Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07262229

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes E-health Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Self-management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle de pneumologie de l'Hôpital de Rolle

Rolle, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Trial methodological feasibility indicator - Time required to complete recruitment

    Time frame: T0 - End of face-to-face PR program (Researchers expect to need 3 months to recruit 20 participants.)

  2. Trial methodological feasibility indicator - Consent rate

    Time frame: T0: Within 72 hours after completion of the face-to-face PR program

    Consent rate: proportion of eligible participants who sign the informed consent form

  3. Trial methodological feasibility indicator - Retention rates

    Time frame: T -1: 1 week before completion of the face-to-face PR program (±72 hours)

    Retention rate: proportion of enrolled participants who remain in the study until the final assessment point

  4. Trial methodological feasibility indicator - Acceptance rate of the allocated group

    Time frame: T -1: 1 week before completion of the face-to-face PR program (±72 hours)

    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.

  5. Trial methodological feasibility indicator - Proportion of missing data in the completed questionnaires/pedometer

    Time frame: 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)

  6. Intervention feasibility indicator - Intervention fidelity

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

    Exposure rate to all content available within the mobile application

  7. Intervention feasibility indicators - Number of technical problems auto reported by the patient

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

  8. Intervention feasibility indicator - Potential refinements after the completion of the pilot study

    Time frame: From the start of the intervention to study completion, assessed for up to 9 months.

    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

  9. Intervention acceptability indicators - App usage

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

    Daily App Login Status

  10. Intervention acceptability indicators - Intervention acceptance

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

    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.

Secondary outcomes

  1. Preliminary effectiveness measures - Main variable: number of daily steps

    Time frame: 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)

    Yamax Power Walker EX-510 pedometer over 5 consecutive days

  2. Preliminary effectiveness measures - secondary variable: Self-management

    Time frame: 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)

    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.

  3. Preliminary effectiveness measures - secondary variable: Motivational regulation of physical activity

    Time frame: 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)

    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.

  4. Preliminary effectiveness measures - secondary variable: Health-related quality of life

    Time frame: 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)

    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

  5. Preliminary effectiveness measures - secondary variable: severity of dyspnea

    Time frame: 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)

    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

  6. Preliminary effectiveness measures - secondary variable: number of exacerbations

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

    Self-reported data

  7. Preliminary effectiveness measures - secondary variable: number of hospitalizations

    Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

    Self-reported data

Sponsors and collaborators

Lead sponsor

Institut et Haute Ecole de la Santé la Source

Other

Registry information

Official study title

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

Acronym: Respir'airBPCO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.