Health Condition 1: A157- Primary respiratory tuberculosis
Conditions
Interventions
Intervention1: Pulmonary Rehabilitation: Home based PR regime administered for 8 weeks short arm and 24 weeks duration extended PR arm
Control Intervention1: Standard of care: Standard of care arm no
Sponsors
US National Institutes of Health
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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 Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy Bronchodilators and/or corticosteroids inhaled or otherwise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6MWT Timepoint: Mean distance compared between study arms at 48 weeks after enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 Minute walk testTimepoint: Mean 6MWT distance compared between study arms at 8 16 and 24 weeks after enrollment Difference between study arms in the absolute and percent change in mean 6MWT distance at 8 16 24 and 48 weeks after enrollment Difference between study arms in the proportion of participants with an MCID change in the 6MWT distance by 8 16 24 and 48 weeks after enrollment ;Lung function FEV1 and FVC Timepoint: FEV1 and FVC volume compared between study arms at 24 and 48 weeks after enrollment. Difference between study arms in the absolute and percent change in FEV1 and FVC volumes by 8 16 24 and 48 weeks after enrollment Difference between study arms in the proportion of participants with an MCID change in FEV1 and/or FVC 8 16 24 and 48 weeks after enrollment ;SGRQ mMRC CRQ CAT scoresTimepoint: Total and sub-domain questionnaire scores compared between study arms at 8 16 24 48 weeks after enrollment Difference between study arms in the absolute and percent change in questionnaire scores 8 16 24 and 48 weeks after enrollment Difference between study arms in the proportion of participants with an MCID change in questionnaire scores 8 16 24 and 48 weeks after enrollment | — |
Countries
India
Contacts
Public ContactDr Vidya Mave
Symbiosis Medical College for Women
Outcome results
None listed