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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT07709507
- Acronym / sponsor ID
- UMFCV-PTLD-2026-001
- Conditions
- Post-tuberculosis Lung Disease, Tuberculosis (TB)
- Keywords
- pulmonary rehabilitation, dyspnea, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Filantropia HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Pulmonary Rehabilitation Plus Standard Care | Experimental | Behavioral: Individualized Pulmonary Rehabilitation Program, Other: Standard Post-Tuberculosis CareParticipants 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 CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Age 18 years or older.
Key exclusion criteria (7 listed)
- • Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Pulmonary Rehabilitation ProgramThe 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 | Behavioural | Individualized Pulmonary Rehabilitation Plus Standard Care |
| Standard Post-Tuberculosis CareStandard Post-Tuberculosis Care | Other | Individualized Pulmonary Rehabilitation Plus Standard Care, Standard Post-Tuberculosis Care |
Primary outcome
Change From Baseline in EUROHIS-QOL-8 Total Score
Time frame: Baseline, Week 8, and Week 20.
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.
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
Time frame: Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Post-tuberculosis Lung Disease
Recruiting
Effectiveness of Chat-based Mobile Application for Consultation (Zalo) in Improving Compliance With Follow-up Tests After Abnormal Chest X-ray Findings Interpret by Artificial Intelligent
Lung Cancer, Tuberculosis (TB)
Not yet recruiting
Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease
Post Tuberculosis
RecruitingObservational study
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
TB - Tuberculosis, HIV/AIDS
Recruiting
Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
TB - Tuberculosis, TB
Recruiting
Paediatric Post-TB Pulmonary Rehab Study
Tuberculosis in Children, Chronic Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAGDALENA-RODICA TRAISTARU, Professor, PhD (+40723766778, rodica.traistaru@umfcv.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in EUROHIS-QOL-8 Total Score (time frame: Baseline, Week 8, and Week 20.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.