A clinical trial of pulmonary rehabilitation to improve lung health in TB.
- Conditions
- Health Condition 1: A157- Primary respiratory tuberculosis
- Registration Number
- CTRI/2023/08/056956
- Lead Sponsor
- S National Institutes of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease.Participants with just smear microscopy results will be enrolled provisionally to stay within the window of enrollment. Thereafter, if the culture results indicate drug resistance, the participant will be offered the opportunity to participate in follow-up visits, can continue with the intervention, but the data will not be considered in the final analysis.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6MWT <br/ ><br>Timepoint: <br/ ><br>Mean distance compared between study arms at 48 weeks after enrollment
- Secondary Outcome Measures
Name Time Method