Pulmonary rehabilitation to reduce post-tuberculosis lung problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: agupte1@bu.edu
• Phone: 617-358-2454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.