Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFilantropia Hospital
About this trial
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
Qualifiers
• 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.
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- Individualized Pulmonary Rehabilitation Program
- Standard Post-Tuberculosis Care
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov