Pulmonology · Medical Literature
Self-management digital intervention to promote physical activity in people living with chronic obstructive pulmonary disease: a pilot randomised controlled trial study protocol.
Abstract
Self-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. 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. 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. NCT07262229.
Clinical relevance
COPD self-management remains critically underdelivered: fewer than 2% of eligible patients participate in pulmonary rehabilitation (PR), and approximately 40% of those who do enroll fail to complete it—driven by dyspnoea, deconditioning, motivational deficits, and access barriers. This pilot RCT addresses the post-PR maintenance gap by evaluating a theory-based mobile health (mHealth) intervention (Respir'air BPCO) designed to sustain physical activity and self-management competencies after structured PR ends. Clinicians managing COPD in outpatient and pulmonary settings should follow this work closely, as scalable digital self-management tools could substantially extend the benefits of PR to a largely unreached patient population.
Key findings
1. PARTICIPATION GAP: Fewer than 2% of COPD patients access PR programmes, and ~40% who enroll do not complete them—establishing the clinical unmet need this trial targets. 2. STUDY DESIGN: Pilot RCT with n=20 COPD patients from a Swiss pulmonary centre, randomised 1:1 (stratified by GOLD stage) at PR completion to a mobile app-based self-management intervention (Respir'air BPCO) versus usual care alone. 3. FEASIBILITY ENDPOINTS: Primary methodological outcomes include recruitment duration, consent rate, retention rate, allocated group acceptance, and data completeness; intervention fidelity and technical problem frequency are also captured. 4. ACCEPTABILITY METRICS: App usage analytics and the validated Treatment Acceptability and Preferences (TAP) questionnaire will quantify patient acceptance of the digital format. 5. PRELIMINARY EFFICACY OUTCOMES: Daily step count (pedometer), COPD-specific self-care (SC-COPD Inventory), motivational regulation (BREQ-3), health-related quality of life (SGRQ and EQ-5D-5L), dyspnoea severity (mMRC), and exacerbation/hospitalisation rates will be assessed at T0 (post-PR), T1 (3 months), and T2 (6 months). 6. ANALYTICAL APPROACH: Intention-to-treat analyses using generalised linear mixed-effects models (GLMMs) with accommodation of missing data under standard assumptions; results will be reported as effect sizes with confidence intervals—no p-value thresholds for superiority are specified, consistent with the pilot/feasibility design. NOTE: No efficacy effect size data are yet available, as this is a published protocol.
Practice implications
Pulmonologists and respiratory nurses should recognise the post-PR maintenance window (0–6 months) as the highest-risk period for physical deconditioning relapse and consider theory-based mHealth tools as adjuncts for patients who have completed structured PR, particularly those with documented barriers to centre-based follow-up. Patient selection for such digital interventions should account for GOLD stage (used here as a stratification variable), baseline exercise tolerance, and digital literacy, and clinicians should proactively screen for technical access barriers before prescribing app-based self-management. Pending full RCT evidence, this pilot will provide critical feasibility, fidelity, and acceptability benchmarks that will inform the design, sample size, and intervention refinement of a definitive efficacy trial—making familiarity with its methodology essential for interpreting future results.