Chronic Obstructive Pulmonary DiseaseNCT05314686
Telerehabilitation - Technical Validity and Clinical Feasibility
An observational study of Chronic Obstructive Pulmonary Disease, run by ADIR Association at 1 site in France.
Trial summary
This prospective study will be held in two steps. The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker. and Telerehabilitation
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 28 Aug 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Chronic obstructive pulmonary disease
Who may be able to join
- Age superior to eighteen years.
- Stable (> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV
- Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer).
- With or without oxygen during exercise.
- Specific inclusion criteria for the first step of the study:
- Able to perform forty-five minutes of exercise training on a cycle ergometer.
Show all 14Show fewer
- Specific inclusion criteria for the second phase of the study:
- Person of legal age who may be present during home exercise sessions (relatives).
- Non-inclusion Criteria:
- Pregnancy or likely to be.
- Guardianship.
- Unable to consent.
- Referred to pulmonary rehabilitation before lung cancer surgery.
- Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled in the next few months.
Who cannot join
- Consent withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Validity and Clinical Feasibility of Using a Telerehabilitation System Using Advanced Telehealth Technologies
This prospective study will be held in two steps.
The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker.
The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below.
Read the detailed description
Before taking part in the study, participants will undergo an incremental cardiopulmonary exercise testing as their baseline assessment before referral to a pulmonary rehabilitation program.
Participants referred for pulmonary rehabilitation to the ADIR Association will be screened for eligibility. They will be contacted to initiate their program. During the first session, they will be offered to participate in the study.
This protocol will be held in two steps : the first step will aim to assess the clinical validity of the data transmitted remotely through the system (from two different devices) and the second step will aim to assess the clinical feasibility of using the system in the home environment.
Participant recruitment for each of these steps will be performed chronologically (the first twenty eligible participants will participate in the technical validity step of the study and the last twenty eligible participants will participate in the clinical feasibility step).
Step one: Clinical validity. The first step of the study aims to assess the clinical validity of data transmitted remotely from two devices connected to the telerehabilitation system (a. oximetry data during exercise and b. daily step count from a commercially available physical activity tracker).
- Oxymetry data during exercise on a cycle ergometer. Participants who agree to participate will be trained to use the system within the pulmonary rehabilitation centre. Training includes different steps such as to turn on the tablet, to connect to the application, to start the session using the app, to synchronise the oximeter with the app, to perform the session and to validate the end of the session. Participants will be asked to perform five endurance exercise sessions of forty-five minutes each, over five different days, within the centre. During these sessions a connected pulsed oximeter device will record heart rate and transcutaneous oxygen saturation at a frequency of one hertz. These data will be recorded in the internal memory of the oximeter itself as well as transmitted in real-time through Bluetooth to the app. The app will transmit the data to a secured remote server through the Global System for Mobile communication network. These two datasets (those locally stored and those remotely transmitted) will be analysed and compared (proportion of artefact, data deletion, data transformation, comparability etc - see outcomes for further details).
- Data from a physical activity tracker.
Concurrently, the same participants will be asked to wear a physical activity tracker over a ten-day period. The data (daily step count) will be automatically and daily transmitted to the app through Bluetooth and then from the app to the remote secured server. Participants will be asked to remove the sensor when going to bed and to note the number of steps displayed on the screen on a standardized data sheet.
Step two: Clinical feasibility. The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment), during an eight week period.
During their initial pulmonary rehabilitation session (held in the centre), participants will be offered to perform their pulmonary rehabilitation program at home, using the telerehabilitation system. Those who agree to participate will be taught to use the system during this first face-to-face session. The telerehabilitation system as well as a cycle ergometer will be subsequently provided in their home environment by a local home healthcare provider.
The telerehabilitation program will take place over an eight-week period and includes:
- Endurance exercise training on a cycle ergometer (performed independently with remote monitoring or through video conference (also with remote monitoring), according to the participant's preference), three times per weeks. The duration of the sessions along with the training intensity will be progressively adjusted using an automated algorithm (aimed to first increase the training duration up to forty-five minutes and then workload intensity). The algorithm is based on previous sessions performed, monitored data and perceived exertion.
- Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per weeks (thirty minutes).
- Daily walking (automated coaching based on Demeyer et al. Thorax. 2017).
- Self management education (one to nine sessions according to each individual's needs, scheduled through videoconference).
- A self evaluation of symptoms through daily or weekly questionnaires.
Different types of alerts will be triggered at the center according to remote monitoring : "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".
Participants will be encouraged to contact physiotherapists at the centre for any situation that would require assistance (related to their program or to cope with any technical issue).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker., Telerehabilitation
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Telerehabilitation, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker.Other
- Five exercise sessions of forty-five minutes within the centre on a cycle ergometer using a pulse oximetry device connected to the telerehabilitation system through Bluetooth. Data recorded in the internal memory of the pulse oximeter will be compared with those transmitted through the telerehabilitation system.
- Ten days of use of a physical activity tracker connected to the telerehabilitation system. Self-reported daily step count by the participants (using a standardized data sheet) will be compared with the daily step count transmitted through the telerehabilitation system.
TelerehabilitationOther
An eight-week program including:
- Endurance training on a cycle ergometer (performed independently with remote monitoring or through video conference, according to the participant's preference), three times per week. Training prescription is progressively adjusted using an automated algorithm (aimed to first increase the training duration and then workload intensity).
- Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per week (thirty minutes).
- Daily walking with automated coaching.
- Self management education (one to nine sessions according to each individual needs, scheduled through videoconference).
- A self evaluation of symptoms through daily or weekly questionnaires. Different types of alert will be triggered at the center according to remote monitoring: "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".
| Study group | Role | What they receive |
|---|---|---|
| Technical validity of data transmitted remotely. | The first twenty participants will participate in the step of the study aimed at assessing the technical validity of data transmitted remotely from devices connected to the telerehabilitation system. Receives: Other: Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker. | |
| Clinical feasibility. | The last twenty participants will perform their pulmonary rehabilitation program at home using the telerehabilitation system over an eight-week period. Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.
Comparison of paired datasets between the data recorded locally within the internal memory of the pulse oximeter and those collected from the telerehabilitation system.
Measured: Data will be recorded immediately after the intervention.
Technical validity of the data transmitted remotely - physical activity tracker - concordance between datasets.
Comparison of paired dataset between the daily data, either automatically collected from the telerehabilitation system or self-reported by the participant (visually displayed on the physical activity tracker).
Measured: Data will be recorded immediately after the intervention.
Technical validity of the data transmitted remotely - pulse oximeter - proportion of sessions transmitted.
The number of exercise sessions retrieved from the telerehabilitation system will be expressed in relation to the number of sessions performed.
Measured: Data will be recorded immediately after the intervention.
Technical validity of the data transmitted remotely - physical activity tracker - proportion of sessions transmitted.
The number of days with physical activity data retrieved from the telerehabilitation system will be expressed in relation to the number of days that the tracker has been worn by the participant.
Measured: Data will be recorded immediately after the intervention.
Technical validity of the data transmitted remotely - pulse oximeter - proportion of common usable data.
The proportion of data without artefacts will be compared between datasets. Artefacts will be identified for heart rate when values indicate two hundred fifty beats per minute and for transcutaneous oxygen saturation when values indicate hundred percent.
Measured: Data will be recorded immediately after the intervention.
Technical validity of the data transmitted remotely - pulse oximeter - number of session required to be autonomous when using the system.
Participants will be taught to use the system and they will be requested to set data collection autonomously during the four next sessions. They will be considered autonomous when they will be able to set data collection autonomously without error. The number of sessions (after the first session) required to reach autonomy will be collected.
Measured: Data will be recorded immediately after the intervention.
Secondary outcomes (21)
Endurance exercise capacity - constant workload exercise testing.
Time to exhaustion (in second) during a constant workload exercise testing on a cycle ergometer at seventy-five percent of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing.
Measured: Baseline and immediately after the intervention.
Endurance exercise capacity - six-minute walking test.
Number of meters performed during the six-minutes walking test, performed in a thirty metre long corridor.
Measured: Baseline and immediately after the intervention.
Endurance exercise capacity - six-minute stepper test.
Number of steps performed during the six-minutes stepper test.
Measured: Baseline and immediately after the intervention.
Maximal voluntary isometric quadriceps force.
Data will be recorded using a handheld manometer.
Measured: Baseline and immediately after the intervention.
Self-reported quality of life.
Saint George's Respiratory Questionnaire.
Measured: Baseline and immediately after the intervention.
Functional dyspnea.
Modified Medical Research Council dyspnea scale.
Measured: Baseline and immediately after the intervention.
Health status.
Chronic obstructive pulmonary disease Assessment Test.
Measured: Baseline and immediately after the intervention.
Anxiety.
Hospital And Anxiety questionnaire - anxiety sub scale.
Measured: Baseline and immediately after the intervention.
Depression.
Hospital And Anxiety questionnaire - depression sub scale.
Measured: Baseline and immediately after the intervention.
Cognitive Function.
Montreal Cognitive Assessment test.
Measured: Baseline and immediately after the intervention.
Objective physical activity.
Objective physical activity will be assessed using a physical activity tracker (different from the one used with the telerehabilitation system) and expressed as daily step count over a ten-day period. A given day will be considered as valid if the device is worn at least eight hours and the outcome will be considered as valid for a given participant if the measurement includes at least four valid week days.
Measured: Baseline and immediately after the intervention.
Adherence - exercise training.
Adherence will be assessed as the number of exercise training sessions performed in relation to the number of sessions prescribed.
Measured: Data will be collected through study completion, an average of 8 weeks.
Adherence - self-management education.
Adherence will be assessed as the number of self-management education sessions performed in relation to the number of sessions prescribed.
Measured: Data will be collected through study completion, an average of 8 weeks.
Adherence - symptoms monitoring questionnaires.
Adherence will be assessed as the number of days with fulfilled questionnaires relative to the number of days.
Measured: Data will be collected through study completion, an average of 8 weeks.
Use of the telerehabilitation system.
Logs related to the different components of the programs will be retrieved from the telerehabilitation system (number of click to each component of the eight-week period).
Measured: Data will be collected through study completion, an average of 8 weeks.
Usability of the system.
Usability of the system will be assessed using the System Usability Scale.
Measured: Data will be collected immediately after the intervention.
Satisfaction - standardized questionnaire.
Satisfaction will be assessed using the Client Satisfaction Questionnaire-8.
Measured: Data will be collected immediately after the intervention.
Satisfaction - purpose designed survey.
Satisfaction will be assessed using purpose designed surveys intended for participants, their relatives and healthcare professional in charge of telerehabilitation program (Lickert scale).
Measured: Data will be collected immediately after the intervention.
Emotional perception of the system.
Emotional perception of the system will be assessed using Emocards.
Measured: Data will be collected immediately after the intervention.
Participant's flow.
Participant's flow with the system will be assessed using the FKS scale from Rheinberg et al. (2003).
Measured: Data will be collected immediately after the intervention.
Motivation to participate in the program using the telerehabilitation system.
Motivation will be assessed through a one hour semi-directed interview.
Measured: Data will be collected immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Nov 2022
- Primary completion31 Jul 2025
- Study completion28 Aug 2025
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Collaborators
- Union des Kinésithérapeutes Respiratoires, CogSci, KerNel Biomedical, Groupe Havrais d'Aide aux Handicapés Respiratoires
- Responsible party
- Sponsor
- Investigators
- Tristan Bonnevie, PT, PhD, Principal investigator, ADIR Association, Rouen University, Rouen, FranceAntoine Cuvelier, MD, Prof, Study chair, CHU-Hôpitaux de Rouen, Rouen, France.Jean-François Muir, MD, Prof, Study chair, ADIR Association, Rouen, France.Francis-Edouard Gravier, PT, PhD, Study chair, ADIR Association, Rouen, France.Aurélie Vallée, PhD, Study chair, CogSci, Rouen, France.Michelle Leclerc, PT, MSc, Study chair, Union des Kinésithérapeutes Respiratoires, Rouen, France.Zoe McKeough, PT, Prof, Study chair, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314686
- Sponsor's protocol ID
- TelerehApp-Valid/Feasib
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sayegh JPE, Gravier FE, Clet A, Kerfourn A, Muir JF, Cuvelier A, Boujibar F, Banovic I, Dupont L, Viacroze C, Artaud-Macari E, McKeough Z, Bonnevie T. Technical and clinical feasibility of a pulmonary telerehabilitation model for people with COPD. Arch Phys Med Rehabil. 2026 Oct 12:S0003-9993(26)00945-7. doi: 10.1016/j.apmr.2026.10.001. Online ahead of print.
PubMed 42863686
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Validity and Clinical Feasibility of Using a Telerehabilitation System Using Advanced Telehealth Technologies
- ClinicalTrials.gov ID
- NCT05314686
- Acronym / sponsor ID
- TelerehApp-Valid/Feasib
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Telerehabilitation, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Collaborators
- Union des Kinésithérapeutes Respiratoires, CogSci, KerNel Biomedical, Groupe Havrais d'Aide aux Handicapés Respiratoires
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 6 Apr 2022 (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.
This prospective study will be held in two steps.
The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker.
The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below.
Detailed description
Before taking part in the study, participants will undergo an incremental cardiopulmonary exercise testing as their baseline assessment before referral to a pulmonary rehabilitation program.
Participants referred for pulmonary rehabilitation to the ADIR Association will be screened for eligibility. They will be contacted to initiate their program. During the first session, they will be offered to participate in the study.
This protocol will be held in two steps : the first step will aim to assess the clinical validity of the data transmitted remotely through the system (from two different devices) and the second step will aim to assess the clinical feasibility of using the system in the home environment.
Participant recruitment for each of these steps will be performed chronologically (the first twenty eligible participants will participate in the technical validity step of the study and the last twenty eligible participants will participate in the clinical feasibility step).
Step one: Clinical validity. The first step of the study aims to assess the clinical validity of data transmitted remotely from two devices connected to the telerehabilitation system (a. oximetry data during exercise and b. daily step count from a commercially available physical activity tracker).
- Oxymetry data during exercise on a cycle ergometer. Participants who agree to participate will be trained to use the system within the pulmonary rehabilitation centre. Training includes different steps such as to turn on the tablet, to connect to the application, to start the session using the app, to synchronise the oximeter with the app, to perform the session and to validate the end of the session. Participants will be asked to perform five endurance exercise sessions of forty-five minutes each, over five different days, within the centre. During these sessions a connected pulsed oximeter device will record heart rate and transcutaneous oxygen saturation at a frequency of one hertz. These data will be recorded in the internal memory of the oximeter itself as well as transmitted in real-time through Bluetooth to the app. The app will transmit the data to a secured remote server through the Global System for Mobile communication network. These two datasets (those locally stored and those remotely transmitted) will be analysed and compared (proportion of artefact, data deletion, data transformation, comparability etc - see outcomes for further details).
- Data from a physical activity tracker.
Concurrently, the same participants will be asked to wear a physical activity tracker over a ten-day period. The data (daily step count) will be automatically and daily transmitted to the app through Bluetooth and then from the app to the remote secured server. Participants will be asked to remove the sensor when going to bed and to note the number of steps displayed on the screen on a standardized data sheet.
Step two: Clinical feasibility. The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment), during an eight week period.
During their initial pulmonary rehabilitation session (held in the centre), participants will be offered to perform their pulmonary rehabilitation program at home, using the telerehabilitation system. Those who agree to participate will be taught to use the system during this first face-to-face session. The telerehabilitation system as well as a cycle ergometer will be subsequently provided in their home environment by a local home healthcare provider.
The telerehabilitation program will take place over an eight-week period and includes:
- Endurance exercise training on a cycle ergometer (performed independently with remote monitoring or through video conference (also with remote monitoring), according to the participant's preference), three times per weeks. The duration of the sessions along with the training intensity will be progressively adjusted using an automated algorithm (aimed to first increase the training duration up to forty-five minutes and then workload intensity). The algorithm is based on previous sessions performed, monitored data and perceived exertion.
- Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per weeks (thirty minutes).
- Daily walking (automated coaching based on Demeyer et al. Thorax. 2017).
- Self management education (one to nine sessions according to each individual's needs, scheduled through videoconference).
- A self evaluation of symptoms through daily or weekly questionnaires.
Different types of alerts will be triggered at the center according to remote monitoring : "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".
Participants will be encouraged to contact physiotherapists at the centre for any situation that would require assistance (related to their program or to cope with any technical issue).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technical validity of data transmitted remotely. | – | Other: Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker.The first twenty participants will participate in the step of the study aimed at assessing the technical validity of data transmitted remotely from devices connected to the telerehabilitation system. |
| Clinical feasibility. | – | Other: TelerehabilitationThe last twenty participants will perform their pulmonary rehabilitation program at home using the telerehabilitation system over an eight-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive pulmonary disease
Key inclusion criteria (14 listed)
- Age superior to eighteen years.
- Stable (> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV
- Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer).
- With or without oxygen during exercise.
- Able to perform forty-five minutes of exercise training on a cycle ergometer.
Key exclusion criteria (1 listed)
- Consent withdrawal
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 |
|---|---|---|
| Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker.1. Five exercise sessions of forty-five minutes within the centre on a cycle ergometer using a pulse oximetry device connected to the telerehabilitation system through Bluetooth. Data recorded in the internal memory of the pulse oximeter will be compared with those transmitted through the telerehabilitation system. 2. Ten days of use of a physical activity tracker connected to the telerehabilitation system. Self-reported daily step count by the participants (using a standardized data sheet) will be compared with the daily step count transmitted through the telerehabilitation system. | Other | Technical validity of data transmitted remotely. |
| TelerehabilitationAn eight-week program including: * Endurance training on a cycle ergometer (performed independently with remote monitoring or through video conference, according to the participant's preference), three times per week. Training prescription is progressively adjusted using an automated algorithm (aimed to first increase the training duration and then workload intensity). * Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per week (thirty minutes). * Daily walking with automated coaching. * Self management education (one to nine sessions according to each individual needs, scheduled through videoconference). * A self evaluation of symptoms through daily or weekly questionnaires. Different types of alert will be triggered at the center according to remote monitoring: "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms". | Other | Clinical feasibility. |
Primary outcome
Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.
Time frame: Data will be recorded immediately after the intervention.
Comparison of paired datasets between the data recorded locally within the internal memory of the pulse oximeter and those collected from the telerehabilitation system.
Technical validity of the data transmitted remotely - physical activity tracker - concordance between datasets.
Time frame: Data will be recorded immediately after the intervention.
Comparison of paired dataset between the daily data, either automatically collected from the telerehabilitation system or self-reported by the participant (visually displayed on the physical activity tracker).
Technical validity of the data transmitted remotely - pulse oximeter - proportion of sessions transmitted.
Time frame: Data will be recorded immediately after the intervention.
The number of exercise sessions retrieved from the telerehabilitation system will be expressed in relation to the number of sessions performed.
Technical validity of the data transmitted remotely - physical activity tracker - proportion of sessions transmitted.
Time frame: Data will be recorded immediately after the intervention.
The number of days with physical activity data retrieved from the telerehabilitation system will be expressed in relation to the number of days that the tracker has been worn by the participant.
Technical validity of the data transmitted remotely - pulse oximeter - proportion of common usable data.
Time frame: Data will be recorded immediately after the intervention.
The proportion of data without artefacts will be compared between datasets. Artefacts will be identified for heart rate when values indicate two hundred fifty beats per minute and for transcutaneous oxygen saturation when values indicate hundred percent.
Technical validity of the data transmitted remotely - pulse oximeter - number of session required to be autonomous when using the system.
Time frame: Data will be recorded immediately after the intervention.
Participants will be taught to use the system and they will be requested to set data collection autonomously during the four next sessions. They will be considered autonomous when they will be able to set data collection autonomously without error. The number of sessions (after the first session) required to reach autonomy will be collected.
21 secondary outcomes
Endurance exercise capacity - constant workload exercise testing.
Time frame: Baseline and immediately after the intervention.
Endurance exercise capacity - six-minute walking test.
Time frame: Baseline and immediately after the intervention.
Endurance exercise capacity - six-minute stepper test.
Time frame: Baseline and immediately after the intervention.
Maximal voluntary isometric quadriceps force.
Time frame: Baseline and immediately after the intervention.
Self-reported quality of life.
Time frame: Baseline and immediately after the intervention.
Functional dyspnea.
Time frame: Baseline and immediately after the intervention.
Health status.
Time frame: Baseline and immediately after the intervention.
Anxiety.
Time frame: Baseline and immediately after the intervention.
Depression.
Time frame: Baseline and immediately after the intervention.
Cognitive Function.
Time frame: Baseline and immediately after the intervention.
Objective physical activity.
Time frame: Baseline and immediately after the intervention.
Adherence - exercise training.
Time frame: Data will be collected through study completion, an average of 8 weeks.
Adherence - self-management education.
Time frame: Data will be collected through study completion, an average of 8 weeks.
Adherence - symptoms monitoring questionnaires.
Time frame: Data will be collected through study completion, an average of 8 weeks.
Use of the telerehabilitation system.
Time frame: Data will be collected through study completion, an average of 8 weeks.
Usability of the system.
Time frame: Data will be collected immediately after the intervention.
Satisfaction - standardized questionnaire.
Time frame: Data will be collected immediately after the intervention.
Satisfaction - purpose designed survey.
Time frame: Data will be collected immediately after the intervention.
Emotional perception of the system.
Time frame: Data will be collected immediately after the intervention.
Participant's flow.
Time frame: Data will be collected immediately after the intervention.
Motivation to participate in the program using the telerehabilitation system.
Time frame: Data will be collected immediately after the intervention.
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 4 Sep 2025.
- Derived from this study: PubMed 42863686Sayegh JPE, Gravier FE, Clet A, Kerfourn A, Muir JF, Cuvelier A, Boujibar F, Banovic I, Dupont L, Viacroze C, Artaud-Macari E, McKeough Z, Bonnevie T. Technical and clinical feasibility of a pulmonary telerehabilitation model for people with COPD. Arch Phys Med Rehabil. 2026 Oct 12:S0003-9993(26)00945-7. doi: 10.1016/j.apmr.2026.10.001. Online ahead of print.
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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.
Tristan Bonnevie, PT, PhD principal investigator
ADIR Association, Rouen University, Rouen, France
Antoine Cuvelier, MD, Prof study chair
CHU-Hôpitaux de Rouen, Rouen, France.
Jean-François Muir, MD, Prof study chair
ADIR Association, Rouen, France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by ADIR Association at 1 site 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 14 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: finished, as of the sponsor's last update on 4 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 1 site 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?
Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets. (time frame: Data will be recorded immediately after the intervention.). The study lists 6 primary outcomes in all. 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 NCT05314686, 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 4 Sep 2025.