NCT07164742

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 690 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 clearance techniques. 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

• TB - Tuberculosis
• TB
• TB Infection

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2026-03-18
• Primary completion: 2028-09-15
• Completion: 2028-09-15
• First posted: 2025-09-10
• Last updated: 2026-03-27

Locations

2 sites across 1 country: India