Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 8 week (short arm) Intervention - pulmonary rehabilitation, 24 week (long arm) Intervention - pulmonary rehabilitation.
- Who it may be relevant to
- Registry conditions: TB - Tuberculosis, TB, TB Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial
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.
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.
Interventions
- 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.
Primary outcome measures
- Six-Minute Walk Test (6MWT) distance (meters) [Time frame: 48 weeks post enrollment]
Secondary outcome measures (12)
- Six minute walk test (6MWT) distance (meters) [Time frame: 8,16 & 24 weeks post enrollment]
- Absolute percent change in Mean Six minute walk test (6MWT) distance [Time frame: 8,16, 24 & 48 weeks post enrollment]
- Proportion of Participants with change in Six minute walk test (6MWT) distance (meters) [Time frame: 8,16, 24 & 48 weeks post enrollment]
- St. George's Respiratory Questionnaire (SGRQ) score [Time frame: 8,16,24 & 48 weeks post enrollment]
- Absolute change in score for St. George's Respiratory Questionnaire (SGRQ) [Time frame: 8,16,24 & 48 weeks post enrollment]
- Percent change in score for St. George's Respiratory Questionnaire (SGRQ) [Time frame: 8,16,24 & 48 weeks post enrollment]
- Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ) [Time frame: 8,16,24 & 48 weeks post enrollment]
- Modified Medical Research Council (mMRC) Dyspnoea Scale [Time frame: 8,16,24 & 48 weeks post enrollment]
- Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale [Time frame: 8,16,24 & 48 weeks post enrollment]
- Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale [Time frame: 8,16,24 & 48 weeks post enrollment]
- Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale [Time frame: 8,16,24 & 48 weeks post enrollment]
- Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score [Time frame: 8,16,24 & 48 weeks post enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 2 centers
- Yenepoya (Deemed to be University — Mangalore
- Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center — Pune
Identifiers
NCT: NCT07164742 · IRB00412142 · 1R01AI169588-01A1