<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/NCT02263716</url>
  </required_header>
  <id_info>
    <org_study_id>141504</org_study_id>
    <nct_id>NCT02263716</nct_id>
  </id_info>
  <brief_title>Actigraphy to MEasuRe Intensive Care Unit Activity</brief_title>
  <acronym>AMERICA</acronym>
  <official_title>Actigraphy to MEasuRe Intensive Care Unit Activity (AMERICA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine whether accelerometry can be used to measure physical activity&#xD;
      occurring during routine clinical care in a diverse population of patients with medical or&#xD;
      surgical critical illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients that meet inclusion criteria will have a wristwatch size, lightweight ActiGraph&#xD;
      GT3X+ placed at each of three body sites, the dominant-side wrist, right hip and&#xD;
      dominant-side ankle to objectively measure physical activity. Patients will wear the&#xD;
      ActiGraph devices during two 30-minute periods of direct observation. To compare activity&#xD;
      counts measured by the ActiGraph devices with directly observed purposeful physical activity,&#xD;
      we will record the time and type of physical activity performed by patients such as sitting&#xD;
      at the edge of the bed, sitting in a bedside chair, transferring to a chair, standing and&#xD;
      ambulating. The data acquired from this observational (AMERCIA) study will seek to establish&#xD;
      the feasibility of using accelerometers to measure activity in a diverse population of&#xD;
      patients with medical or surgical critical illness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Feasibility of accelerometers to measure physical activity in patients with a critical illness.</measure>
    <time_frame>1 Day</time_frame>
    <description>To determine the validity of activity counts from each of the three accelerometry sites (wrist, hip and ankle) with direct observation acting as the reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of accelerometry devices.</measure>
    <time_frame>1 Day</time_frame>
    <description>We will assess tolerability of the ActiGraph devices through the assessment of the number of total hours devices are worn (out of 120 hours of possible measurement time). We will record the time of device removal and replacement as well as reasons for device removal. Patients will be routinely evaluated for device-related discomfort and devices will be repositioned or removed accordingly. Finally, at the conclusion of the study period, patients will be surveyed regarding the tolerability of the devices.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Disability</condition>
  <condition>Physical Activity</condition>
  <condition>Aging</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Accelerometer</arm_group_label>
    <description>Utilize accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A diverse population of adult patients with medical or surgical critical illness in the&#xD;
        ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be included if they are:&#xD;
&#xD;
          1. adult patients,&#xD;
&#xD;
          2. admitted to the medical or surgical ICU,&#xD;
&#xD;
          3. receiving or have received invasive or non-invasive mechanical ventilation for&#xD;
             respiratory failure or vasopressors for shock (i.e., cardiogenic, hemorrhagic, septic&#xD;
             or undifferentiated shock) within the last 48 hours, and&#xD;
&#xD;
          4. who are receiving routine physical and occupational therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they meet any of the following criteria:&#xD;
&#xD;
          1. Those who have severe physical disability that prevented independent living prior to&#xD;
             their illness,&#xD;
&#xD;
          2. Those unable to speak and communicate in English,&#xD;
&#xD;
          3. Expected death within 24 hours of enrollment or lack of commitment to aggressive&#xD;
             treatment by the family or medical team (i.e., likely to withdraw life support&#xD;
             measures within 24 hours of screening),&#xD;
&#xD;
          4. Inability to obtain informed consent from authorized surrogate;&#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>Nathan E. Brummel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Nathan Brummel</investigator_full_name>
    <investigator_title>Instructor in Medicine</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>Activities of Daily Living</keyword>
  <keyword>Delirium</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Critical Illness</keyword>
  <keyword>Aging</keyword>
  <keyword>Accelerometery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT02263716
org study id: 141504
nct id: NCT02263716
lead sponsor: 
has dmc: No
This study is to determine whether accelerometry can be used to measure physical activity
      occurring during routine clinical care in a diverse population of patients with medical or
      surgical critical illness.
Patients that meet inclusion criteria will have a wristwatch size, lightweight ActiGraph
      GT3X+ placed at each of three body sites, the dominant-side wrist, right hip and
      dominant-side ankle to objectively measure physical activity. Patients will wear the
      ActiGraph devices during two 30-minute periods of direct observation. To compare activity
      counts measured by the ActiGraph devices with directly observed purposeful physical activity,
      we will record the time and type of physical activity performed by patients such as sitting
      at the edge of the bed, sitting in a bedside chair, transferring to a chair, standing and
      ambulating. The data acquired from this observational (AMERCIA) study will seek to establish
      the feasibility of using accelerometers to measure activity in a diverse population of
      patients with medical or surgical critical illness.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of accelerometers to measure physical activity in patients with a critical illness.
time frame: 1 Day
description: To determine the validity of activity counts from each of the three accelerometry sites (wrist, hip and ankle) with direct observation acting as the reference.
measure: Tolerability of accelerometry devices.
time frame: 1 Day
description: We will assess tolerability of the ActiGraph devices through the assessment of the number of total hours devices are worn (out of 120 hours of possible measurement time). We will record the time of device removal and replacement as well as reasons for device removal. Patients will be routinely evaluated for device-related discomfort and devices will be repositioned or removed accordingly. Finally, at the conclusion of the study period, patients will be surveyed regarding the tolerability of the devices.
arm group label: Accelerometer
description: Utilize accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan E. Brummel, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Nathan Brummel
investigator title: Instructor in Medicine
mesh term: Critical Illness