<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/NCT04481490</url>
  </required_header>
  <id_info>
    <org_study_id>20-005866</org_study_id>
    <nct_id>NCT04481490</nct_id>
  </id_info>
  <brief_title>A Study to Objectively Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation</brief_title>
  <official_title>Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 purpose of this study is to assess exercise patterns during home-based or center-based&#xD;
      cardiac rehabilitation participation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants enrolled in either home-based or center-based cardiac rehabilitation will be&#xD;
      instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and&#xD;
      12-weeks, to objectively measure their physical activity level during the cardiac&#xD;
      rehabilitation program. A questionnaire will also be completed by the participant at baseline&#xD;
      and 12-weeks to subjectively measure their physical activity level, based on self-report&#xD;
      activities over the previous 7-days.&#xD;
&#xD;
      Enrollment in home-based versus center-based cardiac rehabilitation will be based on the&#xD;
      availability of cardiac rehabilitation facilities and/or patient preference. There is no&#xD;
      random allocation or assignment to groups by the study team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Stopped due to lack of personnel and funding support&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry</measure>
    <time_frame>Baseline, 4-weeks, 8-weeks, and 12-weeks</time_frame>
    <description>Change in minutes at a moderate-vigorous activity intensity are objectively measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends in moderate-vigorous activities per day, and will be worn by the participant for 7-days. A higher number of minutes per day indicates a greater physical activity level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire</measure>
    <time_frame>Baseline, 12-weeks</time_frame>
    <description>Change in minutes at a moderate-vigorous activity intensity are subjectively measured (self-reported) using the International Physical Activity Questionnaire (IPAQ). The IPAQ captures the number of minutes a participant spends in moderate-vigorous activities per day, based on participant's reporting of the previous 7-days. A higher number of minutes per day indicates a greater physical activity level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.</measure>
    <time_frame>Baseline, 4-weeks, 8-weeks, and 12-weeks</time_frame>
    <description>Change in minutes spent in inactive (sedentary) behavior, measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends inactive per day, and will be worn by the participant for 7-days. A higher number of minutes per day of inactive time indicates increased sedentary behavior.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Cardiac Valve Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Home-based</arm_group_label>
    <description>Cardiac rehabilitation (including exercise training) delivered in a home-based setting, facilitated remotely by Mayo Clinic staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Center-based</arm_group_label>
    <description>Cardiac rehabilitation (including exercise training) delivered in a center-based setting, facilitated in person by Mayo Clinic staff.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with qualifying indication for cardiac rehabilitation (e.g. acute coronary&#xD;
        syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass&#xD;
        grafting, stable angina, heart failure).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult 18 years and older.&#xD;
&#xD;
          -  Able to provide consent.&#xD;
&#xD;
          -  Has a qualifying indication for cardiac rehabilitation and able to participate in&#xD;
             cardiac rehabilitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to participate in cardiac rehabilitation.&#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>Amanda Bonikowske, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Amanda R. Bonikowske</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cardiac rehabilitation</keyword>
  <keyword>physical activity</keyword>
  <keyword>accelerometry</keyword>
  <keyword>home-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
    <mesh_term>Infarction</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/NCT04481490
org study id: 20-005866
nct id: NCT04481490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess exercise patterns during home-based or center-based
      cardiac rehabilitation participation.
Participants enrolled in either home-based or center-based cardiac rehabilitation will be
      instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and
      12-weeks, to objectively measure their physical activity level during the cardiac
      rehabilitation program. A questionnaire will also be completed by the participant at baseline
      and 12-weeks to subjectively measure their physical activity level, based on self-report
      activities over the previous 7-days.

      Enrollment in home-based versus center-based cardiac rehabilitation will be based on the
      availability of cardiac rehabilitation facilities and/or patient preference. There is no
      random allocation or assignment to groups by the study team.
observational model: Cohort
time perspective: Prospective
measure: Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry
time frame: Baseline, 4-weeks, 8-weeks, and 12-weeks
description: Change in minutes at a moderate-vigorous activity intensity are objectively measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends in moderate-vigorous activities per day, and will be worn by the participant for 7-days. A higher number of minutes per day indicates a greater physical activity level.
measure: Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire
time frame: Baseline, 12-weeks
description: Change in minutes at a moderate-vigorous activity intensity are subjectively measured (self-reported) using the International Physical Activity Questionnaire (IPAQ). The IPAQ captures the number of minutes a participant spends in moderate-vigorous activities per day, based on participant's reporting of the previous 7-days. A higher number of minutes per day indicates a greater physical activity level.
measure: Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.
time frame: Baseline, 4-weeks, 8-weeks, and 12-weeks
description: Change in minutes spent in inactive (sedentary) behavior, measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends inactive per day, and will be worn by the participant for 7-days. A higher number of minutes per day of inactive time indicates increased sedentary behavior.
arm group label: Home-based
description: Cardiac rehabilitation (including exercise training) delivered in a home-based setting, facilitated remotely by Mayo Clinic staff.
arm group label: Center-based
description: Cardiac rehabilitation (including exercise training) delivered in a center-based setting, facilitated in person by Mayo Clinic staff.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amanda Bonikowske, PhD
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Amanda R. Bonikowske
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Heart Valve Diseases
mesh term: Infarction
sharing ipd: No