Rehabilitation and airway clearance technique education in nontuberculous mycobacterial pulmonary disease: protocol for the NTM-Rehab study

Abstract

BACKGROUND: Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic, often progressive, respiratory infection with an increasing global incidence that is frequently accompanied by bronchiectasis. Although antimicrobial therapy is the cornerstone of treatment, culture conversion is often incomplete, and structural lung disease persists; therefore, pulmonary rehabilitation (PR) and airway clearance techniques (ACTs) have been advocated as adjuncts. However, prospective cohort evidence of these measures in patients with NTM-PD is lacking. METHODS: NTM-Rehab is a single-center, prospective, observational cohort study conducted at Seoul National University Bundang Hospital, Republic of Korea. Adults (≥20 years) with NTM-PD diagnosed according to the 2020 ATS/ERS/ESCMID/IDSA criteria are enrolled in a pragmatic 8-week PR and ACT education program delivered as five biweekly sessions comprising ACT education, individually tailored aerobic and resistance exercise, and reassessment. Assessments (spirometry, sputum microbiology, chest imaging, patient-reported outcomes, and physical performance testing) are performed at baseline, week 8, and month 6, with data collected through an electronic case report form. The co-primary outcomes are the change in forced expiratory volume in 1 s and forced vital capacity, sputum culture conversion rate, and six-minute walk distance; secondary outcomes are disease-specific and generic health-related quality of life. The analyses will characterize longitudinal changes and their determinants. CONCLUSION: NTM-Rehab will provide the first prospectively collected clinical data on structured PR and ACT education in NTM-PD and inform evidence-based, non-pharmacological management of this chronic respiratory disease. This study was approved by the Institutional Review Board of Seoul National University Bundang Hospital (B-2501-949-303) and registered at ClinicalTrials.gov (NCT06838442).