Effect of music-guided breathing training combined with singing on pulmonary rehabilitation in COPD patients: a randomized controlled trial protocol.

BACKGROUND: Pulmonary rehabilitation (PR) is effective for improving symptoms and functional status in patients with chronic obstructive pulmonary disease (COPD), particularly respiratory training. However, its effectiveness is often compromised by poor adherence. Music therapy has increasingly being applied to COPD PR, due to its safety, low cost, and potential to motivate and enhance participation. Therefore, an integrated intervention combining music-guided breathing training and singing may represent a more appealing alternative rehabilitation strategy. This study protocol aims to evaluate whether this music-based integrated intervention is non-inferior to conventional PR therapy in terms of functional mobility, adherence and other patient-centered outcomes will be assessed as secondary or exploratory outcomes. METHODS: This is a multicenter, double-arm, parallel-group, randomized controlled non-inferiority trial. We plan to recruit 76 patients with stable moderate-to-severe COPD, and randomize them in a 1:1 ratio to either the Music Therapy group (MTG) or the Conventional Pulmonary Rehabilitation group (CPRG). The MTG will receive music-guided breathing exercises and singing; the CPRG will receive non-music-guided breathing exercises and aerobic exercise. Both groups undergo interventions at a frequency of 60 min per session, 3 times per week, for 6 weeks. The primary outcome is the between-group difference in change in the 6-min walk distance (6MWD) from baseline to week 6, assessed under a non-inferiority framework. Key secondary outcomes include dyspnea severity, respiratory health status, pulmonary function, and adherence-related measures. Exploratory outcomes include arterial blood gas parameters, Traditional Chinese Medicine (TCM) syndrome assessment, patient satisfaction, safety, and the number of acute exacerbations of COPD (AECOPD) during the 1-year post-intervention follow-up. This trial protocol has been approved by the ethics committees of all participating centers. DISCUSSION: This study aims to evaluate whether an integrated rehabilitation intervention of music-guided breathing training and singing is non-inferior to conventional PR in terms of functional outcomes for patients with COPD. Secondary outcomes, including adherence, feasibility, and patient-reported measures, will be assessed as secondary or exploratory outcomes and interpreted cautiously. The findings may help inform the development of alternative rehabilitation strategies for this population. CLINICAL TRIAL REGISTRATION: https://itmctr.ccebtcm.org.cn, identifier ITMCTR2026000211.