<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/NCT03270124</url>
  </required_header>
  <id_info>
    <org_study_id>ACTIVE AFTER TAVR</org_study_id>
    <nct_id>NCT03270124</nct_id>
  </id_info>
  <brief_title>A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement</brief_title>
  <official_title>A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University 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>
      This study is being performed in patients who have undergone transcatheter aortic valve&#xD;
      replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a&#xD;
      novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness&#xD;
      tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles&#xD;
      related to activities of daily living. We will evaluate the effect of these interventions on&#xD;
      physical performance and several quality of life domains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in three phases. Subjects who have been treated commercially with&#xD;
      TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1.&#xD;
      Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m&#xD;
      walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and&#xD;
      answer quality of life questions on the iPad about their activities and quality of life.&#xD;
      After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair&#xD;
      stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently&#xD;
      provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and&#xD;
      complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be&#xD;
      randomized to one of two arms. In one arm, they will have a daily activity goal and&#xD;
      resistance exercises; in the other arm, there will not be a daily activity goal and no&#xD;
      resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6&#xD;
      minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as&#xD;
      well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to&#xD;
      track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS&#xD;
      Questionnaires, and end of study questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 24, 2020</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>Average Daily Steps</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average daily steps over the intervention period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Physical Performance Battery score</measure>
    <time_frame>6 week value, adjusted for baseline value</time_frame>
    <description>Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life as measured with the KCCQ Overall Summary Score</measure>
    <time_frame>6 week value, adjusted for baseline value</time_frame>
    <description>KCCQ overall summary score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5 meter gait time at the end of the intervention period</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>5 meter gait time at the end of the intervention period, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair Sit to Stand Test</measure>
    <time_frame>6 week value, adjusted for baseline value</time_frame>
    <description>Time to complete 5 chair stands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance Test Score at the end of the intervention period</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Balance Test Score at the end of the intervention period, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minute walk</measure>
    <time_frame>6 week value, adjusted for baseline value</time_frame>
    <description>6 minute walk distance at the end of the intervention period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip</measure>
    <time_frame>6 week value, adjusted for baseline value</time_frame>
    <description>Handgrip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of hours per day with 250 or more steps</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average number of hours per day with 250 or more steps over the intervention period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function as assessed by the NIH PROMIS computerized adaptive test</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as assessed by the NIH PROMIS computerized adaptive test</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue as assessed by the NIH PROMIS computerized adaptive test</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea as assessed by the NIH PROMIS computerized adaptive test</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Active Minutes (total)</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average daily active minutes (total)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Active Minutes of Moderate to High Intensity</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average daily minutes of moderate to high intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary Minutes</measure>
    <time_frame>Randomization to 6 weeks</time_frame>
    <description>Average daily sedentary minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Steps</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Average daily steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Active Minutes (total)</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Average daily active minutes (total)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Active Minutes of Moderate to High Intensity</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Average daily active minutes of moderate to high intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Sedentary Minutes</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Average daily sedentary minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KCCQ Overall Summary Score</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>KCCQ overall summary score, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Physical Health</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Mental Health</measure>
    <time_frame>6 weeks post baseline to end of study</time_frame>
    <description>Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>No Resistance Exercise and No Activity Goal Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blinded use of Fitbit with no daily activity goal and no resistance exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance Exercise and Activity Goal Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily Activity Goal</intervention_name>
    <description>Patients are given a tailored daily activity goal in terms of steps per day for which to aim.</description>
    <arm_group_label>Resistance Exercise and Activity Goal Arm</arm_group_label>
    <other_name>Resistance Exercise and Activity Goal Arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance Exercises</intervention_name>
    <description>Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.</description>
    <arm_group_label>Resistance Exercise and Activity Goal Arm</arm_group_label>
    <other_name>Resistance Exercise and Activity Goal Arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily Activity Recording</intervention_name>
    <description>A Fitbit will be worn by all participants to record daily activity.</description>
    <arm_group_label>No Resistance Exercise and No Activity Goal Arm</arm_group_label>
    <arm_group_label>Resistance Exercise and Activity Goal Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase 1 - Starts after the TAVR procedure and prior to discharge • Patients treated&#xD;
        commercially with TAVR with a SAPIEN 3 valve&#xD;
&#xD;
        Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit&#xD;
&#xD;
        • Patients enrolled in Phase 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Phase 1 - Starts after the TAVR procedure and prior to discharge&#xD;
&#xD;
          -  Stroke during or immediately after the TAVR procedure prior to discharge&#xD;
&#xD;
          -  Inability to walk&#xD;
&#xD;
          -  Non-English speaking (because the mobile app and CAT questionnaires are only in&#xD;
             English)&#xD;
&#xD;
          -  Physical or neuropsychiatric limitations that would prevent proficient use of the&#xD;
             study tools and successful completion of the physical and quality of life assessments.&#xD;
             These limitations may include, but are not limited to: blindness, neuropathy, severe&#xD;
             tremor or disabling motor deficit, cognitive impairment (documentation of dementia in&#xD;
             the medical record), or illiteracy.&#xD;
&#xD;
          -  Unwillingness or inability of the subject to provide informed consent for Phase 1 (no&#xD;
             LARs allowed)&#xD;
&#xD;
          -  Planned discharge from hospital to skilled nursing or rehabilitation facility&#xD;
&#xD;
        Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit&#xD;
&#xD;
          -  All exclusion criteria from Phase 1 apply&#xD;
&#xD;
          -  Stroke during Phase 1&#xD;
&#xD;
          -  Residing in a skilled nursing facility at the 30 day post-TAVR follow-up visit&#xD;
&#xD;
          -  Patients with unreliable use of the iPad mobile app or Fitbit during Phase 1 (e.g. not&#xD;
             wearing the Fitbit at least 10 waking hours a day for at least 5 days a week)&#xD;
&#xD;
          -  Unwillingness or inability of the subject to provide informed consent for Phases 2/3&#xD;
             (no LARs allowed)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian R Lindman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health - Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://academic.oup.com/ehjdh/advance-article/doi/10.1093/ehjdh/ztab007/6128571?login=true</url>
    <description>Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement.</description>
  </link>
  <reference>
    <citation>Lindman BR, Gillam LD, Coylewright M, Welt FGP, Elmariah S, Smith SA, McKeel DA, Jackson N, Mukerjee K, Cloud H, Hanna N, Purpura J, Ellis H, Martinez V, Selberg AM, Huang S, Harrell FE Jr. Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. Eur Heart J Digit Health. 2021 Feb 4;2(1):90-103. doi: 10.1093/ehjdh/ztab007. eCollection 2021 Mar. Erratum In: Eur Heart J Digit Health. 2021 Nov 21;3(1):115-116.</citation>
    <PMID>34048509</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Brian Lindman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Aortic Valve Stenosis</keyword>
  <keyword>Fitbit</keyword>
  <keyword>iPAD</keyword>
  <keyword>Physical Exercises</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT03270124
org study id: ACTIVE AFTER TAVR
nct id: NCT03270124
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being performed in patients who have undergone transcatheter aortic valve
      replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a
      novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness
      tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles
      related to activities of daily living. We will evaluate the effect of these interventions on
      physical performance and several quality of life domains.
The study will be conducted in three phases. Subjects who have been treated commercially with
      TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1.
      Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m
      walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and
      answer quality of life questions on the iPad about their activities and quality of life.
      After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair
      stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently
      provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and
      complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be
      randomized to one of two arms. In one arm, they will have a daily activity goal and
      resistance exercises; in the other arm, there will not be a daily activity goal and no
      resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6
      minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as
      well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to
      track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS
      Questionnaires, and end of study questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average Daily Steps
time frame: Randomization to 6 weeks
description: Average daily steps over the intervention period
measure: Short Physical Performance Battery score
time frame: 6 week value, adjusted for baseline value
description: Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention
measure: Quality of Life as measured with the KCCQ Overall Summary Score
time frame: 6 week value, adjusted for baseline value
description: KCCQ overall summary score
measure: 5 meter gait time at the end of the intervention period
time frame: Randomization to 6 weeks
description: 5 meter gait time at the end of the intervention period, adjusted for baseline
measure: Chair Sit to Stand Test
time frame: 6 week value, adjusted for baseline value
description: Time to complete 5 chair stands
measure: Balance Test Score at the end of the intervention period
time frame: Randomization to 6 weeks
description: Balance Test Score at the end of the intervention period, adjusted for baseline
measure: 6 minute walk
time frame: 6 week value, adjusted for baseline value
description: 6 minute walk distance at the end of the intervention period
measure: Handgrip
time frame: 6 week value, adjusted for baseline value
description: Handgrip strength
measure: Average number of hours per day with 250 or more steps
time frame: Randomization to 6 weeks
description: Average number of hours per day with 250 or more steps over the intervention period
measure: Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form
time frame: Randomization to 6 weeks
description: Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
measure: Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form
time frame: Randomization to 6 weeks
description: Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
measure: Physical Function as assessed by the NIH PROMIS computerized adaptive test
time frame: Randomization to 6 weeks
description: Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
measure: Depression as assessed by the NIH PROMIS computerized adaptive test
time frame: Randomization to 6 weeks
description: Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
measure: Fatigue as assessed by the NIH PROMIS computerized adaptive test
time frame: Randomization to 6 weeks
description: Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
measure: Dyspnea as assessed by the NIH PROMIS computerized adaptive test
time frame: Randomization to 6 weeks
description: Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
measure: Daily Active Minutes (total)
time frame: Randomization to 6 weeks
description: Average daily active minutes (total)
measure: Daily Active Minutes of Moderate to High Intensity
time frame: Randomization to 6 weeks
description: Average daily minutes of moderate to high intensity
measure: Sedentary Minutes
time frame: Randomization to 6 weeks
description: Average daily sedentary minutes
measure: Daily Steps
time frame: 6 weeks post baseline to end of study
description: Average daily steps
measure: Daily Active Minutes (total)
time frame: 6 weeks post baseline to end of study
description: Average daily active minutes (total)
measure: Daily Active Minutes of Moderate to High Intensity
time frame: 6 weeks post baseline to end of study
description: Average daily active minutes of moderate to high intensity
measure: Daily Sedentary Minutes
time frame: 6 weeks post baseline to end of study
description: Average daily sedentary minutes
measure: KCCQ Overall Summary Score
time frame: 6 weeks post baseline to end of study
description: KCCQ overall summary score, adjusted for baseline
measure: Global Physical Health
time frame: 6 weeks post baseline to end of study
description: Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
measure: Global Mental Health
time frame: 6 weeks post baseline to end of study
description: Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
arm group label: No Resistance Exercise and No Activity Goal Arm
arm group type: Active Comparator
description: Blinded use of Fitbit with no daily activity goal and no resistance exercises
arm group label: Resistance Exercise and Activity Goal Arm
arm group type: Experimental
description: Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
intervention type: Behavioral
intervention name: Daily Activity Goal
description: Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
arm group label: Resistance Exercise and Activity Goal Arm
other name: Resistance Exercise and Activity Goal Arm
intervention type: Behavioral
intervention name: Resistance Exercises
description: Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.
arm group label: Resistance Exercise and Activity Goal Arm
other name: Resistance Exercise and Activity Goal Arm
intervention type: Behavioral
intervention name: Daily Activity Recording
description: A Fitbit will be worn by all participants to record daily activity.
arm group label: No Resistance Exercise and No Activity Goal Arm
arm group label: Resistance Exercise and Activity Goal Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian R Lindman, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://academic.oup.com/ehjdh/advance-article/doi/10.1093/ehjdh/ztab007/6128571?login=true
description: Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement.
citation: Lindman BR, Gillam LD, Coylewright M, Welt FGP, Elmariah S, Smith SA, McKeel DA, Jackson N, Mukerjee K, Cloud H, Hanna N, Purpura J, Ellis H, Martinez V, Selberg AM, Huang S, Harrell FE Jr. Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. Eur Heart J Digit Health. 2021 Feb 4;2(1):90-103. doi: 10.1093/ehjdh/ztab007. eCollection 2021 Mar. Erratum In: Eur Heart J Digit Health. 2021 Nov 21;3(1):115-116.
PMID: 34048509
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Brian Lindman
investigator title: Associate Professor
mesh term: Aortic Valve Stenosis
sharing ipd: No