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NCT Number: NCT07164742

Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)

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.

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Key information

Conditions

TB - Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections TB TB Infection Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yenepoya (Deemed to be University, Mangalore, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

8 week (short arm) Intervention - pulmonary rehabilitation

Behavioral

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 rehabilitation

Behavioral

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 outcomes

  1. Six-Minute Walk Test (6MWT) distance (meters)

    Time frame: 48 weeks post enrollment

    Mean distance compared between study arms

Secondary outcomes

  1. Six minute walk test (6MWT) distance (meters)

    Time frame: 8,16 & 24 weeks post enrollment

    Mean 6MWT distance compared between study arms at 8,16 & 24 weeks after enrollment.

  2. Absolute percent change in Mean Six minute walk test (6MWT) distance

    Time frame: 8,16, 24 & 48 weeks post enrollment

    Difference between study arms in the absolute and percent change in mean 6MWT distance

  3. Proportion of Participants with change in Six minute walk test (6MWT) distance (meters)

    Time frame: 8,16, 24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with an Minimal Clinically Important Difference (MCID) change in the 6MWT distance

  4. St. George's Respiratory Questionnaire (SGRQ) score

    Time frame: 8,16,24 & 48 weeks post enrollment

    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.

  5. Absolute change in score for St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in questionnaire score

  6. Percent change in score for St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the percent change in questionnaire score

  7. Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with an MCID change in questionnaire score

  8. Modified Medical Research Council (mMRC) Dyspnoea Scale

    Time frame: 8,16,24 & 48 weeks post enrollment

    The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

  9. Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in questionnaire score

  10. Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the percent change in questionnaire score

  11. Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with an MCID change in questionnaire score

  12. Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score

    Time frame: 8,16,24 & 48 weeks post enrollment

    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.

  13. Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in questionnaire score

  14. Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the percent change in questionnaire score

  15. Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with an MCID change in questionnaire score

  16. COPD Assessment Test (CAT) score

    Time frame: 8,16,24 & 48 weeks post enrollment

    CAT total score range is from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.

  17. Absolute change in COPD Assessment Test (CAT) score

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in questionnaire score

  18. Percent change in COPD Assessment Test (CAT) score

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the percent change in questionnaire scores 8,16, 24 & 48 weeks after enrollment.

  19. Proportion of participants with a change in COPD Assessment Test (CAT) score

    Time frame: 8,16,24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with an MCID change in questionnaire score

  20. FEV1 volume (mL) - Lung function

    Time frame: 24 & 48 weeks post enrollment

    FEV1 volume (mL) compared between study arms at 24 & 48 weeks after enrollment.

  21. Absolute change in FEV1 volume (mL) - Lung function

    Time frame: 8, 16, 24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in FEV1 volume

  22. Percent change in FEV1 volume (mL) - Lung function

    Time frame: 8, 16, 24 & 48 weeks post enrollment

    Difference between study arms in the percent change in FEV1 volume by 8,16, 24 & 48 weeks after enrollment.

  23. Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function

    Time frame: 8, 16, 24 & 48 weeks post enrollment

    Difference between study arms in the proportion of participants with a MCID change in FEV1 and/or FVC

  24. FVC volume (mL) - Lung function

    Time frame: 24 & 48 weeks post enrollment

    FVC volume (mL) compared between study arms

  25. Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC)

    Time frame: 8,16, 24 & 48 weeks post enrollment

    Difference between study arms in the absolute change in FVC volume

  26. Percent change in FVC volume (mL) - Lung function (FEV1 and FVC)

    Time frame: 8,16, 24 & 48 weeks post enrollment

    Difference between study arms in the percent change in FVC volumes

Other outcomes

  1. Proportion of participants experiencing unfavorable treatment outcomes (Exploratory Outcome Measure)

    Time frame: 4, 8,12, 16, 20, 24, & 48 weeks post enrollment

    Arm comparisons of the proportion of participants experiencing any unfavorable TB treatment outcome of failure, recurrence, or death

Study contacts

Contact information is provided by the study sponsor or research team.

Akshay Gupte, PhD MBBS MSPH

CONTACT

[email protected]

617-358-2454

Jonathan Golub, PhD MPH

CONTACT

[email protected]

443-287-2969

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial

Acronym: TB Pure

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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