Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
| Registry | NCT07709507 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Filantropia Hospital (Other) |
| Conditions | Post-tuberculosis Lung Disease, Tuberculosis (TB) |
| Interventions | Individualized Pulmonary Rehabilitation Program, Standard Post-Tuberculosis Care (Behavioral, other) |
| Dates | start 2026-08-01 (estimated), primary completion 2026-11-15 (estimated), completion 2026-12-10 (estimated), first posted 2026-07-16, last updated 2026-07-16 |
Related Papers Related Patents Related Grants Related Experts
All trials for Post-tuberculosis Lung Disease All trials for Tuberculosis (TB) All trials of Individualized Pulmonary Rehabilitation Program All trials of Standard Post-Tuberculosis Care
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.
Persistent impairment after successfully treated pulmonary tuberculosis is increasingly recognized as an important source of chronic respiratory morbidity. Patients may experience dyspnea, exercise intolerance, fatigue, impaired mobility, and reduced health-related quality of life. Preliminary retrospective data from 37 patients suggested that structured pulmonary rehabilitation may improve the 6-minute walk distance, Timed Up and Go performance, dyspnea, perceived exertion, quality of life, and selected inflammatory indices. However, retrospective allocation and the absence of a longer follow-up limit causal interpretation.
The present study is designed as a prospective, assessor-blinded, parallel-group randomized controlled trial. It will assess both the immediate response to an individualized rehabilitation program and the maintenance of benefit three months after the supervised program has ended. The intervention combines aerobic training, resistance training, breathing exercises, education, and individualized symptom-management strategies. The control group will receive usual post-tuberculosis medical care and general physical-activity advice without a structured supervised pulmonary rehabilitation program during the study period.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Individualized Pulmonary Rehabilitation Plus Standard Care | Experimental | Behavioral: Individualized Pulmonary Rehabilitation Program; Other: Standard Post-Tuberculosis Care | Participants assigned to the experimental arm will receive an 8-week individualized pulmonary rehabilitation program in addition to standard post-tuberculosis medical care. The program will include three supervised sessions per week, each lasting approximately 60 minutes, consisting of aerobic training, resistance exercises, breathing exercises, education, symptom-management strategies, and an individualized home exercise program. Outcome assessments will be performed at baseline, immediately after the 8-week intervention, and three months after completion of the rehabilitation program. |
| Standard Post-Tuberculosis Care | Active comparator | Other: Standard Post-Tuberculosis Care | Participants assigned to the control arm will receive standard post-tuberculosis medical care, including routine clinical follow-up, management of respiratory symptoms and comorbidities, and general recommendations regarding physical activity. Participants in this arm will not receive a structured or supervised pulmonary rehabilitation program during the 20-week study period. Outcome assessments will be performed at baseline, at Week 8, and at Week 20. |
Sex: All, ages: 18 Years to any
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.