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

NCT07164742 | Recruiting

• 2 other identifiers: IRB004121421R01AI169588-01A1
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 2

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.

Conditions

TB - Tuberculosis; TB; TB Infection

Keywords

pulmonary tuberculosis; Pulmonary Rehabilitation; post-tuberculosis respiratory morbidity; Drug-sensitive TB

Outcome Measures

Primary Outcomes (1)

• Six-Minute Walk Test (6MWT) distance (meters)

  Mean distance compared between study arms

  48 weeks post enrollment

Secondary Outcomes (26)

• 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

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

  8,16,24 & 48 weeks post enrollment

Other Outcomes (1)

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

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

Study Arms (3)

Short Arm Intervention

EXPERIMENTAL

8 weeks (short arm) of a pulmonary rehabilitation (PR) program

Behavioral: 8 week (short arm) Intervention - pulmonary rehabilitation

Long Arm Intervention

EXPERIMENTAL

24 weeks (extended arm) of a pulmonary rehabilitation (PR) program

Behavioral: 24 week (long arm) Intervention - pulmonary rehabilitation

Standard of care

NO INTERVENTION

Standard TB treatment without specific pulmonary rehabilitation

Interventions

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.

Long Arm Intervention

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.

Short Arm Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Yenepoya (Deemed to be University

Mangalore, India

RECRUITING

Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center

Pune, India

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Akshay Gupte, PhD MBBS MSPH

  Boston University

  PRINCIPAL INVESTIGATOR

• Jonathan Golub, PhD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akshay Gupte, PhD MBBS MSPH

CONTACT

617-358-2454; agupte1@bu.edu

Jonathan Golub, PhD MPH

CONTACT

443-287-2969; jgolub@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)