About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pulmonary rehabilitation
Procedure/SurgeryIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in exercise capacity, measured by the Incremental Shuttle Walk Test (6ISWT)
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jose Antonio Dominguez Benitez
Lead sponsor
Fundació Institut Germans Trias i Pujol
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: