<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/NCT02966470</url>
  </required_header>
  <id_info>
    <org_study_id>1609018398</org_study_id>
    <nct_id>NCT02966470</nct_id>
  </id_info>
  <brief_title>Hand Grip Strength as a Marker of Frailty in Surgical Patients</brief_title>
  <official_title>Hand Grip Strength as a Marker of Frailty in Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess if grip strength can be used as a single, objective surrogate of&#xD;
      frailty assessment in the surgical population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Frailty is associated with worse outcomes. Current screening surveys are cumbersome, most&#xD;
      containing multiple components. For frail patients particularly, it can be difficult to&#xD;
      ascertain all the information requested. There is a need for a simple, one step, objective&#xD;
      screening measure of frailty. There is some evidence in the medicine patients that grip&#xD;
      strength may be related to frailty, but no such information is available for surgical&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to accrual not met and PI no longer at the institution&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</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>linear regression of grip strength to frailty survey score</measure>
    <time_frame>10 minutes at the time of admission</time_frame>
    <description>Their frailty survey and grip strength scores will also be recorded for analysis.&#xD;
We will analyze the data by linear regression of grip strength to frailty survey score.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>General surgery patient</arm_group_label>
    <description>General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Obtain grip strength from a standardized gripometer</intervention_name>
    <description>Obtain grip strength from a standardized gripometer, 3 times on each hand</description>
    <arm_group_label>General surgery patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical&#xD;
        Critical Care who are over the age of 60.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General surgery patient admitted to the Section of General Surgery, Trauma, and&#xD;
             Surgical Critical Care&#xD;
&#xD;
          -  Age &gt;60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Untreated or metastatic malignancy&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bishwajit Bhattacharya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgical outcomes</keyword>
  <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/NCT02966470
org study id: 1609018398
nct id: NCT02966470
lead sponsor: 
has dmc: No
This study aims to assess if grip strength can be used as a single, objective surrogate of
      frailty assessment in the surgical population.
Frailty is associated with worse outcomes. Current screening surveys are cumbersome, most
      containing multiple components. For frail patients particularly, it can be difficult to
      ascertain all the information requested. There is a need for a simple, one step, objective
      screening measure of frailty. There is some evidence in the medicine patients that grip
      strength may be related to frailty, but no such information is available for surgical
      patients.
observational model: Cohort
time perspective: Prospective
measure: linear regression of grip strength to frailty survey score
time frame: 10 minutes at the time of admission
description: Their frailty survey and grip strength scores will also be recorded for analysis.
We will analyze the data by linear regression of grip strength to frailty survey score.
arm group label: General surgery patient
description: General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60.
intervention type: Device
intervention name: Obtain grip strength from a standardized gripometer
description: Obtain grip strength from a standardized gripometer, 3 times on each hand
arm group label: General surgery patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Bishwajit Bhattacharya, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No