<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/NCT03305926</url>
  </required_header>
  <id_info>
    <org_study_id>CASILLAS FRM 2016</org_study_id>
    <nct_id>NCT03305926</nct_id>
  </id_info>
  <brief_title>Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?</brief_title>
  <acronym>eRCV</acronym>
  <official_title>Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical&#xD;
      capacity, accelerating return to activities and reinsertion and reducing mortality. It&#xD;
      associates reconditioning to effort and therapeutic education for the optimal control of &quot;&#xD;
      risk factors &quot;. It corresponds to a global approach to patients, thus counterbalancing the&#xD;
      tendency to hyperspecialise in medicine. However, because of the lack of specialised centres,&#xD;
      only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in&#xD;
      e-health, the deployment of the Internet and certain &quot; connected &quot; devices may provide&#xD;
      alternatives outside hospital, by enabling the follow-up of patients and their physiological&#xD;
      parameters (heart rate, blood pressure, weigh, physical activity…), and the adaptation -&#xD;
      using an interactive web platform - of the physical activity programme, nutrition, compliance&#xD;
      with medication and weaning from smoking. This project proposes to evaluate the effects of a&#xD;
      so-called &quot; connected &quot; CVR programme, and to show its non-inferiority compared with a&#xD;
      conventional CVR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Early termination due to changes in care management following the COVID context&#xD;
    (remote/connected rehabilitation)&#xD;
  </why_stopped>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Actual">April 20, 2022</completion_date>
  <primary_completion_date type="Actual">April 20, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peak VO2, measured during an effort test</measure>
    <time_frame>Month 2</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Conventional CVR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>eCVR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional CVR programme</intervention_name>
    <description>Programme in a CVR centre involving 20 sessions of reconditioning to effort, 3 times per week for roughly 7 weeks, as well as 14 sessions of therapeutic education in groups.</description>
    <arm_group_label>Conventional CVR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Connected CVR programme</intervention_name>
    <description>First week in the CVR centre with 3 sessions combining reconditioning to effort, individual interviews and targeted therapeutic education, so as to define the objectives and methods of the connected CVR at home for the 6 following weeks.</description>
    <arm_group_label>eCVR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up visit M2</intervention_name>
    <description>Effort test and evaluation at the end of the CVR programme</description>
    <arm_group_label>Conventional CVR</arm_group_label>
    <arm_group_label>eCVR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up vsit M8</intervention_name>
    <description>Evaluation at 8 months following the CVR programme</description>
    <arm_group_label>Conventional CVR</arm_group_label>
    <arm_group_label>eCVR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men or women,&#xD;
&#xD;
          -  aged between 30 and 75 years,&#xD;
&#xD;
          -  presenting coronary artery disease without heart failure (Left ventricular ejection&#xD;
             fraction on echocardiography (Simpson method) &gt; 45 %).&#xD;
&#xD;
          -  Patients who have provided written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults under guardianship&#xD;
&#xD;
          -  Patients without national health insurance cover&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Inability to use connected numeric devices even simple operations (tablette,&#xD;
             cardiofrequency meter, BP monitor…)&#xD;
&#xD;
          -  Heart failure, with a low or preserved left ventricular ejection fraction&#xD;
&#xD;
          -  Contra-indication for cardiovascular rehabilitation :&#xD;
&#xD;
               -  Severe obstructive heart disease (severe and asymptomatic obstacle to left&#xD;
                  ventricular ejection)&#xD;
&#xD;
               -  Acute unstable coronary syndrome&#xD;
&#xD;
               -  Tight aortic valve stenosis&#xD;
&#xD;
               -  Severe progressive cardiac rhythm or conduction disorders without pacing and&#xD;
                  discovered during the initial stress test&#xD;
&#xD;
               -  Intracavitary thrombus&#xD;
&#xD;
               -  Presence of moderate to severe pericardial effusion&#xD;
&#xD;
               -  Severe pulmonary artery hypertension (systolic PAP &gt;70mmHg)&#xD;
&#xD;
               -  Recent history of venous thromboembolism (previous 3 months)&#xD;
&#xD;
               -  Progressive inflammatory or infectious disease&#xD;
&#xD;
               -  Inability to engage in physical exercise&#xD;
&#xD;
          -  Impaired executive functions making it impossible to understand and comply with the&#xD;
             CVR programme (Mini Mental Test &lt; 24)&#xD;
&#xD;
          -  Heart transplant&#xD;
&#xD;
          -  Associated medical condition likely to impair functional capacities (examples:&#xD;
             non-stabilised metabolic disorders such as progressive kidney failure, severe asthenia&#xD;
             related to a severe non-stabilised disorder such as neoplasm, systemic diseases…)&#xD;
&#xD;
          -  Physical disability in the lower limbs that could hamper reconditioning, whether&#xD;
             neurological (central or peripheral), arterial (in particular, peripheral artery&#xD;
             disease with a systolic index &lt; 0.6) or orthopaedic (degenerative or inflammatory&#xD;
             rheumatism)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT03305926
org study id: CASILLAS FRM 2016
nct id: NCT03305926
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical
      capacity, accelerating return to activities and reinsertion and reducing mortality. It
      associates reconditioning to effort and therapeutic education for the optimal control of "
      risk factors ". It corresponds to a global approach to patients, thus counterbalancing the
      tendency to hyperspecialise in medicine. However, because of the lack of specialised centres,
      only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in
      e-health, the deployment of the Internet and certain " connected " devices may provide
      alternatives outside hospital, by enabling the follow-up of patients and their physiological
      parameters (heart rate, blood pressure, weigh, physical activity…), and the adaptation -
      using an interactive web platform - of the physical activity programme, nutrition, compliance
      with medication and weaning from smoking. This project proposes to evaluate the effects of a
      so-called " connected " CVR programme, and to show its non-inferiority compared with a
      conventional CVR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: peak VO2, measured during an effort test
time frame: Month 2
arm group label: Conventional CVR
arm group type: Active Comparator
arm group label: eCVR
arm group type: Experimental
intervention type: Other
intervention name: Conventional CVR programme
description: Programme in a CVR centre involving 20 sessions of reconditioning to effort, 3 times per week for roughly 7 weeks, as well as 14 sessions of therapeutic education in groups.
arm group label: Conventional CVR
intervention type: Other
intervention name: Connected CVR programme
description: First week in the CVR centre with 3 sessions combining reconditioning to effort, individual interviews and targeted therapeutic education, so as to define the objectives and methods of the connected CVR at home for the 6 following weeks.
arm group label: eCVR
intervention type: Other
intervention name: Follow-up visit M2
description: Effort test and evaluation at the end of the CVR programme
arm group label: Conventional CVR
arm group label: eCVR
intervention type: Other
intervention name: Follow-up vsit M8
description: Evaluation at 8 months following the CVR programme
arm group label: Conventional CVR
arm group label: eCVR
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease