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

Johns Hopkins University

Status: Begins enrollment this month

Conditions: TB - Tuberculosis; TB; TB Infection

Treatments: Behavioral: 8 week (short arm) Intervention - pulmonary rehabilitation; Behavioral: 24 week (long arm) Intervention - pulmonary rehabilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07164742

IRB00412142

1R01AI169588-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

1. To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity.
2. To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs.
3. To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.

Enrollment: 690 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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690 participants in 3 patient groups

Short Arm Intervention

Experimental group

Description:

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

Treatment:

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

Long Arm Intervention

Experimental group

Description:

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

Treatment:

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

Standard of care

No Intervention group

Description:

Standard TB treatment without specific pulmonary rehabilitation