Design Paper: The Short- and Long-term Effects of Inspiratory Muscle Training in Patients with Idiopathic Pulmonary Fibrosis—A Multicenter Randomized Controlled Trial (the Breathe IPF Trial)

Abstract

Introduction: Pulmonary rehabilitation is beneficial for patients with idiopathic pulmonary fibrosis (IPF) but is often limited by poor adherence. Inspiratory muscle training (IMT) may represent a more feasible, home-based alternative. This trial aims to evaluate the short- (8-week) and long-term (56-week) effects of IMT using the POWERbreathe Medic Plus in patients with IPF. Methods: This multicenter, open-label, parallel-group, randomized controlled trial will assess the efficacy and safety of device-based IMT. Eligible participants (aged 40-85 years) with stable IPF and modified Medical Research Council dyspnea grades 1-3 will be randomly assigned (1:1) to an IMT group or a control group receiving usual care. The primary endpoint is the change in the St. George’s Respiratory Questionnaire activity domain score from baseline to week 8. Secondary endpoints include pulmonary function, exercise capacity, dyspnea, and quality of life over 56 weeks. Results: This trial will clarify the short- and long-term effects of IMT, as well as its safety, in patients with IPF. Conclusions: This study is the first to evaluate both the short- and long-term effects of IMT on quality of life in IPF. Protocol Registration: The Japan Registry of Clinical Trials (jRCT1042250003).