<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004716</url>
  </required_header>
  <id_info>
    <org_study_id>TELE-REHAB</org_study_id>
    <nct_id>NCT03004716</nct_id>
  </id_info>
  <brief_title>Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System</brief_title>
  <acronym>TELE-REHAB</acronym>
  <official_title>Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ADIR Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ADIR Association</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the feasibility and the reliability of a&#xD;
      telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive&#xD;
      pulmonary disease.&#xD;
&#xD;
      The feasibility is assessed using the patient's satisfaction and it ease of use.&#xD;
&#xD;
      The reliability of the remote telemonitoring system is assessed comparing the local data&#xD;
      (extracted from the monitoring device itself) and the data transmitted through the&#xD;
      telemonitoring platform.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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.</measure>
    <time_frame>HR is assessed during a session of 45min for a total time frame 1h maximum.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <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 2nd session of 45 of aerobic training.</measure>
    <time_frame>HR is assessed during a session of 45min for a total time frame 1h maximum.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <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 3rd session of 45 of aerobic training.</measure>
    <time_frame>HR is assessed during a session of 45min for a total time frame 1h maximum.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <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 4th session of 45 of aerobic training.</measure>
    <time_frame>HR is assessed during a session of 45min for a total time frame 1h maximum.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <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 5th session of 45 of aerobic training.</measure>
    <time_frame>HR is assessed during a session of 45min for a total time frame 1h maximum.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.</measure>
    <time_frame>HR is assessed during 5 training sessions of 45min for a total time frame of 2month.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of the telemedicine gateway in providing data.</measure>
    <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).</time_frame>
    <description>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).&#xD;
Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions (n=25)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction assessed by Likert scale.</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of the patients to be autonomous when using the device.</measure>
    <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.</time_frame>
    <description>Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.</description>
  </secondary_outcome>
  <enrollment type="Actual">5</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Pulmonary Rehabilitation</condition>
  <condition>Telemedicine</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>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.&#xD;
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).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronicle obstructive pulmonary disease reffered for pulmonary&#xD;
        rehabilitation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years ;&#xD;
&#xD;
          -  Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 &lt; 80%) ;&#xD;
&#xD;
          -  Referred for pulmonary rehabilitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman or likely to be ;&#xD;
&#xD;
          -  Patient under guardianship ;&#xD;
&#xD;
          -  Neuropathic disorder ;&#xD;
&#xD;
          -  Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;&#xD;
&#xD;
          -  Progressive cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ADIR Association</name>
      <address>
        <city>Bois-Guillaume</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004716
org study id: TELE-REHAB
nct id: NCT03004716
lead sponsor: 
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.
observational model: Cohort
time perspective: Prospective
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.
description: 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).
measure: 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.
description: 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).
measure: 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.
description: 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).
measure: 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.
description: 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).
measure: 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.
description: 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).
measure: 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.
description: 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).
measure: 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).
description: 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)
measure: 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.
description: 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.
measure: 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.
description: Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.
intervention type: Other
intervention name: Aerobic training
description: 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).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive