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Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT07164742 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.

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📋 Eligibility rules (as published)
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.
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What it tests

  • 8 week (short arm) Intervention - pulmonary rehabilitation
  • 24 week (long arm) Intervention - pulmonary rehabilitation
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Where

2 sites
Yenepoya (Deemed to be University
Mangalore, India
Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center
Pune, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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