Self-management Digital Intervention to Promote Physical Activity in People Living With COPD

NCT07262229 | Active Not Recruiting DMC

• 1 other identifier: Respir'air BPCO
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Self-management; E-health

Keywords

self-management; COPD; eHealth; digital intervention

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• Preliminary effectiveness measures - Main variable: number of daily steps

  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

  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

  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

  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

  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)

Study Arms (2)

Usual Care

NO INTERVENTION

Traditional pulmonologist follow-up, along with physiotherapy sessions

Respir'air BPCO

EXPERIMENTAL

Self-management digital intervention (Respir'air BPCO)

Behavioral: Respir'air BPCO

Interventions

Respir'air BPCO BEHAVIORAL

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.

Respir'air BPCO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut et Haute Ecole de la Santé la Source: lead

Study Sites (1)

Pôle de pneumologie de l'Hôpital de Rolle

Rolle, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Salgado, MSc

  Institut et Haute Ecole de la Santé la Source

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer UAS

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

CH (1)