Home-based telerehabilitation versus center-based pulmonary rehabilitation for COPD
Relative Effect of Home-based Telerehabilitation Compared to Center-based Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Controlled Non-inferiority Study
This trial will test whether home-based telerehabilitation works as well as center-based pulmonary rehabilitation for adults aged 45–80 with moderate to severe COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | ADIR Association Academic / other |
| Locations | 4 sites (Montivilliers and 3 other locations) |
| Trial ID | NCT07025382 on ClinicalTrials.gov |
What this trial studies
Adults referred for pulmonary rehabilitation who meet eligibility criteria are enrolled and assigned to either a home-based telerehabilitation program using telehealth technologies or a standard center-based pulmonary rehabilitation program. The programs deliver supervised exercise training and standard pulmonary rehab components, and patients complete baseline and post-program measures. The primary outcome is change in exercise endurance time before and after the rehabilitation program. The trial targets patients with GOLD stage II–IV COPD who are clinically stable and able to participate safely in exercise.
Who should consider this trial
Good fit: Ideal candidates are adults 45–80 years old with confirmed COPD (GOLD II–IV), clinically stable, referred for pulmonary rehabilitation, living at home with another adult present during sessions, and able to use the program materials and consent.
Not a fit: Patients with visual, cognitive, or hearing impairments that prevent safe use of telehealth, or with orthopedic, neurological, cardiovascular, or neuromuscular conditions that limit exercise, are unlikely to benefit from the telerehabilitation option.
Why it matters
Potential benefit: If successful, telerehabilitation could let more patients complete effective pulmonary rehabilitation at home, improving exercise endurance, symptoms, and access to care.
How similar studies have performed: Previous trials and reviews suggest telerehabilitation can be non-inferior to center-based pulmonary rehabilitation, though results have varied and some control-group outcomes were lower than in large meta-analyses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 45 and 80 years * Confirmed diagnosis of chronic obstructive pulmonary disease, GOLD stage II to IV * Stable condition (no exacerbation in the last month prior to participation) * Referred to a pulmonary rehabilitation program * With or without oxygen during exercise * No pulmonary rehabilitation program in the last 12 months prior to participation * Living at home with another adult present during exercise sessions * Affiliated with a health insurance system * Able to read and understand the information letter and sign the consent form Non-inclusion criteria: * Referred to pulmonary rehabilitation before lung cancer surgery * Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled within the next four months * Visual, cognitive, or auditory impairments incompatible with participation in a tele-pulmonary rehabilitation program * Orthopedic, neurological, cardiovascular, or neuromuscular conditions limiting exercise training on a cycle ergometer * Active cancer * Unable to provide informed consent * Under legal guardianship or curatorship * Pregnant or breastfeeding women Exclusion Criterion: * Withdrawal of consent
Where this trial is running
Montivilliers and 3 other locations
- Groupe Hospitalier du Havre — Montivilliers, France (Not_yet_recruiting)
- Centre Hospitalier des Pays de Morlaix — Morlaix, France (Not_yet_recruiting)
- Association ADIR — Rouen, France (Recruiting)
- Hôpital La Musse — Saint-Sébastien-de-Morsent, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Tristan Bonnevie, PhD — Association ADIR
- Study coordinator: Tristan Bonnevie, PhD
- Email: t.bonnevie@adir-hautenormandie.com
- Phone: 0235592970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.