<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/NCT04458727</url>
  </required_header>
  <id_info>
    <org_study_id>EPICURE</org_study_id>
    <nct_id>NCT04458727</nct_id>
  </id_info>
  <brief_title>Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease</brief_title>
  <acronym>EPICURE</acronym>
  <official_title>Auswertung Von Multi-modalen unterstützenden Maßnahmen in Der Ambulant Kardiologischen Rehabilitation Bei Patienten Mit Einer kardiovaskulären Erkrankung</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AIT Austrian Institute of Technology GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medreha GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZARG - Zentrum für ambulante Rehabilitation Graz GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>REHAmed-tirol GmbH Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universität Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AIT Austrian Institute of Technology GmbH</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>
      Cariovascular diseases (CVD) are the most common cause of death worldwide with high micro- as&#xD;
      well as macro-economic burden. Several modifiable risk factors increase the probability of&#xD;
      contracting a CVE. These risk factors can be positively influenced by a cardiac&#xD;
      rehabilitation measure (CR), which has been shown to reduce mortality in CVD patients and to&#xD;
      reduce the economic burden. An increase in physical activity and performance are central&#xD;
      goals in CR, as they have a positive effect on several cardiovascular risk factors and&#xD;
      correlate strongly with a reduction in mortality in CVD patients. These goals can be achieved&#xD;
      in most CVD patients but can only be achieved by a modification of lifestyle.&#xD;
&#xD;
      In order to positively influence this lifestyle modification beyond the duration of the CR&#xD;
      measure and thus in the long term, CR Phase II should begin as soon as the patient fulfils&#xD;
      one of the well-defined inclusion criteria. CR Phase II can be carried out as an inpatient or&#xD;
      outpatient procedure and depends on the patient's state of health, personal preference and&#xD;
      availability of an outpatient CR facility in the vicinity of the patient. In the Austrian&#xD;
      healthcare system, inpatient CR and thus differs from other European countries. After&#xD;
      completion of phase II, the patient is offered an outpatient phase III with weekly visits to&#xD;
      the outpatient CR facility, so that lifestyle changes achieved at short notice can be&#xD;
      sustainably maintained.&#xD;
&#xD;
      For the secondary prevention of the CVD beyond the CR measure recommend international&#xD;
      guidelines a physical activity of ≥ 150 min with moderate intensity or ≥ 60 to 75 min high&#xD;
      intensity per week. The current study situation allows the statement that a greater benefit&#xD;
      can be expected from more physical activity and that the training should be personalized and&#xD;
      highly titrated. Patients in advanced stages of CVD and very inactive patients, defined as&#xD;
      &lt;14 mets h/week, achieve the greatest health benefit from increased physical activity.&#xD;
      Despite the well-studied benefits, even adherence to the above minimum recommendations for&#xD;
      CVD patients after completion of CR is low. This deficit has been addressed in the latest&#xD;
      European prevention guideline and recommended that patients i) set clearly defined goals, ii)&#xD;
      exercise in the iii) Identify obstacles on the way to achieving the goals so that lifestyle&#xD;
      changes are effective and sustainable and the benefits of physical activity can be achieved&#xD;
      and maintained.&#xD;
&#xD;
      The planned study will investigate the effect of multi-modal support measures to help&#xD;
      patients during the home training phase and their influence on the patients' lifestyle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 10, 2019</start_date>
  <completion_date type="Anticipated">September 9, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 9, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The change of maximal workload during ergometry pre and post home-training</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Patients who used supportive measures during home training</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients who did not use supp. measures during home training</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who undergo the final examination for OUT-III at one of the outpatient&#xD;
        rehabilitation facilities participating in the study are checked by the examining physician&#xD;
        for the above-mentioned inclusion and exclusion criteria. Patients will be included if they&#xD;
        are willing to participate and sign the consent form.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Participation rehabilitation phase III new&#xD;
&#xD;
          -  Documented cardiovascular disease&#xD;
&#xD;
          -  Signed informed-consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Angelika Rzepka, MSc</last_name>
    <phone>0043 664 8561598</phone>
    <email>angelika.rzepka@ait.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dieter Hayn, Dr.</last_name>
    <phone>0043 50550 2953</phone>
    <email>dieter.hayn@ait.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl Mayr, Dr.</last_name>
      <phone>0732 797779</phone>
      <email>Karl.Mayr@cardiomed.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>outpatient cardiac rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04458727
org study id: EPICURE
nct id: NCT04458727
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cariovascular diseases (CVD) are the most common cause of death worldwide with high micro- as
      well as macro-economic burden. Several modifiable risk factors increase the probability of
      contracting a CVE. These risk factors can be positively influenced by a cardiac
      rehabilitation measure (CR), which has been shown to reduce mortality in CVD patients and to
      reduce the economic burden. An increase in physical activity and performance are central
      goals in CR, as they have a positive effect on several cardiovascular risk factors and
      correlate strongly with a reduction in mortality in CVD patients. These goals can be achieved
      in most CVD patients but can only be achieved by a modification of lifestyle.

      In order to positively influence this lifestyle modification beyond the duration of the CR
      measure and thus in the long term, CR Phase II should begin as soon as the patient fulfils
      one of the well-defined inclusion criteria. CR Phase II can be carried out as an inpatient or
      outpatient procedure and depends on the patient's state of health, personal preference and
      availability of an outpatient CR facility in the vicinity of the patient. In the Austrian
      healthcare system, inpatient CR and thus differs from other European countries. After
      completion of phase II, the patient is offered an outpatient phase III with weekly visits to
      the outpatient CR facility, so that lifestyle changes achieved at short notice can be
      sustainably maintained.

      For the secondary prevention of the CVD beyond the CR measure recommend international
      guidelines a physical activity of ≥ 150 min with moderate intensity or ≥ 60 to 75 min high
      intensity per week. The current study situation allows the statement that a greater benefit
      can be expected from more physical activity and that the training should be personalized and
      highly titrated. Patients in advanced stages of CVD and very inactive patients, defined as
      <14 mets h/week, achieve the greatest health benefit from increased physical activity.
      Despite the well-studied benefits, even adherence to the above minimum recommendations for
      CVD patients after completion of CR is low. This deficit has been addressed in the latest
      European prevention guideline and recommended that patients i) set clearly defined goals, ii)
      exercise in the iii) Identify obstacles on the way to achieving the goals so that lifestyle
      changes are effective and sustainable and the benefits of physical activity can be achieved
      and maintained.

      The planned study will investigate the effect of multi-modal support measures to help
      patients during the home training phase and their influence on the patients' lifestyle.
observational model: Other
time perspective: Other
measure: The change of maximal workload during ergometry pre and post home-training
time frame: 1 year
arm group label: Patients who used supportive measures during home training
arm group label: patients who did not use supp. measures during home training
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Angelika Rzepka, MSc
phone: 0043 664 8561598
email: angelika.rzepka@ait.ac.at
last name: Dieter Hayn, Dr.
phone: 0043 50550 2953
email: dieter.hayn@ait.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: Undecided