Post-tuberculosis Lung DiseaseNCT07709507
Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease
A study testing Individualized Pulmonary Rehabilitation Program and Standard Post-Tuberculosis Care in people with Post-tuberculosis Lung Disease and Tuberculosis (TB), run by Filantropia Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-tuberculosis Lung Disease, Tuberculosis (TB)
- What is being tested?
- Individualized Pulmonary Rehabilitation Program and Standard Post-Tuberculosis Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 10 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
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.
Read the detailed description
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.
- Conditions
- Post-tuberculosis Lung Disease, Tuberculosis (TB)
- Being tested
- Individualized Pulmonary Rehabilitation Program, Standard Post-Tuberculosis Care
- Keywords
- pulmonary rehabilitation, dyspnea, quality of life
- Medical subject headings
- Tuberculosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Pulmonary Rehabilitation ProgramBehavioural
The 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 CareOther
Standard Post-Tuberculosis Care
| Study group | Role | What they receive |
|---|---|---|
| Individualized Pulmonary Rehabilitation Plus Standard Care | Experimental | 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. Receives: Behavioral: Individualized Pulmonary Rehabilitation Program; Other: Standard Post-Tuberculosis Care |
| Standard Post-Tuberculosis Care | Active comparator | 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. Receives: Other: Standard Post-Tuberculosis Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, and Week 20.
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.
Measured: Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-tuberculosis Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Design: prospective, single-center, parallel-group randomized controlled trial. * Allocation ratio: 1:1. * Masking: single-blind outcome assessment; open-label treatment delivery. * Participant duration: approximately 20 weeks. * Assessment points: T0 = baseline; T1 = Week 8, immediately after the supervised program; T2 = Week 20, three months after program completion. * Study setting: Rehabilitation Clinic in Filantropia Hospital, Craiova.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filantropia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Kamal, Filantropia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709507
- Sponsor's protocol ID
- UMFCV-PTLD-2026-001
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No