Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
NCT ID: NCT07164742
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
690 participants
INTERVENTIONAL
2026-02-15
2028-09-15
Brief Summary
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Detailed Description
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Objectives:
1. To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity.
2. To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs.
3. To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short Arm Intervention
8 weeks (short arm) of a pulmonary rehabilitation (PR) program
8 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.
Long Arm Intervention
24 weeks (extended arm) of a pulmonary rehabilitation (PR) program
24 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.
Standard of care
Standard TB treatment without specific pulmonary rehabilitation
No interventions assigned to this group
Interventions
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8 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.
24 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Akshay Gupte, PhD MBBS MSPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Jonathan Golub, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Central Contacts
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Other Identifiers
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IRB00412142
Identifier Type: -
Identifier Source: org_study_id
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