NCT07025382 Telerehabilitation Versus Centre-based Pulmonary Rehabilitaztion for Patients With Chronic Obstructive Pulmonary Disease
| NCT ID | NCT07025382 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ADIR Association |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-08-14 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background and study aims: Chronic obstructive pulmonary disease is a leading cause of mortality worldwide. Pulmonary rehabilitation is recommended for patients to improve dyspnea, exercise capacity, and quality of life. Paradoxically, as few as 5 to 10% of eligible patients undergo pulmonary rehabilitation due to barriers such as transportation difficulties and limited availability of pulmonary rehabilitation centers. Home-based pulmonary rehabilitation using advanced telehealth technologies (telerehabilitation) may offer a solution to improve access. This study aims to compare the relative effectiveness of a home-based telerehabilitation program with center-based program. The primary objective is to assess changes in exercise endurance capacity, measured by endurance time, before and after participation of the rehabilitation program. Who can participate? Adults between 45 and 80 years old who are referred for pulmonary rehabilitation and have a confirmed diagnosis of chronic obstrucitve pulmonary disease (GOLD stage II to IV) at any of the participating centers are eligible to participate, whether or not they use oxygen during exercise. Participants must live at home with another adult who is present during exercise sessions. They must not have experienced any exacerbation in the month prior to study inclusion, nor have participated in a pulmonary rehabilitation program within the past year. Participants must not have any scheduled surgery within the next four months, including surgery for lung cancer resection. They must not have active cancer, and must not present any contraindication to exercise or any condition that would limit their ability to use the telerehabilitation system. Eligible participants must be beneficiaries of a social security system and must have read and understood the information letter and signed the informed consent form. What does the study involve? This is a multi-center, randomized controlled trial with two groups: Center-based rehabilitation group: Participants will attend 24 sessions over eight weeks (three sessions per week) at the center. The program includes an initial session of therapeutic education and exercise training, followed by 24 rehabilitation sessions, and a final assessment with educational reinforcement. Home-based rehabilitation group: Participants will have 24 sessions at home over the same period (eight weeks). The program includes an initial in-center assessment session, followed by 24 rehabilitation sessions and a final in-center session for assessment. They will be provided with equipment such as a cycle ergometer, pulse oximeter, physical activity tracker, and a tablet application (TELEREHAPP) to guide and monitor their home-based exercises. Regular phone contact with healthcare professionals will be maintained for support. All participants will undergo assessments before and after the program, including a constant work rate endurance test on a cycle ergometer to measure exercise endurance capacity. What are the possible benefits and risks of participating? Participants may experience improved physical fitness, which could lead to better dyspnea management and better quality of life. Risks may include muscle soreness, fatigue, or injury related to exercise, independently of group allocation. All exercise sessions will be supervised or monitored to minimize these risks. Participants will receive instructions on how to perform exercises safely and will be encouraged to report any adverse effects promptly.
Eligibility 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
Contact & Investigator
Tristan Bonnevie, PhD
PRINCIPAL INVESTIGATOR
Association ADIR
Frequently Asked Questions
Who can join the NCT07025382 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07025382 currently recruiting?
Yes, NCT07025382 is actively recruiting participants. Contact the research team at t.bonnevie@adir-hautenormandie.com for enrollment information.
Where is the NCT07025382 trial being conducted?
This trial is being conducted at Montivilliers, France, Morlaix, France, Rouen, France, Saint-Sébastien-de-Morsent, France.
Who is sponsoring the NCT07025382 clinical trial?
NCT07025382 is sponsored by ADIR Association. The principal investigator is Tristan Bonnevie, PhD at Association ADIR. The trial plans to enroll 90 participants.
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