TB - TuberculosisTB PureNCT07164742
Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
A study testing 8 week (short arm) Intervention - pulmonary rehabilitation and 24 week (long arm) Intervention - pulmonary rehabilitation in people with TB - Tuberculosis and TB, run by Johns Hopkins University at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TB - Tuberculosis, TB, TB Infection
- What is being tested?
- 8 week (short arm) Intervention - pulmonary rehabilitation and 24 week (long arm) Intervention - pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 2 sitesIndia
- Study dates
- 18 Mar 2026to 15 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Yenepoya (Deemed to be University
Mangalore
Poonam R Naik, MD, +91-7259346643, drpoonamnaik@gmail.com
- Recruiting
Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center
Pune
Meenaksh Bhakare, MD, +91-9096555775, meenakshi.bhakare@smcw.siu.edu.in
About this study
Official title: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial
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.
Read the 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.
- Conditions
- TB - Tuberculosis, TB, TB Infection
- Being tested
- 8 week (short arm) Intervention - pulmonary rehabilitation, 24 week (long arm) Intervention - pulmonary rehabilitation
- Keywords
- pulmonary tuberculosis, Pulmonary Rehabilitation, post-tuberculosis respiratory morbidity, Drug-sensitive TB
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 week (short arm) Intervention - pulmonary rehabilitationBehavioural
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.
24 week (long arm) Intervention - pulmonary rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Short Arm Intervention | Experimental | 8 weeks (short arm) of a pulmonary rehabilitation (PR) program Receives: Behavioral: 8 week (short arm) Intervention - pulmonary rehabilitation |
| Long Arm Intervention | Experimental | 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program Receives: Behavioral: 24 week (long arm) Intervention - pulmonary rehabilitation |
| Standard of care | No intervention | Standard TB treatment without specific pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT) distance (meters)
Mean distance compared between study arms
Measured: 48 weeks post enrollment
Secondary outcomes (26)
Six minute walk test (6MWT) distance (meters)
Mean 6MWT distance compared between study arms at 8,16 \& 24 weeks after enrollment.
Measured: 8,16 & 24 weeks post enrollment
Absolute percent change in Mean Six minute walk test (6MWT) distance
Difference between study arms in the absolute and percent change in mean 6MWT distance
Measured: 8,16, 24 & 48 weeks post enrollment
Proportion of Participants with change in Six minute walk test (6MWT) distance (meters)
Difference between study arms in the proportion of participants with an Minimal Clinically Important Difference (MCID) change in the 6MWT distance
Measured: 8,16, 24 & 48 weeks post enrollment
St. George's Respiratory Questionnaire (SGRQ) score
The questionnaire measures respiratory health quality of life in three areas with a total score ranging from 0-100. A higher score indicates poorer health status.
Measured: 8,16,24 & 48 weeks post enrollment
Absolute change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the absolute change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Percent change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the percent change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Modified Medical Research Council (mMRC) Dyspnoea Scale
The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.
Measured: 8,16,24 & 48 weeks post enrollment
Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the absolute change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the percent change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
The CRQ assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total score ranges from 5 - 35. Lower scores indicate higher severity of dyspnea.
Measured: 8,16,24 & 48 weeks post enrollment
Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Difference between study arms in the absolute change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Difference between study arms in the percent change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
COPD Assessment Test (CAT) score
CAT total score range is from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.
Measured: 8,16,24 & 48 weeks post enrollment
Absolute change in COPD Assessment Test (CAT) score
Difference between study arms in the absolute change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
Percent change in COPD Assessment Test (CAT) score
Difference between study arms in the percent change in questionnaire scores 8,16, 24 \& 48 weeks after enrollment.
Measured: 8,16,24 & 48 weeks post enrollment
Proportion of participants with a change in COPD Assessment Test (CAT) score
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Measured: 8,16,24 & 48 weeks post enrollment
FEV1 volume (mL) - Lung function
FEV1 volume (mL) compared between study arms at 24 \& 48 weeks after enrollment.
Measured: 24 & 48 weeks post enrollment
Absolute change in FEV1 volume (mL) - Lung function
Difference between study arms in the absolute change in FEV1 volume
Measured: 8, 16, 24 & 48 weeks post enrollment
Percent change in FEV1 volume (mL) - Lung function
Difference between study arms in the percent change in FEV1 volume by 8,16, 24 \& 48 weeks after enrollment.
Measured: 8, 16, 24 & 48 weeks post enrollment
Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function
Difference between study arms in the proportion of participants with a MCID change in FEV1 and/or FVC
Measured: 8, 16, 24 & 48 weeks post enrollment
FVC volume (mL) - Lung function
FVC volume (mL) compared between study arms
Measured: 24 & 48 weeks post enrollment
Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC)
Difference between study arms in the absolute change in FVC volume
Measured: 8,16, 24 & 48 weeks post enrollment
Percent change in FVC volume (mL) - Lung function (FEV1 and FVC)
Difference between study arms in the percent change in FVC volumes
Measured: 8,16, 24 & 48 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start18 Mar 2026
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akshay Gupte, PhD MBBS MSPH, Principal investigator, Boston UniversityJonathan Golub, PhD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164742
- Sponsor's protocol ID
- IRB00412142
- Other IDs
- 1R01AI169588-01A1
- Acronym
- TB Pure
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No