Self-management digital intervention to promote physical activity in people living with chronic obstructive pulmonary disease: a pilot randomised controlled trial study protocol.

introductionSelf-management is a key component of effective chronic obstructive pulmonary disease (COPD) management and is mainly promoted through pulmonary rehabilitation (PR) programmes. However, less than 2% of patients participate in PR programmes. Among those who do, approximately 40% fail to complete the programme. The reasons for this are multifactorial and include dyspnoea, reduced exercise tolerance, lack of motivation and inadequate transportation and infrastructure to access PR centres. In this context, self-management digital health interventions emerge as a promising approach to support the development of self-management competencies, contribute to changing and maintaining behaviours and prevent a downward spiral of deconditioning in this population. The aim of this study is to evaluate the feasibility, acceptability and preliminary effects of a theory-based self-management digital intervention (Respir'air BPCO) designed to promote physical activity in patients with COPD. METHODS AND ANALYSIS: This pilot randomised controlled trial will enrol 20 patients with COPD who are being followed at a Swiss pulmonary centre. Participants will be randomised using Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage stratification (1:1) at the end of the in-person PR programme into either an experimental group receiving a mobile app-based self-management intervention aimed at promoting physical activity or a control group receiving only usual care. Data will be collected at three time points: immediately after completion of the PR programme (T0), 3 months post-PR (T1) and 6 months post-PR (T2). The study will assess trial methodological feasibility, including recruitment duration, consent rate, retention rate, acceptance of the allocated group and data completeness. Intervention feasibility will be evaluated through intervention fidelity, the number and type of technical problems reported by patients, and patients' and/or researchers' observations regarding the intervention design, content and use to inform future refinements. Intervention acceptability will be assessed using mobile app usage data and the Treatment Acceptability and Preferences questionnaire. In addition, preliminary effects will be evaluated through daily step count (pedometer), self-management (Self-Care in Chronic Obstructive Pulmonary Disease Inventory), motivational regulation of physical activity (Behavioural Regulation in Exercise Questionnaire-3), quality of life (St. George's Respiratory Questionnaire and EuroQol 5-Dimensions-5 Levels), severity of dyspnea (Modified Medical Research Council Dyspnea Scale) and the number of exacerbations and hospitalisations. Analyses will include descriptive statistics and estimation-based comparative analyses using generalised linear mixed-effects models under the intention-to-treat principle, which accommodate missing data under standard assumptions, with reporting of effect sizes and CIs. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Commission of the Canton of Vaud (registration no.: 2025-01697). Results will be published in international peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT07262229.