Pulmonary rehabilitation to reduce post-tuberculosis lung problems

Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial

This trial tests whether an 8-week or 24-week home-based pulmonary rehabilitation program given during treatment can prevent long-term lung problems in adults with drug-sensitive pulmonary tuberculosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 690 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 2 sites (Mangalore and 1 other locations)
• Trial ID: NCT07164742 on ClinicalTrials.gov

What this trial studies

Adults with microbiologically confirmed pulmonary TB who are within two weeks of starting treatment are randomized 1:1:1 to an 8-week pulmonary rehabilitation program, a 24-week program, or standard care. The home-based rehabilitation includes exercise training, counseling and education, and airway clearance techniques delivered alongside routine TB care. Investigators will measure respiratory morbidity over follow-up and compare clinical outcomes, implementation fidelity, and costs between the two PR strategies and standard care. The trial also analyzes clinic-level delivery factors and budget impact to inform programmatic rollout.

Who should consider this trial

Good fit: Adults (≥18 years) with microbiologically confirmed drug-sensitive pulmonary TB who have started treatment within the past two weeks, receive care at a participating site, can complete study visits for 48 weeks, and have access to a smartphone are ideal candidates.

Not a fit: Patients with multi- or extensively drug-resistant TB, extrapulmonary TB without pulmonary involvement, TB meningitis or spinal TB, symptomatic cardiovascular disease, inability to participate in rehabilitation (eg, recent fractures, pregnancy), or those on bronchodilators/corticosteroids are unlikely to benefit from these PR programs.

Why it matters

Potential benefit: If successful, the intervention could reduce chronic breathlessness and improve long-term lung function and quality of life after TB.

How similar studies have performed: Pulmonary rehabilitation is well established for chronic lung diseases and small studies suggest benefit after TB, but randomized evidence for home-based PR initiated during TB treatment is limited.

Eligibility criteria

Inclusion Criteria:

* Age at least 18 years
* Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\*
* Not completed more than 2 weeks of TB treatment
* Receiving TB care at the outpatient clinics at the TB PuRe study sites
* Willingness to complete 48 weeks of study evaluations.
* Access to a smartphone.

Exclusion Criteria:

* Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise)
* Multi or extensively drug-resistant TB disease\*
* Extrapulmonary TB disease at any clinical sites without pulmonary involvement
* TB meningitis or TB of the spine
* Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure.
* Karnofsky Score \< 40 points
* Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy
* Bronchodilators and/or corticosteroids inhaled or otherwise.

Where this trial is running

Mangalore and 1 other locations

• Yenepoya (Deemed to be University — Mangalore, India (RECRUITING)
• Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center — Pune, India (RECRUITING)

Study contacts

• Principal investigator: Akshay Gupte, PhD MBBS MSPH — Boston University
• Study coordinator: Akshay Gupte, PhD MBBS MSPH

Conditions: TB - Tuberculosis, TB, TB Infection, pulmonary tuberculosis, Pulmonary Rehabilitation, post-tuberculosis respiratory morbidity, Drug-sensitive TB