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
This trial does not accept healthy volunteersQualifiers
• 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
Design model
Parallel
Treatments tested in this trial
Individualized Pulmonary Rehabilitation Program
BehavioralThe intervention consists of an 8-week individualized outpatient pulmonary rehabilitation program, delivered through three supervised sessions per week, with each session lasting approximately 60 minutes. Each session will include: 5-10 minutes of warm-up and mobility exercises; 20-30 minutes of individualized aerobic training, such as walking, treadmill exercise, or cycle ergometry; resistance exercises targeting the major upper- and lower-limb muscle groups; breathing exercises, including diaphragmatic breathing, pursed-lip breathing, and thoracic expansion exercises; airway-clearance techniques when clinically indicated; education regarding symptom monitoring, energy conservation, physical activity, treatment adherence, and healthy lifestyle; an individualized home exercise program on non-supervised days. Exercise intensity and progression will be individualized according to baseline functional capacity, symptoms, Borg CR10 score, heart rate, oxygen saturation, comorbidities, and
Standard Post-Tuberculosis Care
Other interventionStandard Post-Tuberculosis Care
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Individualized Pulmonary Rehabilitation Plus Standard CareExperimental treatment 2 interventions
Group B: Standard Post-Tuberculosis CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in EUROHIS-QOL-8 Total Score
Generic quality of life will be assessed using the EUROHIS-QOL-8 questionnaire. The questionnaire contains eight items scored from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating better quality of life. A positive change indicates improvement.
Time frame
Baseline, Week 8, and Week 20.2
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
Respiratory health-related quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ). The total score ranges from 0 to 100, with higher scores indicating greater impairment. The outcome will be calculated as the Week 20 score minus the baseline score. A negative change indicates an improvement in respiratory health-related quality of life.
Time frame
Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.Other outcomes
1
Change From Baseline in Six-Minute Walk Distance
Functional exercise capacity will be assessed using the 6-Minute Walk Test. The total distance walked in six minutes will be recorded in meters. A greater walking distance indicates better functional exercise capacity.
Time frame
Baseline, Week 8, and Week 202
Change From Baseline in Timed Up and Go Test Performance
Functional mobility will be assessed using the Timed Up and Go test. The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds. A shorter completion time indicates better functional mobility.
Time frame
Baseline, Week 8, and Week 20.3
Change From Baseline in Modified Medical Research Council Dyspnea Grade
Dyspnea during daily activities will be assessed using the modified Medical Research Council scale. Scores range from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. A reduction in score indicates improvement.
Time frame
Baseline, Week 8, and Week 20.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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