Chronic Obstructive Pulmonary DiseaseTELE-REHABNCT03004716
Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 1 site in France.
Trial summary
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease. The feasibility is assessed using the patient's satisfaction and it ease of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Telemedicine
- What is being tested?
- Aerobic training
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Who may be able to join
- Age > 18 years ;
- Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 < 80%) ;
- Referred for pulmonary rehabilitation.
Who cannot join
- Pregnant woman or likely to be ;
- Patient under guardianship ;
- Neuropathic disorder ;
- Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;
- Progressive cancer.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.
The feasibility is assessed using the patient's satisfaction and it ease of use.
The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.
- Being tested
- Aerobic training
- 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.
Aerobic trainingOther
5 consecutive patients with chronicle obstructive pulmonary disease are offered to participate in the protocol when they have reached 45 min of aerobic training during their pulmonary rehabilitation program.
During 5 sessions of 45 min, they are monitored with an oximeter device (Nonin 3150) which records heart rate (HR) and oxygen transcutaneous saturation (SpO2). The device also communicates with a telemedicine medical gateway which sends these data to a remote telemedicine center. Data are then provided on a secured online platform and compared with data recorded on the device (Nonin 3150).
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during a session of 45min for a total time frame 1h maximum.
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 2nd session of 45 of aerobic training.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during a session of 45min for a total time frame 1h maximum.
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 3rd session of 45 of aerobic training.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during a session of 45min for a total time frame 1h maximum.
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 4th session of 45 of aerobic training.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during a session of 45min for a total time frame 1h maximum.
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 5th session of 45 of aerobic training.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during a session of 45min for a total time frame 1h maximum.
Secondary outcomes (4)
Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Measured: HR is assessed during 5 training sessions of 45min for a total time frame of 2month.
Reliability of the telemedicine gateway in providing data.
Data will be collected at the end of every sessions. Final endpoint will be the reliability of the telemedicine Gateway in providing data through study completion (5sessions of 45min for 5 different patients).
Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions (n=25)
Measured: 5 sessions of 45min will be carried out for 5 patients for a total time frame of 4months. For every patient, sessions will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions).
Patient's satisfaction assessed by Likert scale.
Data will be presented as the patient's satisfaction of the system on the last of the 5 sessions at the end of the study.
Measured: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Outcome will be assessed during the final session of every patient.
Ability of the patients to be autonomous when using the device.
Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.
Measured: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Data will be collected after every sessions and presented as the number of patients autonomous when using the device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2017
- Study completionMar 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004716
- Sponsor's protocol ID
- TELE-REHAB
- Acronym
- TELE-REHAB
- Status last verified
- Mar 2017
- First submitted
- 21 Dec 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
Publications
Bonnevie T, Gravier FE, Elkins M, Dupuis J, Prieur G, Combret Y, Viacroze C, Debeaumont D, Robleda-Quesada A, Quieffin J, Lamia B, Patout M, Cuvelier A, Muir JF, Medrinal C, Tardif C. People undertaking pulmonary rehabilitation are willing and able to provide accurate data via a remote pulse oximetry system: a multicentre observational study. J Physiother. 2019 Jan;65(1):28-36. doi: 10.1016/j.jphys.2018.11.002. Epub 2018 Dec 17.
PubMed 30573441
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
- ClinicalTrials.gov ID
- NCT03004716
- Acronym / sponsor ID
- TELE-REHAB / TELE-REHAB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.
The feasibility is assessed using the patient's satisfaction and it ease of use.
The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Key inclusion criteria (3 listed)
- Age > 18 years ;
- Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 < 80%) ;
- Referred for pulmonary rehabilitation.
Key exclusion criteria (5 listed)
- Pregnant woman or likely to be ;
- Patient under guardianship ;
- Neuropathic disorder ;
- Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;
- Progressive cancer.
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 |
|---|---|---|
| Aerobic training5 consecutive patients with chronicle obstructive pulmonary disease are offered to participate in the protocol when they have reached 45 min of aerobic training during their pulmonary rehabilitation program. During 5 sessions of 45 min, they are monitored with an oximeter device (Nonin 3150) which records heart rate (HR) and oxygen transcutaneous saturation (SpO2). The device also communicates with a telemedicine medical gateway which sends these data to a remote telemedicine center. Data are then provided on a secured online platform and compared with data recorded on the device (Nonin 3150). | Other | – |
Primary outcome
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training.
Time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 2nd session of 45 of aerobic training.
Time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 3rd session of 45 of aerobic training.
Time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 4th session of 45 of aerobic training.
Time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 5th session of 45 of aerobic training.
Time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
4 secondary outcomes
Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.
Time frame: HR is assessed during 5 training sessions of 45min for a total time frame of 2month.
Reliability of the telemedicine gateway in providing data.
Time frame: 5 sessions of 45min will be carried out for 5 patients for a total time frame of 4months. For every patient, sessions will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions).
Patient's satisfaction assessed by Likert scale.
Time frame: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Outcome will be assessed during the final session of every patient.
Ability of the patients to be autonomous when using the device.
Time frame: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Data will be collected after every sessions and presented as the number of patients autonomous when using the device.
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 14 Mar 2017.
- Derived from this study: PubMed 30573441Bonnevie T, Gravier FE, Elkins M, Dupuis J, Prieur G, Combret Y, Viacroze C, Debeaumont D, Robleda-Quesada A, Quieffin J, Lamia B, Patout M, Cuvelier A, Muir JF, Medrinal C, Tardif C. People undertaking pulmonary rehabilitation are willing and able to provide accurate data via a remote pulse oximetry system: a multicentre observational study. J Physiother. 2019 Jan;65(1):28-36. doi: 10.1016/j.jphys.2018.11.002. Epub 2018 Dec 17.
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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.
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 and Pulmonary Rehabilitation, 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 3 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 14 Mar 2017. 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?
Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training. (time frame: HR is assessed during a session of 45min for a total time frame 1h maximum.). The study lists 5 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 NCT03004716, 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 14 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.