<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/NCT03247933</url>
  </required_header>
  <id_info>
    <org_study_id>TELEREHAB</org_study_id>
    <nct_id>NCT03247933</nct_id>
  </id_info>
  <brief_title>TELEMEDICINE,Maintenance of a Respiratory Rehabilitation Program in Patients With Chronic Obstructive Pulmonary Disease.</brief_title>
  <acronym>TELEREHAB</acronym>
  <official_title>&quot;Clinical Trial Randomized, Controlled, Parallel-group and Open About the Use of&quot;TELEMEDICINE&quot;in the Management of the Maintenance of a Respiratory Rehabilitation Program Phase in Patients With Chronic Respiratory Diseases&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JUAN B GALDIZ ITURRI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Cruces</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Cruces</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic&#xD;
      Obstructive Pulmonary Disease (COPD) with a degree of evidence A.&#xD;
&#xD;
      These benefits are primarily focused on an increase in the capacity of effort for activities&#xD;
      of daily living and in an improvement in the quality of life related to health (HRQOL) a&#xD;
      constant to the RR critique is the fact that the benefits achieved with programmes are lost&#xD;
      in a progressive and constant way once the patient completes the treatment and lost contact&#xD;
      with the team.&#xD;
&#xD;
      The introduction of new technologies in different fields of medicine has been a new approach&#xD;
      when it comes to the management of various diseases and treatments in chronic patients. In&#xD;
      the case of the RR telemedicine provides a new tool.&#xD;
&#xD;
      COPD disease very prevalent and chronic it is generator of a high economic cost. The&#xD;
      possibility of universalizing the rehabilitation treatment would involve a potential savings&#xD;
      in this population group ,another potential benefit is as translational trial as part of the&#xD;
      development of a new technology and its possible application to clinical practice.&#xD;
&#xD;
      General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory&#xD;
      Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful&#xD;
      intervention against the current usual strategy (intensive program of RR and a recommendation&#xD;
      of not protected maintenance program).&#xD;
&#xD;
      Method: clinical trial , open, randomized, multicenter, parallel group, and focus of&#xD;
      superiority with a strategy of Telerehabilitation program respiratory of maintenance after an&#xD;
      intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD&#xD;
      (Bode 3-7).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. SELECTION AND WITHDRAWAL OF SUBJECTS&#xD;
&#xD;
           1.1 INCLUSION CRITERIA&#xD;
&#xD;
           To be eligible to participate in this study, subjects must meet the following inclusion&#xD;
           criteria:&#xD;
&#xD;
           Patients diagnosed with COPD aged less than 75 years BODE index of 3-7 clinical&#xD;
           stability, understood as not having an exacerbation (*) of the COPD and not require&#xD;
           treatment with antibiotics, corticoids systemic and/or hospitalization, at least 1 month&#xD;
           prior to inclusion in the study. You have been reported to the subject and has been&#xD;
           given sufficient time and opportunity to consider their participation has given its&#xD;
           consent in writing. Able to use technology the subject is willing and is able to meet&#xD;
           all the requirements of the study.&#xD;
&#xD;
           (*) Exacerbation: Exacerbation means worsening of two or more of the following main&#xD;
           symptoms for at least 2 consecutive days:&#xD;
&#xD;
           Increase in volume of sputum, sputum Purulence ,Dyspnea&#xD;
&#xD;
           or&#xD;
&#xD;
           • Worsening of any main symptom along with one of the following symptoms for at least 2&#xD;
           consecutive days.&#xD;
&#xD;
             -  Resfriado (rinorrea y/o congestión nasal)&#xD;
&#xD;
             -  Fever without any other cause&#xD;
&#xD;
             -  Cough&#xD;
&#xD;
             -  Wheezing&#xD;
&#xD;
           1.2 Exclusion criteria&#xD;
&#xD;
           Patients who have any of the following exclusion criteria may not be included in the&#xD;
           trial:&#xD;
&#xD;
           • Presence of osteo-muscular pathology that limit or preclude the exercises. Presence of&#xD;
           heart disease which hinders exercise. Patients with bronchiectasis or other respiratory&#xD;
           disorders other than COPD. Comorbidity who hinders or blocks the making of respiratory&#xD;
           rehabilitation of maintenance program. Less than 2 years life expectancy.&#xD;
&#xD;
           Any unstable medical or psychiatric process or substance abuse which, in the opinion of&#xD;
           the investigator, would affect the ability of the patient to complete the study or&#xD;
           impede their participation in the same&#xD;
&#xD;
           Withdrawal of subjects and procedures criteria&#xD;
&#xD;
           Patients may leave the study at any time. Each month the researcher will check filling&#xD;
           in each patient assigned to the experimental group respiratory rehabilitation program.&#xD;
           If a patient does not fill this program for 2 consecutive months, excluding&#xD;
           impossibility for clinical situation and medical criteria, will be removed from the&#xD;
           study.&#xD;
&#xD;
           In addition respiratory rehabilitation maintenance in both treatment groups will be&#xD;
           suspended if any adverse events that justify it at the discretion of the investigator.&#xD;
&#xD;
           If so, the follow-up of the patients will continue also to analyze the results according&#xD;
           to an intention of treatment strategy.La retirada de los sujetos así como sus motivos&#xD;
           quedará reflejada tanto en el historial clínico como en el cuaderno de recogida de&#xD;
           datos.&#xD;
&#xD;
           Any death that occurs during the performance of the EC must be notified immediately to&#xD;
           the promoter and the competent Ethics Committee.&#xD;
&#xD;
           Withdrawals of subjects is not replaced&#xD;
&#xD;
        2. PROTOCOL TREATMENT&#xD;
&#xD;
      The information sheet will be delivered to the patient all of those potentially eligible&#xD;
      patients according to the inclusion criteria marked and no exclusion criteria (point 6) let&#xD;
      them the time needed to read the document and make all ask them as necessary. If the patient&#xD;
      decides to participate in the trial, it will ask you to sign the informed consent form.&#xD;
&#xD;
      SELECTION VISIT&#xD;
&#xD;
      This visit will include the test data for patients diagnosed with COPD, which includes:&#xD;
      &quot;history: on the scale of MRC Dyspnoea score&quot; &quot;physical examination: weight, height, body&#xD;
      mass index, brachial perimeter crease triceps and quadriceps strength &quot; X-ray of thorax and&#xD;
      electrocardiogram respiratory function tests (spirometry, Lung volumes, transfer to CO,&#xD;
      maximum respiratory pressure and blood gas capacity) maximum questionnaire of quality of&#xD;
      life-related lower-limb exercise test with the Health: CRQ (self-administered version), and&#xD;
      SF-36 test of 6 minutes 6 minutes walking test with assessment of breathlessness to the&#xD;
      effort using the Borg scale at the beginning and at the end of six minutes the BODE index&#xD;
      calculation test&#xD;
&#xD;
      Criteria of Inclusion / Exclusion criteria, information to the patient and informed consent&#xD;
      signature, indicating date&#xD;
&#xD;
      On this visit the code of patient will be assigned to each of the patients who accept to&#xD;
      participate in the trial and that sign the informed consent&#xD;
&#xD;
      INTENSIVE REHABILITATION (RRi) (8 weeks- ± 4 days)&#xD;
&#xD;
      Once signed the informed consent (CI) the patient will receive an initial program of&#xD;
      intensive RR (hospital-based program standard according to usual practice) participate in&#xD;
      this phase all the patients in the study and will receive equal treatment. This program will&#xD;
      be taught in groups of 5 patients (approx) and will last a total of 8 weeks. Patients will&#xD;
      have to go to the hospital 3 hours/d 3 days per week where respiratory rehabilitation program&#xD;
      will be intensive.&#xD;
&#xD;
      The program will include the following sections.&#xD;
&#xD;
        1. Education: 4 sessions on knowledge of the disease and medication management learning.&#xD;
&#xD;
        2. General physiotherapy: teach to make the diaphragmatic breathing, drainage of secretions&#xD;
           (if applicable) and relaxation techniques.&#xD;
&#xD;
        3. Muscle training:&#xD;
&#xD;
      3.a.-upper extremity muscles: will be weight-bearing exercises. The initial charge will be&#xD;
      500gr and will increase progressively depending on the tolerance of the patient. The training&#xD;
      time will be 30 minutes.&#xD;
&#xD;
      3.b.-lower extremity muscles: will be made with an antispasm. The initial charge will be 50%&#xD;
      of the maximum load in the progressive stress test. The workload according to the tolerance&#xD;
      of the patient will subsequently increase. The training time will be also of 30 minutes&#xD;
&#xD;
      MAINTENANCE CALENDAR (Visits)&#xD;
&#xD;
      RANDOMIZATION visit (V0) (assignment to the maintenance group)&#xD;
&#xD;
      Once completed the intensive treatment of RR, that same day, all patients participating in&#xD;
      the trial will be distributed randomly to one of the two groups of RR for maintenance&#xD;
      treatment:&#xD;
&#xD;
      -GR1 (TeleRR): will receive an RR of maintenance program with use of support for telemedicine&#xD;
      (TeleRR) all of them will be prescribed treatment program at his own home by the doctor,&#xD;
      initially very similar to the received in the hospital phase.&#xD;
&#xD;
      Them will be provided the material for the realization of the programme of RR: exercise bike,&#xD;
      weights / cufflinks mobile device (PDA/Smartphone) + Pulse Oximeter.&#xD;
&#xD;
      You will indicate them to perform exercises prescribed by your doctor as treatment and that&#xD;
      they complete training on the mobile device data. The patient should be sending the data of&#xD;
      all the days that are scheduled training exercises once have been completed.&#xD;
&#xD;
      -GR2 (control): receive a recommendation from a standard respiratory rehabilitation program&#xD;
      with a minimum monitoring, similar to routine clinical practice.&#xD;
&#xD;
      FOLLOW UP VISITS&#xD;
&#xD;
      In total and after completion of the period of intensive RR, will be planned 3 follow-up&#xD;
      visits that may be NO face-to-face or face-to-face and/or ON - LINE:&#xD;
&#xD;
      Visit 1 - tracking: 3 months (± 1 week) after the last visit of randomization (V0).&#xD;
&#xD;
      Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0).&#xD;
&#xD;
      Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0), ending&#xD;
      the involvement of the patient in the study&#xD;
&#xD;
      NON FACE TO FACE MONITORING&#xD;
&#xD;
      For all visits and patients the participants held a non-contact clinical follow-up through&#xD;
      information systems corresponding in each of the participating centres. Information to pick&#xD;
      up will be:&#xD;
&#xD;
      If there has been a neglect of the RR maintenance, and if it was so, what have been the&#xD;
      causes. If there is a hospital income since the last visit if there is an entry in the&#xD;
      emergency room since the last visit If there are visits to unscheduled primary care by&#xD;
      exacerbation&#xD;
&#xD;
      FACE TO FACE VISITS&#xD;
&#xD;
      In addition to tracking is not face-to-face, there will be a face-to-face follow-up&#xD;
      extraordinary for participating in the trial and that will depend on the group that has been&#xD;
      assigned the patient in which the following tests will be carried out:&#xD;
&#xD;
      - Visit 1 -: 3 months (± 1 week) after the last visit of randomization (V0).&#xD;
&#xD;
      Experimental Group GR1:&#xD;
&#xD;
        -  Physical examination: weight, height and body mass index.&#xD;
&#xD;
        -  Respiratory function tests (spirometry, Lung volumes, transfer to CO, maximum&#xD;
           respiratory pressure and blood gas capacity) quality of life health-related&#xD;
           questionnaires: CRQ (self-administered version), and SF-36&#xD;
&#xD;
        -  Six minutes walking test, assessment of breathlessness to the effort using the Borg&#xD;
           scale at the beginning and at the end of six minutes the BODE index calculation test and&#xD;
           adverse events or adverse reactions that have been able to present during the period&#xD;
           since the previous visit&#xD;
&#xD;
      Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0):&#xD;
&#xD;
      Experimental Group GR1 :&#xD;
&#xD;
      Physical examination: weight, height and body mass index. Respiratory function tests&#xD;
      (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas&#xD;
      capacity) quality of life health-related questionnaires: CRQ (self-administered version), and&#xD;
      SF-36 test of 6 minutes of the March assessment of breathlessness to the effort using the&#xD;
      Borg scale at the beginning and at the end of six minutes the BODE index calculation test&#xD;
      adverse events or adverse reactions that have been able to present during the period from the&#xD;
      previous visit.&#xD;
&#xD;
      Control Group GR2:&#xD;
&#xD;
      • Quality of life health-related questionnaires: CRQ (self-administered version), and SF-36&#xD;
      the 6-minute walking test&#xD;
&#xD;
      - Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0),&#xD;
      where there will be the following&#xD;
&#xD;
      Both Groups GR1 and GR2:&#xD;
&#xD;
      Physical examination: weight, height and body mass index. Respiratory function tests&#xD;
      (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas&#xD;
      capacity) quality of life health-related questionnaires: CRQ (self-administered version), and&#xD;
      SF-36 6MWT, assessment of breathlessness to the effort using the Borg scale at the beginning&#xD;
      and at the end of six minutes the BODE index calculation test and adverse events or adverse&#xD;
      reactions that have been able to present during the period from the previous visit.&#xD;
&#xD;
      ON-LINE FOLLOW UP&#xD;
&#xD;
      Experimental Group GR1&#xD;
&#xD;
      ONLY for patients in the Experimental group, there will be a monitoring On - Line monthly by&#xD;
      filling in Telerhabilitacion RR program through the reception of data from the mobile device&#xD;
      to the patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 24, 2017</completion_date>
  <primary_completion_date type="Actual">February 24, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Coded databases</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months</measure>
    <time_frame>One Year</time_frame>
    <description>a).Effectiveness of an Tele Respiratory Rehabiltation program in the maintenance of benefits after an intensive respiratory rehabilitation. outcomes:A/ the distancecovered (meters) in the 6m Walking test B/ health quality questionnaires. Specific respiratory questionaire (CRQ); General questionaire (SF 36) after 12 months of maintenance program.C/Changes in the multidimensional scale BODE.&#xD;
TeleRR program is clinically effective in the medium and long term by keeping the initial benefits of the intensive RR in aspects such as the capacity of effort (distance in meters), HRQOL and BODE .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific objective: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] .Safety of TeleRehab (mortality an serious events due related to the program)</measure>
    <time_frame>One year</time_frame>
    <description>Safety of TeleRehab defined as directly events related with the program (Injury ,cardiac events, mortality and other events caused during the exercise program),data was recorded in the CRD</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory objective : To assess the cost effectiveness of the experimental strategy vs the usual approach (Time frame One year)</measure>
    <time_frame>Two Years</time_frame>
    <description>Exploratory objective : Evaluate the efficiency between the usual approach and experimental strategy (including the TeleRR program) doing an analysis cost effectiveness</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Telemedicine (TeleRR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance Respiratory Rehabilitation supported by telemedicine (TeleRR).&#xD;
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.&#xD;
The exercises dates must be sent after doing the training each day by the PDA . The dates will be monitoring by the physician .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Practice (Recommendation)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring.&#xD;
Clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine: Maintenance Respiratory Rehabilitation</intervention_name>
    <description>Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance respiratory rehabilitation supported by telemedicine (TeleRR).&#xD;
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.&#xD;
They will be in their homes doing the program of treatment prescribed by the physician. They will be provided with the material that is needed: 1 static bicycle, 2-weights / cufflinks, 3-device mobile (smartphone/PDA) + Pulse Oximeter.&#xD;
The patient must send the exercises every day that are scheduled training exercises once have been completed.</description>
    <arm_group_label>Telemedicine (TeleRR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients with COPD&#xD;
&#xD;
          2. age 8 and 75 (both included)&#xD;
&#xD;
          3. index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and&#xD;
             Exercise)&#xD;
&#xD;
          4. clinical stability, understood as not having an exacerbation (*) of the COPD and do&#xD;
             not require treatment with antibiotics, corticoids systemic and/or hospitalization, at&#xD;
             least in the 30 days prior to their inclusion&#xD;
&#xD;
          5. has given his consent&#xD;
&#xD;
          6. capable of using technology&#xD;
&#xD;
          7. the subject is willing and is able to meet all the requirements of the study. *&#xD;
             Exacerbation : Exacerbation means worsening of two or more of the following main&#xD;
             symptoms for at least 2 consecutive days: dyspnea, volume of sputum; Sputum purulence&#xD;
             o worsening of any main symptom along with one of the following symptoms for at least&#xD;
             2 consecutive days: sore throat; Cold ( nasal congestion); Fever without any other&#xD;
             cause; Cough; Wheezing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Osteo-muscular pathology that limit or preclude the exercises&#xD;
&#xD;
          2. Presence of heart disease which limit exercise program&#xD;
&#xD;
          3. patients with bronchiectasis or other several of COPD respiratory disorders&#xD;
&#xD;
          4. comorbidity that prevent respiratory rehabilitation of maintenance program&#xD;
&#xD;
          5. less than 2 years life expectancy&#xD;
&#xD;
          6. any unstable medical or psychiatric process or substance abuse which, in the opinion&#xD;
             of the investigator, would affect the ability of the patient to complete the study or&#xD;
             impede their participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JUAN B GALDIZ ITURRI, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cruces University Hospital, Biocruces Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cruces University Hospital, Biocruces Institute</name>
      <address>
        <city>Barakaldo</city>
        <state>Bizkaia</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 15, 2015</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Cruces</investigator_affiliation>
    <investigator_full_name>JUAN B GALDIZ ITURRI</investigator_full_name>
    <investigator_title>PhD- Neumologist</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>RESPIRATORY REHABILITATION TELEMEDICINE</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03247933
org study id: TELEREHAB
nct id: NCT03247933
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic
      Obstructive Pulmonary Disease (COPD) with a degree of evidence A.

      These benefits are primarily focused on an increase in the capacity of effort for activities
      of daily living and in an improvement in the quality of life related to health (HRQOL) a
      constant to the RR critique is the fact that the benefits achieved with programmes are lost
      in a progressive and constant way once the patient completes the treatment and lost contact
      with the team.

      The introduction of new technologies in different fields of medicine has been a new approach
      when it comes to the management of various diseases and treatments in chronic patients. In
      the case of the RR telemedicine provides a new tool.

      COPD disease very prevalent and chronic it is generator of a high economic cost. The
      possibility of universalizing the rehabilitation treatment would involve a potential savings
      in this population group ,another potential benefit is as translational trial as part of the
      development of a new technology and its possible application to clinical practice.

      General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory
      Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful
      intervention against the current usual strategy (intensive program of RR and a recommendation
      of not protected maintenance program).

      Method: clinical trial , open, randomized, multicenter, parallel group, and focus of
      superiority with a strategy of Telerehabilitation program respiratory of maintenance after an
      intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD
      (Bode 3-7).
1. SELECTION AND WITHDRAWAL OF SUBJECTS

           1.1 INCLUSION CRITERIA

           To be eligible to participate in this study, subjects must meet the following inclusion
           criteria:

           Patients diagnosed with COPD aged less than 75 years BODE index of 3-7 clinical
           stability, understood as not having an exacerbation (*) of the COPD and not require
           treatment with antibiotics, corticoids systemic and/or hospitalization, at least 1 month
           prior to inclusion in the study. You have been reported to the subject and has been
           given sufficient time and opportunity to consider their participation has given its
           consent in writing. Able to use technology the subject is willing and is able to meet
           all the requirements of the study.

           (*) Exacerbation: Exacerbation means worsening of two or more of the following main
           symptoms for at least 2 consecutive days:

           Increase in volume of sputum, sputum Purulence ,Dyspnea

           or

           • Worsening of any main symptom along with one of the following symptoms for at least 2
           consecutive days.

             -  Resfriado (rinorrea y/o congestión nasal)

             -  Fever without any other cause

             -  Cough

             -  Wheezing

           1.2 Exclusion criteria

           Patients who have any of the following exclusion criteria may not be included in the
           trial:

           • Presence of osteo-muscular pathology that limit or preclude the exercises. Presence of
           heart disease which hinders exercise. Patients with bronchiectasis or other respiratory
           disorders other than COPD. Comorbidity who hinders or blocks the making of respiratory
           rehabilitation of maintenance program. Less than 2 years life expectancy.

           Any unstable medical or psychiatric process or substance abuse which, in the opinion of
           the investigator, would affect the ability of the patient to complete the study or
           impede their participation in the same

           Withdrawal of subjects and procedures criteria

           Patients may leave the study at any time. Each month the researcher will check filling
           in each patient assigned to the experimental group respiratory rehabilitation program.
           If a patient does not fill this program for 2 consecutive months, excluding
           impossibility for clinical situation and medical criteria, will be removed from the
           study.

           In addition respiratory rehabilitation maintenance in both treatment groups will be
           suspended if any adverse events that justify it at the discretion of the investigator.

           If so, the follow-up of the patients will continue also to analyze the results according
           to an intention of treatment strategy.La retirada de los sujetos así como sus motivos
           quedará reflejada tanto en el historial clínico como en el cuaderno de recogida de
           datos.

           Any death that occurs during the performance of the EC must be notified immediately to
           the promoter and the competent Ethics Committee.

           Withdrawals of subjects is not replaced

        2. PROTOCOL TREATMENT

      The information sheet will be delivered to the patient all of those potentially eligible
      patients according to the inclusion criteria marked and no exclusion criteria (point 6) let
      them the time needed to read the document and make all ask them as necessary. If the patient
      decides to participate in the trial, it will ask you to sign the informed consent form.

      SELECTION VISIT

      This visit will include the test data for patients diagnosed with COPD, which includes:
      "history: on the scale of MRC Dyspnoea score" "physical examination: weight, height, body
      mass index, brachial perimeter crease triceps and quadriceps strength " X-ray of thorax and
      electrocardiogram respiratory function tests (spirometry, Lung volumes, transfer to CO,
      maximum respiratory pressure and blood gas capacity) maximum questionnaire of quality of
      life-related lower-limb exercise test with the Health: CRQ (self-administered version), and
      SF-36 test of 6 minutes 6 minutes walking test with assessment of breathlessness to the
      effort using the Borg scale at the beginning and at the end of six minutes the BODE index
      calculation test

      Criteria of Inclusion / Exclusion criteria, information to the patient and informed consent
      signature, indicating date

      On this visit the code of patient will be assigned to each of the patients who accept to
      participate in the trial and that sign the informed consent

      INTENSIVE REHABILITATION (RRi) (8 weeks- ± 4 days)

      Once signed the informed consent (CI) the patient will receive an initial program of
      intensive RR (hospital-based program standard according to usual practice) participate in
      this phase all the patients in the study and will receive equal treatment. This program will
      be taught in groups of 5 patients (approx) and will last a total of 8 weeks. Patients will
      have to go to the hospital 3 hours/d 3 days per week where respiratory rehabilitation program
      will be intensive.

      The program will include the following sections.

        1. Education: 4 sessions on knowledge of the disease and medication management learning.

        2. General physiotherapy: teach to make the diaphragmatic breathing, drainage of secretions
           (if applicable) and relaxation techniques.

        3. Muscle training:

      3.a.-upper extremity muscles: will be weight-bearing exercises. The initial charge will be
      500gr and will increase progressively depending on the tolerance of the patient. The training
      time will be 30 minutes.

      3.b.-lower extremity muscles: will be made with an antispasm. The initial charge will be 50%
      of the maximum load in the progressive stress test. The workload according to the tolerance
      of the patient will subsequently increase. The training time will be also of 30 minutes

      MAINTENANCE CALENDAR (Visits)

      RANDOMIZATION visit (V0) (assignment to the maintenance group)

      Once completed the intensive treatment of RR, that same day, all patients participating in
      the trial will be distributed randomly to one of the two groups of RR for maintenance
      treatment:

      -GR1 (TeleRR): will receive an RR of maintenance program with use of support for telemedicine
      (TeleRR) all of them will be prescribed treatment program at his own home by the doctor,
      initially very similar to the received in the hospital phase.

      Them will be provided the material for the realization of the programme of RR: exercise bike,
      weights / cufflinks mobile device (PDA/Smartphone) + Pulse Oximeter.

      You will indicate them to perform exercises prescribed by your doctor as treatment and that
      they complete training on the mobile device data. The patient should be sending the data of
      all the days that are scheduled training exercises once have been completed.

      -GR2 (control): receive a recommendation from a standard respiratory rehabilitation program
      with a minimum monitoring, similar to routine clinical practice.

      FOLLOW UP VISITS

      In total and after completion of the period of intensive RR, will be planned 3 follow-up
      visits that may be NO face-to-face or face-to-face and/or ON - LINE:

      Visit 1 - tracking: 3 months (± 1 week) after the last visit of randomization (V0).

      Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0).

      Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0), ending
      the involvement of the patient in the study

      NON FACE TO FACE MONITORING

      For all visits and patients the participants held a non-contact clinical follow-up through
      information systems corresponding in each of the participating centres. Information to pick
      up will be:

      If there has been a neglect of the RR maintenance, and if it was so, what have been the
      causes. If there is a hospital income since the last visit if there is an entry in the
      emergency room since the last visit If there are visits to unscheduled primary care by
      exacerbation

      FACE TO FACE VISITS

      In addition to tracking is not face-to-face, there will be a face-to-face follow-up
      extraordinary for participating in the trial and that will depend on the group that has been
      assigned the patient in which the following tests will be carried out:

      - Visit 1 -: 3 months (± 1 week) after the last visit of randomization (V0).

      Experimental Group GR1:

        -  Physical examination: weight, height and body mass index.

        -  Respiratory function tests (spirometry, Lung volumes, transfer to CO, maximum
           respiratory pressure and blood gas capacity) quality of life health-related
           questionnaires: CRQ (self-administered version), and SF-36

        -  Six minutes walking test, assessment of breathlessness to the effort using the Borg
           scale at the beginning and at the end of six minutes the BODE index calculation test and
           adverse events or adverse reactions that have been able to present during the period
           since the previous visit

      Visit 2 - follow-up: 9 months (± 2 weeks) after the last visit of randomization (V0):

      Experimental Group GR1 :

      Physical examination: weight, height and body mass index. Respiratory function tests
      (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas
      capacity) quality of life health-related questionnaires: CRQ (self-administered version), and
      SF-36 test of 6 minutes of the March assessment of breathlessness to the effort using the
      Borg scale at the beginning and at the end of six minutes the BODE index calculation test
      adverse events or adverse reactions that have been able to present during the period from the
      previous visit.

      Control Group GR2:

      • Quality of life health-related questionnaires: CRQ (self-administered version), and SF-36
      the 6-minute walking test

      - Visit 3 - follow-up: 12 months (± 2 weeks) after the last visit of randomization (V0),
      where there will be the following

      Both Groups GR1 and GR2:

      Physical examination: weight, height and body mass index. Respiratory function tests
      (spirometry, Lung volumes, transfer to CO, maximum respiratory pressure and blood gas
      capacity) quality of life health-related questionnaires: CRQ (self-administered version), and
      SF-36 6MWT, assessment of breathlessness to the effort using the Borg scale at the beginning
      and at the end of six minutes the BODE index calculation test and adverse events or adverse
      reactions that have been able to present during the period from the previous visit.

      ON-LINE FOLLOW UP

      Experimental Group GR1

      ONLY for patients in the Experimental group, there will be a monitoring On - Line monthly by
      filling in Telerhabilitacion RR program through the reception of data from the mobile device
      to the patient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Coded databases
measure: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months
time frame: One Year
description: a).Effectiveness of an Tele Respiratory Rehabiltation program in the maintenance of benefits after an intensive respiratory rehabilitation. outcomes:A/ the distancecovered (meters) in the 6m Walking test B/ health quality questionnaires. Specific respiratory questionaire (CRQ); General questionaire (SF 36) after 12 months of maintenance program.C/Changes in the multidimensional scale BODE.
TeleRR program is clinically effective in the medium and long term by keeping the initial benefits of the intensive RR in aspects such as the capacity of effort (distance in meters), HRQOL and BODE .
measure: Specific objective: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] .Safety of TeleRehab (mortality an serious events due related to the program)
time frame: One year
description: Safety of TeleRehab defined as directly events related with the program (Injury ,cardiac events, mortality and other events caused during the exercise program),data was recorded in the CRD
measure: Exploratory objective : To assess the cost effectiveness of the experimental strategy vs the usual approach (Time frame One year)
time frame: Two Years
description: Exploratory objective : Evaluate the efficiency between the usual approach and experimental strategy (including the TeleRR program) doing an analysis cost effectiveness
arm group label: Telemedicine (TeleRR)
arm group type: Experimental
description: The intervention: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance Respiratory Rehabilitation supported by telemedicine (TeleRR).
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
The exercises dates must be sent after doing the training each day by the PDA . The dates will be monitoring by the physician .
arm group label: Clinical Practice (Recommendation)
arm group type: No Intervention
description: No intervention. A recommendation from standard maintenance respiratory rehabilitation program with a minimum monitoring.
Clinical practice.
intervention type: Device
intervention name: Telemedicine: Maintenance Respiratory Rehabilitation
description: Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance respiratory rehabilitation supported by telemedicine (TeleRR).
A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
They will be in their homes doing the program of treatment prescribed by the physician. They will be provided with the material that is needed: 1 static bicycle, 2-weights / cufflinks, 3-device mobile (smartphone/PDA) + Pulse Oximeter.
The patient must send the exercises every day that are scheduled training exercises once have been completed.
arm group label: Telemedicine (TeleRR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: JUAN B GALDIZ ITURRI, PhD
role: Study Chair
affiliation: Cruces University Hospital, Biocruces Institute
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital de Cruces
investigator full name: JUAN B GALDIZ ITURRI
investigator title: PhD- Neumologist
sharing ipd: No