NCT07164742RecruitingNot Applicable
Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial
Johns Hopkins University2 sites in 1 country690 target enrollmentStarted: March 18, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 690
- Locations
- 2
- Primary Endpoint
- Six-Minute Walk Test (6MWT) distance (meters)
Study Overview
Brief 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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of care
No Intervention
Standard TB treatment without specific pulmonary rehabilitation
Short Arm Intervention
Experimental
8 weeks (short arm) of a pulmonary rehabilitation (PR) program
Intervention: 8 week (short arm) Intervention - pulmonary rehabilitation (Behavioral)
Long Arm Intervention
Experimental
24 weeks (extended arm) of a pulmonary rehabilitation (PR) program
Intervention: 24 week (long arm) Intervention - pulmonary rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Six-Minute Walk Test (6MWT) distance (meters)
Time Frame: 48 weeks post enrollment
Mean distance compared between study arms
Secondary Outcomes
- FVC volume (mL) - Lung function(24 & 48 weeks post enrollment)
- Percent change in FVC volume (mL) - Lung function (FEV1 and FVC)(8,16, 24 & 48 weeks post enrollment)
- Absolute change in score for St. George's Respiratory Questionnaire (SGRQ)(8,16,24 & 48 weeks post enrollment)
- Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ)(8,16,24 & 48 weeks post enrollment)
- Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score(8,16,24 & 48 weeks post enrollment)
- Modified Medical Research Council (mMRC) Dyspnoea Scale(8,16,24 & 48 weeks post enrollment)
- Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale(8,16,24 & 48 weeks post enrollment)
- Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale(8,16,24 & 48 weeks post enrollment)
- Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score(8,16,24 & 48 weeks post enrollment)
- Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score(8,16,24 & 48 weeks post enrollment)
- Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore(8,16,24 & 48 weeks post enrollment)
- Absolute change in FEV1 volume (mL) - Lung function(8, 16, 24 & 48 weeks post enrollment)
- Percent change in FEV1 volume (mL) - Lung function(8, 16, 24 & 48 weeks post enrollment)
- Six minute walk test (6MWT) distance (meters)(8,16 & 24 weeks post enrollment)
- Absolute percent change in Mean Six minute walk test (6MWT) distance(8,16, 24 & 48 weeks post enrollment)
- Proportion of Participants with change in Six minute walk test (6MWT) distance (meters)(8,16, 24 & 48 weeks post enrollment)
- St. George's Respiratory Questionnaire (SGRQ) score(8,16,24 & 48 weeks post enrollment)
- Percent change in score for St. George's Respiratory Questionnaire (SGRQ)(8,16,24 & 48 weeks post enrollment)
- Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale(8,16,24 & 48 weeks post enrollment)
- COPD Assessment Test (CAT) score(8,16,24 & 48 weeks post enrollment)
- Absolute change in COPD Assessment Test (CAT) score(8,16,24 & 48 weeks post enrollment)
- Percent change in COPD Assessment Test (CAT) score(8,16,24 & 48 weeks post enrollment)
- Proportion of participants with a change in COPD Assessment Test (CAT) score(8,16,24 & 48 weeks post enrollment)
- FEV1 volume (mL) - Lung function(24 & 48 weeks post enrollment)
- Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function(8, 16, 24 & 48 weeks post enrollment)
- Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC)(8,16, 24 & 48 weeks post enrollment)
Investigators
Study Sites (2)
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