<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/NCT01720472</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00036608</org_study_id>
    <nct_id>NCT01720472</nct_id>
  </id_info>
  <brief_title>Implementing a Physical and Cognitive Performance Assessment Cohort in the MURDOCK Study Community Registry and Biorepository</brief_title>
  <acronym>PPS</acronym>
  <official_title>Implementing a Physical and Cognitive Performance Assessment Cohort in the MURDOCK Study Community Registry and Biorepository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional&#xD;
      Review Board Pro00011196) to specifically target and enroll 1,000 participants across age&#xD;
      groups and other demographic categories in order to develop a diverse cohort with specific&#xD;
      physical and cognitive performance data paired with biological samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MURDOCK Study, proposes this Horizon 2 study to collect a brief physical and cognitive&#xD;
      performance assessment from 1,000 MURDOCK Registry participants. Blood sample aliquots will&#xD;
      also be obtained. These physical and cognitive performance data, paired with -omics data from&#xD;
      plasma and serum sample analyses, offer promise in the discovery of biomarkers for functional&#xD;
      decline. This research will provide an important basis for our understanding of the physical,&#xD;
      lifestyle, and genetic factors which, over the lifespan, contribute to changes in physical&#xD;
      and cognitive capabilities as we age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 28, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Implementing a Physical and Cognitive Performance Assessment Cohort in the MURDOCK Study Community Registry and Biorepository</measure>
    <time_frame>Upto 2 years or 24 months</time_frame>
    <description>Factors associated with physical function and physical activity and change in physical activity and function over two-year follow-up.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Aging</condition>
  <condition>Physical Functioning</condition>
  <condition>Cognitive Functioning</condition>
  <condition>Fitness</condition>
  <arm_group>
    <arm_group_label>Community, Physical Performance</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Biomarker studies</intervention_name>
    <arm_group_label>Community, Physical Performance</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma samples collected from MURDOCK Study enrollment visit and two year follow up&#xD;
      Physical Performance visit.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include 1,000 participants ages 30 and older living in Cabarrus&#xD;
        County and/or the city of Kannapolis, or certain portions of Rowan, Mecklenburg, or Stanly&#xD;
        counties in North Carolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A resident of Cabarrus County and/or the city of Kannapolis (and surrounding regions)&#xD;
             or certain portions of Rowan, Mecklenburg, or Stanly counties in North Carolina for 6&#xD;
             or more months of the year.&#xD;
&#xD;
          -  Age 30 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female that is currently pregnant&#xD;
&#xD;
          -  Having had a heart attack, angina, congestive heart failure, or fluid in the lungs&#xD;
             within the past 6 months&#xD;
&#xD;
          -  Participant that requires consent by a legally authorized representative&#xD;
&#xD;
          -  Participant that cannot walk 30ft without human assistance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miriam C Morey, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bethesda Health Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill Family Medicine</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center NorthEast Medical Arts Building</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ada Jenkins Center</name>
      <address>
        <city>Davidson</city>
        <state>North Carolina</state>
        <zip>28036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrisburg Sleep Center</name>
      <address>
        <city>Harrisburg</city>
        <state>North Carolina</state>
        <zip>28075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Norman Community Health Clinic</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.murdock-study.com/</url>
    <description>MURDOCK Study Physical Performance Cohort</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aging</keyword>
  <keyword>Healthy Aging</keyword>
  <keyword>Physical Performance</keyword>
  <keyword>Physical Functioning</keyword>
  <keyword>Cognitive Functioning</keyword>
  <keyword>Fitness</keyword>
  <keyword>Physical Activity</keyword>
  <!-- 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/NCT01720472
org study id: Pro00036608
nct id: NCT01720472
lead sponsor: 
has dmc: Yes
The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional
      Review Board Pro00011196) to specifically target and enroll 1,000 participants across age
      groups and other demographic categories in order to develop a diverse cohort with specific
      physical and cognitive performance data paired with biological samples.
The MURDOCK Study, proposes this Horizon 2 study to collect a brief physical and cognitive
      performance assessment from 1,000 MURDOCK Registry participants. Blood sample aliquots will
      also be obtained. These physical and cognitive performance data, paired with -omics data from
      plasma and serum sample analyses, offer promise in the discovery of biomarkers for functional
      decline. This research will provide an important basis for our understanding of the physical,
      lifestyle, and genetic factors which, over the lifespan, contribute to changes in physical
      and cognitive capabilities as we age.
observational model: Cohort
time perspective: Prospective
measure: Implementing a Physical and Cognitive Performance Assessment Cohort in the MURDOCK Study Community Registry and Biorepository
time frame: Upto 2 years or 24 months
description: Factors associated with physical function and physical activity and change in physical activity and function over two-year follow-up.
arm group label: Community, Physical Performance
intervention type: Genetic
intervention name: Biomarker studies
arm group label: Community, Physical Performance
Serum and plasma samples collected from MURDOCK Study enrollment visit and two year follow up
      Physical Performance visit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miriam C Morey, Ph.D.
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.murdock-study.com/
description: MURDOCK Study Physical Performance Cohort
responsible party type: Sponsor