, 40 worse | 1 year |
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