Overview
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.
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
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- To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity.
- To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs.
- To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.
Eligibility
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.
