Chronic Obstructive Pulmonary Diseasem-Rehab COPDNCT04550741
Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients
A study testing telerehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Read more about this study
- Who is it for?
- Ages 40 to 78 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Mar 2022to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
- Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
- Patient on RR for four weeks in respiratory rehabilitation center.
- Aged between 40 and 78 years.
Who cannot join
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre hopsitalier universitaire de Montpellier
Montpellier, Occitanie, 34295
Clinique du Souffle
Osséja, 66340
About this study
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
Read more
(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
Read the detailed description
Exclusion criteria:
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
Analysis:
- The main analysis will be the univariate intention-to-treat analysis of the primary outcome.
- Secondary analyzes will include:
- Analysis with intention to treat secondary endpoints.
- Multivariate analysis of the efficiency criteria.
- Univariate and multivariate medico - economic cost - utility analyzes, with their respective sensitivity analyzes.
Protocol:
This prospective, randomized study with two parallel arms, controlled against standard chronic care will be multicentric and open.
- Patients included will be patients diagnosed with COPD who are on RR for four weeks in one of the three centers participating in the study.
- Participation in the study will be offered after verification of the eligibility criteria, during the 3rd week of the stay.
- The information note will then be provided to them.
- After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms:
- - Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
- Control group of 100 patients following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- telerehabilitation
- Keywords
- Chronic obstructive pulmonary disease, Telerehabilitation, Telemedicine, Exercise training, Quality of life, E-health, Connected objects, Care manager
- 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.
telerehabilitationOther
Also called Digital solution of telerehabilitation with remote connected objects
After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. Receives: Other: telerehabilitation |
| Standard chronic care | No intervention | following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated.
The minimum significant difference is 4 points.
Measured: 12 months
Secondary outcomes (4)
Pre-intentional variables
Perceived risk: questionnaire focused on respiratory disease and conditioned by absence of adoption of physical activity behavior.
Expectation of conséquences: questionnaire of the expected effects of Physical activity on physical health and psychological well-being.
Self-efficacy: questionnaire relating to their perceived ability to perform the quantity of physical activity recommended by healthcare professionals.
Intentions: determination and realization of physical activity behavior in the next months.
Measured: baseline
Post-intentional variables
planning: by a Questionnaire relating to the anticipation of the conditions to realize physical activity.
self-efficacy with regard to barriers: questionnaire relating to their perceived ability to perform physical activity recommended despite the difficulties encountered.
Social support:questionnaire relating to the behavior of the entourage habits: questionnaire on automatic nature of physical activity behavior.
Measured: 6 months
Physical Activity behaviors.
Measured by the International Physical Activity Questionnaire as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
walking consider to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
Measured: 12 months
Predictive model of physical activity behavior
Test a predictive model of physical activity behavior at 12 months in each of the two arm groups.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Mar 2022
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
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 DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550741
- Sponsor's protocol ID
- RECHMPL17_0030
- Other IDs
- 2017-A01248-45
- Acronym
- m-Rehab COPD
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients
- ClinicalTrials.gov ID
- NCT04550741
- Acronym / sponsor ID
- m-Rehab COPD / RECHMPL17_0030
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Telerehabilitation, Telemedicine, Exercise training, Quality of life, E-health, Connected objects, Care manager
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 16 Sep 2020 (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.
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
Detailed description
Exclusion criteria:
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
Analysis:
- The main analysis will be the univariate intention-to-treat analysis of the primary outcome.
- Secondary analyzes will include:
- Analysis with intention to treat secondary endpoints.
- Multivariate analysis of the efficiency criteria.
- Univariate and multivariate medico - economic cost - utility analyzes, with their respective sensitivity analyzes.
Protocol:
This prospective, randomized study with two parallel arms, controlled against standard chronic care will be multicentric and open.
- Patients included will be patients diagnosed with COPD who are on RR for four weeks in one of the three centers participating in the study.
- Participation in the study will be offered after verification of the eligibility criteria, during the 3rd week of the stay.
- The information note will then be provided to them.
- After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms:
- - Experimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
- Control group of 100 patients following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home.
The duration of the inclusions is 18 months and the follow-up will be carried out over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: telerehabilitationExperimental group of 100 patients using the M-Réhab BPCO telerehabilitation solution. The solution will be provided during the fourth and final week of RR's stay during which patients will be trained to use all of the solution's features. Patients will carry out the entire post-rehabilitation using the remote rehabilitation solution and will benefit from medical assessments by teleconsultation at 1, 3, 6 and 12 months as well as assessments at 3, 6 and 12 months by filling. electronic auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. |
| Standard chronic care | No intervention | –following usual standard chronic care. Patients will receive during the last week of stay in the center, the usual advice to continue physical activity and nutritional advice at home. The evaluations at 3, 6 and 12 months will be done by electronic filling of auto-questionnaires followed by a telephone quality control if necessary. A final evaluation at 12 months, by videoconference, will be carried out at the patient's home. |
Who may qualify
- Ages
- 40 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
- Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
- Patient on RR for four weeks in respiratory rehabilitation center.
- Aged between 40 and 78 years.
Key exclusion criteria (5 listed)
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
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 |
|---|---|---|
| telerehabilitationAlso: Digital solution of telerehabilitation with remote connected objectsAfter obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group | Other | Telerehabilitation |
Primary outcome
Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
Time frame: 12 months
Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated. The minimum significant difference is 4 points.
4 secondary outcomes
Pre-intentional variables
Time frame: baseline
Post-intentional variables
Time frame: 6 months
Physical Activity behaviors.
Time frame: 12 months
Predictive model of physical activity behavior
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier at 2 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program (time frame: 12 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 NCT04550741, 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 30 Sep 2025.