<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/NCT04451005</url>
  </required_header>
  <id_info>
    <org_study_id>SARC-F</org_study_id>
    <nct_id>NCT04451005</nct_id>
  </id_info>
  <brief_title>Diagnostic Evaluation of Sarcopenia in Elderly Patients</brief_title>
  <official_title>Development of a New Sarcopenia Screening Tool in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related&#xD;
      physiological vulnerability that is associated with or increases the likelihood of adverse&#xD;
      outcomes, including falls, fractures, physical disability and death. The parameters used to&#xD;
      assess sarcopenia in clinical practice have limited use due to their custody.&#xD;
&#xD;
      In this perspective, this study proposes or develops a tool for the diagnosis of having&#xD;
      sarcopenia with a specific boa and a sensitive boa.&#xD;
&#xD;
      low cost and useful.&#xD;
&#xD;
      Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas,&#xD;
      Faculty of Medicine, University of São Paulo will be selected&#xD;
&#xD;
      This study was of clinical importance, due to sarcopenia and a relevant factor, and could&#xD;
      lead to consequences and poor prognosis in patients with gold, and it was not a method of&#xD;
      clinical practice to properly endorse body composition in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an&#xD;
      age-related physiological vulnerability that is associated with an increased likelihood of&#xD;
      adverse outcomes, including falls, fractures, physical disability and mortality. The&#xD;
      parameters used to assess sarcopenia in clinical practice have limited use due to its cost.&#xD;
&#xD;
      In this perspective, this study proposes the development of a tool for the diagnosis of&#xD;
      having sarcopenia with good specificity and good sensitivity and of low cost and useful.&#xD;
&#xD;
      Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas,&#xD;
      Faculty of Medicine, University of São Paulo will be selected. After signing the informed&#xD;
      consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The&#xD;
      data obtained by the methods are treated statistically to obtain correlation and thus a new&#xD;
      tool for the evaluation of sarcopenia patients in the elderly can be developed.&#xD;
&#xD;
      This study is of clinical importance, as sarcopenia is a relevant factor and can lead to&#xD;
      consequences and poor prognosis in elderly patients, and there is no low-cost method in&#xD;
      clinical practice to properly assess body composition in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2016</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 6, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sarcopenia in the elderly</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of sarcopenia in the elderly</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of a new tool for sarcopenia screening</measure>
    <time_frame>12 months</time_frame>
    <description>Development of a new tool for sarcopenia screening</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">403</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Elderly patients with sarcopenia</arm_group_label>
    <description>Elderly patients with sarcopenia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0</intervention_name>
    <description>Elderly patients with sarcopenia</description>
    <arm_group_label>Elderly patients with sarcopenia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly patients over 60 years old, with cognitive ability and interested in participating&#xD;
        in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Sign free and informed consent;&#xD;
&#xD;
          -  Demonstrate interest, conditions and availability to participate in all procedures&#xD;
             included in the study protocol;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate;&#xD;
&#xD;
          -  Patients who have not undergone cognitive testing;&#xD;
&#xD;
          -  Physical amputation;&#xD;
&#xD;
          -  Patients undergoing interventional treatment for sarcopenia;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Dan Linetzky Waitzberg</investigator_full_name>
    <investigator_title>Principal researcher</investigator_title>
  </responsible_party>
  <keyword>Body composition</keyword>
  <keyword>Sarcopenia</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT04451005
org study id: SARC-F
nct id: NCT04451005
lead sponsor: 
has dmc: No
Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related
      physiological vulnerability that is associated with or increases the likelihood of adverse
      outcomes, including falls, fractures, physical disability and death. The parameters used to
      assess sarcopenia in clinical practice have limited use due to their custody.

      In this perspective, this study proposes or develops a tool for the diagnosis of having
      sarcopenia with a specific boa and a sensitive boa.

      low cost and useful.

      Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas,
      Faculty of Medicine, University of São Paulo will be selected

      This study was of clinical importance, due to sarcopenia and a relevant factor, and could
      lead to consequences and poor prognosis in patients with gold, and it was not a method of
      clinical practice to properly endorse body composition in this population.
Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an
      age-related physiological vulnerability that is associated with an increased likelihood of
      adverse outcomes, including falls, fractures, physical disability and mortality. The
      parameters used to assess sarcopenia in clinical practice have limited use due to its cost.

      In this perspective, this study proposes the development of a tool for the diagnosis of
      having sarcopenia with good specificity and good sensitivity and of low cost and useful.

      Elderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas,
      Faculty of Medicine, University of São Paulo will be selected. After signing the informed
      consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The
      data obtained by the methods are treated statistically to obtain correlation and thus a new
      tool for the evaluation of sarcopenia patients in the elderly can be developed.

      This study is of clinical importance, as sarcopenia is a relevant factor and can lead to
      consequences and poor prognosis in elderly patients, and there is no low-cost method in
      clinical practice to properly assess body composition in this population.
observational model: Other
time perspective: Prospective
measure: Sarcopenia in the elderly
time frame: 12 months
description: Evaluation of sarcopenia in the elderly
measure: Development of a new tool for sarcopenia screening
time frame: 12 months
description: Development of a new tool for sarcopenia screening
arm group label: Elderly patients with sarcopenia
description: Elderly patients with sarcopenia
intervention type: Other
intervention name: 0
description: Elderly patients with sarcopenia
arm group label: Elderly patients with sarcopenia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Dan Linetzky Waitzberg
investigator title: Principal researcher
mesh term: Sarcopenia