Telerehabilitation Versus Centre-based Pulmonary Rehabilitaztion for Patients With Chronic Obstructive Pulmonary Disease

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

OTHER

Home-based pulmonary rehabilitation

An eight-week (three sessions per week) telerehabilitation home-based program, including: Twenty-four PR sessions (approximately 1 hour 45 minutes each), including a 15-minute warm-up period, endurance training on a cycle ergometer, muscle strengthening exercises, balance exercises, as well as therapeutic patient education sessions tailored to the patient's needs based on the initial assessment. Training is adjusted according to patient tolerance and healthcare professional recommendations. Participants will receive a cycle ergometer, pulse oximeter, activity tracker, and a tablet application (TELEREHAPP) for guidance throughout the program, remote monitoring, and communication. Home-based sessions include: * Endurance training on the cycle ergometer (15 to 45 minutes per session). * Strength training and balance exercises (30 minutes per session). * Physical activity coaching, including a daily step goal.

OTHER

Center-based pulmonary rehabilitation

An eight-week (three sessions per week) center-based pulmonary rehabilitation program, including: Twenty-four center-based PR sessions (approximately 1 hour 45 minutes each), including a 15-minute warm-up period, endurance training on a cycle ergometer, muscle strengthening exercises, balance exercises, as well as therapeutic patient education sessions tailored to the patient's needs based on the initial assessment. Training is adjusted according to patient tolerance and healthcare professional recommendations.

Sponsors & Collaborators

• Région Normandie

  collaborator OTHER_GOV

• Département de la Seine Maritime

  collaborator UNKNOWN

• European Union

  collaborator OTHER

• Centre Hospitalier des Pays de Morlaix

  collaborator OTHER

• Hopital La Musse

  collaborator OTHER

• Groupe Hospitalier du Havre

  collaborator OTHER

• Groupe Havrais d'Aide aux Handicapés Respiratoires

  collaborator UNKNOWN

• Union des Kinésithérapeutes et des Rééducateurs

  collaborator UNKNOWN

• ADIR Association

  lead OTHER

Principal Investigators

• Tristan Bonnevie, PhD · Association ADIR

• Francis-Edouard Gravier, PhD · Association ADIR

• Antoine Cuvelier, Prof · Association ADIR

• Jean-François Muir, Prof · Association ADIR

• Marc Beaumont, PhD · Centre Hospitalier des Pays de Morlaix

• Guillaume Prieur, PhD · Groupe Hospitalier du Havre - Service de kinésithérapie

• Yann Combret, PhD · Groupe Hospitalier du Havre - Service de kinésithérapie

• Héloïse Baillet, PhD · Hôpital La Musse

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-14

Primary Completion

2028-09-30

Completion

2030-12-31

Countries

• France

Study Locations