Clinical trial NCT07025382: Telerehabilitation Versus Centre-based Pulmonary Rehabilitaztion for Patients With Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Telerehabilitation
Pulmonary rehabilitation
Center-based exercise training
Home-based exercise training
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: ADIR Association
Sponsor class: OTHER
Collaborators: name: Région Normandie
name: Département de la Seine Maritime
name: European Union
name: Centre Hospitalier des Pays de Morlaix
name: Hopital La Musse
name: Groupe Hospitalier du Havre
name: Groupe Havrais d'Aide aux Handicapés Respiratoires
name: Union des Kinésithérapeutes et des Rééducateurs
First posted: 2025-06-17
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized non-inferiority trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Chronic obstructive pulmonary disease is a disabling respiratory condition and a leading cause of mortality worldwide. Suggested treatments are mainly symptomatic and aim to stabilize the progression of the disease. However, a major consequence of COPD is reduced exercise tolerance, which can lead patients to avoid physical activity, further inducing progressive muscle deconditioning and disabling dyspnea.

Pulmonary rehabilitation is recommended by leading international respiratory societies as a core component of the treatment for people with chronic obstructive pulmonary disease. The effectiveness of pulmonary rehabilitation is well established, with numerous studies showing that it improves dyspnea, exercise capacity, quality of life, as well as it reduces mortality and hospital length of stay following exacerbations.

Paradoxically, as few as 5 to 10% of eligible patients undergo pulmonary rehabilitation. Some known barriers to uptake include transportation difficulties and the limited availability of PR centers.

Telerehabilitation may offer an alternative to traditional center-based programs. Results from studies evaluating the clinical benefits of telerehabilitation suggest that it is non-inferior to traditional center-based pulmonary rehabilitation. However, the clinical outcomes reported for the control groups (center-based programs) in these studies were lower than those reported in the reference meta-analysis by McCarthy et al. (2015), which established the benefits of pulmonary rehabilitation, making interpretation of the results difficult. For these reasons, it remains important to continue investigating and comparing these two different modalities.

This study primarily aims to evaluate the relative effect of a 24-session home-based telerehabilitation program compared to a center-based program in patients with chronic obstructive pulmonary disease. The primary outcome is the change in endurance exercise capacity. Secondary outcomes include changes in maximal exercise capacity, functional capacity, quadriceps maximal isometric strength, functional dyspnea, physical activity, sleep quality, self-efficacy, patient autonomy, quality of life, psychological and health status, and cognitive function. Additional outcomes include adherence, environmental impact, a health economic analysis, and a 1-year follow-up to assess hospitalizations, exacerbations, and mortality as well as others outcomes.

Study design :

This is a prospective, multicenter, randomized controlled non-inferiority trial with concealed allocation and a single-blind design (blinded evaluator). Participants will be randomly assigned to one of two groups:

Center-based pulmonary rehabilitation group (24 sessions in total over 8 weeks) : participants will attend 26 center-based visits, over eight weeks, comprising:

* One initiation center-based visit(approximately 3 hours), including an initial assessment by a blinded assessor, self management diagnostic, endurance training on a cycle ergometer, strength training, balance exercises and a leaflet containing educational information and exercise recommendations to guide the patient toward full autonomy.
* 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 as follow :
* Endurance training on the cycle ergometer (15 to 45 minutes per session).
* Strength training and balance exercises (30 minutes per session).
* Physical activity coaching.
* Self management at the center (before or after exercise session).
* One final center-based visit (approximately 3 hours), including a final assessment by a blinded assessor, a program review, and educational reinforcement.

Home based telerehabilitation group (24 sessions in total over 8 weeks) : participants will attend 2 visits at the center and perform 24 sessions at home, over eight weeks, comprising:

* One initiation center-based visit (approximately 3 hours), including an initial assessment by a blinded assessor, self management diagnostic, endurance training on a cycle ergometer, strength training, balance exercises and a leaflet containing educational information and exercise recommendations to guide the patient toward full autonomy as well as patient education on how to use the telerehabilition system.
* 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.
* Regular remote monitoring and support via the tablet application, with weekly check-ins from healthcare professionals.
* Self management through videoconferencing.
* One final center-based session (approximately 3 hours), including a final assessment by a blinded assessor, a program review, and educational reinforcement.

Sample size calculation for non-inferiority study:

Assuming a mean difference of 0 seconds between the two groups in the constant work rate endurance test, a non-inferiority margin of 105 seconds, a conservative standard deviation of 150 seconds, an alpha risk of 0.05, and a beta risk of 0.05, a total of 45 patients per group will be needed, totaling 90 patients.

Statistical analysis:

Categorical data will be presented as counts (percentages). Continuous descriptive data will be expressed as means (standard deviation) or medians (interquartile range), depending on their distribution. The normality of distributions will be assessed using the Kolmogorov-Smirnov test.

The analysis will be performed on an intention-to-treat basis using the last observation carried forward method. A per-protocol sensitivity analysis will also be conducted.

The relative effect of the interventions on the primary outcome and other outcomes with repeated measures will be analyzed using a mixed linear model with group (telerehabilitation or center-based rehabilitation), time of measurement (start and end of the program, 1-year follow-up), and their interaction as fixed effects factors, and participant as a random effect factor. Based on available data from the literature, analyses will be adjusted for age, use of long-term oxygen therapy, baseline 6-minute walk distance (except for analyses already including the 6MWD), functional dyspnea (except for analyses already including dyspnea), Forced Expiratory Volume in 1 Second, number of hospitalizations in the past 12 months, anxiety and depression scores (except for analyses already including these outcomes), as well as health status (except for the analysis already including this outcome).

The relative effect of the interventions on outcomes assessed only at the end of the program (e.g. environmental analysis) will be analyzed using a linear mixed model with group (telerehabilitation or center-based rehabilitation) as a fixed effect factor and participant as a random effect factor. The analysis concerning VO₂ peak will be adjusted for the same covariates as the primary outcome.

The difference in effect between groups will be expressed as a mean difference (95% CI) and interpreted according to the minimal clinically important difference specific to each outcome measure, when available in the literature.

The relative effect of the interventions on health events (exacerbations, hospitalizations, death) and program adherence will be assessed using the relative risk at 1 year (95% CI) and adjusted using the same covariates as for the primary outcome analysis. The hazard ratio for time to first exacerbation or death will also be estimated.

Health economic analysis:

Differences in costs and outcomes will be estimated using the seemingly unrelated regression method. These differences will be adjusted using the same covariates as those used in the clinical analyses of the primary outcome, in addition to the randomization arm and baseline utility score for quality-adjusted life years.

A non-parametric bootstrap will be used to represent uncertainty related to estimates for cost-effectiveness.

Analyses will be performed using GraphPad 8 and R software.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 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

Primary outcomes:
measure: Endurance time
timeFrame: 2 months
Secondary outcomes:
measure: Endurance time
timeFrame: One year
measure: Peak oxygen uptake
timeFrame: 2 months
measure: Peak power output
timeFrame: 2 months
measure: Functional capacity
timeFrame: 2 months
measure: Functional capacity
timeFrame: One year
measure: Quadriceps muscle isometric strength
timeFrame: 2 months
measure: Quadriceps muscle isometric strength
timeFrame: One year
measure: Quality of life - Saint George's Respiratory Questionnaire
timeFrame: 2 months
measure: Quality of life - Saint George's Respiratory Questionnaire
timeFrame: One year
measure: Quality of life - Euro-Qol
timeFrame: 2 months
measure: Quality of life - Euro-Qol
timeFrame: One year
measure: Functional dyspnea
timeFrame: 2 months
measure: Functional dyspnea
timeFrame: One year
measure: Intensity of dyspnea during exercise
timeFrame: 2 months
measure: Intensity of dyspnea during exercise
timeFrame: One year
measure: Intensity of lower limb fatigue during exercise
timeFrame: 2 months
measure: Intensity of lower limb fatigue during exercise
timeFrame: One year
measure: Sensory dimension of dyspnea following exercise
timeFrame: 2 months
measure: Sensory dimension of dyspnea following exercise
timeFrame: One year
measure: Affective dimension of dyspnea following exercise
timeFrame: 2 months
measure: Affective dimension of dyspnea following exercise
timeFrame: One year
measure: Health status
timeFrame: 2 months
measure: Health status
timeFrame: One year
measure: Symptoms of anxiety
timeFrame: 2 months
measure: Symptoms of anxiety
timeFrame: One year
measure: Symptoms of depression
timeFrame: 2 months
measure: Symptoms of depression
timeFrame: One year
measure: Cognitive function
timeFrame: 2 months
measure: Cognitive function
timeFrame: One year
measure: Objective physical activity
timeFrame: 2 months
measure: Objective physical activity
timeFrame: One year
measure: Sleep quality - Pittsburg sleep quality index
timeFrame: 2 months
measure: Sleep quality - Pittsburg sleep quality index
timeFrame: One year
measure: Sleep quality - Visual analog scale
timeFrame: 2 months
measure: Sleep quality - Visual analog scale
timeFrame: One year
measure: Auto-efficacy
timeFrame: 2 months
measure: Auto-efficacy
timeFrame: One year
measure: Autonomy support in health care settings
timeFrame: 2 months
measure: Autonomy support in health care settings
timeFrame: One year
measure: Adherence to exercise training
timeFrame: 2 months
measure: Adherence to self management
timeFrame: 2 months
measure: Environmental impact
timeFrame: 2 months
measure: Exacerbations
timeFrame: One year
measure: Hospitalization rate
timeFrame: One year
measure: Death rate
timeFrame: One year
measure: Health economic evaluation - Cost
timeFrame: 2 months
measure: Health economic evaluation - Cost
timeFrame: One year
measure: Health economic evaluation - Incremental cost utility ratio
timeFrame: 2 months
measure: Health economic evaluation - Incremental cost utility ratio
timeFrame: One year
measure: Health economic evaluation - Incremental cost effectiveness ratio
timeFrame: 2 months
measure: Health economic evaluation - Incremental cost effectiveness ratio
timeFrame: One year
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
city: Rouen
country: France
facility: Association ADIR
city: Saint-Sébastien-de-Morsent
country: France
facility: Hôpital La Musse
Study officials:
affiliation: Association ADIR
name: Tristan Bonnevie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association ADIR
name: Francis-Edouard Gravier, PhD
role: STUDY_CHAIR
affiliation: Association ADIR
name: Antoine Cuvelier, Prof
role: STUDY_CHAIR
affiliation: Association ADIR
name: Jean-François Muir, Prof
role: STUDY_CHAIR
affiliation: Centre Hospitalier des Pays de Morlaix
name: Marc Beaumont, PhD
role: STUDY_CHAIR
affiliation: Groupe Hospitalier du Havre - Service de kinésithérapie
name: Guillaume Prieur, PhD
role: STUDY_CHAIR
affiliation: Groupe Hospitalier du Havre - Service de kinésithérapie
name: Yann Combret, PhD
role: STUDY_CHAIR
affiliation: Hôpital La Musse
name: Héloïse Baillet, PhD
role: STUDY_CHAIR
References:
citation: 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.