Digital gamification-based pursed lip breathing exercises driven by Behaviour Change Wheel in patients with COPD: a feasibility trial protocol using pre-post study design.

introductionEffective chronic obstructive pulmonary disease (COPD) interventions require intensive and repetitive exercises, yet their monotonous nature can reduce adherence. Innovative rehabilitation devices that are safe, user-friendly, engaging and cost-effective are crucial. This study introduces a digital gamification-based approach to pursed lip breathing (PLB) exercises, guided by the Behaviour Change Wheel (BCW) framework. The digital platform transforms traditional PLB into an interactive and enjoyable experience, enhancing motivation and adherence. Using a pre-post study design, this feasibility trial aims to assess the safety, feasibility and acceptability of the digital gamification PLB intervention protocol driven by the BCW framework installed on WeChat (DT-PLB) for home-based COPD management. METHODS AND ANALYSIS: The methodology of this study is divided into two phases. Phase 1 refers to the development of the DT-PLB system based on research evidence, behavioural analysis from the insight of the BCW and stakeholders' perspectives, and phase 2 points to present the pre-post trial design for the DT-PLB system consisting of five smartphone-based software interface modules: Ranking, Report, Daily PLB Tasks, Social Community and Mine. Eligible patients with COPD will be recruited from a university hospital in Sichuan Province, Mainland China. The DT-PLB will be conducted in non-hospital settings for patients with COPD for 10 min per session, three times a day on a daily basis for 8 weeks. Data collection will be conducted at two time points: baseline and post-intervention.Demographic data (eg, age, gender and marital status) will be collected only at baseline. The primary outcome measures in this study will be a series of feasibility outcomes involving participant recruitment and completion of the DT-PLB intervention. Additionally, several clinical outcomes in terms of the effects of the DT-PLB intervention on dyspnoea, exercise capability, quality of life, and pulmonary function index will be evaluated as secondary outcomes. ETHICS AND DISSEMINATION: This study has received Manchester Metropolitan University ethical approval (REC reference 56631) and the Affiliated Hospital of Southwest Medical University ethical approval (REC reference KY2023105). The findings from DT-PLB will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, DT-PLB will be directly applied to the Affiliated Hospital of Southwest Medical University to manage PLB exercises. TRIAL REGISTRATION NUMBER: NCT06063733.