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

NCT07025382 | Recruiting

• 1 other identifier: TELEREHA-COPD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Telerehabilitation; Pulmonary rehabilitation; Center-based exercise training; Home-based exercise training; Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Endurance time

  Endurance time will be assessed during a constant work rate endurance test (75% of peak power output) on a cycle ergometer before and after the prehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 105 seconds.

  2 months

Secondary Outcomes (51)

• Endurance time

  One year

• Peak oxygen uptake

  2 months

• Peak power output

  2 months

• Functional capacity

  2 months

• Functional capacity

  One year

Study Arms (2)

Home-based pulmonary rehabilitation

EXPERIMENTAL

24 home-based pulmonary rehabilitation sessions

Other: Home-based pulmonary rehabilitation

Center-based pulmonary rehabilitation

ACTIVE COMPARATOR

24 center-based pulmonary rehabilitation sessions

Other: Center-based pulmonary rehabilitation

Interventions

Home-based pulmonary rehabilitation OTHER

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.

Home-based pulmonary rehabilitation

Center-based pulmonary rehabilitation OTHER

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.

Center-based pulmonary rehabilitation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• ADIR Association: lead
• Région Normandie: collaborator
• Département de la Seine Maritime: collaborator
• European Union: collaborator
• Centre Hospitalier des Pays de Morlaix: collaborator
• Hopital La Musse: collaborator
• Groupe Hospitalier du Havre: collaborator
• Groupe Havrais d'Aide aux Handicapés Respiratoires: collaborator
• Union des Kinésithérapeutes et des Rééducateurs: collaborator

Study Sites (4)

Groupe Hospitalier du Havre

Montivilliers, 76290, France

NOT YET RECRUITING

Centre Hospitalier des Pays de Morlaix

Morlaix, 29600, France

NOT YET RECRUITING

Association ADIR

Rouen, 76000, France

RECRUITING

Hôpital La Musse

Saint-Sébastien-de-Morsent, 27180, France

NOT YET RECRUITING

Related Publications (1)

• McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.

  PMID: 25705944 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tristan Bonnevie, PhD

  Association ADIR

  PRINCIPAL INVESTIGATOR

• Francis-Edouard Gravier, PhD

  Association ADIR

  STUDY CHAIR

• Antoine Cuvelier, Prof

  Association ADIR

  STUDY CHAIR

• Jean-François Muir, Prof

  Association ADIR

  STUDY CHAIR

• Marc Beaumont, PhD

  Centre Hospitalier des Pays de Morlaix

  STUDY CHAIR

• Guillaume Prieur, PhD

  Groupe Hospitalier du Havre - Service de kinésithérapie

  STUDY CHAIR

• Yann Combret, PhD

  Groupe Hospitalier du Havre - Service de kinésithérapie

  STUDY CHAIR

• Héloïse Baillet, PhD

  Hôpital La Musse

  STUDY CHAIR

Central Study Contacts

Tristan Bonnevie, PhD

CONTACT

0235592970; t.bonnevie@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician wil be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized non-inferiority trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 17, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication.
• Access Criteria: Data will be made available upon request, for research purpose. Request should be send to t.bonnevie@adir-hautenormandie.com

Locations

FR (4)