Status:
NOT_YET_RECRUITING
Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
TB - Tuberculosis
TB
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
8 weeks (short arm) or 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT07164742
Start Date
January 15 2026
End Date
September 15 2028
Last Update
December 11 2025
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