COPD (Chronic Obstructive Pulmonary Disease)Respir'airBPCONCT07262229
Self-management Digital Intervention to Promote Physical Activity in People Living With COPD
A study testing Respir'air BPCO in people with COPD (Chronic Obstructive Pulmonary Disease) and Self-management, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Self-management, E-health
- What is being tested?
- Respir'air BPCO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- cognitive impairment diagnosed by the medical team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Being tested
- Respir'air BPCO
- Keywords
- self-management, COPD, eHealth, digital intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respir'air BPCOBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Traditional pulmonologist follow-up, along with physiotherapy sessions |
| Respir'air BPCO | Experimental | Self-management digital intervention (Respir'air BPCO) Receives: Behavioral: Respir'air BPCO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial methodological feasibility indicator - Time required to complete recruitment
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the start of the intervention to study completion, assessed for up to 9 months.
Intervention acceptability indicators - App usage
Daily App Login Status
Measured: 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.
Measured: 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
Yamax Power Walker EX-510 pedometer over 5 consecutive days
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start22 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut et Haute Ecole de la Santé la Source
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Salgado, Institut et Haute Ecole de la Santé la Source
- Investigators
- Ricardo Salgado, MSc, Principal investigator, Institut et Haute Ecole de la Santé la Source
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262229
- Sponsor's protocol ID
- Respir'air BPCO
- Acronym
- Respir'airBPCO
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Salgado R, Amiguet M, Costa P, Delmas P, Padilha JM. Self-management digital intervention to promote physical activity in people living with chronic obstructive pulmonary disease: a pilot randomised controlled trial study protocol. BMJ Open. 2026 Jul 24;16(7):e116719. doi: 10.1136/bmjopen-2026-116719.
PubMed 42498466
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management Digital Intervention to Promote Physical Activity in People Living With Chronic Obstructive Pulmonary Disease: a Pilot Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT07262229
- Acronym / sponsor ID
- Respir'airBPCO / Respir'air BPCO
- Keywords
- self-management, COPD, eHealth, digital intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institut et Haute Ecole de la Santé la SourceUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Traditional pulmonologist follow-up, along with physiotherapy sessions |
| Respir'air BPCO | Experimental | Behavioral: Respir'air BPCOSelf-management digital intervention (Respir'air BPCO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
- cognitive impairment diagnosed by the medical team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respir'air BPCOSelf-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. | Behavioural | Respir'air BPCO |
Primary outcome
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.)
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
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
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.
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)
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
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)
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
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
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 42498466Salgado R, Amiguet M, Costa P, Delmas P, Padilha JM. Self-management digital intervention to promote physical activity in people living with chronic obstructive pulmonary disease: a pilot randomised controlled trial study protocol. BMJ Open. 2026 Jul 24;16(7):e116719. doi: 10.1136/bmjopen-2026-116719.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Salgado, MSc principal investigator
Institut et Haute Ecole de la Santé la Source
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respir'air BPCO in people with COPD (Chronic Obstructive Pulmonary Disease) and Self-management, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.