Chronic Obstructive Pulmonary Disease (COPD)TELEREHA-COPDNCT07025382
Telerehabilitation Versus Centre-based Pulmonary Rehabilitaztion for Patients With Chronic Obstructive Pulmonary Disease
A study testing Home-based pulmonary rehabilitation and Center-based pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD), run by ADIR Association at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Home-based pulmonary rehabilitation and Center-based pulmonary rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Aug 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- Withdrawal of consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Groupe Hospitalier du Havre
Montivilliers, 76290
Guillaume Prieur, PhD, 0232733232 ext. +33, guillaume.prieur@ch-havre.fr
- Not yet recruiting
Centre Hospitalier des Pays de Morlaix
Morlaix, 29600
Marc Beaumont, PhD, 0298626160 ext. +33, mbeaumont@ch-morlaix.fr
- Recruiting
Association ADIR
Rouen, 76000
Tristan Bonnevie, PhD, 0235592970 ext. +33, t.bonnevie@adir-hautenormandie.com
- Not yet recruiting
Hôpital La Musse
Saint-Sébastien-de-Morsent, 27180
Héloïse Baillet, PhD, 0232293031 ext. +33, h.baillet@hlrs-lamusse.net
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Home-based pulmonary rehabilitation, Center-based pulmonary rehabilitation
- Keywords
- Telerehabilitation, Pulmonary rehabilitation, Center-based exercise training, Home-based exercise training, Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitationOther
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.
Center-based pulmonary rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based pulmonary rehabilitation | Experimental | 24 home-based pulmonary rehabilitation sessions Receives: Other: Home-based pulmonary rehabilitation |
| Center-based pulmonary rehabilitation | Active comparator | 24 center-based pulmonary rehabilitation sessions Receives: Other: Center-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (51)
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.
Measured: One year
Peak oxygen uptake
Peak oxygen uptake will be assessed during an incremental cardiopulmonary exercise testing on a cycle ergometer before and after the rehabilitation program.
Measured: 2 months
Peak power output
Peak power output will be assessed during an incremental cardiopulmonary exercise testing on a cycle ergometer before and after the rehabilitation program.
Measured: 2 months
Functional capacity
Functional capacity will be assessed using the six-minute-walk test before and after the rehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 25 meters.
Measured: 2 months
Functional capacity
Functional capacity will be assessed using the six-minute-walk test before and after the rehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 25 meters.
Measured: One year
Quadriceps muscle isometric strength
Maximum voluntary quadriceps muscle isometric strength will be assessed by dynamometry before and after the rehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 7.5 Nm.
Measured: 2 months
Quadriceps muscle isometric strength
Maximum voluntary quadriceps muscle isometric strength will be assessed by dynamometry before and after the rehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 7.5 Nm.
Measured: One year
Quality of life - Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. This self-administered questionnaire ranges from 0 to 100, with higher values indicating greater impairment in health-related quality of life. The established minimal clinically important difference for this questionnaire has been established at -4 points.
Measured: 2 months
Quality of life - Saint George's Respiratory Questionnaire
Quality of life will be assessed using the Saint George's Respiratory Questionnaire. This self-administered questionnaire ranges from 0 to 100, with higher values indicating greater impairment in health-related quality of life. The established minimal clinically important difference for this questionnaire has been established at -4 points.
Measured: One year
Quality of life - Euro-Qol five-dimension five-level questionnaire
Quality of life will be assessed using the Euro-Qol five-dimension five-level (EQ-5D-5L) before and after the rehabilitation program and after 1 year of the enrollement date. The EQ-5D-5L consists of five dimensions, each rated on five levels of severity. Responses are converted into a single utility index score, ranging from less than 0 (representing health states worse than death) to 1 (perfect health), with higher scores indicating better health-related quality of life.
The EQ visual analogue scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), will also be recorded.
Measured: 2 months
Quality of life - Euro-Qol five-dimension five-level questionnaire
Quality of life will be assessed using the Euro-Qol five-dimension five-level (EQ-5D-5L) before and after the rehabilitation program and after 1 year of the enrollement date. The EQ-5D-5L consists of five dimensions, each rated on five levels of severity. Responses are converted into a single utility index score, ranging from less than 0 (representing health states worse than death) to 1 (perfect health), with higher scores indicating better health-related quality of life.
The EQ visual analogue scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), will also be recorded.
Measured: One year
Functional dyspnea
Functional dyspnea will be assessed using the modified medical research council (mMRC) scale before and after the rehabilitation program and after 1 year of the enrollement date. The mMRC score ranges from 0 to 4, with lower scores indicating less severe functional dyspnea. The pre-specified minimal clinically important difference is set at -1 point.
Measured: 2 months
Functional dyspnea
Functional dyspnea will be assessed using the modified medical research council (mMRC) scale before and after the rehabilitation program and after 1 year of the enrollement date. The mMRC score ranges from 0 to 4, with lower scores indicating less severe functional dyspnea. The pre-specified minimal clinically important difference is set at -1 point.
Measured: One year
Intensity of dyspnea during exercise
The intensity of dyspnea during constant workload exerice test will be assessed using the 10-Borg scale every 30 second during the test. The intensity of dyspnea will be evaluated using the Borg scale, which ranges from 0 to 10. This scale allows for values between 0 (absence of breathlessness) and 10 (maximal breathlessness). Patients will be asked, "What is the intensity of your breathlessness?" The minimal clinically important difference for this outcome is 1 point.
Measured: 2 months
Intensity of dyspnea during exercise
The intensity of dyspnea during constant workload exerice test will be assessed using the 10-Borg scale every 30 second during the test. The intensity of dyspnea will be evaluated using the Borg scale, which ranges from 0 to 10. This scale allows for values between 0 (absence of breathlessness) and 10 (maximal breathlessness). Patients will be asked, "What is the intensity of your breathlessness?" The minimal clinically important difference for this outcome is 1 point.
Measured: One year
Intensity of lower limb fatigue during exercise
The intensity of lower limb fatigue during constant workload exerice test will be assessed using the 10-Borg scale every 30 second during the test. The intensity of lower limb fatigue will be evaluated using the Borg scale, which ranges from 0 to 10. This scale allows for values between 0 (absence of breathlessness) and 10 (maximal breathlessness). Patients will be asked, "What is the intensity of the fatigue in your legs?" The minimal clinically important difference for this outcome is 1 point.
Measured: 2 months
Intensity of lower limb fatigue during exercise
The intensity of lower limb fatigue during constant workload exerice test will be assessed using the 10-Borg scale every 30 second during the test. The intensity of lower limb fatigue will be evaluated using the Borg scale, which ranges from 0 to 10. This scale allows for values between 0 (absence of breathlessness) and 10 (maximal breathlessness). Patients will be asked, "What is the intensity of the fatigue in your legs?" The minimal clinically important difference for this outcome is 1 point.
Measured: One year
Sensory dimension of dyspnea following exercise
he sensory dimension of dyspnea will be assessed using French version of the Multidimensional Dyspnea Profile questionnaire, taking into account the last 30 seconds of effort during the constant workload exercise test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a greater sensory dimension of dyspnea. The established minimal clinically important difference for this outcome is 2 points.
Measured: 2 months
Sensory dimension of dyspnea following exercise
he sensory dimension of dyspnea will be assessed using French version of the Multidimensional Dyspnea Profile questionnaire, taking into account the last 30 seconds of effort during the constant workload exercise test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a greater sensory dimension of dyspnea. The established minimal clinically important difference for this outcome is 2 points.
Measured: One year
Affective dimension of dyspnea following exercise
The affective dimension of dyspnea will be assessed using the french version of the Multidimensional Dyspnea Profile questionnaire, considering the last 30 seconds of effort during the constant workload exercise test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a significant affective dimension of dyspnea. The established minimal clinically important difference for this outcome is 3 points.
Measured: 2 months
Affective dimension of dyspnea following exercise
The affective dimension of dyspnea will be assessed using the french version of the Multidimensional Dyspnea Profile questionnaire, considering the last 30 seconds of effort during the constant workload exercise test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a significant affective dimension of dyspnea. The established minimal clinically important difference for this outcome is 3 points.
Measured: One year
Health status
Health status will be assessed using the Chronic obstructive pulmonary disease Assessment Test (CAT) before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 to 40, with higher values indicating greater impairment of health status. The established minimal clinically important difference for this questionnaire is -2.5 points.
Measured: 2 months
Health status
Health status will be assessed using the Chronic obstructive pulmonary disease Assessment Test (CAT) before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 to 40, with higher values indicating greater impairment of health status. The established minimal clinically important difference for this questionnaire is -2.5 points.
Measured: One year
Symptoms of anxiety
Symptoms of anxiety will be assessed using the Hospital Anxiety and Depression questionnaire, anxiety subscore, before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: 2 months
Symptoms of anxiety
Symptoms of anxiety will be assessed using the Hospital Anxiety and Depression questionnaire, anxiety subscore, before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: One year
Symptoms of depression
Symptoms of depression will be assessed using the Hospital Anxiety and Depression questionnaire, depression subscore, before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: 2 months
Symptoms of depression
Symptoms of depression will be assessed using the Hospital Anxiety and Depression questionnaire, depression subscore, before and after the rehabilitation program and after 1 year of the enrollement date. The score ranges from 0 (best) to 21 (worst). The pre-specified minimal clinically important difference is set at -1.5 point.
Measured: One year
Cognitive function
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) test before, after the rehabilitation program and after 1 year of the enrollement date. Scores range from 0 to 30, with higher scores indicating better cognitive function. A score below 26 is considered indicative of mild cognitive impairement. The proportion of participants scoring below this threshold will be reported.
Measured: 2 months
Cognitive function
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) test before, after the rehabilitation program and after 1 year of the enrollement date. Scores range from 0 to 30, with higher scores indicating better cognitive function. A score below 26 is considered indicative of mild cognitive impairement. The proportion of participants scoring below this threshold will be reported.
Measured: One year
Objective physical activity
Objective physical activity will be measured using a triaxial accelerometer (Actigraph GTX3, Actigraph, Pensacola, FL, USA) worn by patients 10 days prior to study enrollement and 10 days after study completion. A measurement day will be considered valid if it includes at least 8 hours of use of the triaxial accelerometer. Physical activity assessment for a given patient will be considered valid if it includes at least 4 valid weekdays (i.e., more than 8 hours/day excluding weekends).
The measurement will be adjusted for sunlight duration (included as a covariate in the analysis) Objective physical activity will also be measured one year after study enrollement.
Measured: 2 months
Objective physical activity
Objective physical activity will be measured using a triaxial accelerometer (Actigraph GTX3, Actigraph, Pensacola, FL, USA) worn by patients 10 days prior to study enrollement and 10 days after study completion. A measurement day will be considered valid if it includes at least 8 hours of use of the triaxial accelerometer. Physical activity assessment for a given patient will be considered valid if it includes at least 4 valid weekdays (i.e., more than 8 hours/day excluding weekends).
The measurement will be adjusted for sunlight duration (included as a covariate in the analysis) Objective physical activity will also be measured one year after study enrollement.
Measured: One year
Sleep quality - Pittsburg sleep quality index
Sleep quality will be assessed using the Pittsburg Sleep Quality Index (PSQI) before and after the rehabilitation program and after 1 year of the enrollement date. Scores range from 0 to 21 with a lower score reflecting a better sleep quality.
Measured: 2 months
Sleep quality - Pittsburg sleep quality index
Sleep quality will be assessed using the Pittsburg Sleep Quality Index (PSQI) before and after the rehabilitation program and after 1 year of the enrollement date. Scores range from 0 to 21 with a lower score reflecting a better sleep quality.
Measured: One year
Sleep quality - Visual analog scale
Sleep quality will also be assessed using a Visual Analog Scale (VAS). Scores range from 0 to 10 with a higher score reflecting a better sleep quality.
Measured: 2 months
Sleep quality - Visual analog scale
Sleep quality will also be assessed using a Visual Analog Scale (VAS). Scores range from 0 to 10 with a higher score reflecting a better sleep quality.
Measured: One year
Auto-efficacy
Auto-efficacy will be measured using the french version of the self-efficacy for managing chronic disease scale before and after the rehabilitation program and after 1 year of the enrollement date. Possible score vary between 6 (weak self-efficacy) and 60 (high self-efficacy).
Measured: 2 months
Auto-efficacy
Auto-efficacy will be measured using the french version of the self-efficacy for managing chronic disease scale before and after the rehabilitation program and after 1 year of the enrollement date. Possible score vary between 6 (weak self-efficacy) and 60 (high self-efficacy).
Measured: One year
Autonomy support in health care settings
Autonomy support in health care settings will be assessed using the brief health care climate questionnaire (HCCQ). Possible scores vary from 6 (low autonomy support) to 42 (high autonomy support).
Measured: 2 months
Autonomy support in health care settings
Autonomy support in health care settings will be assessed using the brief health care climate questionnaire (HCCQ). Possible scores vary from 6 (low autonomy support) to 42 (high autonomy support).
Measured: One year
Adherence to exercise training
Adherence will be assessed as the ratio of completed sessions to prescribed sessions (24 sessions).
Measured: 2 months
Adherence to self management
Adherence will be assessed as the ratio of completed sessions to prescribed sessions.
Measured: 2 months
Environmental impact
The environmental impact will be assessed using the Climate Partner Hub software (Climate Partner®, Munich, Germany) and expressed as equivalent ton of carbon dioxide. The assessment will include a Life Cycle Assessment for each device used in both groups, data transmission and storage on cloud servers for home-based telerehabilitation, and transportation for both groups.
Measured: 2 months
Exacerbations
Exacerbations will be collected during the rehabilitation program, after completion of the program and up to 1 year after enrollement date. They are categorized as follows:
- Mild if they do not require any change in treatment or only an increase in bronchodilator use;
- Moderate if they require the use of corticosteroids and/or antibiotics;
- Severe if they result in hospitalization.
Measured: One year
Hospitalization rate
Hospitalization rate will be collected during the rehabilitation program, after completion of the program and up to 1 year after enrollement date.
Measured: One year
Death rate
Death rate will be collected during the rehabilitation program, after completion of the program and up to 1 year after enrollement date.
Measured: One year
Health economic evaluation - Cost
A health economic evaluation will be conducted to assess the costs associated with each intervention.
Measured: 2 months
Health economic evaluation - Cost
A health economic evaluation will be conducted to assess the costs associated with each intervention.
Measured: One year
Health economic evaluation - Incremental cost utility ratio
A health economic evaluation will be conducted to assess the incremental cost utility ratio per quality-adjusted life year (QALY) gained
Measured: 2 months
Health economic evaluation - Incremental cost utility ratio
A health economic evaluation will be conducted to assess the incremental cost utility ratio per quality-adjusted life year (QALY) gained
Measured: One year
Health economic evaluation - Incremental cost effectiveness ratio
A health economic evaluation will be conducted to assess the incremental cost effectiveness ratio per endurance time gained
Measured: 2 months
Health economic evaluation - Incremental cost effectiveness ratio
A health economic evaluation will be conducted to assess the incremental cost effectiveness ratio per endurance time gained
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start14 Aug 2025
- Primary completionSep 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized non-inferiority trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Collaborators
- Région Normandie, Département de la Seine Maritime, European Union, Centre Hospitalier des Pays de Morlaix, Hopital La Musse, Groupe Hospitalier du Havre, Groupe Havrais d'Aide aux Handicapés Respiratoires, Union des Kinésithérapeutes et des Rééducateurs
- Responsible party
- Sponsor
- Investigators
- Tristan Bonnevie, PhD, Principal investigator, Association ADIRFrancis-Edouard Gravier, PhD, Study chair, Association ADIRAntoine Cuvelier, Prof, Study chair, Association ADIRJean-François Muir, Prof, Study chair, Association ADIRMarc Beaumont, PhD, Study chair, Centre Hospitalier des Pays de MorlaixGuillaume Prieur, PhD, Study chair, Groupe Hospitalier du Havre - Service de kinésithérapieYann Combret, PhD, Study chair, Groupe Hospitalier du Havre - Service de kinésithérapieHéloïse Baillet, PhD, Study chair, Hôpital La Musse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025382
- Sponsor's protocol ID
- TELEREHA-COPD
- Acronym
- TELEREHA-COPD
- Status last verified
- Aug 2025
- First submitted
- 10 Jun 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
Publications
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.
PubMed 25705944
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07025382
- Acronym / sponsor ID
- TELEREHA-COPD / TELEREHA-COPD
- Keywords
- Telerehabilitation, Pulmonary rehabilitation, Center-based exercise training, Home-based exercise training, Chronic Obstructive Pulmonary Disease (COPD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Collaborators
- Région Normandie, Département de la Seine Maritime, European Union, Centre Hospitalier des Pays de Morlaix, Hopital La Musse, Groupe Hospitalier du Havre, Groupe Havrais d'Aide aux Handicapés Respiratoires, Union des Kinésithérapeutes et des Rééducateurs
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized non-inferiority trial with concealed allocation, a blinded assessor, and an intention-to-treat analysis.
| Arm | Type | Receives |
|---|---|---|
| Home-based pulmonary rehabilitation | Experimental | Other: Home-based pulmonary rehabilitation24 home-based pulmonary rehabilitation sessions |
| Center-based pulmonary rehabilitation | Active comparator | Other: Center-based pulmonary rehabilitation24 center-based pulmonary rehabilitation sessions |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (1 listed)
- Withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based pulmonary rehabilitationAn 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 | Home-based pulmonary rehabilitation |
| Center-based pulmonary rehabilitationAn 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. | Other | Center-based pulmonary rehabilitation |
Primary outcome
Endurance time
Time frame: 2 months
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.
51 secondary outcomes
Endurance time
Time frame: One year
Peak oxygen uptake
Time frame: 2 months
Peak power output
Time frame: 2 months
Functional capacity
Time frame: 2 months
Functional capacity
Time frame: One year
Quadriceps muscle isometric strength
Time frame: 2 months
Quadriceps muscle isometric strength
Time frame: One year
Quality of life - Saint George's Respiratory Questionnaire
Time frame: 2 months
Quality of life - Saint George's Respiratory Questionnaire
Time frame: One year
Quality of life - Euro-Qol five-dimension five-level questionnaire
Time frame: 2 months
Quality of life - Euro-Qol five-dimension five-level questionnaire
Time frame: One year
Functional dyspnea
Time frame: 2 months
Functional dyspnea
Time frame: One year
Intensity of dyspnea during exercise
Time frame: 2 months
Intensity of dyspnea during exercise
Time frame: One year
Intensity of lower limb fatigue during exercise
Time frame: 2 months
Intensity of lower limb fatigue during exercise
Time frame: One year
Sensory dimension of dyspnea following exercise
Time frame: 2 months
Sensory dimension of dyspnea following exercise
Time frame: One year
Affective dimension of dyspnea following exercise
Time frame: 2 months
Affective dimension of dyspnea following exercise
Time frame: One year
Health status
Time frame: 2 months
Health status
Time frame: One year
Symptoms of anxiety
Time frame: 2 months
Symptoms of anxiety
Time frame: One year
Symptoms of depression
Time frame: 2 months
Symptoms of depression
Time frame: One year
Cognitive function
Time frame: 2 months
Cognitive function
Time frame: One year
Objective physical activity
Time frame: 2 months
Objective physical activity
Time frame: One year
Sleep quality - Pittsburg sleep quality index
Time frame: 2 months
Sleep quality - Pittsburg sleep quality index
Time frame: One year
Sleep quality - Visual analog scale
Time frame: 2 months
Sleep quality - Visual analog scale
Time frame: One year
Auto-efficacy
Time frame: 2 months
Auto-efficacy
Time frame: One year
Autonomy support in health care settings
Time frame: 2 months
Autonomy support in health care settings
Time frame: One year
Adherence to exercise training
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 25705944McCarthy 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.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tristan Bonnevie, PhD principal investigator
Association ADIR
Francis-Edouard Gravier, PhD study chair
Association ADIR
Antoine Cuvelier, Prof study chair
Association ADIR
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based pulmonary rehabilitation and Center-based pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD), run by ADIR Association at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tristan Bonnevie, PhD (0235592970 ext. +33, t.bonnevie@adir-hautenormandie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.