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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial
- ClinicalTrials.gov ID
- NCT07164742
- Acronym / sponsor ID
- TB Pure / IRB00412142
- Conditions
- TB - Tuberculosis, TB, TB Infection
- Keywords
- pulmonary tuberculosis, Pulmonary Rehabilitation, post-tuberculosis respiratory morbidity, Drug-sensitive TB
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Short Arm Intervention | Experimental | Behavioral: 8 week (short arm) Intervention - pulmonary rehabilitation8 weeks (short arm) of a pulmonary rehabilitation (PR) program |
| Long Arm Intervention | Experimental | Behavioral: 24 week (long arm) Intervention - pulmonary rehabilitation24 weeks (extended arm) of a pulmonary rehabilitation (PR) program |
| Standard of care | No intervention | –Standard TB treatment without specific pulmonary rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8 week (short arm) Intervention - pulmonary rehabilitation8 weeks (short arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques. | Behavioural | Short Arm Intervention |
| 24 week (long arm) Intervention - pulmonary rehabilitation24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques. | Behavioural | Long Arm Intervention |
Primary outcome
Six-Minute Walk Test (6MWT) distance (meters)
Time frame: 48 weeks post enrollment
Mean distance compared between study arms
26 secondary outcomes
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
Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore
Time frame: 8,16,24 & 48 weeks post enrollment
COPD Assessment Test (CAT) score
Time frame: 8,16,24 & 48 weeks post enrollment
Absolute change in COPD Assessment Test (CAT) score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent change in COPD Assessment Test (CAT) score
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with a change in COPD Assessment Test (CAT) score
Time frame: 8,16,24 & 48 weeks post enrollment
FEV1 volume (mL) - Lung function
Time frame: 24 & 48 weeks post enrollment
Absolute change in FEV1 volume (mL) - Lung function
Time frame: 8, 16, 24 & 48 weeks post enrollment
Percent change in FEV1 volume (mL) - Lung function
Time frame: 8, 16, 24 & 48 weeks post enrollment
Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function
Time frame: 8, 16, 24 & 48 weeks post enrollment
FVC volume (mL) - Lung function
Time frame: 24 & 48 weeks post enrollment
Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC)
Time frame: 8,16, 24 & 48 weeks post enrollment
Percent change in FVC volume (mL) - Lung function (FEV1 and FVC)
Time frame: 8,16, 24 & 48 weeks post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for TB - Tuberculosis
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akshay Gupte, PhD MBBS MSPH principal investigator
Boston University
Jonathan Golub, PhD MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akshay Gupte, PhD MBBS MSPH (617-358-2454, agupte1@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) distance (meters) (time frame: 48 weeks post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.