<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/NCT03228225</url>
  </required_header>
  <id_info>
    <org_study_id>SMC-17-4154</org_study_id>
    <nct_id>NCT03228225</nct_id>
  </id_info>
  <brief_title>Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1</brief_title>
  <official_title>Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk&#xD;
      according to national guidelines. We plan to gradually reduce the number of institution based&#xD;
      CR and increase the tele monitored exercise sessions performed in the community. Stress test&#xD;
      will be preformed before the intervention and after completing 6 month.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following the standard rehabilitation intake process (physician visit, nurse intake, exercise&#xD;
      physiologist consultation based on stress test and clinical data passed from the physician)&#xD;
      all subjects will begin their secondary prevention program including on-site supervised&#xD;
      training, nurse case management, plus dietitian and psychological consultation as necessary.&#xD;
      During the study weeks subjects will wear the smartwatch (Polar Inc.) in order to collect&#xD;
      de-identified data (heart rate, step count, walk speed etc.) and will upload data to the&#xD;
      Polar cloud. No medical data will be uploaded and subjects will only have a coded ID randomly&#xD;
      generated. During the exercise periods (both on-site in the cardiac rehabilitation institute,&#xD;
      and also during the recommended community exercise performed on their own).&#xD;
&#xD;
      Gradually, the number of on-site sessions will decrease from the standard of 8 sessions per&#xD;
      month to zero (each month after the first a reduction of 2 sessions). We plan to reduce the&#xD;
      on-site sessions while increasing the number of home-based session in order to evaluate the&#xD;
      ability to monitor, coach and dynamically adjust the exercise program by combined use of&#xD;
      smartwatch data and telephone contact. Polar exercise watch will be provided and appropriate&#xD;
      operation instructions and education will be given after informed consent.&#xD;
&#xD;
      During the 6 month study period we will contact subjects once or twice weekly in order to&#xD;
      encourage participation, fine-tune the exercise program and to assess secondary prevention&#xD;
      goals.&#xD;
&#xD;
      All subjects will undergo a stress test before and after 6 months of training part of the&#xD;
      standard of care management, as well as dietitian, physician and psychologist consultations&#xD;
      will be offered following the regular schedule of the standard rehabilitation program (at&#xD;
      baseline, 3 months and 6 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single arm non-blinded remote monitored multidisciplinary secondary prevention intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>6 months</time_frame>
    <description>Stress bases METS assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Questioner based assessment of program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to exercise program</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Amount of time exercising at the specified target heart rate zone per week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>QOL questioners</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device ease of use and technical difficulties</measure>
    <time_frame>1, 3 and 6 months</time_frame>
    <description>Questioners and transmission failures or usability issues</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Tele cardiac rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a standard intake process, patients will begin exercise in the institute and will gradually over a period of 6 months reduce the number of institution visits and will concomitantly increase the number of home \ community exercise sessions. During the entire period we will monitor program, coach and fine-tune the exercise program. Weekly exercise data will be securely transmitted to the rehabilitation team (heart rate zones, duration of exercise and type, step count, caloric expenditure, blood pressure and patients reported impressions)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele Cardiac Rehabilitation</intervention_name>
    <description>Comprehensive intervention according to the secondary prevention goals</description>
    <arm_group_label>Tele cardiac rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Coronary disease (S/p ACS, PCI, CABG or stable angina with documented coronary&#xD;
             disease)&#xD;
&#xD;
          -  Age ≥ 21&#xD;
&#xD;
          -  Smartphone with internet connection&#xD;
&#xD;
          -  Willing and able to comply with study protocol and&#xD;
&#xD;
          -  LVEF &gt; 40% and Baseline METS ≥ 5&#xD;
&#xD;
          -  Able to follow the personalized exercise prescription, utilize smartwatch and upload&#xD;
             exercise data per protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart failure (clinical) or unresolved significant arrhythmia (i.e. symptomatic atrial&#xD;
             fibrillation)&#xD;
&#xD;
          -  Significant neurological or cognitive impairment&#xD;
&#xD;
          -  Women of child-bearing potential&#xD;
&#xD;
          -  Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic&#xD;
             value &lt;100 mmHg without symptoms&#xD;
&#xD;
          -  ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or&#xD;
             having undergone CABG surgery within 30 days prior to screening&#xD;
&#xD;
          -  Inability to perform a CPET test due to physical limitations&#xD;
&#xD;
          -  Ischemia per stress test \ nuclear scan or stress echocardiography&#xD;
&#xD;
          -  Severe angina pectoris as defined by CCS &gt;2&#xD;
&#xD;
          -  Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung&#xD;
             involvement) or chronic pulmonary thromboembolic disease (CTED)&#xD;
&#xD;
          -  Severe orthopedic limitations&#xD;
&#xD;
          -  Active myocarditis, constrictive pericarditis, restrictive or hypertrophic&#xD;
             cardiomyopathy&#xD;
&#xD;
          -  Moderate or severe Aortic or Mitral stenosis, moderate or severe mitral regurgitation&#xD;
             due to primary valvular disease&#xD;
&#xD;
          -  Significant anemia (Hb &lt;10 mg/dl)&#xD;
&#xD;
          -  Known drug or alcohol dependence or any other factors which will interfere with the&#xD;
             study conduct or interpretation of the results or in the opinion of the investigator&#xD;
             are not suitable to participate;&#xD;
&#xD;
        Any illness which reduces life expectancy to less than 1 year from screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Meirav Moreno</last_name>
    <phone>97235302361</phone>
    <email>Merav.Moreno@sheba.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Klempfner, Prof.</last_name>
    <phone>97235303068</phone>
    <email>robert.klempfner@sheba.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Klempfner, Prof.</last_name>
    </contact>
    <contact_backup>
      <email>robert.klempfner@sheba.health.gov.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>June 24, 2018</last_update_submitted>
  <last_update_submitted_qc>June 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Robert Klempfner Heart Rehabilitation Institute</investigator_full_name>
    <investigator_title>Director of Cardiac rehabilitation institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03228225
org study id: SMC-17-4154
nct id: NCT03228225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk
      according to national guidelines. We plan to gradually reduce the number of institution based
      CR and increase the tele monitored exercise sessions performed in the community. Stress test
      will be preformed before the intervention and after completing 6 month.
Following the standard rehabilitation intake process (physician visit, nurse intake, exercise
      physiologist consultation based on stress test and clinical data passed from the physician)
      all subjects will begin their secondary prevention program including on-site supervised
      training, nurse case management, plus dietitian and psychological consultation as necessary.
      During the study weeks subjects will wear the smartwatch (Polar Inc.) in order to collect
      de-identified data (heart rate, step count, walk speed etc.) and will upload data to the
      Polar cloud. No medical data will be uploaded and subjects will only have a coded ID randomly
      generated. During the exercise periods (both on-site in the cardiac rehabilitation institute,
      and also during the recommended community exercise performed on their own).

      Gradually, the number of on-site sessions will decrease from the standard of 8 sessions per
      month to zero (each month after the first a reduction of 2 sessions). We plan to reduce the
      on-site sessions while increasing the number of home-based session in order to evaluate the
      ability to monitor, coach and dynamically adjust the exercise program by combined use of
      smartwatch data and telephone contact. Polar exercise watch will be provided and appropriate
      operation instructions and education will be given after informed consent.

      During the 6 month study period we will contact subjects once or twice weekly in order to
      encourage participation, fine-tune the exercise program and to assess secondary prevention
      goals.

      All subjects will undergo a stress test before and after 6 months of training part of the
      standard of care management, as well as dietitian, physician and psychologist consultations
      will be offered following the regular schedule of the standard rehabilitation program (at
      baseline, 3 months and 6 months).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single arm non-blinded remote monitored multidisciplinary secondary prevention intervention
primary purpose: Treatment
masking: None (Open Label)
measure: Exercise capacity
time frame: 6 months
description: Stress bases METS assessment
measure: Subject satisfaction
time frame: 3 and 6 months
description: Questioner based assessment of program
measure: Adherence to exercise program
time frame: 3 and 6 months
description: Amount of time exercising at the specified target heart rate zone per week
measure: Quality of life
time frame: 3 and 6 months
description: QOL questioners
measure: Device ease of use and technical difficulties
time frame: 1, 3 and 6 months
description: Questioners and transmission failures or usability issues
arm group label: Tele cardiac rehabilitation
arm group type: Experimental
description: Following a standard intake process, patients will begin exercise in the institute and will gradually over a period of 6 months reduce the number of institution visits and will concomitantly increase the number of home \ community exercise sessions. During the entire period we will monitor program, coach and fine-tune the exercise program. Weekly exercise data will be securely transmitted to the rehabilitation team (heart rate zones, duration of exercise and type, step count, caloric expenditure, blood pressure and patients reported impressions)
intervention type: Behavioral
intervention name: Tele Cardiac Rehabilitation
description: Comprehensive intervention according to the secondary prevention goals
arm group label: Tele cardiac rehabilitation
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Meirav Moreno
phone: 97235302361
email: Merav.Moreno@sheba.health.gov.il
last name: Robert Klempfner, Prof.
phone: 97235303068
email: robert.klempfner@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Robert Klempfner Heart Rehabilitation Institute
investigator title: Director of Cardiac rehabilitation institute
mesh term: Coronary Artery Disease
sharing ipd: Undecided