Digital Self-Management Intervention to Promote Physical Activity in People Living with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Pilot Study
Résumé de l'étude
Self-management is a key component in the treatment of chronic obstructive pulmonary disease (COPD) and is often encouraged within pulmonary rehabilitation (PR) programs. However, less than 2% of patients participate, and among them, about 40% do not complete the program. The reasons are numerous: shortness of breath, low exercise tolerance, lack of motivation, or difficulties with transportation and access to PR centers. In this context, digital self-management interventions appear to be a promising solution to prevent the progressive deconditioning of individuals with COPD. This study aims to evaluate the feasibility, acceptability, and initial effects of Respir’air COPD, a digital self-management intervention based on a mobile application designed to encourage physical activity. Fifty patients followed at a pulmonary center in Switzerland will be recruited. At the end of their in-person PR program, they will be randomly assigned to two groups: 1) an experimental group using the Respir’air application; and 2) a control group without additional intervention. Data will be collected at three time points: immediately after PR (T0), three months later (T1), and six months later (T2). We will observe: 1) feasibility; 2) acceptability; and 3) preliminary effects (daily step count, self-management capacity, motivation, quality of life, severity of dyspnea, number of exacerbations and hospitalizations). The results will be analyzed using appropriate statistical methods, taking into account missing data and reporting effect sizes and their confidence intervals.
(BASEC)
Intervention étudiée
The studied intervention (Respir’air COPD) consists of using a mobile self-management application aimed at promoting physical activity in patients with COPD. It will be offered as a complement (at the end) of the existing in-person pulmonary rehabilitation (PR) program at the Rolle Hospital. Technically, this intervention will rely on the pre-existing mobile application Breathment® (compatible with iOS and Android), developed by the German company Breathment GmbH. The content developed for this specific intervention is based on the theory of self-care for chronic diseases (Riegel et al., 2019), the theory of self-determination of human motivation (Ryan & Deci, 2017), and the taxonomy of behavioral change techniques (Michie et al., 2015). It also incorporates findings from a literature review, an Umbrella Review (Salgado et al., 2025), and focus groups conducted with healthcare professionals and patients prior to this phase. The mobile application, which will be presented to the teams at the Rolle Hospital before the launch of the pilot study, will include several distinct elements. Tab 1: presented in the form of texts, videos, and/or images, it will include seven modules covering the following topics: overview of COPD; risk factors; diagnosis and management strategies; principles of disease self-management; importance of physical activity; practical ways to integrate physical activity into daily life (e.g., activity suggestions like walking, goal setting); and safety considerations when engaging in physical activity. Tab 2: will provide real-time information on local air quality. Tab 3: will allow tracking and visualizing the history of physical activity. To promote regularity, engagement, and motivation, the application will include several features: a step counter with the ability to set and adjust personalized goals; motivational messages and encouraging feedback.
(BASEC)
Maladie en cours d'investigation
COPD
(BASEC)
a) a diagnosis of COPD according to GOLD classification, stage 1 to 4, category B or E; b) scheduled admission to the Rolle Hospital for a pulmonary rehabilitation program; c) completion of the 3-week pulmonary rehabilitation program; d) age over 18 years; e) ability to provide informed consent; f) access to the Internet; g) possession of a smartphone or tablet; and h) self-reported perception of ease of use of digital devices. (BASEC)
Critères d'exclusion
a) clinical instability confirmed by the healthcare team; b) severe cardiovascular disease confirmed by medical diagnosis; c) recent history of neoplasia or autoimmune disease; other clinical conditions limiting physical activity confirmed by medical diagnosis (e.g., neurological disease); d) another respiratory disease as the primary diagnosis; e) inability to read, understand, or speak French; and f) presence of cognitive disorders diagnosed by the medical team. (BASEC)
Lieu de l’étude
Autre
(BASEC)
Rolle
(BASEC)
Sponsor
Philippe Delmas Institut et Haute École de la Santé La Source Av Vinet 30 - Site de Beaulieu 1004 Lausanne
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Ricardo Salgado
0215564334
r.salgado@clutterecolelasource.chInstitut et Haute École de la Santé La source
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
22.12.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Intervention digitale d’autogestion pour promouvoir l’activité physique chez les personnes vivant avec une bronchopneumopathie chronique obstructive (BPCO) : une étude pilote randomisée contrôlée (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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