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

NCT ID: NCT07262229

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

Traditional pulmonologist follow-up, along with physiotherapy sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Respir'air BPCO

Self-management digital intervention (Respir'air BPCO)

Group Type: EXPERIMENTAL

Respir'air BPCO

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut et Haute Ecole de la Santé la Source

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Salgado

Senior Lecturer UAS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo Salgado, MSc

Role: PRINCIPAL_INVESTIGATOR

Institut et Haute Ecole de la Santé la Source

Locations

Pôle de pneumologie de l'Hôpital de Rolle

Rolle, , Switzerland

Countries

Switzerland

Central Contacts

Ricardo Salgado, MSc

Role: CONTACT

r.salgado@ecolelasource.ch

0041215564334

Philippe Delmas, PhD

Role: CONTACT

p.delmas@ecolelasource.ch

Facility Contacts

Marie Chatillon

Role: primary

marie.chatillon-ouvrard@ghol.ch

0041218221143

Other Identifiers

Respir'air BPCO

Identifier Type: -

Identifier Source: org_study_id