<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/NCT04492644</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH108-REC3-110</org_study_id>
    <nct_id>NCT04492644</nct_id>
  </id_info>
  <brief_title>The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders</brief_title>
  <acronym>NMM</acronym>
  <official_title>The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Medical University Hospital</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 masticatory performance would affect the nutritional status of elderly people. the&#xD;
      prevalence of undernutrition among elderly inpatients is %20-50%. Previous related studies&#xD;
      investigate the masticatory performance with special chewing gum and self-reported&#xD;
      questionnaires. This study observes the correlation of masticatory muscles sEMG, nutritional&#xD;
      status, and handgrip force among elderly inpatients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this cross-sectional study, we enrolled 120 seniors aged 65 and above who are newly&#xD;
      admitted to the Asian University Hospital. Within 24 hours they admitted to the hospital, we&#xD;
      collected the Mini Nutritional Assessment scores, surface electromyography data, handgrip&#xD;
      strength, self-assessment swallowing ability score, and clinical objective data. We performed&#xD;
      the statistics for independent t-test, Pearson correlation analysis, and binary logistic&#xD;
      regression with SPSS 23 software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2019</start_date>
  <completion_date type="Actual">October 3, 2019</completion_date>
  <primary_completion_date type="Actual">October 3, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>masticatory muscle surface EMG</measure>
    <time_frame>Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.</time_frame>
    <description>The sEMG examinations were conducted with a Zebris EMG Bluetooth muscle activity recording system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.</time_frame>
    <description>Nutritional status was measured by the Mini Nutritional Assessment (MNA).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Handgrip force</measure>
    <time_frame>Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.</time_frame>
    <description>Left and right handgrip forces were measured by a Jamar® Hydraulic Hand Dynamometer</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Malnutrition; Moderate</condition>
  <arm_group>
    <arm_group_label>elderly inpatients</arm_group_label>
    <description>Elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious. Elderly individuals who were diagnosed with gastrointestinal (GI) dysfunction, dysphagia, edentulism without rehabilitation with dentures, brain disease, stroke or cancer were excluded due to the possibility of dysphagia, cachexia or masticatory muscle palsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>elderly inpatients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We enrolled 120 elderly inpatients in Asia University Hospital, Taiwan. We included new&#xD;
        elderly inpatients aged 65 years or older who were able to communicate and were clearly&#xD;
        conscious.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  new elderly inpatients aged 65 years or older who were able to communicate and were&#xD;
             clearly conscious&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elderly individuals who were diagnosed with gastrointestinal (GI) dysfunction,&#xD;
             dysphagia, edentulism without rehabilitation with dentures, brain disease, stroke or&#xD;
             cancer were excluded due to the possibility of dysphagia, cachexia or masticatory&#xD;
             muscle palsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yin-Hwa Shih, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asia University</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Alzahrani SH, Alamri SH. Prevalence of malnutrition and associated factors among hospitalized elderly patients in King Abdulaziz University Hospital, Jeddah, Saudi Arabia. BMC Geriatr. 2017 Jul 3;17(1):136. doi: 10.1186/s12877-017-0527-z.</citation>
    <PMID>28673255</PMID>
  </results_reference>
  <results_reference>
    <citation>Berretin-Felix G, Nary Filho H, Padovani CR, Trindade Junior AS, Machado WM. Electromyographic evaluation of mastication and swallowing in elderly individuals with mandibular fixed implant-supported prostheses. J Appl Oral Sci. 2008 Mar-Apr;16(2):116-21. doi: 10.1590/s1678-77572008000200007.</citation>
    <PMID>19089202</PMID>
  </results_reference>
  <results_reference>
    <citation>Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.</citation>
    <PMID>31747030</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Yin-Hwa Shih</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>the elder inpatient,</keyword>
  <keyword>nutritional assessment</keyword>
  <keyword>handgrip strength</keyword>
  <keyword>masticatory electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT04492644
org study id: CMUH108-REC3-110
nct id: NCT04492644
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The masticatory performance would affect the nutritional status of elderly people. the
      prevalence of undernutrition among elderly inpatients is %20-50%. Previous related studies
      investigate the masticatory performance with special chewing gum and self-reported
      questionnaires. This study observes the correlation of masticatory muscles sEMG, nutritional
      status, and handgrip force among elderly inpatients.
In this cross-sectional study, we enrolled 120 seniors aged 65 and above who are newly
      admitted to the Asian University Hospital. Within 24 hours they admitted to the hospital, we
      collected the Mini Nutritional Assessment scores, surface electromyography data, handgrip
      strength, self-assessment swallowing ability score, and clinical objective data. We performed
      the statistics for independent t-test, Pearson correlation analysis, and binary logistic
      regression with SPSS 23 software.
observational model: Case-Only
time perspective: Cross-Sectional
measure: masticatory muscle surface EMG
time frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
description: The sEMG examinations were conducted with a Zebris EMG Bluetooth muscle activity recording system
measure: Nutritional status
time frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
description: Nutritional status was measured by the Mini Nutritional Assessment (MNA).
measure: Handgrip force
time frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
description: Left and right handgrip forces were measured by a Jamar® Hydraulic Hand Dynamometer
arm group label: elderly inpatients
description: Elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious. Elderly individuals who were diagnosed with gastrointestinal (GI) dysfunction, dysphagia, edentulism without rehabilitation with dentures, brain disease, stroke or cancer were excluded due to the possibility of dysphagia, cachexia or masticatory muscle palsy.
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: elderly inpatients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Yin-Hwa Shih, Ph.D.
role: Principal Investigator
affiliation: Asia University
facility: 
country: Taiwan
citation: Alzahrani SH, Alamri SH. Prevalence of malnutrition and associated factors among hospitalized elderly patients in King Abdulaziz University Hospital, Jeddah, Saudi Arabia. BMC Geriatr. 2017 Jul 3;17(1):136. doi: 10.1186/s12877-017-0527-z.
PMID: 28673255
citation: Berretin-Felix G, Nary Filho H, Padovani CR, Trindade Junior AS, Machado WM. Electromyographic evaluation of mastication and swallowing in elderly individuals with mandibular fixed implant-supported prostheses. J Appl Oral Sci. 2008 Mar-Apr;16(2):116-21. doi: 10.1590/s1678-77572008000200007.
PMID: 19089202
citation: Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.
PMID: 31747030
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Yin-Hwa Shih
investigator title: Assistant professor
mesh term: Malnutrition
sharing ipd: No