Facility-based Pulmonary Rehabilitation Intervention Package (PRIP) for individuals with post-tuberculosis lung disease (PTLD) in Odisha, India: A quasi-experimental study protocol

Background

India bears the highest global burden of tuberculosis (TB), and despite microbiological cure, a substantial proportion of individuals develop post-tuberculosis lung disease (PTLD), leading to chronic respiratory impairment, reduced functional capacity, and long-term socioeconomic consequences. Although pulmonary rehabilitation (PR) improves exercise capacity and quality of life and is recommended under the National TB Elimination Programme (NTEP), its application remains nascent in routine service delivery, particularly in resource-constrained settings. The key challenge lies not in clinical efficacy, but in the lack of contextually adapted, health system-integrated delivery models. This study aims to evaluate a structured Pulmonary Rehabilitation Intervention Package (PRIP) within public-sector settings in India.

Methods

A pre-post quasi-experimental design with a non-randomized comparison group will be conducted over 12 months in two phases. Phase 1 involves adaptation of PRIP through desk review and stakeholder consultations. Phase 2 includes implementation across two districts in Odisha: Khurda (intervention, semi-urban) and Malkangiri (comparator, tribal, resource-limited), minimizing contamination and enabling contextual comparison. Participants with PTLD will receive a 12-week structured PR program including aerobic and strength training, airway clearance, and nutritional counselling. Primary outcome is functional capacity measured by the 6-minute walk test, with secondary outcomes including pulmonary function, dyspnea, symptom burden, quality of life, and healthcare utilization. Implementation outcomes will be assessed using the RE-AIM framework, alongside economic evaluation from health system and societal perspectives.

Discussion

This study is designed to evaluate the effectiveness, feasibility, and cost-effectiveness of a structured PRIP for individuals with PTLD within routine public-sector settings in India. Using a quasi-experimental design across two socio-demographically and geographically distinct districts, the study enables a context-sensitive assessment of both intervention outcomes and implementation processes under real-world conditions. By integrating clinical measures, implementation evaluation using the RE-AIM framework, and economic analysis, the study provides comprehensive evidence on scalability and sustainability. The findings will inform integration of PR into the NTEP, particularly in resource-constrained settings. Overall, this study addresses the gap between clinical efficacy and programmatic delivery, supporting a shift from treatment completion to long-term functional recovery and improved quality of life.

Plain language summary

Many people who recover from tuberculosis (TB) continue to experience breathing problems, tiredness, and difficulty carrying out everyday activities. This condition, known as post-tuberculosis lung disease (PTLD), can reduce quality of life long after TB treatment has ended. Although pulmonary rehabilitation a program of supervised exercise, breathing techniques, education, and nutritional support has been shown to improve health in people with chronic lung diseases, it is not routinely available for people with PTLD in India.

This study will evaluate a structured Pulmonary Rehabilitation Intervention Package (PRIP) delivered through government health facilities in Odisha, India. People with PTLD will participate in a 12-week rehabilitation program that includes exercise training, breathing exercises, airway clearance techniques, and nutritional counselling. Their progress will be compared with people receiving usual care in another district. The study will assess whether the program improves physical function, breathing, symptoms, quality of life, and healthcare use. It will also examine whether the program is practical, acceptable, and affordable for routine implementation in the public health system.