# TB PuRe : Pulmonary rehabilitation to reduce post-tuberculosis morbidity

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2024 · $587,913

## Abstract

ABSTRACT
The overarching goal of the Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PuRe) project
is to measure the effectiveness, feasibility, and cost-effectiveness of a pulmonary rehabilitation (PR) program to
prevent post-tuberculosis (TB) respiratory morbidity in India. TB is associated with lung impairment which can
persist despite successful completion of TB treatment. There are an estimated 155 million TB survivors globally,
yet there are no routinely implemented interventions for addressing post-TB respiratory morbidity. PR is a key
component of the management plan for chronic lung diseases and is an effective intervention to improve patient-
centered outcomes. However, the clinical benefit of PR, administered during TB treatment, in preventing post-
TB respiratory morbidity has not been investigated. Furthermore, despite the long natural history of TB disease
and its disproportionate impact in resource limited settings, the feasibility of a home-based PR program for TB
patients is unclear. Therefore, the aims of TB PuRe are: a) to measure the comparative-effectiveness of two
home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity; b) to
describe the intersection between clinic-level service organization, coach intervention delivery fidelity, and client
behavioral action for these two PR programs; c) to compare the costs, cost-effectiveness, and budget impact of
the two different PR strategies implemented as a routine program. To achieve these aims, 690 adult drug-
sensitive pulmonary TB patients with functional impairment at TB treatment initiation will be enrolled at three
geographically and epidemiologically diverse study sites in India. Participants will be randomized in 1:1:1 ratio
into one of the following three study arms: a) 2 months of home-based PR during TB treatment (short PR arm);
b) 2 months of home-based PR during TB treatment followed by 4 additional months of home-based PR for
participants with persistent functional impairment despite 2 months of PR (extended PR arm); c) standard TB
treatment without specific PR (standard-of-care arm). The primary outcome will be the 6-minute walk test
distance compared between short and extended PR arms, and the standard-of-care arm at 12 months after
randomization. We will assess the PR interventions' acceptability to inform adoption of the PR strategies in a
programmatic setting by using the Theoretical Framework for Acceptability. Furthermore, we will empirically
assess societal costs of the two PR programs at the patient-level, factoring the resource-use in the process of
development of programmatic infrastructure, implementation, service delivery, and patient costs. Cost-
effectiveness of the two programs will be assessed based on Health-related Quality of Life (HrQOL) outcomes
assessment. Our study, if significant, will generate the strongest evidence to date to support routine
implementation of a systematic PR pro...

## Key facts

- **NIH application ID:** 10915401
- **Project number:** 5R01AI169588-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** JONATHAN E. GOLUB
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $587,913
- **Award type:** 5
- **Project period:** 2023-09-01 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10915401

## Citation

> US National Institutes of Health, RePORTER application 10915401, TB PuRe : Pulmonary rehabilitation to reduce post-tuberculosis morbidity (5R01AI169588-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10915401. Licensed CC0.

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