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Not Yet Recruiting NCT07709507

Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease

Conditions: Post-tuberculosis Lung Disease, Tuberculosis (TB)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Filantropia Hospital

Summary

Post-tuberculosis lung disease (PTLD) refers to persistent respiratory symptoms, functional limitation, and/or structural or physiological abnormalities after completion of anti-tuberculosis treatment. These consequences can reduce exercise capacity and quality of life. This randomized controlled study will evaluate whether an individualized pulmonary rehabilitation program provides greater and more sustained improvement than standard care in adults with PTLD. Participants will be allocated in a 1:1 ratio to an 8-week supervised pulmonary rehabilitation program plus standard care or to standard care alone. Assessments will be performed at baseline (T0), immediately after the 8-week program (T1), and 3 months after program completion (T2; Week 20). The primary outcome will be the change in St George's Respiratory Questionnaire total score from baseline to Week 20. Secondary outcomes will include exercise capacity, mobility, dyspnea, perceived exertion, additional quality-of-life measures, blood-cell-derived inflammatory indices, adherence, and adverse events.

Eligibility Criteria

Inclusion Criteria: * • Age 18 years or older. * Documented history of pulmonary tuberculosis with anti-tuberculosis treatment completed according to national standards. * No clinical evidence of active or relapsed tuberculosis at enrollment; microbiological reassessment will be performed when clinically indicated. * Persistent respiratory symptoms, exercise limitation, or functional impairment considered attributable to post-tuberculosis lung disease. * Clinical stability for at least 4 weeks before randomization, with no acute respiratory infection or acute exacerbation requiring treatment change. * Ability to walk independently, with or without a usual assistive device, and to perform the study assessments. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * • Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation. * Acute respiratory infection or acute cardiopulmonary decompensation within 4 weeks before enrollment. * Unstable angina, recent myocardial infarction, uncontrolled arrhythmia, decompensated heart failure, severe uncontrolled hypertension, or another contraindication to exercise testing/training. * Severe neurological, musculoskeletal, or cognitive impairment that prevents safe participation or valid outcome assessment. * Current participation in another structured pulmonary rehabilitation or supervised exercise program. * Planned major surgery or another condition likely to prevent completion of the 20-week follow-up. * Any condition judged by the investigator to make participation unsafe or to substantially interfere with interpretation of the outcomes.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07709507). StuddyBuddy aggregates publicly available trial information.