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RecruitingNot ApplicableNCT07164742

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

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

Sponsor

Johns Hopkins University

Enrollment

690 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

TB - TuberculosisTBTB Infection

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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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Interventions

BEHAVIORAL8 week (short arm) Intervention - pulmonary rehabilitation

8 weeks (short arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

BEHAVIORAL24 week (long arm) Intervention - pulmonary rehabilitation

24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

Locations(2)

Yenepoya (Deemed to be University

Mangalore, India

Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center

Pune, India

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NCT07164742

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