Self-management Digital Intervention to Promote Physical Activity in People Living With COPD (Respir'airBPCO)

Self-management Digital Intervention to Promote Physical Activity in People Living With Chronic Obstructive Pulmonary Disease: a Pilot Randomized Controlled Trial Study Protocol

The goal of this pilot randomized controlled trial 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 Chronic Obstructive Pulmonary Disease (COPD) after completion of a pulmonary rehabilitation program.

The main question it aims to answer is:

Is the Respir'air BPCO intervention (mobile app) feasible, acceptable, and preliminarily effective in increasing physical activity, enhancing self-management, improving motivation, and quality of life, while reducing dyspnea severity, exacerbations, and hospitalizations, compared with no additional intervention?

Researchers will compare an experimental group (receiving the Respir'air BPCO intervention + usual care) to a control group (no additional intervention, only usual care)

Participants will:

Be assigned either to the control group, receiving no additional intervention beyond usual care (traditional pulmonologist follow-up), or to the experimental group, receiving access to the Respir'air BPCO mobile app in addition to usual care.

• Complete baseline assessments immediately after finishing their in-person pulmonary rehabilitation program.
• Complete follow-up assessments at 3 months and 6 months after the start of the intervention

Study Overview

• Status: Active, not recruiting
• Conditions: Self-management; E-health; COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Behavioral: Respir'air BPCO

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Rolle, Switzerland
    • Pôle de pneumologie de l'Hôpital de Rolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. a GOLD COPD diagnosis stage 1 to 4, classification B or E;
2. admitted electively at Hospital for PR;
3. had completed the pulmonary rehabilitation program;
4. age over 18 years;
5. ability to provide informed consent;
6. internet access;
7. ownership of a smartphone or tablet;
8. self-assessed perceived ease of use of digital devices.

Exclusion Criteria:

1. clinical instability confirmed by the team of healthcare professionals;
2. severe cardiovascular disease confirmed by medical diagnosis;
3. recent history of neoplasia or autoimmune disease; other physical activity-limiting clinical condition confirmed by medical diagnosis (e.g. neurological disease);
4. other respiratory disease as primary diagnosis; e) inability to read, understand or speak French;

f) cognitive impairment diagnosed by the medical team.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Traditional pulmonologist follow-up, along with physiotherapy sessions
Experimental: Respir'air BPCO; Self-management digital intervention (Respir'air BPCO)	Behavioral: Respir'air BPCO; Self-management digital intervention (Respir'air BPCO) grounded in theory (Self-Care Theory of Chronic Illness, Self-Determination Theory of Human Motivation, and the Behavior Change Techniques taxonomy). The mobile application includes educational resources (text, video, images), examples of physical activities (walking, etc), environmental data (air quality), a personal activity log (daily steps), reminders and motivational messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial methodological feasibility indicator - Time required to complete recruitment		T0 - End of face-to-face PR program (Researchers expect to need 3 months to recruit 20 participants.)
Trial methodological feasibility indicator - Consent rate	Consent rate: proportion of eligible participants who sign the informed consent form	T0: Within 72 hours after completion of the face-to-face PR program
Trial methodological feasibility indicator - Retention rates	Retention rate: proportion of enrolled participants who remain in the study until the final assessment point	T -1: 1 week before completion of the face-to-face PR program (±72 hours)
Trial methodological feasibility indicator - Acceptance rate of the allocated group	Acceptance rate will be assessed using administrative study records. It will be defined as the proportion of enrolled participants who agree to participate in the group to which they were allocated (control or intervention) immediately after randomization.	T -1: 1 week before completion of the face-to-face PR program (±72 hours)
Trial methodological feasibility indicator - Proportion of missing data in the completed questionnaires/pedometer		T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Intervention feasibility indicator - Intervention fidelity	Exposure rate to all content available within the mobile application	T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Intervention feasibility indicators - Number of technical problems auto reported by the patient		T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Intervention feasibility indicator - Potential refinements after the completion of the pilot study	A digital logbook for researchers' use, to record any observations or comments (patients and/or researchers perspectives) regarding the intervention design, content and/or usage, with the aim of informing potential refinements after the completion of the pilot study	From the start of the intervention to study completion, assessed for up to 9 months.
Intervention acceptability indicators - App usage	Daily App Login Status	T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Intervention acceptability indicators - Intervention acceptance	French-adapted version of the Treatment Acceptance and Preference (TAP) questionnaire.Responses are scored on a five-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"), with higher scores reflecting greater acceptance.	T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary effectiveness measures - Main variable: number of daily steps	Yamax Power Walker EX-510 pedometer over 5 consecutive days	T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: Self-management	Self-Care in Chronic Obstructive Pulmonary Disease Inventory (SC-COPDI). Overall standardized scores ranges for each of the three subscales range from 0 to 100. Higher scores indicate higher levels of self-care in COPD patients.	T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: Motivational regulation of physical activity	French-version of the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3). The score is obtained by averaging responses on a Likert scale ranging from "not at all true" (0) to "very true" (4). Higher scores indicate higher levels of motivation corresponding to the factor being assessed.	T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: Health-related quality of life	French version of the disease-specific St George's Respiratory Questionnaire. Each item is assigned a weight based on the level of distress attributed to each symptom or condition described. Overall scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived suffering). A higher score means a poorer quality of life. French version of the EQ-5D-5L questionnaire. Each dimension is rated according to five levels of severity: from "no problem" (0) to "extreme problem" (4). EQ-5D-5L includes a visual analog scale (VAS) that allows participants to rate their general state of health on a scale from 0 to 100. Higher scores correspond to better health-related quality of life	T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: severity of dyspnea	French version of the mMRC Dyspnoea Scale. Uses a scale from 0 to 4. A score of 4 represents the highest severity of the dyspnea	T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: number of exacerbations	Self-reported data	T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Preliminary effectiveness measures - secondary variable: number of hospitalizations	Self-reported data	T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Collaborators and Investigators

• Sponsor: Institut et Haute Ecole de la Santé la Source
• Investigators: Principal Investigator: Ricardo Salgado, MSc, Institut et Haute Ecole de la Santé la Source

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: COPD; self-management; eHealth; digital intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Respir'air BPCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in publications, including demographic characteristics, outcome measures, and study variables necessary to reproduce the analyses, will be made available upon reasonable request to the Principal Investigator.

Given the relatively small sample size and the detailed clinical information collected in this single-centre study, full anonymization in the legal sense (i.e., irreversible de-identification with no reasonable means of re-identification) may not be achievable for all variables. A disclosure risk assessment will therefore be conducted once data collection is complete, to determine an appropriate level of data granularity. Depending on the outcome of this assessment, high-risk quasi-identifiers (e.g., precise age, detailed geographic or clinical subgroup information) may be generalized, aggregated, or withheld, and data will be shared through a secure transfer platform.

• IPD Sharing Time Frame: Data and supporting documents will be made available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter. Recipients will be required to securely destroy all shared at the end of the approved project.

IPD Sharing Access Criteria

Access will be granted to qualified researchers whose proposed use of the data has been approved following review by the Principal Investigator (or, in the event of the PI's unavailability, a designated institutional data steward) and is consistent with the participants' informed consent, the original ethical approval, and applicable Swiss and, where relevant, other data protection regulations.

Requests must include a methodologically sound research proposal and will be evaluated for consistency with the scope of participant consent. Data will be shared as de-identified datasets after execution of a Data Sharing Agreement (DSA). The DSA will require the recipient to: (a) not attempt to re-identify participants; (b) not redistribute the data to third parties; (c) store and process the data under specified security standards; and (d) destroy the data at the end of the agreed period.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No