Post TuberculosisAFTER-TBNCT07731009
Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease
A study testing Pulmonary rehabilitation in people with Post Tuberculosis, run by Jose Antonio Dominguez Benitez.
Trial summary
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment. One of the most important of these complications is post-tuberculosis lung disease (PTLD), which can cause persistent breathing problems, reduced physical… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Post Tuberculosis
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2031
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Criteria aplicable to all participants:
- Ability and willingness to provide written informed consent (or assent with parental/legal guardian consent for minors).
- Willingness and ability to comply with study procedures and scheduled visits.
- Willingness and ability to participate in a pulmonary rehabilitation programme, including: supervised exercise, respiratory physiotherapy, health education and psychosocial support.
- Enrolment at one of the participating study sites.
- COHORT 1: People with pulmonary tuberculosis
Show all 18Show fewer
- Diagnosis of pulmonary TB confirmed by bacteriological methods (genotypic or phenotypic assays).
- Drug-susceptible or drug-resistant TB are both eligible.
- Initiation of anti-TB treatment within ≤14 days prior to enrolment.
- Identified through passive, active or intensified case finding strategies, including healthcare facilities, contact tracing, or community screening.
- COHORT 2: People with PTLD
- History of bacteriologically confirmed pulmonary TB and completion of anti-TB treatment.
- No evidence of active TB disease at the time of enrolment.
- Enrolment must occur within 6 months after completion of TB treatment, or at study entry if the participant already has a previously established diagnosis of PTLD.
- Presence of post-tuberculosis lung disease (PTLD), defined as abnormalities in at least two of the following domains:
- _Impaired lung function_
- _Persistent respiratory symptoms (e.g., cough, dyspnoea)_
- _Structural abnormalities on chest imaging_
Who cannot join
- Diagnosis with extrapulmonary TB without pulmonary TB.
- Anti-TB treatment initiated more than 14 days before study enrolment.
- Pregnant women or those with suspected pregnancy will be excluded from the study, since chest X-rays are contraindicated to avoid any potential adverse effect on foetal development.
- Participants who are unable or unwilling to give their written informed consent to participate in the study or whose parents/legal guardians are unable or unwilling to provide consent for paediatric participants.
- Participants aged <5 or >65 years old due to age-related biological response impairments that can bias the analyses.
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: Advancing Prevention, Treatment, and Pulmonary Rehabilitation of Post-Tuberculosis Lung Disease Via Approaches That Reveal Mechanisms and Identify Diagnostic, Progression, and Treatment-Response Markers
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment. One of the most important of these complications is post-tuberculosis lung disease (PTLD), which can cause persistent breathing problems, reduced physical capacity, and poor quality of life. Despite its high burden, PTLD is still poorly understood, and effective strategies for prevention, early detection, and long-term management are limited.
The AFTER-TB study aims to address these gaps by combining long-term follow-up of people with TB with the evaluation of pulmonary rehabilitation (PR) strategies for those who develop PTLD. The study includes three groups: people with active TB who are followed over time, people with established PTLD, and healthy individuals without TB to provide basal values. By following people from the start of TB treatment, the study will identify who develops PTLD and which clinical, biological, and imaging factors contribute to lung damage or recovery. In addition, the study will collect detailed information on symptoms, lung function, imaging, and biological samples over time. Advanced laboratory techniques will be used to identify biomarkers linked to disease progression or protection, as well as bacterial genetic factors that may influence long-term lung outcomes. This information will help improve early diagnosis and risk stratification. AFTER-TB study will also implement a comprehensive pulmonary rehabilitation programme that includes exercise training, respiratory physiotherapy, education for healthy habits, and psychosocial support. The impact of rehabilitation on physical capacity, lung function, and quality of life will be assessed over time. Overall, the AFTER-TB study combines clinical follow-up, biological research, and pulmonary rehabilitation to generate new knowledge that can improve the prevention and management of PTLD, ultimately supporting better long-term health and quality of life for TB survivors.
- Conditions
- Post Tuberculosis
- Being tested
- Pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
In the AFTER-TB study, PR is conceived as a multicomponent intervention structured around three integrated pillars: (i) pulmonary physiotherapy and training exercise; (ii) education for healthy habits, focused on information, education and counselling/communication (IEC) strategy; and (iii) psychosocial support.
| Study group | Role | What they receive |
|---|---|---|
| Hospital/Tele-pulmonary rehabilitation | Active comparator | Not described Receives: Procedure: Pulmonary rehabilitation |
| Community-based pulmonary rehabilitation | Active comparator | Not described Receives: Procedure: Pulmonary rehabilitation |
| Early Pulmonary Rehabilitation Intervention (EPRI) | Active comparator | Not described Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise capacity, measured by the Incremental Shuttle Walk Test (6ISWT)
Measured: Baseline, month 3 (end of the PR programme) and at 6- and 12-month follow-up
Change in health-related Quality of Life (QoL) questionnaire: WHOQOL-BREF adults, PedsQL 4.0 in children and complemented by an age-adapted SGRQ in adolescents.
Measured: From baseline to month 12 of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post TuberculosisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, uncontrolled, multi-arm parallel-group, interventional study
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Antonio Dominguez Benitez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Antonio Dominguez Benitez, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731009
- Sponsor's protocol ID
- RB-26-035
- Acronym
- AFTER-TB
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Prevention, Treatment, and Pulmonary Rehabilitation of Post-Tuberculosis Lung Disease Via Approaches That Reveal Mechanisms and Identify Diagnostic, Progression, and Treatment-Response Markers
- ClinicalTrials.gov ID
- NCT07731009
- Acronym / sponsor ID
- AFTER-TB / RB-26-035
- Conditions
- Post Tuberculosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Jose Antonio Dominguez BenitezUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 28 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.
Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment. One of the most important of these complications is post-tuberculosis lung disease (PTLD), which can cause persistent breathing problems, reduced physical capacity, and poor quality of life. Despite its high burden, PTLD is still poorly understood, and effective strategies for prevention, early detection, and long-term management are limited.
The AFTER-TB study aims to address these gaps by combining long-term follow-up of people with TB with the evaluation of pulmonary rehabilitation (PR) strategies for those who develop PTLD. The study includes three groups: people with active TB who are followed over time, people with established PTLD, and healthy individuals without TB to provide basal values. By following people from the start of TB treatment, the study will identify who develops PTLD and which clinical, biological, and imaging factors contribute to lung damage or recovery. In addition, the study will collect detailed information on symptoms, lung function, imaging, and biological samples over time. Advanced laboratory techniques will be used to identify biomarkers linked to disease progression or protection, as well as bacterial genetic factors that may influence long-term lung outcomes. This information will help improve early diagnosis and risk stratification. AFTER-TB study will also implement a comprehensive pulmonary rehabilitation programme that includes exercise training, respiratory physiotherapy, education for healthy habits, and psychosocial support. The impact of rehabilitation on physical capacity, lung function, and quality of life will be assessed over time. Overall, the AFTER-TB study combines clinical follow-up, biological research, and pulmonary rehabilitation to generate new knowledge that can improve the prevention and management of PTLD, ultimately supporting better long-term health and quality of life for TB survivors.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, uncontrolled, multi-arm parallel-group, interventional study
| Arm | Type | Receives |
|---|---|---|
| Hospital/Tele-pulmonary rehabilitation | Active comparator | Procedure: Pulmonary rehabilitation |
| Community-based pulmonary rehabilitation | Active comparator | Procedure: Pulmonary rehabilitation |
| Early Pulmonary Rehabilitation Intervention (EPRI) | Active comparator | Procedure: Pulmonary rehabilitation |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Criteria aplicable to all participants:
- Ability and willingness to provide written informed consent (or assent with parental/legal guardian consent for minors).
- Willingness and ability to comply with study procedures and scheduled visits.
- Willingness and ability to participate in a pulmonary rehabilitation programme, including: supervised exercise, respiratory physiotherapy, health education and psychosocial support.
- Enrolment at one of the participating study sites.
Key exclusion criteria (5 listed)
- Diagnosis with extrapulmonary TB without pulmonary TB.
- Anti-TB treatment initiated more than 14 days before study enrolment.
- Pregnant women or those with suspected pregnancy will be excluded from the study, since chest X-rays are contraindicated to avoid any potential adverse effect on foetal development.
- Participants who are unable or unwilling to give their written informed consent to participate in the study or whose parents/legal guardians are unable or unwilling to provide consent for paediatric participants.
- Participants aged <5 or >65 years old due to age-related biological response impairments that can bias the analyses.
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 |
|---|---|---|
| Pulmonary rehabilitationIn the AFTER-TB study, PR is conceived as a multicomponent intervention structured around three integrated pillars: (i) pulmonary physiotherapy and training exercise; (ii) education for healthy habits, focused on information, education and counselling/communication (IEC) strategy; and (iii) psychosocial support. | Procedure or surgery | Community-based pulmonary rehabilitation, Early Pulmonary Rehabilitation Intervention (EPRI), Hospital/Tele-pulmonary rehabilitation |
Primary outcome
Change in exercise capacity, measured by the Incremental Shuttle Walk Test (6ISWT)
Time frame: Baseline, month 3 (end of the PR programme) and at 6- and 12-month follow-up
Change in health-related Quality of Life (QoL) questionnaire: WHOQOL-BREF adults, PedsQL 4.0 in children and complemented by an age-adapted SGRQ in adolescents.
Time frame: From baseline to month 12 of follow-up.
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 28 Jul 2026.
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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 Pulmonary rehabilitation in people with Post Tuberculosis, run by Jose Antonio Dominguez Benitez.
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 18 inclusion and 5 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 28 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 Jose Dominguez (+34 935 54 30 50 ext. 6500, jadominguez@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise capacity, measured by the Incremental Shuttle Walk Test (6ISWT) (time frame: Baseline, month 3 (end of the PR programme) and at 6- and 12-month follow-up). 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 28 Jul 2026.