Efficacy Evaluation of Digital-Based Respiratory Healthcare Program (Digital Lung-Conduction Exercise) for Patients and High-risk Groups with Chronic Obstructive Pulmonary Disease: A Study Protocol for Randomized, Assessor-blind, Parallel Clinical Tr

Objective: The purpose of this study is to evaluate the efficacy of a digital-based respiratory healthcare program (lung-conduction exercise, LCE) as respiratory rehabilitation for patients and high-risk groups with chronic obstructive pulmonary disease (COPD).Methods: This study is a protocol for a randomized, assessor-blind, parallel clinical trial. A total of 45 participants diagnosed with, or at high risk for, COPD will be recruited and randomly allocated to three groups (digital LCE, conventional LCE, and control group) in a 1:1:1 allocation ratio. The digital LCE group will perform digital LCE using a mobile application, electronic breathing sensor mask, and smart watch once daily, 5 days per week, for 8 weeks. The conventional LCE group will perform LCE without digital devices, and the control group will receive no intervention. The primary outcome measure is the change in chest expansion from baseline to visit 4. Secondary outcome measures include the Breathlessness, Cough, and Sputum Scale (BCSS), short-term effects on chest expansion, pulmonary function test, maximum inspiratory pressure, maximum expiratory pressure, 6-minute walk test, modified Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and St. George’s Respiratory Questionnaire (SGRQ).Conclusion: This study will demonstrate the efficacy of digital LCE for patients and high-risk groups with COPD. The results of this study will provide clinical evidence for digital LCE in patients with chronic respiratory diseases who need respiratory rehabilitation.