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.