<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/NCT03801460</url>
  </required_header>
  <id_info>
    <org_study_id>AC201810</org_study_id>
    <nct_id>NCT03801460</nct_id>
  </id_info>
  <brief_title>Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study</brief_title>
  <acronym>PREPARE-TAVR</acronym>
  <official_title>Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      The PREPARE TAVR pilot study will examine the effects of remotely administered physiological&#xD;
      reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post&#xD;
      TAVR in frail older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to evaluate the effects of a home based exercise and&#xD;
      dietary intervention program on the quality of life (QOL) and clinical outcomes in frail&#xD;
      adults undergoing Transcatheter aortic valve replacement (TAVR) procedures. Patients will be&#xD;
      randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all&#xD;
      medical care as decided by their treating physicians or assigned to a home based program&#xD;
      known as remotely administered physiological reconditioning (RPR) program which will include&#xD;
      receiving personalized instructions for a progressive exercise program and dietary changes.&#xD;
      Patients will be contacted for regular phone and in-person follow up for monitoring their&#xD;
      progress. The primary endpoint will be quality of life as assessed by KCCQE questionnaires at&#xD;
      one-year post TAVR. The secondary endpoints include length of stay post TAVR, all-cause&#xD;
      mortality, repeat hospitalization and a composite of all-cause mortality and repeat&#xD;
      hospitalization at one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <intervention_model_description>Prospective, multicenter, randomized trial with objective end points assessment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessed in a blinded manner</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>One year</time_frame>
    <description>Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LOS</measure>
    <time_frame>Index hospitalization</time_frame>
    <description>Length of stay post TAVR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>one year</time_frame>
    <description>Composite of mortality and repeat hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Frailty</condition>
  <condition>Transcatheter Aortic Valve Replacement</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>SOC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RAPR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remotely administered physiological reconditioning program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remotely administered physiological reconditioning program</intervention_name>
    <description>Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.</description>
    <arm_group_label>RAPR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Short Physical Performance Battery Protocol (SPPB) score &lt; 9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe liver disease defined by Childs Pugh class &gt;B or MELD score &gt;15.&#xD;
&#xD;
          -  Severe kidney disease defined by eGFR &lt;30 mL/min.&#xD;
&#xD;
          -  Hospital admission during the 4 weeks prior to randomization.&#xD;
&#xD;
          -  Montreal objective cognitive assessment (MOCA) score &lt;18.&#xD;
&#xD;
          -  Mechanical fall in the past month.&#xD;
&#xD;
          -  Unstable angina during the previous month.&#xD;
&#xD;
          -  Myocardial infarction during the previous month.&#xD;
&#xD;
          -  Unsuccessful completion of the one-week run-in phase.&#xD;
&#xD;
          -  Syncopal episode during exercise during run-in phase&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asim Cheema, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Syed Ishba</last_name>
    <phone>416-620-9600</phone>
    <email>ishba.syed@unityhealth.to</email>
  </overall_contact>
  <location>
    <facility>
      <name>Southlake Hospital</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asim Cheema, MD</last_name>
      <phone>416-620-9600</phone>
      <email>acheema@southlakeregional.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</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>Frailty</mesh_term>
  </condition_browse>
  <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/NCT03801460
org study id: AC201810
nct id: NCT03801460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The PREPARE TAVR pilot study will examine the effects of remotely administered physiological
      reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post
      TAVR in frail older adults.
The main objective of this study is to evaluate the effects of a home based exercise and
      dietary intervention program on the quality of life (QOL) and clinical outcomes in frail
      adults undergoing Transcatheter aortic valve replacement (TAVR) procedures. Patients will be
      randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all
      medical care as decided by their treating physicians or assigned to a home based program
      known as remotely administered physiological reconditioning (RPR) program which will include
      receiving personalized instructions for a progressive exercise program and dietary changes.
      Patients will be contacted for regular phone and in-person follow up for monitoring their
      progress. The primary endpoint will be quality of life as assessed by KCCQE questionnaires at
      one-year post TAVR. The secondary endpoints include length of stay post TAVR, all-cause
      mortality, repeat hospitalization and a composite of all-cause mortality and repeat
      hospitalization at one year.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, multicenter, randomized trial with objective end points assessment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcomes assessed in a blinded manner
measure: Quality of Life (QOL)
time frame: One year
description: Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best.
measure: LOS
time frame: Index hospitalization
description: Length of stay post TAVR
measure: MACE
time frame: one year
description: Composite of mortality and repeat hospitalization
arm group label: SOC
arm group type: No Intervention
description: Standard of Care
arm group label: RAPR
arm group type: Experimental
description: Remotely administered physiological reconditioning program
intervention type: Other
intervention name: Remotely administered physiological reconditioning program
description: Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.
arm group label: RAPR
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: No
last name: Asim Cheema, MD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Syed Ishba
phone: 416-620-9600
email: ishba.syed@unityhealth.to
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No